乙型肝炎特异性转移因子的制备及鉴定

目的 ]探索羊脾乙型肝炎特异性转移因子的更高效的制备方法 .方法 ]用乙型肝炎疫苗辅以福氏完全佐剂免疫绵羊 ,在细胞介导免疫应答的高峰期放血 ,从羊脾脏和白细胞透析物中制备乙型肝炎特异性转移因子 .用一系列理化性状及药典规定项目对制品进行检定 ,并采用小鼠皮肤试验检定制品的特异性活性 .结果 ]经检定表明符合生物制品标准 ,并证实该乙型肝炎特异性转移因子具有抗原特异性 ,能在体外转移对乙型肝炎病毒的免疫性 .结论 ]制备的乙型肝炎特异性转移因子是一种可用于治疗乙型肝炎的安全有效的免疫调节剂

Preparation and identification of specific transfer factor for hepatitis B virus

OBJECTIVETo study the methods of preparing the specific transfer factor of hepatitis B virus (HBV-STF) with sheep spleen in order to supply qualified HBV-STF products for clinic. METHODSWhen the cell-mediated immunity reached the peak level in the immunized sheep, the HBV-STF was prepared with the spleen and leukocytes of the sheep immunized by HBV vaccine and complete freund adjuvant.All items of the products were wholly detected according to the requirements of biological product and the specific activity of HBV-STF was determined by means of the mouse skin test. RESULTSIt was found that HBV-STF had the function of transferring HBV specific cellular immunity in vitro and raised the specificity of HBV-STF.CONCLUSIONThe qualified HBV-STF product produced by this method is a safe and high effective immuno-regulator for treating viral hepatitis B.