公开(公告)号：EP0781559A3

公开(公告)日：1998-12-16

申请号：EP96308676

申请日：1996-11-29

申请人： CHEMO SERO THERAPEUT RES INST ,  NOF CORP

发明人： MIYAHARA TOKUJI ,  TAKASE KOZO ,  SAITO KOICHI ,  KISHIMOTO YOKO ,  TOKUYAMA SATORU

IPC分类号： A61K39/39 ,  A61K9/113

CPC分类号： A61K39/39 ,  A61K2039/55566 ,  Y10S514/937 ,  Y10S514/938 ,  Y10S514/939 ,  Y10S514/943

摘要： 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°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.

摘要翻译： 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， 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％的含有生物可接受和有效量的抗原的水相D），以及任选的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，外部水相F）包含0.2-20重量％的乳化剂 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，并且对药物的需求优异，例如 稳定和安全。