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Recombination human acidic mechanocyte growth factor temperature sensitive type gel preparation and preparation method thereof

A technology of fibroblasts and growth factors, applied in medical preparations with no active ingredients, medical preparations containing active ingredients, drug combinations, etc., can solve the problems of haFGF gel formula and preparation process that have not been seen, and achieve Reduce the pain of medication, easy to clean, the effect of a reasonable matrix

Active Publication Date: 2010-10-13
GUANGZHOU BIOPHARMACEUTICAL R&D CENT OF JINAN UNIV CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] At present, there is an invention patent with patent number 02130957.4 that discloses haFGF aerosol, but there is no report on the formula and preparation process of haFGF gel

Method used

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  • Recombination human acidic mechanocyte growth factor temperature sensitive type gel preparation and preparation method thereof
  • Recombination human acidic mechanocyte growth factor temperature sensitive type gel preparation and preparation method thereof
  • Recombination human acidic mechanocyte growth factor temperature sensitive type gel preparation and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0020] prescription:

[0021] aFGF 4.5×10 6 IU

[0022] Heparin sodium 1.5×10 6 IU

[0023] Poloxamer 407 200g

[0024] Glycerin 50g

[0025] Ethanol 50g

[0026] Ethyl p-hydroxybenzoate 2g

[0027] Water for injection up to 1000g

[0028] Preparation:

[0029] Take 800ml water for injection, add 200g poloxamer while stirring, fully swell to form a solution at 4°C, add 50g glycerin, 50g ethanol and 2g ethyl p-hydroxybenzoate, mix well, and then under the conditions of 0.1Mpa and 121°C Autoclave for 15 minutes, cool to 4℃, make the matrix part, mix rh-aFGF (4.5×106IU) solution and heparin sodium (1.5×106IU) in a ratio of 3:1, filter and sterilize, add to the sterile Add sterile water for injection to 1000 g in the post-bacterial gel matrix, slowly stir and mix uniformly to prepare rh-aFGF temperature-sensitive gel.

[0030] Stability test of rh-aFGF temperature-sensitive gel:

[0031] Prepare rh-aFGF temperature-sensitive gel according to Example 1. Take an appropriate amount of the gel and ...

Embodiment 2

[0041] prescription:

[0042] aFGF 3×10 6 IU

[0043] Heparin Sodium 1×10 6 IU

[0044] Poloxamer 407 280g

[0045] Glycerin 70g

[0046] Propylene glycol 30g

[0047] Yamanashi 5g

[0048] Water for injection up to 1000g

[0049] Take 800ml water for injection, add 280g poloxamer while stirring, fully swell at 4℃ to form a solution, add 70g glycerol, 30g propylene glycol and 5g sorbic acid, mix well, then autoclave at 0.1Mpa, 121℃ 15 Minutes, cool to 4°C, make the matrix part, add rh-aFGF(3×10 6 IU) solution and heparin sodium (1×10 6 IU) Mix well at a ratio of 3:1, filter and sterilize, add to the sterilized gel matrix, add sterilized water for injection to 1000g, slowly stir and mix evenly to make rh-aFGF temperature-sensitive gel Agent.

Embodiment 3

[0051] prescription:

[0052] aFGF 5.7×10 6 IU

[0053] Heparin Sodium 1.9×10 6 IU

[0054] Poloxamer 407 300g

[0055] Dextran 2.5g

[0056] Ethanol 20g

[0057] Sodium benzoate 1g

[0058] Water for injection up to 1000g

[0059] Take 800ml water for injection, add 300g poloxamer while stirring, fully swell to form a solution at 4℃, add 80g glycerol, 20g ethanol and 1g sodium benzoate, mix well, then autoclave at 0.1Mpa, 121℃ 15 After cooling to 4℃, make the matrix part, take 2.5g of dextran and dissolve it with appropriate amount of water for injection, add rh-aFGF (5.7×10 6 IU) and heparin sodium (1.9×10 6 IU) Mix the solution at a ratio of 3:1 and mix it evenly, filter and sterilize and add it to the sterilized gel matrix, add sterilized water for injection to 1000g, slowly stir and mix well to make rh-aFGF temperature sensitive Type gel.

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Abstract

The invention provides a temperature-sensitive gel of recombinant human acid fibroblast growth factor (rh-aFGF) and the preparation method of the gel. The temperature-sensitive gel of recombinant human acid fibroblast growth factor of the invention contains the recombinant human acid fibroblast growth factor and a gel matrix, which are the active components, wherein the gel matrix contains poloxamer based on the weight of 10 to 50 percent of the gel matrix. The rh-aFGF solution is added under the liquor state, so the uniformity of the preparation is better, and at the same time the operation under 4 DEG C can keep the stability of the rh-aFGF better.

Description

Technical field: [0001] The invention belongs to the field of pharmaceutical preparations, and relates to a recombinant human acidic fibroblast growth factor (hereinafter referred to as rh-aFGF) temperature-sensitive gel for treating wounds caused by burns, scalds and ulcers. The invention also relates to this Preparation method of temperature-sensitive gel. Background technique: [0002] Acidic fibroblast growth factor (aFGF) is the second member of the FGFs family to be isolated and purified. Thomas was isolated and purified from cow brain in 1984 to obtain a mixture of polypeptides of two sizes (140aa and 134aa). A broad-spectrum mitogen with 55% amino acid sequence identical to the cationic polypeptide basic fibroblast growth factor (bFGF) isolated from the bovine pituitary. aFGF is mainly distributed in organs or tissues such as the brain, pituitary gland, nerve tissue, retina, adrenal gland, heart and bone, and has very little content in other tissues. Human acidic fibrob...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K38/18A61K9/00A61K47/34A61P17/02A61K47/10
Inventor 黄亚东李校堃项琪赵文苏志坚张卉
Owner GUANGZHOU BIOPHARMACEUTICAL R&D CENT OF JINAN UNIV CO LTD
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