内消瘰疬片HPLC指纹图谱研究及多指标成分定量分析  

Fingerprint and Multi-component Determination of NeiXiao LuoLi Tablets by HPLC

作　　者：高杨[1] 胡玉凯 李国维 刘晴 郑琳玉 金俊杰 GAO Yang;HU Yu-kai;LI Guo-wei;LIU Qing;ZHENG Lin-yu;JIN Jun-jie(Department of Pharmacy,Nanjing Integrated Traditional Chinese and Western Medicine Hospital,Nanjing University of Chinese Medicine,Nanjing 210014,China;Nanjing Haichang Chinese Medicine Corporation,Nanjing 210061,China;Dept.of Gynaecology,the Affiliated Hospital of Nanjing University of TCM,Nanjing 210029,China)

机构地区：[1]南京中医药大学附属南京市中西医结合医院药剂科,江苏南京210014 [2]南京海昌中药集团有限公司,江苏南京210061 [3]南京中医药大学国家教育部中药炮制规范化及标准化工程研究中心,江苏南京210023

出　　处：《海峡药学》2022年第9期42-46,共5页Strait Pharmaceutical Journal

基　　金：江苏省科技成果转化专项资金项目(BA2018002);南京中医药大学自然基金项目(XZR2020100);南京市中西医结合医院院内课题(SZE202215)。

摘　　要：目的建立内消瘰疬片HPLC指纹图谱,测定其主要成分(芍药苷、苯甲酸、毛蕊异黄酮葡萄糖苷、迷迭香酸)的量,为其质量控制提供可靠方法。方法采用C_(18)色谱柱,以乙腈-0.1%磷酸水溶液为流动相,梯度洗脱,流速1.0 mL·min^(-1),检测波长230 nm,柱温35℃,进样量10μL;建立内消瘰疬片HPLC指纹图谱,对其主要成分含量测定。结果确定内消瘰疬片HPLC指纹图谱,指认9个成分。芍药苷、苯甲酸、毛蕊异黄酮葡萄糖苷、迷迭香酸分离度良好,精密度和重复性试验RSD均<3.0%,供试品溶液在24 h内稳定,线性关系良好(r>0.9995);加样回收率在97.37%~99.76%,RSD<2.7%;含量范围为0.0640%~0.0724%、0.0073%~0.0097%、0.0026%~0.0032%、0.0085%~0.0093%。结论所建立内消瘰疬片质量控制方法可以有效地评价其质量。OBJECTIVE To establish HPLC fingerprint of NeiXiao LuoLi Tablets and determine the main components(paeoniflorin,benzoic acid,calycosin 7-0-β-D-glucopyranoside and rosmarinic acid),so as to provide reliable method for quality control.METHODS The analysis was carried out on an analytical column C_(18) with gradient elution of acetonitrilel-0.1%phosphoric acid aqueous solution at a flow rate of 1.0 mL·min^(-1).The detection wavelength was set at 230 nm.The column temperature was 35℃and the injection volume was 10μL.The HPLC fingerprint of NeiXiao LuoLi tablets was established,and the contents were determined.RESULTS 14 common peaks were found in fingerprints of NeiXiao LuoLi tablets,9 of which were identified as p-Hydroxybenzoic acid,paeoniflorin,benzoic acid,calycosin 7-0-β-D-glucopyranoside,isoquercitrin,rosmarinic acid,cinnamic acid,quercetin,formononetin by comparison with the reference substances.Paeoniflorin,benzoic acid,calycosin 7-0-β-D-glucopyranoside and rosmarinic acid were well separated under the chromatographic conditions.The RSD values for precision and repeatability were all less than 3.0%and the test solution was stable in 24 hours.All the compounds had good linearity and wide linear range(r>0.9950).The sample recoveries were ranged from 97.37%to 99.76%,RSD<2.7%.The contents of paeoniflorin,benzoic acid,calycosin 7-0-β-D-glucopyranoside and rosmarinic acid in 10 batches of NeiXiao LuoLi tablets were 0.0640%~0.0724%、0.0073%~0.0097%、0.0026%~0.0032%、0.0085%~0.0093%,respectively.CONCLUSION The established fingerprints and assay methods offered effective evaluation approach for the control of NeiXiao LuoLi tablets.

关 键 词：内消瘰疬片 指纹图谱 质量控制 芍药苷 苯甲酸 毛蕊异黄酮葡萄糖苷 迷迭香酸 

分 类 号：R927[医药卫生—药学]