篇名 | 廣告類中藥製劑之品質調查-保肝、補腎滋養類 |
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卷期 | 18 |
並列篇名 | Survey on the Quality of Commercial Chinese Herbal Preparations-Hepatic Category, Renaltonic Category |
作者 | 秦玲 、 林秀珍 、 盧芬鈴 、 鄭淑晶 、 黃成禹 、 溫國慶 、 林哲輝 、 廖俊亨 |
頁次 | 079-086 |
關鍵字 | 中藥製劑 、 保肝類 、 補腎滋養類 、 品質調查 、 Chinese herbal preparations 、 Hepatic category 、 Renaltonic category 、 Survey 、 TSCI |
出刊日期 | 200009 |
此次調查之檢體係於民國八十六年九、十月間自行自台北、高雄縣市之各藥房 購得60件及各縣市衛生局於民國八十七年十二月至八十八年五月間抽驗39件檢體, 總計99件(其中包括保肝類75件,補腎滋養類24件)。依各產品原查驗登記規格與 方法包括:外觀、平均重量、重量差異、崩散度、總灰分、酸不溶性灰分、重金 屬、成分比對等檢驗及標示檢查。檢驗之結果,99件中有34件不符規定佔34.3%, 其中檢出處方外成分者達14件(14.1%),酸不溶性灰分不符者10件(10.1%),灰分不 符者8件(8.1%),重量差異不符者6件(6.1%),平均重量不符者6件(6.1%),檢出防腐 劑Sorbic acid成分者2件(2.0%)及崩散度不符者1件(1.0%)。至於標示檢查不符藥事 法第七十五條之規定者11件(11.1%)。本調查結果,曾於八十八年九月十七日發佈新 聞在案。
In this survey, ninety-nine samples (including seventy-five samples for Hepatic category, twenty-four samples for Renaltonic category) were analyzed to evaluate the quality, the results showed the following. Fourteen(14.1%) of the total samples were found to illegally contain crude drugs that formulas were not labelled. Ten(10.1%), eight(8.1%), six( 6.1%) and one(1.0%) of the total samples were found without the specification of acid insoluble ash, total ash, weight variation n average weight and disintegration respectively. Two(2.0%) samples were found to be adulterated with antiseptic Sorbic acid. Eleven(ll.l%) of the total samples failed to meet the labelling requirement of Pharmaceutical Affair Law.