摘要
报道综合型试验的建立过程,以建立药用辅料中乳酸测定方法为例介绍综合型试验概念。学生参与编程制作正交分析模板;以正交试验选择考查该方法的4个重要因素及水平。确立方法后按中国药典要求做方法学研究。模板成功建立于Excel平台,正交试验获得了方法优选条件参数,方法按中国药典规定进行论证:线性范围为2～100μg/mL;检出限为0.5μg/mL;平均回收率为0.96;日内RSD为0.02。综合型实验效果较好,所建测定方法已符合2010年中国药典关于杂质限量检测方法的规定,是检测此类辅料中乳酸含量的可行方法。
This paper aims to report the establishment of the process of an orthogonal experiment, and introduce the concept of orthogonal experiment by the example of developing measurement of lactic acid level in pharmaceutical excipient. The orthogonal experiment model was programmed by students. Then four important factors of the method were chosen by orthogonal test. After that research methodology was selected according to the Pharmacopoeia of People＇ s Republic of China 2010. Accordingly, the model was established successfully on Excel. The optimum parameter of the method was chosen by orthogonal experiment, and the method was demonstrated according to the regulation of the Pharmacopoeia of People＇ s Republic of China. The linear range was 2 - 100 μg/ml; the detection limit was 0.5 μg/ ml; the average recovery was 0. 96; and the intraday RSD was 0. 02. Good result is achieved in the orthogonal experiment, which shows that the method established above has met the regulation of the Pharmacopoeia of People＇ s Republic of China 2010, and it is a feasible way to measure the level of lactic acid in this kind of adjuvant.
出处
《实验室研究与探索》
CAS
北大核心
2012年第9期36-39,共4页
Research and Exploration In Laboratory
基金
安徽省教育厅自然科学重点项目(KJ2007135AZC)
安徽省十一五科技攻关重点项目(06013062A)
关键词
综合型实验
分析测试
正交试验
聚乳酸
乳酸
高效液相色谱法
comprehensive experiment
analytical testing
orthogonal experiment
poly L-lactic acid（ PLLA）
lactic acid
high performance liquid chromatography（HPLC）
