芍甘胶囊质量控制标准的研究

Study on Quality Control of Shaogan Capsules

目的制定芍甘胶囊的质量控制标准。方法采用TLC法在同一薄层板上同时鉴别芍甘胶囊中芍药苷、甘草酸铵；采用HPLC测定芍甘胶囊中芍药苷含量，色谱条件：C18色谱柱，流动相为乙腈-乙酸-三乙胺-水（15：0．3：0．3：85），检测波长为230nm；采用HPLC测定芍甘胶囊中甘草酸铵含量，色谱条件：C18色谱柱，流动相为乙腈-0．017mol·L^-1磷酸水溶液-三乙胺（35：65：0．3），检测波长为250nm。结果薄层鉴别试验中，芍药苷和甘草酸铵的色斑能完全分开且样品中其他成分对鉴别没有干扰。芍药苷和甘草酸铵分别在0．4-2μg和1．44-4．32μg范围内均呈良好的线性关系，芍药苷和甘草酸铵的平均回收率为97．53％和98．64％，RSD分别为1．05％和1．16％。3批样品的芍药苷含量分别是40．28、40．32、40．35mg/粒；甘草酸铵含量分别是20．27、20．06,20．72mg/粒。结论本文所制定芍甘胶囊的定性和定量方法简便，重复性好，结果可靠，可作为芍甘胶囊的质量控制标准。

Aim To study quality control of Shaogan Capsules. Methods Paeoniflorin and ammonium glycyrrhizinate in Shaogan Capsules were identified by TLC simultaneously. The content of paeoniflorin in Shaogan Capsules was determined by HPLC on C18-ODS Column using acetonitrile-acetic acid-triethylamine-water（ 15： 0. 3： 0. 3：85 ） as a mobile phase. The detection wavelength set at 230nm. The content of ammonium glycyrrhizinate in Shaogan Capsules was determined by HPLC on C18-ODS Column using acetonitrile-0. 017mol·L^-1 phosphoric acid-triethylamine（35： 65： 0. 3 ） as a mobile phase, the detection wavelength was set at 250nm. Results The spots of paeoniflorin and ammonium glycyrrhizinate can be separated completely and the assay can avoid being influenced by other spots. Paeoniflorin and ammonium glycyrrhizinate had a good linearity （ r = 0. 999 5 ） in the range of 0. 4 - 2μg and 1.44 -4.32 μg, respectively. The average recovery of paeoniflorin and ammonium glycyrrhizinate was 97.53 % with RSD 1.05% （ n = 6） and 98.64% with RSD 1. 16% （ n = 6） , respectively. The content of paeoniflorin in Shaogan Capsulae from three samples was 40.28,40.32,40.35mg per capsule, respectively. The content of ammoglycyrrhizinate in Shaogan Capsulae from three samples was 20.27,20.06,20.72mg per capsule, respectively. Conclusion The method is simple, sensitive, reliable, and can be applied to quality control of Shaogan Capsules.