The Use of Quality Control Parameters in the Evaluation of Vegetable Crude Drugs
CHAPTER ONE
AIMS AND OBJECTIVES OF THE STUDY
The objective of this study is to determine the use of quality control parameters in the evaluation of vegetable crude drugs.
CHAPTER TWO
LITERATURE REVIEW
HERBAL MEDICINE
An herb is a plant or part of a plant valued for its medicinal, aromatic, or savoury qualities. Herbs can be viewed as biosynthetic chemical laboratories, producing a number of chemical compounds. Herbal remedies or medicines consist of portions of plants or unpurified plant extracts containing several constituents, which often work together synergistically. As per WHO definition, there are three kinds of herbal medicines: raw plant material, processed plant material and medicinal herbal products. Herbal drugs are finished labelled products that contain active ingredients such as aerial or underground parts of plant or other plant material or combination thereof, whether in the crude state or as plant preparations. Herbal medicine or herbalism is the use of herbs or herbal products for their therapeutic or medicinal value. They may come from any part of the plant but are most commonly made from leaves, roots, bark seeds, and flowers. They are eaten, swallowed, drunk, inhaled, or applied topically to the skin. Herbal products often contain a variety of naturally-occurring biochemicals from plants, many of which contribute to the plant’s medicinal benefits. Chemicals known to have medicinal benefits are referred to as “active ingredients” or “active principles” and their presence depends on a number of factors including the plant species, the time and season of harvest, the type of soil, the way the herb is prepared. Herbal medicines may contain excipients in addition to the active ingredients.
Medicines containing plant material combined with chemically defined active substances, including chemically defined, isolated constituents of plants are not considered to be herbal medicines. Exceptionally, in some countries herbal medicines may also contain, by tradition, natural organic or inorganic active ingredients which are not of plant origin”. (Copper, et al., 1986).
The use of herbal medicines has increased remarkably in line with the global trend of people returning to natural therapies. Herbal medicine products are dietary supplements that people take to improve their health and are sold as tablets, capsules, powders, teas, extracts and fresh or dried plants. Herbals are traditionally considered harmless and increasingly being consumed by people without prescription. However, some can cause health problems, some are not effective and some may interact with other drugs. To avoid confusion with culinary herbs, herbs and plant extracts that have some association with medicinal uses are called “Herbal Medicinal Products”.
CHAPTER THREE
RESEARCH METHODOLOGY
RESEARCH DESIGN
This study made use of the qualitative research design. This design has to do with expository analysis using secondary data and qualitative tools of analysis. This is mostly used in the case where primary data through the use of questionnaires cannot be used or is not relevant to the topic under consideration. This design is suitable for this study as it involves review of peer articles, journals and publications as it relates to the use of quality control parameters in the evaluation of vegetable crude drugs.
DATA AND SOURCES
The data used for this study were mostly secondary data sourced from secondary sources. These include the use of scholarly articles, journals, publications and previous research work related to the use of quality control parameters in the evaluation of vegetable crude drugs.
CHAPTER FOUR
RESULTS
REGULATION OF HERBAL (VEGETABLE CRUDE) MEDICINES
Each country or area should adopt a regulatory system to manage the appropriate use of herbal medicines. National regulation and registration of herbal medicines vary from country to country. Adopting a regulatory mechanism will to ensure that herbal medicines have acceptable quality, safety and efficacy (WHO 1998). The regulatory herbal medicines are may be categorized as either prescription or non prescription medicines. If trade in a particular herbal product is made between countries where different regulatory status is given, reclassification of the regulatory status in the importing country not only depends on the nature or characteristics of the product itself, but on the regulatory frame work of the importing country (WHO 2004). The WHO guidelines for the assessment of herbal medicines should be consulted when assessment process for herbal medicines are being prepared.
CHAPTER FIVE
SUMMARY AND CONCLUSION
SUMMARY
The quantitative determination of constituents has been made easy by recent developments in analytical instrumentation. Recent advances in the isolation, purification, and structure elucidation of naturally occurring metabolites have made it possible to establish appropriate strategies for the determination and analysis of quality and the process of standardization of herbal preparations. Classification of plants and organ- isms by their chemical constituents is referred to as chemotaxonomy. TLC, HPLC, GC, quantitative TLC (QTLC), and high-performance TLC (HPTLC) can deter- mine the homogeneity of a plant extract (Ebel S, 1987). Over-pressured layer chromatography (OPLC), infrared and UV-VIS spectrometry, MS, GC, liquid chromatography (LC) used alone, or in combinations such as GC/MS, LC/MS, and MS/MS, and nuclear magnetic resonance (NMR), are powerful tools, often used for standardization and to control the quality of both the raw material and the finished product. The results from these sophisticated techniques provide a chemical fingerprint as to the nature of chemicals or impurities present in the plant or extract.
CONCLUSION
Herbal (vegetable crude) medicines have the potential for improving public health at low cost. Phyto-medicines, if combined with preventive medical practice, could be a cost- effective, practical way to shift modern health care from treatment to prevention. Quality control for efficacy and safety of herbal products is of utmost importance. The assurance of the safety of a herbal drug requires monitoring of the quality of the finished product as well as the quality of the consumer information on the herbal remedy.
REFERENCES
- Akerele O. Summary of WHO guidelines for the as- sessment of herbal medicine. HerbalGram.1993; 28:13-19.
- AOAC. Official methods of analysis of AOAC Interna- tional, 18thedn. AOAC International, Guaithersburg, MD, 2005; 28.
- Bauer R, Tittel G. Quality assessment of herbal prepa- rations as a precondition of pharmacological and clinical studies. Phytomedicine. 1996;2:193-198.
- Boumans P.W.J.M. Inductively coupled plasma emis- sion Spectroscopy part 1. John Wiley &sons, New Yark, 1999.
- De smet P.A.G.M, Keller K, Hansel R, Chandler R.F. Ad- verse Effects of Herbal drugs, vol.1. Spinger-verlag, Heidelberg. 1992.
- De Smet PAGM. Overview of herbal quality control. Drug Inf. J. 1999; 33:717 – 724.
- Ebel S, Gigalk HJ, Voelkl S. AMDHPTLC Analysis of Me- dicinal Plants. Proceedings of 4th Intrenational sym- posium of Instrumental HPTLC, Selvino/Bargamo at Italy. 1987; 113.
- EMEA. Guidelines on Quality of herbal medicinal prod- ucts. European Agency for the Evaluation of medi- cinal products (EMEA), Landon, 1998.
- EMEA. Points to consider on good agricultural and collection practice for starting materials of herbal origin. EMEA/HMPWP/31/99 review. European agency for the evaluation of medicinal plants (EMEA), London, 2002.
- Europien Pharmacopiea,3rd edn. Strasbourg council of Europe, 1996.