复方灵丹胶囊成型工艺及质量控制考察  

Molding Process and Quality Control Investigation of Compound Lingdan Capsules

作　　者：王化宇[1] 孟美[1] 任钰[1] 张炜煜[1] 

机构地区：[1]长春中医药大学,长春130117

出　　处：《中国实验方剂学杂志》2013年第9期55-59,共5页Chinese Journal of Experimental Traditional Medical Formulae

基　　金：吉林省科技发展计划项目(20110949)

摘　　要：目的:优选复方灵丹胶囊的成型工艺并建立其质量标准。方法:采用干法制粒技术,通过单因素试验优选复方灵丹胶囊成型工艺;采用TLC对处方中丹参和山豆根进行定性鉴别;采用HPLC测定丹参酮IIA和丹酚酸B含量。结果:优选的成型工艺为取处方量药材提取物,加3%滑石粉,混合均匀,干法制粒,填充于0号胶囊。丹参和山豆根的薄层鉴别斑点清晰,阴性无干扰;丹参酮ⅡA在0.155～0.003 1 g.L-1呈良好线性关系,平均回收率100.9%,RSD 1.25%;丹酚酸B在0.035～1.750 g.L-1呈良好线性关系,平均回收率101.1%,RSD 1.52%。结论:胶囊的成型工艺操作简单,所建立的质量控制方法专属性强,重复性好,可用于复方灵丹胶囊的质量评定。Objective：To optimize molding process of compound Lingdan capsules and establish its standard.Method：Dry granulation technology was adopted,molding technology of compound Lingdan capsules was optimized by single factor test;TLC was used for qualitative identification of Salvia miltiorrhiza and Sophora tonkinensisi;The content of tanshinone IIA and salvianolic acid B was determined by HPLC.Result：The best molding process of compound Lingdan capsules was as following：took prescription amount herbs extracts,added 3% talc,mixed evenly,dry granulating and then filled into 0 capsule.The spots of S.miltiorrhiza and S.tonkinensisi on TLC plates were clear without interference by the blank reference;Anshinone IIA showed a good linear relationship at the range of 0.155-0.003 1 g · L-1,the average recovery was 100.9% with RSD of 1.25%;Salvianolic acid B showed a good linear relationship at the range of 1.750-0.003 5 g·L-1,the average recovery was 101.1% with RSD of 1.25%.Conclusion：This optimized process was simple and stable.This established quality control method was specific and reproducible,which could be applied to quality assessment of compound Lingdan capsules.

关 键 词：复方灵丹胶囊 成型工艺 质量标准 

分 类 号：R283.6[医药卫生—中药学]