复方补气口服液的质量标准研究

Quality standard of compound BuQi oral liquid

采用TLC法对复方补气口服液中的炙黄芪、人参、菟丝子进行定性鉴别,采用HPLC法测定制剂中黄芪甲苷含量。结果表明,炙黄芪、人参、菟丝子的TLC法鉴别专属性均好;黄芪甲苷在1.402~14.024μg进样量的对数值(X)与峰面积的对数值(Y)呈良好的线性关系,回归方程为Y=1.6735X+1.9263,R2=0.9992(n=5),平均加样回收率为99.40%,RSD为4.15%(n=6)。研究建立的方法专属性强,简便快捷,结果可靠,可作为复方补气口服液的质量控制方法。

Astragali radix praeparata cum melle,ginseng radix et rhizoma,and cuscutae semen were identified qualitatively by TLC in compound BuQi oral liquid.The content of astragaloside IV in compound BuQi oral liquid was determined by HPLC.The results showed that the TLC of astragali radix praeparata cum melle,ginseng radix et rhizoma,and cuscutae semen were good in the separation degree.There was a good linear relationship between the logarithm(X)of the injection amount and the logarithm(Y)of the peak area within the range of 1.402~14.024μg.The regression equation was Y=1.6735X+1.9263,r=0.9992(n=5).The average recovery rate was 99.40%and the RSD was 4.15%(n=6).The method established in this study is specific,simple,fast and reliable,and can be used for quality control of compound BuQi oral liquid.