扶正解毒口服液质量控制方法研究

Study on Quality Control Method of Fuzheng Jiedu Oral Liquid

目的建立扶正解毒口服液的质量控制方法。方法采用TLC法对扶正解毒口服液中的板蓝根、黄芪和淫羊藿进行鉴别;采用HPLC法测定(R,S)-告依春的含量。结果在薄层色谱鉴别中均能检出板蓝根、黄芪和淫羊藿的特征性斑点;以(R,S)-告依春对照品浓度为横坐标,峰面积为纵坐标,以峰面积(Y,μv)对浓度(X,μg/ml)进行线性回归,绘制标准曲线,其回归方程为:Y=45784.94X-17640.25,相关系数r=0.99997,试验结果表明:(R,S)-告依春浓度在4.63～123.38μg/ml,呈良好的线性关系。标准中建立的(R,S)-告依春的含量测定方法耐受性良好、灵敏度高、重现性好、专属性强,可以有效控制产品的质量。结论本方法能准确、可靠的对扶正解毒口服液中(R,S)-告依春含量进行测定,可作为该制剂的质量控制方法。

Objective To establish a quality control method for Fuzheng Jiedu Oral Liquid. Methods TLC method was used to identify Radix Isatidis, Astragalus and Epimedium in Fuzheng Jiedu Oral Liquid. The content of (R, S)-Gu Yichun was determined by HPLC. Results The characteristic spots of Radix Isatidis, Astragalus and Epimedium were detected in the identification of TLC;the concentration of (R, S)-Guyuechun reference was taken as the abscissa, the peak area was the ordinate, and the peak area was(Y,μv) linear regression of concentration (X,μg / ml), draw a standard curve, the regression equation is: Y=45784.94X-17640.25, correlation coefficient r=0.99997, the test results show:(R, S)- The concentration of spring was in the range of 4.63~123.38 μg/ml, showing a good linear relationship. The method for determining the content of (R, S)-Yueyichun established in the standard is well tolerated, sensitive, reproducible and specific, which can effectively control the quality of the product.Conclusion The TLC method can accurately and reliably determine the content of (R,S)-Gu Yichun in Fuzheng Jiedu Oral Liquid, which can be used as the quality control method of the preparation.