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A kind of recombinant human growth hormone injection and preparation method thereof

A technology of human growth hormone and injection, which is applied in the direction of drug combinations, pharmaceutical formulas, medical preparations of non-active ingredients, etc., can solve the problems of reduced stability and pain, achieve good stability, reduce pain, and enhance use safety effect

Active Publication Date: 2019-02-05
ZHONGSHAN HYGENE BIOPHARM
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, there are still technical problems such as very painful injection site and reduced stability

Method used

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  • A kind of recombinant human growth hormone injection and preparation method thereof
  • A kind of recombinant human growth hormone injection and preparation method thereof
  • A kind of recombinant human growth hormone injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0013] prescription:

[0014] Material composition

[0015] Preparation method: a. Weigh poloxamer 188 and mannitol, add 30ml of water for injection and stir respectively, fully dissolve and mix, add glycerin diluted with 30ml of water to obtain a stock solution, add recombinant human growth hormone stock solution and cholesterol in the stock solution, set b. In a grade A environment, filter the medicinal solution obtained in step a through a 0.22 μm microporous membrane, and then pack it into a glass sleeve for a pen-type syringe.

Embodiment 2

[0017] prescription:

[0018] Material composition

[0019] Preparation method: a. Weigh L-histidine and mannitol, add 20ml of water for injection and stir respectively, fully dissolve and mix, add glycerin diluted with 40ml of water to obtain a stock solution, add recombinant human growth hormone stock solution and cholesterol to the stock solution, and b. In a grade-A environment, filter the medicinal solution obtained in step a through a 0.22 μm microporous membrane, and pack it separately to obtain the medicinal solution.

Embodiment 3

[0021] prescription:

[0022] Material composition

[0023] Preparation method: a. Weigh L-histidine, poloxamer 188 and mannitol, respectively add 25ml of water for injection, stir, fully dissolve and mix, add 50ml of glycerin diluted with water to obtain a stock solution, add recombinant human growth Hormone stock solution and cholesterol, constant volume, to obtain liquid medicine; b. Under A-level environment, filter the liquid medicine obtained in step a through a 0.22 μm microporous filter membrane, and then pack to obtain.

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PUM

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Abstract

The invention discloses a recombinant human growth hormone injection and a preparation method thereof. The recombinant human growth hormone injection is composed of, 2-7 mg / ml of recombinant human growth hormone, 2-7 mg / ml of cholesterol, 0-3 mg / ml of L-histidine, 0-5 mg / ml of poloxamer 188, 25-35 mg / ml of mannitol, 8-12 mg / ml of glycerinum and water for injection. The recombinant human growth hormone injection can significantly reduce pain during injection as well as incidence of adverse reaction of injected parts and is good in stability and has certain clinical advantages.

Description

technical field [0001] The invention relates to a recombinant human growth hormone injection and a preparation method thereof. Background technique [0002] Human growth hormone (hGH) is a protein hormone secreted by the anterior lobe of the pituitary gland. It contains 191 amino acid residues, has a molecular weight of 22KDa, has two S-S, and has no glycosylation modification. It is the most important hormone for human growth after birth. hormones. Recombinant human growth hormone (rhGH) is a recombinant protein that uses genetic engineering to separate the human growth hormone gene from the chromosomal DNA strand, recombine it on a plasmid, and express it with different expression systems. The amino acid content, spatial conformation and sequence of rhGH are exactly the same as those of human growth hormone, and it has the same biological effect as human endogenous growth hormone. Clinically, it is mainly used to treat or alleviate childhood dwarfism, tissue repair, burn...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K38/27A61K9/08A61K47/28A61P5/06A61P3/00
CPCA61K9/0019A61K9/08A61K38/27A61K47/28A61P3/00A61P5/06
Inventor 翁樑郭丽丽于占东丁芳张少珍郭井妹
Owner ZHONGSHAN HYGENE BIOPHARM
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