103年度糖尿病治療劑及安眠藥等製劑之品質監測

Surveillance on the Quality of Antidiabetic and Hypnotic Preparations

黃秋羽(CHIU-YU HUANG)；吳珍瑗(CHEN-YUAN WU)；張靜嘉(CHING-CHIA CHANG)；林美智(MEI-CHIH LIN)；陳玉盆(YU-PEN CHEN)；周秀冠 (HSIU-KUAN CHOU)；陳惠芳(HWEI-FANG CHENG)

糖尿病治療劑 ； 安眠藥 ； antidiabetic agents ； hypnotics ； metformin hydrochloride ； zolpidem tartrate

食品藥物研究年報

6期（2015 / 12 / 01）

153 - 158

繁體中文

103年度藥品品質監測計畫係以風險評估為原則，選定糖尿病治療劑(含metformin hydrochloride成分)及安眠藥(含zolpidem tartrate成分)等口服劑型之製劑進行藥品品質監測，並於1至9月間委由全國各縣市衛生局，前往轄區內醫院、診所、藥局、藥商及製藥廠抽驗市售檢體共56件(國產43件，輸入13件)，參照藥典之規範及原核准之檢驗規格與方法，進行鑑別、溶離度、單位劑量均一度、含量測定及類緣化合物等項目之檢驗。總計56件檢體中1件不合格，為含metformin hydrochloride成分製劑之溶離度試驗1件不合格。

In order to ensure the quality of the marketed antidiabetic agents and hypnotic oral dosage form preparations, fifty six samples of metformin hydrochloride and zolpidem tartrate preparations were collected from hospitals, clinics, pharmacy stores and pharmaceutical manufacturers in Taiwan by local health authorities from January to September 2014. Samples were analyzed by the methods as described in the Ch. P. 7 / USP 36 with authorized specifications. The analysis items included appearance, average weight, identification, assay, dissolution, uniformity of dosage unit and organic impurities. Only one sample failed on the specification of dissolution, all the others met the compendia requirements.