臺灣地區市售安比西林(Ampicillin)膠囊製劑效價之調查

An Investigation on Amplicillin Potency in Taiwan Area

10.6946/ASRNL.198609.0031

張天馨(Tien-Hsin Chang)；陳溢松(Yih-Song Chen)；陳玉儀(Yu-Yi Chen)

藥物食品檢驗局調查研究年報

4號（1986 / 09 / 01）

31 - 32

繁體中文

於民國73年5-6月間，由全省各縣市抽驗國產及進口安比西林(Ampicillin)製劑共302件（其中國產276件，進口26件），依據C.F.R. 1981§ 436.204碘定量滴定法測試其力價，發現國產安比面林製劑有95件未達合格標準，不合格率為34.4%。進口品有5件未達合格標凖，不合格率為19.2%。依x^2測驗分析結果，國產與輸入安比西林製劑品質無顯著差異。但是，此結果可能是取樣數目懸殊所造成。

Three hundred and two ampicillin drugs were collected from different counties and cities of Taiwan during May to June of 1984. Among them, 276 samples were domestic and 26 imported. The potency of them was analyzed quantitatively by the iodometric method. The ampicillin potency hi 95 domestic samples (ca. 34.4%) and 5 imported samples (ca. 19.2%) was found to be under 90%. The domestic and imported ampicillin drug were compared by the X^2 test and no significant difference was found. The fact that the potency of one third of the domestic ampicillin drugs in the market was under the 90-120% potency requirement of the government regulation needs close attention.