第九批人用狂犬病疫苗国家标准品的协作标定

Collaborative calibration of the 9th national standard for human rabies vaccine

目的对制备的第九批候选人用狂犬病疫苗国家标准品的效价进行协作标定,并最终赋值。方法组织人用狂犬病疫苗生产、研发等有资质的实验室,以第七批狂犬病疫苗国际标准品(NIBSC代码:16/204)为检测标准品,采用NIH法对候选狂犬病疫苗国家标准品进行效价测定。对协作标定单位的检测结果进行统计学分析,取有效检测值的几何均值作为候选标准品的最终效价值。根据国家药品标准物质制备的要求,对该候选标准品进行热加速破坏后检测糖蛋白抗原,考察其稳定性。结果参加协作标定的单位有20家,剔除未严格按照协作标定SOP操作的2家,剩余协作单位数据均有效,经统计学分析,第九批狂犬病疫苗国家标准品效价最终赋值为11.4 IU/mL,95%可信限为10.9~11.9 IU/mL,ED_(50)的95%参考范围为2.10~2.75。37℃放置不同时间(2、4、8和16周)糖蛋白抗原检测结果未见明显差异。结论完成了第九批候选人用狂犬病疫苗国家标准品(批号:201906001)的协作标定,其效价赋值科学、严谨、数据可靠,热稳定性符合要求。目前该标准品已获得国家药品标准物质委员会批准使用,对人用狂犬病疫苗的质量控制,尤其是有效性的质控具有重要意义。

Objective To collaboratively calibrate and finally assign the potency of the 9th national standard for human rabies vaccine for candidate.Methods Qualified laboratories for the production,research and development of human rabies vaccines were organized to determine the potency of candidate national standard for rabies vaccines by using NIH method,with the 7th international standard for rabies vaccines(NIBSC code:16/204)as the reference standard.The detection results were statistically analyzed,and the geometric mean of effective detection values was taken as the final potency value of the candidate standard.According to the requirements of the preparation of national drug reference materials,the candidate standard was destroyed by heat acceleration,and then detected for the glycoprotein antigen to investigate the stability.Results A total of 20 laboratories participated in the collaborative calibration,of which the two laboratories that did not strictly follow the collaborative calibration SOP were excluded,and the data of the remaining collaborative laboratories were valid.After statistical analysis,the final potency of the 9th national standard for rabies vaccine was 11.4 IU/mL,the 95% confidence limit was 10.9~11.9 IU/mL,and the 95% reference range of ED_(50)was 2.10~2.75.There was no significant difference in the results of glycoprotein antigen detection under different time conditions(2,4,8 and 16 weeks)at 37℃.Conclusion The collaborative calibration research of the 9th national standard for human rabies vaccine(batch number:201906001)has been completed,the potency assignment is scientific and rigorous,the data was reliable,and the thermal stability meets the requirements.At present,this standard has been approved by the National Drug Reference Material Committee,which is of great significance to the quality control of human rabies vaccine,especially the quality control of effectiveness.