The Use Of Quality Control Parameters In The Evaluation Of Vegetable Crude Drugs

Project and Seminar Material for Pharmaceutical Science

Project and Seminar Material for Pharmaceutical Science


Abstract


Medicinal plants constitute a source of raw material for both traditional system of medicine and modern medicine. Herbal medicines (both crude and processed) have the potential for improving public health at low cost and comparison with modern medicines, the occurrence of undesirable side effects seems to be less frequent. In most countries herbal products are launched in to the market without proper scientific evaluation and any mandatory safety, toxicological studies. This study was therefore aimed at investigating the use of quality control parameters in the evaluation of vegetable crude drugs. Adopting a regulatory mechanism will help ensure that herbal medicines have acceptable quality, safety and efficacy. The WHO guidelines for the assessment of herbal medicines should be consulted when assessment for vegetable crude medicines are being prepared.

Quality control for the safety and efficacy of herbal drug is essential. The quality control of phyto-pharmaceuticals may be defined as the status of a drug, which is determined either by identity, purity, drug contents and other physico-chemical properties and biological parameters or by the manufacturing process. Quality assurance of herbal medicinal product is not only the responsibility of manufacturers but also the regulatory bodies. The assurance of the safety of an herbal drug requires monitoring of the quality of the consumer information on the herbal remedy.

 


Table Of Content


Preliminary Page(s)

  • Title
  • Declaration
  • Approval
  • Dedication
  • Acknowledgement
  • Abstract
  • Table of Content

Chapter One

1.0 Introduction

  • 1.1 Background Of The Study
  • 1.2 Statement Of Problem
  • 1.3 Aims And Objectives Of The Study

Chapter Two

2.0 Literature Review

  • 2.1 Herbal Medicine
  • 2.2 Standardization Of Botanical Herbs And Quality Of Botanical Preparations
  • 2.3 Conventional Method For Standardization Of Herbal Formulation
  • 2.4 Current Regulations For Standardization Of Crude Drugs
  • 2.5 Standardization And Quality Control Parameters For Evaluation Of Herbal Crude Drugs
  • 2.6 Purity Determination
  • 2.7 World Health Organization (Who) Guidelines For Quality Standardized Herbal Formulations
  • 2.8 Quality Control Of Crude Materials

Chapter Three

3.0 Research Methodology

  • 3.1 Research Design
  • 3.2 Data And Sources
  • 3.3 Data Analysis

Chapter Four

4.0 Results

  • 4.1 Regulation Of Herbal (Vegetable Crude) Medicines
  • 4.2 Need Of Quality Control In Regulation Of Herbal Drugs
  • 4.3 Need Of Quality Assurance In Regulation Of Herbal Drugs
  • 4.4 Parameters For Quality Control Of Herbal Drugs

Chapter Five

5.0 Summary And Conclusion

  • 5.1 Summary
  • 5.2 Conclusion
  • References

Chapter One


1.0 Introduction

1.1 Background Of The Study

The universal role of plants in the treatment of disease is exemplified by their employment in all the major systems of medicine irrespective of the underlying philosophical premise. How and when such medicinal plants were first used ,is, in many cases, lost in pre-history, indeed animals other than man , appear to have their own materia medica (Prajapati, et al., 2003). Nevertheless, it can be said with certainty that vegetable kingdom already existed when man made his appearance on earth. As man began to acquire closure acquaintance with his environment, he began to know more about plants, as these were the only curative agents he had. As he progressed and evolved, he was not only able to sort out which plants could be eaten, but also began to associate curative characteristics with certain plants.

The World Health Organization (WHO, 1978) estimated that 4 billion people(80%) of the world population presently use herbal medicine for one form of primary health or another. Early human recognised their dependence on nature for a healthy life and since that time, humanity has depended on the diversity of plant resources for food, clothing, shelter, and medicines to cure myriads of ailments. However, man did not require the modern methods of investigation to collect for himself a materia medica of plants which he often used in conjunction with magical and other ritual practices. It is interesting to reflect that such collection of herbal medicines compiled over centuries by trial and error, and presumably using the patient as the experimental animal throughout, must surely contain some materials worthy of further investigation and should not be too readily discarded.

Medicinal plants are of great value in the field of treatment and cure of disease. Over the years, scientific research has expanded our knowledge of the chemical effects and composition of the active constituents which determine the medicinal properties of plants. It has now been a universally accepted fact that the plant drugs and remedies are far more safe than synthetic medicines for curing complex diseases. Large numbers of alkaloids, glycosides, and antibiotics have been isolated, identified and used as curative agents. In the western world, as people are becoming aware of the potency and side effects of synthetic drugs, there is an increasing interest in the plant based remedies with a basic approach towards the nature. The future development of Pharmacognosy as well as herbal drug industry would be largely dependent upon the reliable methodologies for identification of marker compounds of the extracts, and also upon the standardization and quality control of these extracts.


1.2 Statement Of Problem

The quality control of phytopharmaceuticals may be defined as the status of a drug, which is determined either by identity, purity, content, and other chemical, physical or biological properties, or by the manufacturing process. Quality control is based on three important pharmacopeial definitions:

Identity:

Is the herb the one it should be?

Purity:

Are there contaminants, e.g., in the form of other herbs which should not be there?

Content or assay:

Is the content of active constituents within the defined limits?

Little more needs to be said about the present day importance of medicinal plants for it will be apparent to know that the plant themselves either in the form of crude drugs or even more important for the medicinally active materials isolated from them have been and always will be an important aid to physician in the treatment of disease.


1.3 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 Five


5.0 Summary And Conclusion

5.1 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.


5.2 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.


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