摘要
目的采用UPLC法建立穿心莲标准汤剂的质量评价方法。方法依照中药饮片标准汤剂制备要求,制备21批穿心莲饮片标准汤剂,建立超高效液相特征图谱分析方法,以穿心莲内酯为参照,建立新穿心莲内酯、14-去氧穿心莲内酯和脱水穿心莲内酯的一测多评法,并与外标法测定结果比较。结果采用《中药色谱指纹图谱相似度评价系统(2012版)》软件进行特征图谱分析,共标定7个共有峰,指认了木犀草素-7-O-β-D-葡萄糖醛酸苷、穿心莲内酯、新穿心莲内酯、14-去氧穿心莲内酯和脱水穿心莲内酯5个成分,一测多评法与外标法测定各成分含量结果RSD均在3%以内。结论所建立的特征图谱和一测多评方法准确、可靠,可较全面地反映穿心莲标准汤剂的内在质量,为穿心莲配方颗粒及其他制剂的质量评价提供依据。
Objective To establish quality evaluation method of Andrographis paniculata standard decoction by UPLC.Methods 21 batches of Andrographis paniculata standard decoctions were prepared according to the standardization method of TCM decoction pieces.The UPLC characteristic chromatograms analysis method was established.With andrographolide as a reference,quantitative analysis of multi-components by single marker(QAMS)was established for new neoandrographolide,14 deoxyandrographolide and dehydrated andrographolide.The results were compared with the external standard method(ESM)to determine the accuracy of the method.Results Similarity Evaluation System for Chromatographic Fingerprint of TCM(2012 edition)was used to analyze and compare the characteristic chromatograms,and seven common peaks were determined and five were identified including luteolin-7-O-β-D-glucuronide,andrographolide,neoandrographolide,14-deoxyandrographolide and dehydroandrographolide.The RSDs of content results of each component by QAMS and ESM were all within 3%.Conclusion The determination method was reliable and accurate,which could be used to reflect the intrinsic quality of Andrographis paniculata standard decoction comprehensively and provide the basis for the quality evaluation of Andrographis paniculata formula granules and other preparations.
作者
马智玲
王晓亚
杜微波
张志强
沈建梅
刘艳
MA Zhiling;WANG Xiaoya;DU Weibo;ZHANG Zhiqiang;SHEN Jianmei;LIU Yan(Taiyuan Xiaodian District People’s Hospital,Taiyuan 030032,China;Beijing Kangrentang Pharmaceutical Co.,Ltd,Beijing 101301,China;Institute of Chinese Materia Medica,China Academy of Chinese Medical Sciences,Beijing 100700,China)
出处
《药学实践与服务》
2026年第1期46-52,共7页
Journal of Pharmaceutical Practice and Service
关键词
穿心莲
标准汤剂
UPLC
一测多评法
特征图谱
质量标准
Andrographis paniculata
standard decoction
UPLC
QAMS
characteristic chromatogram
quality standard
