Porcine fibrinogen freeze-dried preparation, preparation process and application of porcine fibrinogen freeze-dried preparation
A technology for fibrinogen and freeze-dried preparations, which is applied in the field of pig-derived fibrin freeze-dried preparations, can solve the problems that the reconstitution time cannot be effectively improved, and achieve the effects of shortening the preparation time, short reconstitution time, and good clarity
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Embodiment 1
[0025] 1. A freeze-dried preparation of porcine-derived fibrinogen, calculated per mL of preparation, comprising:
[0026] Pig-derived fibrinogen 100mg, sodium chloride 12mg, sodium citrate 10mg, arginine hydrochloride 90mg, mannitol 1mg, poloxamer 188 1mg, trehalose 0.5mg, sodium alginate 0.5mg.
[0027] 2, the preparation technology of described porcine source fibrinogen freeze-dried preparation, comprises as follows:
[0028] The precipitate obtained by cold ethanol precipitation of pig plasma is pig-derived fibrinogen. After the precipitate is rinsed with water for injection, it is dissolved with a buffer solution containing sodium citrate, sodium chloride, and arginine hydrochloride (buffer solution formula: citric acid Sodium 10g / L, sodium chloride 12g / L, arginine hydrochloride 90g / L; use hydrochloric acid or sodium hydroxide to adjust the pH to 7.0), stir evenly for 1-2 hours, then add mannitol, poloxamer 188, Trehalose, sodium alginate, so that the concentrations of m...
Embodiment 2
[0036] 1. A freeze-dried preparation of porcine-derived fibrinogen, calculated per mL of preparation, comprising:
[0037] Pig-derived fibrinogen 100mg, sodium chloride 6mg, sodium citrate 5mg, arginine hydrochloride 60mg, polysorbate 201.2mg, sucrose 0.5mg, sodium alginate 0.5mg.
[0038] 2, the preparation technology of described porcine source fibrinogen freeze-dried preparation, comprises as follows:
[0039] The precipitate obtained by cold ethanol precipitation of pig plasma is pig-derived fibrinogen. After the precipitate is rinsed with water for injection, it is dissolved with a buffer solution containing sodium citrate, sodium chloride, and arginine hydrochloride (buffer solution formula: citric acid Sodium 5g / L, sodium chloride 6g / L, arginine hydrochloride 60g / L; use hydrochloric acid or sodium hydroxide to adjust the pH to 7.0), stir evenly for 1-2 hours, then add polysorbate 20, sucrose, alginic acid Sodium, so that the concentrations of polysorbate 20, sucrose, a...
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