治療指數狹窄之口服製劑品質監測   全文下載

Surveillance On The Quality of Marketed Oral Preparations Whose Active Ingredients Have A Narrow Therapeutic Index In Taiwan, 2022

111年度藥品品質監測計畫係以風險評估為原則，選定治療安全範圍較狹窄之成分（含Levonorgestrel、Levothyroxine、Phenobarbital、Phenytoin及Warfarin成分）之口服製劑市售品進行品質監測，並於1至7月間委由全國各地方政府衛生局，前往轄區內醫院、診所、藥局、藥商及製造廠抽驗產品共計32件（國產25件、輸入7件），參照中華藥典第九版、英國藥典2022及原核准檢驗規格與方法，進行主成分鑑別、含量測定、溶離、劑型單元含量均一度、有機不純物等項目之檢驗。經檢驗32件檢體皆符合規定。

This study aimed to survey the quality of the marketed oral preparations containing active ingredients with a narrow therapeutic index, including Levonorgestrel, Levothyroxine, Phenobarbital, Phenytoin, and Warfarin. A total of 32 samples (25 domestic and 7 imported) were collected from hospitals, clinics, pharmacies, pharmaceutical firms and pharmaceutical manufacturers by local health authorities over the period of January-July 2022. All samples collected were inspected for quality control testings, including identification, assay, dissolution, uniformity of dosage units, and organic impurities. The analytical methods applied in evaluation consist of the regulations of Taiwan Pharmacopeia 9th edition, the British Pharmacopoeia 2022, and in-house methods from the manufactures with authorized specifications. The results indicated that all of the 32 samples met the requirements.