天舒滴丸正丁醇去除工艺优选及正丁醇残留量检测  

Optimal Technique for Eliminating n-Butyl Alcohol and Determination of n-Butyl Alcohol Vestigial in Tianshu Dropping Pills

作　　者：王锦玉[1] 张旭[1,2] 仝燕[1] 吴建雄[3] 徐连明[3] 王智民[1] 

机构地区：[1]中国中医科学院中药研究所,北京100700 [2]天津中医药大学,天津300073 [3]江苏康缘药业股份有限公司现代中药研究院,江苏连云港222000

出　　处：《中国实验方剂学杂志》2011年第10期15-17,共3页Chinese Journal of Experimental Traditional Medical Formulae

基　　金：“重大新药创制”科技重大专项(2009ZX09301-0052009ZX09308-0032009ZX09313-032)

摘　　要：目的:优选天舒滴丸正丁醇去除最佳工艺,并对其中间体浓缩液进行正丁醇残留量检测。方法:采用正交试验设计,运用气相色谱法测定正丁醇残留量,并以正丁醇残留量为正交试验考察指标,优选最佳工艺。结果:最佳去除工艺为80℃旋转蒸发3次,每次加入0.25倍量水,正丁醇残留量检测方法回收率为101.13%,RSD 1.10%,符合药典规定限量标准。结论:优选得到的去除工艺稳定可行,正丁醇残留量检测方法简便,重复性好,可作为该产品的企业内控质量标准之一。Objective：To establish a optimum process for eliminating n-butyl alcohol in TianShu dropping pills and detect vestigial of n-butyl alcohol in intermediate of concentrated solution.Method：To use the orthogonal experimental design method and be taken as evaluating norms by vestigial of n-butyl alcohol,the analysis of vestigial of n-butyl alcohol was carried out on GC and optimized the conditions.Result：The optimal technique for eliminating n-butyl alcohol was 80 ℃ reduced-pressure distillation with three times.The solution add 0.25 times of water every time.The recovery of eliminating n-butyl alcohol was 101.13% with RSD of 1.10%.Conclusion：The optimal technique was convenient,efficient,accurate,reliable and with good replications.

关 键 词：正舒滴丸 正丁醇 正交试验 气相色谱法 

分 类 号：R283.6[医药卫生—中药学]