冻干人用狂犬病疫苗渗透压摩尔浓度的质量评价  

Quality evaluation of osmotic pressure offreeze-dried rabies vaccine for human use

作　　者：王云鹏[1] 曹守春[1] 李加[1] 石磊泰[1] 咸瑞卿 吴小红[1] 赵丹华 叶强[1] WANG Yunpeng;CAO Shouchun;LI Jia;SHI Leitai;XIAN Ruiqing;WU Xiaohong;ZHAO Danhua;YE Qiang(Key Laboratory of the Ministry of Health for Research on Quality and Standardization of Biotech Products,Division of Arbovirus Vaccine,National Institutes for Food and Drug Control,Beijing 102629,China;Shandong Institute for Food and Drug Control,Jinan 250101,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 [2]山东省食品药品检验研究院,山东济南250101

出　　处：《药学研究》2024年第12期1168-1173,共6页Journal of Pharmaceutical Research

摘　　要：目的了解冻干人用狂犬病疫苗渗透压摩尔浓度的质控现状,同时探索影响渗透压摩尔浓度的主要疫苗组分,以期为冻干人用狂犬病疫苗的质量评价提供数据支持。方法采用《中国药典》2020年版(三部)中渗透压摩尔浓度测定法,对国内8家企业的80批冻干人用狂犬病疫苗进行测定。为了解冻干人用狂犬病疫苗主要组分的渗透压摩尔浓度情况,对疫苗所用主要辅料,如人血白蛋白、右旋糖酐、蔗糖、麦芽糖和明胶等进行了渗透压摩尔浓度测定,并对疫苗溶剂磷酸盐缓冲液进行渗透压摩尔浓度测定。通过对国内某企业多批渗透压摩尔浓度检验数据进行趋势分析,以了解疫苗生产中该项目的批间差异性。结果我国不同企业冻干人用狂犬病疫苗的渗透压摩尔浓度质控限定标准并不统一,在200~600 mOsmol·kg^(-1)之间。对于冻干人用狂犬病疫苗而言,辅料中疫苗稳定剂的含量与渗透压摩尔浓度结果相关,影响因素较大的有蔗糖和麦芽糖。疫苗溶剂磷酸盐缓冲液因含有NaCl、KCl,其渗透压摩尔浓度相对较高,不同企业的渗透压摩尔浓度在238~325 mOsmol·kg^(-1)之间。对国内某企业184批次制品的趋势分析,结果显示平均检测值为(386.0±19.3)mOsmol·kg^(-1),均在行动限内,批间一致性良好。结论不同企业冻干人用狂犬病疫苗渗透压摩尔浓度限定标准各异,其主要影响因素为磷酸盐缓冲液、蔗糖和麦芽糖等。渗透压摩尔浓度与冻干人用狂犬病疫苗的安全性有关,本研究将对该项目的标准化提供技术支持,对冻干人用狂犬病疫苗质量评价具有指导意义。Objective To understand the quality control status of osmotic pressure molar concentration of freeze-dried human rabies vaccine and explore the main vaccine components that affect osmotic pressure molar concentration,so as to provide data support for the quality evaluation of freeze-dried human rabies vaccine.Methods The osmotic pressure molar concentration determination method in the third volume of the Chinese Pharmacopoeia was used to determine 80 batches of freeze-dried human rabies vaccine from 8 domestic companies.In order to understand the osmotic pressure molar concentration of the main components of freeze-dried human rabies vaccine,the osmotic pressure molar concentration of the main excipients used in the vaccine,such as human serum albumin,dextran,sucrose,maltose and gelatin,was determined;And the osmotic pressure molar concentration of the vaccine solvent phosphate buffer was determined.The trend analysis of the osmotic pressure molar concentration test data of multiple batches of a domestic company was carried out to understand the batch-to-batch variability of this project in vaccine production.Results The quality control limit standards of osmotic pressure molar concentration of freeze-dried human rabies vaccine from different companies in my country are not uniform,ranging from 200 to 600 mOsmol·kg^(-1).For freeze-dried human rabies vaccine,the content of vaccine stabilizer in the excipient is related to the osmotic pressure molar concentration result,and the factors with greater influencing factors are sucrose and maltose.The osmotic pressure molar concentration of vaccine solvent phosphate buffer is relatively high because it contains NaCl and KCl.The osmotic pressure molar concentration of different companies is between 238 and 325 mOsmol·kg^(-1).The trend analysis results of 184 batches of products from a domestic company showed that the average detection value was(386.0±19.3)mOsmol·kg^(-1),which was within the action limit and had good batch consistency.Conclusion The osmotic pressure mo

关 键 词：狂犬病疫苗 质量控制 渗透压测定 评价分析 

分 类 号：R917[医药卫生—药物分析学]