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Preparation of fibroblast growth factor-1 modified gel and its application in the treatment of diabetic foot

A fibroblast and growth factor technology, applied in the field of biomedicine, can solve the problems of reducing the quality of life of patients, reducing the ability to resist infection, and immune dysfunction, etc., and achieve the effects of increasing clinical application, promoting effective healing, and delaying release

Active Publication Date: 2015-11-25
安徽鑫华坤生物工程有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Ischemia and nerve injury reduce local tissue healing ability and anti-infection ability, so the wound is not easy to heal
In terms of pathophysiology, it mainly manifests as abnormal metabolism of wound tissue cells and immune dysfunction, especially the dysfunction of local macrophages and mast cells in the wound, accompanied by impaired growth factor function in the wound microenvironment, and local microcirculation perfusion disturbance in the wound. Tissue hypoxia, etc., resulting in long-lasting wounds and ulcers that are difficult to heal, often leading to gangrene or amputation, which greatly reduces the quality of life of patients, and the treatment is quite difficult, the cycle is long, and the medical expenses are high. great pain and heavy burden

Method used

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  • Preparation of fibroblast growth factor-1 modified gel and its application in the treatment of diabetic foot
  • Preparation of fibroblast growth factor-1 modified gel and its application in the treatment of diabetic foot
  • Preparation of fibroblast growth factor-1 modified gel and its application in the treatment of diabetic foot

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0024] Example 1 production loading FGF-1 135 gel

[0025] Substrate swelling and sterilization: Add glycerin to Carbomer 940, stir and mix well, fully swell with appropriate amount of water for injection, adjust the pH value to form a transparent gel, and autoclave at 121°C for 30 minutes. Ready to use after cooling;

[0026] Protein sterilization and filtration: add recombinant human fibroblast growth factor-1 modified protein, human serum albumin and heparin into cooled water for injection, mix well, and filter with a 0.22 μm filter membrane to sterilize under sterile conditions ;

[0027] Gel preparation: under aseptic conditions, fully mix the above two substances, and divide into packages.

[0028] As a matrix material, carbomer has good ductility, is easy to apply and adhere to the skin, is non-irritating to the skin and mucous membranes, and can absorb tissue infiltration fluid, which is conducive to the discharge of secretions; it is non-greasy, releases drugs quic...

Embodiment 2

[0029] Embodiment 2 measures gel activity

[0030]The activity of the gel was determined by tetramethylazolium salt colorimetric method (MTT method). Balb / c3T3 cells were cultured in complete medium at 37°C and 5% CO2 until logarithmic growth phase. Discard the culture medium in the culture flask, digest and collect the cells, add complete medium to adjust the concentration of the cell suspension, so that the density of the cells to be tested is 50,000-100,000 / ml, inoculate 100 μl per well in a 96-well cell culture plate, Cultivate at 37°C and 5% CO2 for 24 hours, then change the maintenance medium and continue to cultivate for 24 hours. Discard the maintenance solution, add the standard substance and the gel sample solution dissolved in the medium and diluted at a certain concentration, 100 μl per well, and incubate in a 37°C, 5% CO2 incubator for 64h to 72h. Add 20 μl of MTT solution to each well and continue to incubate for 5 h. Pour off the liquid, add 100 μl dimethyl s...

Embodiment 3

[0031] Embodiment 3 measures the stability of gel

[0032] According to the test results of the stability of the gel at different temperatures, the gel has no mildew and its appearance, pH value and other physical and chemical indicators have not changed after being stored at 4°C, 25°C, and 37°C for 12 months. ; The biological activity of the drug-loaded gel has poor stability at room temperature, and the activity is significantly reduced after being placed for 3 months, while low temperature conditions have no obvious impact on the storage of the drug-loaded gel.

[0033] Table 1FGF-1 gel at 25 ℃ stability test result

[0034]

[0035] Table 2FGF-1 gel stability test results at 4°C

[0036]

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Abstract

The invention provides a preparation method of a gel containing a fibroblast growth factor-1 modified body and an application thereof for treating chronic skin ulcer caused by diabetic foot. The gel disclosed by the invention comprises the following components: 20000-80000 IU of recombinant human fibroblast growth factor-1 modified body (FGF-1135) protein, 10 pg to 40 mu g of low molecular weight heparin sodium, 0.2-1.0 g of glycerol, 50-150 mg of a protein protectant, and 0.03-0.05g of a gel substrate, wherein the pH value is adjusted; and water for injection is added to be 10 ml. Compared with the original sequence, the fibroblast growth factor-1 modified body used in the invention is more steady; after being prepared into the gel, the fibroblast growth factor-1 modified body is more convenient for clinical application; the better stability and slow-release effects can be achieved; the bioavailability of protein is increased; the gel is more beneficial to treating diabetic foot; and the gel can be also used for treating burning, scalding and other chronic and refractory ulcers.

Description

technical field [0001] The invention relates to a recombinant human fibroblast growth factor-1 transformant (FGF-1 135 ) The preparation and application of a gel for treating diseases such as diabetic foot and other diseases belong to the field of biomedicine. Background technique [0002] Diabetes mellitus (DM) is a systemic metabolic disease caused by multiple factors. At present, more than 180 million people in the world suffer from diabetes, which has become a major global public health problem. About 30% to 80% of diabetic patients have skin lesions, which seriously endanger the health of diabetic patients, and the most typical and harmful one is diabetic foot. Diabetic foot (Diabetic Foot, DF) is one of the common chronic complications of DM, which is mainly the result of comprehensive factors based on the disorder of glucose metabolism. Hyperglycemia, hyperlipidemia and their metabolites caused by metabolic abnormalities in diabetes can, on the one hand, cause the d...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/06A61K38/18A61K47/32A61P9/14A61P17/02A61P3/10
Inventor 田海山李校堃王晓杰金利泰姜潮唐禄
Owner 安徽鑫华坤生物工程有限公司
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