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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 current method for determining the quality standard of Xuesaitong injection and to verify it with methodology. METHODS: C18 column (200mm×4.6mm, 5μm) was used. Acetonitrile-water was used as mobile phase. Gradient elution [acetonitrile-water (19∶81) for 15min, acetonitrile-water was changed over 45min (36∶64) )]; flow rate: 1 mL · min-1; detection wavelength 203nm; column temperature 25 °C; injection volume 10μL. RESULTS: The contents of notoginsenoside R1, ginsenoside Rg1 and ginsenoside Rb1 in 20 batches of samples were determined by the standard method and this method. Results The content of ginsenoside Rg1 and ginsenoside Rb1 measured by this method was significantly lower than that measured by standard method, but there was no significant difference in the content of notoginsenoside R1. Conclusion: There are obvious defects in the current quality standard of Xuesaitong injection. This study provides a basis for improving the quality standard.