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作 者:郭飞宇[1] 邹武斌 GUO Fei-yu;ZOU Wu-bin(Yichun Professional Technology Institute,Yichun 336000,China;Jiangxi jiminxinxin Pharmaceutical Co.,Ltd.,Yichun 336000,China)
机构地区:[1]宜春职业技术学院,江西宜春336000 [2]江西济民可信药业有限公司,江西宜春336000
出 处:《海峡药学》2025年第1期26-29,共4页Strait Pharmaceutical Journal
摘 要:目的建立益血膏的高效液相色谱(HPLC)指纹图谱。方法采用HPLC-二级管阵列检测器(DAD)技术。以芍药苷为参照峰建立10批样品HPLC-DAD指纹图谱。采用中药色谱指纹图谱相似度评价系统(2012版)进行相似度评价。结果分离出6个共有峰,鉴定指认了芍药苷。对工艺变更后的3批样品进行检验,其相似度0.911~0.984。结论所建立的方法精密度、重现性、稳定性良好,可用于控制益血膏的批间差异,保障产品的均一性。OBJECTIVE To establish a high-performance liquid chromatography(HPLC)fingerprint of YiXue Ointment.METHODS The HPLC diode array detector(DAD)technology was adopted.Establish HPLC-DAD fingerprint spectra of 10 batches of samples using paeoniflorin as the reference peak.Using the similarity evaluation system of traditional Chinese medicine chromatography fingerprint(2012 version)for similarity evaluation.RESULTS Six common peaks were separated,indicating the identification of paeoniflorin.The similarity of the three batches of samples after the process change was 0.911-0.984.CONCLUSION The established method has good precision,reproducibility,and stability,and can be used to control the inter batch differences of YiXue Ointment,ensuring the uniformity of the product.
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