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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 investigate the thermal stability of UniJect syringes pre-filled with Hepatitis B (HBV) vaccine in order to investigate the feasibility of its use outside the cold chain. Methods The regular ampoules were packed with UniJect pre-filled recombinant hepatitis B vaccine (yeast) at 37 ℃ for 14,30,45 days. The in vitro relative potency (RP) of the two vaccines was tested. The temperature-sensitive indicator (VVM30) used for vaccine preservation was placed at 37 ° C for 30 days, during which the color change was monitored continuously. Results Five batches of routinely packed recombinant hepatitis B vaccine (Yeast) and the same batch of UniJect syringes were packaged for hepatitis B vaccine. All vaccines RP still met the requirements within 14 days of storage at 37 ° C. After 30 days of storage at 37 ° C, one batch of hepatitis B vaccine RP does not meet the requirements; placed at 37 ℃ 45d, 5 batches of routine dispensing hepatitis B vaccine RP does not meet the requirements. The UniJect syringe pre-filled hepatitis B vaccine at 37 ℃ placed 14,30,45 d, RP are in line with requirements. Three batches of VVM30 tags were dried at 37 ° C and one batch of VVM30 tags was immersed in water for 30 days at 37 ° C. The color change was linear and the critical period for color change was 21 days. Conclusions UniJect syringes pre-filled with recombinant hepatitis B vaccine (yeast) have good thermal stability and, in conjunction with the VVM30 label, ensure that hepatitis B vaccines delivered and preserved off the cold chain are used with the desired efficacy.