抗高血壓藥之品質監測

Surveillance on the Quality of Marketed Antihypertensive Preparations in Taiwan

以風險評估為原則，選定含diltiazem hydrochloride或indapamide成分之抗高血壓藥進行品質監測。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抗高血壓藥共計37件，其中含diltiazem hydrochloride成分者20件（國產16件，輸入4件）；含indapamide成分者17件，（國產12件，輸入5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，結果全部合格。

In order to survey the quality of the marketed antihypertensive preparations in Taiwan area, a total of 37 samples, including diltiazem hydrochloride and indapamide antihypertensive 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, USP 30 with authorized specifications. The items of analysis included the appearance, average weight, identification, assay, dissolution, and content uniformity. All samples met the compendial requirements for diltiazem hydrochloride and indapamide.