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Evidence-Based Validation of Herbal Medicine -

Evidence-Based Validation of Herbal Medicine (eBook)

Pulok K. Mukherjee (Herausgeber)

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2015 | 1. Auflage
556 Seiten
Elsevier Science (Verlag)
978-0-12-800996-3 (ISBN)
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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
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

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

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...

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Buying eBooks from abroad
For tax law reasons we can sell eBooks just within Germany and Switzerland. Regrettably we cannot fulfill eBook-orders from other countries.

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