祛风止痛颗粒的质量标准研究

Study on quality standard of Qufeng Zhitong granules

目的建立祛风止痛颗粒的质量标准。方法采用薄层色谱（TLC）法对方中补骨脂、青风藤进行定性鉴别;采用高效液相色谱法（HPLC）对方中补骨脂所含补骨脂素和异补骨脂素的质量分数进行测定,以Agilent Elipse-plus C18（4.6 mm×250 mm,5μm）为色谱柱,甲醇-水（体积比43∶57）为流动相,检测波长为246 nm。结果在TLC中能检出补骨脂、青风藤的特征斑点,且阴性对照无干扰。补骨脂素在0.048 3-0.482 6μg范围内,异补骨脂素在0.046 7-0.466 5μg范围内与峰面积积分值呈良好线性关系,r值均为0.999 9,平均加样回收率分别为99.28%、98.78%,RSD值分别为1.69%、0.89%（n=9）。结论所建立的方法简便准确、快速、专属性高、重复性好、结果可靠,可用于祛风止痛颗粒的质量控制。

Objective To establish the quality standard of Qufeng Zhitong granules. Methods TLC was used for the qualitative identification of Psoraleae fructus and Sinomenii caulis. Agilent Elipse-plus Cl8 column was used with the mobile phase of methanol-water （43：57）, and the detection wavelength was set at 246 nm. Results The TLC spots were clear and well-separated without interference of negative samples. The linear relationship of psoralen was good within the range of 0.048 3-0.482 6 μg （r = 0.999 9）, and the linear relationship of isopsoralen was good at the range of 0.046 7-0.466 5 μg （r= 0.999 9）. The average recoveries were 99.28% （RSD = 1.69%） and 98.78% （RSD = 0.89%） （n = 9）, respectively. Conclusion The method is simple and accuracy, quick, highly specific and reliable with good repeatability, which could be used for the quality control of Qufeng Zhitong granules.