短波紫外线对人凝血因子Ⅷ中猪细小病毒灭活的研究

Study in inactivation of porcine parvovirus in human coagulation factor Ⅷ by short-wave ultraviolet-C

目的 研究短波紫外线（short-wave ultraviolet C，UV-C）对人凝血因子Ⅷ（human coagulation factor Ⅷ ，FⅧ）中猪细小病毒（porcine parvovirus ，PPV）的灭活的效果。方法 将PPV作为指示病毒与FⅧ中间品混合，用紫外灭活仪UVivatec分别以200、300 和400 J/m2 UV-C进行灭活。将UV-C灭活的FⅧ接种ST细胞并进行培养，采用细胞病变（cytopathic effect，CPE）法检测病毒，并以Reed-Muench法计算病毒滴度。对所有UV-C灭活后未出现CPE的样品盲传3 代，验证灭活效果；同时对UV-C灭活前后的FⅧ活性进行检测。结果 3个照射剂量的UV-C灭活后，FⅧ中的PPV滴度降低均0.1 ml ≥4.62 lg半数组织培养感染剂量，所有未出现CPE的样品盲传至第3代均未检到病毒。UV-C灭活的FⅧ的活性无明显降低，且各项质量指标均符合药典的要求。结论 UV-C可有效灭活无包膜病毒 PPV，且对FⅧ活性无明显影响。

Objective To investigate the effect of short -wave ultraviolet- C（UV-C）on inactivating porcine parvovirus（PPV）in human coagulation factor Ⅷ （FⅧ）. Methods PPV was mixed with the FⅧ intermediate as an indicator virus. The FⅧ intermediates containing PPVs were inactivated using UVivatec instrument with 200, 300 and 400 J/m2 UV-C. The FⅧs inactivated by UV-C were inoculated in ST cells and cultured. PPV was detected by cytopathic effect （CPE） method and the virus titer was calculated by Reed-Muench method. The samples without CPE were cultured 3 blind passages to verify the inactivation effect. At the same time, the FⅧ activities before and after UV-C inactivation were detected. Results The PPV titers in FⅧ all decreased more than 4.62 lg 50% tissue culture infective per0.1ml after UV-C inactivation with 3 different exposure doses. PPVs were not detected in the samples without CPE cultured to 3rd blind passage. The activities of FⅧ inactivated by UV-C did not decrease significantly, and each quality index met the requirements of pharmacopeia. Conclusion UV-C can inactivate nonenveloped virus PPV, and has no influence on the FⅧ activity.