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新型冠状病毒灭活疫苗测定能力验证研究

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目的 通过开展新型冠状病毒灭活疫苗pH值、渗透压摩尔浓度、铝含量的测定能力验证,评价疫苗质控实验室及疫苗生产企业实验室的检测能力。方法 采用f检验和t检验对新型冠状病毒灭活疫苗样品开展均匀性和稳定性考察,样品通过均匀性稳定性检验后冷链运输分发至各参加实验室。以Z比分数评价参加实验室的pH值、渗透压摩尔浓度、铝含量检测能力。结果 全国共有30家实验室参加本次能力验证活动,pH值、铝含量考核结果均为满意,2家实验室渗透压摩尔浓度考核结果为不满意,后经参加测量审核,获得满意结果。结论 参加本次能力验证的省级疫苗质控实验室以及疫苗生产企业具有较好的检测能力和质控水平。
Proficiency Testing of Inactivated COVID-19 Vaccine
OBJECTIVE To evaluate the testing capability of the vaccine quality control laboratories and vaccine manufacturer laboratories which participated in the proficiency testing of pH,osmotic pressure molar concentration and aluminum content of inactiva-ted COVID-19 vaccine.METHODS Samples of inactivated COVID-19 vaccine were tested for uniformity and stability by F-test and t-test,and then distributed to participating laboratories by cold chain transportation.The abilities of the participating laboratories for determination of pH,osmotic pressure molar concentration,and aluminum content were evaluated by Z ratio.RESULTS A total of 30 laboratories across the country participated in this proficiency testing,and the pH and aluminum content assessment results were all satisfactory,while the osmotic pressure molar concentration results of two laboratories were unsatisfactory.After participating in meas-urement audits,satisfactory results were obtained.CONCLUSION The provincial vaccine quality control laboratories,and vaccine production enterprises participating in this proficiency testing have good testing capabilities and quality control levels.

COVID-19vaccinepH,osmotic pressure molar concentrationaluminum contentproficiency testing

高晓明、徐康维、鲁旭、乔志中、权娅茹、李长贵、项新华

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中国食品药品检定研究院,北京 102629

新型冠状病毒 疫苗 pH值 渗透压摩尔浓度 铝含量 能力验证

2024

中国药学杂志
中国药学会

中国药学杂志

CSTPCD北大核心
影响因子:0.957
ISSN:1001-2494
年,卷(期):2024.59(23)