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

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II_A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Ⅱ_A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。

Abstract:

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 II_A 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 II_A 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.