基于超分子“气析”理论的双黄连口服液中金(山)银花替代研究  

Study on Substitution of Lonicerae Japonicae Flos(Lonicerae Flos)in ShuangHuangLian Oral Liquid Based on Supramolecular“Gas Evolution”Theory

作　　者：许键权 周塬钦 汤卓翰 林云 周春娇 张良琦 贺福元[1,2] 肖美凤 XU Jian-quan;ZHOU Yuan-qin;TANG Zhuo-han;LIN Yun;ZHOU Chun-jiao;ZHANG Liang-qi;HE Fu-yuan;XIAO Mei-feng(College of Pharmacy,Hunan University of Traditional Chinese Medicine,Changsha 410208,China;Hunan Key Laboratory of Medicinal Properties and Preparation of Traditional Chinese Medicine,Changsha 410208,China)

机构地区：[1]湖南中医药大学药学院,湖南长沙410208 [2]中药成药性与制剂制备湖南省重点实验室,湖南长沙410208

出　　处：《海峡药学》2025年第1期17-21,共5页Strait Pharmaceutical Journal

基　　金：湖南省大学生创新创业训练计划项目(S202310541074)。

摘　　要：目的利用指纹图谱总量统计矩法对金(山)银花制备的双黄连口服液进行分析,为金(山)银花“异原等效”性研究提供依据。方法采用《中国药典》的方法制备金(山)银花双黄连口服液,测定其绿原酸、咖啡酸、3,5-二咖啡酰奎宁酸、黄芩苷、连翘苷、黄芩素的含量;采用指纹图谱相似度评价制备的金(山)银花双黄连口服液,计算指纹图谱的总量统计矩参数。结果10批金(山)银花双黄连口服液中绿原酸、黄芩苷、连翘苷含量均符合药典标准;10批金银花和10批山银花分别制备的双黄连口服液相似度均在0.979以上,10批金银花与山银花双黄连口服液间相似度均在0.973以上;金(山)银花双黄连口服液总量一阶矩(RSD分别为3.1%,1.2%)、总量二阶矩(RSD分别为2.3%,2.2%)较稳定且无显著性差异,表明金银花和山银花制备的双黄连口服液体外“印迹模板”特征相似。结论采用指纹图谱相似度评价体系和总量统计矩可联合表征金(山)银花双黄连口服液体外“印迹模板”特征。OBJECTIVE In order to provided the basis for the study of“heterogenic equivalence”,the total statistical moment method of fingerprint was used to analyze ShuangHuangLian Oral Liquid prepared by Lonicerae Japonicae Flos(Lonicerae Flos).METHODS Use the method of“Chinese Veterinary Pharmacopoeia”to prepare ShuangHuangLian Oral Liquid prepared by Lonicerae Japonicae Flos(Lonicerae Flos),determine the contents of Chlorogenic acid,Caffeic acid,3,5-Dicaffeoylquinic acid,Baicalin,Forsythin,Baicalein.Use the similarity of fingerprint to evaluate ShuangHuangLian Oral Liquid prepared by Lonicerae Japonicae Flos(Lonicerae Flos)to calculate the total statistical moment parameters of fingerprints.RESULTS The contents of Chlorogenic acid,Baicalin and Forsythin in 10 batches of Lonicerae Japonicae Flos(Lonicerae Flos)ShuangHuangLian Oral Liquid were all in line with pharmacopoeia standards;the similarity of ShuangHuangLian Oral Liquid prepared by 10 batches of Lonicerae Japonicae Flos and 10 batches of Lonicerae Flos were all above 0.979;the similarity between 10 batches of Lonicerae Japonicae Flos and Lonicerae Flos ShuangHuangLian Oral Liquid was above 0.973;the first-order moment(RSD were 3.1%,1.2%)and second-order moment(RSD were 2.3%,2.2%)of Lonicerae Japonicae Flos(Lonicerae Flos)ShuangHuagLian Oral Liquid were stable and had no significant difference,the results showed that the characteristics of“imprinting template”of ShuangHuangLian Oral Liquid prepared by Lonicerae Japonicae Flos and Lonicerae Flos were similar in vitro.CONCLUSION Fingerprint similarity evaluation system and total statistical moment can be used to characterize the in vitro“imprinting template”characteristics of Lonicerae Japonicae Flos(Lonicerae Flos)ShuangHuangLian Oral Liquid.

关 键 词：超分子“印迹模板” 总量统计矩 指纹图谱 双黄连口服液 金银花 山银花 UPLC 

分 类 号：R927[医药卫生—药学]