Freeze-drying protective agent for human blood coagulation factor VIII and preparation method of freeze-drying protective agent

2013 
The invention discloses a formula of a human albumin and sugar free freeze-drying protective agent for a human blood coagulation factor VIII. The freeze-drying protective agent comprises the following components (concentration mol/L): 10-200 of sodium chloride, 2-50 of sodium citrate, 50-600 of glycine, 1-30 of calcium chloride and 1-200 of lysine hydrochloride. According to the formula, indicator viruses in a human blood coagulation factor VIII product can be effectively activated by using a dry heating method, the activity of a haematogenous human blood coagulation factor VIII is effectively protected in freeze-drying heat inactivation and long-term storage processes, and the human albumin and sugar free freeze-drying protective agent has the advantages that the virus inactivating effect is good; the recessive pollution can be avoided because no human albumin and other components of animal origin are added; the production cost can be effectively reduced because the components in the formula are simple; the concentration of the sodium chloride and the osmotic pressure of a product are well compatible with a human body; the concentration of the sodium chloride in the formula is beneficial to the freeze drying and long-term storage of the product; glycine contains amino groups and carboxy groups so that the freeze-dried product has the advantages of strong buffering effect, no sugar, good heat resistance, short redissolving time and the like.
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