兽用中药玉屏风口服液质量标准提升研究

Study on Improvement of Quality Standard of Yupingfeng Oral Liquid

建建立一种可同时测定玉屏风口服液中升麻素苷、5-0-甲基维斯阿米醇苷、毛蕊异黄酮葡萄糖苷含量的高效液相色谱法(HPLC)。采用以十八烷基硅烷键合硅胶为填充剂的色谱柱(5μm 4.6×250mm),以乙睛和0.2%磷酸溶液为流动相进行梯度洗脱,流速1.0mL·min^(-1),柱温30℃,检测波长254nm,进样体积10μL。检测的三种成分在测定的质量浓度范围内线性关系良好,r值均为0.999,平均加样回收率均在96%~102%之间,相对标准偏差均小于2.0%。试验精密度、重复性、准确性和稳定性良好。新建立的检测方法简单、准确、高效,为进一步提升玉屏风口服液的质量控制提供了依据。

To establish a high performance liquid chromatography(HPLC)method for the simultaneous determination of glucoside,5-O-methyl Visamitol side and calynoisoflavone glucoside in Yupingfeng oral liquid.The chromatography was performed on a column(5μm 4.6×250 mm)with acetonitrile and 0.2% phosphoric acid as the fillers.The flow rate was 1.O mL·min^(-1).The column temperature was 30℃.The detection wavelength was 254 nm and the sample volume was 10μg.The linear relationship of the three components was good in the range of mass concentration,r values were 0.999,the average recoveries were between 96% and 102%,and the relative standard deviations were less than 2.0%.The test has good precision,repeatability,accuracy and stability.The newly established detection method is simple,accurate and efficient,which can provide a basis for the quality control of Yupingfeng oral liquid.