乳块消片HPLC指纹图谱的建立及特征峰的归属分析  

Establishment of HPLC Fingerprint of Rukuaixiao Tablet and the Attribution Analysis of Characteristic Peaks

作　　者：吴燕红 陈希 许妍 孙磊[2] 邬秋萍 万林春 WU Yan-hong;CHEN Xi;XU Yan;SUN Lei;WU Qiu-ping;WAN Lin-chun(Jiangxi Provincial Research Institute Ror Drug Control,Jiangxi Provincial Engineering Research Center For Drug and Medical Device Quality,Jiangxi Nanchang 330029,China;National Institutes for Food and Drug Control,Beijing 100050,China)

机构地区：[1]江西省药品检验检测研究院,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 [2]中国食品药品检定研究院,北京100050

出　　处：《中国药物评价》2020年第1期41-45,共5页Chinese Journal of Drug Evaluation

基　　金：江西省食品药品监督管理局科研项目(No.2016YP07);国家自然科学基金(No.81303214)。

摘　　要：目的:探索基于全峰归属的乳块消片指纹图谱测定法.方法:采用HPLC法,色谱条件为:Techmate C18(4.6×250 mm,5μm)色谱柱,流动相A:乙腈,流动相B:0.2%磷酸溶液,梯度洗脱,流速:1 mL·min-1,柱温30℃,检测波长282 nm.通过对21批乳块消片样品的测定,生成对照图谱,在"中药色谱指纹图谱相似度评价系统(2012版)"软件计算相似度.结果:建立的指纹图谱标定共有峰9个,采用化学对照品和对照药材比对的方法对共有峰全部指认.21批样品的相似度均大于0.90,表明该药物总体质量较稳定.结论:该方法能很好地用于乳块消片整体质量控制,可作为现行质量标准的有力补充.Objective:To explore the fingerprint detection method of rukuaixiao tablet based on full peak attribution.Methods:HPLC method was used.Chromatographic conditions:Techmate C 18(4.6×250 mm,5μm)column,mobile phase A:acetonitrile,mobile phase B:0.2%phosphoric acid solution,gradient elution,flow rate was 1 mL·min-1,column temperature was 30℃,detection wavelength was 282 nm.A reference fingerprint was generated after measuring 21 batches of samples,and the similarity was calculated on the"Chinese Medicine Chromatographic Fingerprint Similarity Evaluation System(2012 Edition)"software.Results:A total of 9 characteristic peaks was calibrated by the established fingerprint methiod.All the common peaks were identified by comparison of both chemical reference and control herbs.The similarity of the 21 batch samples was greater than 0.90,indicating that the overall quality of the drug was relatively stable.Conclusion:The method can be well used for the overall quality control of rukuaixiao tablet,and can be used as powerful supplement to the current quality standards.

关 键 词：乳块消片 指纹图谱 特征峰 归属分析 

分 类 号：R284[医药卫生—中药学]