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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

Pending Publication Date: 2020-11-20
SHANGHAI LIKANGRUI BIOLOGICAL ENG
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] In the prior art, it is common to add some solubilizers to improve the solubility of solid proteins, but for porcine fibrinogen preparations, this addition cannot effectively improve the reconstitution time

Method used

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  • Porcine fibrinogen freeze-dried preparation, preparation process and application of porcine fibrinogen freeze-dried preparation

Examples

Experimental program
Comparison scheme
Effect test

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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Abstract

The invention belongs to the field of biopharmaceuticals, and particularly relates to a porcine fibrinogen freeze-dried preparation, a preparation process and application of the porcine fibrinogen freeze-dried preparation. By per mL of preparation, the porcine fibrinogen freeze-dried preparation comprises: porcine fibrinogen 100 mg, sodium chloride 4-12 mg, sodium citrate 5-15 mg, arginine hydrochloride 60-90 mg and an adjuvant 2-10 mg; the adjuvant includes: one or more of a polyhydroxy compound, a non-ionic surface active agent, saccharides and a disintegrating agent. The preparation processis shown as follows: after the porcine fibrinogen is dissolved with a buffer solution containing the sodium citrate, the sodium chloride and the arginine hydrochloride, the adjuvant is added, stirring and dissolving are performed to obtain a porcine fibrinogen freeze-dried solution, and the porcine fibrinogen freeze-dried solution is aseptically filtered with a filter membrane of 0.22[mu]m, and is split-charged, and freeze-dried to obtain the porcine fibrinogen freeze-dried preparation. The porcine fibrinogen freeze-dried preparation of the invention has high instant solubility, short re-dissolving time, high re-dissolving solution clarity, and no protein precipitation.

Description

technical field [0001] The invention belongs to the field of biopharmaceuticals, and in particular relates to a freeze-dried preparation of pig-derived fibrin, a preparation process and an application thereof. Background technique [0002] In sudden accidents in traffic accidents and clinical operations, it is often easy to cause massive bleeding, especially on the battlefield, failure to stop bleeding in time is the main cause of casualties. Therefore, effective control of bleeding conditions is the first step in emergency care, and having a broad-spectrum hemostatic material to seal the bleeding point can greatly reduce the probability of patient death. Absorbable hemostatic materials have received extensive attention and research because of their rapid hemostasis and their ability to degrade in vivo. Absorbable hemostatic materials mainly include fibrin, medical collagen, gelatin, oxidized regenerated cellulose, alginate, chitosan, and cyanoacrylic acid. Among them, the...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K38/36A61K9/19A61K47/18A61L24/10A61L24/00A61P7/04
CPCA61L24/108A61L24/0015A61K38/363A61K9/19A61K47/183A61P7/04A61L24/001A61L2400/04A61L2300/254A61L2300/418
Inventor 吴剑英樊婷婷刘璐张理火张军东
Owner SHANGHAI LIKANGRUI BIOLOGICAL ENG
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