重组人肿瘤坏死因子(rhTNF-α)国家标准品的研制

Collaborative Study of the National Standard for Recombinant Human Tumor Necrosis Factor α(rhTNF-α)

目的:建立符合WHO重组细胞因子要求,用于rhTNF质量控制的国家标准品.方法:用NIBSC提供的国际标准品为标准,采用L929细胞体外活性测定系统,按统一方案组织了4家实验室,对这批rhTNF-α国家标准品(批号960508)的效价进行协作标定.结果:经统计学分析,均数的95%可信区间为3289～4266IU/支,单次测定的95%标准值范围为1735～8087IU/支.这批国家标准品效价确定为3500IU/支.4种不同温度存放27个月的样品,效价测定结果表明其效价稳定.结论:这批rhTNF-α经统一协作,质量可靠,效价稳定,可用作国家标准品使用.

Objective: To establish National Standard of rhTNF-α complying with the requirements of research and quality control. Methods: National Standard of rhTNF-α were assayed against international standard (NIBSC) of rhTNF-α by cytotoxicity bioassay (L929 ) in vitro. The collaborative study has been carried out among four laboratories. Results: Based on the statistical analysis the results show that mean pf 95 % confidence interval is 3 289 ~ 4 266 IU per ampoule; the 95 % reference range is 1 735 ~ 8 087 IU per ampoule. Based on this study, the potency of rhTNF-α standard is defined as 3500 IU per ampoule. Stability tests indicate that the bioactivity has not been changed significandy under the storage of four different temperautres for 27 monthes. Conclusion: The preparation of rhTNF-α met the requirement of quality and could be used as a National Standard.