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台灣地區市售安比西林(AMPICILLIN)膠囊製劑力價之調查

An Investigation for the Potency of Ampicillin Capsules in Taiwan Area

摘要


本計畫於民國80年度,由全省各縣市抽購國產及進口安比西林(Ampicillin)。服膠囊製劑共50件,其中國產46件,進口4件。依據U.S.P. XXII之高效液相析法(High Performance Liquid chromatograph),日本抗生物質醫藥品慕準解說(MRAP)上所載之分光光度法及微生物法測定其力價,結果有5件未達合格標準,不合格率為10.0%。

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並列摘要


In order to understand the potency of ampicillin capsules, fifty samples (46 domestic, 4 imported) were purchased from different counties and cities in Taiwan during September 1990 to March 1991. All of the samples were deter-minecylinder-plate method and optical method as described in Minimum Requirements for Antibiotic Products of Japan. The results showed that 5 samples (10.0%) failed to meet the potency requirement of the government regulation (90-120%).

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