103年度中藥製劑摻加西藥成分檢驗之能力試驗

Results of Proficiency Testing in 2014: Chinese Herbal Medicine Adulteration

廖彩汝(Cai-Ru Liao)；江爾蕓(Erh-Yun Chiang)；李婉媜(Wan-Chen Lee)；吳正寧(Zheng-Ning Wu)；李明鑫(Ming-Shin Lee)；蔡淑貞(Shu-Jean Tsai)

能力試驗 ； 中藥 ； 西藥 ； proficiency testing ； Chinese herbal medicine ； adulteration

食品藥物研究年報

6期（2015 / 12 / 01）

295 - 300

繁體中文

103年度舉辦檢驗機構對於中藥製劑摻加西藥成分之檢驗能力試驗，測試樣品係以市售科學中藥粉末(大柴胡湯)為基質，添加Carbetapentane(感冒藥類)、Furosemide(降壓、利尿類)、Metformin(治糖尿病類)、Vardenafil(補腎滋養類(壯陽類))等4種西藥成分，其判定標準係以各測試項目之定性結果評定。參與本次能力試驗之檢驗機構有11家(包括5縣市衛生局及6家民間檢驗機構)，測試結果評列為「滿意」有9家(81.8%)，「不滿意」有2家檢驗機構(18.2%)，其中參加之檢驗機構為食品藥物管理署(下稱食藥署)認證項目者計5家，皆呈滿意結果。透過本次能力試驗，可知檢驗機構對中藥製劑摻加西藥成分之檢驗能力表現良好，另提供檢驗機構間檢驗技術能力鑑別之機會，除可作為檢驗機構持續改進其品質管理系統之參考，亦為食藥署監控認證檢驗機構檢驗品質依據之一。

A proficiency test was held in 2014 in order to understand the analytical competency of laboratories in testing for Chinese herbal medicine adulteration. A total of 11 laboratories participated in the test, including 5 and 6 laboratories from local health bureaus and private sectors, respectively. The analytical results were obtained using qualitative analysis. The sample of Chinese herbal medicine powder was spiked with Carbetapentane, Furosemide, Metformin and Vardenafil, and was shown to be consistent and effective in terms of homogeneity and stability. Among the laboratories evaluated, the satisfactory percentages were 90.9, 100.0, 90.9 and 100% for Carbetapentane, Furosemide, Metformin and Vardenafil, respectively. 9 and 2 laboratories were graded as satisfactory and unsatisfactory, respectively. Laboratories graded as ‘unsatisfactory’ were all unaccredited laboratories. Laboratories with accredited items were all found to be satisfactory in this proficiency testing. This test also provided the opportunity for laboratories to assess their performance in relation to other laboratories and make necessary improvements to their quality system.