106年度類固醇外用製劑（triamcinolone acetonide）及口服製劑（dexamethasone）之品質監測

Study of Quality Surveillance on the Topical Steroids Preparations (Triamcinolone Acetonide) and Oral Steroids Preparations (Dexamethasone) in 2017

106年度藥品品質監測計畫係以風險評估為原則，選定類固醇外用製劑（triamcinolone acetonide）及口服製劑（dexamethasone）等市售品進行藥品品質監測，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71件（國產68件，輸入3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、單位劑量均一度及含量測定等項目之檢驗。總計71件檢體中，不合格者1件，為triamcinolone acetonide外用製劑之含量測定項不符合規定；其餘部分皆合格。本計畫監測結果將提供作為藥政管理之參考。 This project surveyed the quality of topical and oral steroid preparations on the market in Taiwan. From January to June 2017, local health authorities acquired 71 samples of triamcinolone acetonide topical preparations and dexamethasone oral preparations from hospitals, clinics, pharmacy, pharmaceutical firms and pharmaceutical manufacturers. These samples were analyzed by the methods described in the Chinese Pharmacopoeia VIII/USP 39/USP 40 with authorized specifications. Several test items such as identification, dissolution, uniformity of dosage units and assay were included. The results showed that one sample of topical triamcinolone acetonide preparations failed the test for specification of assay, and all the others met the compendial requirements. The surveillance results of this project will be provided as reference for drug administration and management.