Oxygen preparations used in the treatment of acne and wounds, as well as preparation methods and application devices.

Abstract

This paper describes an oxygen preparation for the treatment of acne and wounds, as well as its preparation method and application device. The oxygen-containing preparation comprises an oxygen bag containing an oxygen-containing pouch. The pouch wall is permeable to oxygen and has an airtight section for controlling the oxygen transfer and diffusion rate, or alternatively, the pouch wall is permeable to oxygen and has an airtight section for controlling the oxygen transfer and diffusion rate. The airtight section has a thickness of 5-500 μm, and the oxygen permeability of the airtight section is 0.0000001 cm2·s·0.1 MPa-0.1 ml / cm2·s·0.1 MPa. This oxygen-containing preparation not only provides oxygen molecules to acne and wound surfaces, killing anaerobic bacteria and promoting wound healing, but also provides oxygen partial pressure and oxygen tension, ensuring oxygen content throughout use. Furthermore, the gas exchange mechanism allows for the exchange of carbon dioxide with cells, enhancing the therapeutic effect.

Description

[Technical Field]

[0001] The present invention relates to the field of oxygen preparation technology, and is particularly concerned with oxygen preparations used in the treatment of acne and wounds, as well as preparation methods and application devices. [Background technology]

[0002] According to literature, acne is divided into several types based on severity, age, and physical condition. The most common type is ordinary acne, also known as common acne. In addition to ordinary acne, there is also complex acne, a complex type in which severe nodules, cysts, sinuses, and scars appear simultaneously. Explosive acne refers to patients whose symptoms suddenly worsen and who experience systemic symptoms such as fever, joint pain, and anemia. Drug-induced acne refers to acne-like skin lesions caused by androgens and glucocorticoids. There are also other types such as baby acne and premenstrual acne. More than 90% of adolescents are affected by this condition, and it can also occur on the face, chest, back, and other areas. The pathogenic mechanism is complex, primarily due to excessive secretion from the sebaceous glands, which leads to keratinization and embolism of the hair follicles and sebaceous gland catheters. In an anaerobic environment, the parasitic acne bacteria in the hair follicles proliferate and multiply. Various types of acne can cause problems, including inflammatory erythema, papules, pustules, blackheads, nodules, and cysts, and in severe cases, proliferative hypertrophic or depressed atrophic scars can occur. Acne often affects beauty, social life, work, marriage, and quality of life. Therefore, acne patients desperately seek treatment.

[0003] Currently, clinical treatments often involve drugs and hormones, which have unique therapeutic effects but also have many side effects, such as redness, endocrine disruption, and the irritation and teratogenicity of retinoid drugs when used in large amounts for a long period of time. Patent CN115737674A discloses a gas-based oxygen-delivering wound dressing and its manufacturing method. The dressing consists of, from top to bottom, a waterproof membrane, a gas storage container, an absorbent pad, and a protective membrane. The gas storage container has small holes in its container wall, which are covered with a water-soluble material and / or a breathable membrane. Pressurized oxygen is stored within the gas storage container. While this method can autonomously deliver oxygen, it has drawbacks, such as poor control of the oxygen injection and release rates and poor oxygen release efficiency, resulting in poor therapeutic efficacy and safety issues. Summary of the Invention [Problem to be solved by the invention]

[0004] In view of the shortcomings of the prior art, the present invention aims to provide an oxygen preparation for the treatment of acne and wounds, a method for preparing the same, and an application device, which solve the problems of the prior art, such as insufficient control of the amount of oxygen released, insufficient effectiveness of oxygen release, and safety risks. [Means for solving the problem]

[0005] In one aspect of the present invention, there is provided an oxygen preparation for use in treating acne and wounds, the bag comprising a pouch for containing oxygen, part or all of the wall of the pouch being configured with a vent for allowing oxygen to pass through and controlling the diffusion rate of oxygen transfer. The thickness of the ventilation part is 0.0000001 cm 2 ·s·0.1MPa-0.1ml / cm 2 The oxygen permeability of the ventilation part is adjusted by controlling the thickness of the oxygen bag. When the thickness of the ventilation part is 5 to 500 μm, the oxygen release rate is 0.1 ml / cm. 2 ·s·0.1MPa to 0.0000001cm 2 ·s·Decreases to 0.1MPa.

[0006] "Part" means that part of the bag is breathable and the rest is non-breathable. "All" means that the entire bag is breathable. Furthermore, the ventilation portion is a non-porous ventilation membrane or a hydrophilic ventilation membrane including a microporous ventilation membrane grafted with a hydrophilic compound. The inventors discovered that the oxygen release rate is faster when the ventilation part is a hydrophilic breathable membrane. This is thought to be because the hydrophilic breathable membrane is highly hydrophilic and biocompatible, which allows it to adhere more firmly to skin cells, making it easier to fuse with the extracellular matrix secreted by the cells and facilitating oxygen release. Furthermore, liquids such as the extracellular matrix enter the oxygen bag and push out oxygen molecules, creating an oxygen partial pressure on the skin surface and enhancing the therapeutic effect.

[0007] Non-porous breathable membranes transfer oxygen molecules from one area of ​​high concentration and pressure to another through transport, conduction, and volatilization of polymeric carriers. Non-porous breathable membranes include TPEE breathable membranes and TPU breathable membranes. Micro-porous breathable membranes provide openings suitable for oxygen diffusion, allowing oxygen to diffuse efficiently within the appropriate channels. Micro-porous breathable membranes include polytetrafluoroethylene membranes, polyvinyl octadiene membranes, polypropylene membranes, polyether sulfoxide membranes, polyvinyl fluoride membranes, and polydimethylsiloxane membranes. Additionally, the hydrophilic compound includes one or more of polyvinyl alcohol, acrylic acid, polyethylene glycol, and hydroxyethyl methylacrylate.

[0008] The hydrophilic compound modification improves the facial structure and hydrophilic energy of the microporous breathable membrane, making it more permeable to small oxygen molecules and improving the permeability and tissue compatibility of the microporous breathable membrane. Furthermore, the bag is divided into several equal or unequal partitions that are independent of each other, each containing a vent. wherein the cross-sectional area of ​​the compartment is 1-4cm 2 and the volume is 1-8cm 3 is; Alternatively, the micro-compartments have a size of 0.01 to 100 μm and a density of 10 to 5000 cubic meters.

[0009] The pouch of this invention can be made in different sizes and shapes as required, and the compartments can also be made in different sizes and shapes, with each compartment being an independent piece that can be cut as desired. For example, when treating the face, different shapes and sizes can be designed for different areas to provide better comfort and therapeutic effects. When used to treat sinus wounds and cavity-shaped anaerobic areas, the design features micro-compartments to ensure oxygen release and therapeutic effects.

[0010] Additionally, the outer surface of the vent is covered with a gel layer containing oxygen-carrying carriers. The gel layer is sticky and not only transports oxygen, but also prevents oxygen molecules from diffusing outside the area covered by the air sac, increasing the oxygen concentration on the skin surface. It can also be applied to the surface of acne or wounds to fix the oxygen sacs in place.

[0011] Additionally, the oxygen carrier may include one or more of perfluorobutylfuran, perfluorotributylamine, fluoroene E4, perfluoronaxene, perfluoromethylnaxene, perfluorotripropanolamine, polyvinylpyrrolidone. Oxygen carriers can not only transport oxygen, but also penetrate deep into the skin, allowing oxygen to penetrate the skin and enter the tissues, thereby enhancing the therapeutic effect of oxygen. In addition, carbon dioxide can be released from cells, further enhancing the therapeutic effect. At the same time, the oxygen carriers can also contain moisturizing small molecule components, such as vitreous acid.

[0012] Another aspect of the present invention is to provide a method for preparing an oxygen preparation for acne and wounds, comprising the steps of: S1: Prepare the ventilation part: Prepare a non-porous ventilation membrane or hydrophilize a microporous ventilation membrane using the surface contact method to obtain the ventilation part: S2: Prepare the oxygen bag: Process the ventilation part into the oxygen bag by suction, blowing or foaming method; Or, by using the plastic absorption method, the blowing method or the foaming method to provide a non-permeable part, and then by combining the breathable part with the breathable part through heat pressing or adhesive bonding, an oxygen bag can be obtained; Preferably, the method also includes preparing a gel layer, which is applied to the surface of the breathable membrane of the oxygen capsule.

[0013] Yet another aspect of the present invention is an oxygen preparation for use in treating acne or wounds, including a non-breathable container, an oxygen generator, and a sterile packaging bag, as well as a method for preparing the same and an application device. Gas-impermeable containers are used to supply and store oxygen in oxygen bags. The cylinder and the lid are hermetically connected, and an oxygen inlet is provided on the cylinder or the lid; The oxygen generator is used to generate oxygen and deliver the oxygen to the gas-impermeable container, and the oxygen generator is connected to the gas-impermeable container via an oxygen input port.

[0014] Sterile packs are used to package oxygen packs and keep them sterile. In addition, the aseptic packaging bag has a bag body, a heat-sealing line and a corner break; the four sides of the package body are provided with a heat-sealing line that is fixedly connected to it.

[0015] Another aspect of the present invention is to provide the application of oxygen preparations in the preparation of medicaments for treating acne and wounds or for reducing inflammatory responses. What is known is that by adding particles of highly absorbent resins such as polyclinic polymer to the chamber of prepared oxygen bags, they absorb wound exudate, prevent the wound from becoming soaked, extend the usage time, and at the same time push out gas molecules from the bubbles, improving the therapeutic effect.

[0016] When using, cover with an alginate sheet, hydrocolloid, oil gauze, etc., and then attach an oxygen bag to secure it in place, or apply a breathable adhesive to the surface of the gas molecule permeable membrane and secure it in place, or secure it in place with gas molecule impermeable tape.

[0017] The technical principle of this invention is as follows: The invention controls the speed of oxygen molecule transfer by adjusting the thickness and material properties of the ventilation section, and then coats the surface of the ventilation section with gelatin. Gelatin is sticky, and not only transports oxygen, but also prevents oxygen molecules transferred into the air sac from spreading outside, thereby increasing the oxygen concentration on the skin surface. It is also applied to the surface of acne and pimples to fixate the oxygen sac. Furthermore, we discovered that when Perflunaxen small molecular polymer is used as an oxygen carrier, it not only transports oxygen to the skin surface, but also penetrates deep into the skin, allowing oxygen to penetrate the skin and into the tissue, enhancing the therapeutic effect of oxygen. Furthermore, carbon dioxide is released from cells, further enhancing the therapeutic effect. [Effects of the Invention]

[0018] Compared with the prior art, the present invention has the following beneficial effects: (1) The oxygen preparation of this invention not only provides oxygen molecules to acne and wounds, but also eliminates anaerobic bacteria and promotes wound healing. It ensures the oxygen content during use. It also exchanges carbon dioxide with cells through gas exchange, enhancing the therapeutic effect. (2) The gel layer containing the oxygen carrier of the present invention has a certain viscosity, which ensures that the seal of the contact surface does not leak, while at the same time increasing the oxygen partial pressure and oxygen pressure at the contact surface. At the same time, the small molecule technology used can allow oxygen molecules to penetrate from the oxygen material and penetrate deep into the contact surface, thereby achieving optimal therapeutic effects. (3) The ventilation part of the oxygen preparation of the present invention is a hydrophilic ventilation membrane, which not only promotes oxygen release but also enhances the synergistic effect with the coagulation layer, improving the therapeutic effect of the oxygen preparation. (4) The oxygen suppository of the present invention is a sterile product and can be sterilized by various sterilization methods. It can be used by filling oxygen into an oxygen bag at the bedside during transportation, ensuring the safety and effectiveness of the product. The transportation of sterile products is particularly safe. (5) The manufacturing process of the present invention is simple and convenient. [Brief explanation of the drawings]

[0019] [Figure 1] FIG. 10 is a schematic diagram of an application device according to a third embodiment of the present invention. [Figure 2] FIG. 10 is a side view of an oxygen-containing agent according to a third embodiment of the present invention. [Figure 3] 1 is a graph showing oxygen release from an oxygen-containing agent in Test Example 1 of the present invention. DETAILED DESCRIPTION OF THE INVENTION

[0020] Next, specific embodiments will be described using examples. The technical aspects of the present invention are further described below in connection with the accompanying drawings and embodiments: GT700 aqueous gel, tetrahydroxypropylethyleneamine, mevalonate lactone are purchased from Edico. [Example]

[0021] [Example 1] Preparation of oxygen preparations for acne and wounds 1. Preparation of microporous aerated membrane grafted with hydrophilic compounds. After combining the polytetrafluoroethylene membrane and the polyethylene octadiene membrane, the membrane is immersed in a polyethylene glycol solution for 15 hours, removed, and dried to obtain a hydrophilic, microporous, breathable membrane. 2. The gas-impermeable part prepared from LDPE material is bubble-absorbed, and then combined with the hydrophilic microporous breathable membrane prepared in step 1 using heat and pressure to form an oxygen bag with a thickness of 70 μm. 3. A fluoronaprone gel is covered with a hydrophilic microporous breathable membrane; or the gel layer is applied directly to the skin surface. The specific preparation method for the gel layer is as follows: Phase A: 5% Heijiru, 5% Diglycerin, 10% PG carbonate, 3% Dimethylsilane of PEG18 methyl ether; Phase B: deionized water 68.6 + 5, GT700 aqueous gel 1.5%, EDTA 0.2%, Arabescol and Ogen gel 0.3%; Phase C: 4-hydroxypropylethylenediamine 3% (PH6-7.5); Phase D: 3% hydroxybenzoate, 5% fluoronaphthalene, carbon dioxide and nitrogen molecular sieve adsorption fine powder; Phases A, B and D are mixed homogeneously at high speed, and during the mixing process, 5% NaOH aqueous solution is added to adjust the pH value to 6-7; then, phase A is mixed homogeneously at high speed with phase B, phase C is added and mixed homogeneously at high speed again, and finally phase D is mixed homogeneously at high speed and the can is sealed. Other materials for the gas-impermeable parts include PET, PU, ​​PA, and PVC. [Example]

[0022] [Example 2] Preparation of oxygen preparation for acne and wounds 1. Preparation of microporous aerated membrane grafted with hydrophilic compounds. The polyvinyl fluoride membrane is immersed in a polyethylene glycol solution for 20 hours, then removed and dried to obtain a hydrophilic, microporous, breathable membrane. 2. The hydrophilic microporous breathable membrane prepared in step 1 was processed into an oxygen bag by adsorption method, with a thickness of 200 μm. 3. Polyethylene pyrrolidone is made into a gel and coated onto the surface of the hydrophilic microporous breathable membrane. [Example]

[0023] [Example 3] Application of oxygen preparations for acne and wounds As shown in Figure 1, the application device consists of a gas-impermeable container 1, an oxygen generator 2, and a sterile packaging bag 3. The empty gas-impermeable container 1 is a storage container for supplying oxygen to the oxygen bag 4, and includes a hermetically connected tube and a lid with an oxygen inlet.

[0024] The oxygen generator 2 is for generating oxygen and transporting the oxygen to the gas-impermeable container 1, and is connected to the gas-impermeable container 1 via the oxygen inlet. The aseptic packaging bag 3 is provided in the gas-impermeable container 1 to package the oxygen bag 4 and keep it sterile. The aseptic packaging bag 3 includes a bag body, a heat-sealing line and a tear-off corner; the four sides of the package body are provided with heat-sealing lines that are fixedly connected to it.

[0025] When prepared by the method of Example 1, the oxygen bag 4 contained nine independent spacers 5, each with a cross-sectional area of ​​1 cm , as shown in FIG. 2 The volume is 1 ml, and the spacer 5 is filled with air. As shown in Figure 2, the partition 5 has a vent 6 at the bottom, and the oxygen permeability of the vent 6 is 1.7 ml / cm 2 The oxygen pressure is 0.1 MPa. The oxygen bag 4 is sealed in the sterile bag 3 and sterilized with epoxyethane. The expiration date is 2 years.

[0026] To use, oxygen bag 4, which has been sterilized one hour in advance, is placed inside sterile packaging bag 1 and sealed, and oxygen is simultaneously injected through oxygen generator 2. There is a partial pressure difference between the gas molecules in oxygen bag 1 and oxygen bag 4, and after one hour, the partial pressure difference will transfer the oxygen molecules into oxygen bag 4. Oxygen bag 4 with sterile pack 3 attached is removed from breathable container 1, and the breathable part 6 side of sterile pack 3 is attached to the acne or wound.

[0027] Test Example 1 Ventilation effectiveness test. (1) Skin preparation: A healthy Wistar mouse was selected and anesthetized with 10% chloral hydrate solution via intraperitoneal injection. The hair on the back was carefully removed with surgical scissors, and the skin was then carefully peeled away to remove the subcutaneous fat and tissue. b. Wash the skin several times with saline, cut out an appropriate size piece, store in a refrigerator at -20°C, and use within one week. c. Before starting the permeation test, remove the skin from the refrigerator and allow it to thaw naturally in room temperature saline.

[0028] (2) Penetration test. The mouse skin prepared in (1) was used as a vector and fixed between the supply chamber and receiving chamber of the micro-oximeter. The oxygen bag prepared in Example 1 was attached to the mouse skin on the supply chamber side, which had been coated with a gel layer. The skin was then immersed in deionized water, placed on a vibrating sieve, and placed in a constant temperature box. The temperature was set at 37°C, and a trace oxygen meter sensor was connected to the receiving chamber side. In this example, the oxygen content of the oxygen bag was 50 ml, and the volume of the receiving chamber side was 400 ml. Figure 3 shows a graph of oxygen release.

[0029] Test Example 2 Administering oxygen preparations to acne Experimental Group 1: Oxygen preparation prepared in Example 3 Experimental Group 2: Similar to the experimental group, except that the microporous breathable membrane was not hydrophilically modified. Experimental group 3: Similar to the experimental group, but without the addition of the gel layer.

[0030] Control group 1: Retinoid acid cream. Control group 2: No treatment. Thirty male SD mice were used, 3–5 weeks old and weighing 100–120 g. Preparation of mouse acne models: The right ears of mice were shaved and randomly divided into two groups, A and B. Group A consisted of 3 mice, and Group B consisted of 27 mice. Group A was the blank control group, and Group B was the acne model group. After one week of normal feeding, injections began. Group A received no treatment. Group B received 50 μl of Propionibacterium acnes suspension once daily in the center of the right inner ear. Seven days after injection, two mice were randomly selected and four pieces of the right ear were extracted using a 3 mm diameter punch. Routine HE pathological examination revealed that the skin of mice in Group B developed acne-like lesions, including pimples, papules, and pustules, which were red and hard in texture, indicating the formation of mouse acne models.

[0031] Model Grouping and Results: 25 rats were divided into five groups of five. Groups 1-4 received experimental group 1, experimental group 2, experimental group 3, and control group 1, respectively. Group 5 received control group 2. The treatment was administered to the center of the inner right ear of each mouse. Control group 1 received 0.1g. Experimental groups 1-3 received treatment at one interval. Each group received treatment twice daily for three weeks. 24 hours after the final treatment, a 3mm punch was used to prepare a full-thickness ear specimen for standard HE pathological examination.

[0032] Results: After three weeks of packet administration, the number of spinous cell layers in the experimental group had not returned to the normal level of two layers in the right ears of mice, but the number of hair follicle keratinized cells and local skin damage in the dermal layer of inflammatory cells was significantly reduced. Experimental group 2: The number of spinous cell layers recovered from the original 10 layers to 4 layers, with a small amount of hair follicle keratinized cells and a reduction in local skin damage and inflammatory cells in the dermal layer. Experimental group 3: The number of spinous cell layers recovered from the original 10 layers to 5 layers, with moderate but relatively coarse hair follicle keratinized cells and a slight reduction in local skin damage and inflammatory cells in the dermal layer. In the control group, the number of spinous cell layers had already recovered to 4 layers, with a small amount of hair follicle keratinized cells and a reduction in local skin damage and inflammatory cells in the dermal layer. Control group 2: The epidermis was still thickened, with a large amount of hair follicle keratinized cells and a large loss of local skin damage and inflammatory cells in the dermal layer.

[0033] Finally, the above embodiments are intended to illustrate, but not limit, the technical aspects of the present invention. Although the present invention has been described in detail with reference to preferred embodiments, those skilled in the art will understand that the technical aspects of the present invention can be modified or substituted with equivalents without departing from the spirit and scope of the technical aspects of the present invention. All of these should be included in the scope of the claims of the present invention. [Explanation of symbols]

[0034] 1, gas-impermeable container 2, oxygen generator 3, sterile packaging bag 4, oxygen bag 5, spacer 6, ventilation part

Claims

1. An oxygen preparation used in the treatment of acne and wounds, characterized by: an oxygen bag containing a bag for containing oxygen, part or all of the bag wall of the bag being composed of a vent that is permeable to oxygen and controls the rate of oxygen transfer diffusion; The thickness of the ventilation part is 5 to 500 μm, and the oxygen permeability of the ventilation part is 0.0000001 cm 2 ・ s ・ 0.1MPa- 0.1ml / cm 2 ・ s ・ 0.1MPa.

2. The oxygen preparation used for treating acne or wounds according to claim 1, wherein the ventilation part is a non-porous ventilation membrane or a hydrophilic ventilation membrane including a microporous ventilation membrane grafted with a hydrophilic compound.

3. The oxygen preparation for use in the treatment of acne and wounds according to claim 2, wherein the hydrophilic compound comprises one or more of polyvinyl alcohol, acrylic acid, polyvinyldiol, and hydroxyethyl methylacrylate.

4. An oxygen preparation used for treating acne and wounds, wherein the bag is divided into several independent equal or unequal partitions each having a vent, and the partitions have a cross-sectional area of ​​1-4 cm. 2 , with a volume of 1-8 cm 3 The oxygen repellent according to claim 1, characterized in that it is a micro-compartment, the size of which is 0.01 to 100 μm and the density of which is 10 to 5000 cubic meters.

5. 10. The oxygen repellent according to claim 1, which is used for the treatment of acne and wounds, wherein the outer surface of the ventilation part is covered with a gel layer containing an oxygen carrier.

6. 6. The oxygen preparation of claim 5, wherein the oxygen carrier comprises one or more of perfluorobutylfuran, perfluorotributylamine, fluorodione E4, perfluoronaxene, perfluoromethylnaxene, perfluorotripropanolamine, polyethylene, and pyrrolidone.

7. The oxygen preparation used for treating acne and wounds according to any one of claims 1 to 6 and its preparation method are characterized by comprising the following steps: S1: Prepare the ventilation part: Prepare a non-porous ventilation membrane, or use the surface contact method to hydrophilize a microporous ventilation membrane to obtain a ventilation part. S2: Prepare the oxygen bag: Process the breathable part into the oxygen bag by the suction, blowing or foaming method; or prepare an impermeable part by the suction, blowing or foaming method, and then combine the breathable part with the breathable part by heat pressing or gluing to obtain the oxygen bag; preferably, this also includes preparing a gel layer. Cover the surface of the breathable part of the oxygen capsule with the gel layer.

8. This is an oxygen preparation and its application device used for treating acne and wounds. Its features include an airtight container, an oxygen generator, and a sterile packaging bag. The airtight container is used to supply and store oxygen in the oxygen bag. The oxygen generator is used to generate oxygen and transport it to the gas-impermeable container. The oxygen generator is connected to the gas-impermeable container via an oxygen input port. The sterile pack is used to package the oxygen pack and keep it sterile.

9. The oxygen preparation and its application device are used to treat acne and wounds, and the aseptic packaging bag has a bag body, a heat-pressure sealing line and corners, and the four sides of the bag body are provided with heat-pressure sealing lines fixedly connected to it, as described in claim 8.

10. The oxygen preparation for treating acne or wounds according to any one of claims 1 to 6 is used for preparing a medicine for treating wounds or reducing inflammatory responses.

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