血塞通注射液HPLC数字化指纹图谱研究

目的:建立血塞通注射液HPLC数字化指纹图谱。方法:采用反相高效液相色谱法。大连江申CenturySILC18 BDS(250mm×4.6mm,5μm),流动相为水-乙腈梯度洗脱,流速0.9mL/min。紫外检测波长203nm,柱温(40.0±0.5)℃,进样量5μL。以"中药指纹图谱超信息特征数字化评价系统"软件进行评价。结果:以人参皂苷Rb1峰为参照物峰,确定14个共有峰,建立了血塞通注射液HPLC数字化指纹图谱。应用色谱指纹图谱指数F等参数对不同批次血塞通注射液HPLC指纹图谱的超信息特征进行了数字化评价,同时应用双定性双定量相似度法和系统指纹定量法评价血塞通注射液质量。结论:所建立HPLC数字化指纹图谱具有较好的精密度和重现性,适用于血塞通注射液药材的质量控制。

Study on the Digital Fingerprints of Xuesaitong Injection by HPLC

Objective：A new method for the overall quality control of Xuesaitong Injection has been established by HPLC digital fingerprint.Methods：The chromatographic fingerprints were obtained by injecting 5μL of the sample solution each time on a CenturySIL C18 BDS column（250mm×4.6mm,5μm） with the gradient elution solvent system composed of water and acetonitrile.The flow rate was 0.9 mL/min,the column temperature was maintained at（40.0±0.5）℃ and the detection wavelength was set at 203nm.The chromatographic fingerprints were evaluated by the software of the digitized evaluation system of Traditional Chinese Medicine fingerprint with the super information characteristics.Results：14 co-possessing peaks were selected as the fingerprint peaks of Xuesaitong Injection and the similarities between the chromatographic fingerprints and the herbal drugs were calculated by taking Rb1 peak as the reference peak.The chromatographic fingerprints were also evaluated by the chromatographic fingerprint index（F）.The quality of xuesaitong Injection was evaluated by dual qualitative and dual quantitative similaritives and the systematic quantified fingerprint method.Conclusion：This method with good precision and reproducibility can be applied in the quality control of Xuesaitong Injection.