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 6000 Broken Sound Parkway NW, Suite 300 Boca Raton, FL 33487-2742 © 2019 by Taylor & Francis Group, LLC CRC Press is an imprint of Taylor & Francis Group, an Informa business No claim to original U.S. Government works Printed on acid-free paper International Standard Book Number-13: 978-1-138-03694-9 (Hardback) This book contains information obtained from authentic and highly regarded sources. Reasonable efforts have been made to publish reliable data and information, but the author and publisher can- not assume responsibility for the validity of all materials or the consequences of their use. 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CCC is a not-for-profit organization that provides licenses and registration for a variety of users. For organizations that have been granted a photocopy license by the CCC, a separate system of payment has been arranged. Trademark Notice: Product or corporate names may be trademarks or registered trademarks, and are used only for identification and explanation without intent to infringe. 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 Visit the Taylor & Francis Web site at http://www.taylorandfrancis.com and the CRC Press Web site at http://www.crcpress.com 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