泄热一号颗粒质量研究

Quality Research of Xiereyihao Particles

目的制定制剂泄热一号颗粒的质量控制指标。方法对制剂中胆南星、瓜蒌、枳实3味药材采用TLC法进行定性鉴别,大黄药材中的大黄素和大黄酚总量采用RP-HPLC法测定。结果 TLC斑点分离好、清晰、阴性无干扰;大黄素、大黄酚分别在0.031 68-0.316 8μg、0.032 896-0.328 96μg范围内线性关系良好,r均为0.999 9,平均回收率分别为98.17%、99.34%,RSD分别为1.53%、2.88%。结论本实验所用方法对制剂的质量能够达到有效控制。

Objective Study on the quality research of hospital preparations xiereyihao particles. Methods By thin layer chromatography bile arisaema,trichosanthis fructus,fructus aurantii immaturus were differentiated,and to develop a HPLC method for determination of emodin,chrysophanol in rhubarb. Results The TLC spots developed were quite clear; emodin and chrysophanol were in good linearity over the ranges of 0. 031 68 ~ 0. 316 8 μg、0. 032 896 ~ 0. 32896 μg respectively,r were 0. 999 9,the average recoveries were 98. 17% 、99. 34%,with RSD of1. 53% 、2. 88% respectively. Conclusion This method can be used for quality control of hospital preparations xiereyihao particles.