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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 a method for the determination of the size and distribution of viral vector gene products. Methods: Malvern Zetasizer Nano ZS-type nano-particle sizer, sodium chloride injection as a diluent to the appropriate dilution of the sample, the determination by manual measurement. Results: The average diameter of 60 nm standard nanoparticles was 61.24 ± 0.68 nm and the polydispersity index (PDI) was 0.020 ± 0.012 nm. The recombinant human P53 adenovirus was assayed six times with an average particle size of 122.42 ± 1.80 nm and a relative standard deviation (RSD) of 1.4%. The PDI value was 0.056 ± 0.014 nm with a RSD of 25.1%. Recombinant human P53 adenovirus injection stored at 37 ℃, the average particle size and PDI values increased significantly over time. By 28 days, the average particle size increased to 130.50 and the PDI increased to 0.265. Conclusion: The dynamic light scattering method is rapid, simple and accurate and can be used to detect the particle size and distribution of gene delivery products.