生物样品测定分析方法中提取回收率的探讨

发布时间：2018-04-24 03:36

本文选题：药代动力学 + 回收率　；参考：《中华中医药杂志》2015年03期

【摘要】：目的:验证提取回收率的范围限定是否应当列入生物样品测定方法学规范中。方法:以芍药苷为代表药物,大鼠血浆为基质,分别采用蛋白沉淀法(PP)和固相萃取法(SPE)进行生物样品的前处理,对所得的精密度、准确度和提取回收率3个主要指标进行数据分析,并进行口服给药后大鼠体内芍药苷药时曲线的测定。结果:不同前处理方法所得的样品,在精密度、准确度两项指标上并无数理统计差异,提取回收率存在显著差异,但对大鼠口服芍药苷的药动学指标检测并无影响,两种方法均测得芍药苷均在30min有最大吸收,Cmax-PP=(597.49±58.90)ng/m L,Cmax-SPE=(615.50±22.52)ng/m L。结论:在药物研发中,根据被测药物的浓度、基质效应的影响,合理选择前处理方法,而不将提取回收率限定范围作为方法学确证的判断指标是值得提倡的环保经济的研究原则。
[Abstract]:Objective: to verify whether the range limit of extraction recovery should be included in the methodology of biological sample determination. Methods: Paeoniflorin was used as representative drug and rat plasma as matrix. Protein precipitation method and SPE method were used to pretreat biological samples. Three main indexes of accuracy and recovery were analyzed, and the time curve of paeoniflorin in rats after oral administration was determined. Results: there was no statistical difference in precision and accuracy between different pretreatment methods, and there was significant difference in extraction recovery, but there was no effect on pharmacokinetics of paeoniflorin taken orally in rats. Both methods showed that paeoniflorin had the maximum absorption in 30min (597.49 卤58.90)ng/m / L) and Cmax-SPE (615.50 卤22.52)ng/m / L). Conclusion: according to the influence of drug concentration and matrix effect in drug development, the pretreatment method should be selected reasonably. However, it is worth advocating the research principle of environmental protection economy that the limit range of recovery rate is not taken as the judgment index confirmed by methodology.
【作者单位】：北京中医药大学中药学院;清华大学生物医学测试中心;
【基金】：国家科技重大专项课题(No.2012ZX09103201-026)~~
【分类号】：R961

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