摘要
目的:建立胆黄润肠丸的HPLC指纹图谱,考察不同批次胆黄润肠丸质量的一致性,为完善该制剂的质量评价体系奠定基础。方法:采用YMC-Pack C4色谱柱(250mm×4.6mm,5μm),流动相甲醇-0.1%磷酸溶液梯度洗脱,流速1.0mL·min-1,检测波长270nm,柱温30℃,进样量10μL,对所得各样品的指纹图谱进行整体相似度计算,并对其共有色谱峰峰面积进行聚类分析。结果:通过"中药色谱指纹图谱相似度评价系统2004A版"分析确定了18个共有峰,10批胆黄润肠丸的指纹图谱相似度均大于0.89,通过聚类分析大致可分为3类。结论:建立的HPLC指纹图谱方法操作简便,准确稳定,重复性好,为胆黄润肠丸的质量控制提供了有效的手段。
OBJECTIVE To establish an HPLC fingerprint of Danhuang Runchang Pills（DRP）,determine 10 batches of samples and lay a foundation for improving quality evaluation system of DRP.METHODS HPLC separation was performed on a YMC-Pack C4reversed-phase column in gradient mode of methyl alcohol-0.1% phosphoric acid with UV detection at 270 nm.Column temperature was kept at 30 ℃,and flow rate of mobile phase was at 1.0 mL/min.Fingerprint similarities and cluster analysis were obtained based on chromatographic peaks in detected samples.RESULTS Eighteen common peaks were selected as fingerprint peaks of DRP,and five common peaks were determined by relative times of standard substance.Similarities of 10 batches of DRP were all more than 0.89 and analyzed samples were geographically classified into three classes.CONCLUSION The established HPLC fingerprint of DRP has desirable precision,reproducibility,and can provide a basis for quality evaluation of DRP.
出处
《中国医院药学杂志》
CAS
CSCD
北大核心
2016年第9期719-723,共5页
Chinese Journal of Hospital Pharmacy
基金
常州市科技计划项目(编号:2014274)
南京市科技计划项目(编号:201304045)
