军事医学2025，Vol.49Issue(1)：35-40,6.DOI:10.7644/j.issn.1674-9960.2025.01.006
冷冻干燥与干热病毒灭活工艺对人血α2-巨球蛋白生物活性的影响
Effects of freeze-drying and dry heat virus inactivation processes on the biological activities of human plasma derived α2-macroglobulin
摘要
Abstract
Objective To assess the impact of freeze-drying and dry heat virus inactivation processes on the activity ofα2-macroglobulin(A2M)derived from human plasma Cohn fraction Ⅳ.Methods A2M derived from human plasma Cohn fraction Ⅳ was prepared and subjected to programmed freeze-drying with dry heat virus inactivation.The lyophilized products were evaluated for their appearance,water content,and validation of the viral inactivation process.The bioactivity of the products before and after lyophilization as well as before and after dry heat inactivation was determined via trypsin inhibition,and the comparisons were studied.Results The appearance of the lyophilized product was fluffy,and the water content was(5.83±0.45)％.The specific activities of the samples before and after lyophilization were(10.199±0.137)and(10.033±0.201)μg/mg,respectively,with no statistically significantdifference between the two groups(P＞0.05).The viral inactivation of the samples was carried out by using dry heat inactivation conditions at 100 ℃ for 30 min.After inactivation,the reduction was ≥5.125 LgTCID50/0.1 mL in Pseudorabies virus(PRV)titers,≥4.500 LgTCID50/0.1 mL in Sindbis virus(SinV)titers,≥6.375 LgTCID50/0.1 mL in encephalomyocarditis virus(EMCV)titers,and≥4.500 LgTCID50/0.1 mL in porcine parvovirus(PPV)titers.The specific activities of the samples before and after dry heat were(9.921±0.292)and(10.091±0.278)μ g/mg,respectively,with no statistically significant difference between the two groups.Conclusion A2M derived from human plasma Cohn fraction Ⅳ,when subjected to freeze-drying followed by dry heat inactivation at 100 ℃ for 30 minutes,can effectively inactivate viruses without altering the biological activity of the product.关键词
α2-巨球蛋白/Cohn组分Ⅳ/冷冻干燥/干热法病毒灭活/生物活性Key words
α2-macroglobulin/Cohn fraction Ⅳ/freeze-drying/dry heat virus inactivation/bioactivity分类
医药卫生引用本文复制引用
丰腾,马玉媛,祁芳玲,王强,王蕊,王少伟,贾俊婷,陈崇伟,章金刚,袁方..冷冻干燥与干热病毒灭活工艺对人血α2-巨球蛋白生物活性的影响[J].军事医学,2025,49(1):35-40,6.基金项目
北京市科技计划项目(Z221100007922031) （Z221100007922031）
