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題 名 | 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 |
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作 者 | 黃秋羽; 楊明玉; 王博譽; 陳玉盆; 施養志; | 書刊名 | 食品藥物研究年報 |
卷 期 | 3 2012.11[民101.11] |
頁 次 | 頁204-209 |
分類號 | 412.36 |
關鍵詞 | 類固醇; 外用製劑; Betamethasone; Betamethasone esters; Betamethasone dipropionate; Betamethasone valerate; Topical corticosteroid preparations; |
語 文 | 中文(Chinese) |
中文摘要 | 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。 |
英文摘要 | 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. |
本系統中英文摘要資訊取自各篇刊載內容。