Stability of tick-borne encephalitis inactivated vaccine(0. 5 mL/dose)with pre-potting syringe
10.13200/j.cnki.cjb.004472
- VernacularTitle:预灌封注射器森林脑炎灭活疫苗（0.5 mL/剂）的稳定性
- Author:
CHEN Nana
- Publication Type:Journal Article
- From:
Chinese Journal of Biologicals
2025;38(05):526-530
- CountryChina
- Language:Chinese
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Abstract:
Objective To evaluate the stability of tick-borne encephalitis inactivated vaccine(0. 5 mL/dose) with pre-pottingsyringe in order to ensure the effectiveness and safety of the product. Methods The optimized stock solution of tick-borneencephalitis inactivated vaccine(0. 5 mL/dose, pre-potting syringe) was stored at(5 ± 3) ℃ for 120 days. The indicators ofsterility, antigen content, protein content, bovine serum albumin residue and hamster kidney cell protein residue weredetected and compared with those of vaccine before optimization(0. 1 mL/dose, vial). The long-term stability(0-33 monthsat 2-8 ℃), accelerated stability [0, 3, 6 months at(25 ± 2) ℃] and accelerated destruction stability [0, 7, 14 days at(37 ±1) ℃] of the optimized tick-borne encephalitis inactivated vaccine were investigated according to the relevant requirements ofTechnical Guidelines for Stability Research of Biological Products, including appearance, titer, aluminum content, osmoticmolar concentration and other indicators. Results Before and after optimization, all indicators of the stock solution of tick-borne encephalitis inactivated vaccine were qualified. There was no statistically significant difference in bovine serumalbumin residue and hamster kidney cell protein residue(F = 3. 33 and 0. 61, P = 0. 077 and 0. 627, respectively), but theF P differenceofproteincontentwasstatisticallysignificant(=38.07,<0.05),whileallofthemwerewithinthestandard rangeof ≤ 80 μg/mL. After optimization, the indicators of long-term stability, accelerated stability and accelerated destructionstability of the finished product of tick-borne encephalitis inactivated vaccine were all qualified. In the tests of long-termstability, respectively the vaccine titer after optimization was significantly higher than that before optimization(F = 62. 32,P < 0. 05); the differences of osmotic pressure molar concentration were statistically significant(F = 40. 47 and 12. 50 respec-tively, each P < 0. 05), but the fluctuation was controlled within the standard range of 240-320 mOsmol/kg. Conclusion Tick-borne encephalitis inactivated vaccine(0. 5 mL/dose) with pre-potting syringe has good stability under the conditions of long-term storage, transportation and short-term overtemperature, and its quality meets the standard.
