注射用益气复脉(冻干)的质量标志物研究

Study on quality marker of Yiqi Fumai Lyophilized Injection

注射用益气复脉(冻干)是由红参、麦冬和五味子3味药材精制而成,临床上主要用于治疗冠心病劳累型心绞痛气阴两虚证及冠心病所致慢性左心功能不全II、III级气阴两虚证。根据质量标志物概念,从物质基础、药效、网络药理、药动学及药性等方面对注射用益气复脉(冻干)质量标志物进行预测分析,初步确定人参皂苷Rb1、Rg1、Rf、Rh1、Rc、Rb2、Ro、Rg3及麦冬皂苷C、麦冬苷元-3-O-α-L-吡喃鼠李糖基-(1→2)-β-D-吡喃葡萄糖苷、偏诺皂苷元-3-O-α-L-吡喃鼠李糖基-(1→2)-β-D-吡喃木糖基-(1→4)-β-D-吡喃葡萄糖苷、果糖、五味子醇甲13个成分为质量标志物,并以此为核心建立全程质量控制体系。基于质量标志物对注射用益气复脉(冻干)进行质控方法研究,可以为中药注射剂质量评价提供新的研究思路。

Yiqi Fumai Lyophilized Injection is a modern preparation composed of Panax ginseng,Ophiopogon japonicas,and Schisandra chinensis.Clinically,it is mainly used for the treatment of cardiovascular diseases such as angina pectoris of coronary heart disease and chronic cardiac insufficiency.According to the concept of quality markers(Q-markers),the Q-markers of Yiqi Fumai Lyophilized Injection were predicted and analyzed from the aspects of chemical components,drug effect,network pharmacology,pharmacokinetics,and drug property.Based on the above studies,13 components of ginsenosides Rb1,Rg1,Rf,Rh1,Rc,Rb2,Ro,Rg3,ophiopojaponin C,phiogenin-3-O-α-L-rhamnopyranosyl-(1→2)-β-D-glucopyranoside,pennogenin-3-O-α-L-rhamnopyranosyl-(1→2)-β-D-xylopyranosyl-(1→4)-β-D-glucopyranoside,fructose,and schisandrin A were identified as Q-markers.According to the Q-markers,we established quality system for process control.The study of Yiqi Fumai Lyophilized Injection based on Q-markers can provide new research ideas for quality assessment of traditional Chinese materia medica injection.