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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 Relieve the pain of medication, maintain stability, and achieve long-lasting drug effects

Active Publication Date: 2008-03-19
BIOPHARM RES & DEV CENT JINAN
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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

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0020] prescription:

[0021] aFGF 4.5×10 6 IU

[0022] Sodium heparin 1.5×10 6 IU

[0023] Poloxamer 407 200g

[0024] Glycerin 50g

[0025] Ethanol 50g

[0026] Ethylparaben 2g

[0027] Add water for injection to 1000g

[0028] Preparation:

[0029] Take 800ml of water for injection, add 200g of poloxamer while stirring, fully swell at 4°C to form a solution, add 50g of glycerin, 50g of ethanol and 2g of ethyl p-hydroxybenzoate, mix well, and then under the condition of 0.1Mpa, 121°C Autoclave for 15 minutes, cool to 4°C, and make 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 sterile Add sterilized water for injection to 1000 g into the sterilized gel matrix, stir slowly and mix evenly, and make rh-aFGF temperature-sensitive gel.

[0030] Stability test of rh-aFGF thermosensitive gel:

[0031] Prepare the rh-aFGF temperature-sensitive gel according to Example 1, take an appropriate amou...

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] Sorbic acid 5g

[0048] Add water for injection to 1000g

[0049] Take 800ml of water for injection, add 280g of poloxamer while stirring, fully swell at 4°C to form a solution, add 70g of glycerin, 30g of propylene glycol and 5g of sorbic acid, mix well, and then autoclave at 0.1Mpa, 121°C for 15 Minutes, cooled to 4 ℃, made matrix part, rh-aFGF (3 × 10 6 IU) solution and sodium heparin (1×10 6 IU) mixed evenly in a ratio of 3:1, filtered and sterilized, added to the sterilized gel matrix, added sterilized water for injection to 1000g, stirred slowly and mixed evenly, and made rh-aFGF thermosensitive gel agent.

Embodiment 3

[0051] prescription:

[0052] aFGF 5.7×10 6 IU

[0053] Sodium heparin 1.9×10 6 IU

[0054] Poloxamer 407 300g

[0055] Dextran 2.5g

[0056] Ethanol 20g

[0057] Sodium Benzoate 1g

[0058] Add water for injection to 1000g

[0059] Take 800ml of water for injection, add 300g of poloxamer while stirring, fully swell at 4°C to form a solution, add 80g of glycerin, 20g of ethanol and 1g of sodium benzoate, mix well, and then autoclave at 0.1Mpa, 121°C for 15 Minutes, cooled to 4 ℃, made the matrix part, took 2.5g of dextran and dissolved it with an appropriate amount of water for injection, added rh-aFGF (5.7×10 6 IU) and heparin sodium (1.9×10 6 IU) according to the ratio of 3:1, mix the solution evenly, filter and sterilize, add it to the sterilized gel matrix, add sterilized water for injection to 1000g, stir slowly and mix evenly, and make rh-aFGF thermosensitive 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 wound damage caused by burns, scalds, and ulcers. The preparation method of thermosensitive gel. Background technique: [0002] Acidic fibroblast growth factor (aFGF) is the second member of the FGFs family to be isolated and purified. Thomas isolated and purified a mixture of two sizes of polypeptides (140aa and 134aa) from bovine brain in 1984. It is A broad-spectrum mitogen, which has 55% identical amino acid sequence with cationic polypeptide basic fibroblast growth factor (bFGF) isolated from bovine pituitary gland. aFGF is mainly distributed in organs or tissues such as brain, pituitary gland, nerve tissue, retina, adrenal gland, heart and bone, and its content is very small in other tissues. Human acidic fibroblast growth factor (haFGF)...

Claims

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Application Information

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Patent Type & Authority Applications(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 BIOPHARM RES & DEV CENT JINAN
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