妇康宝口服液的液相指纹图谱研究  

Study on HPLC Fingerprint of Fukangbao Oral Liquid

作　　者：周志强 刘桂凤 洪挺 许妍 肖小武 ZHOU Zhiqiang;LIU Guifeng;HONG Ting;XU Yan;XIAO Xiaowu(Jiangxi Institute for Drug Control,NMPA Key Laboratory of Quality Evaluation of Traditional Chinese Patent Medicine,Jiangxi Province Engineering Research Center of Drug and Medical Device Quality,Nanchang Jiangxi 330029,China)

机构地区：[1]江西省药品检验检测研究院,国家药品监督管理局中成药质量评价重点实验室,江西省药品与医疗器械质量工程技术研究中心,江西南昌330029

出　　处：《药品评价》2023年第9期1078-1081,共4页Drug Evaluation

基　　金：江西省药品监督管理局科研项目(2020JS15)

摘　　要：目的通过高效液相色谱法建立妇康宝口服液的指纹图谱,为科学评价及有效控制妇康宝口服液的质量提供依据。方法采用ACE Excel 5 C_(18)-AR色谱柱(250 mm×4.6 mm,5μm),以乙腈-0.1%磷酸溶液为流动相,梯度洗脱,流速为1.0 mL/min,检测波长为250 nm,柱温30℃;利用中药色谱指纹图谱相似度评价系统(2012年版)建立对照指纹图谱并计算相似度。结果11批妇康宝口服液样品的指纹图谱共标定了19个共有色谱峰,通过对照品和对照药材比对,共指认了11个色谱峰,相似度在0.774~0.979之间。结论该方法简单快捷、重现性好,能够从整体性、均一性方面对妇康宝口服液的质量进行有效控制。Objective To establish HPLC fingerprint of fukangbao oral liquid,and to provide a reliable method for scientific evaluation and effective quality control of fukangbao oral liquid.Methods The ACE Excel 5 C18-AR(250 mm×4.6 mm,5μm)was used with the mobile phase consisted of acetonitrile-0.1%phosphoric acid in gradient mode,the detection wavelength was 250 nm,the flow rate was 1.0 mL/min,the temperature of column was 30℃.The control fingerprint was established by similarity evaluation system of chromatographic fingerprint of traditional Chinese medicine(2012 Edition),and the similarity was evaluated.Results The fingerprint of fukangbao oral liquid with 19 common peaks,and 11 of them were identified by comparing with both the reference substance and the control herbs.The similarity of the 11 batch samples ranges from 0.774-0.979.Conclusion The method is simplicity and reproducible,can be used for the quality control of fukangbao oral liquid in integration and uniformity.

关 键 词：妇康宝口服液 指纹图谱 相似度 特征峰 

分 类 号：R284.1[医药卫生—中药学]