市售四十種中藥材化學規格及兒茶與青黛主成分含量測定之研究;Studies on the Chemical Specification of Forty Chinese Crude Drugs and Quantitative Analysis of Major Ingredients of Ercha and Qingdai

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题名:	市售四十種中藥材化學規格及兒茶與青黛主成分含量測定之研究;Studies on the Chemical Specification of Forty Chinese Crude Drugs and Quantitative Analysis of Major Ingredients of Ercha and Qingdai
作者:	吳麗娟;Li-Chuan Wu
贡献者:	中國醫藥大學：中國藥學研究所博士班
关键词:	中藥材;乾燥減重;總灰分;酸不溶性灰分;稀醇抽提物;水抽提物;HPLC;Chinese herbs;Chemical specification;loss on drying;total ash;acid-insoluble ash;diluted ethanol-soluble extractive;water-soluble extractive
日期:	2006-05-27
上传时间:	2009-08-11 10:25:24 (UTC+8)
摘要:	行政院衛生署中醫藥委員會經數年努力完成國內第一部中華中藥典（已改名台灣傳統藥典），於九十三年三月九日公告，並自九十三年五月一日起實施，其中所列各藥材之化學規格，大部份仰賴行政院衛生署藥物食品檢驗局過去數年在中醫藥委員會所資助之研究經費下完成。第一版中華中藥典收載中藥品項僅200種，距離大陸中華人民共和國藥典及日本藥局方收載之品項仍有相當大之距離，須在再版中增補品項，因此未來新收載品項之化學規格的建立，實為極重要之課題。本研究針對大陸藥典2000年版一部收載但中華中藥典中未收載之中藥材品項，去除台灣地區較少或未見使用之品項，選擇八角茴香、人參葉、太子參、牛蒡子、川牛膝、懷牛膝、味牛膝、火麻仁、石膏、北沙參、玄明粉、半邊蓮、半枝蓮、肉蓯蓉、血竭、決明子、紅大戟、紅花、蒼朮、穀精草、沉香、卷柏、草果、黑胡椒、白胡椒、柿蒂、胖大海、蓮鬚、海金沙、桑螵蛸、紫草、紫菀、黑芝麻、馬勃、西紅花、冰片(合成龍腦)、赤石脂、青果、兒茶、青黛等四十種藥材，分別赴全省北、中、南、東各地購買市場品每種藥材皆20件，計800件之檢品，就乾燥減重、總灰分、酸不溶灰分、稀醇抽提物及水抽提物等項目進行試驗。另外並選擇青黛、兒茶二種藥材進行指標成分catechin、epicatechin、indigo、indirubin進行含量分析。收集之40種藥材中，其中海金沙為不易收集之品項，海金沙摻雜有泥沙之品項有18項，並且發現有以蒲黃偽海金沙有1項，共收集39個品項，才收齊20項正確的海金沙，另外有五種藥材原本也要進行其化學檢測。但因山慈菇、貫眾不易購得正確的藥材，亞麻子難以購得，芒硝品質不易控制，粉防己品種混亂不易區別而無法進行。部份藥材如海金沙、貫眾、山慈菇等不易購得正品，另外粉防己、沉香、冰片等藥材在藥店之等級價位差距極大，將來測定規格標準時以何等級為準，須再斟酌。本實驗以統計學原理訂定檢體數據之Mean ± S.D. 為實驗建議值，作為上述四十種藥材各項試驗之參考規格，以供參考。並於94年12月9日邀請國內部分GMP數家中藥廠與藥檢局代表討論實驗結果，再加上彙集文獻中相關檢驗資料一並整理歸納。綜合以上結果，四十種藥材中，每種藥材各檢體之五項試驗結果，與其Mean ± S.D.值比較，其中乾燥減重、總灰分、酸不溶性灰分三項之試驗值分部低於Mean＋S.D.值者，以及稀醇抽提物、水抽提物兩項之試驗值分部高於Mean－S.D.值者，單一藥材二十件檢體之五項檢驗結果皆尚屬分佈於合理範圍之藥材，四十件藥材中有三十八件皆符合合理範圍。僅有玄明粉及兒茶之數值差異較大。 Most of the crude drugs sold in Taiwan markets were imported from Mainland China, the quality of the drugs may vary due to various factors. In order to assure the quality of the crude drugs, a guide line for the quality control of the crude drugs is essential which includes their origin, morphological characteristics and chemical specifications. Through years of efforts, Committee of Chinese Medicine and Pharmacy, completed the first version of Chinese Herbal Pharmacopeia and was, announced on March 9, 2004 and implemented on May 1, 2004. The pharmacopeia was renamed as Taiwan Herbal Pharmacopeia in 2004. The first version included 200 Chinese crude drugs species. The chemical specification of those items were based on the data from three prerious projects carried out by Bureau of Food and Drug Analysis, Department of Health, sponsored by Committee of Chinese Medicine and Pharmacy. However the items included were too less comparing to the numbers of items included either in the Pharmacopeia, PRC, 2000 or Japanese Pharmacopeia, 14th Edition, 1996. More items should be included in the upcoming revised version. Then chemical specification of those new items needed to be established. In view of this demands, the Committee of Chinese Medicine and Pharmacy listed the establishment of chemical specification of crude drugs as priority projects. This study selected 40 commonly used items which were recorded in PRC Pharmacopeia but not in Taiwanese Herbal Pharmacopeia. Twenty specimen of each herbs were Purchased around the island. A total of 800 specimen were collected. Five tests including loss on drying, total ash, acid-insoluable ash, diluted ethanol-soluable extractive, water-soluable extractive of 20 samples of each herbs were analyzed. Additionally, Ercha and Qingdain were selected for HLPC analysis of their marker constituents. The statistical analytic values of 20 specimen, Mean+S.D. or Mean-S.D. were recommended as standard criteria. Among the 40 species collected, Spora Lygodii was found to be adulterated with sand and Pollen Typhae. Initially Cremastrae Seu Pleiones Psaudobulbus, Dryopteridis Crassirhizomatis Rhizoma, Lili Semen, Sulfas Natrii and Stephaniae Tetrandrae Radix were included in the items for chemical specification identification and were deleted due to difficulties in collecting enough correct sample for analysis. During the project period, we also consulted staffs from Bureau of Food and Drug Analysis and QC staffs from some GMP Pharmaceutical factories to ensure the feasibility of the specification. The results will be provided as major references for revising the new edition of the Taiwanese Herbal Pharmacopeia.
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