预灌封灭菌注射用水在ACYW135群脑膜炎球菌多糖疫苗中的应用  

Application of pre-filled sterile water for injection in group ACYW135 meningococcal polysaccharide vaccine

作　　者：张冉 孙刚刚 石献华 ZHANG Ran;SUN Ganggang;SHI Xianhua(Production Department I,Production Center,Bejing Zhifei Luzhu Biopharmaceutical Co.,Ltd.,Beijing 100176,China)

机构地区：[1]北京智飞绿竹生物制药有限公司生产中心生产三部,北京100176

出　　处：《微生物学免疫学进展》2024年第1期55-61,共7页Progress In Microbiology and Immunology

摘　　要：目的 研究预灌封灭菌注射用水作为ACYW135群脑膜炎球菌多糖疫苗稀释剂的质量和稳定性,探索疫苗的新型组合包装形式。方法 依据《中华人民共和国药典》2020版(简称《中国药典》)要求,连续生产3批次预灌封灭菌注射用水并检定合格,将其与3批次检定合格的ACYW135群脑膜炎球菌多糖疫苗进行组合包装。检测预灌封灭菌注射用水和组合包装中以稀释剂复溶后的脑膜炎球菌多糖疫苗的质量和稳定性。结果 3批次预灌封灭菌注射用水在(40±2)℃、相对湿度(75±5)%条件下放置6个月的加速稳定性试验中,分别按规定于0、1、2、3、6个月取样检测;在(30±2)℃、相对湿度(65±5)%条件下放置48个月的长期稳定性试验中,于0、3、6、9、12、18、24、36、48个月取样检测;各取样节点的检测结果均符合《中国药典》“灭菌注射用水”标准。3批次脑膜炎球菌多糖疫苗在37℃放置6个月的加速稳定性试验中,分别按规定于0、1、2、3、6个月以稀释剂复溶后取样检测;在2~8℃放置48个月的长期稳定性试验中,于0、3、6、9、12、18、24、36、48个月以稀释剂复溶后取样检测;各项检测结果均符合《中国药典》“ACYW135群脑膜炎球菌多糖疫苗”标准。结论 预灌封灭菌注射用水作为ACYW135群脑膜炎球菌多糖疫苗稀释剂具备适用性,该组合包装形式可为疫苗包装提供新选择。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 determinate the quality and stability of pre-filled sterilized water for injection and meningococcal polysaccharide vaccines after reconstitution 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 respectively. In the long-term stability test of placed at(30±2) ℃ and relative humidity(65±5)% for 48 months, the samples 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 diluent. 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 meningococcal polysaccharide vaccine, and this combination packaging form provides a new option for vaccine packaging.

关 键 词：预灌封 灭菌注射用水 疫苗稀释剂 ACYW135群脑膜炎球菌多糖疫苗 组合包装 稳定性 

分 类 号：R392-33[医药卫生—免疫学]