血塞通注射液含量测定方法的改进

Improving HPLC method for the determination of content of Xuesaitong injection

目的:对现行血塞通注射液质量标准含量测定方法进行了改进,并做了方法学验证。方法:采用C18色谱柱(200mm×4.6mm,5μm);以乙腈-水为流动相,梯度洗脱[乙腈-水(19∶81)保持15min,经45min将乙腈-水变为(36∶64)];流速:1mL·min-1;检测波长203nm;柱温25℃;进样量10μL。结果:采用标准法和本法测定了20批样品中三七皂苷R1、人参皂苷Rg1和人参皂苷Rb1的含量。结果本法测得的人参皂苷Rg1和人参皂苷Rb1含量比标准法测得的含量明显偏低,而三七皂苷R1含量无明显差别。结论:血塞通注射液现行质量标准存在明显缺陷,本项研究为质量标准提高提供了依据。

Objective:To improve the HPLC method for the determination of notoginsenoside R1,ginsenoside Rg1 and ginsenoside Rb1 in Xuesaitong injection,and test the new determination method.Methods:HPLC with Lichrospher C18 column(200 mm×4.6 mm,5 μm),the mobile phase was acetonitrile(A)and water(B)with gradient elution mode at the flow rate of 1 mL·min-1.The gradient condition was 0-15 min,A:19%,B:81%;15-60 min,A:19%→36%,B:81%→64%.The detection wavelength was 203 nm,and column temperature was 25 ℃.Results:The contents of notoginsenoside R1,ginsenoside Rg1and ginsenoside Rb1 of 20 samples were determined by the current HPLC method and improved HPLC method.The content of ginsenoside Rg1 and ginsenoside Rb1 by improved HPLC determination was less than that by current HPLC determination,but there was not much difference about the content of notoginsenoside R1.Conclusion:The current quality standard of Xuesaitong injection is not perfect.This paper has given the basis for improving the quality standard of Xuesaitong injection.