基于降解动力学模型的丹酚酸B稳定性研究  

Stability of salvianolic acid B based on degradation kinetic models

作　　者：刘文康 胡先润 程雪梅[1] 刘伟[3] 魏海 王长虹[1] LIU Wen-kang;HU Xian-run;CHENG Xue-mei;LIU Wei;WEI Hai;WANG Chang-hong(Ministry of Education Key Laboratory for Standardization of Chinese Medicines,Shanghai Municipal Key Laboratory for Compound Chinese Medicines,Institute of Chinese Materia Medica,Shanghai University of Traditional Chinese Medicine,Shanghai 201203,China;Institute of Interdisciplinary Integrative Medicine Research,Shanghai University of Traditional Chinese Medicine,Shanghai 201203,China;National Administration of Traditional Chinese Medicine Grade Three Laboratory for Traditional Chinese Medicine Preparations,Department of Pharmacy,Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine,Shanghai 201203,China)

机构地区：[1]上海中医药大学中药研究所,中药标准化教育部重点实验室,上海市复方中药重点实验室,上海201203 [2]上海中医药大学交叉科学研究院,上海201203 [3]上海中医药大学附属曙光医院药学部,国家中医药管理局中药制剂三级实验室,上海201203

出　　处：《中成药》2025年第3期733-739,共7页Chinese Traditional Patent Medicine

基　　金：国家重点研发计划“中医药现代化研究重点专项”(2022YFC3501701);中国科技协会青年托举工程项目(2020QNRC001);上海市复方中药重点实验室(上海中医药大学)开放课题基金(21DZ2270500);上海市教委和上海市教育发展基金“晨光计划”项目(20CG50)。

摘　　要：目的考察丹酚酸B稳定性。方法HPLC法测定丹酚酸B含量,分析其在不同pH缓冲液中的化学稳定性、不同浓度H_(2)O_(2)中的氧化稳定性,以及人工胃液、人工肠液、生物基质中的生物稳定性,并对其降解动力学进行拟合。结果丹酚酸B在酸性和弱酸性缓冲液、人工胃液中较稳定,而在中性和碱性缓冲液、人工肠液、H_(2)O_(2)、生物基质中的稳定性较差。该成分在回肠匀浆液中的降解过程符合一级动力学模型,而在pH 7.4缓冲液、人工肠液、H_(2)O_(2)及胃、十二指肠、空肠、结肠匀浆液中的符合二级动力学模型。结论生物基质、氧化剂、碱性环境会影响丹酚酸B稳定性。本实验对丹酚酸B相关产品的开发应用具有重要意义。AIM To investigate the stability of salvianolic acid B.METHODS HPLC was adopted in the content determination of salvianolic acid B,after which the chemical stability in different pH of buffer solutions,oxidation stability in different concentrations of H_(2)O_(2),and biological stability in artificial gastric fluid,artificial intestinal fluid and biological matrices were analyzed,and its degradation kinetics was fitted.RESULTS Salvianolic acid B was stable in acidic and weakly acidic buffer solutions and artificial gastric fluid,which demonstrated poor stability in neutral and alkaline buffer solutions,artificial intestinal fluid,H_(2)O_(2)and biological matrices.The degradation process of this constituent accorded with the first-order kinetic model in ileum homogenate,and the second-order kinetic model in pH 7.4 buffer solution,artificial intestinal fluid,H_(2)O_(2)and stomach,duodenum,jejunum,colon homogenates.CONCLUSION Biological matrices,oxidants and alkaline environment can affect the stability of salvianolic acid B.This experimental exhibits important significance for the development and application of salvianolic acid B-related products.

关 键 词：丹酚酸B 稳定性 降解动力学 HPLC 

分 类 号：R969.1[医药卫生—药理学]