101年度中藥製劑重金屬殘留檢驗之能力試驗

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。

關鍵字

能力試驗；生化湯；重金屬

並列摘要

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.

並列關鍵字

proficiency testing ； Chinese herbal formulations ； heavy metals

國際替代計量

101年度中藥製劑重金屬殘留檢驗之能力試驗

全文下載

主題瀏覽