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    Total nutrient admixtures as stable multicomponent liquids or dry powders and methods for the preparation thereof
    58.
    发明授权
    Total nutrient admixtures as stable multicomponent liquids or dry powders and methods for the preparation thereof 失效
    总营养混合物作为稳定的多组分液体或干燥粉末及其制备方法

    公开(公告)号：US5997904A

    公开(公告)日：1999-12-07

    申请号：US723805

    申请日：1996-09-30

    申请人： Shlomo Magdassi ,  Andrew Yang ,  Chunlin Tao ,  Neil P. Desai ,  Zhiwen Yao ,  Patrick Soon-Shiong

    发明人： Shlomo Magdassi ,  Andrew Yang ,  Chunlin Tao ,  Neil P. Desai ,  Zhiwen Yao ,  Patrick Soon-Shiong

    IPC分类号： A23L33/00 ,  A61K9/00 ,  A61K9/50 ,  A61K9/51 ,  A61K47/48 ,  A61K49/18 ,  A61K49/22 ,  A61K9/14

    CPC分类号： A61K9/0029 ,  A23L33/40 ,  A61K9/0026 ,  A61K9/5052 ,  A61K9/5169 ,  B82Y5/00

    摘要： In accordance with the present invention, there are provided stabilized total nutrient admixture (TNA) compositions which are useful for the in vivo parenteral delivery of pharmacologically acceptable lipids or fats, as well as methods for the preparation thereof. In particular, the pharmacologically acceptable lipid or fat is contained within a protein walled shell. In a particular embodiment of the invention, a TNA composition using human serum albumin (HSA) as a stabilizer has been prepared as a convenient three-in-one formulation (i.e., containing a fat emulsion, dextrose, and amino acids plus electrolytes). This "three-in-one" formulation can be prepared in liquid form or in dry form (comprising submicron-sized nanoparticles). The dried material is stable, even under long term storage, and is easily reconstituted immediately before use by simply adding sterile water (with or without vitamin supplementation). This serves to rehydrate the powder into a TNA suitable for injection. The long shelf life, ease of reconstitution, and single-component injectability of invention compositions provide significant cost savings, as such compositions can be reconstituted and administered safely, even in the home. In addition, HSA, the stabilizing agent of choice for use in the practice of the present invention, has been shown to improve survival and wellness when given as a supplement to patients receiving conventional forms of total nutrient admixtures.

    摘要翻译： 根据本发明，提供了可用于体内胃肠外递送药理学上可接受的脂质或脂肪的稳定的总营养混合物（TNA）组合物，以及其制备方法。 特别地，药理学上可接受的脂质或脂肪包含在蛋白质壁壳内。 在本发明的一个具体实施方案中，已经制备了使用人血清白蛋白（HSA）作为稳定剂的TNA组合物作为方便的三合一制剂（即含有脂肪乳剂，葡萄糖和氨基酸加电解质）。 这种“三合一”制剂可以以液体形式或干燥形式（包括亚微米尺寸的纳米颗粒）制备。 干燥的材料即使在长期储存下也是稳定的，并且在使用之前通过简单地加入无水（有或没有维生素补充剂）容易地重构。 这用于将粉末再水合成适合注射的TNA。 本发明组合物的长保存期限，易于重构和单组分可注射性提供显着的成本节约，因为即使在家中也可安全地重构和施用这些组合物。 此外，HSA是用于本发明实践的选择的稳定剂，已经显示出，当给予作为补充常规形式的总营养混合物的患者时，HSA可改善存活和健康。