Dry heat treatment stabilizing agent for human coagulation factor VIII and vWF (von willebrand factor) compound or human coagulation factor VIII preparation

Abstract

The invention discloses a dry heat treatment stabilizing agent for a human coagulation factor VIII and vWF compound or a human coagulation factor VIII preparation. The stabilizing agent of the invention comprises histidine or its salt, arginine or its salt, lysine or its salt, mannitol, mycose, and sucrose, and also can comprise one or several of common glycine, sucrose, common salt, calcium chloride, sodium citrate, and heparins. Experiments prove that the human coagulation factor VIII and vWF compound or the human coagulation factor VIII preparation contains 0.1-10% of histidine or its salt, 0.1-10% of arginine or its salt, and one or several of 0.1-10% of lysine or its salt, 0.1-10% of glycine, 0.1-10% of mannitol, 0.1-10% of sucrose, and 0.1-10% of mycose, so the human coagulation factor VIII and vWF compound or the human coagulation factor VIII preparation can effectively inactivate viruses under a 80-100DEG C dry heat environment, can effectively protect the activity of the human coagulation factor VIII, and has a qualified freeze-drying appearance and a redissolving appearance. So the stabilizing agent of the invention can be used as the dry heat treatment stabilizing agent for the human coagulation factor VIII and vWF (von willebrand factor) compound or the human coagulation factor VIII preparation.

Description

technical field [0001] The invention belongs to the technical field of medicine, and relates to a stabilizer capable of reducing the activity loss of human coagulation factor VIII when a compound of human coagulation factor VIII and vWF or human coagulation factor VIII preparation is inactivated by dry heat virus. Specifically, human albumin is not added to the complex of human coagulation factor VIII and vWF or human coagulation factor VIII, but mannitol or / and amino acids or their salts are added, and inactivated by dry heat (80°C or 100°C) When the virus is active, it can maintain the stability of the physical and chemical properties of various proteins in the preparation, prevent protein denaturation and precipitation; reduce the loss of coagulation factor activity and increase the recovery rate of coagulation factor VIII. Background technique [0002] Plasma-derived Human coagulation factor VIII preparations (Plasma-derived Human coagulation factor VIII, pdFVIII) are is...

AI Technical Summary

Problems solved by technology

However, the protective effect in actual use is not ideal, and the recovery rate of coagulation factor activity before and after the actual dry heat treatment is difficult to reach or exceed 75%, which is difficult to meet the needs of large-scale production

So far, there are no literature and patent reports on the use of mannitol or / and histidine, arginine, and lysine for the complex of human coagulation factor VIII and vWF or the dry heat treatment stabilizer of human coagulation factor VIII preparations

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