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藥物食品檢驗局調查研究年報

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篇名 市售中藥藥酒品質調查
卷期 16
並列篇名 Survey on the quality of Medicated Liquor
作者 鄭淑晶張麗雲秦玲黃成禹溫國慶廖俊亨
頁次 098-107
關鍵字 中藥藥酒Medicated LiquorTSCI
出刊日期 199809

中文摘要

本調查之檢體係於八十五年九月至十月間自台北縣市地區計購得66件, 扣除藥品許可證已註銷者2件及無藥品許可證字號者1件,計檢驗63件檢體。 本品質調查顯示藥酒之標示不符藥事法第七十五條之規定者占66.7%為最, 内容量未標示及内容量低於標示量95%合計達41.3%居次,其他依序為含醇量 不符者34.9%,内置藥材者占28.6%,比重不符者14.3%,成分不符者6.3%, 外觀顏色不符者4.8%。另外有品名與原核准不符者4件(6.3%),同一藥品許可 證但有二或三種包裝、標籤者亦達9種,其他尚有未標示許可證字號者1件, 已註銷者2件以及變更前之舊產品2件仍流通於市面,或外銷產品流於内銷者3 件等問題。 根據本市售調查中發現,藥酒之含醇量不符者其數值均有偏低情形,故 本組另依衛生署公告之藥酒基準方之組成分量配製探討其含醇量結果,建議 各藥酒基準方含醇量規格建議範圍如下: 五加皮藥酒:以米酒頭為原料酒者為20.0〜29.0%v/v,以高粱酒為原料 酒者為38.0〜47.0%v/v。十全大補藥酒、史國公藥酒、虎骨木瓜藥酒、周公 百歲藥酒、周公百歲藥酒加味、龜鹿二仙藥酒:以米酒頭為原料酒者為25.0 〜34.0%v/v ,以高粱酒為原料酒者為49.0〜58.0% v/v。本調查係本局之比較 檢驗,曾於八十六年一月二十二日發布新聞在案。

英文摘要

In this survey, of 66 samples their results showed the following. 66.7% of the total samples failed to meet the label requirement of the Pharmaceutical Affair Law. 41.3%, 34.9% and 14.3% of the total samples were found to be out of specification with labeled volume, alcohol content and speific gravity respectively. 28.6% of the total samples were found to illegally contain crude drugs in their respective bottles. 6.3% and 4.8% of the total samples failed to meet the items of identification and appearance requirements respectively. There were nine kinds of samples having different packaging and labeling but each with the same permit number. One sample even had no permit number on its label. In spite of having been cancelled or having it s permit numbers changed, two samples were still sold in retail outlets. Three samples belonged to export products but were sold in the domestic marke

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