归芍调经口服液质量标准研究

Study on Quality Standard of Guishaotiaojing Oral Liquid

目的建立归芍调经口服液的质量标准。方法采用薄层色谱法对归芍调经口服液中当归、赤芍、延胡索进行定性鉴别;采用高效液相色谱法测定制剂中芍药苷的含量。色谱柱为Agilent Zorbax SB-C18(250mm×4.6mm,5μm);柱温:25℃;以甲醇-0.05mol/L磷酸二氢钾溶液为流动相进行梯度洗脱;流速1.0mL/min;检测波长:230nm。结果当归、赤芍、延胡索的TLC特征斑点清晰,分离度好,阴性对照无干扰;芍药苷在163.36-980.16 ng范围内线性关系良好,其回归方程为:Y=1.2156X+125.87,相关系数r=0.99999。加样回收率为98.40%,RSD为1.75%。结论本方法可靠、准确、重现性好,可作为归芍调经口服液的质量控制方法。

Objectve To establish the quality standards of Guishaotiaojing oral liquid. Methods TLC was used to distinguish the Angelieae sinensis radix, Paeoniae radix rubra and Corydalls rhlzoma in Guishaotiaojing oral liquid; the content of paeoniflorin was determined by HPLC. Results The prescription of Angelicae sinensis radix, Paeoniae radix rubra and Corydalls rhlzoma has distinguishing characteris- tics without the interference of the blank control. Paeoniflorin in the framework of 163.36 - 980. 16 ng showed a good linear relationship, with the regression equation：Y = 1. 2156X ＋ 125.87, r =0. 99999. The average recovery was 98.40% , and RSD was 1.75%. Conclusion This method is simple, accurate, and reproducible, it can be used to control the quality of Guishaotiaojing oral liquid.