- 期刊
102年度抗凝血劑、類固醇及抗生素等製劑之品質監測
Surveillance on the Quality of Anticoagulant Corticosteroid and Antibiotic Preparations in Taiwan
摘要
102年度藥品品質監測計畫係以風險評估為原則，參考國內外不良品回收事件不合格率較高、生產過程易產生類緣化合物／分解物、慢性病患長期使用之藥品及近期使用率漸增且國內尚未執行該品項之品質監測等評估因子，選定抗凝血劑（含clopidogrel bisulfate成分）與類固醇（含betamethasone成分）等口服劑型及抗生素（含amoxicillin成分）口服及注射劑型之市售品進行藥品品質監測，並於1至9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85件（國產67件，輸入18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、含量測定及類緣化合物相關項目等試驗之檢驗。總計85件檢體中1件不合格，不合格檢體及項目為含betamethasone成分之溶離度試驗。
並列摘要
In order to survey the quality of the marketed anticoagulant agents, corticosteroid oral dosage form preparations and antibiotics oral dosage form or injection preparations in Taiwan area, eighty five samples of clopidogrel bisulfate/betamethasone/amoxicillin preparations were acquired from different counties and cities in Taiwan from January to September in 2013. Samples were analyzed by the methods described in the Ch. P. 7/USP 35 with authorized specifications. The analytical items included identification, dissolution, content uniformity, assay and percentage of related compounds. The results showed that one sample failed to meet the specification of dissolution. Others met the compendia requirements.
延伸閱讀
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