Quality analysis of Xiao'er Magan granules based on chemometrics combined with quantitative analysis of different components
10.12173/j.issn.1008-049X.202401049
- VernacularTitle:基于化学计量学结合差异成分定量的小儿麻甘颗粒质量分析
- Author:
Yiqin FEI
1
,
2
,
3
;
Pan LYU
;
Ping YANG
;
Fangling ZHAN
;
Ling XU
Author Information
1. 湖北省药品监督检验研究院(武汉 430075)
2. 国家药品监督管理局中药质量控制重点实验室(武汉 430075)
3. 湖北省药品质量检测与控制工程技术研究中心(武汉 430075)
- Keywords:
Xiao'er Magan granules;
Chemometrics;
Fingerprints;
Difference analysis of component content;
Ultra-performance liquid chromatography/quadrupole time-of-flight-tandem mass spectrometry;
Quality analysis
- From:
China Pharmacist
2024;27(6):937-950
- CountryChina
- Language:Chinese
-
Abstract:
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 Xiaoer Magan granules.
