猪脾乙肝特异性转移因子的研制

Study on the Preparation of Hepatitis B Specific Transfer Factor with Pig Spleens

探索猪脾乙肝特异性转移因子（ＰＳＨＢＶ－ＴＦ）的制备方法，为临床提供合格的ＰＳＨＢＶ－ＴＦ制品。方法：用乙肝疫苗辅以佐剂对猪进行全程免疫，然后从猪脾中提制ＰＳＨＢＶ－ＴＦ；采用小鼠皮肤试验检测制品的特异性活性，并按卫生部规程要求对制品进行全检。结果：ＰＳＨＢＶ－ＴＦ具有抗乙肝特异性活性，即能转移针对乙肝病毒的特异性细胞免疫反应； ３批制品所有项目符合规程要求。结论：本法可制备出合格的 ＰＳＨＢＶ－ＴＦ制品，且适合于大规模化生产。

Purpose:The method of preparing hepatitis B specific transfer factor with pig spleen (PSHBV-TF) should be explored in order to provide qualified PSHBV--TF product for clinical uses. methods: Pigs were whole course immunized with hepatitis B vaccine and subsidiary adjuvant; PSHBV--TF was refined from the pigs spleens. The specific activity of PSHBV--TF was determined by means of the mouse skin test. All items of the products were wholly deteCted according to the requirements of Ministry of Public Health. Results: PSHBV--TF has a anti--hepalitis B specific activity, i. e. it can transter specific cell immunoreaction against hepatitis B virus. 3 lots of products accord with the requirements. Conclusion: Qualified PSHBV--TF product can be produced by adopting this method. The method is suitable to large stale production.