WO2022133628A1

WO2022133628A1 - Degradable liquid band-aid and preparation method therefor

Info

Publication number: WO2022133628A1
Application number: PCT/CN2020/137861
Authority: WO
Inventors: 吴克
Original assignee: 江苏奇力康皮肤药业有限公司
Priority date: 2020-12-21
Filing date: 2020-12-21
Publication date: 2022-06-30

Abstract

A degradable liquid Band-Aid, comprising the following components in parts by weight: 30-40 parts of keratin, 15-30 parts of methyl cellulose, 10-25 parts of carboxymethyl chitosan, 2-6 parts of polyvinylpyrrolidone-vinyl acetate copolymer, 0.5-1.5 parts of glycerin, 25-30 parts of ethanol, 30-40 parts of ethyl acetate, 15-25 parts of diacetone alcohol, and 20-30 parts of distilled water. Degradable keratin, methylcellulose, carboxymethyl chitosan and polyvinylpyrrolidone-vinyl acetate copolymer are used together as film-forming agents, so that a film-forming body is very elastic, has good tensile strength and is degradable.

Description

A kind of degradable liquid band-aid and preparation method thereof

technical field

The invention belongs to the technical field of medical devices, in particular to a degradable liquid band-aid and a preparation method thereof.

Background technique

Traditional Band-Aids cannot fully cover wounds with long and irregular shapes, and are also inconvenient to use at joints, easily deformed, and need to be replaced repeatedly. Due to the above inconveniences of traditional Band-Aids, convenient and practical liquids have appeared in recent years. Formulation Band-Aid, Liquid Band-Aid can dry quickly and form a breathable, waterproof and elastic protective film, which can fit wounds of various sizes and shapes. The biofilm-forming materials of common liquid Band-Aid products on the market can be mainly divided into chemical and biological film-forming materials. Chemical film-forming materials include cyanoacrylates, nitrocellulose, polyvinyl alcohol, polyvinyl acetal, polyurethane, etc. , but most materials are non-degradable and easy to pollute the environment. Chitosan is commonly used as biofilm-forming material, but pure chitosan film has poor tensile strength and elasticity, resulting in brittleness and poor adhesion. wound, causing inconvenience to the patient.

In view of the deficiencies in the prior art, it is necessary to provide a degradable liquid Band-Aid and a preparation method thereof.

SUMMARY OF THE INVENTION

In view of the deficiencies in the prior art, the main purpose of the present invention is to provide a degradable liquid Band-Aid, using degradable keratin, methylcellulose, carboxymethyl chitosan and polyvinylpyrrolidone-acetic acid The combination of vinyl ester copolymer as a film-forming agent makes the film-forming body rich in elasticity, good in tensile strength and degradable.

In order to realize the above-mentioned purpose of the present invention, the present invention provides the following technical solutions:

A degradable liquid Band-Aid, comprising the following components by weight: 30-40 parts of keratin, 15-30 parts of methyl cellulose, 10-25 parts of carboxymethyl chitosan, polyvinylpyrrolidone-vinyl acetate copolymerization 2-6 parts of glycerol, 0.5-1.5 parts of glycerol, 25-30 parts of ethanol, 30-40 parts of ethyl acetate, 15-25 parts of diacetone alcohol, 20-30 parts of distilled water;

Among them, degradable keratin, methyl cellulose, carboxymethyl chitosan, polyvinyl pyrrolidone-vinyl acetate copolymer are combined as film-forming materials, keratin and methyl cellulose improve the flexibility of the film, carboxymethyl cellulose Chitosan-based film improves the air permeability of the film through the antibacterial and moisturizing properties of the film, and polyvinylpyrrolidone-vinyl acetate copolymer.

The present invention also provides a preparation method of a degradable liquid Band-Aid, comprising the following steps:

1) take the ethanol, ethyl acetate, diacetone alcohol of formula quantity and place in the first container and mix;

2) in above-mentioned mixture, add the glycerol of formula amount and stir and dissolve;

3) then adding keratin in the first container under stirring, until completely dissolved, to obtain the first solution;

4) Add 30%-40% of the distilled water of the formula amount into the second container, then add the methyl cellulose of the formula amount into the second container under stirring, and heat up to about 90 ° C after being dispersed evenly, and stir to accelerate the methyl cellulose. The base cellulose is dissolved and allowed to cool to obtain a second solution;

5) add the distilled water of surplus in the 3rd container;

6) take by weighing the carboxymethyl chitosan and polyvinylpyrrolidone-vinyl acetate copolymer of the formula amount and stir to dissolve in the third container to obtain the third solution;

7) After mixing the first solution, the second solution and the third solution, stir evenly to obtain a degradable liquid Band-Aid.

One of the technical solutions in the above-mentioned technical solutions has the following advantages or beneficial effects:

Degradable keratin, methylcellulose, carboxymethyl chitosan and polyvinylpyrrolidone-vinyl acetate copolymer are used as film-forming agents, so that the formed film is elastic, good in tensile strength and degradable ;

As a film-forming agent, keratin has good biodegradability and biocompatibility, as well as excellent water resistance and toughness, without any irritation to the skin;

Methylcellulose has excellent wetting, dispersing, adhesive, thickening, emulsifying, water-retaining and film-forming properties, as well as impermeability to oils, and is non-toxic, non-sensitizing, and non-irritating The film formed has excellent toughness, flexibility and transparency, and the coordination effect with keratin improves the softness and elasticity of the film, so that the film has good tensile strength;

The use of chitosan as a biofilm-forming material has the functions of bacteriostasis, hemostasis, healing, analgesia and moisturizing, and can promote the division of epithelial cells, fibroblasts and other cells and the growth of extracellular matrix, and significantly accelerate the wound surface healing and reduce scarring;

Using polyvinylpyrrolidone-vinyl acetate copolymer as one of the film-forming materials, it has excellent properties such as non-toxic and tasteless, no irritation to the skin, no pollution, close contact with the skin, and easy natural degradation. Pyrrolidone-vinyl acetate copolymer is a highly cross-linked polymer material with a three-dimensional network structure, which can be used as a porogen to improve the air permeability of the membrane;

Glycerol is used as a plasticizer to make the film have good softness, which can moisturise the skin, moisturise the wound and accelerate wound healing;

Ethanol, ethyl acetate, and diacetone alcohol are all good volatile solvents, which are helpful for rapid film formation. The combination of ethanol, ethyl acetate, and diacetone alcohol is used as a solvent, which reduces the amount of ethanol and reduces the need for application to wounds. Painful irritation.

Detailed ways

It should be understood that terms such as "having", "comprising" and "including" as used herein do not assign the presence or addition of one or more combinations.

Example 1

A degradable liquid Band-Aid, comprising the following components by weight: 30 parts of keratin, 15 parts of methyl cellulose, 10 parts of carboxymethyl chitosan, 2 parts of polyvinylpyrrolidone-vinyl acetate copolymer, and 0.5 parts of glycerin parts, 25 parts of ethanol, 30 parts of ethyl acetate, 15 parts of diacetone alcohol, and 20 parts of distilled water.

The preparation method of the degradable liquid Band-Aid comprises the following steps:

5) add the distilled water of surplus in the 3rd container;

As a film-forming agent, keratin has good biodegradability and biocompatibility, as well as excellent water resistance and toughness. The protein liquid Band-Aid has no toxic side effects and no irritation to the skin. The protein liquid band-aid is easy to apply, can form a film within 1-2 minutes after being applied to the wound, and can be used for the protection of various wounds. Moreover, the protein liquid Band-Aid is soft and elastic in texture, has good fit with the skin, can perform any bending movement with the skin, and is not easy to fall off. In addition, the protein liquid band-aid has good water permeability and air permeability, and can also play the roles of hemostasis, pain relief and sterilization, and at the same time, it can effectively promote the healing of wounds.

Methylcellulose, abbreviated as MC, is a white or off-white fibrous or granular powder, odorless and tasteless. MC is almost insoluble in absolute ethanol, ether and acetone. It disperses and swells rapidly in hot water at 80-90°C, and dissolves rapidly after cooling down. The aqueous solution is quite stable at room temperature and has excellent wettability, dispersibility, adhesion, thickening, emulsification, water retention and Film formation, and impermeability to grease. The formed film has excellent toughness, flexibility and transparency. Methylcellulose is widely used in various preparations, cosmetics and foods, and is generally considered to be non-toxic, non-sensitizing, and non-irritating.

Chitosan has good film-forming properties and is a commonly used biofilm-forming material. It also has the functions of antibacterial, hemostasis, healing, analgesia, and moisturizing, and can promote the division of epithelial cells, fibroblasts and other cells. and extracellular matrix growth, significantly accelerate wound healing, and reduce scarring. Carboxymethyl chitosan is a water-soluble chitosan derivative with many properties, such as strong antibacterial properties, preservation of freshness, an amphoteric polyelectrolyte, etc. It has many applications in cosmetics, medicine, etc. One of the most studied chitosan derivatives in recent years, its stable properties, antibacterial and anti-infection, are of great significance in medicine and health care products.

Polyvinylpyrrolidone-vinyl acetate copolymer is a very ideal film-forming material with alcohol solubility. It has good non-toxic and tasteless, no irritation to the skin, no pollution, close contact with the skin, easy to degrade naturally and other excellent properties. nature. Polyvinylpyrrolidone-vinyl acetate copolymer is completely soluble in water, also soluble in ethanol, isopropanol, propylene glycol, glycerol, low molecular weight polyethylene glycol and other solvents as well as ester and ketone solvents, slightly soluble in ether and Hydrocarbon solvents. Polyvinylpyrrolidone-vinyl acetate copolymer is a highly cross-linked polymer material with a three-dimensional network structure, which can be used as a porogen.

Glycerol is glycerol, which is colorless, odorless, sweet in taste, and has a clear and viscous liquid appearance. It is an organic substance that can absorb moisture from the air, as well as hydrogen sulfide, hydrogen cyanide and sulfur dioxide. It is miscible with water and ethanol, 1 part can be dissolved in 11 parts of ethyl acetate, about 500 parts of ether, insoluble in benzene, carbon disulfide, chloroform, carbon tetrachloride, petroleum ether, chloroform, oil. Glycerol is a commonly used plasticizer, which gives the film good softness, moisturizing the skin, moisturizing the wound, and accelerating wound healing.

Ethanol, ethyl acetate, and diacetone alcohol are all good volatile solvents that facilitate rapid film formation.

Example 2

A degradable liquid Band-Aid, comprising the following components by weight: 35 parts of keratin, 25 parts of methylcellulose, 20 parts of carboxymethyl chitosan, 4 parts of polyvinylpyrrolidone-vinyl acetate copolymer, 1 part of glycerin parts, 28 parts of ethanol, 35 parts of ethyl acetate, 20 parts of diacetone alcohol, and 25 parts of distilled water.

The preparation method of the degradable liquid Band-Aid is as in Example 1.

Example 3

A degradable liquid Band-Aid, comprising the following components by weight: 40 parts of keratin, 30 parts of methyl cellulose, 25 parts of carboxymethyl chitosan, 6 parts of polyvinylpyrrolidone-vinyl acetate copolymer, and 1.5 parts of glycerin parts, 30 parts of ethanol, 40 parts of ethyl acetate, 25 parts of diacetone alcohol, and 30 parts of distilled water.

The preparation method of the degradable liquid Band-Aid is as in Example 1.

Comparative Example 1

This comparative example is different from Example 3 in that it does not contain keratin and methyl cellulose. The plan is as follows:

A degradable liquid Band-Aid, comprising the following components by weight: 25 parts of carboxymethyl chitosan, 6 parts of polyvinylpyrrolidone-vinyl acetate copolymer, 1.5 parts of glycerin, 30 parts of ethanol, and 40 parts of ethyl acetate, 25 parts of diacetone alcohol and 30 parts of distilled water.

2) in the above-mentioned mixture, add the glycerol of formula amount and stir and dissolve, obtain the first solution;

3) add the distilled water of formula quantity in the second container;

4) take by weighing the carboxymethyl chitosan and polyvinylpyrrolidone-vinyl acetate copolymer of the formula amount and stir to dissolve in the second container to obtain the second solution;

5) After mixing the first solution and the second solution, stir evenly to obtain a degradable liquid Band-Aid.

Comparative Example 2

The difference between this comparative example and Example 3 is that it does not contain carboxymethyl chitosan. The plan is as follows:

A degradable liquid Band-Aid, comprising the following components by weight: 40 parts of keratin, 30 parts of methylcellulose, 6 parts of polyvinylpyrrolidone-vinyl acetate copolymer, 1.5 parts of glycerin, 30 parts of ethanol, ethyl acetate 40 parts, 25 parts of diacetone alcohol, 30 parts of distilled water.

5) add the distilled water of surplus in the 3rd container;

6) take by weighing the polyvinylpyrrolidone-vinyl acetate copolymer of the formula amount and stir to dissolve in the third container to obtain the third solution;

Comparative Example 3

The difference between this comparative example and Example 3 is that it does not contain polyvinylpyrrolidone-vinyl acetate copolymer. The plan is as follows:

A degradable liquid band-aid, comprising the following components by weight: 40 parts of keratin, 30 parts of methylcellulose, 25 parts of carboxymethyl chitosan, 1.5 parts of glycerol, 30 parts of ethanol, and 40 parts of ethyl acetate, 25 parts of diacetone alcohol and 30 parts of distilled water.

5) add the distilled water of surplus in the 3rd container;

6) take by weighing the carboxymethyl chitosan of the formula amount and stir to dissolve in the third container to obtain the third solution;

Test Example 1

About 4 g of the liquid band-aids obtained by the solutions provided in Examples 1-3 and Comparative Examples 1-3 were taken, cast flat, dried naturally, and prepared into films, and then the effects were compared. The three aspects of excess rate and aseptic effect are compared, wherein, the tensile strength of the film is tested according to GB13022-91 plastic film tensile properties test method; the water vapor transmission rate is tested according to YY/T0471.2-2004 contact wound dressing test Methods The water vapor transmission rate was tested by operation, and the sterility was checked according to the second appendix XIH of the Chinese Pharmacopoeia in 2010. The results are shown in Table 1.

Table 1 Properties of the degradable liquid Band-Aids provided by Examples 1-3 and Comparative Examples 1-3

It can be seen from Table 1 that, compared with Comparative Examples 1-3, Example 1-3 adopts the main film-forming agent ethyl cellulose and carboxymethyl chitosan to form a composite film. Through the synergistic effect of degradable keratin and methyl cellulose, the film has high tensile strength and can prevent the contamination of the wound by external bacteria. The carboxymethyl chitosan has anti-inflammatory, hemostatic and moisturizing effects to promote the rapid healing of the wound. The polyvinylpyrrolidone-vinyl acetate copolymer has good air permeability and is a good porogen.

Test case 2

200 cases of volunteers with skin damage were randomly divided into 2 groups, namely the test group and the control group, with 100 people in each group. The test group used the liquid Band-Aid of Example 3, and the control group used the purchased liquid Band-Aid of Japan's Kobayashi Pharmaceutical Co., Ltd. to observe the curative effect. From the hemostatic effect, anti-inflammatory effect and isolation effect, the results are shown in Table 2.

Table 2 Test results of test group and control group

group

hemostatic effect

Anti-inflammatory effect

isolation effect

试验组test group	9898	9797	9696
对照组control group	8484	8181	8585

As can be seen from Table 2, the liquid Band-Aid of Example 3 has better hemostatic effect, anti-inflammatory effect and isolation effect.

It can be seen that the degradable liquid Band-Aid of the present invention uses degradable keratin, methyl cellulose, carboxymethyl chitosan and polyvinylpyrrolidone-vinyl acetate copolymer as a film-forming agent, which makes the film-forming body full of elasticity , good tensile strength, and degradable.

Although the embodiment of the present invention has been disclosed as above, it is not limited to the application listed in the description and the embodiment, it can be applied to various fields suitable for the present invention, and those skilled in the art can easily Additional modifications are implemented, therefore, the invention is not to be limited to the specific details and specific embodiments shown and described herein without departing from the general concept defined by the appended claims and the scope of equivalents.

Claims

A degradable liquid Band-Aid, characterized in that it comprises the following components by weight: 30-40 parts of keratin, 15-30 parts of methylcellulose, 10-25 parts of carboxymethyl chitosan, polyvinylpyrrolidone- 2-6 parts of vinyl acetate copolymer, 0.5-1.5 parts of glycerin, 25-30 parts of ethanol, 30-40 parts of ethyl acetate, 15-25 parts of diacetone alcohol, 20-30 parts of distilled water;

Among them, degradable keratin, methyl cellulose, carboxymethyl chitosan, polyvinyl pyrrolidone-vinyl acetate copolymer are combined as film-forming materials, keratin and methyl cellulose improve the flexibility of the film, carboxymethyl cellulose The base chitosan improves the air permeability of the film through the antibacterial and moisturizing properties of the film, and the polyvinylpyrrolidone-vinyl acetate copolymer.
A kind of preparation method of degradable liquid Band-Aid as claimed in claim 1, is characterized in that, comprises the following steps:

1) take the ethanol, ethyl acetate, diacetone alcohol of formula quantity and place in the first container and mix;

2) in above-mentioned mixture, add the glycerol of formula amount and stir and dissolve;

3) then adding keratin in the first container under stirring, until completely dissolved, to obtain the first solution;

4) Add 30%-40% of the distilled water of the formula amount into the second container, then add the methyl cellulose of the formula amount into the second container under stirring, and heat up to about 90 ° C after being dispersed evenly, and stir to accelerate the methyl cellulose. The base cellulose is dissolved and allowed to cool to obtain a second solution;

5) add the distilled water of surplus in the 3rd container;

6) take by weighing the carboxymethyl chitosan and polyvinylpyrrolidone-vinyl acetate copolymer of the formula amount and stir to dissolve in the third container to obtain the third solution;

7) After mixing the first solution, the second solution and the third solution, stir evenly to obtain a degradable liquid Band-Aid.