Method of controlling structure stability of collagen fibers produced from solutions or dispersions treated with sodium hydroxide for infectious agent deactivation

摘要

In accordance with the present invention, it has been discovered that the stability of collagen fibers is altered upon treatment of a solution or dispersion of the collagen fibers with a chemical reagent for the inactivation of infectious agents. This fiber destabilization makes it difficult to formulate the collagen fibers to final product when the formulation contains an ingredient which alters the destabilized collagen fibers. Collagen fiber stability in a collagen dispersion can be controlled using either a physical fiber-stabilizing agent or a chemical fiber-stabilizing agent. The physical fiber-stabilizing agent is used to protect the stability of the assembled fibers, without providing for covalent bonding between fibrils which make up the fibers. The chemical fiber-stabilizing agent is used to provide covalent bonding between fibrils, whereby the fibers are stabilized. A stabilized dispersion of collagen fibers is achieved by the presence of a physical fiber-stabilization means comprising a polymeric material of the kind which is capable, at sufficient concentration, of causing collagen fibers to precipitate from solution. Preferred polymeric materials are water soluble or water miscible. Preferably the water soluble or water miscible polymeric material is biocompatible, such as a polyethylene glycol or derivatives thereof. A stabilized dispersion of collagen fibers is also prepared by using a chemical fiber-stabilizing agent which crosslinks fibrils within the fiber, stabilizing the fiber. A preferred method of stabilizing the collagen fiber produced from a solution or a dispersion of collagen treated with an agent for the inactivation of infectious agents is to stabilize the collagen fiber subsequent to the treatment, by using one of the physical or chemical fiber-stabilizing means. $$