107年度類固醇外用製劑（Betamethasone esters）、抗生素（Levofloxacin）及心血管用藥（Atenolol）等口服製劑之品質監測   全文下載

Quality Surveillance on the Preparations of Steroids (Betamethasone esters), Antibiotics (Levofloxacin) and Cardiovascular Drugs (Atenolol)

107年度藥品品質監測計畫以風險評估為原則，選定含類固醇類（Betamethasone esters）外用製劑、抗生素（含Levofloxacin成分）及心血管用藥（含Atenolol成分）等口服製劑之市售品進行監測，並於1至6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、藥商及製藥廠抽驗市售檢體共97件（國產89件，輸入8件），參照藥典規範及原核准檢驗規格與方法，進行鑑別、溶離度、單位劑量均一度、含量測定及有機不純物等項目之檢驗。總計97件檢體中，不合格者4件，為含Betamethasone valerate成分外用製劑2件之含量測定及含Atenolol成分口服製劑2件之溶離度不符合規定，其餘皆合格，本計畫監測結果將提供作為藥政管理參考。

This study aimed to survey the quality of the marketed topical steroid preparations and oral preparations of antibiotics/cardiovascular drugs in Taiwan. 97 samples in total (89 domestic and 8 imported) were collected from hospitals, clinics, pharmacy, pharmaceutical firms and pharmaceutical manufacturers by local health authorities over the period of January-June 2018. All collected samples were submitted for quality control testing terms, including identification, dissolution, uniformity of dosage units, assay and impurity tests. The analytical methods used in evaluating the individual medicine types were consisted of monographs from “Ch. P. VIII, USP 40-NF35” and in-house methods from the manufactures with authorized specifications. The results showed that 2 samples of topical steroid preparations containing Betamethasone esters did not meet the requirements for drug content and 2 samples of atenolol tablets failed the dissolution test; all other items passed the required standards. The surveillance results of this project will be provided as reference for drug administration and management.