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Recombinant leukocyte inhibitory factor and leech peptide chimeric protein freeze-dried preparation for injection and preparation method thereof

A freeze-dried preparation and inhibitory factor technology, which are used in the freeze-dried preparation of recombinant leukocyte inhibitory factor and leech peptide chimeric protein and the field of preparation thereof

Pending Publication Date: 2021-09-10
LUNAN PHARMA GROUP CORPORATION
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

At present, recombinant leukocyte inhibitory factor and leech peptide chimeric protein preparations are rarely reported, so the preparation of recombinant leukocyte inhibitory factor and leech peptide chimeric protein for injection is of great significance

Method used

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  • Recombinant leukocyte inhibitory factor and leech peptide chimeric protein freeze-dried preparation for injection and preparation method thereof
  • Recombinant leukocyte inhibitory factor and leech peptide chimeric protein freeze-dried preparation for injection and preparation method thereof
  • Recombinant leukocyte inhibitory factor and leech peptide chimeric protein freeze-dried preparation for injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0054] (1) Prescription

[0055]

[0056] (2) Preparation of leukocyte inhibitory factor for injection and leech peptide chimeric protein freeze-dried preparation:

[0057] a. Preparation of liquid formulations before lyophilization:

[0058] Add the prescribed amount of mannitol, povidone K12, sucrose, recombinant leukocyte inhibitory factor and leech peptide chimeric protein stock solution into the citric acid-sodium citrate buffer solution with pH 5.0, stir to dissolve, and make the components after mixing The concentration is as shown in the above table, and the pH is adjusted to 5.0 with 0.1mol / L hydrochloric acid solution or sodium hydroxide, and the obtained medicinal solution is filled into a vial through a 0.22 μm filter membrane, half-tightened, and put into a freeze dryer Freeze-dried in medium;

[0059] b. The freeze-drying procedure of leukocyte inhibitory factor for injection and leech peptide chimeric protein freeze-dried powder injection is as follows:

...

Embodiment 2

[0064] (1) Prescription

[0065]

[0066] (2) Preparation of leukocyte inhibitory factor for injection and leech peptide chimeric protein freeze-dried preparation:

[0067] a. Preparation of liquid formulations before lyophilization:

[0068] Add the prescribed amount of mannitol, povidone K17, sucrose, recombinant leukocyte inhibitory factor and leech peptide chimeric protein stock solution into the citric acid-sodium citrate buffer solution of pH 4.5, stir and dissolve, so that the components after mixing The concentration is as shown in the above table, and the pH is adjusted to 4.5 with 0.1mol / L hydrochloric acid solution or sodium hydroxide, and the obtained medicinal solution is filled into a vial through a 0.22 μm filter membrane, half-tightened, and put into a freeze dryer Freeze-dried in medium;

[0069] b. The freeze-drying procedure of leukocyte inhibitory factor for injection and leech peptide chimeric protein freeze-dried powder injection is as follows:

[0...

Embodiment 3

[0074] (1) Prescription

[0075]

[0076] (2) Preparation of leukocyte inhibitory factor for injection and leech peptide chimeric protein freeze-dried preparation:

[0077] a. Preparation of liquid formulations before lyophilization:

[0078] Add the prescribed amount of mannitol, povidone K25, trehalose, recombinant leukocyte inhibitory factor and leech peptide chimeric protein stock solution into the citric acid-sodium citrate buffer solution with pH 5.5, stir to dissolve, and make the components after mixing The concentration is shown in the above table, and its pH is adjusted to 5.5 with 0.1mol / L hydrochloric acid solution or sodium hydroxide, and the obtained medicinal solution is filled into a vial through a 0.22 μm filter membrane, half-tightened, and put into a freeze-dried Freeze-dried in the machine;

[0079] b. The freeze-drying procedure of leukocyte inhibitory factor for injection and leech peptide chimeric protein freeze-dried powder injection is as follows:...

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Abstract

The invention belongs to the technical field of protein and polypeptide drugs, and particularly relates to a recombinant leukocyte inhibitory factor and leech peptide chimeric protein freeze-dried preparation and a preparation method thereof. The lyophilized powder for injection comprises the recombinant leukocyte inhibitory factor and leech peptide chimeric protein, an excipient, a cryoprotectant, and a buffer system. By researching different excipients, cryoprotectants, buffer systems and freeze-drying curves, the recombinant leukocyte inhibitory factor and leech peptide chimeric protein freeze-drying preparation for injection is provided, which is good in appearance, good in resolubility, high in activity, less in impurity, low in side effect, high in safety and stable in quality. The problems of unstable protein, easy aggregation and denaturation, reduced activity and the like are solved. The preparation is convenient to use, quick to absorb and convenient for storage and transport.

Description

technical field [0001] The invention belongs to the technical field of protein and polypeptide medicines, and in particular relates to a freeze-dried preparation of recombinant leukocyte inhibitory factor and leech peptide chimeric protein and a preparation method thereof. Background technique [0002] Cerebrovascular disease is one of the three major causes of death in human diseases at present. It has the characteristics of high disability rate and fatality rate, and seriously endangers human health. Among them, ischemia cerebral vascular disease (ICVD) is more common clinically. Accounting for about 60% to 70% of all cerebrovascular patients, it can be divided into two categories: global cerebral ischemia and focal cerebral ischemia, and its pathogenesis is not yet fully understood. Studies have shown that cerebral edema and excessive inflammatory response are important causes of cerebral ischemia and ischemia-reperfusion injury. After cerebral ischemia, a large amount o...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K38/58A61K47/26A61P35/00A61K38/20
CPCA61K9/0019A61K9/19A61K38/58A61K38/2093A61K47/26A61P35/00
Inventor 张贵民李娜张培彪刘忠
Owner LUNAN PHARMA GROUP CORPORATION
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