降血糖用藥之品質監測

Surveillance on the Quality of Marketed Antidiabetic Preparations in Taiwan

本監測計畫以風險評估為原則，選定含Glipizide成分之最常用降血糖用藥進行品質監測。於民國97年1月至6月間，由全國21縣市衛生局，赴轄區內醫院診所、藥局、藥廠、代理商及物流中心抽驗市售含Glipizide成分降血糖用藥檢體共計13件，國產品10件，輸入品3件。參照中華藥典第六版、USP 30版及各該藥品原核准查驗登記之檢驗規格及方法，進行一般檢查「外觀、平均重量（內容量）及重量（內容量）差異」、主成分鑑別、溶離度試驗、含量均一度試驗及含量測定等重點項目檢驗，結果1件國產品檢體外觀及平均重量與原核准檢驗規格不符，判定不合格。不合格率7.7%。不合格產品已函送原抽驗衛生單位依違反藥事法處辦。

In order to survey the quality of the marketed antidiabetic preparations in Taiwan area, a total of 13 samples of Glipizide antidiabetic preparations were acquired from different counties and cities in Taiwan during January thru June 2008. Samples were analyzed by the methods as described in the Ch. P. VI with authorized specifications. The items of analysis included the appearance, average weight, identification, assay, dissolution and content uniformity. The results indicated that one sample (7.7%) failed to meet the specification of appearance and average weight. Others met the compendial requirements for Glipizide.