基于活血化瘀主效成分群的红花注射液质量评价研究

项目名称： 基于活血化瘀主效成分群的红花注射液质量评价研究

项目编号： No.81503241

项目类型： 青年科学基金项目

立项/批准年度： 2016

项目学科： 医药、卫生

项目作者： 高雯

作者单位： 中国药科大学

项目金额： 18万元

中文摘要： 红花是传统的活血化瘀中药，其现代制剂红花注射液是由红花经水提醇沉等工艺加工而得，临床主要用于治疗闭塞性心脑血管疾病。2012年卫生部药品标准对其质量标准进行了提升，但其质量控制指标与药效的关系仍有待进一步研究。本项目拟以化学成分-药效关联为核心，以质量“安全有效、稳定可控”为目的，对红花注射液开展研究，具体包括：（1）红花注射液化学成分及体内代谢产物表征；（2）以原型成分及代谢产物为对象，利用主效成分群迭代筛选策略，寻找能够代表红花注射液活血化瘀疗效的主效成分群，探索成分间可能的协同整合模式；（3）通过多样本量效关联分析，探讨制剂中主效成分群的含量变化对药效的影响，建立以主效成分群为标示量的红花注射液质量控制新模式。本研究将促进中药质量评价模式逐步从“单成分、指标成分、部分评价”向“多成分、药效成分、整体评价”转变，为中药药效物质及质量控制研究提供借鉴。

中文关键词： 红花注射液；活血化瘀；主效成分群；量效关系；质量控制

英文摘要： Carthami Flos (Safflower), a traditional Chinese medicine, is used as an anticoagulation drug in China for a long time. The Safflower injection was prepared by extracts of Carthami Flos for the treatment of occlusive cerebrovascular disease. Although the quality control standard of Safflower injection were improved by Ministry of Health in 2012, the relations between chemical components and pharmacodynamics were still ambiguous. Our researches will focus on the relations between chemical components and pharmacodynamics of Safflower injection, and aim to establish a safe and effective quality control method. Firstly, we will characterize the compounds and its metabolites from Safflower injection and then prepare these compounds; Secondly, screening the main components which possess the ability of anticoagulation is carried on by exploring the association between pharmacodynamics and prototype components and its metabolites; In the end, the quality control standard of Safflower injection will be determined through the content-response relationship, in vivo activity tracing and the contents of main components which possess the ability of anticoagulation. This study intends to promote the quality control of traditional Chinese medicine, gradually changing from single-component, index components, partial control to multi-component, medicinal ingredients, the overall control, and make a revolutionary investigation in quality control of traditional Chinese medicine research.

英文关键词： Safflower Injection;Blood-activating and stasis-dissolving;Main-therapeutic combinatorial components;Dose-effect relationship;Quality control