鼠神经生长因子国家标准品的研制

Preparation of national standard for mouse nerve growth factor

目的制备检测鼠神经生长因子（mouse nerve growth factor,m NGF）效价的国家标准品。方法按照WHO相关要求进行m NGF国家标准品制备、分装、冻干及各项指标检测,以NGF国际标准品（Code93/556）为标准进行协作标定。结果 m NGF国家标准品原液纯度均达98.0%以上,其他理化及生物活性指标也均达到生物制品规程相关要求,冻干m NGF外观、无菌试验均合格,水分为0.9%,分装精度为0.49%,在-20、4、25和37℃放置6个月,其生物学活性保持稳定。该标准品经5家实验室协作标定共测定21次,平均效价为13 018 U/支,均值95%置信区间为12 408-13 657 U/支。结论该批m NGF国家标准品各项指标均符合要求,可作为国家标准品使用,效价定为13 000 U/支。

Objective To prepare a national standard for test the potency of mouse nerve growth factor（m NGF）. Methods The national standard for m NGF was prepared, filled, lyophilized and subjected to control tests according to the rele-vant requirements of WHO, and calibrated cooperatively using international standard（Code93 / 556）of NGF as a standard.Results The purity of bulk of national standard for m NGF reached more than 98. 0%, while other physiochemical and biological activity indexes reached the relevant requirements. The freeze-dried m NGF was qualified in inspection of final containers and sterility test, of which the residual moisture content was 0. 9%, the filling precision was 0. 49%, and the biological activity was stable after storage at-20, 4, 25 and 37 ℃ for 6 months. The standard was calibrated for 21 times by 5 laboratories, of which the mean potency was 13 018 U per container, with a 95% confidence interval of 12 408 -13 657 U per container. Conclusion All the quality indexes of this batch of national standard for m NGF met the relevant requirements, of which the potency was defined as 13 000 U per container.