Quality Control of Herbal Drugs

AUTHOR: Dr. Pulok K. Mukherjee
PUBLISHER: Business Horizons
ISBN: 9788190078849
YEAR: 2002 – First Edition, 2005, 2007, 2008 – Reprinted
PAGES: 800
SIZE: 18.5 X 25 X 4.2 cm.
BINDING: Hard
LANGUAGE: English

ABOUT THE BOOK: Therapeutic potentials of herbal drug ranges from parts of plants, through simple extracts to isolated active constituents. There has been a resurgence of interest on plants and plant derived products as a source of medicine in the last few decades. Herbal products have occupied a major part in curing different human ailments, but what about the quality of those products? Certain of these drugs have been known and are being used by man for many centuries, while others are still being isolated and evaluated. Dealing with natural products, the most vital and potent therapeutic importance is the medicinal plants - the noun is common, the adjective is common place and their juxtaposition introduces a concept that is not always easy to define, as it is the same for their quality and purity. Herbal drugs have become one of the totems in this era of phytotherapy. The medicinal plants have enormous commercial potentials throughout the globe. Along with the increased interest in herbal medicines, there has been an explosion in the amount of literature on the subject and quality control is of utmost essential in this respect the world over. In the herbal boom worldwide, it is estimated that high quality phyto-medicinals will provide safe and effective medication and scientists engaged therein will find this book most useful for their work for providing the necessary information in every respects.
This text is intended to present elements of both methods and theoretical backgrounds of different aspects on quality control and standardization of herbal drugs and formulations. More emphasis has been made on classical pharmacognostical and phytochemical approaches dealing with different aspects of quality control and standardization by virtue of new techniques and these have therefore been integrated. As the importance of adequate botanical, chemical and pharmacological evaluation of natural products used in different alternative systems of medicine is becoming increasingly widespread, even "Folk medicine" is being referred to as "Traditional medicine". In this respect, I hope that chemists/scientists will get some new guidelines and approaches on screening, evaluation, quality control and standardization of herbal drugs from different chapters of this book.
It is my belief that the information presented in this volume will have a considerable impact on the standardization profiles and quality control of botanicals having therapeutic potentials. Pharmacists, regulators, scientists and interested lay persons can no longer disregard the scientific and clinical evidences supporting herbal utility simply by claiming ignorance of data available in this field. The examples and evidences represented in this treatise strongly support the quality parameters as well as the different screening profiles of therapeutically important herbal drugs. This will facilitate to improve the concepts of the herbal medicines on one hand and increased usage of desirable standardized conventional drugs on the other hand. For far to long, the use of natural medicine in India as well as in other developing and developed countries has depended largely on folklore-traditional concepts.
Particularly in India, Ayurveda, Siddha, Unani etc. consists of large number of herbal remedies, being used from ancient times and having their potential therapeutic claims with their quality control specification no doubt. These medicaments however, suffer from lack of standardization parameters and proper documentation based on scientific screening procedures. Publication of this book will, without question, become a significant landmark, a milestone of achievements, in the development of phytomedicines and its wide application of human health.
An effort has been made to highlight the various developments taking place at a steady growth of the subject. The significant modern approaches have been described in various chapters including evaluation and quality control of herbal drugs with WHO guidelines and other official monographs. Various parameters on quality control including good agricultural practice, pharmacological and antimicrobial screening procedures have been included in different chapters. Specific chromatographic analysis procedures for some selected plants based on marker compound analysis have also been included.
In the Appendixes, the addresses of different organizations along with internet websites of various organizations related to herbal drugs have been included. Some useful references on the standardization profiles of the herbal drugs will definitely be useful for the research workers and chemists to have a handy tool to proceed with different facets of herbal drugs standardization and quality control.
Thus there has been an exhaustive attempt put forward to provide the pharmacists in general and the academics /industrial chemists/ research and development scientists in particular to proceed with different aspects of herbal products. The bibliographical details are indicative rather than extensive and it is intended for readers who want more. Thus a balanced view on different features of the traditional and modern aspects of standardization and quality control of natural products have been made and hope that the text will provide the readers with an accurate update on different aspects of quality control and standardization on herbal drugs and formulations.

The most exhaustive and comprehensive book ever available on the subject.
    • Safety and Toxicity in Herbal Drugs
    • Ethnobotany in Drug Evaluation
    • Macro-Morphographical Studies
    • Development of Standardization Parameters
    • Phytoconstituents and Their Analysis
    • Extraction of Herbal Drugs
    • TLC - Detailed Procedures and Guidelines
    • HPTLC - Densitometry
    • Pharmacological Screening of Herbal Drugs
    • Good Agricultural and Harvesting Practices
    • Quality Assurance and Stability Testing of Herbal Drugs
    • Analytical Profiles of Selected Medicinal Plants
        Plus Annexed Information
        Additional References
        Internet Resources for further information
        International Associations/Organizations

You Need This Book If You Are:
    • Grower of medicinal herbs
    • Wholesaler/Distributor
    • Manufacturer of Herb Extracts
    • Manufacturer of Herbal Formulations
    • Researcher
    • Academician
    • Regulatory Affairs Specialist

ABOUT THE AUTHOR: Dr. Pulok K. Mukherjee (Ph.D. Pharmacy) is a renowned personality in the field of Herbal Drug Research and is presently working at The Department of Pharmaceutical Technology, Jadavpur University, Kolkata (India). He is involved in research on screening, isolation, formulation, evaluation and standardization of botanicals. He has been awarded the Career Award for Young Teachers from AICTE and BOYSCAST Fellowship from DST, Ministry of Science and Technology (Govt, of India). He has to his credit over 100 research papers published in various Indian and international journals of repute and one patent. He is on the editorial board of Phytotherapy Research (a reputed international journal) and attended numerous phytomedicine conferences (and chaired some sessions) around the world. He is an active member of different international organizations including Drug Information Association (DIA), USA, International Society of Ethnopharmacology (ISE), Phytochemical Society of Europe (PSE) etc. He has worked at the Leiden/Amsterdam Center for Drug Research, The Netherlands and interacts with international experts in the field of pharmacognosy on a regular basis.

CONTENTS:
Foreword
Preface

Part - I: Introduction
ALTERNATIVE SYSTEMS OF MEDICINE
    1. Historical Overview of Indian System of Medicine
    2. Ayurveda – The Ancient Traditional Medicine
    3. Siddha System of Medicine
    4. Unani System of Medicine
    5. Homeopathic Remedies
    6. Tibetan System
    7. Natural Products from Modern Medicine
    8. Quality Control in Traditional Systems of Medicine
    9. Limitations of Traditional Experience
    10. Role of Traditional System of Medicine in Primary Health Care
    11. World Situation on Traditional Medicine
    12. Traditional Chinese Herbal Medicine and it’s Evaluation
    13. Development of Traditional System of Medicine in India
    14. Prospects of Traditional Medicine
    15. References
HERBAL REMEDIES – TOXICITY AND REGULATIONS
    1. Importance of Herbal Therapies
    2. Herbals versus Conventional Drugs
    3. Efficacy of Herbal Medicinal Products
    4. Validation of Herbal Therapies
    5. Safety in Herbal Drugs
    6. Toxicity in Herbals and Their Interactions
    7. Adverse Reactions and Safety in Herbal Medicine
    8. General Concepts of Evaluation and Quality Control
    9. Pharmacodynamic and Pharmacokinetic Issues
    10. Assessment by Drug Regulators
    11. Herbal Drug Regulations in India
    12. Basic and Applied Research
    13. Bioassay-Guided Separation and Structural Characterization
    14. References
ETHNOBOTANY AND ETHNOPHARMACOLOGY
    1. Ethnobotany in Herbal Drug Evaluation
    2. Impact of Ethnobotany in Traditional Medicine
    3. The Extent of Plant Kingdom in Medicine
    4. Ethnopharmacology in Drug Evaluation
    5. New Developments in Herbals
    6. Biological Diversity – Role in Herbal Drug Development
    7. Drug Discovery from Natural Products
    8. Issues in Medicinal Plant Research
    9. References

Part II - Quality Control Techniques
ADULTERATION AND DETERIORATION
    1. Introduction
    2. Types of Adulteration or Substitution of Herbal Drugs
    3. Causes and Measures for Adulterations
    4. Deterioration of Herbal Drugs
    5. Control Measures for Deterioration
    6. References
FACTORS AFFECTING HERB QUALITY
    1. Introduction
    2. Quality Standards of Herbal Products
    3. Factors Relating To Quality of Herbal Drugs
    4. Ecological Factors
    5. Quality Assurance of Herbal Drugs
SAMPLING PROCEDURES
    1. Sampling Procedures
    2. Determination of Foreign Matter
MORPHOLOGICAL EXAMINATIONS
    1. Organoleptic Evaluation
    2. Macromorphological Evaluation
    3. Cytomorphological Evaluation of Herbal Drugs
MICROSCOPICAL EVALUATION
    1. Introduction
    2. Instruments for Microscopical Study
    3. Evaluation of Crude Drugs by Microscopy
    4. Microscopical Methods
    5. Quantitative Analytical Microscopy
DEVELOPMENT OF STANDARDIZATION PARAMETERS
    1. General Information
    2. Determination of Solvent Extractive Values
    3. Determination Ash Values
    4. Determination of Total Solids
    5. Determination of Crude Fibre
    6. Determination of Moisture Content
    7. Determination of Essential Oils in Crude Drugs
    8. Microbial Infestation and its Determination
    9. Determination of Bitterness Value
    10. Determination of Hemolytic Activity
    11. Determination of Swelling Index
    12. Determination of Foaming Index
    13. Determination of Tannins
    14. Determination of Arsenic and Heavy Metals
    15. Pesticides
PHYTOCONSTITUENTS AND THEIR ANALYSIS
    1. Introduction
    2. Importance of Phytoconstituents in Therapy
    3. Qualitative Analysis of Crude Drug Extracts and Isolates
    4. Alkaloids and Their Analysis
    5. Volatile Oils, Spices and their Analysis
    6. Fixed Oils Fats and Waxes
    7. Phenylpropanoids and their Analysis
    8. Flavonoids
    9. Resins and Resinous Plant Drugs and their Analysis
    10. Tannins and their Analysis
    11. Terpenoids and their Analysis
    12. Glycosidal Components and their Analysis
    13. Fluorescent Substances and their Analytical Parameters
    14. Colouring Matters and their Analysis
    15. Proteinaceous Components and their Analysis
    16. Steroids
    17. Carbohydrates and their Analysis
EXTRACTION OF HERBAL DRUGS
    1. Introduction
    2. Basic Principles and Rationale
    3. Pre Extraction Operations for Crude Drugs
    4. Effect of Solvent, Solvent Mixtures and Solution on Extraction
    5. Characteristics of Phytoconstituents
    6. Procedures for Extraction of Herbal Drugs
    7. Interfering Compounds In Extraction of Desired Phytoconstituents
    8. Extraction Methods for Specific Phytochemical Groups
    9. Treatment of Drug Residue after Extraction
    10. References
THIN LAYER CHROMATOGRAPHY
    1. Introduction
    2. Basic Principles of TLC
    3. Mechanisms for the Separation of Phytoconstituents
    4. Adsorbents for Quantitative Thin-Layer Chromatography
    5. Preparation of the Layers
    6. Preparation and Application of Samples
    7. Determination of Suitable Separation Conditions
    8. Development of Chromatogram
    9. Detection of Herbal Drugs and Extracts by TLC
    10. Evaluation of the TLC Plates
    11. TLC Bioautography
    12. Quantitative Thin Layer Chromatography
    13. Assay of Steroids in Phyto-Formulations
    14. Assay of Alkaloids
    15. Analytical Procedures for Some Bioactive Materials
    16. References
HIGH PERFORMANCE THIN LAYER CHROMATOGRAPHY
    1. HPTLC and Its Advantages
    2. Requirements for HPTLC Standardization
    3. Theory and Instrumentation of HPTLC
    4. Theoretical Considerations for Quantitative Analysis
    5. Specual techniques in In-situ Quantitative Evaluation
    6. Quantitative HPTLC for Pharmaceutical Applications
    7. TLC-Densitometry in the Standardization of Medicinal Plant Extracts
    8. Referencs

Part III - Biological Screening
PHARMACOLOGICAL SCREENING OF HERBAL DRUGS
    1. Introduction
    2. Need For Phyto-Pharmacological Evaluation
    3. Hippocratic Screening for Evaluation of Natural Products
    4. New Strategies for Evaluating Natural Products
    5. Evaluation of Antidiabetic Agents
    6. Evaluation of Hepatoprotective Agents
    7. Evaluation of Liver Carcinogenesis
    8. Evaluation of Diuretic Agents
    9. Evaluation of Antidiarrhoeal Agents
    10. Evaluation of Uterine Tonic Agents
    11. Evaluation of Anti Ulcers Agents
    12. Evaluation of Hypolipidemics Agents
    13. Evaluation of Wound Healing Agents
    14. Evaluation of Anti-Tussive Agents
    15. Evaluation of Cardiovascular Agents
    16. Evaluation of Anti-inflammatory Agents
    17. Evaluation of Analgesic/Antinociceptive Agents
    18. Evaluation of Antipyretic Agents
    19. Evaluation of Repellant and Anti-feedant
    20. Evaluation of Antioxidant Agents
    21. Evaluation of Enzyme Activators and Inhibitor Agents
    22. Evaluation of Myorelaxant and Antispasmodic Agents
    23. Evaluation of CNS Agents
    24. Evaluation of Natural Products Active on Brain
    25. Evaluation of Antifertility Agents
    26. Evaluation of Tyrosinase Inhibitory Agents
    27. References
ANTIMICROBIAL AND PARASITICIDAL SCREENING OF HERBAL DRUGS
    1. Introduction
    2. Preparation of Plant Samples for Antimicrobial Screening
    3. General Methods for Antimicrobial Screening
    4. Some Phyto-constituents with Antimicrobial Activity
    5. Antibacterial Screening Method
    6. Assay For Phytopharmaceuticals Having Antifungal Activity
    7. Screening For Anti-micobacterial Activity
    8. Molluscicidal and Piscicidal Activity Evaluation
    9. Evaluation of Antigiardial Effect
    10. Assay For Antimalarial Activity
    11. Assays For Amoebicidal Activity
    12. References
SCREENING FOR ANTIVIRAL ACTIVITY
    1. Introduction
    2. Phytoconstituents with Antiviral Potentials
    3. General Concepts of Evaluation
    4. Factors Influencing Evaluation
    5. Requirements for Host Cells, Organisms and Culture Media
    6. General Screening Procedures for Antiviral Testing
    7. Evaluation of Cytotoxicity
    8. Antiviral Screening Models
    9. Evaluation of Anti-influenza Activity
    10. Preparation of Different Reagents for Antiviral Study
    11. References

Part IV - Legal Aspects
GOOD AGRICULTURAL AND HARVESTING PRACTICES
    1. Introduction
    2. Good Harvesting Practices
    3. Good Agricultural Practices
    4. Documentation Required
QUALITY ASSURANCE AND STABILITY TESTING OF HERBAL DRUGS
    1. Indicative Substances for Quality Assurance
    2. Gmp and Haccp in Traditional Systems of Medicine
    3. Physical Quality Assurance
    4. Quality Assurance by Cultivation and Breeding
    5. Stabilization and Stability
    6. Methods of Stabilization
    7. Validation of Analytical Procedures
    8. References
ANALYTICAL PROFILES OF SELECTED MEDICINAL PLANTS
    1. Introduction
    2. General Guidelines
    3. Preparation of Spray Reagents
    4. Analytical Profiles
        a. Acorus calamus
        b. Adhatoda vasica
        c. Aegle marmelos
        d. Andrographis paniculata
        e. Bacopa monnieri
        f. Berberis aristata
        g. Boswellia serrata
        h. Cassia tora
        i. Centella asiatica
        j. Coleus forskohlii
        k. Commiphora mukul
        l. Curcuma longa
        m. Emblica officinalis
        n. Gardenia gummifera
        o. Gloriosa superba
        p. Glycyrrhiza glabra
        q. Mallotus philippinensis
        r. Mangifera indica
        s. Peganum harmala
        t. Phyllanthus amarus
        u. Piper longum
        v. Piper nigrum
        w. Psoralea corylifolia
        x. Withania somnifera
        y. Zingiber officinale

Annexure – 1 Websites on Herbal Medicines
Annexure – 2 International Herbal Organizations and Associations
Annexure – 3 References on Quality Control of Natural Products
Index
Acknowledgements