透明质酸钠的热稳定性及降解动力学模型  

Thermal stability and degradation kinetic model of sodium hyaluronate

作　　者：袁西伦 王文斌 吴剑英 YUAN Xi-lun;WANG Wen-bin;WU Jianying(Shanghai Haohai Biological Technology,Shanghai 201600,China)

机构地区：[1]上海昊海生物科技股份有限公司,上海201600

出　　处：《生物医学工程与临床》2023年第6期712-717,共6页Biomedical Engineering and Clinical Medicine

摘　　要：目的考察透明质酸钠的热稳定性,并建立降解动力学模型。方法通过分子排阻色谱法检测透明质酸钠的相对分子质量(Mr),考察不同温度下(60℃、80℃、100℃、115℃和121℃)透明质酸钠的稳定性和经高温灭菌后(121℃)透明质酸钠在不同温度下(25℃、40℃、50℃和60℃)的稳定性,通过软件将透明质酸钠Mr的对数(lnMr)与时间(t)进行线性拟合,建立降解动力学模型。结果在60℃、80℃、100℃、115℃和121℃下透明质酸钠Mr的lnMr与t的线性拟合相关系数(R2)分别是0.98877、0.99976、0.97869、0.98149和0.98926,均具有较好的相关性。经高温灭菌后(121℃),透明质酸钠在25℃、40℃、50℃和60℃下lnMr与t的线性拟合R2分别是0.32102、0.84761、0.80870和0.99016,除60℃下具有较好的相关性外,其他温度条件下的相关性均较差。结论透明质酸钠在60℃、80℃、100℃、115℃和121℃下属于一级降解动力学,其热降解活化能Ea=120.012 kJ/mol。高温灭菌后透明质酸钠的稳定性在大于60℃仍属于一级降解动力学,低于60℃时初始降解速度较快,但4~6个月后,其Mr下降逐步变慢,其降解不属于一级动力学。Objective To investigate the thermal stability of hyaluronic acid and establish degradation kinetic model.Methods The relative molecular mass(Mr)of sodium hyaluronate was detected by molecular exclusion chromatography.The stability of sodium hyaluronate at different temperatures(60℃,80℃,100℃,115℃and 121℃)and the stability of sodium hyaluronate at different temperatures(25℃,40℃,50℃and 60℃)after high-temperature sterilization(121℃)were inves tigated.The logarithm of sodium hyaluronate mass(lnMr)and time(t)were linearly fitted by software to establish degradation kinetic model.Results At 60℃,80℃,100℃,115℃and 121℃,the linear fitting correlation coefficients(R2)of lnMr of sodium hyaluronate with t were 0.98877,0.99976,0.97869,0.98149 and 0.98926,respectively,which showed good correlation.After high-temperature sterilization(121℃),the linear fitting R2 of lnMr of sodium hyaluronate with t at 25℃,40℃,50℃and 60℃were 0.32102,0.84761,0.80870 and 0.99016,respectively.Except for the good correlation at 60℃,the correlation at other temperatures was poor.Conclusion It is demonstrated that sodium hyaluronate was first-order degradation kinetics of at 60℃,80℃,100℃,115℃and 121℃,and its thermal degradation activation energy was Ea=120.012 kJ/mol.The stability of sodium hyaluronate after high temperature sterilization is still the first-order degradation kinetics above 60℃.The initial degradation rate is faster below 60℃,while the Mr gradually decreases after 4-6 months,and degradation is not the first-order kinetics.

关 键 词：透明质酸钠 稳定性 热降解动力学 

分 类 号：R318.08[医药卫生—生物医学工程] O636.1[医药卫生—基础医学]