- 期刊
含類固醇類（betamethasone esters）外用製劑之品質監測
Surveillance on the Quality of Marketed Betamethasone Esters Topical Preparations in Taiwan
摘要
100年度藥品品質監測計畫係以風險評估為原則，選定含類固醇類（betamethasone esters）成分之外用製劑進行藥品品質監測，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、代理商及製藥廠抽驗市售檢體共90件（國產82件，輸入8件），參考美國藥典第34版之檢驗規格及方法，開發並經確效可同時檢測betamethasone、betamethasone acetate、betamethasone benzoate、betamethasone dipropionate、betamethasone 17-valerate、betamethasone 21-valerate及betamethasone 21-aldehyde等西藥成分之定性及定量分析方法，進行含量測定及層析法純度檢查之分析。總計90件檢體中16件含量測定不合格。不合格率為17.8%。另外在層析法純度檢查之背景值調查部分，有47件檢體檢出betamethasone 21-valeate成分，3件檢體檢出betamethasone成分，12件檢體檢驗分析之層析圖譜中有其他類似betamethasone成分特徵光譜之層析峰出現，90件檢體均未檢出betamethasone 21-aldehyde成分。
並列摘要
In order to survey the quality of the marketed topical corticosteroid (betamethasone esters) preparations in Taiwan area, a total of 90 samples of topical betamethasone dipropionate/valerate preparations were acquired from different counties and cities in Taiwan from January to June 2011. Samples were tested by a stability high-performance liquid chromatographic method that has been developed and validated for the analysis of betamethasone, betamethasone acetate, betamethasone benzoate, betamethasone dipropionate, betamethasone 17-valerate, betamethasone 21-valerate and betamethasone 21-aldehyde in topical dosage forms, in accordance with USP 34th ed. The results showed that 16 samples (17.8%) failed to meet the specification of assay.