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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×75μm 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。
Objective: To establish capillary electrophoresis fingerprints (CEFPs) of Tianwang Buxin wan (TWBXW). Methods: The square electrolyte was used to select the background electrolyte (BGE), and the chromatographic fingerprint index (F) was used to optimize the test conditions. The optimum conditions were 50 mmol.L-1 borax-50 mmol.L- 3: 5) as BGE, uncoated quartz capillary (75 cm × 75 μm ID, effective separation length of 63 cm) with UV detection wavelength of 203 nm and operating voltage of 15 kV. Cluster analysis of 12 batches of samples identified the use of 11 batches of control CEFP (RCEFP) as a standard for 12 batches of TWBXW quality by systematic fingerprinting. Results: Taking ferulic acid peak as the reference peak, 14 common peaks were identified and TWBXW-CEFP was established. Systematic fingerprint quantitative method identified S2, S6, S7, S10 and S11 good quality, S4 and S8 good quality, S5 and S9 quality, S1 and S3 general quality, S12 quality. Conclusion: The method has good precision and repeatability, which provides a new reference for the quality control of Tianwang Buxin pills.