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頁籤選單縮合
題名 | 101年度中藥製劑重金屬殘留檢驗之能力試驗=Results of Proficiency Testing in 2012: Heavy Metals in Chinese Herbal Formulations |
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作者 | 江爾蕓; 李婉媜; 李明鑫; 陳惠芳; | 書刊名 | 食品藥物研究年報 |
卷期 | 4 2013.11[民102.11] |
頁次 | 頁399-409 |
分類號 | 412.36 |
關鍵詞 | 能力試驗; 生化湯; 重金屬; Proficiency testing; Chinese herbal formulations; Heavy metals; |
語文 | 中文(Chinese) |
中文摘要 | 101年度舉辦實驗室對於中藥製劑重金屬檢驗能力試驗,測試樣品係以生化湯為基質,參與測試之實驗室有 23家,包括 1縣市衛生局及 22家民間實驗室。測試結果除以 Robust-Z進行判定,│ Z│≦ 2為滿意, 2<│Z│<3為應注意,│ Z│≧ 3為不滿意外,其結果為應注意或不滿意者再以回收率進行判定,測試結果介於添加值之 80-110%範圍內者評定為「滿意」;介於 70-80%或110-120%範圍內,評定為「應注意」;超出此範圍之測試結果,評定為「不滿意」,各項重金屬評定標準係以 Robust-Z或回收率擇優者為評定結果。評列為「滿意」有 9家(39.1%),「應注意」有 8家(34.8%),「不滿意」有 6家實驗室 (26.1%)。本次參加之實驗室為 TFDA認證項目者共計 9家,其中評列為「不滿意」有 3家實驗室,除提供矯正報告,並以盲樣檢體進行複測後已完成改善。透過本次能力試驗,提供實驗室間檢驗技術能力比較之機會,可作為實驗室持續改進其品質管理系統之參考。 |
英文摘要 | A proficiency test was held in 2012 in order to understand the analytical competence of laboratories in testing for heavy metals in Chinese herbal formulations. The formulations used as the test materials were consistent and effective in terms of homogeneity and stability. A total of 23 laboratories participated in the test.The analytical results were graded using Robust-Z and recovery statistics. The three grading categories of Robust-Z were as follows: |Z| score≦2 was “satisfactory”, 2 < |Z| < 3 was “acceptable” and |Z|≧3 was “unsatisfactory”. The results of spiking experiments were categorized as follows: 80-110% recovery was “satisfactory”, 70-80% or 110-120% recovery was “acceptable” and < 70% or > 120% recovery was “unsatisfactory”. The better of the two results was used. Among the laboratories evaluated, 9, 8 and 6 laboratories were graded as satisfactory, acceptable and unsatisfactory, respectively. Laboratories graded in the category of “unsatisfactory” were required to provide a corrective action report and take a second test. The proficiency test allowed laboratories to monitor and improve their competency and assess their performance in relation to other laboratories. |
本系統之摘要資訊系依該期刊論文摘要之資訊為主。