动态光散射法测定病毒载体基因治疗产品的平均粒径及粒径分布  

Measurement of Particle Size and Distribution of Viral Vector Gene Therapy Products Using Dynamic Light Scattering(DLS)

作　　者：李永红[1] 毕华[1] 陈伟[1] 饶春明[1] 

机构地区：[1]中国食品药品检定研究院卫生部生物技术产品检定方法及其标准化重点实验室,北京100050

出　　处：《现代生物医学进展》2014年第34期6611-6613,共3页Progress in Modern Biomedicine

基　　金：国家高技术研究发展(863)计划(2012AA020805);国家科技重大专项(2012ZX09304010)

摘　　要：目的:建立病毒载体基因产品的粒径及分布的测定方法。方法:采用马尔文Zetasizer Nano ZS型纳米粒度仪,以氯化钠注射液作为稀释剂对样品进行适当稀释后,用手动测量方式进行测定。结果:测定的60 nm标准纳米粒子平均粒径为61.24±0.68nm,多分散指数(polydispersity index,PDI)为0.020±0.012 nm。重组人新型P53腺病毒注射液测定6次,平均粒径为122.42±1.80 nm,相对标准偏差(RSD)为1.4%;PDI值为0.056±0.014 nm,RSD为25.1%。重组人新型P53腺病毒注射液于37℃存放时,平均粒径和PDI值随时间延长有显著增加。至28天时,平均粒径增加到130.50,PDI值增加到0.265。结论:动态光散射法快速、简便、准确,可用于病毒载体基因治疗产品的粒径及分布的检测。Objective： To establish the method to measure particle size and distribution of viral vector gene therapy products.Methods： The size and distribution were measured by Nano Particle Analyzer（Malvern Zetasizer Nano ZS） using sodium chloride injection as diluting agent, and manual operation mode was adopted. Results： The measurement result of the 60 nm nanosphere size standard showed that the z-average diameter was 61.24±0.68 nm, and the polydispersity index（PDI） was 0.020±0.012. After measured by 6 times the z-average diameter result of the new type of recombinant human P53-adenovirus（new P53-Adv） injection was 122.42±1.80 nm, and relative standard derivation（RSD） was 1.4%. The PDI value of the new P53-Adv injection was 0.056±0.014, and relative standard derivation（RSD） was 25.1%. When the new P53-Adv injections were stored at 37℃, the z-average diameter and PDI value increased with the incubation time. After incubation of 28 days the z-average diameter increased to130.50 nm, and the PDI increased to0.265. Conclusion： The dynamic light scattering method which is fast, simple and accurate, can be used to measure the particle size and distribution of viral vector gene therapy products.

关 键 词：动态光散射 粒径 粒径分布 病毒载体基因治疗产品 质量控制 

分 类 号：R917[医药卫生—药物分析学]