药用辅料——高分子聚合材料测定方法的正交试验  

The orthogonal test study of pharmaceutical polymeric materials determination

作　　者：江旭光[1,2] 储成顶[1,3] 鲍时根[3] 朱玉俊[3] 

机构地区：[1]安徽医科大学理化中心,安徽合肥230032 [2]安徽城市管理职业学院,安徽合肥230061 [3]合肥工业大学控释药物研究所,安徽合肥230009

出　　处：《安徽大学学报（自然科学版）》2012年第3期95-100,共6页Journal of Anhui University(Natural Science Edition)

基　　金：安徽省"十一五"科技攻关重点资助项目(06013062A);安徽省教育厅自然科学基金重点资助项目(KJ2007135AZC)

摘　　要：设计正交试验,建立药用辅料——高分子聚合材料测定方法.以L9(34)正交试验考查该方法的4个重要因素及水平.确立方法后按2010年中国药典要求做方法学研究.结果表明:该法检测的线性范围为2～100μg.mL-1;r=0.999 8;检出限为0.5μg.mL-1;该方法的平均回收率为0.96;日内RSD为0.02.该方法符合2010年中国药典关于杂质限量检测方法的规定,是检测此类PLLA辅料中乳酸含量的可行方法.A determination method of pharmaceutical polymeric materials was established by designing an orthogonal test. Four important factors and levels of the method were examined by orthogonal test [ L9 （34） 1. Then the research methodology was done according to Pharmacopoeia of People＇s Republic of China 2010. The linear range was from 2 to 100 μg·mL-1（ r =0.999 8） ,the detection limit was 0.5 μg· mL-1 ,the average recovery was 0.96, intraday RSD was 0.02. The method has met the detection rule of limited impurities according to Pharmacopoeia of People＇s Republic of China 2010. It was feasible to measure the level of lactic acid in this kind of PLLA adjuvant.

关 键 词：正交试验 高分子聚合材料 PLLA 乳酸 

分 类 号：O655.9[理学—分析化学]