血通胶囊质量控制研究

目的建立完善的医院制剂质量标准以提高医院制剂血通胶囊的可控性和稳定性。方法从定性、定量两方面进行研究,用薄层色谱法对血通胶囊中何首乌、水蛭、大黄三味中药定性鉴别;用高效液相色谱法对何首乌中二苯乙烯苷进行含量测定。结果三味药材薄层色谱图斑点清晰,具有专属性;二苯乙烯苷标曲线性关系良好,精密度、重复性、稳定性和回收率实验结果较好。结论该方法能准确可靠地进行定性、定量检测,能有效地控制血通胶囊的质量。

Study on quality control of Xuetong Capsule

  Objective:To establish the perfect quality standard for hospital pharmaceutical preparation and improve the controllability and stability of Xuetong Capsule. Methods From the qualitative and quantitative analysis,the qualitative identification of three kinds of Chinese materia medica including Radix Polygoni Multiflori,Hirudo and Radix et Rhizoma Rhei in Xuetong Capsule was performed by thin-layer chromatography,and the content determination of tetrahydroxystilbene glucoside in Radix Polygoni Multiflori was performed by high performance liquid chromatography.  Results: The three medicinal materials show the clear spots in thin layer chromatography with specificity. There is good linearity on the calibration curve of tetrahydroxystilbene glucoside,and the detection results of accuracy,repeatability,stability and recovery rate meet the requirement.  Conclusion: The method is accurate and reliable for qualitative and quantitative detection,which can effectively control the quality of Xuetong Capsule.