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廣告類中藥製劑之品質調查-補心、減肥類

Survey on the Quality of Commerical Chinese Herbal Preparations-Sedative Category, Anorexic Category

摘要


本調查之檢體係於民國八十八年九月至八十九年五月間由各縣市衛生局抽得50件檢體(其中包括補心類27件,減肥類23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、成分比對等之檢驗及標示之檢查。檢驗結果,50件檢體中有14件不符規定,佔28.0%,其中酸不溶性灰分不符者8件(16.0%),總灰分不符者7件(14.0%),平均重量不符者及檢出防腐劑Sorbic acid成分者各為3件(6.0%),外觀項不符者及檢出處方外成分者各為l件(2.0%)。至於標示不符藥事法第七十五條之規定者l件(2.0%)。上述檢驗結果,均逐案函覆原送地方衛生機關依法處理。

並列摘要


In this survey, fifty samples (including twenty-seven samples for Sedative Category, twenty-three samples for Anorexic Category) were analyzed to evaluate the quality, and the results were as following. Eight (16.0%), seven (14.0%), three (6.0%) and one (2.0%) of the total samples failed to meet the specification of acid insoluble ash, total ash, average weight and appearance respectively. Three (6.0%) of the total samples were found to be adulterated with antiseptic Sorbic acid. One (2.0%) of the total samples was found to illegally contain crude drugs that formulas were not labelled. Another one (2.0%) of the total samples did not meet the labelling requirement of Pharmaceutical Affair Law.

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