Monographs on selected medicinal plants of ghana launched by the ministry of health




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MONOGRAPHS ON SELECTED MEDICINAL PLANTS OF GHANA LAUNCHED BY THE MINISTRY OF HEALTH

Introduction

One of the key challenges to the development of African traditional Medicine is that it has not been written down let alone codifying and standardizing it into a body of knowledge or into a single compendium for its official protection, development or study. The knowledge has been passed on by oral tradition from generation to generation but a considerable amount of the knowledge has now reached the public domain by way of individuals who are willing to share the knowledge, and through research and scientific publications. This was made possible partly due to community education, the activities of researchers and Ethno-medical anthropologists. Through training of traditional medicine practitioner, there has been increased understanding and goodwill between indigenous health practitioners and modern bio-medical scientist although part of traditional medicine knowledge is still held as secret between very few close family members. There is however, enough knowledge in the public domain for research and development of potentially useful medicines. This development together with other factors such as the search for better and safer medicines, availability of scientific and technological capacity to harness indigenous knowledge, has brought about the resurgence of interest in herbal medicines in even the most highly industrialized countries. Paradoxically, in this area where Africa ought to have a comparative advantage, we have highly stigmatized herbal and natural medicine due to its association to some bad practices and magico-religious activities. There is also low application of technology, lack of data-bases and networks for scientific information and standard documents that would have driven medicines development and regulation.

However, contrary to opinion in many circles that traditional medicine lack good science, there are now abundant research works in herbal and natural medicine available locally and on the international scene. 350 reviewed documents have been identified by internet search engines as credible references. Since herbal medicine constitutes the largest aspect of traditional medicine, some compilations have been made on herbal medicines in the form of handbooks and publications, whilst others are in the form of data-bases that have been networked to registered experts.

The challenge to us in Africa and for that matter Ghana is to begin to compile this knowledge and scientific research works into books, compendia, and pharmacopoeia and on electronic data-bases. Attempts that have been made in Ghana include the following publications:



Publication

Author

Content

Year

Woody Plants of Ghana

Irvine

Botanical/ethno medical

1961

Useful Plants of Ghana

Abbiw

Botanical/ethno-medical

1990

Ghana Herbal Pharmacopoeia, Edn. 1

Consortium

Botanical/ethno-medical

1995

Floristic Studies in Ghana and Pharmacopoeia

CSIR

Botanical/ethno-medical

2001


Ghana Herbal Pharmacopoeia (Revised)

CSIR

Phytochemical/pharmacological

2007

African Herbal Pharmacopoeia

AU

Ethno-Medical/Botanical

1996

WHO Monographs on 26 Selected Medicinal plants Vol.1

WHO-HQ

Scientific Information

1996

WHO monographs on 30 Selected Medicinal Plants Vol. 2

WHO-HQ

Scientific Information

2002

What Are Monographs?

Monographs can be said to be a summary of scientific information on a single topic in medical science targeted towards informing medical professionals. These are usually compiled into encyclopedias, Medical Dictionaries, compendia of global repute and data-bases that are reviewed by experts. In the case of pharmaco-therapeutic chemicals and medicines, the monographs are compiled into pharmacopoeias and their presentation must necessarily include a description of the substance, in terms of physical and chemical properties, its identity and purity tests and methods for its derivation, standardization and use. The contents of monographs are usually presented in standardized or stereotyped formats. The profile of information included in monographs depends on their targeted usage.

Pharmacopoeia monographs usually focuses on standards specifications for evaluating the raw material and assay of the material from products derived from it. In Pharmacopoeia Monographs, experimental pharmacology, clinical data and information on medicinal products and formulations, spectral information are considered as additional information to standards or described as Extra-pharmacopoeia, Schedules and Annexes.

The Scope and Value of Pharmacopoeia Monographs

The standards in pharmacopoeias are targeted to inform manufacturers, bulk purchasers, drug regulators, standards specifications authorities, freight inspectors, and health professionals. Pharmacological and clinical information are however targeted to inform healthcare providers, medicine researchers and drug regulators. In other words, they are relevant for ensuring quality of raw material substances used in manufacture of medicines as well as the quality of manufactured products emanating from them. However pharmacopoeial monographs in themselves cannot produce quality assurance since they do not usually provide extra information on how the standards specified can be achieved. This would remain the experience of individual manufactures, technical experts and researchers. This is why manufacturer’s information and specifications are also as important. Monographs also are limited to cover the most essential or commonly used substances. For this reason, Limit tests for presence of micro-organisms, Pharmcokinetics and Bio-equivalence studies, have become part of WHO pre-qualification requirements and requirements of some standards authorities for approval of imports and manufacture of special medicines for programmed diseases of public health importance. These do not usually form part of pharmacopoeial standards and would remain the experience of specific reference laboratories and standards authorities.



Typical Format of Monographs Including Monographs on Medicinal Plants

Monographs on medicinal plants present peculiar challenges. There is the need to provide both the botanical description as well as the chemical characterization of the medicinal plants. Methods for standardization and bio-assays must necessarily be included. Below is a format for presenting Pharmacopoeial monographs of pure chemical compounds as compared to the format for presenting WHO and other Monographs on Medicinal Plants.



A Typical Monograph of Pure chemicals

From Beckett and Stenlake

Practical Pharmaceutical Chemistry


A Common Format for Monographs of Official Drug Preparations and Substances (e.g.Tabs, Caps): from Ajibola A. Olaniyi

Principles of Drug Quality Assurance and Pharmaceutical Analysis



Title (Approved name and Adopted Name)

Main Name

Structural Formula

Other Names

Molecular Formula and Weight

Chemical Name, graphic and Molecular Formula

Definition

Method of derivation and Purity Tests

Standard of Purity

Physical and Chemical Description

Physical characteristics

Solubility Profile in common solvents

Test For Verification and Identity (Including

Absorbance)



Identification ( By Scientific tests)

Limit Tests for Contaminants

Dissolution Rate (especially for tablets and capsules)

Physical Constants (e.g. Solubility, optical rotation and PH of a standard solution)

Uniformity of Content

Quantitative Evaluation of Purity

Methods of Assay of Strength

Storage Conditions

Storage and Labeling Requirements

Labeling Conditions

Actions and Uses

Regulatory Requirements

Usual Dose Ranges

Cautionary Notices

Dose-forms and Strengths Available

A Typical Herbal Pharmacopoeial Monograph WHO Monographs on Medicinal Plants

Structure



Based on Nigerian Herbal Pharmacopoeia And Ghana’s Herbal Pharmacopoeia, 2007

1. Title based on Approved International name or taxonomy

  1. Title by Approved Botanical Name




2. Common Name

  1. Definition

3. Local Names

  1. Synonym

4. Geographical Distribution

  1. Selected Vemacular Names

5. General Description of Plant

  1. Geographical Distribution

6. Ethno-medical Uses

  1. Description

7. Morphological parts Used as Drug and Definition

  1. Part of Plant Material of Interest

8. Description of Drug by Macroscopy

  1. Organoleptic Properties

9. Description of drug by Microscopy

  1. Microscopic characteristics

10. Chemical and bio-activity Profile

  1. Powdered Plant Material

11. Test for Identity and Purity

  1. General Identity Tests

12. Chromatographic Finger Printing as a quick standard assessment but other separation techniques may be uses e.g. TLC, HPLC

  1. Purity tests

13. Chemical Tests and Assays

  1. Chemical Assay including absorbance

14. Indications and Dosage

  1. 11. Major chemical Constituents

15. Contraindications/Adverse Effects/Precautions

  1. 12. Medicinal Uses (Clinical, Ethno medical, experimental)

16. Storage conditions

  1. 13. Pharmacology(Experimental, Microbiology, Toxicological and Clinical)

17 Posology

  1. Contraindications/adverse reactions

18 References

  1. Dosage Forms




  1. Posology




  1. references

Whilst the Nigerian Herbal Pharmacopoeia, like a typical pharmacopoeia monographs, focus on description, standards specifications and associated formularies, the Ghana Herbal Pharmacopoeia was formatted along the style of the WHO monographs which essentially composes of summaries of general scientific information, pharmacological and clinical information emanating from research and development and use of the product.

The Objectives of the Monographs on Medicinal Plants

The current monographs on medicinal plants are therefore not pharmacopoeia monographs and do not therefore emphasize on botanical descriptions, chemical assays and standards of raw materials. However, elaborate references have been given to other documents. Standards would be the emphases of the new West African Herbal Pharmacopeia which is being developed by WAHO- the West African Health Organization as common standard specifications for West African medicinal plants.

The emphasis of this current herbal monograph is to inform users of the Recommended List of Herbal Medicines for Primary Healthcare, which was launched along side the monographs, about pharmacological information, clinical data and expected adverse effects, proposed dose ranges and the related selected herbal products. Although the scientific information is on individual medicinal plants composing the list of products, it generally predicts the performance and expected side effects of the combination products which have been judged by the Food and Drugs Board to be stable and safe to use. The information is to guide the proposed pilot official use of approved herbal medicines in public hospital facilities and selected private herbal clinic facilities which may be accredited to operate under the National Health Insurance Scheme. The proposal is currently receiving the highest consideration by the Health Sector and would be soon outdoored.

The Role of Pharmacists

The Medical Herbalists is a health professional or cadre, who has undertaken a four-year clinical programme in herbal medicine. They are expected to work under supervision as equivalent to Physician Assistants, to provide herbal medicine treatment services. Medical Doctors who have been oriented in herbal medicine would supervise this new carrier pathway. The Director General of Ghana Health Service (GHS) has directed that herbal medicine services may be established as separate units within GHS facilities. However, in order to separate the diagnosis and management functions from dispensing, the hospital pharmacy and community pharmacies, should be sufficiently prepared to produce, procure, store and dispense herbal medicines. The pharmacy should also serve as information resource for herbal medicines. The Monographs on herbal medicines and the Recommended Formulary of herbal medicines, together with the Ghana Herbal Pharmacopoeia, The Food and Drugs Board Drug Register and other data-bases, would be an invaluable resource to the success of this programme for the official inclusion of herbal medicines in healthcare delivery and the National Health Insurance Scheme. Pharmacists in the selected centres, which would be dedicated as pilots, may contact the National Drug Information Centre, The Chief Pharmacist, the Pharmacy Council Offices or the Pharmaceutical Society Office, for further information and to procure copies of the Monographs and Herbal Formulary. The Traditional and Alternative Medicine Directorate of the Ministry of Health would stand-by to support this process.



Conclusion

It would be useful to re-state that herbal medicine practice that would be mainstreamed into healthcare would and should be backed by good science. The WHO since the year 2002 has been pursuing a strategy towards institutionalizing procedures for the safety, efficacy, access and rational use of herbal medicines under structured regulatory, legislative and administrative frameworks. The Ministry of Health is at the verge of piloting the establishment of herbal medicine units in both selected accredited herbal and public health clinics and hospitals. To this end all efforts are being made to obtain a network of information on herbal medicine research in country and from data-bases in other countries in order to continually update the system.

Let us discuss what would make such a health system continually functional and how it can help curb other excesses in herbal medicine practice, at the next publication of this journal.

Attached is a monograph on Cassia alata from the Monographs on Medicinal Plants that was launched, for the perusal of the reader.


Cassia alata

Botanical name


Cassia alata

Local name(s)


Osempe; Duawusu (Twi); asenti (Ga-Adangbe); agbobladzoe (Ewe)

Chemical constituents


Anthraquinones, flavonoid, glycosides; essential fatty acids, protein; minerals (e.g. calcium, magnesium, sodium, manganese and zinc) ((Yadav and Kalidhar 1994; Mora et al 1991; Ukhun and Ifebigh 1988; Gupta and Singh 1991)).

Suggested method of standardisation


As indicated earlier by Nyarko et al in the Harmonized Procedures for Assessing the Safety, Efficacy and Quality of Plant Medicines in Ghana and from other pharmacopoeal monographs.

Pharmacology

Experimental pharmacology

Hexane fractions of C. alata caused a marked cytotoxic effect on breast cancer, urinary bladder cancer and colon cancer cell lines in a dose dependent manner (Olarte et al 2006).

An extract of the leaves of C. alata and kaempferol 3-0-sophoroside, a polyphenolic constituent of the plant, exhibited significant analgesic effect in vivo (Palanichamy 1988; Palanichamy and Nagarajan 1990). Palanichamy et al (1988) also studied the anti-diabetic effect of the leaf extract in streptozotocin-induced hyperglycemic rats and obtained results comparable to that of glibenclamide. The extract had no effect on glucose levels in normoglycemic animals. The leaf extract also showed antifungal activity in vitro (Palanichamy and Nagarajan, 1990), probably due to the presence of chrysophanol (Chopra et al 1956). Antibacterial activity of the crude extracts of C. alata has been demonstrated in-vitro (Limsong et al 2004). Crude ethanol and water extract of leaves and barks from C. alata possessed anti-candida activity. Results were comparable to standard antifungal drug (Somchit et al 2003). A 10-year human study indicates that the leaf extract can be used to treat Pityriasis versicolor with no side-effects (Damodaran and Venkataraman 1994). The methanol extracts of leaves, flowers, stem and root barks of Cassia alata showed a broad spectrum of antibacterial activity (Khan et al 2001). Ethanolic leaf extract exhibited high activity against various species of derrnatophytic fungi but low activity against non-dermatophytic fungi. Bacterial and yeast species, however, showed resistance against in vitro treatment with the extract (Ibrahim and Osman 1995). Topical administration of ointments made with ethanolic extracts of leaves of Senna alata, Lantana camara and Mitracarpus scaber on chronic crusty or acute lesions of dermatophilosis, induces healing of the disease infected animals treated without recurrence (Ali-Emmanuel et al 2003). Leaves of C. podocarpa Guill. and Perr. and of senna had identical laxative potency (Elujoba et al 1989).


Medicinal uses

Traditional system/folk medicine

Treatment of skin diseases (e.g. ringworm, eczema, chronic pruritis, itching); constipation; bronchitis and asthma; liver diseases and gastrointestinal problems snake-bite; scorpion-sting; leprosy; wounds (Chopra et al 1956; Kirtikar and Basu 1975; Dey and Bahadur 1973; Dey and Bahadur 1973; Perry 1980) and in (Bokemo 1984; Ibrahim and Osman 1995; Palanichamy and Nagarajan 1990; Khan et al 2001).
Uses as described in pharmacopoeia

Abortifacient; antibacterial; antifungal; choleretic; digestive; diuretic; febrifuge; hypoglycaemic; insect repellent; insecticidal; laxative; purgative; vermifuge (Assane, 1993; (GHP, 1992); for the treatment of ascites; constipation; craw-craw, dermatitis; dhobey-itch; dystocia; eczema; gonorrhoea; leprosy; mycosis; parturition; ringworm; shingles; stomach ache; tattoo; tinea (Mshana et al 2000; GHP 1992).
Uses supported by experimental or clinical data

Antidiabetic; antifungal; antibacterial; analgesic; laxative

Precautions and toxicology


Seeds of C. pordocarpa are claimed to produce toxic symptoms by ingestion unless it is steam fried. (GHAFTRAM sources-Ghana ). Toxicity is suspected to result from a toxoalbumin cell content which is denatured by heat. (WAHO Presentation)). Short-term (upto 6-8 weeks) external application is preferred. Other uses are to be supported by expert advice, in small doses and for short periods. Toxicity in animals is exhibited by loss of appetite and ematiation (Sodipo et al. Nigeria).

Contraindications


Pregnancy and lactation; intestinal obstruction; inflammatory bowel disorders; idiopathic abdominal pains; haemorrhoids; colitis; ulcer.

Adverse effects


Long-term use may cause electrolyte loss and pigmentation of the intestinal mucosa. Extracts may cause nausea and vomiting in large doses.

Dosage form


Tincture; infusion (tea); decoction

Posology or recommended dose


Infusion (hot or cold): the dried pods or leaves should be steeped in warm water for 6-12 hours; 1 tsp in ca. 150 ml of water; filter after 10 minutes; drink one cup in the morning and/or before going to the bed (BHC, 1992)

Powder: 1-2 g in 150 ml of water (as purgative)

Tincture: 1:5 in 50% alcohol; take 2-4 ml before bedtime (http://holistic-online.com/Herbal-Med/_Herbs/ h205.htm).

References


  1. Ali-Emmanuel N, Moudachirou M, Akakpoc JA, Quetin-Leclercq J (2003). Treatment of bovine dermatophilosis with Senna alata, Lantana camara and Mitracarpus scaber leaf extracts. Journal of Ethnopharmacology 86 (2003) 167–171

  2. Assane M, (1993) Choleretic effects of Cassia alata Linn in the rat. Dakar Med.; 38(1): 73-77

  3. Bokemo W (1984). Les plantes antilepreuses de Kisangani, Haut Zaire. Bulletin Royal Society Belgium 117, 305-311.

  4. Bradley PR, ed. (1992). British Herbal Compendium. Bournemouth (UK): British Herbal Medicine Association; 1, 199.

  5. Chopra RN, Nayar SL and Chopra IC (1956). Glossary of Indian Medicinal Plants. Council of Scientific and Industrial Research, New Delhi, p. 54.

  6. Damodaran S, Venkataraman S (1994). A study on the therapeutic efficacy of Cassia alata, Linn. leaf extract against Pityriasis versicolor. Journal of Ethnopharmacology 42, 19-23.

  7. Dey KL, Bahadur R (1973) The Indigenous Drugs of India, 2nd Edn. Pama Primlane Publishers, New Delhi, 70.

  8. Elujoba AA, Ajulo OO, Iweibo GO (1989). Chemical and biological analyses of Nigerian Cassia species for laxative activity. Journal of Pharmaceutical and Biomedical Analysis, 7(12): 1453-1457.

  9. Ghana Herbal Pharmacopoeia (1992). The Advent Press: Accra, Ghana; 4-6

  10. Gupta D, Singh J (1991). Flavonoid glycosides from Cassia alata. Phytochemistry 30:2761-2763.

  11. http://holistic-online.com/Herbal-Med/_Herbs/ h205.htm.

  12. Ibrahim D, Osman H (1995). Antirnicrobial activity of Cassia alata from Malaysia. Journal of Ethnopharmacology 45, 151-156

  13. Khan MR, Kihara M, Omoloso AD (2001). Antimicrobial activity of Cassia alata. Fitoterapia 72, 561-564.

  14. Kirtikar KR, Basu BD (1975) Indian Medicinal Plants Vol. II, 2nd Edn. Jayyed Press, Delhi, pp. 870 - 872.

  15. Limsong J, Benjavongkulchai E, Kuvatanasuchati J (2004). Inhibitory effect of some herbal extracts on adherence of Streptococcus mutans. Journal of Ethnopharmacology 92, 281–289

  16. Morah FNI, Otumu HE (1991). Cassia alata seeds constituents. Jamaican Journal of Sciences and Technology 2, 14-16.

  17. Mshana, N.R., Abbiw, D.K., Addae-Mensah, I., Ahiyi, M.R.A. et al., (2000). Traditional medicine and pharmacopoeia. Contribution to the revision of Ethnobotanical and Floristics Studies of Ghana. Organisation of African Unity/Scientific, technical and research committee.

  18. Ogunti EO, Elujoba AA (1993). Laxative activity of Cassia alata. Fitoterapia 64, 437-439.

  19. Olarte EI, Herrera AA, Villasenor IM, Jacinto SD (2006). Selective cytotoxicity of an isolate from Cassia alata L. leaves. Poster Abstracts - Experimental Therapy. Cancer Prevention 59.

  20. Palanichamy S, Nagarajan S (1990). Analgesic activity of Cassia alata leaf extract and kaemperol 3-O-sophoroside. Journal of Ethnopharmacology 29, 73-78

  21. Palanichamy S and Nagarajan S (1990). Antifungal activity of Cassia alata leaf extract. Journal of Ethnopharmacology 29, 337-340.

  22. Palanichamy S, Bhaskar EA, Bakthavathsalam R, Nagarajan S (1991). Wound healing activity of Cassia alata. Fitoterapia 62, 153-156.

  23. Palanichamy S, Nagarajan S, Devasagayam M (1988). Effect of Cassia alata leaf extract on hyperglycemic rats. Journal of Ethnopharmacology 22, 81-90.

  24. Palanichamy S (1988). Cassia alata: A Study of its Pharrnacognosy. Phytochemistry, Pharmacology and Formulation. Ph.D. Thesis, Bharathidasan University Tiruchirapalli, India.

  25. Perry LM (1980). Medicinal plants of East and Southeast Asia: attributed properties and uses. Cambridge, Massachusetts and London: The MIT Press, 209.

  26. Yadav SK, Kalidhar SB (1994). Alquinone: An Anthraquinone from Cassia alata. Planta Medica 60(6): 601.

  27. Somchit MN, Reezal I, Nur IE, Mutalib AR (2003). In vitro antimicrobial activity of ethanol and water extracts of Cassia alata. Journal of Ethnopharmacology 84, 1-4.

  28. Ukhun ME, Ifebigh EO (1988). Compositional Chemistry of Cassia alata Seeds. Food Chemistry 30, 205-210.

Foot notes:

Some Combination Products

  1. Ako Herbal Tonic 5. Joy Ointment

  2. Hayaat Tonic 6. Nobi Cream

  3. Odo Pee Ointment 7. Megyefo Cream

  4. Chocho Cream 8. Mayah Herbal Soap



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