黄芪多糖脂质体的制备和稳定性研究

A STUDY ON THE PREPARATION AND STABILITY OF APS LIPOSOMES

本文用均匀设计方法筛选了黄芪多糖脂质体的处方并考查了脂质体的几种制备方法，采用筛选的处方和熔融法制备了十几批黄芪多糖脂质体，制备的黄芪多糖脂质体体系稳定，由化学稳定性预测黄芪多糖脂质体20℃贮存期为1．44年；测定了黄芪多糖脂质体的粒度分布，90％以上粒子粒径1μm以下，40℃保温3个月粒子粒径不变．在此基础上进一步研究证明了黄芪多糖脂质体比黄芪多糖普通制剂和空白脂质体具有更加显著的免疫增强效果．

In this Study, 6 factors and 10 levels of each variable are selected with a computer by Uniform Design Method for preparing APS Liposomes. The optimal procedure for preparingAPS Liposomes is established and it suits mass serial production in a pharmaceutical factory.The shelflife of APS Liposomes at 20℃ is 1. 44 years. Diameters of vesicles(＞90%) in APS Liposomes are shorter than 1 μm, and the system is stable. At 40℃ for three months diameters of vesicles of APS Liposomes remain unchange. In terms of effects of APS Liposomes on phagocytosis, serum HC_(50) and delayed hypersensitivity of mice, APS Liposomes are a more effective immunopotentiator than APS and Empty Liposomes. Studies reported in this paper establish a foundation for production and clinical application of APS Liposomes.