三鞭胶囊质量标准改进与提高研究

Quality standard improvement for Sanbian capsules

目的完善三鞭胶囊质量标准,提高其质量控制水平。方法采用TLC法对三鞭胶囊中当归、白芍、天花粉、甘草进行定性鉴别,建立高效液相色谱法同时测定其芍药苷和甘草酸的含量。结果薄层色谱中斑点清晰,阴性样品无干扰;芍药苷质量浓度在4.479~89.59μg·mL^(-1)与峰面积线性关系良好,线性回归方程为Y=12.302X-2.551(r=0.9999),平均回收率均大于100.1%,RSD均小于1.8%;甘草酸质量浓度在6.393~127.9μg·mL^(-1)与峰面积线性关系良好,线性回归方程为Y=8.4047X-1.9773(r=0.9999),平均回收率均≥99.5%,RSD均小于0.79%。结论本研究建立的方法可用于三鞭胶囊质量控制。

Objective To improve the quality standard and quality control level for Sanbian capsules.Methods TLC method was used to identify Angelicae Sinensis Radix,Paeoniae Radix Alba,Radices Trichosanthisand,and Glycyrrhizae Radix et Rhizoma.The content of paeoniflorin and glycyrrhizic acid was determined by HPLC.Results The characteristic spots were clear,and the negative sample showed no interference.The linear relationship of paeoniflorin was 4.479~89.59μg·mL^(-1),and the linear regression equation was Y=12.302X-2.551(r=0.9999).The average recoveries were all higher than 100.1%and the RSDs were all less than 1.8%;the linear relationship of glycyrrhizic acid was 6.393~127.9μg·mL^(-1),and the linear regression equation was Y=8.4047X-1.9773(r=0.9999);the average recoveries were all no less than 99.5%and RSDs all less than 0.79%.Conclusion The established qualitative and quantitative methods can be used for the quality control of Sanbian capsules.