基于多指标成分分析及化学计量学的扶脾止泻颗粒质量评价研究  

Evaluation of Fupi Zhixie Granules Based on Multi-index Component Analysis and Chemometrics

作　　者：夏舒鋆 魏谭军[1] 陈飞 魏旭 王春龙 肖成[1] XIA Shujun;WEI Tanjun;CHEN Fei;WEI Xu;WANG Chunlong;XIAO Cheng(Department of Pharmacy,Dazhou Integrated TCM&Western Medical Hospital&Dazhou Second People's Hospital,Dazhou 635000,China)

机构地区：[1]达州市中西医结合医院&达州市第二人民医院药学科,四川达州635000

出　　处：《现代中药研究与实践》2024年第3期58-65,共8页Research and Practice on Chinese Medicines

基　　金：四川省重大科技专项项目(2020YFS0533);四川省中央引导地方科技发展专项(2023ZYD0283)。

摘　　要：目的建立扶脾止泻颗粒多指标成分定量的方法,并借助化学计量学及GRA手段评价其综合质量。方法采用HPLC法同时测定扶脾止泻颗粒中3'-羟基葛根素、葛根素、3'-甲氧基葛根素、木香烃内酯、去氢木香内酯、23-乙酰泽泻醇C、23-乙酰泽泻醇B、去氢土莫酸、土莫酸、去氢茯苓酸和茯苓酸含量。结合化学计量学挖掘影响扶脾止泻颗粒产品质量的差异标志物。以相对关联度为测度,对扶脾止泻颗粒综合质量进行评价。结果11种成分在各自范围内线性关系良好(r>0.999),平均加样回收率(n=9)在96.85%~100.10%之间(RSD<2.0%)。化学计量学分析显示茯苓酸、葛根素、23-乙酰泽泻醇B和木香烃内酯是影响扶脾止泻颗粒产品质量的主要因子。GRA结果显示相对关联度在0.3404~0.5759之间。结论所建立的方法操作便捷,结果准确,可用于扶脾止泻颗粒质量的综合评价。Objective To establish a method for quantifying the multiple indicator components of Fupi Zhixie Granule,and to evaluate its comprehensive quality using chemometrics and GRA methods.Methods HPLC was used to determine the contents of 3'-hydroxypuerarin,puerarin,3'-methoxypuerarin,costunolide,dehydrocostuslactone,23-acetate alisol C,23-acetate alisol B,dehydrotumulosic acid,tumulosic acid,dehydropachymic acid and pachymic acid of Fupi Zhixie Granule.Chemometrics was used to mine differential markers affecting the productquality of Fupi Zhixie Granule.The relative correlation degree was used to analyze the comprehensive quality of Fupi Zhixie Granule was evaluated by GRA.Results The 11 components had good linear relationships within their respective ranges(r>0.999),and the average recovery rate(n=9)were 96.85%-100.10%(RSD<2.0%).Chemometric analysis showed that pachymic acid,puerarin,23-acetate alisol B and costunolide were the main potential markers affecting the quality of Fupi Zhixie Granule.The relative correlation degree of GRA were 0.3404-0.5759,and it was helpful for preparation production unit to analyze the root causes of batch differences.Conclusion The established HPLC multiple indicator components quantitative combined chemometrics and GRA method can be used for the quality comprehensive evaluation of Fupi Zhixie Granule.

关 键 词：扶脾止泻颗粒 高效液相色谱法 多指标成分 化学计量学 灰色关联度分析 综合评价 

分 类 号：R284.1[医药卫生—中药学]