桑仁清肺口服液的质量标准提升研究

Research on the Promotion of Sangrenqingfei Oral Liquid Quality Standard

关键词:  桑仁清肺口服液  HPLC  甘草酸  质量标准

Key words:  Sangrenqingfei oral liquid  HPLC  Glycyrrhizic acid  quality standard

摘要:

为了解决桑仁清肺口服液甘草鉴别斑点不清晰无法判定结果的问题,完善质量标准,采用HPLC法测定桑仁清肺口服液中的甘草酸含量,色谱条件为：Agilent ZORBAX SB-C18色谱柱(4.6 mm×250 mm,5μm)；乙腈-0.1%磷酸(33:67)为流动相；检测波长为250nm。研究结果表明,甘草酸在19.09μg/ml~305.50μg/ml范围内具有良好的线性关系,其回归方程为y=7.17956x-12.98810,R_²=0.99932,平均回收率为102.92%,RSD为0.86%。本方法简单准确重复性好,能更好地控制桑仁清肺口服液的质量,可作为桑仁清肺口服液的质量标准。

Abstract:

In order to solve the problem that the spots were not clear and the result could not be determined, the content of glycyrrhizic acid in Sangrenqingfei Oral Liquid was determined by HPLC. Stationary phase were performed on Agilent Zorbax SB-C18 column (4.6 mm×250 mm, 5μm) and the mobile phase was acetonitrile and 0.1% phosphoric acid (33:67), the detection wavelength was 250nm. The results showed that glycyrrhizic acid had a good linear relationship when the garden in range of 19.09 to 305.50μg. Its regression equation was y = 7.17956X-12.98810 and R²=0.99932. The average recovery was 102.92% and RSD was 0.86%. This method was simple, accurate and reproducible, which could better control the quality of the Sangrenqingfei Oral Liquid, and could be used as the quality standard of Sangrenqingfei Oral Liquid.