金牡感冒片的质量标准研究

Study on Quality Standard of Jinmu Ganmao Tablets

目的：建立金牡感冒片的质量标准。方法：采用薄层色谱法对金牡感冒片中金银花、牡荆根、三叉苦、山甘草、薄荷油进行定性鉴别;采用高效液相色谱法测定制剂中绿原酸的含量,色谱柱为ODS-BP（250 mm×4.6 mm,5μm）,流动相为乙腈-0.1%磷酸溶液（11∶89,V/V）,柱温为25℃流速为1.2 ml/min,进样量为5μl,检测波长为327 nm。结果：金银花、牡荆根、三叉苦、山甘草、薄荷油的薄层色谱图斑点清晰、分离度好、专属性强、阴性无干扰。绿原酸的质量浓度在14.448-168.560μg/ml范围内与峰面积积分值呈良好的线性关系（r=0.9995）;精密度、稳定性、重复性试验的RSD〈2%;平均加样回收率为99.82%,RSD=2.40%（n=9）。结论：所建标准可用于金牡感冒片制剂的质量控制。

OBJECTIVE：To establish the quality standard of Jinmu ganmao tablets. METHODS：The qualitative identification of Lonicerae japonicae,Vitex negundo,Evodia lepta,Mussaenda Pubescentis,mentha arvensis oil were carried out by TLC. The content of chlorogenic acid was determined by HPLC. The determination was performed on ODS-BP（250 mm×4.6 mm,5 μm）column with mobile phase consisted of acetonitrile-0.1% phosphoric acid solution（11∶89,V/V）at the flow rate of 1.2 ml/min. The column temperature was 25 ℃and the sample size was 5 μl. The detection wavelength was set at 327 nm. RESULTS：TLC sports were fairly clear,separated well and specific yet without interference from negative control. The linear range of chlorogenic acid was 14.448-168.560 μg/ml（r=0.999 5）with an average recovery of 99.28%（RSD=2.40%,n=9）. RSDs of precision,stability and reproducibility tests were lower than 2%. CONCLUSIONS：The established quality standard is suitable for the quality control of Jinmu ganmao tablets.