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| 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) |
| 投稿时间：2014-07-09 修订日期：2014-07-09 |
| DOI： |
| 中文关键词: 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 |
| 英文关键词: Dynamic light scattering size size distribution viral vector gene therapy products quality control. |
| 基金项目:国家高技术研究发展计划(863)计划(2012AA020805)；国家科技重大专项(2012ZX09304010) |
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| 中文摘要: |
| 【】 目的 建立病毒载体类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60nm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122.4±1.8 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 122.4±1.8 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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