CN106563156A - Gel wound dressing having film-forming property - Google Patents

Abstract

The invention discloses a formula and a preparation method of a gel wound dressing, which is characterized in that it consists of raw materials in terms of mass percentage: 0.5-3% of carbomer, 1-10% of polyvinylpyrrolidone (PVP), polyethylene Alcohol (PVA) 1-10%, polyethylene glycol (PEG4000) 1-5%, ethylenediaminetetraacetic acid disodium (EDTA disodium) 0.05-0.1%, collagen 0.1-0.5%, chitosan 0.1-0.5% %, glycerin 1-8%, and the balance is deionized water. The present invention overcomes the defects of a single type of dressing, not only can effectively absorb wound exudate, keep the wound clean and moist, but also form a film with a certain mechanical strength on the skin wound to protect the wound, and at the same time have antibacterial, anti-inflammatory, and wound-promoting properties. Healing effect. The invention has uniform and delicate texture, no peculiar smell, no poison, no irritation, good biocompatibility, and is easy to apply and remove.

Description

A film-forming gel wound dressing

technical field

The invention relates to the technical field of medicine, in particular to a film-forming gel wound dressing.

Background technique

Skin is one of the most important organs of the human body, which undertakes important physical, chemical and biological barrier functions. At the same time, due to direct contact with the external environment, the skin is also the most vulnerable human organ. Skin wounds such as knife wounds, scalds, abrasions, and bumps in daily life are one of the main factors that endanger human life and health, and also bring a lot of inconvenience to people's work and life. Therefore, effective protection and treatment of skin wounds is particularly important.

Traditional dressings such as cotton pads, gauze, soft linen, etc. have a strong ability to absorb wound exudate, so as to protect the wound to a certain extent, but traditional dressings have great limitations, such as inconvenient use, unsightly, no Moisturizing, has no effect on promoting wound healing, and is also easy to cause trauma infection. With the gradual improvement of people's living standards, traditional dressings can no longer meet people's medical needs. Therefore, the research and development of new medical wound dressings is imminent. At present, the use of new dressings has become more popular in developed countries, and the development and application of wound dressings have gradually been strengthened in China. With the rapid development of the polymer industry, dressings made of polymer materials are also increasing. The wound dressings used for clinical treatment mainly include the following types: film, liquid, spray, hydrogel, etc. Among them, the film-type dressing can form an effective protective layer on the wound to resist the invasion of bacteria and prevent infection, but the main disadvantage of this dressing is that its water absorption capacity is limited, and it is easy to cause the accumulation of exudate. Hydrogel is a polymer network swollen in water or physiological fluid. It is soft in nature. As a wound dressing, it can effectively absorb wound exudate, and has a good moisturizing effect, preventing dehydration and dryness of the wound surface, and can effectively relieve the wound. The patient's discomfort and pain, but the mechanical strength of the hydrogel dressing needs to be improved. An ideal wound dressing should have the following functions: resist the invasion of exogenous substances and prevent infection; prevent excessive loss of wound water or tissue fluid; adhere well to the wound, but should not adhere too tightly to the wound to cause secondary damage; moisturize Breathable without causing accumulation of exudate; good biocompatibility; good mechanical strength; convenient and comfortable to use.

At present, breakthroughs have been made in the research of new wound dressings, but a single type of dressing has certain defects, and there is still a distance from the requirements of ideal dressings. Therefore, it is still an important task to develop medical dressings that can meet various needs. question.

Contents of the invention

In order to overcome the defects of a single type of dressing, the present invention provides a film-forming gel medical wound dressing, which can not only form a film with a certain mechanical strength to protect the wound, prevent infection, sterilize and reduce inflammation, but also absorb wound exudate. fluid to keep the wound surface moist and promote wound healing. The object of the present invention is to provide this gel wound dressing formula and its preparation method.

The technical scheme of the present invention is as follows: a kind of gel that is mainly made up of macromolecule material, the raw material composition by mass percentage: carbomer 0.5～3%, polyvinylpyrrolidone (PVP) 1～10%, polyvinyl alcohol ( PVA) 1-10%, polyethylene glycol (PEG4000) 1-5%, ethylenediaminetetraacetic acid disodium (EDTA disodium) 0.05-0.1%, collagen 0.1-0.5%, chitosan 0.1-0.5%, Glycerin 1-8%, the balance is deionized water.

The preparation method of gel wound dressing of the present invention is as follows:

(1) Weigh EDTA disodium and dissolve in deionized water to obtain EDTA disodium salt solution, which is set aside.

(2) Dissolve carbomer in (1) salt solution, stir to dissolve and swell completely, then add PVA, stir and mix well, heat in a water bath at 80-90°C to completely dissolve and disperse PVA, cool to room temperature, adjust pH to 5-6. as component one.

(3) Dissolve PVP in deionized water, heat in a water bath at 80-90°C, and dissolve completely to obtain a viscous liquid, then add PEG4000 and stir to dissolve. as component two.

(4) dissolving collagen or chitosan in dilute acid, stirring, standing still, and naturally swelling for several hours to obtain collagen or chitosan sol. As component three.

(5) Mix component 1, component 2 and component 3, stir fully and evenly, and adjust the pH of the system to 5-6. Then add the prescribed amount of glycerin to the system, stir and mix for several hours to obtain a transparent or translucent hydrogel. Filling, sterilizing, and packaging obtain the hydrogel wound dressing.

Carbomer is a class of very important rheology regulators. The neutralized carbomer is an excellent gel matrix, which has important functions such as thickening, bonding, and emulsification; polyvinyl alcohol (PVA) is an excellent synthetic Membrane material, also has good biodegradability, cohesive force, wear resistance, hygroscopicity, etc.; polyvinylpyrrolidone (PVP) is also an excellent film-forming material, and has good biocompatibility, cohesive force , hygroscopicity, etc.; polyethylene glycol PEG4000 is used for matrix filling and viscosity adjustment in the present invention; glycerin is a humectant, which plays the role of lubrication, increasing product viscosity and adhesion; collagen plays moisturizing, hemostasis, and promotes The role of wound repair; chitosan plays the role of antibacterial, hemostasis, and promote wound healing; disodium edetate is a complexing agent and antioxidant; deionized water is used as a solvent for each component.

The beneficial effects of the present invention are as follows: ①Before use, keep the state of hydrogel in the package, and evenly apply it to the skin wound, and gradually become a film with a certain mechanical strength. The film fits well with the skin, protects the wound, and prevents secondary Injury and bacterial invasion; ② breathable and moisturizing to the skin, and at the same time absorb wound exudate to avoid infection; ③ antibacterial, anti-inflammatory, and promote wound healing; ④ easy to remove after use, just tear off the formed film from the skin . The invention satisfies various requirements of medical wound dressing and is very suitable for popularization and implementation.

detailed description

Below in conjunction with embodiment the present invention is described in further detail:

Embodiment one:

(1) Weigh 0.05% disodium EDTA and dissolve it in deionized water to form a saline solution for later use. Weigh 1% carbomer, slowly disperse into the above saline solution, stir for 1 hour and then let it stand for 2 hours to fully dissolve and swell the carbomer, at this time the carbomer solution has strong fluidity. Weigh 3% PVA and add it to the carbomer solution, and magnetically stir it in a water bath at 80°C for 2 hours to dissolve the PVA to form a transparent viscous solution. After cooling to room temperature, adjust the pH to 5-6 with triethanolamine.

(2) Weigh 2% PVP and dissolve it in deionized water, stir magnetically in a water bath at 80°C for 1 hour to dissolve the PVP to form a transparent viscous liquid, then add 1% PEG4000, use residual temperature and stir to dissolve PEG4000 quickly, and cool to Set aside at room temperature.

(3) Prepare an appropriate amount of dilute acetic acid solution with a pH of 2-3, add 0.2% collagen to it, stir to disperse the collagen evenly, let stand at room temperature for 2-3 hours to fully dissolve and swell the collagen, and then adjust the pH to 5-6 with triethanolamine.

(4) Mix the solutions obtained in steps (1) and (3) first, then mix the solution obtained in step (2) with it, then add 1% glycerin, stir for 2 to 3 hours to fully mix the raw materials, and adjust the temperature of the system. The final pH was 6, and a transparent hydrogel was obtained. Filling, sterilizing, and packaging obtain the hydrogel wound dressing.

Embodiment two:

Preparation steps (1) and (2) are the same as in Example 1.

(3) An appropriate amount of dilute acetic acid solution with a pH of 2 to 3 is prepared, and 0.1% chitosan is dissolved therein to obtain an acidic viscous liquid.

(4) Add the solution obtained in step (3) to the solution obtained in step (1) several times. During the addition process, use triethanolamine to adjust the pH of the mixed system at 5 to 6. After (1) and (3) are completely mixed , then mix the solution obtained in step (2) with it, then add 1% glycerin, stir for 2-3 hours to fully mix the raw materials, adjust the final pH of the system to 6, and obtain a translucent hydrogel. Filling, sterilizing, and packaging obtain the hydrogel wound dressing.

Embodiment three:

(1) Weigh 0.05% disodium EDTA and dissolve it in deionized water to form a saline solution for later use. Weigh 1% carbomer, slowly disperse into the above saline solution, stir for 1 hour and then let it stand for 2 hours to fully dissolve and swell the carbomer, at this time the carbomer solution has strong fluidity. Weigh 5% PVA and add it to the carbomer solution, and magnetically stir in a water bath at 80°C for 2 hours to dissolve the PVA to form a transparent viscous solution. After cooling to room temperature, adjust the pH to 5-6 with triethanolamine.

(2) Dissolve 0.2% collagen or 0.1% chitosan in an appropriate amount of dilute acetic acid solution with a pH of 2 to 3, add the solution obtained in step (1) several times, and use triethanolamine to adjust the pH of the mixed system to remain at 5 ～6. After mixing completely, add 1% PEG4000 aqueous solution and 1% glycerin, stir for 2～3 hours to fully mix all raw materials, adjust the final pH of the system to 6, and obtain a hydrogel. Filling, sterilizing, and packaging obtain the hydrogel wound dressing.

Embodiment four:

(1) Weigh 0.05% disodium EDTA and dissolve it in deionized water to form a saline solution for later use. Weigh 1% carbomer, slowly disperse into the above saline solution, stir for 1 hour and then let it stand for 2 hours to fully dissolve and swell the carbomer, at this time the carbomer solution has strong fluidity. Adjust the pH of the carbomer solution to 5-6, and the viscosity of the solution increases to form a gel matrix.

(2) Weigh 5% PVP and dissolve it in deionized water, stir magnetically in a water bath at 80°C for 1 hour to dissolve the PVP to form a transparent viscous liquid, then add 1% PEG4000, use residual temperature and stir to dissolve PEG4000 quickly, and cool to Set aside at room temperature.

(3) Dissolve 0.2% collagen or 0.1% chitosan in an appropriate amount of dilute acetic acid solution with a pH of 2 to 3, then mix with the carbomer gel matrix obtained in step (1), and pay attention to the pH of the price adjustment system during the mixing process. 5-6, then add the solution obtained in step (2), mix thoroughly, then add 1% glycerin, stir for 2-3 hours to fully mix the raw materials, adjust the final pH of the system to 6, and obtain a hydrogel. Filling, sterilizing, and packaging obtain the hydrogel wound dressing.

Claims (6)

1. a kind of hydrogel Wound dressing, it is characterised in that raw material composition by mass percentage：Carbomer 0.5～3%, gathers Vinylpyrrolidone (PVP) 1～10%, polyvinyl alcohol (PVA) 1～10%, Polyethylene Glycol (PEG4000) 1～5%, ethylenediamine Tetraacethyl disodium (EDETATE SODIUM) 0.05～0.1%, collagen 0.1～0.5%, shitosan 0.1～0.5%, glycerol 1～8% is remaining Measure as deionized water.

2. the Wound dressing according to claims 1, it is characterised in that：The preferred Carbomer974 of the carbomer or card ripple The mixing of nurse U10, or both.

3. the Wound dressing according to claims 1, it is characterised in that：The medical filmogen is polyvinylpyrrolidine Ketone (PVP) or polyvinyl alcohol (PVA), or both mixing.

4. the Wound dressing according to claims 1, it is characterised in that：The addition of formula ratio collagen or shitosan, can Promote wound repair.

5. the Wound dressing according to claims 1, it is characterised in that：PEG4000 increases thin as one of filling substrate The compactness of film.

6. a kind of preparation method of hydrogel Wound dressing, it is characterised in that：Comprise the steps：

(1) weigh EDETATE SODIUM by formula ratio to be dissolved in deionized water, obtain EDETATE SODIUM saline solution.By the carbomer of formula ratio In being dissolved in the saline solution, stirring makes to be completely dissolved swelling, adds formula ratio PVA, stirring and evenly mixing, in 80～90 DEG C of water-baths plus Heat makes PVA be completely dissolved dispersion, is cooled to room temperature, adjusts pH to 5～6.

(2) formula ratio PVP is dissolved in deionized water, 80～90 DEG C of heating in water bath are completely dissolved and obtain thick liquid, then is added Enter PEG4000, stirring and dissolving.

(3) collagen or shitosan are dissolved in diluted acid, are stood after stirring, naturally swelling a few hours, obtain collagen or shitosan Colloidal sol.

(4) each component obtained in (1), (2), (3) step being mixed, is stirred, the pH of regulation system is maintained at 5～ 6.Then the glycerol of formula ratio is added in the system, stirring mixing a few hours, product final pH is adjusted 5～6, obtains transparent Or translucent hydrogel.Fill, sterilizing, packaging obtain final product hydrogel Wound dressing.