CAJ | 학술논문

背景：巴斯德消毒法对白蛋白的病毒灭活条件已很完善，可不要求进行病毒灭活验证，但将其应用于血红蛋白类血液代用品病毒灭活的研究在国内外尚未见有系统报道。目的：探讨巴斯德消毒法对血红蛋白类血液代用品理化性质及生物学功能的影响。方法：取适量脐血，经离心、洗血、破膜、添加稳定剂处理后，对照组于55℃水浴加热，待血红蛋白溶液温度达到(55±1)℃开始计时，2 h后加热处理完成；巴氏消毒组于60℃水浴加热，待血红蛋白溶液温度达到(60±1)℃开始计时，10 h后加热处理完成，该过程持续通氮保护。然后置冰浴冷却到4℃以下，低温高速离心，微孔滤膜过滤，得到纯化及病毒灭活的脐血血红蛋白。结果与结论：巴氏消毒组与对照组制品外观都为红色澄明液体；在得率、高铁血红蛋白含量、氧结合量方面两组差异无显著性意义；两组的纯度都在98%以上；两种纯化方法并没有对血红蛋白携氧功能造成影响。因此，可以用巴斯德病毒灭活的方法来代替一直在使用的55℃，2 h的热敏法纯化方式。这样不仅能保证血红蛋白的理化性质、生物学性质，还能同时达到病毒灭活的目的。
배경：파사덕소독법대백단백적병독멸활조건이흔완선，가불요구진행병독멸활험증，단장기응용우혈홍단백류혈액대용품병독멸활적연구재국내외상미견유계통보도。목적：탐토파사덕소독법대혈홍단백류혈액대용품이화성질급생물학공능적영향。방법：취괄량제혈，경리심、세혈、파막、첨가은정제처리후，대조조우55℃수욕가열，대혈홍단백용액온도체도(55±1)℃개시계시，2 h후가열처리완성；파씨소독조우60℃수욕가열，대혈홍단백용액온도체도(60±1)℃개시계시，10 h후가열처리완성，해과정지속통담보호。연후치빙욕냉각도4℃이하，저온고속리심，미공려막과려，득도순화급병독멸활적제혈혈홍단백。결과여결론：파씨소독조여대조조제품외관도위홍색징명액체；재득솔、고철혈홍단백함량、양결합량방면량조차이무현저성의의；량조적순도도재98%이상；량충순화방법병몰유대혈홍단백휴양공능조성영향。인차，가이용파사덕병독멸활적방법래대체일직재사용적55℃，2 h적열민법순화방식。저양불부능보증혈홍단백적이화성질、생물학성질，환능동시체도병독멸활적목적。
BACKGROUND:Pasteurization is a perfect method for albumin virus inactivation, which may not be required for virus inactivation validation. However, there are no systematical reports concerning virus inactivation of hemoglobin blood substitutes. OBJECTIVE:To explore the effects of pasteurization on the physicochemical properties and biological function of hemoglobin blood substitutes. METHODS:Appropriate cord blood samples were taken fol owed by centrifugation, washing blood, rupture of membranes, stabilizer treatment. In the control group, the samples were placed in 55℃water bath, and when the temperature of hemoglobin solution reached (55±1)℃, a heat treatment began and lasted for 2 hours. In the pasteurization group, the samples were placed in 60℃water bath, and when the temperature of hemoglobin solution reached (60±1)℃, a heat treatment began and lasted for 10 hours. The heating process was under continues nitrogen protection. Then, the hemoglobin solution was placed in ice bath and cooled to below 4℃fol owed by low-speed centrifugation and filtration via microporous membrane, purification and viral inactivation thereby to obtain cord blood hemoglobin. RESULTS AND CONCLUSION:The products in the pasteurization group were al red clear liquid. There was no significant difference between the two groups in the yield, methemoglobin concentration, and oxygen-carrying capacity. The purification of the two groups was more than 98%. Two kinds of purification methods had no effects on the oxygen-carrying capacity of hemoglobin. Therefore, pasteurization method can replace thermosensitive purification method of 55℃, 2 hours. The pasteurization method wil not only ensure the physicochemical and biological properties of hemoglobin, but also achieve the purpose of virus inactivation.