肝素纯化工艺中离子交换树脂的选择与应用研究

研究比较了5种树脂对肝素的吸附能力,从中选出S5428阴离子交换树脂来纯化肝素。通过对各因素的研究,确定了树脂对肝素的静态、动态吸附以及解吸的最佳条件。结果表明:静态吸附的温度45℃,pH 8.0的条件下吸附2 h,肝素的吸附率为90.5%;层析柱的动态吸附温度45℃,肝素溶液进样浓度1.0 mg/mL,进样速度1.5 mL/min,树脂柱能处理1.5 BV肝素液而不发生泄露,吸附量为3.05 mg/mL,达到饱和吸附时可处理4BV的料液,吸附量为9.18 mg/mL;采用2.0 mol/L NaCl洗脱,洗脱流速1.5 mL/min,肝素解吸率可达95.8%,肝素效价可达150 U/mg,效价回收率98%。

Selection and Application of Ion Exchange Resin for Heparin Purification Process

Five kinds of resins were compared for the heparin adsorption capability,and S5428 ion exchange resin was chosen as the best.On the basis of single factor test,the optimum conditions of static and dynamic adsorption heparin were determined.The results showed that the rate of heparin adsorption was 90.5% under the temperature of 45 ℃,pH 8.0,and 2 h adsorption in the static adsorption experiment.The dynamic adsorption conditions of ion exchange chromatography(IEC) were determined as follows:the temperature of 45 ℃,the concentration of heparin solution 1 mg/mL,feed rate 1.5 mL/min,1.5 BV of heparin solution through the resin column without leaking,the adsorption capacity of 3.05 mg/mL,4 BV of saturated adsorption,and the adsorption capacity of 9.18 mg/mL.And 2.0 mol/L NaCl was applied as elution with flow rate 1.5 mL/min.Under these conditions,the rate of heparin desorption was 95.8%,the potency of purified heparin was 150 U/mg,and the potency recovery was 98%.