摘要
目的通过化学计量学结合成分含量差异分析的方法,对市售小儿麻甘颗粒的质量进行分析。方法采用超高效液相色谱-四级杆-飞行时间质谱法进行基础成分轮廓谱研究;使用偏最小二乘-判别分析量化并筛选质量差异标志物,建立差异成分的多组分定量及指纹图谱方法,使用主成分分析并计算主成分综合得分。结果轮廓谱鉴定出12个共有峰,分别归属于地骨皮、桑白皮、苦杏仁、甘草、紫苏子、黄芩6味药材;以变量重要性投影值>1为标准,筛选出4个质量差异标志性成分(桑皮苷A、苦杏仁苷、迷迭香酸、黄芩苷);45批样品指纹图谱相似度在0.867~0.997之间,标定14个成分,指认出桑皮苷A、L-苦杏仁苷、苦杏仁苷、迷迭香酸、黄芩苷、汉黄芩苷、黄芩素、汉黄芩素8个成分。各企业主成分1的得分排序为:G>H>A>C>E>D>F>I>B;主成分2的得分排序为:F>G>H>B>E>D>C>A>I;综合得分排序为:G>H>C>A>E>F>D>I>B。结论企业G和H的制剂质量最优。建立的指纹图谱及质量差异性成分定量方法准确可靠,可为小儿麻甘颗粒的质量分析提供参考。
Objective To analyse the quality of Xiao’er Magan granules by the combination of chemometrics and difference analysis of component content.Methods The ultra-performance liquid chromatography/quadrupole time-of-flight-tandem mass spectrometry(UPLC-Q-TOF/MS)method was used to study the characteristic spectrum of basic components.The partial least squares discriminant analysis was used to quantify and screen the markers of quality difference,the methods of muti-component quantification for differential components and fingerprint were established,and the principal component analysis was used to calculate the comprehensive scores of principal components.Results The 12 common peaks were identified by the characteristic spectrum,which were attributed to 6 medicinal herbs,namely Rhizome,Mulberry bark,Bitter almond,Licorice,Perilla seed and Scutellaria.Taking the variable importance projection value>1 as the criterion,4 characteristic components of quality differences(mulberry A,amygdalin,rosmarinic acid and baicalin)were screened out.The fingerprints similarity of 45 batches of samples were 0.867-0.997.14 components were calibrated,and 8 components were identified,which were mulberroside A,L-amygdalin,amygdalin,rosmarinic acid,baicalin,oroxindin,baicalein and wogonin.The scores of principal component 1 of each enterprise were as follows:G>H>A>C>E>D>F>I>B.The scores of principal component 2 were as follows:F>G>H>B>E>D>C>A>I.The ranking of the comprehensive scores was as follows:G>H>C>A>E>F>D>I>B.Conclusion The preparation quality of enterprise G and H is the best.The established fingerprint and quantitative method of quality differential components are accurate and reliable,which can provide reference for the quality analysis of Xiao’er Magan granules.
作者
费毅琴
吕盼
杨萍
占方玲
徐玲
FEI Yiqin;LYU Pan;YANG Ping;ZHAN Fangling;XU Ling(Hubei Institute for Drug Control,Wuhan 430075,China;NMPA key Laboratory of Quality Control of Chinese Medicine,Wuhan 430075,China;Hubei Engineering Research Center for Drug Quality Control,Wuhan 430075,China)
出处
《中国药师》
CAS
2024年第6期937-950,共14页
China Pharmacist
基金
2022年国家药品抽检计划项目。
关键词
小儿麻甘颗粒
化学计量学
指纹图谱
成分含量差异分析
超高效液相色谱-四级杆-飞行时间质谱
质量分析
Xiao’er Magan granules
Chemometrics
Fingerprints
Difference analysis of component content
Ultra-performance liquid chromatography/quadrupole time-of-flighttandem mass spectrometry
Quality analysis
