预灌封注射器装灭菌注射用水作为水痘减毒活疫苗稀释剂的质量和稳定性研究  

Study on the quality and stability of sterile water for injection prefilled in syringe as varicella vaccine diluent

作　　者：杨月莲[1] 周峰[1] 王亮[1] 袁剑[1] 蒋樱[1] 谢蕾[1] 王伟[1] 

机构地区：[1]上海生物制品研究所有限责任公司生物技术制品中心,200051

出　　处：《国际生物制品学杂志》2016年第5期218-221,共4页International Journal of Biologicals

摘　　要：目的 研究预灌封注射器装灭菌注射用水（注射器装灭菌水）作为水痘减毒活疫苗（水痘疫苗）稀释剂的质量及稳定性,用以取代原有的安瓿瓶装灭菌注射用水.方法 连续生产并分装3批注射器装灭菌水,依据《中华人民共和国药典》2010年版二部（药典二部）附录XIXC“原料药与药物制剂稳定性试验指导原则”,对注射器装灭菌水的质量和稳定性进行研究;同时将注射器装灭菌水作为水痘疫苗的稀释剂,观察水痘疫苗的质量及稳定性.结果 3批注射器装灭菌水在相对湿度（60±10）％的条件下分别于（40±2）℃放置6个月和（25±5）℃放置42个月,各项检测结果均符合药典二部“灭菌注射用水”标准.3批以注射器装灭菌水作为稀释剂的水痘疫苗的加速和长期稳定性试验结果均符合“水痘减毒活疫苗注册标准”的要求,疫苗的病毒滴度≥3.3 lg噬班形成单位/0.5 ml,牛血清白蛋白残留量＜50 ng/ml,抗生素残留量＜50 ng/剂.结论 注射器装灭菌水可作为水痘疫苗的稀释剂.Objective To study the quality and stability of sterile water for injection prefilled in syringe （syringe-prefilled sterile water） as varicella vaccine diluent,and use it to replace sterile water for injection loaded in ampoule bottle.Methods Three batches of syringe-prefilled sterile water were prepared,and their quality and stability were studied in accordance with appendix XIX C ＂Guiding Principles For The Stability Test of Raw Materials and Pharmaceutical Preparations＂ in Chinese Pharmacopeia 2010 edition （Volume Ⅱ）.Meanwhile,syringe-prefiled sterile water was used as varicella vaccine diluent,and the quality and stability of varicella vaccines were observed.Results After 6 months at （40 ±2） ℃ and 42 months at （25 ±5） ℃ with relative humidity of （60 ± 10）%,respectively,all 3 batches of syringe-prefilled sterile water met the requirements of ＂Sterile Water for Injection ＂ in China Pharmacopeia 2010 edition （Volume Ⅱ）.The accelerated and long-term stability test results of 3 batches of varicella vaccines with syringe-prefilled sterile water as diluent all met requirements of ＂Registration Criteria of Live Attenuated Varicella Vaccine＂.Viral titers,bovine serum albumin and antibiotic residuals of varicella vaccines were ≥3.3 lg plaque-forming unit/0.5 ml,〈 50 ng/ml and 〈50 ng/dose,respectively.Conclusion Syringe-prefilled sterile water can be used as varicella vaccine diluent.

关 键 词：水 辅药 注射器 水痘疫苗 药物稳定性 

分 类 号：R392-33[医药卫生—免疫学]