抗抑鬱藥及呼吸道用藥之品質監測

Surveillance on the Quality of Marketed Antidepressant and Respiratory System Drugs Preparations in Taiwan

楊明玉(Ming-Yu Yang) ； 張淑涵(Shu-Han Chang) ； 呂理福(Li-Fu Liu,) ； 黃明權(Ming-Chuan Huang) ； 鄒玫君(Meir-Chyun Tzou)

《食品藥物研究年報》 1期 (2010/11) Pp. 131-139

https://doi.org/10.6945/ARFDR.201011.0131

摘要

本調查計畫以風險評估為原則，98年度選定抗抑鬱藥trazodone hydrochloride成分及呼吸道用藥loratadine與terbutaline sulfate成分之藥品進行品質監測。自民國98年1月至6月間委由全國各縣下衛生局，赴轄區內醫院診所、藥局及製藥廠抽驗市售檢體共32件，其中trazodone hydrochloride成分者11件（均屬國產）；loratadine成分者14件（國產11件，輸入3件）；terbutallne Sulfate成分者7件（均屬國產）。參照中華藥典第六版及美國藥典第31版之檢驗規格及方法，進行一般檢查（外觀、平均重量（內容量））、主成分鑑別、溶離度試驗、含量均一度試驗及含量到定等項目檢驗。檢驗結果均符合規定。

關鍵字

抗抑鬱藥 ； 呼吸道用藥 ； trazodone hydrochloride ； loratadine ； terbutaline sulfate

並列摘要

In order to survey the quality of the marketed antidepressant and respiratory system drugs preparations in Taiwan area, a total of 32 samples, including trazodone hydrochloride antidepressant preparations, and loratadine or terbutaline sulfate respiratory system drugs preparations, were acquired from different counties and cities in Taiwan from January to June 2009. Samples were analyzed by the methods as described in the Ch. P. VI, USP 31 with authorized specifications. The items of analysis included the appearance, average weight, identification, assay, dissolution, and content uniformity. All samples met the compendia requirements for trazodone hydrochloride, loratadine and terbutaline sulfate.

並列關鍵字

antidepressant preparations ； respiratory system drugs preparations ； trazodone hydrochloride ； loratadine ； terbutaline sulfate