指纹图谱和化学模式识别评价前列舒通胶囊的质量  

Quality evaluation of Qianlie Shutong capsules based on fingerprints and chemical pattern recognition

作　　者：程茜菲[1,2] 张玩涛 彭修娟 炊晨阳[1] 王珊 刘金华 卢颖[3] 刘峰 CHENG Qianfei;ZHANG Wantao;PENG Xiujuan;CUAN Chenyang;WANG Shan;LIU Jinhua;LU Ying;LIU Feng(Shaanxi Institute of International Trade and Commerce,Xi'an,Shaanxi,712046 P.R.China;Collaborative Innovation Center of Green Manufacturing Technology of Traditional Chinese Medicine in Shaanxi Province,Xi'an,Shaanxi,712046 P.R.China;Baoding Tianhao Pharmaceutical Limited Company,Baoding,Hebei,071000 P.R.China;Shaanxi Buchang Pharmaceutical Limited Company,,Xi'an,Shaanxi,710075 P.R.China)

机构地区：[1]陕西国际商贸学院,陕西西安712046 [2]陕西省中药绿色制造技术协同创新中心,陕西西安712046 [3]保定天浩制药有限公司,河北保定071000 [4]陕西步长制药有限公司,陕西西安710075

出　　处：《华西药学杂志》2023年第1期95-99,共5页West China Journal of Pharmaceutical Sciences

基　　金：陕西省中医药管理局科研项目立项(2021-ZZ-ZY005,2021-ZZ-ZY006);陕西省科技厅重点研发计划项目(2022SF-355)。

摘　　要：目的 建立前列舒通胶囊的HPLC指纹图谱并结合化学模式识别,对前列舒通胶囊的整体质量进行评价。方法 采用HPLC法测得18批样品的色谱图,并进行相似度分析;以22个共有峰的峰面积为变量,进行聚类分析、主成分分析和正交偏最小二乘法-判别分析。结果 18批样品的指纹图谱中有22个共有峰,相似度均大于0.98,造成不同批次间的差异性成分为F3、F7、F16、F21等4个峰,其中,F16为盐酸小檗碱。结论 所用方法准确可行,可为“药材-中间体-成品”全过程的质量控制提供依据。OBJECTIVE To establish an HPLC fingerprints of Qianlie Shutong capsules and evaluate its quality combined with chemical pattern recognition.METHODS The chromatograms of 18 batches of samples were determined by HPLC,and the similarity analysis was carried out.Cluster analysis, principal component analysis and orthogonal partial least squares discriminant analysis were carried out with 22 common peak areas as variables.RESULTS Totally 22 common peaks were determined in 18 batches of samples, the similarity was greater than 0.98,resulting in four peaks of F3,F7,F16 and F21,among which F16 was berberine hydrochloride.CONCLUSION The fingerprint combined with chemical pattern recognition analysis was used to evaluate the quality of Qianlie Shutong capsules.This method was accurate and feasible, which laied a foundation for the quality control of the whole process of “medicinal materials-intermediates-finished products”.

关 键 词：前列舒通胶囊 指纹图谱 化学模式识别 差异性标志物 全过程质量控制 高效液相色谱仪 盐酸小檗碱 

分 类 号：R917[医药卫生—药物分析学]