咳欣康片质量标准研究

Quality Standards Research of Kexinkang Tablets

目的： 建立咳欣康片质量控制方法。方法： 采用薄层色谱法（TLC）对咳欣康片处方中桔梗、黄芩、甘草进行定性鉴别；采用HPLC测定制剂中苦杏仁苷的含量。资生堂CAPCELL PAK C18MG色谱柱（4.6 mm×250 mm，5 μm），乙腈-甲醇-水-醋酸（7：7：86：0.02）为流动相，检测波长215 nm，流速1 mL·min-1。结果： 桔梗、黄芩、甘草的TLC鉴别法专属性强，简单可行。HPLC含量测定，苦杏仁苷在0.044~0.327 g·L-1与峰面积呈良好的线性关系（r=0.999 5，n=7），苦杏仁苷的平均回收率为98.9%，RSD 1.2%。结论： 该试验建立的方法简便快捷，重复性好，能更为有效的控制咳欣康片的质量。

Objective： To establish a quality control method of Kexinkang tablets. Method： Platycodonis radix, Scutellariae radix, Glycyrrhizae radix rhizoma were identified by TLC, respectively. Amygdalin in Kexinkang tablets was determined by HPLC.The chromatographic column was the Shiseido CAPCELL PAK C18 MG（4.6 mm×250 mm,5 μm）.The mobile phase consisted acetonitrile-methanol-water-acetic acid（7：7：86：0.02）.The detection wavelength was 210 nm;the flow rate was 1.0 mL·min-1. Result： TLC was a specific method for the identification of Kexinkang tablets. Ursolic acid showed a good linear relation in the range of 0.044-0.327 g·L-1 （r=0.999 5, n=7）, the average recovery was 98.9% with RSD of 1.2%. Conclusion： The method is simple, sensitive and reproducible. It can be used to control the quality of Kexinkang tablets.