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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± 0.68 nm，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。

英文摘要:

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 60nm 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 to 0.265.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.

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