Liu Yingchun, Sun Guoxiang, Wang Yan, Yang Lanping, Yang Fangliang
Key Laboratory of Structure-Based Drug Design and Discovery, Ministry of Education, School of Pharmaceutical Engineering, Shenyang Pharmaceutical University, Shenyang, P. R. China.
Pharmaceutical Informatics Laboratory, School of Pharmacy, Shenyang Pharmaceutical University, Shenyang, P. R. China.
J Sep Sci. 2015 Jun;38(12):2174-81. doi: 10.1002/jssc.201500145. Epub 2015 May 15.
Micellar electrokinetic chromatography fingerprinting combined with quantification was successfully developed and applied to monitor the quality consistency of Weibizhi tablets, which is a classical compound preparation used to treat gastric ulcers. A background electrolyte composed of 57 mmol/L sodium borate, 21 mmol/L sodium dodecylsulfate and 100 mmol/L sodium hydroxide was used to separate compounds. To optimize capillary electrophoresis conditions, multivariate statistical analyses were applied. First, the most important factors influencing sample electrophoretic behavior were identified as background electrolyte concentrations. Then, a Box-Benhnken design response surface strategy using resolution index RF as an integrated response was set up to correlate factors with response. RF reflects the effective signal amount, resolution, and signal homogenization in an electropherogram, thus, it was regarded as an excellent indicator. In fingerprint assessments, simple quantified ratio fingerprint method was established for comprehensive quality discrimination of traditional Chinese medicines/herbal medicines from qualitative and quantitative perspectives, by which the quality of 27 samples from the same manufacturer were well differentiated. In addition, the fingerprint-efficacy relationship between fingerprints and antioxidant activities was established using partial least squares regression, which provided important medicinal efficacy information for quality control. The present study offered an efficient means for monitoring Weibizhi tablet quality consistency.
胶束电动色谱指纹图谱结合定量分析方法已成功开发并应用于监测胃必治片的质量一致性,胃必治片是一种用于治疗胃溃疡的经典复方制剂。采用由57 mmol/L硼酸钠、21 mmol/L十二烷基硫酸钠和100 mmol/L氢氧化钠组成的背景电解质来分离化合物。为优化毛细管电泳条件,应用了多元统计分析。首先,确定影响样品电泳行为的最重要因素为背景电解质浓度。然后,建立了以分离度指标RF为综合响应的Box-Benhnken设计响应面策略,以关联因素与响应。RF反映了电泳图中的有效信号量、分离度和信号均匀性,因此被视为一个优良指标。在指纹图谱评价中,建立了简单定量比值指纹图谱法,从定性和定量角度对中药/草药进行综合质量判别,该方法能很好地区分同一厂家的27个样品的质量。此外,采用偏最小二乘回归建立了指纹图谱与抗氧化活性之间的指纹图谱-药效关系,为质量控制提供了重要的药效学信息。本研究为监测胃必治片质量一致性提供了一种有效手段。