中国药房2024，Vol.35Issue(8)：948-954,7.DOI:10.6039/j.issn.1001-0408.2024.08.09
骨骼风痛片的综合质量评价
Comprehensive quality evaluation of Guge fengtong tablets
摘要
Abstract
OBJECTIVE To establish a method for the content determination of 11 components such as protodioscin in Guge fengtong tablets,and to evaluate the comprehensive quality of Guge fengtong tablets by combining with chemometric analysis and entropy weight-technique for order preference by similarity to ideal solution(EW-TOPSIS)method.METHODS HPLC method was adopted.The determination was performed on Agilent Eclipse Plus C18 column with a mobile phase consisted of acetonitrile-0.2%phosphoric acid solution at the flow rate of 1.0 mL/min by gradient elution.The column temperature was set at 30℃.The detection wavelengths were set at 203 nm(0-28 min,protodioscin,methyl protodioscin,pseudoprotodioscin,dioscin)and 280 nm(28-60 min,catechin,epicatechin,liquiritigenin,medicarpin,6-gingerol,8-gingerol,10-gingerol);the sample size was 10 μL.Using epicatechin as the internal reference,quantitative analysis of multi-components by single marker(QAMS)method was used to determine the contents of protodioscin,methyl protodioscin,pseudoprotodioscin,dioscin,catechin,liquiritigenin,medicarpin,6-gingerol,8-gingerol and 10-gingerol,which were compared with the results of the external standard method.SPSS 26.0 software and SIMCA 14.1 software were used for principal component analysis and orthogonal partial least squares-discriminant analysis,with variable importance in projection(VIP)value greater than 1 as the standard,to screen for differential markers that affect the quality;the EW-TOPSIS method was adopted to evaluate the quality of 15 batches of samples comprehensively.RESULTS The contents of protodioscin,methyl protodioscin,pseudoprotodioscin,dioscin,catechin,liquiritigenin,medi-carpin,6-gingerol,8-gingerol and 10-gingerol determined by HPLC combined with QAMS were 6.330-10.863,1.150-2.274,0.431-0.740,2.818-4.823,0.826-1.510,0.043-0.094,0.079-0.231,0.479-1.020,0.146-0.288,0.118-0.318 mg/g,respectively;there were no statistical significances,compared with the external standard method(P＞0.05).A total of 15 batches of samples were clustered into 3 groups,with S1-S6,S7-S10,and S11-S15 clustered into one group,respectively.The VIP values of protodioscin,epicatechin,dioscin and 6-gingerol were greater than 1.Euclidean closeness values of the optimal solution(Ci)for 15 batches of samples were 0.163 5 to 0.703 7,and Ci values of S11-S15 were all higher than 0.6.CONCLUSIONS The established QAMS method is accurate and simple,and can be used for comprehensive quality evaluation of Guge fengtong tablets,by combining with chemometric analysis and EW-TOPSIS method.Protodioscin,epicatechin,dioscin and 6-gingerol are the differential markers that affect the quality of Guge fengtong tablets.Samples S11-S15 have better quality.关键词
骨骼风痛片/一测多评法/化学计量学分析/熵权优劣解距离法/含量测定/差异标志物Key words
Guge fengtong tablets/QAMS/chemometric analysis/EW-TOPSIS method/content determination/differential markers分类
医药卫生引用本文复制引用
吉顺莉,周虹,王永智,殷晓芹..骨骼风痛片的综合质量评价[J].中国药房,2024,35(8):948-954,7.基金项目
江苏省高等学校基础科学(自然科学)研究重大项目(No.23KJA360007) （自然科学）
