干热法对猪凝血酶的病毒灭活效果及其对凝血酶活性影响的评价  

Evaluation of virus dry heat on porcine thrombin inactivation effect and its influence on thrombin activity

作　　者：李岳飞[1] 刘艳秋[2] 王智鼎[1] 宋艳[1] 孙德军[1] 

机构地区：[1]吉林大学药学院再生医学科学研究所生物药物与分子靶向药物教研室,吉林长春130021 [2]敦化市疾病预防控制中心

出　　处：《中国输血杂志》2013年第12期1205-1208,共4页Chinese Journal of Blood Transfusion

基　　金：国家高技术研究发展计划(863)(2006AA020503)

摘　　要：目的探讨干热法对猪凝血酶冻干制剂的病毒灭活效果及灭活后对凝血酶活性造成的影响。方法向猪凝血酶冻干制剂500 U、2 000 U中加入辛德毕斯病毒（Sindbis）、猪细小病毒（PPV）、脑心肌炎病毒（EMCV）和伪狂犬病病毒（PRV）4种病毒,各病毒滴度依次为6.83、6.57、6.34、6.96 Log10/0.1 mL,在98-100℃沸水中经30min干热病毒灭活后检测病毒灭活效果和对凝血酶活性影响。结果经干热法病毒灭活后,猪凝血酶冻干制剂中Sindbis、PPV、EMCV和PRV的病毒滴度分别由6.83、6.57、6.34、和6.96 Log10/0.1 mL降至1.21、1.43、0.96和1.38Log10/0.1 mL,经干热法处理后500 U的凝血酶冻干制剂活性损失≤10%,2 000 U的≤4%。结论干热法可有效降低猪凝血酶冻干制剂中指示病毒的滴度,处理后的凝血酶活性仍在国家药典规定范围,不失为1种凝血酶冻干制剂病毒灭活的安全﹑有效方法。Objective To investigate the effect and activity influence for virus inactivation of porcine thrombin by dry heating. Methods Adding Sindbis virus with 6. 83 Log10 /0. 1mL,PPV 6 with. 57 Log10 /0. 1mL,EMCV with 6. 34 Log10 / 0. 1 mL and PRV with 6. 96 Log10 /0. 1mL to porcine thrombin samples of 500 U,and 2 000 U. Virus inactivation with boiling water（ 98 ~ 100℃,30 min）,then detectied the effect and activity influence of porcine thrombin. Results After dry heating the TCID50 of the Sindbis virus,PPV,EMCV and PRV effectively decreased from 6. 83,6. 57,6. 34,and 6. 96 Log10 /0. 1 mL to 1. 21,1. 43,0. 96 and 1. 38 Log10 /0. 1 mL,the activity loss of 500 U thrombin lyophilized preparation was ≤ 10%,2 000 U ≤ 4%. Conclusion The indicator virus titer of porcine thrombin lyophilized preparation could be effectively decreased,and the influence on processed thrombin activity is in line with national standards. So it is an effective method for virus inactivation of porcine thrombin lyophilized preparation.

关 键 词：猪凝血酶 干热法 病毒灭活 指示病毒 病毒滴度 凝血酶活性 

分 类 号：R373[医药卫生—病原生物学] R392-33[医药卫生—基础医学]