川菊止痛胶囊质量标准研究

Study on Quality Standards for Chuanju Zhitong Capsule

目的:制定川菊止痛胶囊(批准文号:黑药制字Z20100226)的质量控制方法。方法:本实验运用薄层色谱法(TLC)定性鉴别川菊止痛胶囊中葛根、防风两味中药,高效液相色谱法(HPLC)用于测定葛根素和洋川芎内脂A的含量。结果:葛根、防风薄层色谱斑点分离效果好、显色清晰、无干扰且重复性好;高效液相色谱法(HPLC)用于建立川菊止痛胶囊中葛根素和洋川芎内脂A的含量测定方法,测得3批样品中葛根素的质量分数为2.60、2.64、2.56 mg/g,3批样品中洋川芎内脂A的质量分数为2.21、2.18、2.20 mg/g,其葛根素与洋川芎内脂A线性范围分别为32～192、256.3～768.9μg/mL,葛根素与洋川芎内脂A回归方程分别为Y=6.62×105X-800(r=0.9999)、Y=8.562×105X-20630(r=0.9998),平均回收率分别为98.86%(RSD 1.56%)、98.77%(RSD 1.62%)。结论:本实验成功建立川菊止痛胶囊质量控制方法,所建立方法操作简便、研究结果准确、重复性好,可用于川菊止痛胶囊主要成分的定性鉴别和含量测定。

Objective:To establish the quality standards for Chuanju Zhitong Capsule. Methods:The thin-layer chromatography was used for qualitative identification of Puerariae lobatae Radix and Saposhnikoviae Radix. HPLC was used for quantitative detected of puerarin and senkyunolide A. Results:The separation effect of Puerariae lobatae Radix and Saposhnikoviae Radix TLC spots was good and clear with the characteristics of no-interference and good repeatability. HPLC method was used for determined the content of puerarin and senkyunolide A. The content of puerarin in three batches of samples was determined as 2.60,2.64,2.56 mg/g,and the senkyunolide A of puerarin in three batches of samples was determined as 2.21,2.18,2.20 mg/g. The calibration curve of puerarin and senkyunolide A were 32-192μg/mL,256.3-768.9μg/mL,respectively. The regression equation of puerarin and senkyunolide A were Y=6.62×10^5 X-800(r=0.9999)and Y=8.562×10^5 X-20630(r=0.9998),respectively. The recovery of puerarin and senkyunolide A were 98.86%(RSD 1.56%)and 98.77%(RSD 1.62%). Conclusion:This method could used for quality control of Chuanju Zhitong Capsule,and this method was simple,accurate and reproducible,it can be used for qualitative identification and content determination of main constituents of Chuanju Zhitong Capsule.