110年度降血壓藥（含Valsartan成分）、降血脂藥（含Atorvastatin calcium及Pitavastatin calcium成分）及降血糖藥（含Acarbose成分）等口服製劑之品質監測   全文下載

Surveillance on the Quality of Oral Preparations of Antihypertensives, Anti-hyperlipidemic Agents, and Anti-diabetic agents in Taiwan, 2021

110年度藥品品質監測計畫係以風險評估為原則，選定降血壓藥（含Valsartan成分）、降血脂藥（含Atorvastatin calcium及Pitavastatin calcium成分）及降血糖藥（含Acarbose成分）等口服製劑市售品進行品質監測，並於1至8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、製造廠及藥商抽驗產品共82件（國產60件，輸入22件），參照中華藥典第八版、美國藥典第43版、日本藥典第17版、食品藥物管理署公開建議檢驗方法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、有機不純物及亞硝胺類化合物等項目之檢驗。結果82件檢體中，計有2件含Atorvastatin calcium成分製劑之含量測定不符合原廠規格，其中1件之有機不純物亦不符合其原廠規格，本計畫監測結果將提供作為行政管理參考。

This study aimed to survey the quality of the marketed oral preparations of antihypertensives, antihyperlipidemic agents and anti-diabetic agents in Taiwan. A total of 82 samples (60 domestic and 22 imported) were collected from hospitals, clinics, pharmacies, pharmaceutical firms and pharmaceutical manufacturers by local health authorities over the period of January to August 2021. All samples collected were inspected for quality control testings, including identification, assay, dissolution, uniformity of dosage units, organic impurities, and nitrosamines impurities. The analytical methods applied in evaluation consisted of the regulations of Ch. P VIII, USP 43, JP XVII, TFDA-published testing methods and in-house methods from the manufactures with authorized specifications. The results indicated that 2 out of the 82 samples did not meet the requirements, including two samples of atorvastatin calcium tablets failed to meet the authorized specification of drug content, and one of them also failed to meet the authorized specification of organic impurities. The surveillance results will be used for administrive management reference.