人参益元颗粒质量控制方法研究

Study on Quality Control Method of Renshen Yiyuan Granules

目的:采用薄层色谱法和高效液相色谱法建立人参益元颗粒的质量控制方法。方法:采用薄层色谱法定性鉴别人参益元颗粒中人参、黄芪、炙甘草、白术;高效液相色谱法(HPLC)对人参益元颗粒中芍药苷进行含量测定。结果:采用薄层色谱法建立了益元颗粒中人参、黄芪、炙甘草、白术的定性鉴别方法,斑点清晰,阴性无干扰。采用高效液相色谱法建立了益元颗粒中芍药苷含量测定的方法,具体为采用Alphasil VC-C 18(4.6 mm×250 mm,5μm)色谱柱,以乙腈-0.2%磷酸溶液(17∶83)为流动相,检测波长230 nm,流速1.0 mL·min^(-1),柱温25℃,进样量10μL。该方法专属性强,芍药苷在23.35~116.74μg·mL^(-1)(r=0.9998)范围内线性关系良好,平均回收率为99.56%,RSD为1.40%。结论:本研究所建立的薄层色谱法鉴别及HPLC含量测定方法专属性强、重现性好,可用于人参益元颗粒的质量控制。

Objective:The quality control method of renshen yiyuan granules was established by TLC and HPLC.Methods:TLC was used to qualitatively identify the components of Panax ginseng,Astragali radix,baked licorice and Atractylodes macrocephala in renshen yiyuan granules,and the content of paeoniflorin in renshen yiyuan granules was determined by HPLC.Results:The qualitative identification methods of the components of Panax ginseng,Astragali radix,baked licorice and Atractylodes macrocephala in renshen yiyuan granules were established by TLC.The TLC chromatography showed the same color spots in the same position of the corresponding control drugs,and the negative samples showed no interference.A HPLC method for determination the content of paeoniflorin in renshen yiyuan granules was established.The Alphasil VC-C 18(4.6 mm×250 mm,5μm)column was used with acetonitrile-0.2%phosphate solution(17∶83)as the mobile phase.The detection wavelength was 230 nm.The flow rate was 1.0 mL·min^(-1).The column temperature was 25℃and the injection volume was 10μL.The method established has strong specific,and paeoniflorin had a good linear relationship in the range of 23.35-116.74μg·mL^(-1)(r=0.9998).The average recovery rate was 99.56%,and RSD was 1.40%.Conclusion:The TLC identification method and the HPLC method for the content determination established in this study have strong specificity and good reproducibility,which can be used for the quality control of renshen yiyuan granules.