疏风解毒胶囊的系统质量标准提升研究

Promotion on systematic quality standard of Shufeng Jiedu Capsule

提出中药材和复方中药质量研究思路和模式,应用该模式方法对疏风解毒胶囊原料药材和制剂进行了系统的质量标准提升研究。对虎杖、连翘、板蓝根、柴胡、败酱草、马鞭草、芦根、甘草8味药材的化学物质组进行辨识,指认确定184个成分,建立8个药材的指纹图谱;通过化学物质组与抗炎药效相关性研究,确定10个成分为疏风解毒胶囊的主要抗炎药效物质基础,建立了疏风解毒胶囊的多指标成分定量测定方法和指纹图谱控制方法。实现对疏风解毒胶囊质量标准的全面提升。

The idea and model of quality research on traditional Chinese medicinal materials and compound Chinese materia medica were established and this method was applied tO systematical promoting the quality standard of raw herbal materials and preparation of Shufeng Jiedu Capsule （SJC）. The chemical components from Polygoni Cuspidati Rhizoma et Radix, Forsythiae Fructus, lsatidis Radix, Bupleuri Radix, Patriniae cum Radice Herba, Verbenae Herba, Phragmitis Rhizoma, and Glycyrrhizae Radix et Rhizoma were identified and 184 compounds were determined. The fingerprints of the eight medicinal materials were established, 10 compounds were identified as the anti-inflammatory substance of SJC by studying the correlation between chemical components and their anti-inflammation effect. The methods of multi-component determination and fingerprint controlling have been established and the quality standard of SJC has been improved comprehensively.