更年静心胶囊质量标准研究

目的:建立更年静心胶囊的质量标准。方法:采用薄层色谱(TLC)法对处方中的女贞子、何首乌、黑芝麻、合欢花等药材进行鉴别;采用高效液相色谱(HPLC)法测定白芍中芍药苷的含量:色谱柱为ODS(3)C18(250mm×4.6mm,5μm),流动相为乙腈-0.1%磷酸(16∶84),流速为1.0mL.min-1,检测波长为230nm。结果:女贞子、何首乌、黑芝麻、合欢花的TLC斑点清晰,分离度良好。芍药苷的检测浓度在0.256 2~1.281 0μg.mL-1范围内与峰面积积分值呈良好线性关系(r=0.999 9);平均加样回收率为101.86%,RSD=1.72%(n=5)。结论:所建标准可用于更年静心胶囊的质量控制。

On Quality Criteria of Gengnianjingxin Capsules

OBJECTIVE:To establish the quality criteria for Gengnianjingxin capsules.METHODS:The constituents of Fructus Ligustri Lucidi,Radix Polygoni Multiflori,Semen Sesami Nigrum,and Flos Albiziae etc in Gengnianjingxin capsules were identified by TLC; the content of Paeoniflorin in Gengnianjingxin capsules was determined by HPLC. The chromatographic separation was performed on a ODS-(3)C18 column with mobile phase consisted of acetonitrile-phosphate 0.1% (16∶84) at a flow rate of 1.0mL·min-1. The detection wavelength was 230nm. RESULTS:Fructus Ligustri Lucidi,Radix Polygoni Multiflori,Semen Sesami Nigrum,and Flos Albiziae were all well-separated and clear spots were noted in TLC. The calibration curve was linear for Peoniflorin in the range of 0.256 2～1.281 0μg·mL-1(r=0.999 9), with the average recovery rate of 101.86% and RSD of 1.72%(n=5),CONCLUSION:The established criteria are suitable for the quality control of Gengnianjingxin capsules.