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    • 1. 发明授权
    • Oil adjuvant vaccine and method for preparing same
    • 油佐剂疫苗及其制备方法
    • US5814321A
    • 1998-09-29
    • US758374
    • 1996-11-29
    • Tokuji MiyaharaKozo TakaseKoichi SaitoYoko KishimotoSatoru Tokuyama
    • Tokuji MiyaharaKozo TakaseKoichi SaitoYoko KishimotoSatoru Tokuyama
    • A61K39/39A61K45/00A61K9/107
    • A61K39/39A61K2039/55566Y10S514/937Y10S514/938Y10S514/939Y10S514/943
    • A water-in-oil type oil adjuvant vaccine comprises 20 to 90% by weight of an oil phase A) which is in a liquid state at ordinary temperature; 0.5 to 30% by weight of an emulsifying agent comprising a non-ionic surfactant B) which is a partial ester derived from a polyhydric alcohol carrying at least three hydroxyl groups and a fatty acid and which is in a liquid state at 40.degree. C. and a polyoxyethylene (20 to 60 moles) hydroxy fatty acid triglyceride C); and 5 to 75% by weight of an aqueous phase D) containing a biologically acceptable and effective amount of antigens, and optionally E) 0.01 to 10% by weight of an amino acid or a salt thereof and 0.01 to 10% by weight of a non-reducing sugar or a sugar alcohol having at least 5 hydroxyl groups in the molecule. In addition, a water-in-oil-in-water type oil adjuvant vaccine comprises the foregoing water-in-oil type oil adjuvant vaccine as an internal phase and an outer aqueous phase F) comprising 0.2 to 20% by weight of an emulsifying agent which comprises a non-ionic surfactant and which has an overall HLB value of not less than 10. The oil adjuvant vaccines show a high ability to induce an antibody-production over a long period of time and are excellent in requirements for medicines such as stability and safety.
    • 油包油型油佐剂疫苗含有20〜90重量%的油相A),其在常温下为液态; 0.5至30重量%的包含非离子表面活性剂B)的乳化剂,其为衍生自至少三个羟基和脂肪酸的多元醇的偏酯,并且在40℃处于液态。 和聚氧乙烯(20至60摩尔)羟基脂肪酸甘油三酯C); 和5至75重量%的包含生物可接受和有效量的抗原的水相D),以及任选地E)0.01至10重量%的氨基酸或其盐和0.01至10重量%的 非还原糖或分子中具有至少5个羟基的糖醇。 此外,水包油包水型油佐剂疫苗包含上述油包水型油佐剂疫苗作为内相和外水相F),其包含0.2-20重量%的乳化剂 药物,其包含非离子表面活性剂,其总体HLB值不小于10.油佐剂疫苗显示出在长时间内诱导抗体产生的高能力,并且对药物如 稳定性和安全性。