鸡卵黄乙型肝炎特异性转移因子口服液的制备及其免疫活性鉴定

目的制备鸡卵黄乙肝病毒特异性转移因子（EYHBV-STF）口服液，并鉴定其活性，探索一种新型、有效治疗乙肝的免疫调
节剂。方法采用乙肝疫苗免疫母鸡，从卵黄中提取乙型肝炎病毒特异转移因子（HBV-STF），进行理化特性等检测。采用白细
胞粘附抑制试验检测转移因子的免疫活性，将其制成口服液，经小鼠灌胃后，迟发型皮肤超敏反应试验鉴定其体内特异性细胞
免疫活性，免疫脏器指数鉴定其非特异性免疫活性。同时分别与经注射或口服途径的EYHBV-STF组、传统方法制备的猪脾乙
肝特异性转移因子组、猪脾非特异性转移因子组及未经免疫的鸡卵黄提取液组进行比较。结果EYHBV-STF口服液各项理化
特性及安全实验指标符合TF生物制品标准，体外实验能明显抑制正常小鼠白细胞黏附，体内实验能显著增强小鼠足垫肿胀度
反应，提示该制品可将供体的乙肝抗原特异性皮肤迟发型超敏反应转移给受体，并能够显著提高免疫脏器指数（P<0.01），与注
射EYHBV-STF、传统方法制备的注射、口服PHBV-STF 对照组比较，各项实验指标结果相近（P>0.05）。结论口服
EYHBV-STF与注射途径同样具有依赖乙肝抗原的特异性细胞免疫活性，可明显增强正常小鼠特异性细胞免疫功能。

Preparation and immunological evaluation of oral solution of egg yolk-derived hepatitisB virus-specific transfer factor

Objective To prepare the oral solution of egg yolk hepatitis B virus (HBV)-specific transfer factor (EYHBV-TF) and
evaluate its immunological activity as an immune regulator against hepatitis B. Methods From hens immunized with the
Hepatitis B vaccine the egg yolk was isolated to extract the specific transfer factor EYHBV-TF, and its physicochemical
properties were examined. Leukocyte adhesion inhibition test (LAI) was performed to detect the immunogenic activity of
EYHBV-TF. The solution of EYHBV-TF was then administered orally in normal mice, and the specific cellular immune activity
induced was assayed with delayed type skin hypersensitivity test (DTH), with the non-specific immune activity assessed with
immune organ index. The immune responses induced by oral EYHBV-STF solution were compared with those by EYHBV-STF
injection and by different dosages (injection and oral) of porcine spleen HBV-specific transfer factor (PSHBV-STF), porcine
spleen nonspecific transfer factor, and egg yolk extracts from non-immunized hens. Results The prepared EYHBV-STF oral
solution, which met the standards for biological products, could inhibit leukocyte adhesion in vitro and significantly enhance
mouse foot pad swelling, demonstrating its capability of transferring antigen-specific delayed type hypersensitivity reactions
to naive recipient. EYHBV-STF oral solution also significantly improved the immune organ index in mice (P<0 01) with similar
effects to those caused by EYHBV-STF injections and by PSHBV-STF injection and oral solution. Conclusion Orally
administered EYHBV-STF and EYHBV-STF injection both possess hepatitis B antigen-specific cellular immune activity and can
significantly enhance specific cellular immune responses.