第九批狂犬病疫苗效力检定用国家标准品的制备和质量研究  

Preparation and quality study of the 9th batch of national standards for rabies vaccine potency testing

作　　者：王云鹏[1] 李加[1] 石磊泰[1] 吴小红[1] 赵丹华 叶强[1] 李玉华[1] 曹守春[1] WANG Yunpeng;LI Jia;SHI Leitai;WU Xiaohong;ZHAO Danhua;YE Qiang;LI Yuhua;CAO Shouchun(Division of Arbovirus Vaccine,National Institutes for Food and Drug Control,Key Laboratory of the Ministry of Health for Research on Quality and Standardization of Biotech Products,Beijing 102629,China)

机构地区：[1]中国食品药品检定研究院虫媒病毒疫苗室,卫生部生物技术产品检定方法及其标准化重点实验室,北京102629

出　　处：《微生物学免疫学进展》2024年第2期8-13,共6页Progress In Microbiology and Immunology

摘　　要：目的 制备第九批狂犬病疫苗效力检定用国家标准品,并进行质量研究。方法 按照《中华人民共和国药典》2015版(三部)(简称《中国药典》)中关于国家药品标准品制备的相关要求,采用生物反应器工艺,以Vero细胞为基质培养狂犬病病毒CTN-1V疫苗株,经收获、超滤浓缩、病毒灭活和水解后,层析柱纯化得到疫苗原液。采用ELSIA对原液中的糖蛋白抗原含量进行测定,以终浓度为3.0%的人血清白蛋白为稳定剂,并按原液糖蛋白抗原含量7.0 EU/mL进行半成品配制,之后按1.0 mL/支规格进行无菌分装,采用2台冻干机冻干,批号分别为201906001-01、201906001-02,对分装冻干候选标准品的外观、分装精度和均匀性进行检查。并依据《中国药典》中冻干人用狂犬病疫苗制品相关标准分别对单次收获液、疫苗原液和冻干标准品的无菌检查等项目进行了检定。结果 单次病毒收获液、原液质量均符合要求,该批原液中糖蛋白抗原含量为25.9 EU/mL。标准品冻干成品外观、分装精度和均匀性均符合标准物质的要求。另外,该2批候选标准品的渗透压、pH、水分等项目均符合《中国药典》的相关要求。结论 本研究制备的候选标准品各项质量检测指标均符合《中国药典》的各项要求,分装精度和均匀性良好,可在完成效价值的协作标定并经批准后作为第九批狂犬病疫苗国家标准品使用。Objective To prepare the 9th of national standards for rabies vaccine potency testing and conduct quality research. Methods In accordance with the relevant requirements for the preparation of national drug standards in the 2015 Edition(Part Three) of Pharmacopoeia of the People's Republic of China(Chinese Pharmacopoeia),a bioreactor technology was used to culture rabies virus CTN-1V vaccine using Vero cells as the matrix, and the vaccine stock solution was obtained through harvesting, ultrafiltration concentration, virus inactivation and hydrolysis, and then purification by chromatographic column. The glycoprotein antigen content of the stock solution was determined using ELSIA,Human serum albumin at a final concentration of 3.0% was used as the stabilizer, and the semi-finished product was prepared at a glycoprotein antigen content of 7.0 EU/mL,after which it was aseptically dispensed at a specification of 1.0 mL/vial, and lyophilized using two lyophilizers with batch numbers of 201906001-01 and 201906001-02,respectively. The appearance, packaging accuracy and uniformity of the packaged freeze-dried candidate standards were checked. The sterility inspection and other items of the single harvest solution, vaccine stock solution and freeze-dried standard products were tested. According to the relevant standards for freeze-dried human rabies vaccine products in Chinese Pharmacopoeia. Results The quality of the single virus harvest and stock solution met the requirements, and the glycoprotein antigen content in this batch of stock solution was 25.9 EU/mL. The appearance, packaging accuracy and uniformity of the freeze-dried standard product all meet the requirements of the standard material. In addition, the osmotic pressure, pH, moisture and other items of these two batches of candidate standards all meet the requirements of Chinese Pharmacopoeia. Conclusion The candidate standards prepared in this study meet the requirements of Chinese Pharmacopoeia,with good precision and homogeneity, and can be used as the ninth

关 键 词：狂犬病疫苗 疫苗效价 标准品 制备 质量指标 

分 类 号：R392[医药卫生—免疫学]