清开灵注射液特征图谱及其质量相关性研究

HPLC specific chromatogram of Qingkailing injection and its application in quality control

目的:建立清开灵注射液及其中间品的高效液相色谱特征图谱。方法:利用HPLC/UV,采用Phenomenex Luna C18色谱柱(250 mm×4.6 mm,5μm);流动相:0.5%甲酸水溶液(A)-甲醇(B);线性梯度洗脱:0～75 min,A-B(100∶0)→A-B(0∶100);流速:0.5 mL.min-1;检测波长:254 nm;柱温:30℃。结果:在规范的生产条件下,各样品的特征图谱与其均谱比较相似度均可以保持在0.95以上。结论:本法为中药样品比较以及中药注射液的质量控制提供了基础和方法模式。

Objective：To establish HPLC specific chromatogram of Qingkailing injection and its medium products.Methods：Phenomenex Luna C18（250 mm×4.6 mm,5 μm） column was adopted;The mobile phase was 0.5% formic acid（A）-methanol（B） with linear gradient elution[0-75 min,A-B（100∶0）→A-B（0∶100）] at the flow rate of 0.5 mL·min-1;The detection wavelength was 254 nm,and the column temperature was 30 ℃.Results：The similarities of samples,which obtained from controlled producing conditions,retain 0.95 up with specific chromatograms comparison by their averaged chromatogram.Conclusion：The results provide a strategy for TCM injection quality control and sample evaluation.