虚寒胃痛胶囊的质量标准研究

目的：建立HPLC法检测虚寒胃痛胶囊中芍药苷和黄芪甲苷的含量测定方法。方法：1芍药苷采用Diamonsil C18（4.6 mm×200 mm,5μm）色谱柱,流动相为甲醇-0.02 mol/L磷酸二氢钾溶液（28∶72）;流速1.0mL/min。2黄芪甲苷采用VP-ODS（4.6 mm×150 mm,5μm）色谱柱,流动相为乙腈-水（35∶65）为流动相,流速1.0 mL/min。结果：1芍药苷进样量在0.05109~2.5545μg范围内呈良好线性关系,平均回收率为96.5%（n=6,RSD=0.88%）。2黄芪甲苷进样量在0.4892~12.23μg范围内呈良好线性关系,平均回收率为94.5%（n=6,RSD=3.0%）。结论：该方法准确可靠,无干扰,可用于虚寒胃痛胶囊的质量控制。

Quality Study on Xuhan Weitong Capsule

Objective：To establish the quantitative method of Paeoniflorinand Astragaloside A in Xuhan Weitong Capsules by HPLC. Method：（1）Paeoniflorin：The separation was performed on a Diamonsil C18（4, 6 mm × 200 mm, 5 μm） packed with a 5 μm stationary phase. The mobile phase consisted of Methanol - 0.02 mol/L Potassium Phosphate Mono- basic （28 ： 72）. The nebulizer nitrogen flow rate was 1.0 mL/min. （2）Astragaloside A ： The separation was performed on a VP - ODS（4.6 mm × 150 mm,5μ m） packed with a 5 μm stationary phase. The mobile phase consisted of acetonitrile - water （35：65 ）. The nebulizer nitrogen flow rate was 1.0 mL/min. Results： （1）The liner range of Paeoniflorin was O. 05109 - 2. 5545 μg （ r = 0. 9999）. The average recovery was 96.5% （ n = 6, RSD = 0.88% ）. （2）The liner range of Astragaloside A was 0. 4892 - 12.23 μg （r = 0. 9999）. The average recovery was 94.5% （n = 6, RSD = 3.0% ）. Conclusion：h was proved that the HPLC method was accurate and could be used for the quality control of Xuhan Weitong Capsules.