血塞通分散片指纹图谱研究

Research of Fingerprint of Xuesaitong Dispersible Tablets

目的建立血塞通分散片的指纹图谱,利用相似度值控制产品的质量稳定性。方法利用反相液相色谱法进行梯度洗脱,agilent色谱柱,流动相为乙腈和水梯度洗脱,流速1m L/min,紫外检测波长203nm,柱温(25±0.5)℃,进样量20μL,以"中药指纹图谱评价系统"软件进行评价。结果以三七总皂苷对照品为参照,三七皂苷R_1、人参皂苷Rg_1、Re、Rb_1、Rd为共有峰,建立了血塞通分散片指纹图谱的评价体系,应用指纹图谱相似度值及相对保留时间等参数对不同批次血塞通分散片HPLC指纹图谱进行质量评价。结论该方法所建立的指纹图谱方法重现性和精密度良好,适用于血塞通分散片的质量控制。

Objective To establish the fingerprint of Xuesaitong dispersible tablets, and control the quality stability of products by the similarity value stability. Methods Gradient elution by reversed phase high performance liquid chromatography, agilent chromatography column. The mobile phase was acetonitrile and water gradient elution, flow rate of lml/min, UV detection wavelength at 203nm, column temperature at （25± 0.5）℃, the sample size of 20μL, and the chromatographic fingerprint evaluation system software was evaluated. Results To take the control of Panax notoginseng saponins as a veference, Panax notoginseng saponin R1, ginseng saponin Rg1, Re, Rb1, Rd were common peaks, and the fingerprint evaluation system was established of Xuesaitong dispersible tablets, the quality was evaluated by the fingerprint chromatogram similarity value and relative retention time etc. parameters of different batches of Xuesaitong injection points scattered pieces of the HPLC fingerprints. Conclusion The fingerprint established by this method has good reproducibility and precision, which applies to the quality control of Xuesaitong dispersed tablet＇ s.