山七丹参丸的质量标准研究

Study on quality standard for Shanqidanshen pills

目的:建立山七丹参丸的定性与定量检测方法,并制定质量标准。方法:对山七丹参丸中丹参、三七、山楂采用TLC定性鉴别;丹参中的丹参酮ⅡA含量用HPLC法检测,色谱柱为Inertsil ODS-SP (4.6 mm×150 mm,5μm),流动相为甲醇-水(80∶20),检测波长270 nm,流速1.0 m L/min,柱温30℃,进样量10μL。结果:所建立TLC法斑点清晰,分离效果好,阴性无干扰;含量测定中丹参酮ⅡA的回归方程为C=1.678 9×10-5A+0.001 131 97,r=0.999 9,表明丹参酮ⅡA在0.007 6~0.190 0μg范围内呈良好的线性关系,计算得平均加样回收率为102.7%,RSD为0.95%(n=9)。结论:本研究方法简单易行,专属性强,准确可靠,可用于山七丹参丸的质量控制。

To establish the qualitative and quantitative determination methods and set quality standard for Shanqidanshen pills.Methods:Identification of Radix Salvia Miltiorrhizae,Radix Notoginseng,Fructus Crataegus by TLC;Content determination of tanshinoneⅡA in Radix Salvia Miltiorrhizae by HPLC.Inertsil ODS-SP(4.6 mm×150.0 mm 5μm)chromatography column was used with the mobile phase of methanol-water(80∶20),determine wavelength 270 nm,the flow rate of 1.0 mL/min,the column temperature 30℃and sample 10μL.Results:The TLC spots were fairly clear and the result of separation was good,the negative control showed no interference,The regression equation of content determination of tanshinoneⅡA was C=1.678 9×10-5 A+0.001 131 97,r=0.999 9,which showed that there was a good linear relationship at the range of0.007 6~0.190 0μg for tanshinoneⅡA.The average recovery was 102.7%and RSD was 0.95%(n=9).Conclusion:The qualitative and quantitative method established in this study was simple,specific,accurate and reliable,and can effectively control the quality of Shanqidanshen pills.