养胃健脾颗粒质量标准研究

Quality Standard for Yangwei Jianpi Granules

目的:建立养胃健脾颗粒的质量标准,加强养胃健脾颗粒的质量控制。方法:使用TLC法鉴别丹参、白芍、延胡索、木香;用HPLC测定芍药苷含量,色谱柱为依利特C18(250mm×4.6mm,5μm);流动相为乙腈-水(16∶84);柱温25℃;进样量10μL;流速:1.0mL/min;检测波长:230nm。结果:TLC斑点清晰,阴性无干扰;芍药苷在1.22μg~12.20μg范围内与峰面积呈良好的线性关系(r=0.9998),平均加样回收率为97.80%(RSD=1.45%,n=6)。结论:该方法准确可靠,快速简便,可用于养胃健脾颗粒的质量控制。

Objective:To establish the quality standard of Yangwei Jianpi granuLes and to enhance the quality controllability of Yangwei Jianpi granuLes.Methods:TLC was adopted in the qualitative identification of Salvia miltiorrhiza Bge,Paeonia tacti lora Pall,Rhizoma Corydaalis,Radix Aucklandiae;HPLC was used for the content determination of paeoniflorin.The column was Elit C18(250 mm×4.6 mm,5μm);the mobile phase was acetonitrile-water(16∶84);column temperature 25℃;injection volume 10μL;flow rate:1.0 mL/min;detection wavelength:230 nm.Results:The TLC spots were clear without negative interference;paeoniflorin showed good linear relationships within the ranges of 1.22μg~12.20μg(r=0.9998),whose average recoveries were97.35%,(RSD=1.21%,n=6).Conclusion:The method is accurate,reliable,fast and simple,and can be used for the quality control of Yangwei Jianpi granuLeson.