Method for preparing freeze-dried human blood coagulation factor VIII
A human blood coagulation factor and freeze-drying technology, which is applied in the field of preparation of freeze-dried human blood coagulation factor VIII, can solve the problems of low product yield and success rate, and achieve the effects of avoiding Al3+ residues, improving product quality, and ensuring stability
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Embodiment 1
[0035] A preparation method of freeze-dried human blood coagulation factor VIII, comprising the following process: using water for injection containing 3-10 IU / ml of heparin as heparin sodium solution to dissolve cryoprecipitate, taking the supernatant after PEG precipitation, and centrifugally filtering, 24-26 ℃ S / D inactivation, DEAE Sepharose Fast Flow chromatography column equilibration, adsorption, washing, elution, molecular membrane ultrafiltration, preparation, sterilization and packaging, freeze-drying, capping, 99.5-100.5 ℃ dry heat inactivation; The specific process is as follows:
[0036] 1. Take plasma cryoprecipitate that meets the requirements of the pharmacopoeia: melt at room temperature for 1-2 hours, process into small pieces of 1.5-2.5cm, and wet crush;
[0037] 2. Cryoprecipitate dissolution: place the cryoprecipitate in 5-6 times the volume of heparin sodium solution, stir for 1 hour, then adjust the pH to 6.5-7.5 with 1mol / L HCl, continue stirring for 20...
Embodiment 2
[0068] The basic requirements are the same as those in Embodiment 1.
[0069] A preparation method of freeze-dried human blood coagulation factor VIII, comprising the following process: using water for injection containing 3-10 IU / ml of heparin as heparin sodium solution to dissolve cryoprecipitate, taking the supernatant after PEG precipitation, and centrifugally filtering, 24-26 ℃ S / D inactivation, DEAE Sepharose Fast Flow chromatography column equilibration, adsorption, washing, elution, molecular membrane ultrafiltration, preparation, sterilization and packaging, freeze-drying, capping, 99.5-100.5 ℃ dry heat inactivation; The specific process is as follows:
[0070] 1. Take plasma cryoprecipitate that meets the requirements of the pharmacopoeia: melt at room temperature for 1-2 hours, process into small pieces of 1.5-2.5cm, and wet crush;
[0071] 2. Cryoprecipitate dissolution: place the cryoprecipitate in 5-6 times the volume of heparin sodium solution, stir for 1 hour,...
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