CN113181420B - Liquid wound dressing for quickly repairing skin superficial injury and preparation method thereof - Google Patents
Liquid wound dressing for quickly repairing skin superficial injury and preparation method thereof Download PDFInfo
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L26/00—Chemical aspects of, or use of materials for, wound dressings or bandages in liquid, gel or powder form
- A61L26/0061—Use of materials characterised by their function or physical properties
- A61L26/0066—Medicaments; Biocides
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L26/00—Chemical aspects of, or use of materials for, wound dressings or bandages in liquid, gel or powder form
- A61L26/0004—Chemical aspects of, or use of materials for, wound dressings or bandages in liquid, gel or powder form containing inorganic materials
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L26/00—Chemical aspects of, or use of materials for, wound dressings or bandages in liquid, gel or powder form
- A61L26/0009—Chemical aspects of, or use of materials for, wound dressings or bandages in liquid, gel or powder form containing macromolecular materials
- A61L26/0014—Chemical aspects of, or use of materials for, wound dressings or bandages in liquid, gel or powder form containing macromolecular materials obtained by reactions only involving carbon-to-carbon unsaturated bonds
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L26/00—Chemical aspects of, or use of materials for, wound dressings or bandages in liquid, gel or powder form
- A61L26/0061—Use of materials characterised by their function or physical properties
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
- A61L2300/40—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
- A61L2300/404—Biocides, antimicrobial agents, antiseptic agents
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
- A61L2300/40—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
- A61L2300/412—Tissue-regenerating or healing or proliferative agents
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
- A61L2300/40—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
- A61L2300/412—Tissue-regenerating or healing or proliferative agents
- A61L2300/414—Growth factors
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- Animal Behavior & Ethology (AREA)
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- Life Sciences & Earth Sciences (AREA)
- Engineering & Computer Science (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Inorganic Chemistry (AREA)
- Materials For Medical Uses (AREA)
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Abstract
The invention relates to a liquid wound dressing for quickly repairing skin superficial injury and a preparation method thereof, wherein the liquid wound dressing comprises the following components: the cell factor PDGF-BB, polyvinyl butyral, a betaine surfactant, polyacrylic acid and deionized water. The liquid wound dressing provided by the invention can form a waterproof, breathable and bacterium-resistant protective film on the surface of a wound, plays a role of physical barrier, prevents bacteria and foreign matters from invading the wound, and creates a wound healing environment; can protect the new tissue after being smeared and accelerate the healing of the wound.
Description
Technical Field
The invention belongs to the field of biomedical materials, and particularly relates to a liquid wound dressing for quickly repairing skin superficial injury and a preparation method thereof.
Background
Since wounds caused by situations such as cuts, abrasions, bruises, falls, contusions and the like are inevitably encountered in daily life, it is not uncommon to perform necessary treatments of wounds, such as debridement and hemostasis and application of medical dressings to wounds.
In recent years, with the remarkable increase of self-care consciousness of families, common people are generally equipped with various conventional care products such as a wound dressing, an iodophor, an alcohol sprayer, a medical cotton ball or cotton swab, a forceps, a thermometer, a sphygmomanometer, a blood glucose meter, various test papers, and the like. The wound dressing is suitable for self-treatment of mild small wounds or household autonomous treatment, and the trouble of going to and from hospitals is eliminated, so that the wound dressing is more and more concerned and favored by people as a common nursing article. It is due to the foregoing that various medical dressings come in transit.
The conventional wound covering has the functions of covering a wound and stopping bleeding, but has the problems of poor air permeability, poor comfort and poor compliance, and can cause pain in the removing process. Because the liquid adhesive bandage has the advantages of good air permeability, film feeling, transparency, water resistance and the like, the liquid adhesive bandage has a good application prospect compared with the traditional adhesive bandage such as a bundy (benzalkonium chloride) adhesive bandage.
The film forming time of the liquid dressing in the prior art is usually within five minutes, wherein the film forming speed of the cellulose nitrate liquid dressing is the fastest, and the wound can be covered within thirty seconds, so that the wound can be covered within a very short time.
Chinese patent application CN111790003A discloses a wound dressing for promoting rapid repair of skin injury and a preparation method thereof. The novel wound dressing contains 10-20% of polyglutamic acid, 10-20% of Arabic gum, 10-20% of glycerol, 20-40% of deionized water, 0.5-1% of ferulic acid, 1-2% of keratin (from wool), 4-6% of tridecapeptide and 10-20% of aerosol. The prepared liquid wound dressing has good antibacterial, anti-inflammatory and skin repairing performances, can quickly form a film on damaged skin, prevents bacteria and foreign matters from invading, can keep moisture for the wound while ensuring the air permeability of the wound, creates a good environment for the skin regeneration of the wound, has good biocompatibility and biodegradability, and can avoid secondary wound caused to the wound during dressing change.
Chinese patent application CN111467562A discloses a liquid wound dressing for rapidly repairing skin superficial injury and a preparation method thereof, wherein each kilogram of the liquid wound dressing contains the following raw materials by mass: 40-60 g of trehalose, 25-35 g of pentanediol, 12-28 g of glycerol, 0.1-4 g of sodium alginate and 0.3-1.7 g of ethyl p-hydroxybenzoate. The prepared liquid wound dressing has the advantages of fast film forming time on the damaged skin, good inhibition of the growth of bacteria on the wound surface, good repair environment for the skin, good repair effect on superficial damage of the skin, high repair efficiency and short application time.
Although the prior art has different liquid wound dressings, there is still a need in the art to develop a liquid wound dressing for rapidly repairing superficial skin injuries, which simultaneously satisfies the requirements of strong air permeability, strong film forming capability and better repairing effect on superficial skin injuries.
Disclosure of Invention
Based on the background technology, the technical problem to be solved by the invention is to provide the liquid wound dressing for rapidly repairing the skin superficial injury, which simultaneously has the advantages of strong air permeability, strong film forming capability and better repairing effect on the skin superficial injury. In order to realize the purpose of the invention, the following technical scheme is adopted:
one aspect of the invention relates to a liquid wound dressing for rapid repair of superficial skin lesions, characterized in that it comprises: the cell factor PDGF-BB, polyvinyl butyral, a betaine surfactant, polyacrylic acid and deionized water.
PDGF is a known multipotent cell growth factor in the prior art and is classified into three AA/AB/BB classes. The cell factor PDGF-BB (recombinant human platelet derived growth factor promotes fibroblast growth factor) has physiological activity and has a promoting effect on skin and soft tissue injuries, wherein the BB type can promote the growth of fibroblasts. The cytokine PDGF-BB used in the present examples was purchased from Shanghai Huichi Biotech, Inc.
In the present invention, polyvinyl butyral has a strong film forming ability, but has a defect of being difficult to dissolve in water, and in the present invention, by using a betaine type surfactant in combination, on the one hand, the solubility of polyvinyl butyral can be improved, and by using polyacrylic acid in combination, the film forming ability can be further improved. On the other hand, the antibacterial effect of the betaine type surfactant can be fully utilized, and the betaine type surfactant is matched with the cell factor PDGF-BB to play a role in synergistic bacteriostasis.
In a preferred embodiment of the present invention, the ratio of the amounts of the cytokine PDGF-BB, the polyvinyl butyral, the betaine type surfactant, and the polyacrylic acid is 0.001 to 0.002: 1-2: 2-4.
In a preferred embodiment of the present invention, the betaine-type surfactant is selected from N-dodecyl-N, N-dimethyl-N-carboxymethylbetaine and/or N- (alkylthiopropylidene) dimethylbetaine.
In a preferred embodiment of the invention, the liquid wound dressing further comprises a pH adjuster, which helps to reduce irritation by adjusting the pH of the liquid wound dressing to around 7, for example to a pH of 6.8 to 7.4.
In a preferred embodiment of the invention, the liquid wound dressing does not contain organic solvents. The present invention has a strong film-forming ability even if it does not contain an organic solvent, and contributes to the reduction of irritation.
In a preferred embodiment of the invention, the liquid wound dressing further comprises an aerosol-forming propellant. Preferably, the propellant is compressed nitrogen and/or carbon dioxide.
In another aspect of the present invention, it also relates to a method for preparing the above liquid wound dressing, which comprises the steps of:
1. preparation of solution a: adding deionized water accounting for 60-80% of the total amount of the preparation into a preparation tank, adding N- (alkyl sulfo propylidene) dimethyl betaine, dissolving, adding polyvinyl butyral, and stirring for 10-20 min to obtain a solution A;
2. preparation of solution B: dissolving polyacrylic acid in the rest deionized water, and stirring for 15-20 min to obtain a solution B;
3. preparation of solution C: mixing the solution A and the solution B, homogenizing at a high speed for 5-7 min until no granular solid component exists in the whole system, adding a cell factor PDGF-BB, cooling to room temperature, and adjusting the pH value to obtain a solution C;
4. and (3) preparing a finished product: and (3) instantly (within 1 second) sterilizing the solution C at high temperature, and finally filling the solution C under pressure and adding compressed nitrogen to obtain a finished product.
Advantageous effects
The liquid wound dressing provided by the invention can form a waterproof, breathable and bacterium-resistant protective film on the surface of a wound, plays a role of physical barrier, prevents bacteria and foreign matters from invading the wound, and creates a wound healing environment; can protect the new tissue after being smeared and accelerate the healing of the wound. In addition, the product provided by the invention does not contain organic solvent, does not generate obvious stimulation to wounds, and does not generate allergy and drug resistance.
Detailed Description
In order to further understand the present invention, the technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the embodiments of the present invention, and it is obvious that the described embodiments are only a part of the embodiments of the present invention, and not all embodiments. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention.
Unless otherwise specified, the reagents involved in the examples of the present invention are all commercially available products, and all of them are commercially available.
Example 1:
(1)
a preparation method of a liquid wound dressing for promoting rapid repair of skin injury comprises the following steps:
cytokine 1mg
Polyvinyl butyral 1g
N- (Alkylthiopropylidene) dimethylbetaine 1g
Polyacrylic acid 3g
proper amount of pH regulator
50g of deionized water
The preparation method comprises the following steps:
1. preparation of solution a: adding deionized water accounting for 70% of the total amount of the solution into a preparation tank, adding N- (alkyl sulfo-propylidene) dimethyl betaine, dissolving, adding polyvinyl butyral, and stirring for 10-20 min to obtain a solution A;
2. preparation of solution B: dissolving polyacrylic acid in the rest deionized water, and stirring for 15-20 min to obtain a solution B;
3. preparation of solution C: mixing the solution A and the solution B, homogenizing at a high speed for 5-7 min until no granular solid component exists in the whole system, adding a cell factor PDGF-BB, cooling to room temperature, and adjusting the pH to 7.0 to obtain a solution C;
4. and (3) preparing a finished product: and (3) instantly (within 1 second) sterilizing the solution C at a high temperature of 135 ℃ to obtain the liquid wound dressing for promoting the rapid repair of the skin injury, and finally adding compressed nitrogen through pressure filling to obtain a finished product.
Example 2:
the same as in example 1, except that N-dodecyl-N, N-dimethyl-N-carboxymethylbetaine was used instead of N- (alkylthiopropylidene) dimethylbetaine.
Comparative example 1:
the same as in example 1, except that the polyacrylic acid was replaced with sodium alginate.
Comparative example 2:
the same as in example 1, except that the N- (alkylthio propylidene) dimethyl betaine was replaced with tween 80.
Example 3: safety test
The liquid wound dressings of examples 1-2 and comparative examples 1-2 were subjected to an animal skin irritation test, a skin sensitization test, and an in vitro cytotoxicity test, respectively, and the results showed that examples 1-2 and comparative example 1 were safe and non-toxic, and comparative example 2 caused redness and swelling of the animal skin.
Example 4: air permeability test
1. Device for measuring the position of a moving object
A box made of corrosion resistant material having outer dimensions of about 95mm x 25mm x 20mm, a net mass of not more than 60g, closed except for a 80mm x 10mm rectangular opening at the top, and completely impermeable to water or water vapor except for the opening (covered with test material).
2. Step (ii) of
A dish containing about 1kg of anhydrous calcium chloride was placed in an electric drying oven with a circulating air facility and the temperature was maintained at 36-38 ℃. Five small boxes meeting the requirements are taken, about 2g of absorbent cotton is placed in each box, and about 20ml of water is poured in each box. The liquid wound dressing is applied directly to the surface of a single layer of gauze to ensure that after film formation, the gauze covers the top of the opening (only the film is in contact with the box), and the material is pressed without stretching the material so that the opening is completely sealed. Absorbent cotton for ensuring moisture does not contact the lower surface of the test material. The width of the material must be at least 5mm greater than the opening dimension.
The sealed boxes were weighed to the nearest milligram and placed in an oven for about 18 hours (recording time to the nearest 15 min). The box was removed from the oven, allowed to cool at standard atmospheric pressure for 1h, and weighed again to the nearest milligram.
3. Results
Water vapor permeation per 24h was calculated using the open area and mass loss at the top of each box and is expressed in grams per square meter (g.m-2). The water vapor permeation per 24h should be more than or equal to 500 g.m-2And the surface has good air permeability. Wherein the water vapor permeation per 24h of example 1 should be ≥ 600 g.m-2In example 2, the water vapor permeation per 24 hours should be not less than 680 g.m-2In comparative example 1, the water vapor permeation per 24 hours should be less than or equal to 360 g.m-2In comparative example 2, the water vapor permeation per 24 hours should be not more than 420 g.m-2。
Example 5: experiment of water resistance
The liquid wound dressing is directly smeared on the surface of a single-layer gauze, and after the liquid wound dressing is formed into a film, the detection is carried out according to the method of the Chinese people's republic of China medical and drug industry standard YY/T0471.3-2004.
As a result: the liquid wound dressings of example 1 and example 2 have the ability to withstand a hydrostatic pressure of 500mm for 300s on a single gauze surface, indicating good water resistance. Comparative example 1 can withstand hydrostatic pressure of 500mm only for 120s, and comparative example 2 can withstand hydrostatic pressure of 500mm only for 165 s.
Example 6 efficacy test
Collecting volunteers with skin superficial injury in the age of 20-36 years, wherein the wound area is 2-5 cm2And the depth is within 0.5 cm. There was no active bleeding or only minor bleeding after treatment.
Grouping: a total of 50 persons were collected, randomly grouped, 10 persons per group.
The treatment method comprises the following steps: when the wound dressing is used, the wound is cleaned, the liquid wound dressing is sprayed on the wound after being dried, the wound dressing is continuously used for 3 days, the repairing condition is observed after 2, 4 and 6 days respectively, and the wound surface reduction rate is calculated.
Wound surface shrinkage rate: (area of wound surface before repair-area of wound surface after repair)/area of wound surface before repair × 100%.
Criteria for good repair: after repair, the wound surface is closed, no scar is seen, and the skin surface is smooth.
Results the following table 1:
the results show that compared with the comparative examples 1-2, the liquid wound dressing provided by the invention can form a waterproof, breathable and bacterium-resistant protective film on the surface of a wound, plays a role of physical barrier, prevents bacteria and foreign matters from invading the wound and creates a wound healing environment; can protect the new tissue after being smeared and accelerate the healing of the wound. In addition, the product provided by the invention does not contain organic solvent, does not generate obvious stimulation to wounds, and does not generate allergy and drug resistance.
The foregoing describes preferred embodiments of the present invention, but is not intended to limit the invention thereto. Modifications and variations of the embodiments disclosed herein may be made by those skilled in the art without departing from the scope and spirit of the invention.
Claims (6)
1. A liquid wound dressing for the rapid repair of superficial skin lesions, comprising: the cell factor PDGF-BB, polyvinyl butyral, a betaine surfactant, polyacrylic acid and deionized water; the weight ratio of the cell factor PDGF-BB, the polyvinyl butyral, the betaine type surfactant and the polyacrylic acid is 0.001-0.002: 1-2: 2-4, the liquid wound dressing does not contain an organic solvent, and the betaine type surfactant is selected from N-dodecyl-N, N-dimethyl-N-carboxymethyl betaine and/or N- (alkyl sulfo propylidene) dimethyl betaine.
2. The liquid wound dressing of claim 1, further comprising a pH adjuster.
3. The liquid wound dressing according to claim 1, having a pH of 6.8 to 7.4.
4. The liquid wound dressing of claim 1, further comprising an aerosol-forming propellant.
5. The liquid wound dressing according to claim 4, the propellant being compressed nitrogen and/or carbon dioxide.
6. A method of making a liquid wound dressing according to any of claims 1 to 5, comprising the steps of:
(1) preparation of solution a: adding deionized water accounting for 60-80% of the total amount of the preparation into a preparation tank, adding N- (alkyl sulfo propylidene) dimethyl betaine, dissolving, adding polyvinyl butyral, and stirring for 10-20 min to obtain a solution A;
(2) preparation of solution B: dissolving polyacrylic acid in the rest deionized water, and stirring for 15-20 min to obtain a solution B;
(3) preparation of solution C: mixing the solution A and the solution B, homogenizing at a high speed for 5-7 min until no granular solid component exists in the whole system, adding a cell factor PDGF-BB, cooling to room temperature, and adjusting the pH value to obtain a solution C;
(4) and (3) preparing a finished product: and (3) instantly sterilizing the solution C at high temperature, and finally filling the solution C under pressure and adding compressed nitrogen to obtain a finished product.
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| Application Number | Priority Date | Filing Date | Title |
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| CN202110493035.3A CN113181420B (en) | 2021-05-07 | 2021-05-07 | Liquid wound dressing for quickly repairing skin superficial injury and preparation method thereof |
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| Application Number | Priority Date | Filing Date | Title |
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| CN202110493035.3A CN113181420B (en) | 2021-05-07 | 2021-05-07 | Liquid wound dressing for quickly repairing skin superficial injury and preparation method thereof |
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| CN113181420A CN113181420A (en) | 2021-07-30 |
| CN113181420B true CN113181420B (en) | 2022-03-11 |
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Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102772801A (en) * | 2012-08-10 | 2012-11-14 | 江苏长泰药业有限公司 | Wound spray for treating bruises and preparation method of wound spray |
| CN106176688A (en) * | 2016-08-16 | 2016-12-07 | 深圳市华生元基因工程发展有限公司 | A kind of wound repair liquid and preparation method thereof |
| CN108135745A (en) * | 2016-06-29 | 2018-06-08 | 艾威医药科技（芜湖）有限公司 | Composition is formed for effective novel fast deposition film for the treatment of of wounds |
| CN110251720A (en) * | 2019-07-22 | 2019-09-20 | 陕西佰傲再生医学有限公司 | Liquid dressing and preparation method thereof |
-
2021
- 2021-05-07 CN CN202110493035.3A patent/CN113181420B/en active Active
Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102772801A (en) * | 2012-08-10 | 2012-11-14 | 江苏长泰药业有限公司 | Wound spray for treating bruises and preparation method of wound spray |
| CN108135745A (en) * | 2016-06-29 | 2018-06-08 | 艾威医药科技（芜湖）有限公司 | Composition is formed for effective novel fast deposition film for the treatment of of wounds |
| CN106176688A (en) * | 2016-08-16 | 2016-12-07 | 深圳市华生元基因工程发展有限公司 | A kind of wound repair liquid and preparation method thereof |
| CN110251720A (en) * | 2019-07-22 | 2019-09-20 | 陕西佰傲再生医学有限公司 | Liquid dressing and preparation method thereof |
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