基于组分结构理论的丹参滴注液的多维结构过程动态质量控制研究  

Study on "multi-dimensional structure and process dynamics quality control system" of Danshen infusion solution based on component structure theory

作　　者：封亮[1] 张明华[1,2] 顾俊菲[1] 王桂有 赵自育 贾晓斌[1,3,2] 

机构地区：[1]江苏省中医药研究院国家中医药管理局中药释药系统重点研究室,江苏南京210028 [2]江苏大学药学院,江苏镇江212013 [3]安徽天洋药业有限公司,安徽天长239304

出　　处：《中国中药杂志》2013年第21期3622-3626,共5页China Journal of Chinese Materia Medica

基　　金：国家自然科学基金项目(81202906);江苏省自然科学基金项目(BK2012491);江苏省中医药领军人才项目(2006)

摘　　要：中药制剂产品成分复杂、制剂工艺过程环节众多,实行符合中药制剂产品特征的质量控制是中药制剂产品临床疗效和安全性的切实保证。丹参滴注液是中医临床常用的一种制剂,但其质量控制局限于成品的单一指标,无法保证丹参滴注液的内在质量。本课题组曾基于"组分结构理论"提出"多维结构过程动态质量控制"的技术体系,从与功效相关物质基础、安全性相关物质基础、滴注液剂型特征以及制剂工艺过程动态多环节、多层次地对丹参滴注液的质量进行控制。该文为中药制剂产品的质量控制提供了新的见解和模式。As traditional Chinese medicine（TCM） preparation products feature complex compounds and multiple preparation processes, the implementation of quality control in line with the characteristics of TCM preparation products provides a firm guarantee for the clinical efficacy and safety of TCM preparation products. Danshen infusion solution is a preparation commonly used in clinic, but its quality control is restricted to indexes of finished products, which can not guarantee its inherent quality. Our study group has proposed ＂multi-dimensional structure and process dynamics quality control system＂ on the basis of ＂component structure theory＂, for the purpose of controlling the quality of Danshen infusion solution at multiple levels and in multiple links from the efficacy-related material basis, the safety-related material basis, the characteristics of dosage form to the preparation process. This article, we bring forth new ideas and models to the quality control of TCM preparation products.keywords：Danshen infusion solution

关 键 词：丹参滴注液 组分结构理论 质量控制 多维结构 过程动态 

分 类 号：R286.0[医药卫生—中药学]