【摘要】 为选择合适的的冻干A、C群脑膜炎球菌结合疫苗的稀释液,以注射用水(H2O)、生理盐水(NS)、磷酸盐缓冲液(PBSpH6.8～7.2)作为候选稀释液,进行了相关溶解度、pH、渗透压、异常毒性、免疫原性的检测比较。溶解度、pH、免疫原性结果显示三种稀释液无差异;H2O作为稀释液的渗透压不符合人用制剂渗透压的要求,另两者则符合要求;三种稀释液溶解制品后的pH检测数据均符合要求,但PBS的缓冲能力更强。故认为PBS更适合作为冻干A、C群脑膜炎球菌结合疫苗的稀释液。更多还原

【Abstract】 To select a diluent suitable for reconstitution of freeze-dried meningococcal group A and C conjugate vaccine.Using sterile water for injection(H2O),normal saline(NS),and phosphate buffer PBS pH6.8-7.2)as diluents the solubility,pH,osmotic pressure,abnormal toxicity,and immunogenicity for the reconstitution of a freeze-dried meningococcal conjugate vaccine were compared.Solubility,abnormal toxicity,immunogenicity test results showed that there are no significant difference;the data showed that osmotic pressure of water as diluent is out of the requirement of injection osmotic pressure used for people,the NS and PBS are appropriate,but PBS is more buffering of pH than those of H2O and NS.So PBS is a suitable diluent for reconstitution of the freeze-dried meningococcal group A and C conjugate vaccine.更多还原