多组分定量联合化学计量学及灰色关联度分析骨力胶囊质量评价  

Quality evaluation of Guli capsules based on multicomponent quantification,chemometrics and grey relational analysis

作　　者：王青霞[1] 汪滨[2] 汤样华[3] 俞明义 王晓燕 Wang Qing-xia;Wang Bin;Tang Yang-hua;Yu Ming-yi;Wang Xiao-yan(Department of Pharmacy,Traditional Chinese Medical Hospital of Xiaoshan District of Hangzhou&Jiangnan Hospital Affiliated to Zhejiang Chinese Medical University,Hangzhou 311201,China;Department of Neurosurgery,Traditional Chinese Medical Hospital of Xiaoshan District of Hangzhou&Jiangnan Hospital Affiliated to Zhejiang Chinese Medical University,Hangzhou 311201,China;Department of Orthopaedics,Traditional Chinese Medical Hospital of Xiaoshan District of Hangzhou&Jiangnan Hospital Affiliated to Zhejiang Chinese Medical University,Hangzhou 311201,China;Zhejiang Institute for Food and Drug Control,Hangzhou 310052,China)

机构地区：[1]杭州市萧山区中医院(浙江中医药大学附属江南医院)药学部,杭州311201 [2]杭州市萧山区中医院(浙江中医药大学附属江南医院)神经外科,杭州311201 [3]杭州市萧山区中医院(浙江中医药大学附属江南医院)骨科,杭州311201 [4]浙江省食品药品检验研究院,杭州310052

出　　处：《中国药物应用与监测》2024年第1期29-33,共5页Chinese Journal of Drug Application and Monitoring

基　　金：浙江省中医药科学研究基金项目(2022ZB298)。

摘　　要：目的建立骨力胶囊多组分定量检测方法,探索化学计量学及灰色关联度分析模型在其质量评价中的应用。方法采用HPLC法,乙腈-0.2%醋酸为流动相梯度洗脱;检测波长为270、430和250 nm;以葛根素为内参物,建立多组分定量分析模式。再通过化学计量学及GRA评价其综合质量。结果外标法方法学验证结果均符合要求;相对校正因子法和外标法的定量结果显示二者差异无统计学意义。化学计量学分析结果显示淫羊藿苷、葛根素、朝藿定、补骨脂素和姜黄素为骨力胶囊的代表性差异成分;GRA模型稳定,相对关联度在0.3095~0.6145。结论所建立的方法简便实用,化学计量学和GRA可用于评价骨力胶囊的整体质量。Objective To establish a multicomponent quantification method for Guli capsules and explore the application of chemometrics and grey relational analysis(GRA)in the quality evaluation of them.Methods Samples were gradiently eluted with acetonitrile-0.2%acetic acid as the mobile phase based on high-performance liquid chromatography(HPLC)method.The detection wavelengths were 270,430 and 250 nm.A multicomponent quantitative analysis mode was established with puerarin as the internal standard.The comprehensive quality of Guli capsules was evaluated by chemometrics and GRA.Results The results of methodological verification of external standard method(ESM)met the requirements.There was no significant difference between the quantitative results obtained by relative correction factor method and ESM.Chemometrics analysis showed that icariin,puerarin,epimedin,psoralen and curcumin were the representative differential components of Guli capsules.The GRA model was stable,and the relative correlation was from 0.3095 to 0.6145.Conclusion The established method wis simple and practical,and chemometrics and GRA could be used to evaluate the overall quality of Guli capsules.

关 键 词：骨力胶囊 一测多评法 灰色关联度分析法 化学计量学 综合评价 

分 类 号：R286.0[医药卫生—中药学]