Acid-resistant oral double-layer capsule and preparation method thereof

The invention belongs to the field of drug delivery systems, and particularly relates to an acid-resistant oral double-layer capsule and a preparation method thereof. The double-layer capsule comprises an outer capsule and an inner capsule located in the outer capsule, the outer capsule is an enteric capsule, the inner capsule contains acid-sensitive active pharmaceutical ingredients, and a pharmaceutically acceptable hydrophobic ester oil or a pharmaceutically acceptable water absorbent is filled between the outer capsule and the inner capsule. The double-layer capsule can improve the long-term storage stability, improve the acid-resistant effect and improve the survival rate of the probiotics after being acted by gastric acid. 本发明属于药物递送系统领域，具体涉及一种耐酸的口服双层胶囊及其制备方法。所述双层胶囊包括外胶囊和位于其内的内胶囊，所述外胶囊为肠溶胶囊，所述内胶囊内含酸敏感的药物活性成分，外胶囊和内胶囊之间填充药学上可接受的疏水酯类油或药学上可接受的吸水剂。本发明的双层胶囊能提升长期储存稳定性，改善耐酸效果，提高益生菌经胃酸作用后的存活率。