| 国产麻腮风联合减毒活疫苗的稳定性观察 |
| |
| 引用本文： | 陈哲文,杨文震,吴落天,晏子厚.国产麻腮风联合减毒活疫苗的稳定性观察[J].国际生物制品学杂志,2018,41(3):105-109. |
| |
| 作者姓名： | 陈哲文 杨文震 吴落天 晏子厚 |
| |
| 作者单位： | 201401 上海生物制品研究所有限责任公司质量保证部（陈哲文、吴落天），疫苗二室（杨文震），总经理办公室（晏子厚） |
| |
| 摘 要： | 目的 观察国产麻腮风联合减毒活疫苗（麻腮风疫苗）的稳定性。方法 取24批上海生物制品研究所有限责任公司（上海公司）2008－2017年生产的麻腮风疫苗，按照国家食品药品监督管理局批准的麻腮风疫苗注册标准和中国药典的要求进行各项检定：在0个月进行热稳定性试验；在0和18个月进行鉴别试验，外观、水分、无菌、异常毒性检查，牛血清白蛋白残留量、抗生素残留量（2010年10月以后）、细菌内毒素（2013年12月以后）、pH值和渗透压摩尔浓度检测（2015年12月以后）；在0、6、12、18个月进行病毒滴定。同时对新、老车间生产的各3批疫苗进行加速稳定性与长期稳定性试验，重点考察水分和病毒滴度。结果 麻腮风疫苗在有效期内各项指标检定结果均符合注册标准和药典要求。质量可比性研究结果显示新老车间生产的疫苗质量相似。疫苗中水分都不高于3.0%，麻疹、腮腺炎、风疹病毒滴度分别为3.3～4.3 、4.6～5.6 、3.3～4.3 半数细胞培养感染量/ml。结论 上海公司10年间生产的麻腮风疫苗质量稳定、安全有效。
|
| 关 键 词： | 麻疹-腮腺炎-风疹疫苗 稳定性 病毒滴定 |
The stability observation of domestic Measles,Mumps and Rubella combined vaccine,live |
| |
| Affiliation: | Department of Quality Assurance, Shanghai Institute of Biological Product Co., Ltd., Shanghai 201401, China |
| |
| Abstract: | Objective To observe the stability of domestic Measles, Mumps and Rubella combined vaccine, live (MMR vaccine). Methods 24 lots of MMR vaccines produced by Shanghai Institute of Biological Products Co., Ltd. (SIBP) in 2008-2017 were tested according to the MMR vaccine registration standards approved by China Food and Drug Administration and the regulations demonstrated in Chinese pharmacopoeia. The thermostability test was performed in month 0. The identity test and tests for appearance, moisture content, sterility, abnormal toxicity, residual bovine serum albumin, residual antibiotics (lots after October 2010), abnormal toxicity (lots after December 2013), pH and osmolarity (lots after December 2015) were performed in months 0 and 18. The virus titration was performed in months 0, 6, 12 and 18. The quality comparability study of the production site change were performed at the same time through accelerated and long-term stability tests for 3 lots each of MMR vaccines produced in new and old workshops. The key examination items were moisture content and virus titer. Results All testing results of MMR vaccine met the registration standards and relevant regulations within the period of validity. Quality comparability study showed that the qualities of products by the new and old workshops were comparable. The moisture content was≤3.0%, and the virus titers of measles, mumps and rubella were 3.3～4.3, 4.6～5.6 and 3.3～4.3 50% cellculture infective dose/ml, respectively. Conclusion The MMR vaccines produced by SIBP in 2008-2017are safe and effective with stable quality. |
| |
| Keywords: | Measles-mumps-rubella vaccine Stability Virus titration |
|
| 点击此处可从《国际生物制品学杂志》浏览原始摘要信息 |
|
点击此处可从《国际生物制品学杂志》下载全文 |
|
