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响应面法优化人绒毛膜促性腺激素(hCG)中间体提取工艺

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人绒毛膜促性腺激素(hCG)中间体是重要的医药原料,为优化hCG中间体提取工艺,提高hCG提取效率,本研究以hCG粗品为原料,使用乙酸钠缓冲液一步浸提法从hCG粗品中提取hCG中间体,先以单因素实验研究了缓冲液浓度、液料比、搅拌时间和搅拌温度对hCG中间体提取效价的影响,在此基础上通过响应面实验优化了提取工艺.结果表明:影响hCG中间体效价的因素从大到小排序为液料比、搅拌时间、缓冲液浓度、搅拌温度,液料比和缓冲液浓度两因素之间的交互作用对hCG中间体效价有显著影响,以此建立提取hCG中间体效价多元回归数学模型.优化后的提取hCG中间体工艺最佳条件为乙酸钠缓冲液浓度为0.15 mol/L、液料比(mL/g)为11∶1、搅拌时间为2 h、搅拌温度为10℃,在此条件下,提取后hCG中间体效价为259.55 IU/mg.该工艺较传统工艺参数明确,步骤简单,减少了原辅材料使用,提取用时减少了 50%,hCG中间体效价提高了 29.78%,应用前景广阔.
Optimization of extraction process for hCG intermediates using response surface methodology
HCG intermediates are important pharmaceutical raw materials.The one-step extraction method was utilized to extract hCG intermediates from hCG crude with sodium acetate buffer.To optimize this extraction process and improve the extraction efficiency,single factor experiments were designed to study the effects of buffer concentration,liquid-solid ratio,stir time,and stir temperature on the extraction potency of hCG intermediates.Based on the results from response surface methodology,the factors affecting the potency of hCG intermediates ranked in descending order as follows:liquid-solid ratio,stir time,buffer concentration,stir temperature.In addition,the interaction between liquid-solid ratio and buffer concentration had a significant impact on the potency of hCG intermediates.Moreover,a multiple regression mathematical model was established to evaluate the extraction potency of hCG intermediates.The optimal conditions for the one-step extraction of hCG intermediates using sodium acetate buffer were shown below:sodium acetate buffer concentration at 0.15 mol/L,liquid-solid ratio(mL/g)as 11∶1,stir time for 2 hours,stir temperature at 10 ℃.Under the above conditions,the potency of the extracted hCG intermediates reached 259.55 IU/mg.Compared with traditional processes,our new method adopted clearer parameters and simpler procedures,which could,reduce the use of raw materials,shorten the extraction time by 50%,and improve the potency of hCG intermediates by 29.78%.

human chorionic gonadotropin intermediatepotencybuffer extraction methodresponse surface optimization

雷涛、咸庆东、咸洪泉

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青岛农业大学生命科学学院,山东青岛 266109

斯坦德科创医药科技(青岛)有限公司,山东 青岛 266000

hCG中间体 效价 缓冲液浸提法 响应面优化

2025

生物加工过程
南京工业大学

生物加工过程

影响因子:0.529
ISSN:1672-3678
年,卷(期):2025.23(1)