廣告類中藥製劑之品質調查－－保肝、補腎滋養類   全文下載

Survey on the Quality of Commercial Chinese Herbal Preparations-Hepatic Category, Renaltonic Category

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、average weight and disintegration respectively. Two (2.0%) samples were found to be adulterated with antiseptic Sorbic acid. Eleven (11.1%) of the total samples failed to meet the labelling requirement of Pharmaceutical Affair Law.