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目的观察中试阶段制备的冻干龋齿DNA疫苗的稳定性。方法将中试阶段制备的3批冻干龋齿DNA疫苗于-70℃放置16个月,每隔2个月对其外观、溶解时间、水分、溶解后pH值及质粒超螺旋比例进行观察及检测。结果在16个月的观察中,冻干龋齿DNA疫苗外观呈乳白色疏松体,溶解时间小于1 min,水分<3%,pH值在7.30~7.46之间;保存16月的3批冻干龋齿DNA疫苗的质粒超螺旋比例达85.02%~97.15%,各项指标均合格,稳定性好。结论冻干龋齿DNA疫苗符合“预防用DNA疫苗临床前研究技术指导原则”中的各项指标,疫苗质量较为稳定。
Objective To observe the stability of lyophilized dental caries DNA vaccine prepared in pilot stage. Methods Three batches of lyophilized dental caries DNA vaccine prepared in the pilot stage were placed at -70 ℃ for 16 months. The appearance, dissolution time, water content, dissolved pH value and supercoiled plasmid ratio were observed and detected every two months . Results In the 16-month observation, the appearance of lyophilized dental caries DNA vaccine was milky white loose body, the dissolution time was less than 1 min, the water content was less than 3% and the pH value was between 7.30 and 7.46. The plasmid super-helix ratio of the vaccine reached 85.02% ~ 97.15%. All the indexes were qualified and the stability was good. Conclusion The freeze-dried dental caries DNA vaccine conforms to the indicators in the “Precautionary DNA Vaccine Preclinical Technical Guidelines”, and the quality of the vaccine is relatively stable.