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电阻法测定人乳头瘤病毒病毒样颗粒的粒径

路琼 纳涛 黄维金 聂建辉

药学研究2025,Vol.44Issue(2):123-126,4.
药学研究2025,Vol.44Issue(2):123-126,4.DOI:10.13506/j.cnki.jpr.2025.02.004

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

路琼 1纳涛 2黄维金 1聂建辉1

作者信息

  • 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
  • 折叠

摘要

Abstract

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

Key words

Coulter resistance method/HPV/Particle size and particle size distribution/Virus like particles

分类

药学

引用本文复制引用

路琼,纳涛,黄维金,聂建辉..电阻法测定人乳头瘤病毒病毒样颗粒的粒径[J].药学研究,2025,44(2):123-126,4.

基金项目

国家重点研发计划项目(No.2021YFC2302505) (No.2021YFC2302505)

药学研究

2095-5375

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