扶正化瘀方中多种组分的定量测定

Quality evaluation for Fuzheng Huayu drug delivery system

目的对扶正化瘀方(丹参、虫草菌丝、绞股蓝、五味子及松花粉)进行质量评价研究,旨从效应组分层面、有效成分层面,多维地体现其内涵质量。方法采用HPLC法测定扶正化瘀方君药效应组分中丹酚酸B和原儿茶醛;采用比色法测定绞股蓝总皂苷、绞股蓝总多糖及虫草总多糖。结果 3批扶正化瘀方中总皂苷平均质量分数为0.148 mg/g,平均回收率为101.7%,RSD为2.67%;总多糖平均质量分数为73.24 mg/g,平均回收率为96.45%,RSD为1.05%;丹酚酸平均质量分数为52.98 mg/g,平均回收率为101.59%,RSD为1.87%;原儿茶醛平均质量分数为1.05 mg/g,平均回收率为100.87%,RSD为2.40%。结论所建立的分析方法灵敏度高,准确性、重复性及稳定性均良好,可用于扶正化瘀方的质量控制。

AIM To establish the quality evaluation for Fuzheng Huayu drug delivery system（Savia miltiorrhiza Radix et Rhizoma,Cordyceps Mycelium,Gynostemmatis pentaphylli Herba,Schisandrae chinensis Fructus,Pini Pollen）.METHODS HPLC method was used for determining the contents of salvianolic acid b and protocatechuic aldehyde of Savia miltiorrhiza Radix et Rhizoma.UV spectrophotometric method was used for determining total saponin and polysaccharides of Gynostemmatis pentaphylli Herba,and total polysaccharides of Cordyceps.RESULTS Average ginsenoside Rb1 content in three batches of Fuzheng Huayu drug delivery system was 0.148 mg/g.The average recovery was 101.7% and the RSD was 2.67%.Average glucose content was 73.24 mg/g.The average recovery was 96.45% and the RSD was 1.05%.Average salvianolic acid B content was 52.98 mg/g.The average recovery was 101.59% and the RSD was 1.87%.Average protocatechuic aldehyde content was 1.05 mg/g.The average recovery was 100.87% and the RSD was 2.40%.CONCLUSION The method is high sensitive,accurate,reproducible and stable.It can be used for the quality control of FuzhengHuayu drug delivery system.