Shi Min, Sun Wanyang, Sun Guoxiang, Zhang Jing
College of Pharmacy, Yaoke University i.e. Shenyang Pharmaceutical University, Shenyang, P. R. China.
J Sep Sci. 2016 May;39(9):1776-84. doi: 10.1002/jssc.201600099. Epub 2016 Apr 21.
A micellar electrokinetic chromatography fingerprint coupled with quantification was developed for assessing the quality consistency of Danshen tablets, a traditional Chinese medicine, with pharmacological activities of activating blood to remove blood stasis and regulating the flow of vital energy to alleviate pain. Square optimization method was proposed to select the suitable background electrolyte. Subsequently, the index of chromatographic fingerprints F was simultaneously employed as an objective function to evaluate capillary electrophoresis conditions. After that, the method was proved to meet the fingerprint analysis criteria by evaluating stability, linearity, limit of detection, limit of quantification, precision, accuracy, and repeatability. Moreover, systematic quantified fingerprint method was used to evaluate chromatographic fingerprints of 30 batches of samples in terms of both quality and quantitation. The result indicated that the chemical compositions of samples were basically similar while their contents showed marked variation. In addition, the fingerprint-efficacy relationship was established using partial least squares model, which can serve as anti-oxidant activity evaluation of Danshen tablets as well as a reference for the selection of active constituents. The proposed method can be applied for the holistic quality control of Danshen tablets.
建立了胶束电动色谱指纹图谱结合定量分析方法,用于评价具有活血化瘀、理气止痛药理活性的中药丹参片的质量一致性。提出了方阵优化法以选择合适的背景电解质。随后,将色谱指纹图谱指数F同时用作目标函数来评估毛细管电泳条件。在此之后,通过评估稳定性、线性、检测限、定量限、精密度、准确度和重复性,证明该方法符合指纹图谱分析标准。此外,采用系统定量指纹图谱法从质量和定量两方面对30批样品的色谱指纹图谱进行评价。结果表明,样品的化学成分基本相似,但其含量存在显著差异。此外,利用偏最小二乘模型建立了指纹图谱-药效关系,可作为丹参片抗氧化活性评价以及活性成分筛选的参考。所提出的方法可应用于丹参片的整体质量控制。