Mukherjee Evidence-Based Validation of Herbal Medicine

1. Auflage 2015
ISBN: 978-0-12-800996-3
Verlag: Elsevier Science & Techn.
Format: EPUB
Kopierschutz: 6 - ePub Watermark

E-Book, Englisch, 556 Seiten

Evidence-Based Validation of Herbal Medicines brings together current thinking and practice in the areas of characterization and validation of natural products. This book reviews all aspects of evaluation and development of medicines from plant sources, including their cultivation, collection, phytochemical and phyto-pharmacological evaluation, and therapeutic potential. Emphasis is placed on describing the full range of evidence-based analytical and bio-analytical techniques used to characterize natural products, including -omic technologies, phyto-chemical analysis, hyphenated techniques, and many more. - Includes state-of-the-art methods for detecting, isolating, and performing structure elucidation by degradation and spectroscopic techniques - Covers biosynthesis, synthesis, and biological activity related to natural products - Consolidates information to save time and money in research - Increases confidence levels in quality and validity of natural products

Autoren/Hrsg.

Mukherjee, FAScT

Inhaltsverzeichnis

1;Front Cover;1
2;EVIDENCE-BASED VALIDATION OF HERBAL MEDICINE;4
3;Copyright;5
4;Contents;6
5;Contributors;12
6;Foreword;14
6.1;EVIDENCE-BASED MEDICINE, A NEED FOR PARADIGM SHIFT!;14
7;Preface;16
7.1;EVIDENCE-BASED VALIDATION OF HERBAL MEDICINE;16
8;Acknowledgments;18
8.1;EVIDENCE-BASED VALIDATION OF HERBAL MEDICINE;18
9;Chapter 1 - Quality Related Safety Issue-Evidence-Based Validation of Herbal Medicine Farm to Pharma;20
9.1;1.1 HEALTH CARE THROUGH HERBAL MEDICINE;21
9.2;1.2 INTEGRATED APPROACHES FOR DEVELOPMENT OF HERBAL MEDICINE;21
9.3;1.3 USE OF HERBS IN TM;23
9.4;1.4 GLOBALIZATION OF TM;23
9.5;1.5 TM INSPIRED DRUG DISCOVERY AND DRUG DEVELOPMENT;25
9.6;1.6 ISSUES FOR QUALITY CONTROL AND QUALITY ASSURANCE OF HERBAL MEDICINE;26
9.7;1.7 MARKER ANALYSIS AND STANDARDIZATION OF BOTANICALS;28
9.8;1.8 PHARMACOVIGILANCE OF HERBAL MEDICINE;30
9.9;1.9 SAFETY ISSUES ON HERBAL MEDICINE-CYTOCHROME P450 STUDY;32
9.10;1.10 HERB-DRUG INTERACTIONS;40
9.11;1.11 SYSTEM BIOLOGY AND METABOLOMICS;41
9.12;1.12 INTERNATIONAL HARMONIZATION;43
9.13;1.13 CONCLUSION;43
9.14;Acknowledgments;44
9.15;References;44
9.16;1. LIST OF ABBREVIATIONS;47
10;Chapter 2 - Value Chains of Herbal Medicines—Ethnopharmacological and Analytical Challenges in a Globalizing World;48
10.1;2.1 INTRODUCTION;48
10.2;2.2 THE CONCEPT OF VALUE CHAINS;49
10.3;2.3 THE MEDICINAL PLANT VALUE CHAINS—RESEARCH NEEDS;49
10.4;2.4 MEDICINAL PLANT VALUE CHAINS IN ASIA;50
10.5;2.5 MEDICINAL PLANT PRODUCTION IN CHINA AND INDIA;51
10.6;2.6 SUPPLY, DEMAND, AND SUSTAINABILITY;53
10.7;2.7 THE TEA VALUE CHAIN;54
10.8;2.8 THE GINSENG VALUE CHAIN;55
10.9;2.9 PLANT METABOLOMICS AND ANALYTICAL CHALLENGES;56
10.10;2.10 DISCUSSION;58
10.11;Acknowledgments;61
10.12;References;61
10.13;2. LIST OF ABBREVIATIONS;63
11;Chapter 3 - Traditional Herbal Medicine, Pharmacognosy, and Pharmacopoeial Standards: A Discussion at the Crossroads;64
11.1;3.1 INTRODUCTION;65
11.2;3.2 HISTORICAL PERSPECTIVES ON TRADITIONAL HERBAL MEDICINE;66
11.3;3.3 MODERN MEDICINE—AN AMERICAN CASE HISTORY;74
11.4;3.4 TRADITIONAL HERBAL MEDICINES: CENTURIES OF EMPIRICISM;78
11.5;3.5 TRADITIONAL MEDICINE: THERAPEUTICS, DEFINITIONS, AND ORIENTATIONS;80
11.6;3.6 STANDARD OF HERBAL DRUGS IN EARLY PHARMACOPOEIAS;85
11.7;3.7 OTHER QUALITATIVE FACTORS NOT CONSIDERED IN PHARMACOPOEIAS;95
11.8;3.8 PREVENTIVE CARE AND SELF-RESPONSIBILITY;98
11.9;3.9 CONCLUSION;99
11.10;References;100
12;Chapter 4 - Taxonomy—An Irreplaceable Tool for Validation of Herbal Medicine;106
12.1;4.1 INTRODUCTION;106
12.2;4.2 VOUCHER SPECIMENS;107
12.3;4.3 PLANT IDENTIFICATION;114
12.4;4.4 LABEL REQUIREMENTS FOR BOTANICAL SUPPLEMENTS AND OTHER MATERIALS IN TRADE;116
12.5;4.5 THE PROBLEM OF LACKING VOUCHERS AND INCORRECT IDENTIFICATION;116
12.6;4.6 PROBLEMS WITH THE LACK OF TAXONOMIC ATTENTION;116
12.7;4.7 CONCLUSIONS;135
12.8;References;136
13;Chapter 5 - Validation of Medicinal Herbs for Skin Aging;138
13.1;5.1 INTRODUCTION;139
13.2;5.2 CONSEQUENCES OF HERBAL COSMETIC;139
13.3;5.3 SKIN AGING;140
13.4;5.4 FACTORS ASSOCIATED WITH SKIN AGING;141
13.5;5.5 PHOTOPROTECTIVE MECHANISM OF BIOACTIVE MOLECULES;143
13.6;5.6 NATURAL BIOACTIVE MOLECULES AGAINST SKIN AGING;147
13.7;5.7 FEW MEDICINAL PLANTS USEFUL IN SKIN AGING;147
13.8;5.8 MANAGEMENT OF SKIN AGING;160
13.9;5.9 CONCLUSION;162
13.10;Acknowledgments;162
13.11;References;162
13.12;5. LIST OF ABBREVIATIONS;166
14;Chapter 6 - Proangiogenic Potential of Medicinal Plants in Wound Healing;168
14.1;6.1 INTRODUCTION;168
14.2;6.2 PHASES OF WOUND HEALING;169
14.3;6.3 ANGIOGENESIS AND ITS ROLE IN WOUND HEALING;170
14.4;6.4 PLANTS WITH PROANGIOGENIC POTENTIAL;171
14.5;6.5 CONCLUSION;179
14.6;References;180
14.7;6. LIST OF ABBREVIATIONS;183
15;Chapter 7 - Pharmacovigilance: Tools in Establishing the Safety and Acceptability of the Natural Health Products—Clinical E ...;184
15.1;7.1 INTRODUCTION;184
15.2;7.2 BRIEF HISTORICAL REVIEW;185
15.3;7.3 ADVERSE REACTIONS;185
15.4;7.4 PHARMACOVIGILANCE;186
15.5;7.5 ADVERSE EFFECTS AND HERBAL ADVERSE EFFECTS;186
15.6;7.6 PHARMACOVIGILANCE AND HERBAL PHARMACOVIGILANCE;187
15.7;7.7 TOXICOLOGICOLOGIST'S TOOLKITS;189
15.8;7.8 CONCLUSIONS;191
15.9;References;191
15.10;7. LIST OF ABBREVIATIONS;193
16;Chapter 8 - Validation of Antiviral Potential of Herbal Ethnomedicine;194
16.1;8.1 INTRODUCTION;195
16.2;8.2 RATIONALE FOR ANTIVIRAL DRUG DEVELOPMENT;195
16.3;8.3 DEVELOPMENT OF EFFECTIVE ANTIVIRAL DRUGS;196
16.4;8.4 MEDICINAL PLANTS AS A SOURCE OF ANTIVIRAL DRUGS: AN OVERVIEW;196
16.5;8.5 METHODS FOR THE VALIDATION OF ANTIVIRAL ACTIVITY OF PLANTS;197
16.6;8.6 FUTURE PROSPECTS AND DIRECTIONS;215
16.7;References;215
16.8;8. LIST OF ABBREVIATIONS;219
17;Chapter 9 - Harmonization of Regulatory Requirements in Europe to Ensure Quality, Safety and Efficacy of Herbal Medicinal P ...;220
17.1;9.1 INTRODUCTION;220
17.2;9.2 HMPC: ESTABLISHMENT AND WORKING STRUCTURE;221
17.3;9.3 BASIC LEGAL DEFINITIONS AND ACCESS TO THE MARKET;222
17.4;9.4 MONOGRAPHS AND LIST ENTRIES: WELL-ESTABLISHED USE AND TRADITIONAL USE;223
17.5;9.5 PROCEDURE TO ESTABLISH MONOGRAPHS;224
17.6;9.6 USAGE AND ACCEPTANCE OF MONOGRAPHS;225
17.7;9.7 GUIDANCE ON QUALITY, EFFICACY, AND SAFETY: COORDINATION;232
17.8;9.8 OUTLOOK;232
17.9;CONFLICT OF INTEREST;234
17.10;References;235
17.11;9. LIST OF ABBREVIATIONS;235
18;Chapter 10 - Bioavailability of Herbal Products: Approach Toward Improved Pharmacokinetics;236
18.1;10.1 INTRODUCTION;237
18.2;10.2 FACTORS AFFECTING BIOAVAILABILITY AND PHARMACOKINETICS OF HERBAL PRODUCTS;237
18.3;10.3 THE BIOAVAILABILITY AND PHARMACOKINETICS OF SOME HERBS AND PHYTOCONSTITUENTS;243
18.4;10.4 CHALLENGES IN DEVELOPING A HERBAL FORMULATION;249
18.5;10.5 NOVEL DRUG DELIVERY TECHNOLOGY FOR HERBAL FORMULATION;250
18.6;10.6 PHOSPHOLIPID COMPLEX OF HERBS—MODIFICATION OF BIOAVAILABILITY AND EFFICACY;256
18.7;10.7 CONCLUSION;260
18.8;Acknowledgment;260
18.9;References;260
18.10;10. LIST OF ABBREVIATIONS;264
19;Chapter 11 - Good Quality and Clinical Practices for the Future Development of Herbal Medicines;266
19.1;11.1 INTRODUCTION;266
19.2;11.2 QUALITY ISSUES: LACK OF GMP OR FAILURE TO COMPLY WITH CGMP GUIDELINES;268
19.3;11.3 SAFETY OF HMS IN THE UNITED STATES, EUROPE, AND ASIA;269
19.4;11.4 EFFICACY: THE IMPORTANCE OF RANDOMIZED CONTROLLED CLINICAL TRIALS;272
19.5;11.5 FUTURE OUTLOOK FOR HMS;274
19.6;References;275
19.7;11. LIST OF ABBREVIATIONS;277
20;Chapter 12 - Traditional Medicine-Inspired Evidence-Based Approaches to Drug Discovery;278
20.1;12.1 INTRODUCTION;278
20.2;12.2 AYURVEDA INSPIRATION;279
20.3;12.3 REVERSE PHARMACOLOGY;281
20.4;12.4 SEMECARPUS ANACARDIUM CASE;281
20.5;12.5 FORMULATION DISCOVERY;282
20.6;12.6 PHYTOPHARMACEUTICALS AS DRUGS;283
20.7;12.7 CLINICAL RESEARCH;283
20.8;12.8 THE ARTREX STORY;284
20.9;12.9 FORMULATIONS FOR ARTHRITIS;284
20.10;12.10 RASAYANA AND IMMUNOADJUVANTS;285
20.11;12.11 DISCOVERY APPROACHES;287
20.12;12.12 HERB–DRUG INTERACTIONS;287
20.13;12.13 QUALITY CONTROL AND STANDARDIZATION;287
20.14;12.14 EVIDENCE-BASED AYURVEDIC MEDICINE;288
20.15;12.15 CONCLUSION;288
20.16;References;288
21;Chapter 13 - Evaluation of Bioactive Compounds as Acetylcholinesterase Inhibitors from Medicinal Plants;292
21.1;13.1 INTRODUCTION;293
21.2;13.2 CHOLINERGIC PATHWAY;293
21.3;13.3 CHOLINESTARASE INHIBITORS FOR LEARNING AND MEMORY;294
21.4;13.4 MEDICINAL PLANTS FOR THE MANAGEMENT OF COGNITIVE DISORDER;296
21.5;13.5 PHYTOCONSTITUENTS FOR THE MANAGEMENT OF COGNITIVE DISORDER;302
21.6;13.6 CONCLUSION;321
21.7;Acknowledgments;321
21.8;References;321
21.9;13. LIST OF ABBREVIATIONS;325
22;Chapter 14 - Drugs and Drug Leads Based on Natural Products for Treatment and Prophylaxis of Malaria;326
22.1;14.1 MALARIA;326
22.2;14.2 DRUG FOR TREATMENT OF MALARIA;328
22.3;14.3 MALARIA PREVENTION THROUGH VECTOR CONTROL;333
22.4;14.4 EVIDENCE-BASED USE OF PHYTOMEDICINES;333
22.5;14.5 CONCLUSION;336
22.6;References;337
23;Chapter 15 - Evaluation of Natural Products against Biofilm-Mediated Bacterial Resistance;340
23.1;15.1 INTRODUCTION;340
23.2;15.2 BIOFILM FORMATION;342
23.3;15.3 MECHANISM FOR RESISTANCE DUE TO BIOFILM;343
23.4;15.4 BIOFILM AND QUORUM SENSING;344
23.5;15.5 QUORUM SENSING AS A TARGET FOR ANTIMICROBIAL THERAPY;348
23.6;15.6 NATURAL PRODUCTS AS A QS INHIBITOR;350
23.7;15.7 SYNERGY WITH THE NATURAL PRODUCTS AND CONVENTIONAL ANTIBIOTICS;351
23.8;15.8 CONCLUSIONS;351
23.9;Acknowledgments;353
23.10;References;353
23.11;15. LIST OF ABBREVIATIONS;357
24;Chapter 16 - Clinical Effects of Caraway, a Traditional Medicine for Weight Loss;358
24.1;16.1 INTRODUCTION;358
24.2;16.2 MATERIALS AND METHODS;366
24.3;16.3 RESULTS;367
24.4;16.4 DISCUSSION;371
24.5;16.5 CONCLUSIONS;376
24.6;16.6 SUMMARY;376
24.7;Acknowledgment;376
24.8;References;376
24.9;16. LIST OF ABBREVIATIONS;381
25;Chapter 17 - Challenges in Identification of Potential Phytotherapies from Contemporary Biomedical Literature;382
25.1;17.1 DESCRIPTION OF MEDICINAL USES OF PLANTS;382
25.2;17.2 BIOMEDICAL LITERATURE;383
25.3;17.3 CONCEPT RECOGNITION;384
25.4;17.4 IDENTIFYING POTENTIAL PLANT–THERAPY RELATIONSHIPS;387
25.5;17.5 CONCLUSION;388
25.6;References;388
25.7;17. LIST OF ABBREVIATIONS;390
26;Chapter 18 - Botanicals as Medicinal Food and Their Effects against Obesity;392
26.1;18.1 INTRODUCTION;392
26.2;18.2 PATHOGENESIS OF OBESITY AND MANAGEMENT STRATEGIES;393
26.3;18.3 PHYTOCHEMICALS USEFUL AGAINST METABOLIC DISORDER;396
26.4;18.4 HERB AS FOOD USEFUL IN OBESITY MANAGEMENT;406
26.5;18.5 MEDICINAL PLANT FOR TREATMENT OF OBESITY;415
26.6;18.6 PROSPECT OF PHYTOCHEMICALS, FOODS AND BOTANICALS IN OBESITY MANAGEMENT;416
26.7;18.7 CONCLUSION;417
26.8;Acknowledgment;417
26.9;References;417
26.10;18. LIST OF ABBREVIATIONS;421
27;Chapter 19 - Applications of High Performance Liquid Chromatography in the Analysis of Herbal Products;424
27.1;19.1 INTRODUCTION;425
27.2;19.2 HIGH PERFORMANCE LIQUID CHROMATOGRAPHY (HPLC);425
27.3;19.3 HERBAL PRODUCTS;429
27.4;19.4 TYPES OF ANALYSIS OF HERBAL PRODUCTS;430
27.5;19.5 ANALYSIS OF HERBAL PRODUCTS BY HIGH PERFORMANCE LIQUID CHROMATOGRAPHY;433
27.6;19.6 CONCLUSIONS;442
27.7;References;442
27.8;19. LIST OF ABBREVIATIONS;444
28;Chapter 20 - Ayurveda – Opportunities for Developing Safe and Effective Treatment Choices for the Future;446
28.1;20.1 AYURVEDA THE SCIENCE OF LIFE;447
28.2;20.2 KNOWLEDGE BASE OF ANCIENT INDIA;451
28.3;20.3 DRAVYAGUNA: PHARMACODYNAMIC CLASSIFICATION OF HERBS IN AYURVEDA;453
28.4;20.4 NIDANA SAMPRAPTI: DISEASE PATHOGENESIS IN AYURVEDA;454
28.5;20.5 PANCHAKARMA THERAPY: PERSONALIZED DETOXIFICATION AND REJUVENATION THERAPY;457
28.6;20.6 AYURVEDA: REDISCOVERING NOVEL THERAPIES;461
28.7;20.7 RASASHASTRA: THE MYSTERY OF ANCIENT CHEMISTRY;465
28.8;20.8 AYUR-PHARMACOEPIDEMIOLOGY;467
28.9;20.9 CONCLUSION;469
28.10;References;470
29;Chapter 21 - Discovery and Development of Lead Compounds from Natural Sources Using Computational Approaches;474
29.1;21.1 INTRODUCTION;474
29.2;21.2 NPS IN DRUG DISCOVERY;476
29.3;21.3 CHEMOINFORMATIC ANALYSIS OF NATURAL PRODUCTS;476
29.4;21.4 MOLECULAR DATABASES FOCUSED ON NPS AND NP DERIVATIVES;481
29.5;21.5 VIRTUAL SCREENING AND TARGET FISHING;483
29.6;21.6 NPS AS LEADS FOR CHALLENGING AND EMERGING TARGETS;485
29.7;21.7 UNCOVERING BIOACTIVITIES OF NPS OF DIETARY ORIGIN;488
29.8;21.8 CONCLUDING REMARKS;489
29.9;Acknowledgments;489
29.10;References;489
29.11;21. LIST OF ABBREVIATIONS;494
30;Chapter 22 - Infrared Spectroscopic Technologies for the Quality Control of Herbal Medicines;496
30.1;22.1 INTRODUCTION;496
30.2;22.2 TECHNICAL PRINCIPLES;497
30.3;22.3 IR IMAGING SPECTROSCOPY;499
30.4;22.4 CHEMOMETRICS INCLUDING DATA PREPROCESSING;502
30.5;22.5 AD- AND DISADVANTAGES OF NIR AND IMAGING SPECTROSCOPY;503
30.6;22.6 QUANTITATIVE ANALYSIS OF SECONDARY METABOLITES;503
30.7;22.7 QUALITATIVE ANALYSIS: CLASSIFICATION, DISCRIMINATION AND/OR AUTHENTICATION;508
30.8;22.8 IR IMAGING SPECTROSCOPY STUDIES;509
30.9;22.9 REGULATORY ISSUES;510
30.10;Acknowledgments;510
30.11;References;510
30.12;22. LIST OF ABBREVIATIONS;512
31;Chapter 23 - Antimicrobial Secondary Metabolites—Extraction, Isolation, Identification, and Bioassay;514
31.1;23.1 INTRODUCTION;514
31.2;23.2 EXTRACTION AND ISOLATION OF METABOLITES FOR ANTIMICROBIAL POTENTIALS;516
31.3;23.3 IDENTIFICATION OF COMPOUNDS;517
31.4;23.4 BIOASSAY: METHODS COMMONLY USED FOR THE SCREENING OF ANTIMICROBIAL ACTIVITY;519
31.5;23.5 ANTIMICROBIAL SECONDARY METABOLITES;521
31.6;23.6 CONCLUSION;528
31.7;References;529
31.8;23. LIST OF ABBREVIATIONS;531
32;Chapter 24 - Uses of Herbals in Cardiac Diseases: Priority of Evidence Over Belief;534
32.1;24.1 INTRODUCTION;534
32.2;24.2 EPIDEMIOLOGY OF CVD;535
32.3;24.3 HERBAL DRUG VERSUS MODERN MEDICINE;535
32.4;24.4 VALIDATION OF INDIAN MEDICINAL PLANTS FOR CARDIOPROTECTION;535
32.5;24.5 EXPERIMENTAL DATA OBTAINED FROM INDIAN MEDICINAL PLANTS FOR CARDIOVASCULAR ACTIVITY;536
32.6;24.6 MEDICINAL PLANTS USED FOR CARDIOVASCULAR DISEASES OTHER THAN INDIAN MEDICINAL PLANTS;539
32.7;24.7 DATA OBTAINED FROM HUMAN STUDIES WITH MEDICINAL PLANTS FOR CARDIOVASCULAR EFFECTS;539
32.8;24.8 INDIAN INITIATIVES;545
32.9;24.9 CONCLUSION;545
32.10;References;545
32.11;24. LIST OF ABBREVIATIONS;548
33;Index;550

Leseproben

Chapter 1

Quality Related Safety Issue-Evidence-Based Validation of Herbal Medicine Farm to Pharma

Pulok K. Mukherjee, Shiv Bahadur, Sushil K. Chaudhary, Amit Kar,  and Kakali Mukherjee     School of Natural Product Studies, Department of Pharmaceutical Technology, Jadavpur University, Kolkata, India

Abstract

Because of their unique effects and relatively low side effects, herbal medicine has been gaining popularity all over the world. Quality control is a challenge to ensure safety, efficacy, and batch-to-batch consistency of herbal products due to the complexity of phytochemical constituents. Generally, it is believed that the risk associated with herbal drugs is very less, but several reports on serious reactions are indicating the need for the development of safety profiles; effective regulatory guidelines; and quality control systems for authentication, isolation, and standardization of herbal medicine. Lack of strict guidelines on the assessment of safety and efficacy, quality control, safety monitoring, and knowledge on traditional medicine (TM) are the main aspects that are found in different regulatory systems. Proper validation of herbs used in TM needs to be done for their promotion and development.

Keywords

Herb–drug interaction; Marker profiling; Pharmacovigilance; Quality control; Safety evaluation; Standardization

Outline

1.1 Health Care through Herbal Medicine 2

1.2 Integrated Approaches for Development of Herbal Medicine 2

1.2.1 Opportunities and Challenges in Herbal Medicine 2

1.2.2 Several Aspects for Revitalization of Medicinal Plants 3

1.3 Use of Herbs in TM 4

1.4 Globalization of TM 4

1.4.1 Strategies for Globalization of TM 5

1.5 TM Inspired Drug Discovery and Drug Development 6

1.6 Issues for Quality Control and Quality Assurance of Herbal Medicine 7

1.6.1 Contamination 8

1.6.2 Adulteration 8

1.6.3 Misidentification 8

1.6.4 Nonuniform Chemical Constituents 9

1.6.5 Pharmacopoeial Standards for Evaluation of Herbal Products 9

1.7 Marker Analysis and Standardization of Botanicals 9

1.7.1 Applications of Marker Profiling 11

1.8 Pharmacovigilance of Herbal Medicine 11

1.8.1 Why Pharmacovigilance for Herbal Drugs? 12

1.8.2 Steps to Initiate Herbal Pharmacovigilance 12

1.9 Safety Issues on Herbal Medicine-Cytochrome P450 Study 13

1.9.1 Cimicifuga racemosa (Family: Ranunculaceae) 14

1.9.2 Boswellia serrata (Family: Burseraceae) 14

1.9.3 Gardenia jasminoids (Family: Rubiaceae) 16

1.9.4 Matricaria recutita (Family: Asteraceae) 16

1.9.5 Echinacea purpurea (Family: Asteraceae) 17

1.9.6 Ginkgo biloba (Family: Ginkgoaceae) 17

1.9.7 Evodia rutaecarpa (Family: Rutaceae) 17

1.9.8 Hydrastis Canadensis (Family: Ranunculaceae) 17

1.9.9 Piper methysticum (Family: Piperaceae) 18

1.9.10 Radix pueraria (Family: Fabaceae) 19

1.9.11 Phyllanthus amarus (Family: Euphorbiaceae) 20

1.9.12 Valeriana officinalis (Family: Valerianaceae) 20

1.9.13 Triphala 20

1.9.14 Trikatu 20

1.9.15 Murraya koenigii (Family: Rutaceae) 21

1.9.16 Glycyrrhiza glabra (Family: Fabaceae) 21

1.10 Herb-Drug Interactions 21

1.10.1 Synergistic Effects of Herbs 21

1.11 System Biology and Metabolomics 22

1.12 International Harmonization 24

1.13 Conclusion 24

Acknowledgments 25

References 25

List of abbreviations 28

1.1. Health Care through Herbal Medicine

Herbal medicines attract the interest of both patients and scientists, in all aspects of drug development from natural products and also for validation of traditional medicine (TM). Several developing countries rely on TM because of their accessibility and affordability, and scientists all over the world consider medicinal plants as a source of new chemical entities and use them to isolate compounds such as digoxin, morphine, taxol, atropine, and vinblastine [1]. Herbal medicines have an important position in health care systems worldwide; their current assessment and quality control are a major bottleneck. Many adverse events of herbal medicines can be attributed to the poor quality of the raw materials or the finished products. Quality issues of herbal medicines can be classified into two categories, external and internal. External issues include toxic metals, pesticides residues, microbes, adulteration, and misidentification of medicinal plants. The internal issues affecting the quality of herbal medicines are complexity and nonuniformity of the ingredients. Through the use of modern analytical methods and pharmaceutical techniques, previously unsolved internal issues have become solvable [2]. The increasing search for therapeutic agents derived from plant species is justified by the emergence of diseases. Medicinal plants serve as the most valuable source for curing many diseases. Herbal medicines include herbal extracts, herbal drug preparations, and herbal drugs. Herbal drugs are unprocessed parts of plants or whole plants [3]. Herbs include crude plant material such as leaves, flowers, fruit, seed, stems, wood, bark, roots, rhizomes, or other plant parts, which may be entire, fragmented, or powdered. Herbal preparations include comminuted or powdered materials or extracts, tinctures, and fatty oils of herbal materials, which may be produced by extraction, fractionation, purification, concentration, or other physical or biological processes [4].

Modern allopathic medicine has developed from ancient medicine, and it is likely that many important new remedies were discovered and commercialized following the leads provided by traditional knowledge and experiences. The study of these traditions not only provides an insight into how the field has developed but it is also a fascinating example of our ability to develop a diversity of cultural practices [5]. The administering of a pure chemical or a plant extract containing the same chemical entity is essentially different. The difference is mainly due to the complexity of a plant extract that introduces many variables to conventional phytomedicinal research, which could possibly contribute to chemical complexity and bioactivity. On administration of plant material of Artemisia annua versus the pure drug, for example, artemisinin, showed that the bioavailability from the leaves was 45 times more than that of the pure drug [6]. Thus, the complexity of the plant extract could have contributed to the increased bioavailability and thus the bioactivity. A genuine interest on various traditional practices now exists among practitioners of modern medicine and a number of practitioners of traditional, indigenous, or alternative systems are beginning to accept and use some of the modern technologies. Proper methodologies for the research and development, manufacturing, and quality control of the formulations in TM and investigations of the therapeutic potentials of plants used in those systems with support of scientific methods may help to use them with maximum possible efficacy [7].

1.2. Integrated Approaches for Development of Herbal Medicine

The international trade in herbal medicine has attracted most of the pharmaceutical companies, including the multinationals. Until a few years ago, only small companies had interest in the marketing of herbal medicines. Currently, several large multinational companies are interested in commercializing herbal drugs [8]. The world market for herbal medicine, including herbal products and raw materials, has been estimated to have an annual growth rate upto 15%. Several integrated approaches in herbal research for promotion and development of natural products are shown in Figure 1.1.

1.2.1. Opportunities and Challenges in Herbal Medicine

With the global increase in the demand for medicinal plant or plant-derived medicines, there is a call for ensuring the quality and safety of herbal drugs using several modern analytical techniques. Chemical constituents in herbal medicine may vary depending on harvest seasons, plant origins, drying processes, and other related factors. Thus, it seems to be necessary to determine most of the phytochemical constituents of herbal products in order to ensure the reliability and repeatability of pharmacological and clinical research, to understand their bioactivities and possible side effects so as to enhance the quality of the herbal products [9]. Quality control of herbal medicines aims to ensure their quality, safety, and efficacy. The lack of chemical markers remains a major problem for the quality control of herbal medicines. In many cases, we do not have sufficient chemical and pharmacological data of chemical markers. Further, there are many technical challenges in the production of markers. For example, temperature, light, and solvents often cause degradation and/or transformation of purified components; isomers and conformations may also cause changes in the markers. However, a concept of understanding the...