100年度中藥摻西藥（壯陽藥）檢驗之能力試驗

為瞭解我國實驗室對於中藥摻西藥（壯陽藥）之檢測能力，本局首次於100年度舉辦中藥摻西藥（壯陽藥）能力試驗，測試項目包括tadalafil （犀利士主成分）、sildenafil （威而鋼主成分）及yohimbine （育亨賓）等3項，測試樣品係以市售中藥粉為基質，每瓶測試樣品內含2種壯陽藥，每種壯陽藥各含2種不同濃度，並將其分為3組，每間實驗室隨機分配2組測試樣品。能力試驗期間並同時執行檢體均一性與穩定性試驗，評估結果良好，參與的實驗室有9家，包括2縣市衛生局及7家民間實驗室，其中通過本局認證該項目之實驗室有2家，包括1家縣市衛生局。測試結果與設定值相符合者為合格標準，判定為滿意；與設定值不符合之測試結果，判定為不滿意。9家實驗室中tadalafil評列為滿意者佔88.9%，sildenafil評列為滿意者佔100.0%，yohimbine評列為滿意者佔66.7%。本局認證之實驗室均評列為滿意，顯示通過該認證之實驗室對中藥摻西藥之檢驗能力表現較好。透過本次能力試驗，藉由實驗室間檢驗技術之能力比對，提供實驗室持續改進其品質管理系統外，亦可作為本局實驗室認證管理之參考。

關鍵字

能力試驗；中藥；西藥；壯陽藥；犀利士；威而鋼；育亨賓

並列摘要

A proficiency test was held for the first time in 2011 to evaluate the analytical competence of multiple laboratories for Chinese herbal medicine adulteration (aphrodisiac). The commercial Chinese herbal medicine powder was used as the testing materials that showed consistent and effective in terms of homogeneity and stability. A total of 9 laboratories participated in the test, including 2 and 7 laboratories from local health bureaus and private sectors, respectively.The analytical results used qualitative analysis into two grading categories as follows: the same as setting as 'satisfactory' and different from setting as 'unsatisfactory'. Among the laboratories evaluated the satisfactory percentages were 88.9, 100.0 and 66.7% for medicines tadalafil, sildenafil and yohimbine, respectively.Laboratories graded in the category of 'unsatisfactory' were all unaccredited laboratories. It showed that laboratories with accredited items were all satisfactory in this proficiency testing. Laboratories are expected to consistently improve their quality control system through this proficiency testing.

並列關鍵字

proficiency test ； Chinese herbal medicine ； adulteration ； aphrodisiac ； tadalafil ； sildenafil ； yohimbine

國際替代計量

100年度中藥摻西藥（壯陽藥）檢驗之能力試驗

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