摘要
目的建立肺宁片的高效液相色谱(HPLC)指纹图谱。方法采用HPLC,Wondasil C_(18) Superb(4.6 mm×250 mm,5μm)色谱柱,以乙腈-0.4%磷酸为流动相进行梯度洗脱,流速1.0 ml/min,测定波长323 nm,柱温30℃。通过中药色谱指纹图谱相似度评价系统(2012年版)对肺宁片样品图谱进行处理分析,建立了肺宁片指纹图谱共有模式并计算出图谱相似度。结果6批肺宁片HPLC指纹图谱标定了共有峰23个,指认了绿原酸、咖啡酸2个特征峰,指纹图谱相似度均大于0.91,方法精密度、稳定性、重复性考察的相对标准偏差均小于3.0%。结论该方法简便、准确、可靠,可用于肺宁片的质量控制。
Objective To establish HPLC fingerprint of Feining Tablets.Methods HPLC was adopted.A Wondasil C_(18) Superb(4.6 mm×250 mm,5μm)column was used,with the mixture of acetonitrile and 0.4%phosphoric acid as mobile phase of gradient elution.The flow rate was 1.0 ml/min,the detective wavelength was set at 323 nm and the column temperature was 30℃.Similarity Evaluation System for Chromatographic Fingerprint of TCM(2012 Edition)was used to process and analyze the fingerprints of Feining Tablets samples.The common pattern was established and the similarity of fingerprints of Feining Tablets was calculated.Results 23 common peaks were found in the fingerprints of 6 batches of Feining Tablets samples and two of them were identified as chlorogenic acid and caffeic acid.The similarities of the HPLC fingerprints were all above 0.91.The RSDs of precision,stability and repeatability tests of the method were all below 3.0%.Conclusion The method is simple,accurate and reliable,and can be used to control the overall quality of Feining Tablets.
作者
程雅婷
张文昭
王健
李洁
郭丽敏
王晓云
王开元
CHENG Ya-ting;ZHANG Wen-zhao;WANG Jian;LI Jie;GUO Li-min;WANG Xiao-yun;WANG Kai-yuan(Qinhuangdao Food and Drug Inspection Center,Qinhuangdao 066000,China;Center for Disease Control and Prevention of Funing District,Qinhuangdao City,Qinhuangdao 066000,China;Qinhuangdao Intellectual Property Protection and Service Center,Qinhuangdao 066000,China)
出处
《食品与药品》
2025年第1期16-19,共4页
Food and Drug
关键词
指纹图谱
肺宁片
绿原酸
咖啡酸
fingerprint
Feining Tablets
chlorogenic acid
caffeic acid
作者简介
程雅婷,副主任中药师,主要从事中药检验和质量标准研究工作,E-mail:583873821@qq.com;通信作者:王开元,工程师,主要从事计量、标准化和知识产权工作,E-mail:582457750@qq.com。
