麻杏甘石湯、四逆散、溫膽湯等三種中藥濃縮方劑之品質評估; Quality Evaluation of Three Chinese Herbal Extracted Preparations - Ma-Xing-Gan-Shi Tang , Si-Ni-San and Wn-Tan-Tong  Produced in Taiwan

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Title:	麻杏甘石湯、四逆散、溫膽湯等三種中藥濃縮方劑之品質評估;Quality Evaluation of Three Chinese Herbal Extracted Preparations - Ma-Xing-Gan-Shi Tang , Si-Ni-San and Wn-Tan-Tong Produced in Taiwan
Authors:	楊琇米;HSIU_ MI YANG
Contributors:	中國醫藥學院中國藥學研究所
Keywords:	濃縮方劑;TLC;HPLC
Date:	1992
Issue Date:	2009-12-22 10:31:56 (UTC+8)
Abstract:	麻杏甘石湯、四逆散、溫膽湯等三種中藥濃縮方劑之品質評估研究生楊琇米中國醫藥學院中國藥學研究所摘要目前國內經評定符合中藥（GMP）濃縮製劑藥廠約有二十餘家，生產各種濃縮方劑及單味製劑，由於各廠製劑售價高低不一，其產品品質究竟如何，值得進一步評估。本研究選擇三種中國醫藥學院附設醫院中藥局使用量較大之三種成方（麻杏甘石湯、四逆散及溫膽湯）為材料，評估其各種品質指標，每一種方劑收集全省市售廠牌8種進行市場品調查外，並與傳統煎劑進行比較，且進行下列各項藥典中生藥製劑之一般化學評估：（1）含菌量測試（2）顯微鏡鏡檢試驗（3）乾燥減重測定（4）灰分測定（5）酸不溶性灰分（6）標準湯劑稀乙醇抽提物測定（7）稀乙醇抽提物之含量測定（8）重金屬含量檢測每一個方劑之不同市場品以其中兩種指標成分以薄層層析分析（TLC），並利用高效液相層析（HPLC）定量予以比較，以確實瞭解台灣市售各種中藥GMP產品之品質情形。就本研究而言，在麻杏甘石湯、四逆散及溫膽湯之各項實驗結果中，得知各藥廠生產之濃縮方劑間的差異頗大，可能由於添加原藥材粗粉而造成含菌量之增加，其中麻杏甘石湯及四逆散表現特別明顯，在經12小時生菌數及沙門氏桿菌的培養之後就全部變色；而溫膽湯卻是在大腸桿菌數測試上較明顯。而顯微鏡鏡檢試驗更發現各藥廠所生產之濃縮方劑皆含有植物纖維；根據行政院衛生署中醫藥委員會，有關申請中藥藥品查驗登記須知規定，亦可加適當中藥原末當賦形劑，其微生物限量規定應比照賦形劑之規定。乾燥減重中的結果中顯示，第五家廠商三種成方製劑的含水百分率最低，但灰分測定及酸不溶性灰分測定之結果卻是第一家廠商較低，得知各藥廠在添加賦型劑時，使用量多寡不一，且乾燥及洗淨過程、運送、保存皆有所不同；而濃縮製劑與標準湯劑水煎煮物所做稀乙醇抽提物的測定更是明顯差異。重金屬檢測試驗的結果雖然皆在標準內，但與原生藥材及水煎煮之粗抽濃縮物間就有明顯的差異；就四逆散而言，濃縮製劑與原生藥材及水煎煮之粗抽濃縮物做比較，鎘及鉛的試驗結果是前者比後兩者低，但砷及銀的含量則是完全相反；行政院衛生署的公告中除了在九十二年七月八日公告有關杜仲等七種中藥材之重金屬限量標準及其相關規定的草案外，少有中藥重金屬的限量規定。薄層層析定性檢驗 (TLC)、高效液相層析法(HPLC)定量試驗之結果中，得知各藥廠在藥材成分含量上仍有顯著差異；藥材的基原、採收部位及採收季節的不同，也會造成指標成分的差異。依行政院衛生署八十九年七月二十四日公告中，就指出麻杏甘石湯需檢附指標成分之定量規格及圖譜等資料。而未曾經行政院衛生署核准之收載於固有典籍之處方則應檢附處方內二成分之高效液相層析法(HPLC)之檢驗方法及圖譜。為確保民眾用藥之安全，及供中醫界用藥之參考，建立各種標準檢測方法及限度規定是必要的，如此才能加速落實中藥GMP制度。; Summary Quality Evaluation Three Chinese Herbal Extracted Preparations Produced in Taiwan of Ma-Xing-Gan-Shi Tang ,Si Ni San, and Wn Tan Tong by Hsiu Mi Yang Graduate Institute of Chinese Pharmaceutical Sciences China Medical College There are more than 20 Pharmaceutical factories manufacturing extracted Powder preparations of Chinese crude drugs in Taiwan. The market price of these preparations varied from company to company. We compared the quality of these preparations and also evaluated the quality between the Chinese herbal formulas preparations and the tranditional Chinese crude drugs. This project selected five most commonly used Chinese herbal formulas preparations ( Ma Xing Gan Shi Tang, Si Ni San, Wn Tan Tong ) used in the China Medical College Hospital. We evaluated the quality between the Chinese herbal formulas preparations and the traditional Chinese crude drug based on the following parameters : ( 1 ) Loss on drying ( 2 ) Total ash content ( 3 ) Acid insoluable ash content ( 4 ) Dilute alcohol extract content We also used TLC, HPLC to compare the quality of preparations between the pharmaceutical factories. The analysis showed the quality of products from different factories varied dramatically. The National Health Bureau should enforce the quantitive analysis of the herbal products so as to guarantee their quality. Finally, we wish the Bureau of National Health Insurance can offer different rates to the healthy organizations, based on the quality of herbal preparations so as to improve the quality of the treatment and accelerate the quality control of G.M.P. products.
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