Objective To study the quality and stability of sterile water for injection in prefilled syringe used as diluent of group ACYW135 meningococcal polysaccharide vaccine,and to explore the new combination packaging form of the vaccine.Methods According to the requirements of the Pharmacopoeia of the People's Republic of China(2020 edition,the Chinese Pharmacopoeia),three batches of qualified pre-filled sterilized water for injection were continuously produced,and three batches of qualified group ACYW135 meningococcal polysaccharide vaccine were packaged in a combination,so as to deter-minate the quality and stability of pre-filled sterilized water for injection and meningococcal polysaccharide vaccines after re-constitution with diluent.Results In the accelerated stability test of 3 batches of pre-filled sterilized water for injection placed at(40±2)℃ and relative humidity(75±5)％for 6 months,the samples were taken at 0,1,2,3 and 6 months re-spectively.In the long-term stability test of placed at(30±2)℃ and relative humidity(65±5)％for 48 months,the sam-ples were taken at 0,3,6,9,12,18,24,36 and 48 months.The test results of each sampling node conformed to the standard of"Sterilized Water for Injection"of Chinese Pharmacopoeia.In the accelerated stability test of 3 batches of meningococcal polysaccharide vaccine placed at 37 ℃ for 6 months,the samples were taken at 0,1,2,3 and 6 months after redissolve with diluent according to the regulations.In the long-term stability test placed at 2-8 ℃ for 48 months,the samples were taken at 0,3,6,9,12,18,24,36,and 48 months after redissolve with dilu-ent.And all the test results conformed to the standard of"Group ACYW135 Meningococcal Polysaccharide Vaccine"of Chinese Pharmacopoeia.Conclusion Pre-filled sterilized water for injection is suitable as the diluent for Group ACYW135 menin-gococcal polysaccharide vaccine,and this combination packaging form provides a new option for vaccine packaging.
Pre-fillingSterile water for injectionVaccine diluentGroup ACYW135 meningococcal polysaccharide vac-cineCombined packaged vaccineStability
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