Film-forming preparation and application of film-forming preparation

Abstract

Film-forming formulations and uses of the film-forming formulations are disclosed. The film-forming preparation comprises a film-forming agent and a film-forming auxiliary agent which are dissolved in a first solvent; the film forming agent is any one or more of poly (hydroxyethyl methacrylate), poly (hydroxyethyl acrylate) and poly (N-isopropylacrylamide); the coalescing agent is polyvinyl butyral; when the film-forming agent contains poly (hydroxyethyl methacrylate) or poly (hydroxyethyl acrylate), the first solvent is any one or more of methanol, ethanol, propanol and butanol; when the film-forming agent only contains poly (N-isopropylacrylamide), the first solvent is any one or more of methanol, ethanol, propanol, butanol, tetrahydrofuran, benzene, toluene, xylene, dichloromethane and chloroform. The film-forming preparation can form a film. When the first solvent is ethanol, the film-forming preparation can be used as a wound dressing. When the mass percent of the film-forming agent and the film-forming auxiliary agent in the film-forming preparation is less than or equal to 25%, the film-forming preparation can be sprayed to form a film.

Description

Technical Field

[0001] The present application relates to the field of gel application, and in particular to a film-forming preparation and the use of the film-forming preparation. Background Art

[0002] In the prior art, hydrogels have been commercially used as wound dressings, such as BioGlue, DuraSeal, CoSeal, etc. Chinese patent application 201410588110.4 discloses a skin repair gel, which contains seaweed food, dimethyl silicone oil, emulsifier, heat preservation agent and water, and is used to cover skin wounds. Chinese patent application 202010335388.6 discloses a transparent photothermal antibacterial gel patch and its preparation and application, and its hydrogel patch base adopts natural hydrogel or synthetic hydrogel. The above-mentioned hydrogel is generally bottled in a gel state and applied to the wound to isolate bacteria from invading when used. Summary of the invention

[0003] The purpose of the present application is to provide a film-forming preparation and the use of the film-forming preparation, which can form a film and further, in the case where the first solvent is ethanol, can also be used as a wound dressing to isolate bacteria.

[0004] In order to achieve the above purpose, the following technical solutions are adopted:

[0005] The first technical solution relates to a film-forming preparation, which includes a film-forming agent and a film-forming aid dissolved in a first solvent; the film-forming agent is any one or more of polyhydroxyethyl methacrylate, polyhydroxyethyl acrylate and poly N-isopropylacrylamide; the film-forming aid is polyvinyl butyral; when the film-forming agent contains polyhydroxyethyl methacrylate or polyhydroxyethyl acrylate, the first solvent is any one or more of methanol, ethanol, propanol and butanol; or when the film-forming agent only contains poly N-isopropylacrylamide, the first solvent is any one or more of methanol, ethanol, propanol, butanol, tetrahydrofuran, benzene, toluene, xylene, dichloromethane and chloroform.

[0006] The second technical solution is based on the first technical solution, wherein the average molecular weight of the film-forming agent is greater than or equal to 5000; the average molecular weight of the film-forming aid is greater than or equal to 25000; and the mass ratio of the film-forming aid to the film-forming agent is greater than or equal to 0.3 to 1.

[0007] The third technical solution is based on the second technical solution, wherein the first solvent is preferably ethanol; when the film-forming agent comprises polyhydroxyethyl methacrylate or polyhydroxyethyl acrylate, the mass percentage of the film-forming agent and the film-forming aid in the film-forming preparation is between 6% and 50%; or when the film-forming agent only comprises poly N-isopropylacrylamide, the mass percentage of the film-forming agent and the film-forming aid in the film-forming preparation is between 8% and 50%.

[0008] The fourth technical solution is based on the third technical solution, wherein, when the film-forming agent does not contain poly (N-isopropylacrylamide), the mass percentage of the film-forming agent and the film-forming aid in the film-forming preparation is between 6% and 50%.

[0009] The fifth technical solution is based on the fourth technical solution, wherein the film-forming agent is preferably polyhydroxyethyl methacrylate.

[0010] The sixth technical solution is based on the third technical solution, wherein the average molecular weight of the film-forming agent is preferably greater than or equal to 10,000.

[0011] The seventh technical solution is based on the third technical solution, wherein the film-forming preparation further includes an antibacterial agent dispersed or dissolved in the first solvent.

[0012] The eighth technical solution is based on the seventh technical solution, wherein the antibacterial agent is one or more of an organic small molecule antibacterial agent, a polymer antibacterial agent, an inorganic ion antibacterial agent and an inorganic antibacterial agent.

[0013] The ninth technical solution is based on the eighth technical solution, wherein the antibacterial agent is preferably benzalkonium chloride, which is an organic small molecule antibacterial agent, and the mass percentage of the antibacterial agent in the film-forming preparation is greater than or equal to 0.1%.

[0014] The tenth technical solution is based on any one of the third to ninth technical solutions, wherein the film-forming preparation further includes a healing promoter dispersed or dissolved in the first solvent.

[0015] The eleventh technical solution is based on the tenth technical solution, wherein the healing promoter is silicone and / or tetrahexyldecyl ascorbate.

[0016] The twelfth technical solution is based on the eleventh technical solution, wherein the healing promoter is preferably tetrahexyldecyl ascorbate, and the mass percentage of the healing promoter in the film-forming preparation is between 0.1% and 2%.

[0017] The thirteenth technical solution is based on any one of the third to ninth technical solutions, wherein the mass percentage of the film-forming agent and the film-forming aid in the film-forming preparation is less than or equal to 25%.

[0018] The fourteenth technical solution is based on the tenth technical solution, wherein the mass percentage of the film-forming agent and the film-forming aid in the film-forming preparation is less than or equal to 25%.

[0019] The fifteenth technical solution is based on the fourteenth technical solution, wherein the healing promoter is preferably tetrahexyldecyl ascorbate, and the mass percentage of the healing promoter in the film-forming preparation is between 0.1% and 2%.

[0020] The sixteenth technical solution relates to the use of a film-forming preparation, wherein the film-forming preparation as described in any one of the third to fifteenth technical solutions is used as a wound dressing to cover a wound on the skin.

[0021] The seventeenth technical solution relates to the use of a film-forming preparation, wherein the film-forming preparation as described in any one of the thirteenth to fifteenth technical solutions is used as a wound dressing to cover a wound on the skin by spraying.

[0022] Compared with the prior art, the above solution has the following beneficial effects:

[0023] The film-forming preparation of the present application is completely different from the hydrogels commercially available or documented for use as wound dressings.

[0024] Film-forming agents include polyhydroxyethyl methacrylate, polyhydroxyethyl acrylate and poly N-isopropyl acrylamide. Among them, polyhydroxyethyl methacrylate and polyhydroxyethyl acrylate are insoluble in water when the molecular weight is large, but because of the large number of hydroxyl groups, they will form hydrogen bonds with water, so they are hydrophilic. According to literature, poly N-isopropyl acrylamide is soluble in water below 32°C, but experiments have found that no dissolution phenomenon is observed even on the skin surface at temperatures below 32°C. Poly N-isopropyl acrylate is also hydrophilic because it has a large number of acyl groups.

[0025] Polyhydroxyethyl methacrylate, polyhydroxyethyl acrylate and poly N-isopropylacrylamide are all non-toxic.

[0026] Poly(hydroxyethyl methacrylate), poly(hydroxyethyl acrylate) and poly(N-isopropylacrylamide) can all be used as hydrogels, but they are not hydrogels with cross-linked structures, so their mechanical properties are poor, especially after swelling in water, which further reduces the mechanical properties and cannot meet the requirements for use of wound dressings.

[0027] Poly(hydroxyethyl methacrylate), poly(hydroxyethyl acrylate) and poly(N-isopropylacrylamide) are all soluble in methanol, ethanol, propanol and butanol. Poly(N-isopropylacrylamide) is also soluble in tetrahydrofuran, benzene, toluene, xylene, dichloromethane and chloroform.

[0028] The film-forming aid is polyvinyl butyral, which is hydrophobic. The film formed by it is highly transparent, elastic, tough and strong, and has low-temperature impact resistance. It is non-toxic, odorless and non-corrosive. However, due to the hydrophobicity of polyvinyl butyral, it cannot absorb tissue fluid and blood, and it is easy to curl and peel after film formation, and it cannot meet the requirements of wound dressing.

[0029] Polyvinyl butyral is soluble in methanol, ethanol, propanol, butanol, tetrahydrofuran, benzene, toluene, xylene, dichloromethane and chloroform.

[0030] In the present application, when the film-forming agent comprises polyhydroxyethyl methacrylate or polyhydroxyethyl acrylate, the film-forming agent and the film-forming aid are both dissolved in methanol, ethanol, propanol and butanol as the first solvent. When the film-forming agent comprises only N-isopropylacrylamide, the film-forming agent and the film-forming aid are both dissolved in methanol, ethanol, propanol, butanol, tetrahydrofuran, benzene, toluene, xylene, dichloromethane and chloroform as the first solvent.

[0031] The film-forming agent and the film-forming aid in the first technical solution are dissolved and blended in the first solvent to form a film-forming preparation. In the film-forming preparation, the polymer chains of the film-forming agent and the film-forming aid are entangled with each other. After the film-forming preparation is applied or sprayed, the first solvent is volatilized, and the film-forming agent and the film-forming aid form a film entangled with each other and having a three-dimensional network structure. The properties of the formed film combine the respective advantages of the film-forming agent and the film-forming aid. First, it is hydrophilic but insoluble in water, and can absorb tissue fluid and blood; secondly, the hydrophobicity of the film-forming aid limits the swelling of the film-forming agent after it meets water, and can withstand water washing, so it shows excellent mechanical properties and strength, and the elasticity, toughness and tensile properties of the film are excellent, and the film is not easy to curl or peel off, and has stronger adhesion; thirdly, the film is transparent, it is easy to observe the wound condition, and the film is not easy to be detected, which is particularly suitable for covering wounds formed by cosmetic surgery; finally, the film has covering and breathability, can isolate bacteria and be breathable.

[0032] The film-forming preparation of the first technical solution is extremely simple to prepare because the film-forming agent and the film-forming aid are both commercially available.

[0033] In the second technical solution, when the average molecular weight of the film-forming agent is less than 5000 or the average molecular weight of the film-forming aid is less than 25000, or when the mass ratio of the film-forming aid to the film-forming agent is less than 0.3 to 1, the film-forming property of the film-forming agent is poor, and the film may not form a film or may be porous or easily broken after forming the film. Therefore, the second technical solution is a more preferred technical solution for the film-forming preparation.

[0034] In the third and fourth technical solutions, when the first solvent is preferably ethanol, ethanol itself has a bactericidal effect and is easy to volatilize, and the film-forming preparation can quickly form a film after being applied or sprayed. When the first solvent is ethanol, if the film-forming agent contains polyhydroxyethyl methacrylate or polyhydroxyethyl acrylate, the mass percentage of the film-forming agent and the film-forming aid in the film-forming preparation cannot be less than 6%; if the film-forming agent only contains poly-N-isopropylacrylamide, the mass percentage of the film-forming agent and the film-forming aid in the film-forming preparation cannot be less than 8%; if the mass percentage of the film-forming agent and the film-forming aid is too small, it is not easy to form a film. If the mass percentage of the film-forming agent and the film-forming aid is higher than 50%, the concentration is too high, and it is not easy to spray or apply.

[0035] In the fifth technical solution, the film-forming agent is preferably poly(hydroxyethyl methacrylate). Poly(hydroxyethyl methacrylate) is approved by FDS to be used as a human implant, and is generally used to manufacture artificial bone implants or contact lenses. Therefore, it is safer to use.

[0036] In the sixth technical solution, when the average molecular weight of the film-forming agent is greater than or equal to 10,000, the mechanical properties of the film formed by the film-forming agent are significantly improved, which is beneficial for use on skin with large isotensile deformation at joints.

[0037] In the seventh and eighth technical solutions, the film-forming preparation also includes an antibacterial agent dispersed or dissolved in the first solvent, which can enhance the sustained antibacterial and antibacterial effects of the film. Among them, the organic small molecule antibacterial agent can be selected from benzalkonium chloride, pyrithione zinc, etc., the inorganic ion antibacterial agent can be selected from silver ions, etc., and the inorganic antibacterial agent can be selected from nanosilver, nanozinc oxide, etc.

[0038] In the ninth technical solution, the antibacterial agent is preferably benzalkonium chloride, which can be dissolved in ethanol.

[0039] In the tenth and eleventh technical solutions, the film-forming preparation also includes a healing promoter dispersed or dissolved in the first solvent, which can increase the healing effect of the film on the wound.

[0040] In the twelfth technical solution, the healing promoter is preferably tetrahexyldecyl ascorbate, which can be dissolved in ethanol, but the solubility does not exceed 2%.

[0041] In the thirteenth, fourteenth and fifteenth technical solutions, the mass percentage of the film-forming agent and the film-forming aid in the film-forming preparation is less than or equal to 25%, so that the film-forming preparation can be attached to and covered on the skin by spraying, which is more convenient to use.

[0042] The sixteenth technical solution is the application of the film-forming preparation whose first solvent is ethanol on wound dressing, which has the technical effects of the technical solutions cited.

[0043] The seventeenth technical solution is the application of the above film-forming preparation to form a wound dressing by spraying, which has the technical effects of the technical solutions cited. BRIEF DESCRIPTION OF THE DRAWINGS

[0044] In order to more clearly illustrate the technical solution of the embodiment, the following briefly introduces the drawings required for use:

[0045] Figure 1 This is a diagram showing the condition of the skin on the back of the hand before the film-forming preparation in Example 1 is sprayed onto the skin on the back of the hand;

[0046] Figure 2 This is a diagram showing the condition of the skin on the back of the hand when the film-forming preparation in Example 1 is just sprayed onto the skin on the back of the hand;

[0047] Figure 3 It is a diagram showing the state of the skin on the back of the hand after the film-forming preparation in Example 1 is sprayed onto the skin on the back of the hand and after the first solvent evaporates;

[0048] Figure 4 This is a diagram showing the condition of the skin on the back of the hand after the film-forming preparation in Example 1 is sprayed onto the skin to form a film and then washed with water;

[0049] Figure 5 This is a photograph of a film formed by spraying the film-forming preparation in Example 1 under a scanning electron microscope;

[0050] Figure 6 This is a photo of the film sample of Example 1 undergoing a fracture stress test;

[0051] Figure 7 This is a photo of the film sample of Example 1 when cracks appear;

[0052] Figure 8 This is a photograph of the membrane sample of Example 1 after being immersed in water for 0 to 1 hour;

[0053] Fig. 9 The photographs are of the film samples of Example 1 after being immersed in water for 2 to 24 hours;

[0054] Fig.10 This is a morphological photograph of the membrane sample of Example 1 after being immersed in water for 24 hours;

[0055] Fig.11 This is a graph showing the mass change of the membrane sample of Example 1 after being immersed in water for 0 to 24 hours;

[0056] Fig.12 This is a photograph of the test film formed after the test film-forming preparation of Example 1 was sprayed onto the skin of the index finger joint;

[0057] Fig.13 This is a photograph of the test film of Example 1 when the index finger joint is bent 90 degrees;

[0058] Fig.14 This is a photo of the test film of Example 1 being carefully peeled off after the index finger joint has been bent and stretched multiple times;

[0059] Fig.15 This is a photograph of the test film formed after the test film-forming preparation of Example 1 was sprayed onto the skin of the elbow joint;

[0060] Fig.16 This is a photograph of the test film of Example 1 when the elbow joint is bent 90 degrees;

[0061] Fig.17 This is a photograph of the test film of Example 1 when the elbow joint is bent 120 degrees;

[0062] Fig.18 This is a photograph of the test film of Example 1 after the elbow joint is flexed and extended multiple times;

[0063] Fig.19 This is a photograph of the test film formed after the test film-forming preparation of Example 1 was sprayed onto the skin of the knee joint;

[0064] Fig. 20 This is a photograph of the test film of Example 1 when the knee joint is bent 90 degrees;

[0065] Fig.21 This is a photograph of the test film of Example 1 when the knee joint is bent 120 degrees;

[0066] Fig. 22 This is a photo of the test film of Example 1 being carefully peeled off after the knee joint has been flexed and extended multiple times;

[0067] Fig.23 These are photos of the film-forming preparation of Example 2 and physiological saline sprayed onto the model skin for 0 to 14 days respectively. DETAILED DESCRIPTION

[0068] In the claims and the description, unless otherwise defined, the terms "first", "second" or "third", etc. are intended to distinguish different objects rather than to describe a specific order.

[0069] In the claims and the description, unless otherwise defined, the terms "includes", "has" and their variations mean "including but not limited to".

[0070] In the claims and the specification, unless otherwise defined, the term "between" is defined as including both endpoints, that is, greater than or equal to a smaller endpoint and less than or equal to a larger endpoint.

[0071] In the claims and description, unless otherwise defined, the term "mass percentage of film-forming agent and film-forming aid in film-forming preparation" means the percentage of the total mass of film-forming agent and film-forming aid in the mass of film-forming preparation.

[0072] In the claims and the specification, unless otherwise defined, the term "ethanol" is not limited to anhydrous ethanol and may contain a small amount of water.

[0073] The technical solutions in the embodiments will be described clearly and completely below in conjunction with the accompanying drawings.

[0074] Embodiment 1

[0075] The film-forming preparation in the embodiment includes a film-forming agent and a film-forming aid dissolved in a first solvent, wherein the first solvent is ethanol. The film-forming agent is polyhydroxyethyl methacrylate, and the film-forming aid is polyvinyl butyral. The average molecular weight of the film-forming agent is 40,000. The average molecular weight of the film-forming aid is 25,000. The mass ratio of the film-forming aid to the film-forming agent is 2 to 1. The mass percentage of the film-forming agent and the film-forming aid in the film-forming preparation is 20%.

[0076] The film-forming preparation in Example 1 is used as a wound dressing to cover the wound on the skin by spraying. The film-forming preparation in Example 1 is contained in a spray bottle, and the spray head is pressed, and the film-forming preparation in Example 1 is sprayed from the spray head to the skin and covers the wound. Figures 1 to 4 , Figures 1 to 4 The figure shows the changes of the skin on the back of the hand before and after the film-forming preparation in Example 1 is sprayed onto the skin on the back of the hand. Figure 1 The condition of the skin on the back of the hand before spraying. Figure 2 This is the condition of the skin on the back of the hand just after spraying. Figure 3 This is the condition of the skin on the back of the hand after the first solvent evaporates. Figure 4 It is the condition of the skin on the back of the hands after washing with water for one minute after film formation. Figures 1 to 4 It can be seen that the film-forming preparation in Example 1 is sprayed on the back of the hand and forms a film after the first solvent evaporates. The film is transparent and difficult to detect. After washing, the film has no obvious change and no obvious swelling occurs, and basically maintains the state before washing.

[0077] See also Figure 5 , Figure 5 FIG. 2 shows a photograph of a film formed by spraying the film-forming preparation in Example 1 under a scanning electron microscope. Figure 5 It can be seen that the film formed by spraying the film-forming preparation in Example 1 is in a dense state, so it can block bacteria.

[0078] The film-forming preparation in Example 1 was sprayed on a glass sheet using a mold, then cast and dried to form a film sample of Example 1 with a length of 80 mm, a width of 15 mm and a thickness of 0.5 mm. If the thickness is less than 0.5 mm, the film sample is difficult to remove from the glass surface.

[0079] The membrane sample of Example 1 was first subjected to a water vapor transmission rate (WVTR) test. In this test, 9 mL of phosphate buffer with a molar concentration of 0.01 mol / L was placed in a 10 mL centrifuge tube. The total mass of the centrifuge tube and the solution was recorded as W 0 The membrane sample of Example 1 is fixed at the opening of the centrifuge tube, and the opening area of ​​the centrifuge tube is measured, and the area is recorded as S. The centrifuge tube is placed in a constant temperature and humidity incubator at a temperature of 37°C and a humidity of 60% for 24 hours, and then the total mass of the centrifuge tube and the solution is weighed again and recorded as W. 2 The experiment was repeated 3 times and the results were averaged. 2 ·day)=(W 2 -W 0 ) / S*100%. According to experimental tests, the water vapor permeability of the film sample of Example 1 can reach 300g / m 2 This shows that the film sample of Example 1 has a certain air permeability.

[0080] See also Figure 6 and Figure 7 ,in, Figure 6 The figure shows the fracture stress test of the film sample of Example 1, wherein the film sample of Example 1 is in the red dotted line frame; Figure 7 The figure shows the situation when cracks appear in the film sample of Example 1. Figure 6 As shown, the film sample of Example 1 was tested using an Instron 5544 universal tensile strength tester at a tensile speed of 10 mm / min. When the tensile force per unit cross-sectional area was maintained at 2.1 MPa, the film sample of Example 1 did not change after 24 hours. Then, the tensile force was gradually increased, as shown in FIG. Figure 7 As shown in the figure, when the tensile stress reaches 7.6 MPa, cracks appear in the film sample of Example 1, and the ductility deformation rate is 110%. It can be seen that the film sample of Example 1 has considerable mechanical properties.

[0081] See also Figures 8 to 11 , Figures 8 to 11 The figure shows the state and quality change of the membrane sample in Example 1 after being immersed in water. Figure 8 and Fig. 9 The graph shows the state of the membrane sample of Example 1 after being immersed in water for 0 to 24 hours. Fig.10 The figure shows the state of the membrane sample of Example 1 after being immersed in water for 24 hours. Fig.11 The graph shows the mass change of the membrane sample of Example 1 after being immersed in water for 0-24 hours. Figures 8 to 10 As shown, after being immersed in water, the membrane structure of the membrane sample of Example 1 is intact and the shape has not changed. Fig.11As shown, the mass of the membrane sample of Example 1 changes very little after being immersed in water for 24 hours, indicating that the membrane sample of Example 1 swells slightly but still has a certain water absorption capacity.

[0082] In order to test the elongation of the film formed by the film-forming preparation in Example 1 when sprayed onto human skin, rhodamine B dye was added to the film-forming preparation in Example 1. The dye was red and its mass percentage in the film-forming preparation was 0.1%, thereby preparing the test film-forming preparation in Example 1.

[0083] See also Figure 12 to Figure 14 , Figure 12 to Figure 14 The test film formed by spraying the test film-forming preparation of Example 1 onto the skin of the index finger joint before and after the index finger joint is flexed and stretched is shown. Fig.12 The test film formed after the test film-forming preparation of Example 1 was sprayed onto the skin of the index finger joint, Fig.13 The test film of Example 1 is bent 90 degrees at the index finger joint. Fig.14 The test film of Example 1 is shown in the following figure when the test film is carefully peeled off after the index finger joint is bent and stretched several times. Figure 12 to Figure 14 As shown, after the test film of Example 1 was subjected to multiple bending and stretching of the index finger joint, the film structure was not damaged. During the process, the deformation of the skin of the index finger joint was measured to be between 110% and 126%.

[0084] See also Figures 15 to 18 , Figures 15 to 18 The diagram shows the changes of the test film formed by spraying the test film-forming preparation on the skin of the elbow joint before and after the elbow joint is flexed and extended. Fig.15 The conditions of the test film formed after the film-forming preparation was sprayed onto the skin of the elbow joint in Example 1. Fig.16 The test film of Example 1 is in the state of bending the elbow joint 90 degrees. Fig.17 The test film of Example 1 is in the state of bending the elbow joint 120 degrees. Fig.18 The test film of Example 1 is tested after the elbow joint is flexed and extended multiple times. Figures 15 to 18 As shown, when the elbow joint of the test film of Example 1 is bent, the film surface is smooth and has no cracks, and after the elbow joint is bent and stretched for many times, the film structure is not damaged. During the process, the measured elbow joint skin deformation is between 110% and 134%.

[0085] See also Figures 19 to 22 , Figures 19 to 22 The diagram shows the changes of the test film formed by spraying the test film-forming preparation on the skin of the knee joint before and after the knee joint is flexed and extended. Fig.19 The conditions of the test film formed after the film-forming preparation is sprayed onto the skin of the knee joint in Example 1. Fig. 20 The test film of Example 1 is in the state of 90 degrees of knee bending. Fig.21The test film of Example 1 is in the state of 120 degrees of knee bending. Fig. 22 The test film of Example 1 is shown in FIG. 1 when the test film is carefully peeled off after the knee joint is bent and stretched multiple times. Figures 19 to 22 As shown, when the knee joint of the test film of Example 1 is bent, the surface of the film is smooth and has no cracks, and after the knee joint is bent and stretched multiple times, the film structure is not damaged. During the process, the deformation of the knee joint skin is measured to be between 110% and 138%.

[0086] Embodiment 2

[0087] The film-forming preparation in Example 2 includes a film-forming agent, a film-forming aid, an antibacterial agent and a healing agent dissolved in a first solvent. The first solvent is ethanol. The film-forming agent is poly(hydroxyethyl methacrylate), and the film-forming aid is polyvinyl butyral. The average molecular weight of the film-forming agent is 40,000. The average molecular weight of the film-forming aid is 25,000. The mass ratio of the film-forming aid to the film-forming agent is 2 to 1. The mass percentage of the film-forming agent and the film-forming aid in the film-forming preparation is 20%. The antibacterial agent can be selected from one or more of an organic small molecule antibacterial agent, a polymer antibacterial agent, an inorganic ion antibacterial agent and an inorganic antibacterial agent that can be dispersed or dissolved in the first solvent. Among them, the organic small molecule antibacterial agent can be selected from benzalkonium chloride, pyrithione zinc, etc., the inorganic ion antibacterial agent can be selected from silver ions, etc., the inorganic antibacterial agent can be selected from nano silver, nano zinc oxide, etc., and the mass percentage of the antibacterial agent in the film-forming preparation is greater than or equal to 0.1%. In this embodiment, the antibacterial agent is benzalkonium chloride, and the mass percentage of the antibacterial agent in the film-forming preparation is 1%. The healing promoter can be selected from silicone and / or tetrahexyldecyl ascorbate, and the mass percentage of the healing promoter in the film-forming preparation is greater than or equal to 0.1%. In this embodiment, the healing promoter is tetrahexyldecyl ascorbate, and the mass percentage of the healing promoter in the film-forming preparation is 1%, and its mass percentage can be selected not to exceed 2%, so that the tetrahexyldecyl ascorbate is dissolved in the first solvent.

[0088] See also Fig.23 , Fig.23 The conditions of the model skin with infected wounds after the film-forming preparation and saline in Example 2 were sprayed respectively from 0 to 14 days. The process of establishing the model skin is as follows: the rats were anesthetized, the skin on the back of the buttocks was depilated, two circular wounds with a diameter of about 1 cm were cut on the depilated skin with surgical scissors, and the methicillin-resistant Staphylococcus aureus liquid (concentration of 1*10 6 CFU) was used to infect the wound with bacteria, and the wound skin was swabbed with a cotton swab the next day and the swab was cultured with a liquid culture medium to confirm that the skin was successfully infected. One of the wounds was sprayed with the film-forming preparation in Example 2 to form an experimental group and observed. The other wound was sprayed with physiological saline to form a control group and observed. Fig.23As shown, the film-forming preparation in Example 2 can heal wounds better than normal saline.

[0089] Comparative Experiment 1

[0090] Comparative experiment 1 is used to verify the solubility of polyhydroxyethyl methacrylate, polyhydroxyethyl acrylate, poly-N-isopropylacrylamide and polyvinyl butyral in various solvents. See Table 1, which shows the solubility of polyhydroxyethyl methacrylate, polyhydroxyethyl acrylate, poly-N-isopropylacrylamide and polyvinyl butyral in various solvents.

[0091] Table 1: Solubility of hydroxyethyl methacrylate, polyhydroxyethyl acrylate, poly (N-isopropylacrylamide) and polyvinyl butyral in various solvents

[0092]

[0093] As can be seen from Table 1, when the film-forming agent includes polyhydroxyethyl methacrylate or polyhydroxyethyl acrylate, the first solvent can only be selected from any one or more of methanol, ethanol, propanol and butanol. When the film-forming agent only includes poly (N-isopropylacrylamide), the first solvent can be selected from any one or more of methanol, ethanol, propanol, butanol, tetrahydrofuran, benzene, toluene, xylene, dichloromethane and chloroform.

[0094] Comparative Experiment 2

[0095] Comparative experiment 2 is used to verify the film-forming properties of polyhydroxyethyl methacrylate, polyhydroxyethyl acrylate or poly N-isopropyl acrylamide and polyvinyl butyral at various molecular weights. See Table 2, which shows the film-forming properties of polyhydroxyethyl methacrylate, polyhydroxyethyl acrylate, poly N-isopropyl acrylamide and polyvinyl butyral at various molecular weights, wherein the first solvent is ethanol, the mass ratio of the film-forming aid to the film-forming agent is 0.3 to 1; and the mass percentage of the film-forming agent to the film-forming aid in the film-forming preparation is 20%.

[0096] Table 2: Film-forming properties of poly(hydroxyethyl methacrylate), poly(hydroxyethyl acrylate), poly(N-isopropylacrylamide) and poly(vinyl butyral) at various molecular weights

[0097]

[0098] As shown in Table 2, no matter whether the film-forming agent is poly(hydroxyethyl methacrylate), poly(hydroxyethyl acrylate) or poly(N-isopropylacrylamide), the average molecular weight must reach 5000 for good film-forming property. If the average molecular weight of the film-forming agent is less than 5000, no film-forming property will be achieved. The average molecular weight of the film-forming aid must reach 25000 for good film-forming property. If the average molecular weight is less than 25000, no film-forming property will be achieved.

[0099] Comparative Experiment 3

[0100] Comparative experiment 3 is used to verify the relationship between the mass ratio of film-forming aid to film-forming agent and film-forming property. Among them, the film-forming agents are polyhydroxyethyl methacrylate, polyhydroxyethyl acrylate and poly N-isopropylacrylamide. See Table 3, which shows the film-forming properties of a film-forming aid with an average molecular weight of 25,000 and various film-forming agents with various average molecular weights at various mass ratios, wherein the first solvent is ethanol, the average molecular weight of the film-forming aid is 25,000, and the mass percentage of the film-forming agent and the film-forming aid in the film-forming preparation is 20%.

[0101] Table 3: Film-forming properties of a film-forming aid with an average molecular weight of 25,000 and various film-forming agents with various average molecular weights at various mass ratios

[0102]

[0103]

[0104] It can be seen from Table 3 that no matter what kind of film-forming agent is used or how large the average molecular weight of the film-forming agent is, the mass ratio of the film-forming aid to the film-forming agent must be greater than 0.3 to 1 for good film-forming properties. If the mass ratio of the film-forming aid to the film-forming agent is less than 0.3 to 1, the film-forming properties are poor.

[0105] Comparative Experiment 4

[0106] Comparative experiment 4 is used to verify the film-forming property and viscosity of various mass percentages of film-forming aids and film-forming agents in film-forming preparations. See Table 4, which shows the film-forming property and viscosity of various mass percentages of film-forming aids and film-forming agents in film-forming preparations under various film-forming agents, and the viscosity is expressed according to whether it is easy to spray and easy to apply, wherein the first solvent is ethanol, the average molecular weight of the film-forming agent is 25,000, the average molecular weight of the film-forming aid is 25,000, and the mass ratio of the film-forming aid to the film-forming agent is 0.3 to 1.

[0107] Table 4: Film-forming properties and viscosities of various film-forming agents at various mass percentages of film-forming aids and film-forming agents in film-forming preparations

[0108]

[0109] It can be seen from Table 4 that when the film-forming agent does not contain poly (N-isopropylacrylamide), the mass percentage of the film-forming agent and the film-forming aid in the film-forming preparation is between 6% and 25%, which is easy to form a film by spraying and has good film-forming properties. When the mass percentage of the film-forming agent and the film-forming aid in the film-forming preparation is between 25% and 50%, it is easy to form a film by spreading and has good film-forming properties. When the film-forming agent only contains poly (N-isopropylacrylamide), the mass percentage of the film-forming agent and the film-forming aid in the film-forming preparation is between 8% and 25%, which is easy to form a film by spraying and has good film-forming properties. When the mass percentage of the film-forming agent and the film-forming aid in the film-forming preparation is between 25% and 50%, it is easy to form a film by spreading and has good film-forming properties. If the mass percentage of the film-forming agent and the film-forming aid in the film-forming preparation is too low, the film-forming properties are not good. If the mass percentage of the film-forming agent and the film-forming aid in the film-forming preparation is too high, it is not easy to form a film.

[0110] Comparative Experiment 5

[0111] Comparative experiment five is used to verify the fracture stress and elongation at break of various film-forming agents at various mass ratios of film-forming aids to film-forming agents. See Table 5, which shows the fracture stress and elongation at break of film samples of various film-forming agents at various mass ratios of film-forming aids to film-forming agents, wherein the first solvent is ethanol, the average molecular weight of the film-forming aid is 25,000, the mass percentage of the film-forming aid and the film-forming agent in the film-forming preparation is 20%, and the unit of fracture stress is MPa. The film sample is made by spraying the film-forming preparation on a glass sheet using a mold, first by casting and drying, and the length of the film sample is 80 mm, the width is 15 mm and the thickness is 0.5 mm. The film sample was tested using an Instron 5544 universal tensile strength testing machine.

[0112] Table 5: List of breaking stress and breaking elongation of film samples of various film formers at various mass ratios of film former to film former

[0113]

[0114] It can be seen from Table 5 that when the average molecular weight of the film former reaches 5000, the average molecular weight of the film-forming aid reaches 25000, and the mass percentage of the film-forming aid to the film former reaches 0.3 to 1, all kinds of film formers can form films and have strong mechanical properties. Among them, due to the large thickness of the film sample, the elongation at break of the film sample is smaller than when it is sprayed on the skin.

[0115] Based on the above embodiments and comparative experiments, in the present application, the film-forming agent is selected from any one or more of polyhydroxyethyl methacrylate, polyhydroxyethyl acrylate and poly N-isopropyl acrylamide, the film-forming aid is polyvinyl butyral, and when the film-forming agent includes polyhydroxyethyl methacrylate or polyhydroxyethyl acrylate, the first solvent is any one or more of methanol, ethanol, propanol and butanol; or when the film-forming agent only includes poly N-isopropyl acrylamide, the first solvent is any one or more of methanol, ethanol, propanol, butanol, tetrahydrofuran, benzene, toluene, xylene, dichloromethane and chloroform. The average molecular weight of the film-forming agent is greater than or equal to 5000, the average molecular weight of the film-forming aid is greater than or equal to 25000, the mass ratio of the film-forming aid to the film-forming agent is greater than or equal to 0.3 to 1, and the film-forming preparation can form a film.

[0116] When the first solvent is ethanol and the film-forming agent includes polyhydroxyethyl methacrylate or polyhydroxyethyl acrylate, the mass percentage of the film-forming agent and the film-forming aid in the film-forming preparation is between 6% and 25%, which is easy to spray to form a film, and the mass percentage of the film-forming agent and the film-forming aid in the film-forming preparation is between 25% and 50%, which is easy to apply to form a film. When the film-forming agent only includes poly-N-isopropylacrylamide, the mass percentage of the film-forming agent and the film-forming aid in the film-forming preparation is between 8% and 25%, which is easy to spray to form a film, and the mass percentage of the film-forming agent and the film-forming aid in the film-forming preparation is between 25% and 50%, which is easy to apply to form a film.

[0117] The properties of the film obtained by the film-forming preparation of the present application combine the respective advantages of the film-forming agent and the film-forming auxiliary agent. First, it is hydrophilic but insoluble in water, and can absorb tissue fluid and blood; secondly, the hydrophobicity of the film-forming auxiliary agent limits the swelling of the film-forming agent after it meets water, and can withstand water washing, thereby showing excellent mechanical properties and strength, and the elasticity, toughness and tensile properties of the film are excellent, and the film is not easy to curl or peel off, and has stronger adhesion; thirdly, the film is transparent, and the wound condition is easy to observe, and the film is not easy to be detected, which is particularly suitable for covering wounds formed by cosmetic surgery; finally, the film has covering and breathability, can isolate bacteria and is breathable.

[0118] The film-forming preparation in the present application is extremely simple to prepare because the film-forming agent and the film-forming aid are both commercially available.

[0119] The film-forming agent is preferably poly(hydroxyethyl methacrylate). Poly(hydroxyethyl methacrylate) is approved by FDS to be used as a human implant, and is generally used to manufacture artificial bone implants or contact lenses. Therefore, it is safer to use.

[0120] When the average molecular weight of the film-forming agent is greater than or equal to 10,000, the mechanical properties of the film formed by the film-forming agent are significantly improved, which is beneficial for use on skin with large isotensile deformation at joints.

[0121] The film-forming preparation includes an antibacterial agent dispersed or dissolved in the first solvent, which can enhance the sustained antibacterial and antibacterial effects of the film. The antibacterial agent is preferably benzalkonium chloride, which can be dissolved in ethanol.

[0122] The film-forming system includes a healing promoter dispersed or dissolved in the first solvent, which can increase the healing effect of the film on the wound. The healing promoter is preferably tetrahexyldecyl ascorbate, which can be dissolved in ethanol, but the solubility does not exceed 2%.

[0123] The mass percentage of the film-forming agent and the film-forming aid in the film-forming preparation is less than or equal to 25%, so that the film-forming preparation can be attached to and covered on the skin by spraying, which is more convenient to use.

[0124] The first solvent is ethanol, and the film-forming preparation can be applied to wound dressings.

[0125] The above specification and description of the embodiments are used to explain the protection scope of the present application, but do not constitute a limitation on the protection scope of the present application.

Claims

1. A film-forming preparation, characterized in that: It includes a film-forming agent and a film-forming aid dissolved in a first solvent; The film-forming agent is any one or more of polyhydroxyethyl methacrylate, polyhydroxyethyl acrylate and poly N-isopropylacrylamide; The film-forming aid is polyvinyl butyral; When the film-forming agent comprises polyhydroxyethyl methacrylate or polyhydroxyethyl acrylate, the first solvent is any one or more of methanol, ethanol, propanol and butanol; or When the film-forming agent only comprises poly (N-isopropylacrylamide), the first solvent is any one or more of methanol, ethanol, propanol, butanol, tetrahydrofuran, benzene, toluene, xylene, dichloromethane and chloroform.

2. The film-forming preparation according to claim 1, characterized in that: The average molecular weight of the film-forming agent is greater than or equal to 5000; the average molecular weight of the film-forming aid is greater than or equal to 25000; the mass ratio of the film-forming aid to the film-forming agent is greater than or equal to 0.3 to 1.

3. The film-forming preparation according to claim 2, characterized in that: The first solvent is preferably ethanol; When the film-forming agent comprises polyhydroxyethyl methacrylate or polyhydroxyethyl acrylate, the mass percentage of the film-forming agent and the film-forming aid in the film-forming preparation is between 6% and 50%; or When the film-forming agent only comprises poly (N-isopropylacrylamide), the mass percentage of the film-forming agent and the film-forming aid in the film-forming preparation is between 8% and 50%.

4. The film-forming preparation according to claim 3, characterized in that: When the film-forming agent does not contain poly (N-isopropylacrylamide), the mass percentage of the film-forming agent and the film-forming aid in the film-forming preparation is between 6% and 50%.

5. The film-forming preparation according to claim 4, characterized in that: The film former is preferably polyhydroxyethyl methacrylate.

6. The film-forming preparation according to any one of claims 3, characterized in that: The average molecular weight of the film former is preferably greater than or equal to 10,000.

7. The film-forming preparation according to claim 3, characterized in that: The film-forming formulation further includes an antimicrobial agent dispersed or dissolved in the first solvent.

8. The film-forming preparation according to claim 7, characterized in that: The antibacterial agent is one or more of an organic small molecule antibacterial agent, a polymer antibacterial agent, an inorganic ion antibacterial agent and an inorganic antibacterial agent.

9. The film-forming preparation according to claim 8, characterized in that: The antibacterial agent is preferably benzalkonium chloride, which is an organic small molecule antibacterial agent. The mass percentage of the antibacterial agent in the film-forming preparation is greater than or equal to 0.1%.

10. The film-forming preparation according to any one of claims 3 to 9, characterized in that: The film-forming formulation further includes a healing promoter dispersed or dissolved in the first solvent.

11. The film-forming preparation according to claim 10, characterized in that: The healing promoter is silicone and / or tetrahexyldecyl ascorbate.

12. The film-forming preparation according to claim 11, characterized in that: The healing promoter is preferably tetrahexyldecyl ascorbate, and the mass percentage of the healing promoter in the film-forming preparation is between 0.1% and 2%.

13. The film-forming preparation according to any one of claims 3 to 9, characterized in that: The mass percentage of the film-forming agent and the film-forming aid in the film-forming preparation is less than or equal to 25%.

14. The film-forming preparation according to claim 10, characterized in that: The mass percentage of the film-forming agent and the film-forming aid in the film-forming preparation is less than or equal to 25%.

15. The film-forming preparation according to claim 14, characterized in that: The healing promoter is preferably tetrahexyldecyl ascorbate, and the mass percentage of the healing promoter in the film-forming preparation is between 0.1% and 2%.

16. Use of a film-forming preparation, characterized in that: The film-forming preparation according to any one of claims 3 to 15, which is used as a wound dressing to cover a wound on the skin.

17. Use of a film-forming preparation, characterized in that: The film-forming preparation according to any one of claims 13 to 15, which is used as a wound dressing to cover a wound on the skin by spraying.

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