Erythrocyte freeze-dried powder preparation for injection and preparation method thereof
A technology for red blood cells and freeze-dried powder, which is used in freeze-dried transportation, extracellular fluid diseases, medical preparations with inactive ingredients, etc. question
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Embodiment 1
[0028] Example 1 Prescription and preparation of erythrocyte freeze-dried powder for injection
[0029] RBC cells 2×10 9 Cells / ml 1000ml
[0030] ectoine 12mg
[0031] Polyvinylpyrrolidone 10mg
[0032] 1) Dosing:
[0033] Red blood cells were washed twice with normal saline, and prepared with sterile water for injection to a concentration of 1×10 9 Cell / ml suspension, then add ectoine and polyvinylpyrrolidone, let stand for 1 hour;
[0034] 2) Freeze-drying:
[0035] a. Pre-freezing: drop the solution in vials from -20°C to -50°C at a rate of 10°C / min, and keep freezing for 2 hours; Raise the temperature to -10°C at a heating rate of 1 minute, and maintain drying for 6 hours; c. Secondary drying: After primary drying, raise the temperature to 25°C at a heating rate of 0.1°C / min, maintain drying for 5 hours, and sterilize and repack.
Embodiment 2
[0036] Example 2 Prescription and preparation of erythrocyte freeze-dried powder for injection
[0037] RBC cells 2×10 9 Cells / ml 1000ml
[0038] Hydroxyectoine 20mg
[0039] Polyvinylpyrrolidone 7mg
[0040] 1) Dosing:
[0041]Red blood cells were washed twice with normal saline, and the concentration was 2×10 with sterile water for injection. 9 Cell / ml suspension, then add hydroxyectoine and polyvinylpyrrolidone, let stand for 1 hour;
[0042] 2) Freeze-drying:
[0043] a. Pre-freezing: drop the solution in vials from -20°C to -50°C at a rate of 10°C / min, and keep freezing for 2 hours; Raise the temperature to -10°C at a heating rate of 1 minute, and maintain drying for 6 hours; c. Secondary drying: After primary drying, raise the temperature to 25°C at a heating rate of 0.1°C / min, maintain drying for 5 hours, and sterilize and repack.
Embodiment 3
[0044] Example 3 Prescription and preparation of erythrocyte freeze-dried powder for injection
[0045] RBC cells 2×10 9 Cells / ml 1000ml
[0046] Hydroxyectoine 30mg
[0047] Trehalose 45mg
[0048] 1) Dosing:
[0049] Red blood cells were washed twice with normal saline, and the concentration was 2×10 with sterile water for injection. 9 Cell / ml suspension, then add ectoine and trehalose, let stand for 1 hour;
[0050] 2) Freeze-drying:
[0051] a. Pre-freezing: drop the solution in vials from -20°C to -50°C at a rate of 10°C / min, and keep freezing for 2 hours; Raise the temperature to -10°C at a heating rate of 1 minute, and maintain drying for 6 hours; c. Secondary drying: After primary drying, raise the temperature to 25°C at a heating rate of 0.1°C / min, maintain drying for 5 hours, and sterilize and repack.
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Abstract
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