一测多评法联合化学计量学及熵权TOPSIS法综合评价复方石淋通胶囊质量  

Comprehensive Quality Evaluation of Compound Shilintong Capsules Based on Multi-Component Quantitative Analysis Combined with Chemometrics and Entropy-Weighted TOPSIS Method

作　　者：张海军[1] 陈争珍 李志明 张贝[1] ZHANG Haijun;CHEN Zhengzhen;LI Zhiming;ZHANG Bei(Yancheng Third People's Hospital·Yancheng Clinical Medical College of Nanjing Medical University,Yancheng,Jiangsu,China 224001;School of Pharmacy,Jiangsu Vocational College of Medicine,Yancheng,Jiangsu,China 224000;School of Pharmacy,Nanjing University of Chinese Medicine,Nanjing,Jiangsu,China 210023)

机构地区：[1]江苏省盐城市第三人民医院·南京医科大学盐城临床医学院,江苏盐城224001 [2]江苏医药职业学院药学院,江苏盐城224000 [3]南京中医药大学药学院,江苏南京210023

出　　处：《中国药业》2025年第6期71-77,共7页China Pharmaceuticals

基　　金：江苏省中医药科技发展计划项目[MS2021008]。

摘　　要：目的建立同时测定复方石淋通胶囊中11种成分的高效液相色谱法,并评价其质量。方法色谱柱为Agilent Eclipse Plus C18柱(250 mm×4.6 mm,5μm),流动相为0.2%甲酸溶液-乙腈(梯度洗脱),流速为1.0 mL/min,检测波长为327 nm(新绿原酸、绿原酸、隐绿原酸)、238 nm(马钱苷、当药苷、断氧化马钱子苷)、340 nm(维采宁-1、新西兰牡荆苷、夏佛塔苷、异夏佛塔苷、异牡荆苷),柱温为30℃,进样量为10μL。以马钱苷为内参,建立其与其他10种成分的相对校正因子(f);计算样品中11种成分的含量,并与外标法检测结果比较。采用化学计量学及熵权优劣解距离(TOPSIS)法对13批样品进行差异分析。结果方法学考察结果均符合2020年版《中国药典》要求;f耐用性良好,两种方法所得含量无显著差异(P>0.05)。化学计量学分析显示13批样品聚为3类;断氧化马钱子苷、夏佛塔苷、马钱苷、新绿原酸、异夏佛塔苷和隐绿原酸是影响13批样品质量的差异标志物。熵权TOPSIS分析显示,13批样品相对贴近度(C_(i))值为0.1709~0.7135,其中4批C_(i)>0.5,质量较好。结论该研究中所建方法可用于复方石淋通胶囊质量的综合评价,不同厂家样品质量存在一定差异。Objective To establish a high-performance liquid chromatography(HPLC)method for the simultaneous determination of 11 marker components in Compound Shilintong Capsules and to evaluate their quality.Methods The chromatographic column was the Agilent Eclipse Plus C18 column(250 mm×4.6 mm,5μm),the mobile phase was 0.2%formic acid solution-acetonitrile(gradient elution),the flow rate was 1.0 mL/min,the detection wavelengths were 327 nm(neochlorogenic acid,chlorogenic acid,cryptochlorogenic acid),238 nm(loganin,swertiamarin,desoxystrychnine),and 340 nm(veronicastroside-1,vitexin-2″-O-rhamnoside,schaftoside,isoschaftoside,isovitexin),the column temperature was 30℃,and the injection volume was 10μL.Loganin was used as an internal standard to establish the relative correction factors(f)for the other 10 components.The content of 11 components in the samples was calculated and compared with results obtained using the external standard method.Chemometric analysis and entropy-weighted Technique for Order of Preference by Similarity to Ideal Solution(TOPSIS)were applied to analyze the differences among 13 batches of samples.Results The methodological validation met the requirements of the 2020 edition of the Chinese Pharmacopoeia.f showed good durability,and there was no significant difference between the two quantification methods(P>0.05).Chemometric analysis classified the 13 batches into three groups,identifying desoxystrychnine,schaftoside,loganin,neochlorogenic acid,isoschaftoside,and cryptochlorogenic acid as key differential markers affecting sample quality.The entropy-weighted TOPSIS analysis showed that the relative closeness(C_(i))values of the 13 batches ranged from 0.1709 to 0.7135,with four batches exhibiting C_(i)>0.5,indicating relatively high quality.Conclusion The method established in this study is suitable for the comprehensive quality evaluation of Compound Shilintong Capsules,revealing certain quality differences among products from different manufacturers.

关 键 词：复方石淋通胶囊 高效液相色谱法 一测多评法 化学计量学 熵权优劣解距离法 质量评价 

分 类 号：R917[医药卫生—药物分析学]