Evidence-Based Validation of Herbal Medicine

Pulok K. Mukherjee

• Publisher: Elsevier
• Year: 2015
• ISBN:
  9780128009963
• Topic: Médecine
• Subtopic: Pharmacologie

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

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 som...