台灣地區市售安莫西林(AMOXICILLIN)膠囊製劑力價之調查

An Investigation for the Potency of Amoxicillin Capsules in Taiwan Area

范燕珍(Yann-Jen Fann) ； 林玉珊(Yu-Shan Lin) ； 許美智(Mei-Chich Hsu) ； 林嘉伯(Chia-Po Lin)

《藥物食品檢驗局調查研究年報》 10號 (1992/09) Pp. 21-25

https://doi.org/10.6946/ASRNL.199209.0021

摘要

本計畫於民國80年度，由全省各縣市抽購國產及進。安莫西林(Amoxicillin)口服膠囊製劑共50件，其中國產47件，進口3件。依據U.S.P.XXII之高效液相層析法(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4件未達合格標準，不合格率為8.0%。

並列摘要

In order to understand the potency of amoxicillin capsules, fifty samples (47 domestic, 3 imported) were purchased from different counties and cities in Taiwan during September 1990 to March 1991. All of the samples were determin performance liquid chromatographic method, the cylinder-plate method and optical method as described in the United State Pharmacopeia and the Minimum Requirements for Antibiotic Products of Japan. The results showed that 4 samples (8.0%) failed to meet the potency requirement of the government regulation (90-120%).