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流感疫苗脂质体干粉的稳定性

Stability of influenza vaccine liposome powder

  • 摘要: 考察制备的流感疫苗脂质体干粉的物理稳定性,确定加入的抗氧化剂维生素E(VitE)用量以及在该用量下产品的生物学稳定性。将样品分别储存于(37±2) ℃,(25±2) ℃,4 ℃下,于规定时间取样测定包封率,以此考察其物理稳定性,发现(37±2) ℃下储存14 d内稳定;(25±2) ℃下90 d内稳定;4 ℃下180 d内稳定。脂质体中加入不同量VitE,储存于(37±2) ℃下,于不同时段取样测定包封率和氧化指数,筛选最佳VitE用量为5%,将含5%VitE的流感疫苗脂质体干粉于(37±2) ℃储存,于1,14,21 d取样,以含6 μg血凝素的流感疫苗脂质体对小鼠肺部灌注免疫后用红细胞凝集抑制法测定抗体滴度,以考察其生物学稳定性,发现该干粉储存21 d后免疫后与免疫前抗体滴度比达19.1,表明流感疫苗脂质体干粉(37±2) ℃储存21 d的生物学稳定性良好。

     

    Abstract: The physical stability of prepared influenza vaccine liposome powder was observed,the portion of vitamin E (VitE) was optimized using encapsulation efficiency and oxidation-index as indexes,and the immunogenicity and biological stability of the product containing the optimized amount of VitE was studied.The liposome powder was put at the temperature of (37±2),(25±2),and 4 ℃ and sampled at due time.The encapsulation efficiency was determined in order to study its physical stability.The liposome powder had satisfying physical stability under (37±2) ℃ for 14 d,(25±2) ℃ for 90 d and 4 ℃ for 180 d.The influenza vaccine liposome powder was stored with varied amount of VitE under (37±2) ℃,the samples were taken at different times,the encapsulation efficiency and oxidation indexes were measured,so that the optimum amount of VitE could be determined.The influenza vaccine liposome powder was stored with optimized VitE under (37±2) ℃ for 1,14 and 21 d,the antibody titers were determined by hemagglutination-inhibition (HI) method after pulmonary delivery to mice at the dose of heamagglutinin (6 μg/mouse).The product with 5% VitE had the highest encapsulation efficiency,optimum outlook,and satisfied biostability under (37±2) ℃ for 21 d.

     

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