冻干甲型肝炎减毒活疫苗规格变更后(复溶后0.5 mL/瓶)的稳定性

Stability of freeze-dried live attenuated hepatitis A vaccine after specification change(0. 5 mL per container after reconstitution)

目的 研究冻干甲型肝炎减毒活疫苗规格变更后(复溶后由1.0 mL/瓶变更为0.5 mL/瓶)的稳定性。方法将3批规格变更后的冻干甲型肝炎减毒活疫苗(复溶后0.5 mL/瓶)试验疫苗于(5±3)℃条件下放置,每隔3个月抽样检测,进行长期稳定性试验;将试验疫苗于(25±2)℃条件下放置6个月,分别于0、1、2、3及6个月取样检测,进行加速稳定性试验;将3批试验疫苗(复溶后0.5 mL/瓶)与2批市售疫苗(复溶后1.0 mL/瓶)于(5±3)℃放置0、9、18个月的产品质量检测结果进行对比分析。结果 3批规格变更后的冻干甲型肝炎减毒活疫苗(复溶后0.5 mL/瓶)试验疫苗成品的长期稳定性试验和加速稳定性试验结果均符合《中国药典》三部(2010版)相关规定;规格变更后的试验疫苗与市售疫苗在(5±3)℃放置0、9和18个月的各项检测结果均达到合格标准。结论 冻干甲型肝炎减毒活疫苗规格变更后稳定性良好。

Objective To investigate the stability of freeze-dried live attenuated hepatitis A(HA)vaccine after change of specification from 1. 0 to 0. 5 mL per container after reconstitution. Methods Three batches of freeze-dried live attenuated HA vaccine with changed specification(0. 5 mL per container after reconstitution)were stored at(5 ± 3)℃,from which samples were taken every 3 months for long-term stability test. The experimental vaccine was stored at(25 ±2) ℃ for 6 months,from which samples were taken 0,1,2,3 and 6 months after storage for accelerated stability test.The control test results of three batches of experimental vaccine(0. 5 mL per container after reconstitution)after storage at(5 ± 3)℃ for 0,9 and 18 months were compared with those of two batches of commercial vaccine(1. 0 mL per container after reconstitution). Results Both the results of long-term and accelerated stability tests of three batches of final products of freeze-dried live attenuated HA vaccine with changed specification(0. 5 mL per container after reconstitution)met the requirements in Chinese Pharmacopoeia(Volume Ⅲ,2010 edition). However,both the control test results of experimental and commercial vaccines met the relevant requirements after storage at(5 ± 3)℃ for 0,9 and 18 months.Conclusion Freeze-dried live attenuated HA vaccine after change of specification showed good stability.