Fingerprinting analysis and quality control methods of herbal medicines

225 Pages·2019·2.637 MB·English

by  Pandey, Ravindra

Fingerprinting Analysis
and Quality Control
Methods of Herbal
Medicines

Fingerprinting Analysis
and Quality Control
Methods of Herbal
Medicines
Ravindra Kumar Pandey
Shiv Shankar Shukla
Amber Vyas
Vishal Jain
Parag Jain
Shailendra Saraf
CRC Press
Taylor & Francis Group
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Library of Congress Cataloging-in-Publication Data
Names: Pandey, Ravindra, author.
Title: Fingerprinting analysis and quality control methods of herbal medicines /
Ravindra Kumar Pandey [and five others].
Description: Boca Raton : CRC Press, Taylor & Francis Group, 2018. | Includes
bibliographical references.
Identifiers: LCCN 2018006941 | ISBN 9781138036949 (hardback)
Subjects: LCSH: Herbs--Therapeutic use--Safety measures. | Materia medica,
Vegetable--Analysis. | Materia medica, Vegetable--Safety measures. |
Chromatographic analysis. | Drugs--Quality control.
Classification: LCC SB293 .F56 2018 | DDC 615.3/21--dc23
LC record available at https://lccn.loc.gov/2018006941
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Contents
List of Figures ..........................................................................................................xv
List of Tables ..........................................................................................................xvii
Preface.....................................................................................................................xix
Authors ....................................................................................................................xxi
Chapter 1 Introduction ..........................................................................................1
1.1 Herbal Drugs .............................................................................2
1.2 Terms Relating to Herbal Medicines .........................................2
1.2.1 Herbal Medicines ........................................................2
1.2.2 Herbal Materials ..........................................................3
1.2.3 Herbal Preparations .....................................................3
1.2.4 Finished Herbal Products or Herbal Medicinal
Products .......................................................................3
1.3 Indian System of Medicine (ISM) .............................................3
1.4 Herbal Regulation in India ........................................................5
1.5 Risk Assessment ........................................................................6
1.6 Quality Control of Herbal Drugs ...............................................6
1.6.1 Identity .........................................................................6
1.6.2 Purity ...........................................................................6
1.6.3 Content or Assay..........................................................7
1.6.4 Several Problems Influence the Quality of
Herbal Drugs ...............................................................8
1.7 Standardization of Herbal Formulation .....................................8
1.7.1 Specification ................................................................9
1.7.2 Specifications for Herbal Substances ..........................9
1.7.3 Characterization ..........................................................9
1.7.4 Pharmacopoeial Tests and Acceptance Criteria ........10
1.7.5 In-Process Tests .........................................................10
1.7.6 Reference Standard ....................................................10
1.8 Drug Adulteration ....................................................................11
1.9 Conclusion ...............................................................................11
References ..........................................................................................12
Chapter 2 Method of Extraction .........................................................................13
2.1 Introduction .............................................................................13
2.2 Solvent for Extraction ..............................................................13
2.3 Selection of the Solvents ..........................................................14
2.4 Regeneration of the Solvent .....................................................14
2.5 Solutions (Solute and Solvent) .................................................15
2.6 Factors Affecting Choice of Extraction Process .....................15
v
vi Contents
2.6.1 Character of Drug ......................................................15
2.6.2 Therapeutic Value of the Drug ..................................15
2.6.3 Stability of Drug ........................................................16
2.6.4 Cost of Drug ..............................................................16
2.6.5 Solvent .......................................................................16
2.6.6 Concentration of Product ...........................................16
2.6.7 Recovery of Solvent from the Marc ..........................16
2.7 Procedures for Extraction of Herbal Drugs .............................16
2.7.1 Maceration .................................................................17
2.7.1.1 Modification of General Processes of
Maceration .................................................18
2.7.2 Vortical or Turbo Extraction......................................19
2.7.3 Ultrasound Extraction ...............................................19
2.7.4 Extractions by Electrical Energy ...............................20
2.7.5 Percolation and Re-Percolation .................................20
2.7.5.1 Percolation Procedure ................................21
2.7.5.2 Modification of the General Process of
Percolation .................................................21
2.7.5.3 Reserved Percolation ..................................22
2.7.6 Cover and Run Down Method ...................................22
2.7.7 Small Scale or Laboratory Scale Extraction .............23
2.7.7.1 Hot Continuous Extractions: Soxhletion ....23
2.7.7.2 Continuous Apparatus
(Official Extractor) ...................................23
2.7.8 Large Scale Extractor (Counter
Current Extractions) ................................................25
2.7.9 Infusion and Decoction .............................................26
2.7.9.1 General Method for Preparing Fresh
Infusion ......................................................26
2.7.10 Aqueous Alcoholic Extraction by Fermentation .......26
2.7.11 Steam Distillation ......................................................27
2.7.12 Supercritical Fluid Extractions ..................................27
2.7.13 Phytonics Process ......................................................28
2.7.14 High Pressure Extraction (HPE) ...............................28
2.8 Conclusions ..............................................................................29
References ..........................................................................................29
Chapter 3 Separation and Isolation of Plant Constituents ..................................31
3.1 Introduction .............................................................................31
3.2 Classes of Phyto-Constituents .................................................31
3.2.1 Glycosides ..................................................................31
3.2.2 Alkaloids ...................................................................32
3.2.3 Flavonoids ..................................................................33
3.2.4 Terpenes .....................................................................34
3.2.5 Phenolics ....................................................................35
Contents vii
3.2.6 Saponins ....................................................................35
3.2.7 Tannins ......................................................................36
3.2.8 Steroids ......................................................................36
References ..........................................................................................36
Chapter 4 Methods of Phyto-Constituent Detection ...........................................39
4.1 Introduction .............................................................................39
4.2 Phytochemical Analysis ..........................................................39
4.2.1 Phytochemical Analysis Tests for Alkaloids .............39
4.2.2 Phytochemical Screening of Anthocyanin ................40
4.2.3 Phytochemical Analysis Tests for
Anthraquinone ...................................................40
4.2.4 Phytochemical Analysis Test for Cardiac
Glycosides ................................................................40
4.2.5 Phytochemical Analysis Tests for Coumarins ...........40
4.2.6 Phytochemical Analysis Tests for Cynogenetic
Glycosides ..................................................................41
4.2.7 Phytochemical Analysis Tests for Phenolics and
Flavonoids ..................................................................41
4.2.8 Phytochemical Analysis Test for Saponins ...............41
4.2.9 Phytochemical Analysis Tests for Triterpenes ..........42
4.2.10 Phytochemical Analysis Tests for Steroids................42
4.2.11 Phytochemical Analysis Tests for Tannins ................42
4.2.12 Phytochemical Analysis Tests for Fixed Oils and
Fats.............................................................................43
4.2.13 Phytochemical Analysis Test for Gums and
Mucilages ...................................................................43
4.2.14 Phytochemical Analysis Tests for Lactones ..............43
4.2.15 Phytochemical Analysis Test for Diterpenes .............43
4.3 Conclusion ...............................................................................43
References ..........................................................................................44
Chapter 5 Regulatory Aspects for Herbal Drugs ................................................45
5.1 Introduction .............................................................................45
5.2 Regulation ................................................................................46
5.2.1 Aim of Regulatory Guidelines for Herbal
Medicines ..................................................................46
5.2.2 Regulation and Registration of Herbal Medicines ....46
5.3 WHO Regulatory Requirements .............................................47
5.3.1 Objectives ..................................................................48
5.3.2 Guidelines for the Regulation of Herbal
Medicines in the Southeast Asia Region ...................48
5.3.3 WHO Guidelines on Safety Monitoring of
Herbal Medicines in Pharmacovigilance Systems ....48
viii Contents
5.3.4 WHO Guidelines on Good Agricultural and
Collection Practices (GACP) for Medicinal Plants ...48
5.3.5 National Policy on Traditional Medicine (TM)
and Regulation of Herbal Medicine ..........................49
5.3.6 WHO Guidelines for Quality Control of Herbal
Formulation ...............................................................49
5.3.7 WHO Guidelines for Herbal Drug Standardization ...49
5.4 Herbal Drug Regulations in India ...........................................50
5.5 Regulatory Aspects and Approval of Herbal Drugs in
Different Countries ..................................................................51
5.5.1 European Herbal Guidelines .....................................52
5.5.1.1 European Medicines Agency—EMA ........52
5.5.2 United States of America ..........................................52
5.5.3 Australia ....................................................................53
References ..........................................................................................53
Chapter 6 Ethnopharmacology of Medicinal Plants ...........................................55
6.1 Introduction .............................................................................55
6.2 Phytotherapy ............................................................................55
6.3 Practicing Herbal Medicine .....................................................56
6.4 Need of Documentation of Ethnopharmacological Plants ......57
6.5 Ethnopharmacognostical Studies of Medicinal Plants of
Chhattisgarh, India ..................................................................57
6.6 Conclusion ...............................................................................59
References ..........................................................................................59
Chapter 7 Quality Control of Herbal Medicine ..................................................61
7.1 Introduction .............................................................................61
7.2 Quality Control: Present Scenario ...........................................61
7.3 Quality Control of Herbal Drugs .............................................62
7.3.1 Identity .......................................................................62
7.3.2 Purity .........................................................................63
7.3.3 Content or Assay........................................................63
7.4 Stability Studies of Herbal Medicines .....................................63
7.4.1 Specific Characteristics of Herbal Medicinal
Products .....................................................................64
7.4.2 Analytical Methods for Herbal Products ...................64
7.4.3 Stability Study of Herbal Drugs ................................64
7.4.4 Shelf Life ...................................................................65
7.4.5 Challenges in Stability Testing of Herbal
Medicinal Products ....................................................65
7.4.6 Predictable Changes in Herbal Drug Material ..........65
7.4.7 Importance of Stability Testing .................................66
Contents ix
7.5 Biological Markers for Herbal Medicines ...............................67
7.5.1 Markers are Categorized into Two Classes ...............67
7.5.1.1 DNA Markers .............................................67
7.5.1.2 Chemical Markers ......................................68
7.6 Conclusion ...............................................................................71
References ..........................................................................................72
Chapter 8 Bioavailability of Herbal Drugs .........................................................75
8.1 Need for Bioavailability Enhancers .........................................75
8.2 Drug Absorption Barriers ........................................................76
8.3 Mechanism of Action of Bioenhancers ...................................76
8.4 Medicinal Plants and their Compounds as Drug
Bioavailability Enhancers ........................................................77
References ..........................................................................................78
Chapter 9 Thermal Analysis of Herbal Drugs ....................................................79
9.1 Introduction .............................................................................79
9.1.1 Thermogravimetry (TG) ............................................79
9.1.1.1 Characteristics ...........................................80
9.1.1.2 Applications of Thermogravimetric
Analysis ......................................................80
9.1.2 Differential Thermal Analysis (DTA) .......................80
9.1.2.1 Characteristics ...........................................80
9.1.2.2 Applications ...............................................81
9.1.3 Dynamic Mechanical Analysis (DMA) ....................81
9.1.3.1 Principles of DMA .....................................81
9.1.3.2 Instrument and Working of DMA .............81
9.1.4 Thermomechanical Analysis (TMA) ........................82
9.1.4.1 Instrumentation of TMA ............................82
9.1.4.2 Applications of TMA .................................83
9.2 Conclusion ...............................................................................84
References ..........................................................................................84
Chapter 10 Validation of Herbal Drugs ................................................................85
10.1 Introduction .............................................................................85
10.2 Concept of Validation ..............................................................86
10.3 Validation of Herbal Drugs .....................................................86
10.4 Process Validation ...................................................................87
10.5 Validation According to WHO ................................................87
10.6 Value Addition .........................................................................87
10.7 Conclusion ...............................................................................88
References ..........................................................................................88