升红颗粒质量标准研究

Study on quality standard of Shenghong Granules

目的：建立升红颗粒的质量控制标准。方法：采用薄层色谱法（TLC）对制剂中鸡血藤、花生红衣进行定性鉴别;采用高效液相色谱法（HPLC）对制剂中儿茶素进行含量测定。色谱柱：SEPAX Amethyst C_（18）（4.6mm×250mm,5μm）;流动相：水-甲醇-乙腈-冰醋酸（90∶5∶5∶0.4）;流速：0.8ml/min;检测波长：280nm;柱温：35℃。结果：TLC谱斑点清晰,分离度良好,阴性对照无干扰。儿茶素进样量在0.0982~3.9269μg范围内与其峰面积积分值呈良好的线性关系（r=0.9999）;平均加样回收率为92.32%,RSD=2.72%（n=6）。结论：该方法简便、快捷、重现性好,可用于升红颗粒的质量控制。

Objective To establish the quality standard of Shenghong granules. Methods Spatholobi Caulis and Testa Arachis in formulation were qualitatively identified by TLC, and the content of catechin was determined by HPLC. The determination was performed on SEPAX Amethyst ClS column with mobile phase consisted of watermethanol -acetonitrile - glacial acetic acid （90： 5： 5： 0. 4） at the flow rate of 0. 8 ml/min. The detection wave length was set at 280 nm, and column temperature was 35μ. Results The TLC spots were fairly clear and well - separated, and the negative control showed no interference. The cateehin showed a good linear relationship at a range of 0. 0982 -3.9269μg, （r =0. 9999）. The average recovery was 92. 32% , and RSD was 2. 72 % （n =6）. Conclusions The established methods are simple, quick and good reproductive, and can be used for the quality control for Shengbong Granules.