天王补心丸毛细管电泳指纹图谱

目的:建立天王补心丸(Tianwang Buxin wan,TWBXW)毛细管电泳指纹图谱(capillary electrophoresis fingerprints,CEFPs).方法:以正方形优化法选择背景电解质(background electrolyte,BGE),采用色谱指纹图谱指数(F)优化试验条件,最终确定以50 mmol· L-1硼砂-50 mmol·L-1磷酸氢二钠(3:5)为BGE,采用未涂层石英毛细管(75 cm×75 μm I.D.,有效分离长度63 cm),紫外检测波长203 nm,运行电压15 kV.对12批样品进行聚类分析确定用其中11批生成对照CEFP(RCEFP),以此RCEFP为标准用系统指纹定量法评价12批TWBXW质量.结果:以阿魏酸峰为参照物峰,确定14个共有峰,建立了TWBXW-CEFP.以系统指纹定量法鉴别出S2,S6,S7,S10和S11质量很好,S4和S8质量好,S5和S9质量中,S1和S3质量一般,S12质量次.结论:该法具有较好的精密度和重复性,为天王补心丸的质量控制提供了新参考.

Capillary Electrophoresis Fingerprints of Tianwang Buxin Wan

Objective:To establish capillary electrophoresis fingerprints(CEFPs) of Tianwang Buxin Wan(TWBXW).Method: Square optimization method was used to choose the background electrolyte(BGE) and index of chromatographic fingerprint(F) was applied to optimize the CEFPs conditions.The CEFPs were obtained by using a 75 cm×75 μm I.D.(the effective length of 63 cm) uncoated fused silica capillary with 50 mmol · L-1 sodium borate-50 mmol · L-1 disodium hydrogen phosphate(3∶5) as the BGE.The running voltage was 15 kV while the detection wavelength was set at 203 nm.The 12 batches of TWBXW were identified by hierachical cluster analysis,and the referential capillary electrophoresis fingerprint(RCEFP) was synthesized from 11 batches of TWBXW according to the results of classification.Taking the RCEFP for the qualified model,the whole 12 batches of TWBXW were evaluated by systematic quantified fingerprint method(SQFM).Result: Fourteen co-possessing peaks were selected as the CEFPs peaks when taking ferulic acid peak as the referential peak,and the identification results obtained by SQFM indicated that the quality of S2,S6,S7,S10 and S11 were better,S4 and S8 were good,S5 and S9 were moderate,S1 and S3 were common and S12 was defective.Conclusion: The results show that the method established is with good precision and reproducibility,which can be served as a novel reference for the quality control of TWBXW.