芎芍方药物制备物的质量表征及其关联分析

Quality characteristics and correlation analysis of medicinal preparations from Xiongshao Fang

目的确定影响芎芍方药物质量的关键因素,优选出芎芍方的最佳药物制备物形式,为创制芎芍方优质抗偏头痛药物奠定基础。方法以药物体系为基础,采用所建立的HPLC-PDA分析法测定芎芍方制备物中主要有效指标性成分的含量。基于制备物主要有效指标性成分的含量、含量相对比值、相对量以及出膏率和抗偏头痛药效对芎芍方药物制备物的质量进行系统表征,并将质量表征结果进行关联分析。结果 3种芎芍方药物制备物形式均表现出抗偏头痛作用,抗偏头痛作用大小为:富集物>醇提物>水提物。通过芎芍方药物制备物药学—药效质量表征关联分析可知,芎芍方富集物有效指标性成分含量高、出膏率低、用量小且抗偏头痛作用强,为抗偏头痛的最佳药物制备物形式。结论基于药物体系所建立的芎芍方有效指标性成分的含量测定方法操作简便、准确、重复性好,可用于芎芍方药物制备物质量表征研究。关联药学—药效分析得出基于药物体系的基本组成及其制备得率,提高关键有效成分的含量,优化组成比例,是提升药物药效的关键因素。

Objective To determin the key factors affecting the quality of Xiongshao Fang and the best preparation forms of medicinal in Xiongshao Fang, laying the groundwork of anti-migraine drug from Xiongshao Fang. Methods Based on drug system, the content of effective index components of preparation of Xiongshao Fang was detected by using HPLC-PDA. The quality of medicinal preparation from Xiongshao Fang were characterized based on the content, relative quantity, relative ratio of content, yield rate and anti-migraine effect, and the characterized results were given correlation analysis. Results The effect of anti-migraine of three medicinal preparations from Xiongshao Fang was listed in the following descending order of enrichment, ethanol extract, and water extract. The enrichment was the best preparation form of medicinal in Xiongshao Fang with the highest content of effective index components, lowest extract rate, lowest dosage and best effect of anti-migraine, resulted from the medicine-efficacy correlation analysis. Conclusion The method of the determination of effective index components from Xiongshao Fang is easy to handle, accurate and highly reproducible. Based on the basic composition and extraction rate of medicinal system, the key factor of increasing medicinal efficacy is promotion of the content and optimization of proportion of the relative effective components.