A Clinician's Guide to Using Granule Extracts by Eric Brand Published by: BLUE POPPY PRESS A Division of Blue Poppy Enterprises， Inc. 1990 North 57th Court， Unit A BOULDER， CO 80301 First Edition， June 2010 ISBNl-891845-51-9 ISBN 978-1-891845-51-2 LCCN #2010907367 COPYRIGHT @ BLUE POPPY PRESS， 2010. All Rights Reserved. All rights reserved. No part of this book may be reproduced， stored in a retrieval system， transcribed in any fonn or by any means， e1ectronic， mechanical， photocopy， recording， or any other means， or translated into any language without the prior written permission of the publisher. DISCLAIMER: The information in this book is given in good faith. Howeve乌 the author and the publishers cannot be held responsible for any error or omission. The publishers wiU not accept liabilities for any injuries or damages caused to the reader that may result from the reader's acting upon or using the content contained in this book. The publishers make this information avail­ able to English-language readers for research and scholarly purposes only. The publishers do not advocate nor endorse self-medication by laypersons. Chinesemedicine is a professional medicine. Laypersons interested in availing themselves of the treatments described in this book should seek out a qualified professional practitioner of Chinese medicine. 10 9 8 7 6 5 4 3 2 1 Printed at Edwards Brothers， Ann Arbor，扣1I on acid free paper and soy inks Cover and text design by Eric Brearton with Honora L. Wolfe Table of Contents Dedication . .. .. vii Preface ............................................ ix 1 Why a Book on Granules? . 1 2 What are Granules? ................. ...... .... ..... 7 The Process of Making Granules - Overview . 8 Understanding Excipients . 9 Understanding the Granule Production Process . 11 Types of Finished Product . .. 24 3 Global Trends in Concentrated Extracts. .27 Taiwan. ... ..........................................29 Mainland China . 31 Korea . .33 4 Understanding Concentration Ratios. 35 What Concentration Ratios Can Tell Us and What They Cannot . 35 -E ·I -E iv A Clinician's Guide to Using Granule Extracts Standardized Extracts and Liquid Extracts. ， ， • • • • • • • 36 The Influence of Excipients on Concentration • • • • • • • • • Ratios . .. ， .38 Variability of Finished Products . .41 Creating Consistency with ζoncentration Ratios . ， • • • .44 5 Dosing Guidelines for Granule Products . ， • • 53 Understanding the Basics with Loose Granules . 53 Dealing with Items that may not be Concent 旧ted.. 55 Main Approaches to Granule Dosage . ， • • • • • • ， • . • • • • • • 63 Dosing Formulas Made From Singles . .. ， • • • • ， • • • • • • • • • • • 86 Dosage When Combining Formulas . 90 Conclusion . ， ， • • • • • • • • • • • • • • • • • • • • • • • • • • • • • .…. 92 6 The Art of Formula Combining ..... ..... ....... ..... ....95 Combining Formulas and Using Base Formulas . ， ， • 97 Small Formula Units . ， • • • • • • • • • • • • ， • • • • • • • 126 Challenges in Formula Combining ....... .... .......... ..140 Case Studies ....................................... 142 7 Setting Up a Granule Pharmacy . 147 • • • • • How to Assess Granule Products. ， • • 147 Compounding Granules and the FDA . 149 Setting Up . 150 Conclusion . 155 Advantages ..... ....... ............. ..............156 • • • ， • • • • • Disadvantages .. ， • • • 157 Table of Contents v The Future of Granules in the West . 159 Glossary . .. 163 1. Full Spectrum Extract . .. 163 2. Standardized Extract . 165 3. Concentration Ratio . 166 4. Marker Compounds ................................167 5. Jin Gao Fen (浸膏粉) . 169 6. Spray Drying . 170 7. GMP ................................ ...... .... .170 8. Excipient ............ ...........................170 9. Ke Li (颗粒) ......... ... ........................ ..170 Appendix: Commonly Used Formulas and Medicinals for Selected Conditions. .. .. 171 Cough ......... ................ ... .... ...... ... 171 Panting ................. .......................... 177 Headache . .. .. 180 Dizziness . .. 185 Eye Diseases . .. 189 Toothache . .. 191 Sore Throat . .. .. 193 Deep-Source Nasal Congestion . .. .. 195 Abdominal Pain . .. 19 8 Vomiting . .. 201 Diarrhea . .. 204 Constipation........................................207 vi A Clinician's Guide to Using Granule Extracts Prolapse of the Rectum ""...... ........ ...... ..... 210 Menstrual Pain . .. .. 210 Stirring Fetus ....... .............. ...... .... ...... 213 Vaginal Discharge ................. ...... ............ 214 Chest Pain .... .......... ...... ，...... ......，....，.. 216 • • • • • • • • • • • • • . • • • •• Water Swelling . ， • • • • • • 218 Sweating Patterns .... ... ，............. ，.... ......，.. 221 • ， • • • • . • • • • • • • • • •• Bibliography . ， • • • . 225 • • • • • •• Generallndex . ， 227 刀lis book is dedicated to the inspirational teachers who have touched my 1价一 Preface Over the past decade， granules have become the most popular adminis­ tration form for Chinese medicine in the West. While granules are well­ known for their convenience and portabilit予few Western practitioners have been adequately exposed to the diverse landscape of clinical styles seen in Asia. Consequently， confusion abounds on issues such as dosage， concentration ratios， and formulation strategies. ηle world of gran叫es is incredibly sophisticated， and practitioners in places such as Taiwan and Japan have been using granules for over 40 years. During my studies in Taiwan， 1 quickly noticed that Taiwanese doctors had a unique style of prescribing gran叫es that was characterized by formula combining and consistent dosing norms. The Taiwanese method was different than what we tended to use in the West， which was based on a mathematical calculation to the raw herb dose weights. Intrigued by the different dosing strategies and formulation styles seen between Taiwan and mainland China， 1 realized that even in the Chi­ nese world there were few texts and resources for approaching the study of granules in a systematic way. With the exception of scientific Iiterature related to plant chemistry and extraction techniques， few aca­ demic titles exist to explore the clinical and cultural issues involved with granules. Most of the people with true expertise in granule manu- IX x A Clinician's Guide to Using Granule Extrac也 fachuing are associated with commercial enterprises or are involved in chemical constituent research; such individuals tend to have a knowl­ edge base that is either highly specialized or potentially biased by their commercial ties. Likewise， most practitioners that use granules clini­ cally have either been exposed to only the Taiwanese method or the mainland Chinese method， and few experts have pioneered academic exchange to compare the two systems. As the陀are few strong prima可resources for studying the culture of granule use， by necessity由is text is not a scholarly work filled with cita­ tions and literature reviews. Rather， it is a practical summ缸y of the ex­ periences and conclusions of a single sincere student who traveled the world to learn more abol1t granules. In the years that 1 spent researching the material that eventually became integrated into吐白book， 1 took many trips th roughout Taiwan and mainland China to visit granule fac­ tories and interview clinical experts. From doctors to researchers to quality control specialists， 1 have tried to ask the right questions to the best experts that 1 can find， but 1 know that my work is still just scratch­ ing the surface. While 1 have learned a great deal along the wa予 1 am al­ ways conscious of the fact 出at my current 山lderstanding remains incomplete and 1 am always humbled by the vast amount of knowledge that still eludes me. It is my sincere hope that由is book will create a foundation for educated discussions abol1t granules， and 1 look forward to the day when more knowledge experts publish works of great schol­ arship that correct my errors and make this small book obsolete. 1 would like to thank the many experts th at have helped me to learn about the art and science of granules. 1 owe a deep debt of gratitude to doctors that are living legends of c1inical medicine， such as Feng Ye， Chang Hen-Hong， and Chang Hsien-Cheh. 1 am also very grateful to the industry experts that patiently answered my manufacturing and QC questions at factories such as Koda， KP， Sunten， Nong's， Guangdong Yi­ fang， Tia叫iang， and many others. My granule knowledge never would have developed without the expert guidance 1 r可�ceived from these ex- cellent clinicians， scientists， and scholars. Finally， 1 am grateful for the feedback and careful editing help that 1 received from the Blue Poppy team， as well as Bob Felt， Nigel Wiseman， Bob Flaws， Charlie Brand， Njemile Carol Jones， and }ocelyn Shinagawa. CHAPTER ONE Whya Book on Granules? …trated herbal extract powders， commonly referred to as c "granules，" are the most common delivery form for Chinese herbal medicine in the West today. Their widespread popularity is due to a va­ riety of factors， chiefly related to convenience， consistency， and safety. However， despite their prominence， most practitioners have only been trained in the clinical use of traditional decoctions and often do not 山1- derstand how to translate 也is knowledge into the effective use of gran­ ules. The aim of this book is to elucidate the clinical trends in granule use， with particular attention to challenging issues such as dosage and formula construction. Most practitioners are drawn to granules because of the convenience they offer. lnde时，