摘要
目的为了观察UniJect注射器预充注乙型肝炎(乙肝)疫苗的热稳定性,以探讨其冷链外使用的可行性。方法将常规安瓶分装与UniJect预充注重组乙肝疫苗(酵母)在37℃放置14、30、45d,检测两种分装疫苗的体外相对效力(RP)。将配合疫苗保存使用的温度敏感指示标签(VVM30)在37℃放置30d,其间对其颜色变化进行连续检测。结果5批常规分装重组乙肝疫苗(酵母)及其同批半成品UniJect注射器分装乙肝疫苗,37℃放置14d内所有疫苗RP仍符合要求;37℃放置30d,有1批常规分装乙肝疫苗的RP不符合要求;37℃放置45d,5批常规分装乙肝疫苗的RP均不符合要求。而UniJect注射器预充注乙肝疫苗37℃放置14、30、45d,RP均符合要求。3批VVM30标签37℃干燥和1批VVM30标签37℃水浸放置30d内,其颜色变化线性良好,颜色变化指示临界期均为21d。结论UniJect注射器预充注重组乙肝疫苗(酵母)热稳定性良好,配合使用VVM30标签,可确保脱离冷链运输和保存的乙肝疫苗在效力符合要求的条件下使用。
Objective To study the application feasibility of UniJect syringe pre-filled HB vaccine with VVM label out of cold chain by detecting the potency stability of the vaccine and the performance of VVM30 label samples heat-treated at 37℃ for different times. Methods The samples of UniJect syringe pre-filled recombinant yeast Hepatitis B vaccine and the comparison counterpart of regular am- poule filled Hepatitis B vaccine were incubated at 37℃ for 14 days,30 days,and 45 days and the relative potencies （RP） of the samples were assayed. The VVM30 label samples for indicating heat exposure accumulative times of vaccine were incubated at 37℃ for 30 days and the color change of the label was tested. Results The potencies for 5 Lots of both UniJect syringe pre-filled recombinant yeast Hepatitis B vaccine and the comparison counterpart of regular ampoule filled Hepatitis B vaccine, the potencies of all vaccines heated at 37℃ for 14 days met the requirements of the HB vaccine. One Lot of regular ampoule filled vaccine heated at 37℃ for 30 days and 5 Lots of regular ampoule filled vaccines heated at 37℃ for 45 days failed the RPs assay,while RPs for 5 Lots of UniJect syringe pre-filled vaccines incubated at 37℃ for 30 days and 45 days were still valid.4 Lots of VVM30 labels heated at 37℃ directly and 1 Lot of VVM30 label submerged in water at 5℃ for 8 hours first then heated at 37℃ for 30 day,the color change linear of the labels was good and the indicating endpoints of the VVM30 at 37℃ were 21 days. Conclusion The thermo-stability for the potency of UniJect syringe pre-filled recombinant yeast HB vaccines is good,along with VVM30 label which performance well for indicating heat exposure accumulative time,the UniJect syringe pre-filled HB vaccine can be transported and used for short-term outside of cold chain safely to improve the first timely dose coverage of HB vaccine at remote undeveloped areas.
出处
《中国计划免疫》
2006年第4期250-253,共4页
Chinese Journal of Vaccines and Immunization
