车前草饮片标准汤剂的制备及质量控制方法研究

Preparation and Quality Standard of Plantaginis herba Pieces Standard Decoction

目的 制备车前草饮片标准汤剂并建立质量标准,为其配方颗粒的质量评价及相关经典名方研究提供参考。方法 根据中药饮片标准汤剂制备原则制备车前草饮片标准汤剂,测定大车前苷的含量并计算转移率、测定汤剂出膏率及pH值,建立HPLC指纹图谱分析方法,并进行相似度计算。结果 12批车前草饮片标准汤剂大车前苷转移率范围为9.0%~30.5%,出膏率范围为17.2%~25.3%,pH范围为4.8~5.7,特征图谱中共有峰10个,指认2个,分别为大车前苷(6号峰)、毛蕊花糖苷(9号峰),并用中药色谱指纹图谱相似度评价系统(2012A)软件进行指纹图谱分析,相似度均> 0.7。结论 建立的制备方法稳定,质量标准完善,适用于车前草配方颗粒及车前草水提物的质量评价。

Objective To prepare Plantaginis herba pieces standard decoction and establish its quality standard.It provides reference for quality evaluation of formula granules and research on related classical herbal formulae.Methods According to the standard of Chinese herbal medicine preparation principle,Plantaginis herba pieces standard decoction was prepared,the transfer rates of plantamajoside,pH,and the extract rate were calculated.The quality standard of this standard decoction was also established.Results The transfer rates of plantamajoside were 9.0%~30.5%,respectively;and the extract rate were 17.2%~25.3%,the pH were 4.8~5.7.10 common peaks were determined in 12 batches of Plantaginis herba pieces standard decoction.Moreover,plantamajoside(peak 6)and acteoside(peak 9)were identified.The similarity evaluation system for chromatographic fingerprint of TCM(2012 A)wase used to analysis of the fingerprint.The similarities of samples were all higher than 0.7.Conclusion The method displays good precision,stability and repeatability in fingerprint analysis which is suitable for the quality evaluation of Plantaginis herba pieces standard decoction.