中药中有害残留物痕量检测分析方法验证原则探讨

Discussion of analytical method validation in trace analysis for harmful residues in Chinese herbs

中药中有害残留物分析属于痕量分析范畴,技术难度较高,分析方法验证技术要求不同于常规的常量或微量分析。为进一步规范该类分析工作,保证分析质量,参考国内外食品、农产品相关法定规程并结合作者实际工作经验,制订了相关的技术规程。本文探讨了痕量残留分析方法验证过程中校准、准确度、精密度、专属性、灵敏度、耐用性等的技术要求。

The analytical method for harmful residues in Chinese herbs belongs to the scope of trace analysis which is difficult in technique. Its technical requirements are different from normal constant and trace analysis. In order to standardize this kind of analysis and guarantee the analytical quality, relative technical regulations were established with reference to the actual experience and the legal regulations for food and agricultural products at home and a- broad. This article introduces the technical requirements for validation of analytical method adopted in trace analy- sis, such as calibration, accuracy, precision, specificity, sensitivity, ruggedness.