臺灣地區市售安比西林膠囊製劑力價之調查   全文下載

Quality of Taiwan Pharmaceuticals: Survey of Ampicillin Capsules

本計畫係於民國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，進行下列各分析項目之檢驗，其中包括外觀、平均重量、重量均一度、鑑別、力價、溶離度、含量均一度及水份含量。檢驗結果有5件檢體力價及含量均一度未達合格標準，不合格率為10.0%。另有3件檢體溶離度不符藥典規定，不合格率為6.0%。

In order to understand the quality of ampicillin capsules, fifty samples (46 domestic, 4 imported) were purchased from different counties and cities in Taiwan during 1991 fiscal year. All of the samples were investigated for appearance, mean weight, weight uniformity, identification of drug, potency, dissolution, content uniformity, and loss on drying. The results showed that 5 samples (10.0%) failed to meet the potency requirement of the official regulation (90- 120%) and the contents of uniformity. Besides, there were three samples (6.0%) did not meet the specification of dissolution test.