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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 detecting the titer of mouse nerve growth factor (m NGF). Methods According to the relevant requirements of WHO, the preparation, aliquoting, lyophilization and various indexes of m NGF national standards were carried out. Collaboratively calibrated with NGF international standards (Code 93/556). Results The purity of m NGF national standard stock solution reached over 98.0%. Other physico-chemical and biological activity indexes also met the requirements of biological products. The appearance of freeze-dried m NGF was qualified and the aseptic test was qualified. The water content was 0.9% 0.49%, at -20,4,25 and 37 ℃ for 6 months, its biological activity remained stable. The standard was calibrated by 5 laboratories for a total of 21 times with an average titer of 13,018 U / branch, with a mean 95% confidence interval of 12 408 to 13 657 U / branch. Conclusion All the indicators of this batch of m NGF national standards meet the requirements and can be used as national standards. The titer is set at 13 000 U / branch.