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

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）口服膠囊製劑共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基準解說（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%。

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%).