105年度心血管用藥、解熱鎮痛藥品藥及抗生素等製劑之品質監測   全文下載

Quality Surveillance Study on the Preparations of Cardiovascular Drugs (Atenolol), Antipyretic Analgesics (Acetaminophen) and Antibiotics (Rifampin)

105年度藥品品質監測計畫係以風險評估為原則，選定心血管用藥（含Atenolol成分）、解熱鎮痛藥品（含Acetaminophen成分）及抗生素（含Rifampin成分）等口服劑型之市售品進行藥品品質監測，並於1至6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88件（國產80件，輸入8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、含量測定及乾燥減重等項目之檢驗。結果88件檢體中，不合格者5件，為含Acetaminophen成分之製劑2件及含Atenolol成分之製劑3件的溶離度不符合規定；其餘部分皆合格。本計畫監測結果將提供藥政管理參考。

This project surveyed oral preparations of cardiovascular drugs, antipyretic analgesics, and antibiotics for the quality test in the Taiwan market. Eighty eight medical preparations contained atenolol, acetaminophen, or rifampin were supported by the local health authorities sampled from the hospitals, clinics, pharmacy, pharmaceutical firms, and pharmaceutical manufacturers in Taiwan during January to June in 2016. Samples were analyzed by the methods described in the Ch. P. VII/USP 38 with authorized specifications. Several test items such as identification, dissolution, uniformity of dosage units, assay, and loss on drying were included. The results showed that two and three samples of acetaminophen and atenolol contained drug preparations, respectively, failed in the specification of dissolution. The surveillance results of this project will be provided to drug administration and management for reference.