中国现代中药2024,Vol.26Issue(2):378-386,9.DOI:10.13313/j.issn.1673-4890.20230628002
基于指纹图谱与化学计量学的藿香正气软胶囊质量控制方法研究
Quality Control Method of Huoxiang Zhengqi Soft Capsules Based on Fingerprint and Chemometrics
摘要
Abstract
Objective:To establish a high performance liquid chromatography(HPLC)fingerprint and multi-index component determination method for Huoxiang Zhengqi Soft Capsules,and to evaluate the quality of the prescription by chemometrics.Methods:HPLC was performed using a SHIMADZU VP-ODS C18 column(250 mm×4.6 mm,5 μm)with acetonitrile-0.1%phosphoric acid aqueous solution as mobile phase in gradient elution.The flow rate was 1.0 mL·min-1,and the gradient wavelength was 254 nm and 283 nm.The column temperature was 30 ℃ and the injection volume was 10 μL.Then the fingerprint and multi-index component determination method were established for analyzing and evaluating the quality of different batches of Huoxiang Zhengqi Soft Capsules in combination with chemometrics.Results:The HPLC fingerprint of Huoxiang Zhengqi Soft Capsules was established,and 22 common peaks were calibrated.The similarity of the fingerprints of 15 batches of samples was above 0.8.Liquiritin,narirutin,hesperidin,oxypeucedanin hydrate,byakangelicol,imperatorin,honokiol,phellopterin,isoimperatorin and magnolol were determined.Chemometrics showed that there were some differences in the quality of Huoxiang Zhengqi Soft Capsules produced by different enterprises,and the quality markers were oxypeucedanin hydrate,honokiol,isoimperatorin,phellopterin,magnolol and liquiritin.Conclusion:The established HPLC fingerprint and multi-index component determination method were accurate and simple,and could be used to evaluate the quality of Huoxiang Zhengqi Soft Capsules in combination with chemometrics.关键词
藿香正气软胶囊/指纹图谱/化学计量学/聚类分析/主成分分析/正交偏最小二乘法-判别分析/质量评价Key words
Huoxiang Zhengqi Soft Capsules/fingerprint/chemometrics/cluster analysis/principal component analysis/orthogonal partial least squares-discriminant analysis/quality evaluation分类
医药卫生引用本文复制引用
马宿杉,苏建,李舒琪,苏紫藤,王常顺,刘永利..基于指纹图谱与化学计量学的藿香正气软胶囊质量控制方法研究[J].中国现代中药,2024,26(2):378-386,9.基金项目
河北省重点研发计划项目(21372502D) (21372502D)