猪脾转移因子的制备和生物学活性研究

Preparation and biological activity research of porcine spleen transfer factor

目的:采用冻融-透析法制备猪脾转移因子,并对其理化性质以及免疫学生物学活性、生物安全性进行初步检定。方法:采用低温匀浆反复冻融新鲜的猪脾脏、无菌离心匀浆脾脏组织液,取上清液透析制备转移因子;以改良Lowry法分别检测多肽含量,并进行理化指标、无菌试验、热原质试验及其生物学活性检测。结果:冻融-透析法制备猪脾转移因子的理化性状符合《中国生物制品》的要求;无菌试验、热原质试验均为阴性;安全试验合格;淋巴细胞转化试验和E花环形成试验证实其具有刺激淋巴细胞增殖生物学活性。结论:成功制备了猪脾脏转移因子,其各项理化指标符合生物制品规程的要求,同时具有较好的非特异性免疫学的生物学活性。

Objective： Preparing pig spleen transfer factor by freeze thaw dialysis method,to preliminarily study the physicochemical properties,the biological activity of immunology and biological safety. Methods： Freezing and thawing fresh pig spleen by cryogenic homogenization repeatedly,getting supernatant dialysis from aseptic centrifugal homogenate of spleen tissue fluid to prepare the transfer factor. The content of polypeptide was detected respectively by modified Lowry polypeptide content; the physicochemical indexes,sterility test,pyrogen test and biological activity were detected too. Results： The physicochemical properties of pig spleen transfer factor by freeze thaw dialysis method consists with＂China Biological Products＂requirement; sterility test and pyrogen test are negative;safety tests is qualified; lymphocyte transformation test and E rosette formation test confirms that it has to stimulate lymphocyte proliferation biological activity. Conclusion： Successfully preparing pig spleen transfer factor,its physicochemical indexes are in line with the requirements for Biological Products,and have good biological activity of nonspecific immunology.