人用狂犬病毒脂质体疫苗的制备及性质

目的制备人用狂犬病毒脂质体疫苗,并考察其制剂学及毒理学性质。方法以氢化大豆磷脂、胆固醇、十八胺为原料,采用反相蒸发法(REV)制备脂质体,加入纯化狂犬病毒抗原,以冻干重建法(DRV)制备狂犬病毒脂质体疫苗。在电镜下观察其形态,测定其包封率和体外释放率,用激光衍射粒度分析仪测定其粒径分布及平均粒径,并进行局部刺激性、过敏反应及异常毒性试验。结果所制备的狂犬病毒脂质体疫苗形态呈圆形或椭圆形,粒径分布均匀,平均粒径为12.25μm左右,包封率在60%以上。无刺激性,无异常毒性,过敏反应检测合格。结论所制备的狂犬病毒脂质体疫苗性质稳定,可作进一步研究。

Preparation and Property of Rabies Virus Liposome Vaccine for Human Use

Objective To prepare the rabies virus liposome vaccine for human use and explore its pharmaceutical and toxicological properties.Methods Prepare liposome with phospholipid,cholesterol and stearylamine by reverse evaporation,then add purified rabies virus antigen for preparation of rabies virus liposome vaccine by lyophilization.Observe the prepared vaccine for morphology under electron microscope,and determine for envelope rate and release in vitro.Analyze the particale distribution and size of the vaccine by laser diffraction particle size analyzer.Perform local stimulation,hypersensitivity and abnormal toxicity tests on the prepared vaccine.Results The prepared rabies virus liposome vaccine under electron microscope were in forms of round or elliptic particles distributed evenly,at a mean size of 12.25 μm.The envelope rate of the vaccine was more than 60%.The vaccine showed no stimulation or abnormal toxicity and was qualified in hypersensitivity test.Conclusion The prepared rabies virus liposome vaccine showed stable property and was value of further study.