电阻法测定人乳头瘤病毒病毒样颗粒的粒径  

Determination of particle size of virus-like particle of HPV by resistance pulse sensor method

作　　者：路琼 纳涛[2] 黄维金 聂建辉 LU Qiong;NA Tao;HUANG Weijin;NIE Jianhui(Division of HIV/AIDS and Sex-transmitted Virus Vaccines,Institute for Biological Product Control,State Key Laboratory of Drug Regulatory Science,NHC Key Laboratory of Research on Quality and Standardization of Biotech Products,NMPA Key Laboratory for Quality Research and Evaluation of Biological Products,National Institutes for Food and Drug Control,Beijing 102629,China;The Cell Collection and Research Center,National Institutes for Food and Drug Control,Beijing 102629,China)

机构地区：[1]中国食品药品检定研究院生物制品检定所艾滋病性病病毒疫苗室,药品监管科学全国重点实验室,国家卫生健康委生物技术产品检定方法及其标准化重点实验室,国家药品监督管理局生物制品质量研究与评价重点实验室,北京102629 [2]中国食品药品检定研究院细胞资源保藏研究中心,北京102629

出　　处：《药学研究》2025年第2期123-126,共4页Journal of Pharmaceutical Research

基　　金：国家重点研发计划项目(No.2021YFC2302505)。

摘　　要：目的建立电阻法测定病毒样颗粒粒径的方法。方法采用库尔特纳米粒度仪对人乳头瘤病毒(human papilloma virus,HPV)疫苗原液的粒径进行测定。从准确性、精密度和重复性进行方法学验证同时与负染电镜结果比较。结果100 nm标准微球平均粒径为(102.00±0.00)nm,测定6次结果为(102.33±0.52)nm。样品测定6次,结果为(78.67±1.37)nm。表明该方法具有较好的准确性、精密度和重复性。样品测量结果与负染电镜结果相当。样品56℃放置30 min,大颗粒最多。结论电阻法可用于病毒样颗粒产品的粒径检测、粒度分布和稳定性监测。Objective To establish a method for determining the particle size of virus like particles using the Resistance Pulse Sensor(RPS)method.Methods The NanoCoulter was used to measure the particle size of the human papillomavirus(HPV)vaccine stock solution.Methodological validation was conducted on accuracy,precision and repeatability,and the particle size detection results were compared with negative staining electron microscopy results.Results The average particle size of 100 nm standard microspheres was(102.00±0.00)nm,and the result of 6 measurements was(102.33±0.52)nm.The sample was measured 6 times and the result was(78.67±1.37)nm.This indicates that the method has good accuracy,precision,and repeatability.The sample measurement results are comparable to the negative staining electron microscopy results.The sample was left at 56℃for 30 minutes,with the highest number of large particles.Conclusion The resistance method can be used for particle size detection distribution and stability monitoring of virus like particle products.

关 键 词：库尔特电阻法 人乳头瘤病毒 粒径与粒径分布 病毒样颗粒 

分 类 号：R927.1[医药卫生—药学]