中国现代中药2025，Vol.27Issue(6)：1134-1142,9.DOI:10.13313/j.issn.1673-4890.20250121002
经典名方清经散基准样品的形态研究和质量表征
Morphological Study and Quality Characterization of Reference Sample of Classical Prescription Qingjing Powder
摘要
Abstract
Objective:To identify the material state of the reference sample of the classical prescription Qingjing Powder and characterize its quality attributes.Methods:The fingerprint of Qingjing Powder was established using ultra-high performance liquid chromatography.The chemical constituents were identified using time-of-flight mass spectrometry.The bioactive components of Qingjing Powder were screened via the traditional Chinese medicine systems pharmacology(TCMSP)database,and a multi-index quantitative method was established.The material basis differences among the decoction,concentrated extract,spray-dried powder,and freeze-dried powder of Qingjing Powder were compared to determine the material form of the reference sample and propose a content range for key constituents.Results:A total of 25 characteristic peaks were identified in the fingerprint of the Qingjing Powder reference sample,among which 18 chemical constituents were characterized.Five bioactive components were selected as quantitative markers,including paeoniflorin,paeonol,berberine hydrochloride,1,3-O-dicaffeoylquinic acid,and cryptochlorogenic acid.The content of paeonol in the decoction of Qingjing Powder decreased significantly during concentration and spray-drying processes.Compared with the corresponding batches of decoction,the fingerprint similarities of the corresponding freeze-dried powder batches were all greater than 0.995.The content of the index components closely matched those of the decoction,indicating preservation of the original material basis.The fingerprint similarities of 15 batches of freeze-dried Qingjing powder were greater than 0.950 compared with the reference chromatogram.Based on the average mass fraction ranges(±30%)of the five compounds,the content limits were established as follows:paeoniflorin(14.05-26.10 mg·g⁻¹),paeonol(2.48-4.60 mg·g⁻¹),berberine hydrochloride(0.92-1.71 mg·g⁻¹),1,3-O-dicaffeoylquinic acid(0.58-1.08 mg·g⁻¹),and cryptochlorogenic acid(0.51-0.95 mg·g⁻¹).All tested batches were within the proposed limits.Conclusion:This study is to compare and determine the material form of the reference sample of Qingjing Powder.Quality evaluation indicators and corresponding content limits were established,providing a scientific reference for the development of compound preparation based on this classical prescription.关键词
清经散/基准样品/物质形态/浓缩/干燥Key words
Qingjing Powder/reference sample/material form/concentration/drying分类
医药卫生引用本文复制引用
梁浩明,兰青山,高永坚,谢瑞强,林碧珊,梁翠婷,汤春花,王宗保..经典名方清经散基准样品的形态研究和质量表征[J].中国现代中药,2025,27(6):1134-1142,9.基金项目
2021年佛山市社会领域科技攻关专项(2120001007987) （2120001007987）
