关键词: 神经生长因子;小鼠;纯化;质量鉴定

    摘 要:目的 研制小鼠神经生长因子(NGF). 方法 采用二次阳离子柱层析法，从雄性小鼠颌下腺分离提取2.5S神经生长因子，建立了稳定的实验室与中试生产工艺，以及相应的质量鉴定规程. 结果 从体质量超过25g，鼠龄大于60d的雄性小鼠体内可获得高纯度、高产量、高活性的2.5S NGF.纯度大于95%，与抗2.5S NGF抗体有特异结合能力，鸡胚背根神经节培养法测定的生物活性显示，其比活性达到5×108 BU·g-1 (BU:生物活性单位)以上，各项指标均符合质量鉴定标准.20g·L-1 人血白蛋白做冻干赋形剂，能有效保护NGF的生物活性. 结论 研制了高质量的冻干小鼠神经生长因子，为NGF的临床前和临床研究奠定了基础.

    Research of lyophilized mouse nerve growth factor

    YAN Zhen，WANG Jun-Lou，WANG Hui，HAN Wei，LI Bo，ZHAO Ning，ZHANG Ying-Qi

    Biotechnology Center，Fourth Military Medical U-niversity，Xi'an710033，China

    Keywords:nerve growth factor;mouse;extraction;quality assurance

    Abstract:AIM To investgate and put NGF on clinic.METHODS With technique of cation-exchange chromatog-raphy，the method of extraction and trial production of2.5S NGF from mouse submandibular glands was established.RESULTS The NGF extracted from mature male mice sub-mandibular glands(body mass>25g，age>60d)reached a high purity(>95%)，good biological activity(specific activi-ty>5×108 BU·g-1 )and high output(4mg NGF/100mice).All the examines met our quality assurance standard.For lyophilization ......