复方茵陈颗粒的质量标准研究

Quality Standard of Compound Yinchen Granules

目的建立复方茵陈颗粒的质量标准。方法采用TLC鉴别法对制剂中茵陈、黄芩、大黄、甘草4种药味进行定性鉴别;以HPLC法测定黄芩中的黄芩苷的含量：色谱柱为Agilent SB-C18（4.6 mm×250 mm,5μm）,流动相为甲醇-0.2%磷酸溶液（52∶48）,检测波长为280 nm。结果各供试品TLC,在与对照品或对照药材相应的位置上显相同颜色的斑点,阴性对照无干扰;黄芩苷在0.0416~1.0390μg范围内线性关系良好,r=1.0000。结论本法操作简单,重复性好,能够有效地控制复方茵陈颗粒的质量。

Objective To establish a quality standard for compound Yinchen granules. Methods The chief components of the preparation： Herba Artemisiae Scopariae,Radix Scutellariae,Radix Et Rhizoma Rhei and Licorice,were identified by TLC qualitatively. The content of baicalin in Radix Scutellariae was determined by HPLC.The separation was performed on Agilent SB-C18（ 4. 6 mm × 250 mm,5 μm） with a mobile phase consisting of methanol-0. 2% phosphoric acid solution（ 52∶ 48）. Results The spots in TLC were clear without interference. The linear range of baicalin was 0. 0416- 1. 0390 μg（ r = 1. 0000）. Conclusion This method is simple,accurate and reproducible,which can be used for quality control of compound Yinchen granules.