ABSTRACT. NiprisanR is an herbal medicine for sickle cell anemia developed in
the National Insti... more ABSTRACT. NiprisanR is an herbal medicine for sickle cell anemia developed in the National Institute for Pharmaceutical Research and Development (NIPRD). It is prepared from pepper seeds [Piper guineense Schum. & Thonn., Piperaceae], clove flower buds [Eugenia caryophyllata Thunb., Myrtaceae], caprium stem [Pterocarpus osun (L.) Craib., Fabaceae], sorghum leaves [Sorghum bicolor (L.) Moench. Poaceae], and “trona” The components were sourced from food dealers and herbalists prequalified as suppliers by the Institute’s department of Medicinal Plant Research and Traditional Medicine (MPRTM), based on the criteria proposed by World Health Organization (WHO, 1998. Quality control methods for medicinal plant materials, pp. 1–115. Geneva: WHO) for the collection and handling of medicinal plant materials. The aim of the work is to establish limits for features that will influence decisions on the components. The paper describes and quantifies as per WHO guidelines of 1998 and British Pharmacopoeia (British Pharmacopoeia, 2004. Volume IV. The Stationery Office Limited, London. Appendix II D, Atomic spectrophotometry: emission and absorption, pp. A143-145. Determination of pH, pp. A143-145; Appendix VL, Determination of pH Values, pp. A199-A200, 2004.), the most striking features of these components and demonstrates that all, except Eugenia caryophyllata, exist in more than one variety. The results, including the occasional presence of lead in trona, are discussed in the context of good manufacturing practice (GMP). KEYWORDS normative study, NiprisanR , herbal medicine, sickle cell anemia, good manufacturing practice
ABSTRACT. In the West, sugar-based, ginger flavored beverages may contain hops,
other flavorings,... more ABSTRACT. In the West, sugar-based, ginger flavored beverages may contain hops, other flavorings, fruit juices, and varying levels of ethanol. Ginger ales contain 0.5%v/v; ginger beers>0.5%; and alcoholic ginger beers 0.5 ≤ 11%. Ales are carbonated by pressurized CO2, while beers and alcoholic beers are carbonated by yeast or ginger beer plant (GBP). In Africa, grain-based beverages include “fura da nono,” “kunu,” and “akamu,” which are spiced with one or more flavorings including ginger, black pepper, clove, chili pepper, or Aframomum alligator peppers. Spices have flavor because they contain essential oils (EOs), which are composed of aroma-active compounds (AACs). The benefits and toxicities of spices are ascribed to their EOs/AACs contents. Aim: Given the toxic potentials of EOs/AACs vis- ` a-vis their benefits, this review aimed to investigate the means by which the levels of EOs/AACs in spiced beverages are regulated. Methodology: The benefits and liabilities of key EOs/AACs of spices were identified and described. The methods for assaying them in raw materials and beverages were also identified. Results: There was a dearth of data on the levels of EOs/AACs in both raw and finished goods. Moreover, their assay methods were found to be tedious and costly. The implications of these findings on regulation are discussed. Conclusions: Owing to the practical difficulties in assaying flavors in beverages, both manufacturers and regulators should focus on: (i) the wholesomeness of raw materials; and (ii) good manufacturing practice (GMP). However, studies aimed at developing more robust methods for flavor should continue. KEYWORDS. Aroma-active compound (AAC), Beverage, Clove, Essential oil (EO), Flavor, Ginger, Hops, Pepper
The genus Gladiolus (Family: Iridaceae) has 260 species of a perennial herb. In West Africa the c... more The genus Gladiolus (Family: Iridaceae) has 260 species of a perennial herb. In West Africa the corms of Gladiolus species are used in food and Traditional Medicine, often in combination with other plant materials. This study aimed at verifying the basis for the use of these corms in both instances. Aqueous extracts of the corms obtained in Benue State, Nigeria, were tested for antimicrobial effects; and screened for key phytochemicals. Antimicrobial effects were evaluated by measuring the diameters of inhibition zones on agar plates, using clinical isolates of the bacteria: Escherichia coli, Pseudomonas aeruginosa, Staphylococcus aureus and Listeria monocytogenes; and the fungi: Candida albicans, Aspergillus niger and Trichophyton mentagrophyte. The results showed that the extracts, at concentrations of 75 – 400 mg of the plant material per mL of water, were active against Pseudomonas aeruginosa and Aspergillus niger, but relatively inactive against the others. The extracts contained alkaloids, tannins, saponins, cardiac glycosides, flavonoids and carbohydrates, but attempts at TLC separation were only marginally successful. The somewhat selective antimicrobial effects of the extracts do however; suggest the basis for the use of these corms. But the presence of cardiac glycosides - a cardiotoxin, calls for caution in their use. Key words: Gladiolus, corm, iridaceae, antimicrobial, food processing, traditional medicine, phytochemicals, Benue State.
Iridaceae, of which Gladiolus is a genus, comprises of 260 species of a perennial herb. In West A... more Iridaceae, of which Gladiolus is a genus, comprises of 260 species of a perennial herb. In West Africa Gladiolus corms are used in food and ethnomedicines for infections, often in combination with other plant materials. The aim of this study is to verify and estimate if the corms have any antimicrobial activities; and to carry out basic phytochemistry of the corms, with a view to gaining some insight into the scientific basis for the use of this plant material in West African Traditional Medicine. In the study aqueous extracts of the Gladiolus corm obtained in Benue State of Nigeria, were tested for antimicrobial effects; and screened for key phytochemicals. Antimicrobial effects were evaluated by measurement of inhibition zones on agar plates using the bacteria, Escherichia coli, Pseudomonas aeruginosa, Staphylococcus aureus and Listeria monocytogenes; and the fungi, Candida albicans, Aspergillus niger and Trichophyton mentagrophyte. The results showed that the extracts were active against Pseudomonas aeruginosa and Aspergillus niger, but relatively inactive against the other microbes; and contain alkaloids, tannins, saponins, cardiac glycosides, flavonoids and carbohydrate. Separation of the constituents was attempted by thin layer chromatography using various solvent systems. The results confirm the scientific basis for the ethnomedical use of Gladiolus corms in West Africa, and are discussed within the context of their economic exploitation. Prospects for more advanced work on the material are also briefly discussed. However, the presence of cardiac glycosides in Gladiolus corm calls for caution in its use. KEYWORDS:Ethnomedical,Gladiolus,Corm, Iridaceae,WestAfrica,Antimicrobial, phytochemical
It is established that many more people are reverting to the use of traditional herbal medicines,... more It is established that many more people are reverting to the use of traditional herbal medicines, especially in the US, where the practice declined partly due to the influential Flexner Report of 1910 that was critical of alternative remedies including herbal. The hope advanced by Erhlich’s chemotherapy or magic bullet in 1909, did pretty much the same to European classical herbalism. In Asia, where Traditional Medicine (TM) enjoys a long history and patronage, the practice is waxing even stronger as millions of non-Asians embrace Traditional Chinese Medicine (TCM) and Indian Ayurvedic Medicine (IAM). However, in most of the Third World, where TM patronage is up to 80% of the population, a more complex situation exists, because: (1) while increasing use of TMs in the West resulted from changing preferences, the endemic high patronage in the Third World resulted from chronic poverty and (2) drug regulators in the Third World (where innovative laws are most needed but least well articulated) lack the resources to properly address the nuances of phytotherapy, the way the US and Europe did in 1994 and 2004, respectively. In particular, the literature revealed the sore need for a fresh global look at the whole subject of herbal clinical trials. When are herbal clinical trials (HCTs) required? When are HCTs probably uncalled for? Clear answers are needed, because: many herbal remedies patronized in the West originate from the Third World, where drug regulators, in their zeal for Western Medicine, have not quite seen why the US and Europe opted to fine-tune their laws on herbal products in 1994 and 2004. This review attempts to bring to the open for discussion and resolution the lingering misunderstanding of the place of clinical trials in herbal drug development, especially among bioprospectors/ sponsors of drug development, researchers and regulators in the Third World.
We noted earlier [1] that 1978 was the turning point in current public perception of traditional
... more We noted earlier [1] that 1978 was the turning point in current public perception of traditional medicine (TM) following the famous WHO declaration at Alma-Ata. That declaration ushered in a positive attitude that paved the way for the present global popularity of TM, especially herbal medicine. We noted earlier also [2,3] that whereas herbal remedies are called dietary supplements in the US, thereby shifting emphasis away from their medicinal attributes, the Dietary Supplement Health Education Act of 1994 [4], which occasioned the shift, actually helped to promote herbal medicine in the US, albeit indirectly, through the innovative provision it made for user information [5,6]. A similar situation obtained in Europe, where the net effect of the laws and rules passed in 2004 on herbal remedies had been to promote their production and use [7, 8]. In terms of trade and economics of herbal drugs, the following fact is notable: Although, Asia contributed only US$ 7.3 billion to herbal world trade in 1999 [9], by 2005, a mere 6 years, China’s contribution alone rose to US$ 14 billion [10]. This stupendous growth was due to policies and programmes that favoured herbal medicine – the cornerstone of Traditional Chinese Medicine (TCM). Similar situations as in China held sway in Japan, South Korea and the Indian sub-continent, where government policies also favoured herbal medicine. However, in many developing countries like Nigeria, a totally different picture obtained, not because policies were expressly against herbal medicine, but in these countries there had been a lingering absence of proper policies and laws supportive of traditional remedies. Another key fact on the political economy of herbal drugs is that: Although, about 80% of people in developing countries depended on herbs, these countries contributed only 7.2% to herbal drug trade in 1999. By contrast, the developed nations, where people relied less on herbs, contributed 55.2%. Asia, less Japan and South Korea, contributed 37.6%. Equally interesting is the comparison of Brazil with Nigeria. Both are rich in medicinal plants and have high populations that depend substantially on herbs. But, while herbs contributed an unknown amount to the Nigerian economy in 2007, in Brazil it contributed US$ 160 million. By contrast, Nigeria’s entire federal budget for health in 2007 was a mere US$ 800 million [2]. These findings earlier led us [11,12] to conclude that developing countries need strategies that will enhance the regulation of herbal drugs and promote their trade. The present article is an attempt to enunciate one of such strategies. It is particularly of note that the superior performance of Brazil in comparison with Nigeria indicates that with proper policies and strategies, herbs can indeed contribute substantially to any economy.
Background. Patients in West Africa where sickle cell anemia (SCA) is endemic have for ages been ... more Background. Patients in West Africa where sickle cell anemia (SCA) is endemic have for ages been treated with natural products, especially herbs, as, is still the case in rural communities. Objective. In this paper we look closely at some of these herbs to see if there are any lessons to be learnt or clues to be found for optimizing the treatments based on them, as had been done in the case of NIPRISAN, which was developed from herbs in Nigeria based on Yoruba Medicine. Methods. Select publications on SCA, its molecular biology and pathology, and actual and experimental cases of herbal treatment were perused in search of molecular clues that can be linked to chemical constituents of the herbs involved. Results. The study revealed that during the last 2-3 decades,much progress was made in several aspects of SCA pharmacology, especially the approval of hydroxyurea. As for SCA herbalism, this paper revealed that antisickling herbs abound inWest Africa and that the most promising may yet be found. Three new antisickling herbs (Entandrophragma utile, Chenopodium ambrosioides, and Petiveria alliacea) were reported in May 2011. At NIPRD, where NIPRISAN was developed, three other recipes are currently awaiting development. Conclusion. The study raised the hope that the search in the Tropics for more effective herbal recipes for managing sickle cell anaemia will be more fruitful with time and effort.
Niprisan is a dry extract preparation of five components: the seeds of Piper guineense; flower bu... more Niprisan is a dry extract preparation of five components: the seeds of Piper guineense; flower buds of Eugenia caryophyllata; stem parts of Pterocarpus osun; leaf stalk of Sorghum bicolor and trona. The product was developed in our Institute from a traditional recipe used in Nigeria for treating sickle cell crises. This study aims to provide for the components, the following specifications: foreign matter; loss on drying; total ash; and water extractable matter, using the methods prescribed by the WHO (1998) for quality control of medicinal plant materials. The trona was analyzed with methods adapted from BP (2004). The results suggest the existence of one variety of E. caryophyllata; but two varieties of S. bicolor and trona, differing in loss on drying; and two varieties of P. guineense and P. osun, differing in both total ash and water extractable matter. The implications of the results for good manufacturing practice are discussed. Key words: Standardization, specifications, components, niprisan, phytomedicine, sickle cell disease
Traditional medicine (TM) as practiced in Nigeria is involved with the management of diseases suc... more Traditional medicine (TM) as practiced in Nigeria is involved with the management of diseases such as (HIV/AIDs), malaria, tuberculosis, diabetes mellitus, hypertension, fungal infections, and cancerous growths among others. Diabetes mellitus is a universal health problem affecting human societies at all stages of development. The prevalence of diabetes mellitus has been increasing steadily in Nigeria and this trend might be attributed to expensive and un- accessible anti diabetic drugs, negative lifestyles and genetic makeup, among other reasons. Most sufferers have therefore resulted to consulting traditional medical practitioners (TMPs) to manage their health conditions. Currently there are no available data on the role and status of traditional medicine practice in the management on diabetes mellitus in Nigeria. A survey was therefore conducted in November 2009 to document the status of traditional medicine practice involved in the management of diabetes mellitus in six geographical zones of the country. Data was collected by oral interviews of over 70 TMPs and their responses documented in a specially designed questionnaire. This paper intends to highlight the results obtained from the survey with the aim of providing a better understanding of TM practice and availability of necessary statistics to aid the promotion, standardization and integration of the practice into national health care system. Key words: Traditional medical practice, diabetes mellitus, medicinal plants, survey.
Abstract- Halofantrine (Hf) is a poorly water-soluble drug for treating malaria in endemic areas ... more Abstract- Halofantrine (Hf) is a poorly water-soluble drug for treating malaria in endemic areas like tropical Africa, where caffeine-containing products are habitually consumed. Previous reports showed that caffeine increased the aqueous solubility of Hf at room temperature over 3 days. The aim of this study was to determine the effect of caffeine and caffeine-containing beverages on dissolution and solubility of Hf and to investigate any possible interactions. The aqueous solubility and dissolution of Hf alone and in the presence of caffeine was investigated at pH 1.3, 5.9 and 7.4 using standard methods. The solubility of Hf in the presence of aqueous extracts of cocoa, coffee, black tea and green tea at pH 5.9 was also investigated. In 1 hour, caffeine markedly increased the aqueous solubility of Hf at pH 1.3, 5.9 and 7.4. Caffeine and caffeine-containing beverages markedly increased the aqueous solubility of Hf by between 100- to more than 1600- fold, with a 1672-fold increase by caffeine (from 76.6 ±7.8 ng/mL to128.2 ± 4.5 mg/mL) at pH 5.9. The dissolution of Hf tablets at pH 1.3, 5.9 and 7.4 showed the respective amounts released as 3.57 ± 0.09, 0.95 ± 0.19 and 0.260 ± 0.043 mg, but introduction of caffeine increased these values to 9.51 ± 0.23, 3.70 ± 0.12 and 0.52 ± 0.10 mg respectively, representing 3-fold, 4-fold and 2-fold respectively. Keywords: caffeine, halofantrine, physicochemical interaction.
Purpose: To develop a novel ultraviolet (UV)–spectrophotometric method for the determination of
d... more Purpose: To develop a novel ultraviolet (UV)–spectrophotometric method for the determination of dihydroartemisinin (DHA) in tablets using p-nitroaniline (PNA) as a derivatizing agent. Methods: Derivatization was based on the reaction between methanol solutions of dihydroartemisinin (DHA) and p-nitroaniline (PNA) in acid medium (1M HCI) at elevated temperature and for a short reaction time. Optimal detector response was obtained within 15 min when the reaction was carried out at 90 0C in a molar ratio of 2:1 (DHA:PNA). The method used for analysis was validated and a linear calibration curve constructed in the range of 30 – 100 μg/mL for the reaction mixture at an absorbance of 290 nm. Results: Separation of adduct from PNA was better achieved on reversed phase thin layer chromatography (TLC) using acetonitrile : water (60:50) or on high performance liquid chromatography (HPLC) with retention times of 2.8 min for PNA and 5.8 min for the adduct. The limit of detection was 6 μg/mL. The method was precise and accurate in the range 100.70 - 100.96 %, with intraday and interday precisions of less than 2 % at concentrations of 40 and 80 μg/mL, respectively. The new method was applied to the assay of two brands of dihydroartemisinin tablets with accuracy similar to that of the International Pharmacopoeia (IP) UV-spectrophotometric method (p > 0.05). Conclusion: The derivatization method is simple, direct, devoid of dilutions and inexpensive in terms of reagent requirements and analyte volume, and has a shorter reaction time, cpmpared with IP method. Based on the foregoing, the method can be adopted as an alternative to the official assay method for routine quality control of dihydroartemisinin tablets. Keywords: Derivatization, Ultraviolet spectrophotometry, Dihydroartemisinin, p-Nitroaniline, Analysis, Assay, Quality control
Introduction: An “aroma-active compound” (AAC) has a “flavor”- ie: a “distinct taste and
odor”. A... more Introduction: An “aroma-active compound” (AAC) has a “flavor”- ie: a “distinct taste and odor”. An example is menthol. All aromatic plants (APs), including some medicinal plants, such as Mentha×piperita (Family Lamiaceae), produce a group of fat-soluble secondary metabolites called “essential oils” (EOs) for various ecophysiological reasons. An EO has a “flavor” because it contains one or more AACs. A typical EO is a complex mixture of several AACs, with wide ranging, dose-dependent pharmacological/ toxic effects. Owing to their complexity and variability, many EOs need to be standardized to ISO’s criteria. Professional use of EOs/ AAPs in food and drugs is controlled by good manufacturing practice (GMP). Aim: Given the immense diversities in sources, chemical structures, and bioactivities of EOs/ AACs, which are greatly patronized in foods and drugs, this review focused on their: i) sources in plants, beneficial attributes and liabilities; and ii) chemistry and analytical methods, in order to gain a better insight into their regulation in foods and drugs. Methodology: Using the 2009 Angiosperm Phylogenic Grouping (APG) of plants as a guide, pertinent literature was perused to ascertain: i) the taxa of APs; ii) their EOs/ AAPs; and iii) the methods for analyzing EOs/ AACs in raw materials (RMs) and finished products (FPs). Results: The literature revealed scores of AACs with varying health implications. But their levels in samples are usually unknown, or extremely hard to ascertain, owing to costs and complexities of the methods used. Conclusions: Given the wide ranging effects of EOs/ AAPs vis-à-vis the dearth of data on their levels in samples, it is recommended that their regulation in FPs should focus on: i) controlling the wholesomeness of RMs; and ii) on enforcing strict GMP in using such RMs. Meanwhile relevant agencies should sponsor research into more cost-effective methods. Keywords: Aroma-active compound (AAC); drug, essential oil (EO); flavor; food; good manufacturing practice (GMP); international organization for standardization (ISO) analytical method; regulation.
Background: The World Health Organization (WHO) recommended that the toxicity data
of a tradition... more Background: The World Health Organization (WHO) recommended that the toxicity data of a traditional medicine (TM) product that has been in use for 20 years or more without untoward effects should be determined, as the first step in its research and development (R&D). Such data in conjunction with efficacy data would be used to develop an appropriate dosage form of the product. A key objective in researching such a product is to validate the basis of the therapy, including the formula. Such validation, and any attempt to modernize the product, should be guided by an understanding of the traditional know-how. The Nigerian National Institute for Pharmaceutical Research and Development (NIPRD) utilized this approach in developing Niprisan, an antisickling drug, based on a TM product used since antiquity in Yoruba Medicine. Aim: This article aimed to advocate the continuance and improvement of the WHO model of herbal drug research and regulation (HDRR) as the most logical approach for adoption by researchers and regulators. Methodology: NIPRD’s adoption of the WHO model since 1989 was reviewed in parallel with trends in herbal drug research worldwide; and within the contexts of regulatory practices by Nigeria’s National Agency for Food and Drug Administration and Control (NAFDAC) and the European Medicines Evaluation Agency (EMEA), with a view to identifying more effective strategies within the WHO paradigm for HDRR. Conclusion: Drug regulatory agencies (DRAs) like NAFDAC require effective laws, policies and quality management systems (QMS) to execute their mandates effectively. On the other hand, NIPRD’s output depends upon proper actions by a seasoned and responsive DRA. Therefore, noting that NIPRD and NAFDAC were both created by military decrees in 1989 and 1992 respectively, rather than by parliament acts, it is recommended that in addition to instituting more effective laws and policies to regulate NAFDAC, both NIPRD and NAFDAC need to adopt and implement suitable QMS for self-regulation, eg: ISO 9001 for whole organizations; and ISO/IEC 17250 for the laboratories. Keywords: Traditional medicine (TM); product; toxicity data; dosage form; research; development; regulation; drug regulatory agency (DRA)
annually worldwide. Effective treatment of TB has been hampered by the emergence of drug resistan... more annually worldwide. Effective treatment of TB has been hampered by the emergence of drug resistant strains of Mycobacterium tuberculosis. The global resurgence of TB and the development of multidrugresistant tuberculosis (MDR TB) and extensively drug-resistant tuberculosis (XDR-TB), call for the development of new anti-tuberculosis drugs to combat this disease. Plant natural products have a proven global history of treating diseases and ailments. This review aims to provide a situation report of on-going global efforts to discover and develop anti-TB drugs from plants, including plants found within Nigeria's rich flora. For two decades, studies on different families and genera of the plant kingdom have shown the great potential of plants as antimycobacterial agents. These motifs, including those from within Nigeria's flora, are discussed. Chemists, biochemists and molecular biologists have also employed technological developments in separation methods, hyphenated techniques, high throughput assays and microarray analysis, to drive the drug discovery process. Nigeria, and indeed, Africa, needs to look inwards to solve the burden of tuberculosis, by tapping on its rich biodiversity, which the continent is endowed with. There is need for the government to be committed and actively fund anti-tuberculosis research.
Quality system is defined as arrangements, procedures, processes and resources; and the
systemati... more Quality system is defined as arrangements, procedures, processes and resources; and the systematic actions necessary to ensure that a manufactured product will meet given specifications. On the other hand, quality control is defined as measures taken, including sampling and testing, to ensure that raw materials, intermediates, packaging materials and finished goods conform to given specifications. Quality specification refers to a written procedure and requirements that a raw material, intermediate or finished good must meet for approval. On the other hand, standard operating procedure (SOP) refers a written procedure, giving step-by-step directions on how a particular operation is to be carried out. Quality manual means, a document that describes the various elements of the system used in assuring the quality of results or products generated by a laboratory or factory. The term quality assurance refers to the totality of all the arrangements made with the objective of ensuring that products are of the quality required for their intended use. Good manufacturing practice (GMP), on the other hand, is that aspect of quality control that deals directly with manufacturing and testing of raw materials, intermediates and finished goods to ensure a product of consistent quality. Essentially, GMP involves two types of control - analytical and inspection, and both require: i) clear instructions for every manufacturing process; ii) a means of controlling and recording every manufacturing process; iii) a means of ensuring that the complete history of a batch can be traced; iv) a mechanism for recalling any batch of product from circulation; v) a system for attending to complaints on quality of product or service; and vii) a programme for training operators to carry out and to document procedures. The foregoing definitions and description of GMP conform to those of WHO (2000). It is also clear from the foregoing that GMPs are not prescriptive instructions on how a manufacturer can produce, but are rather a series of principles that must be observed for quality products, services or results to emerge. Invariably, GMPs are approved and enforced by an appropriate National Agency.
The evidence for using the root of Nauclea latifolia S.M. (Rubiaceae) in treating malaria in Afri... more The evidence for using the root of Nauclea latifolia S.M. (Rubiaceae) in treating malaria in Africa; and the development of Niprd AM1, as an antimalarial phytomedicine from it, are reviewed. This study aimed at paving the way for the registration and controlled production of Niprd-AM1, which was developed by National Institute for Pharmaceutical Research and development (NIPRD), Abuja, Nigeria. The study applied official procedures to authenticate and evaluate the changes that occur during normal storage in the physicochemical variables of the herb and extract. The herb contained alkaloids, saponins, terpenoids, but cardiac and cyanogenic glycosides and anthraquinones were not detected. Heavy metal presence was well below the limits allowed. Most of the quality variables evaluated, including TLCs, remained largely unchanged up to the 39 month of storage, but a few began to decline as from the 21st month. The results are consistent with NIPRD’s intention to regularize the production and use of Niprd-AM1 according to good pharmaceutical practice (GXP), and suggest that the dried herb and extract are stable under tropical room conditions for over a year in sealed glass containers. Keywords: Niprd-AM1; Nauclea latifolia; Antimalarial; Physicochemical; Stability; Good pharmaceutical practice (GXP).
CONAVIR® is an immunostimulant phytomedicine developed at the National Institute for Pharmaceutic... more CONAVIR® is an immunostimulant phytomedicine developed at the National Institute for Pharmaceutical Research and Development, Abuja. The paper describes the steps taken and the results obtained in the attempt to develop specifications for the herbal component – the aerial parts of Andrographis paniculata Ness (Family: Acanthaceae), grown in the Institute’s gardens. The said steps are vital for production as per good manufacturing practice. Qualitative and quantitative tests on the fresh and airdried materials were carried out as prescribed in standard texts. Quantitative results on the dried herb included: bitterness value, 2.86 ± 1.74 x 103 units per g; loss on drying, 10.64 ± 0.36 %w/w; total ash, 14.10 ± 4.49 %w/w; acid insoluble ash, 1.00 ± 0.06 %w/w; and water extractable matter, 30.37 ± 2.63 %w/w. Tests for phytochemicals revealed the presence of glycosides, saponins, tannins and alkaloids, but not of anthraquinones. Normal phase thin layer chromatography of the aqueous or ethanolic extract gave 5 spots, while the reverse phase of the same extracts gave 6. These results, including macroscopic and sensory examinations of the fresh herb, provided the quantitative and descriptive data needed for identifying and characterizing the herbal component of CONAVIR®. Key words: Conavir, immune-booster, phytomedicine, specifications, herbal component, Andrographis paniculata, Acanthaceae, good manufacturing practice (GMP).
This article aimed at evaluating inter-regional differences in herbal drug policies, with a view ... more This article aimed at evaluating inter-regional differences in herbal drug policies, with a view to influencing such policies towards a more vibrant approach that will promote the registration, production and clinical trial of herbal remedies worldwide. The review drew attention to the impact of different national policies on the status and movement of herbal remedies in the world market and revealed a striking paradox - that about 80% of people in developing countries depended on herbs, but contributed only 7.2% to the trade in 1999. By contrast, the developed nations, where people relied less on herbs, contributed 55.2%. Asia, less Japan and South Korea, contributed 37.6%. Equally interesting is the comparison of Brazil with Nigeria. Both are rich in biodiversity and have high populations that depend substantially on herbs. However, while herbs contributed an unknown amount to the Nigerian economy in 2007, in Brazil it contributed US$ 160 million - a whopping 20% of Nigeria’s federal budget for health ($800 million) in 2007. These findings led us to conclude that developing countries need strategies that will promote herbal medicine. The comparison of Brazil with Nigeria revealed that with proper strategies herbal drugs can indeed contribute substantially to any economy. Key words: Nigeria, phytotherapy, inter-regional differences, research, policy, development, developing countries, developed countries, herbal medicine.
Purpose: To characterize the aerial parts of Andrographis paniculata, a bitter Indian herb grown ... more Purpose: To characterize the aerial parts of Andrographis paniculata, a bitter Indian herb grown in Nigeria, for the purpose of quality control. Methods: The determination of bitterness value and of various physicochemical characteristics; tests for key phytochemicals; and thin layer chromatography (TLC) of the air-dried herb, were carried out as prescribed in standard texts. Results: The mean bitterness value of the herb for both men and women was 2.86 ± 1.74 x 103 units per g. The male value (2.07 ± 1.42 x 103) appeared to be lower than the female’s (3.52 ± 1.82 x 103) but the difference was not statistically significant. The results (% w/w) of loss on drying (10.64 ± 0.36), total ash (14.10 ± 4.49), water extractive value (30.37 ± 2.63) and acid insoluble ash (1.00 ± 0.06) were similar to those reported for the Asian plant. The phytochemical tests revealed the presence of glycosides, saponins, tannins and alkaloids, but not of anthraquinones. Normal phase TLC of the drug yielded 5 spots as against 6 spots yielded by reverse TLC. Conclusion: The results provide useful quantitative and descriptive data that are essential for identifying and characterizing the Nigerian grown herb for the purpose of quality control; and confirm key similarities between the Nigerian and the Asian plant. Keywords: Andrographis paniculata, Quality control, Bitterness value, Physicochemical, Phytochemical, Chromatography.
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Papers by Sunday Ameh
the National Institute for Pharmaceutical Research and Development (NIPRD). It is
prepared from pepper seeds [Piper guineense Schum. & Thonn., Piperaceae], clove
flower buds [Eugenia caryophyllata Thunb., Myrtaceae], caprium stem [Pterocarpus
osun (L.) Craib., Fabaceae], sorghum leaves [Sorghum bicolor (L.) Moench.
Poaceae], and “trona” The components were sourced from food dealers and herbalists
prequalified as suppliers by the Institute’s department of Medicinal Plant Research
and Traditional Medicine (MPRTM), based on the criteria proposed by World Health
Organization (WHO, 1998. Quality control methods for medicinal plant materials, pp.
1–115. Geneva: WHO) for the collection and handling of medicinal plant materials.
The aim of the work is to establish limits for features that will influence decisions on
the components. The paper describes and quantifies as per WHO guidelines of 1998
and British Pharmacopoeia (British Pharmacopoeia, 2004. Volume IV. The Stationery
Office Limited, London. Appendix II D, Atomic spectrophotometry: emission and
absorption, pp. A143-145. Determination of pH, pp. A143-145; Appendix VL, Determination
of pH Values, pp. A199-A200, 2004.), the most striking features of these
components and demonstrates that all, except Eugenia caryophyllata, exist in more than one variety. The results, including the occasional presence of lead in trona, are
discussed in the context of good manufacturing practice (GMP).
KEYWORDS normative study, NiprisanR , herbal medicine, sickle cell anemia,
good manufacturing practice
other flavorings, fruit juices, and varying levels of ethanol. Ginger ales contain 0.5%v/v;
ginger beers>0.5%; and alcoholic ginger beers 0.5 ≤ 11%. Ales are carbonated by pressurized
CO2, while beers and alcoholic beers are carbonated by yeast or ginger beer
plant (GBP). In Africa, grain-based beverages include “fura da nono,” “kunu,” and
“akamu,” which are spiced with one or more flavorings including ginger, black pepper,
clove, chili pepper, or Aframomum alligator peppers. Spices have flavor because they
contain essential oils (EOs), which are composed of aroma-active compounds (AACs).
The benefits and toxicities of spices are ascribed to their EOs/AACs contents. Aim:
Given the toxic potentials of EOs/AACs vis- ` a-vis their benefits, this review aimed to
investigate the means by which the levels of EOs/AACs in spiced beverages are regulated.
Methodology: The benefits and liabilities of key EOs/AACs of spices were identified
and described. The methods for assaying them in raw materials and beverages were
also identified. Results: There was a dearth of data on the levels of EOs/AACs in both
raw and finished goods. Moreover, their assay methods were found to be tedious and
costly. The implications of these findings on regulation are discussed. Conclusions: Owing
to the practical difficulties in assaying flavors in beverages, both manufacturers and
regulators should focus on: (i) the wholesomeness of raw materials; and (ii) good manufacturing
practice (GMP). However, studies aimed at developing more robust methods
for flavor should continue.
KEYWORDS. Aroma-active compound (AAC), Beverage, Clove, Essential oil
(EO), Flavor, Ginger, Hops, Pepper
Gladiolus species are used in food and Traditional Medicine, often in combination with other plant materials.
This study aimed at verifying the basis for the use of these corms in both instances. Aqueous extracts of the
corms obtained in Benue State, Nigeria, were tested for antimicrobial effects; and screened for key
phytochemicals. Antimicrobial effects were evaluated by measuring the diameters of inhibition zones on agar
plates, using clinical isolates of the bacteria: Escherichia coli, Pseudomonas aeruginosa, Staphylococcus
aureus and Listeria monocytogenes; and the fungi: Candida albicans, Aspergillus niger and Trichophyton
mentagrophyte. The results showed that the extracts, at concentrations of 75 – 400 mg of the plant material per
mL of water, were active against Pseudomonas aeruginosa and Aspergillus niger, but relatively inactive against
the others. The extracts contained alkaloids, tannins, saponins, cardiac glycosides, flavonoids and
carbohydrates, but attempts at TLC separation were only marginally successful. The somewhat selective
antimicrobial effects of the extracts do however; suggest the basis for the use of these corms. But the presence
of cardiac glycosides - a cardiotoxin, calls for caution in their use.
Key words: Gladiolus, corm, iridaceae, antimicrobial, food processing, traditional medicine, phytochemicals,
Benue State.
for infections, often in combination with other plant materials. The aim of this study is to verify and estimate if the corms have
any antimicrobial activities; and to carry out basic phytochemistry of the corms, with a view to gaining some insight into the
scientific basis for the use of this plant material in West African Traditional Medicine. In the study aqueous extracts of the
Gladiolus corm obtained in Benue State of Nigeria, were tested for antimicrobial effects; and screened for key
phytochemicals. Antimicrobial effects were evaluated by measurement of inhibition zones on agar plates using the bacteria,
Escherichia coli, Pseudomonas aeruginosa, Staphylococcus aureus and Listeria monocytogenes; and the fungi, Candida
albicans, Aspergillus niger and Trichophyton mentagrophyte. The results showed that the extracts were active against
Pseudomonas aeruginosa and Aspergillus niger, but relatively inactive against the other microbes; and contain alkaloids,
tannins, saponins, cardiac glycosides, flavonoids and carbohydrate. Separation of the constituents was attempted by thin
layer chromatography using various solvent systems. The results confirm the scientific basis for the ethnomedical use of
Gladiolus corms in West Africa, and are discussed within the context of their economic exploitation. Prospects for more
advanced work on the material are also briefly discussed. However, the presence of cardiac glycosides in Gladiolus corm
calls for caution in its use.
KEYWORDS:Ethnomedical,Gladiolus,Corm, Iridaceae,WestAfrica,Antimicrobial, phytochemical
medicine (TM) following the famous WHO declaration at Alma-Ata. That declaration
ushered in a positive attitude that paved the way for the present global popularity of TM,
especially herbal medicine. We noted earlier also [2,3] that whereas herbal remedies are
called dietary supplements in the US, thereby shifting emphasis away from their medicinal
attributes, the Dietary Supplement Health Education Act of 1994 [4], which occasioned the
shift, actually helped to promote herbal medicine in the US, albeit indirectly, through the innovative
provision it made for user information [5,6]. A similar situation obtained in Europe,
where the net effect of the laws and rules passed in 2004 on herbal remedies had been
to promote their production and use [7, 8]. In terms of trade and economics of herbal drugs,
the following fact is notable: Although, Asia contributed only US$ 7.3 billion to herbal world
trade in 1999 [9], by 2005, a mere 6 years, China’s contribution alone rose to US$ 14 billion
[10]. This stupendous growth was due to policies and programmes that favoured herbal
medicine – the cornerstone of Traditional Chinese Medicine (TCM). Similar situations as in
China held sway in Japan, South Korea and the Indian sub-continent, where government
policies also favoured herbal medicine. However, in many developing countries like Nigeria,
a totally different picture obtained, not because policies were expressly against herbal
medicine, but in these countries there had been a lingering absence of proper policies and
laws supportive of traditional remedies. Another key fact on the political economy of herbal
drugs is that: Although, about 80% of people in developing countries depended on herbs,
these countries contributed only 7.2% to herbal drug trade in 1999. By contrast, the developed
nations, where people relied less on herbs, contributed 55.2%. Asia, less Japan and South Korea, contributed 37.6%. Equally interesting is the comparison of Brazil with Nigeria.
Both are rich in medicinal plants and have high populations that depend substantially on
herbs. But, while herbs contributed an unknown amount to the Nigerian economy in 2007,
in Brazil it contributed US$ 160 million. By contrast, Nigeria’s entire federal budget for
health in 2007 was a mere US$ 800 million [2]. These findings earlier led us [11,12] to conclude
that developing countries need strategies that will enhance the regulation of herbal
drugs and promote their trade. The present article is an attempt to enunciate one of such
strategies. It is particularly of note that the superior performance of Brazil in comparison
with Nigeria indicates that with proper policies and strategies, herbs can indeed contribute
substantially to any economy.
especially herbs, as, is still the case in rural communities. Objective. In this paper we look closely at some of these herbs to see if
there are any lessons to be learnt or clues to be found for optimizing the treatments based on them, as had been done in the case
of NIPRISAN, which was developed from herbs in Nigeria based on Yoruba Medicine. Methods. Select publications on SCA, its
molecular biology and pathology, and actual and experimental cases of herbal treatment were perused in search of molecular clues
that can be linked to chemical constituents of the herbs involved. Results. The study revealed that during the last 2-3 decades,much
progress was made in several aspects of SCA pharmacology, especially the approval of hydroxyurea. As for SCA herbalism, this
paper revealed that antisickling herbs abound inWest Africa and that the most promising may yet be found. Three new antisickling
herbs (Entandrophragma utile, Chenopodium ambrosioides, and Petiveria alliacea) were reported in May 2011. At NIPRD, where
NIPRISAN was developed, three other recipes are currently awaiting development. Conclusion. The study raised the hope that the
search in the Tropics for more effective herbal recipes for managing sickle cell anaemia will be more fruitful with time and effort.
Eugenia caryophyllata; stem parts of Pterocarpus osun; leaf stalk of Sorghum bicolor and trona. The
product was developed in our Institute from a traditional recipe used in Nigeria for treating sickle cell
crises. This study aims to provide for the components, the following specifications: foreign matter; loss
on drying; total ash; and water extractable matter, using the methods prescribed by the WHO (1998) for
quality control of medicinal plant materials. The trona was analyzed with methods adapted from BP
(2004). The results suggest the existence of one variety of E. caryophyllata; but two varieties of S.
bicolor and trona, differing in loss on drying; and two varieties of P. guineense and P. osun, differing in
both total ash and water extractable matter. The implications of the results for good manufacturing
practice are discussed.
Key words: Standardization, specifications, components, niprisan, phytomedicine, sickle cell disease
Africa, where caffeine-containing products are habitually consumed. Previous reports showed that
caffeine increased the aqueous solubility of Hf at room temperature over 3 days. The aim of this study
was to determine the effect of caffeine and caffeine-containing beverages on dissolution and solubility of
Hf and to investigate any possible interactions. The aqueous solubility and dissolution of Hf alone and in
the presence of caffeine was investigated at pH 1.3, 5.9 and 7.4 using standard methods. The solubility of
Hf in the presence of aqueous extracts of cocoa, coffee, black tea and green tea at pH 5.9 was also
investigated. In 1 hour, caffeine markedly increased the aqueous solubility of Hf at pH 1.3, 5.9 and 7.4.
Caffeine and caffeine-containing beverages markedly increased the aqueous solubility of Hf by between
100- to more than 1600- fold, with a 1672-fold increase by caffeine (from 76.6 ±7.8 ng/mL to128.2 ± 4.5
mg/mL) at pH 5.9. The dissolution of Hf tablets at pH 1.3, 5.9 and 7.4 showed the respective amounts
released as 3.57 ± 0.09, 0.95 ± 0.19 and 0.260 ± 0.043 mg, but introduction of caffeine increased these
values to 9.51 ± 0.23, 3.70 ± 0.12 and 0.52 ± 0.10 mg respectively, representing 3-fold, 4-fold and 2-fold
respectively.
Keywords: caffeine, halofantrine, physicochemical interaction.
dihydroartemisinin (DHA) in tablets using p-nitroaniline (PNA) as a derivatizing agent.
Methods: Derivatization was based on the reaction between methanol solutions of dihydroartemisinin
(DHA) and p-nitroaniline (PNA) in acid medium (1M HCI) at elevated temperature and for a short
reaction time. Optimal detector response was obtained within 15 min when the reaction was carried out
at 90 0C in a molar ratio of 2:1 (DHA:PNA). The method used for analysis was validated and a linear
calibration curve constructed in the range of 30 – 100 μg/mL for the reaction mixture at an absorbance
of 290 nm.
Results: Separation of adduct from PNA was better achieved on reversed phase thin layer
chromatography (TLC) using acetonitrile : water (60:50) or on high performance liquid chromatography
(HPLC) with retention times of 2.8 min for PNA and 5.8 min for the adduct. The limit of detection was 6
μg/mL. The method was precise and accurate in the range 100.70 - 100.96 %, with intraday and
interday precisions of less than 2 % at concentrations of 40 and 80 μg/mL, respectively. The new
method was applied to the assay of two brands of dihydroartemisinin tablets with accuracy similar to
that of the International Pharmacopoeia (IP) UV-spectrophotometric method (p > 0.05).
Conclusion: The derivatization method is simple, direct, devoid of dilutions and inexpensive in terms of
reagent requirements and analyte volume, and has a shorter reaction time, cpmpared with IP method.
Based on the foregoing, the method can be adopted as an alternative to the official assay method for
routine quality control of dihydroartemisinin tablets.
Keywords: Derivatization, Ultraviolet spectrophotometry, Dihydroartemisinin, p-Nitroaniline, Analysis,
Assay, Quality control
odor”. An example is menthol. All aromatic plants (APs), including some medicinal plants,
such as Mentha×piperita (Family Lamiaceae), produce a group of fat-soluble secondary
metabolites called “essential oils” (EOs) for various ecophysiological reasons. An EO has a “flavor” because it contains one or more AACs. A typical EO is a complex mixture of
several AACs, with wide ranging, dose-dependent pharmacological/ toxic effects. Owing
to their complexity and variability, many EOs need to be standardized to ISO’s criteria.
Professional use of EOs/ AAPs in food and drugs is controlled by good manufacturing
practice (GMP).
Aim: Given the immense diversities in sources, chemical structures, and bioactivities of
EOs/ AACs, which are greatly patronized in foods and drugs, this review focused on their:
i) sources in plants, beneficial attributes and liabilities; and ii) chemistry and analytical
methods, in order to gain a better insight into their regulation in foods and drugs.
Methodology: Using the 2009 Angiosperm Phylogenic Grouping (APG) of plants as a
guide, pertinent literature was perused to ascertain: i) the taxa of APs; ii) their EOs/ AAPs;
and iii) the methods for analyzing EOs/ AACs in raw materials (RMs) and finished
products (FPs).
Results: The literature revealed scores of AACs with varying health implications. But their
levels in samples are usually unknown, or extremely hard to ascertain, owing to costs and
complexities of the methods used.
Conclusions: Given the wide ranging effects of EOs/ AAPs vis-à-vis the dearth of data
on their levels in samples, it is recommended that their regulation in FPs should focus on:
i) controlling the wholesomeness of RMs; and ii) on enforcing strict GMP in using such
RMs. Meanwhile relevant agencies should sponsor research into more cost-effective
methods.
Keywords: Aroma-active compound (AAC); drug, essential oil (EO); flavor; food; good
manufacturing practice (GMP); international organization for standardization
(ISO) analytical method; regulation.
of a traditional medicine (TM) product that has been in use for 20 years or more without
untoward effects should be determined, as the first step in its research and development (R&D). Such data in conjunction with efficacy data would be used to develop an
appropriate dosage form of the product. A key objective in researching such a product is to
validate the basis of the therapy, including the formula. Such validation, and any attempt to
modernize the product, should be guided by an understanding of the traditional know-how.
The Nigerian National Institute for Pharmaceutical Research and Development (NIPRD)
utilized this approach in developing Niprisan, an antisickling drug, based on a TM product
used since antiquity in Yoruba Medicine.
Aim: This article aimed to advocate the continuance and improvement of the WHO model
of herbal drug research and regulation (HDRR) as the most logical approach for adoption
by researchers and regulators.
Methodology: NIPRD’s adoption of the WHO model since 1989 was reviewed in parallel
with trends in herbal drug research worldwide; and within the contexts of regulatory
practices by Nigeria’s National Agency for Food and Drug Administration and Control
(NAFDAC) and the European Medicines Evaluation Agency (EMEA), with a view to
identifying more effective strategies within the WHO paradigm for HDRR.
Conclusion: Drug regulatory agencies (DRAs) like NAFDAC require effective laws,
policies and quality management systems (QMS) to execute their mandates effectively. On
the other hand, NIPRD’s output depends upon proper actions by a seasoned and
responsive DRA. Therefore, noting that NIPRD and NAFDAC were both created by military
decrees in 1989 and 1992 respectively, rather than by parliament acts, it is recommended
that in addition to instituting more effective laws and policies to regulate NAFDAC, both
NIPRD and NAFDAC need to adopt and implement suitable QMS for self-regulation, eg:
ISO 9001 for whole organizations; and ISO/IEC 17250 for the laboratories.
Keywords: Traditional medicine (TM); product; toxicity data; dosage form; research;
development; regulation; drug regulatory agency (DRA)
systematic actions necessary to ensure that a manufactured product will meet given
specifications. On the other hand, quality control is defined as measures taken, including
sampling and testing, to ensure that raw materials, intermediates, packaging materials and
finished goods conform to given specifications. Quality specification refers to a written
procedure and requirements that a raw material, intermediate or finished good must meet
for approval. On the other hand, standard operating procedure (SOP) refers a written
procedure, giving step-by-step directions on how a particular operation is to be carried out.
Quality manual means, a document that describes the various elements of the system used
in assuring the quality of results or products generated by a laboratory or factory. The term
quality assurance refers to the totality of all the arrangements made with the objective of
ensuring that products are of the quality required for their intended use. Good
manufacturing practice (GMP), on the other hand, is that aspect of quality control that deals
directly with manufacturing and testing of raw materials, intermediates and finished goods
to ensure a product of consistent quality. Essentially, GMP involves two types of control -
analytical and inspection, and both require: i) clear instructions for every manufacturing
process; ii) a means of controlling and recording every manufacturing process; iii) a means
of ensuring that the complete history of a batch can be traced; iv) a mechanism for recalling
any batch of product from circulation; v) a system for attending to complaints on quality of
product or service; and vii) a programme for training operators to carry out and to
document procedures. The foregoing definitions and description of GMP conform to those
of WHO (2000). It is also clear from the foregoing that GMPs are not prescriptive
instructions on how a manufacturer can produce, but are rather a series of principles that
must be observed for quality products, services or results to emerge. Invariably, GMPs are
approved and enforced by an appropriate National Agency.
The study applied official procedures to authenticate and evaluate the changes that occur during normal storage in the physicochemical variables of the herb and extract.
The herb contained alkaloids, saponins, terpenoids, but cardiac and cyanogenic glycosides and anthraquinones were not detected. Heavy metal presence was well below the limits allowed. Most of the quality variables evaluated, including TLCs, remained largely unchanged up to the 39 month of storage, but a few began to decline as from the 21st month.
The results are consistent with NIPRD’s intention to regularize the production and use of Niprd-AM1 according to good pharmaceutical practice (GXP), and suggest that the dried herb and extract are stable under tropical room conditions for over a year in sealed glass containers.
Keywords: Niprd-AM1; Nauclea latifolia; Antimalarial; Physicochemical; Stability; Good pharmaceutical practice (GXP).
Research and Development, Abuja. The paper describes the steps taken and the results obtained in the
attempt to develop specifications for the herbal component – the aerial parts of Andrographis
paniculata Ness (Family: Acanthaceae), grown in the Institute’s gardens. The said steps are vital for
production as per good manufacturing practice. Qualitative and quantitative tests on the fresh and airdried
materials were carried out as prescribed in standard texts. Quantitative results on the dried herb
included: bitterness value, 2.86 ± 1.74 x 103 units per g; loss on drying, 10.64 ± 0.36 %w/w; total ash,
14.10 ± 4.49 %w/w; acid insoluble ash, 1.00 ± 0.06 %w/w; and water extractable matter, 30.37 ± 2.63
%w/w. Tests for phytochemicals revealed the presence of glycosides, saponins, tannins and alkaloids,
but not of anthraquinones. Normal phase thin layer chromatography of the aqueous or ethanolic extract
gave 5 spots, while the reverse phase of the same extracts gave 6. These results, including
macroscopic and sensory examinations of the fresh herb, provided the quantitative and descriptive
data needed for identifying and characterizing the herbal component of CONAVIR®.
Key words: Conavir, immune-booster, phytomedicine, specifications, herbal component, Andrographis
paniculata, Acanthaceae, good manufacturing practice (GMP).
influencing such policies towards a more vibrant approach that will promote the registration,
production and clinical trial of herbal remedies worldwide. The review drew attention to the impact of
different national policies on the status and movement of herbal remedies in the world market and
revealed a striking paradox - that about 80% of people in developing countries depended on herbs, but
contributed only 7.2% to the trade in 1999. By contrast, the developed nations, where people relied less
on herbs, contributed 55.2%. Asia, less Japan and South Korea, contributed 37.6%. Equally interesting
is the comparison of Brazil with Nigeria. Both are rich in biodiversity and have high populations that
depend substantially on herbs. However, while herbs contributed an unknown amount to the Nigerian
economy in 2007, in Brazil it contributed US$ 160 million - a whopping 20% of Nigeria’s federal budget
for health ($800 million) in 2007. These findings led us to conclude that developing countries need
strategies that will promote herbal medicine. The comparison of Brazil with Nigeria revealed that with
proper strategies herbal drugs can indeed contribute substantially to any economy.
Key words: Nigeria, phytotherapy, inter-regional differences, research, policy, development, developing
countries, developed countries, herbal medicine.
Nigeria, for the purpose of quality control.
Methods: The determination of bitterness value and of various physicochemical characteristics; tests for
key phytochemicals; and thin layer chromatography (TLC) of the air-dried herb, were carried out as
prescribed in standard texts.
Results: The mean bitterness value of the herb for both men and women was 2.86 ± 1.74 x 103 units
per g. The male value (2.07 ± 1.42 x 103) appeared to be lower than the female’s (3.52 ± 1.82 x 103) but
the difference was not statistically significant. The results (% w/w) of loss on drying (10.64 ± 0.36), total
ash (14.10 ± 4.49), water extractive value (30.37 ± 2.63) and acid insoluble ash (1.00 ± 0.06) were
similar to those reported for the Asian plant. The phytochemical tests revealed the presence of
glycosides, saponins, tannins and alkaloids, but not of anthraquinones. Normal phase TLC of the drug
yielded 5 spots as against 6 spots yielded by reverse TLC.
Conclusion: The results provide useful quantitative and descriptive data that are essential for
identifying and characterizing the Nigerian grown herb for the purpose of quality control; and confirm key
similarities between the Nigerian and the Asian plant.
Keywords: Andrographis paniculata, Quality control, Bitterness value, Physicochemical, Phytochemical,
Chromatography.