Dressing and application thereof
By using dressings containing hyaluronic acid or its salts of different molecular weights, trehalose, and phosphate buffer pairs, the problem of damaged skin barrier is solved, enabling skin self-repair and wound healing, and providing safe and effective skin protection.
Patent Information
- Application Number
- CN202411397279.1
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Filing Date
- 2024-10-08
- Publication Date
- 2025-01-10
AI Technical Summary
Existing dressings cannot effectively protect the skin barrier, prevent macromolecular substances from degrading in extreme environments, and cannot simultaneously meet the requirements of good biocompatibility, absorption of wound exudate, prevention of bacterial invasion, and promotion of wound healing.
The dressing, composed of hyaluronic acid or its salts of different molecular weights, trehalose, phosphate buffer pairs, and sodium chloride, protects the extracellular water film of the dermal cells by forming hydrogen bonds with macromolecules through trehalose, and promotes skin barrier repair by combining the water absorption and retention functions of hyaluronic acid or its salts.
It effectively prevents the degradation of macromolecules in the dermis, reduces skin water loss, promotes skin self-repair, provides a safe microenvironment, promotes wound healing, and reduces scar formation.
Smart Images
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Abstract
Description
Technical Field
[0001] The present application relates to the biological field, and in particular to a dressing and uses thereof. Background Art
[0002] The repair of human skin damage is a complex physiological process. The speed of wound healing, the formation and proliferation of scars after healing have always been a problem that has troubled people. To this end, people are striving to find ideal dressings, including good biocompatibility, control and absorption of wound exudate, prevention of bacterial invasion and inhibition of bacterial growth and reproduction, protection of new tissue, accelerated wound healing, prevention and reduction of scars, hemostasis and analgesia, and good mechanical properties.
[0003] Proteins, polysaccharides, fats and other macromolecules in the skin are wrapped by a layer of cell membrane. When the skin is stimulated by extreme environment, water light, injection, rolling needle treatment or the use of inferior products, the epidermis is damaged, causing the skin barrier system to be damaged, the channel between the dermis and the outside world is opened, and the transepidermal water loss rate of the skin increases rapidly. The skin is most prone to dryness and eczema. In histology, there is edema between epidermal cells, enlarged intercellular spaces, and unstable skin brick wall structure, which destroys the original skin barrier and increases transepidermal water loss; inflammatory cell infiltration reduces lipids and natural moisturizing factors, and the skin becomes dry, flaky, and sensitive. When the skin is extremely stimulated, water light, injection, rolling needle treatment or other situations with non-chronic superficial wounds, the water membrane outside the macromolecule cells is destroyed, resulting in irreversible changes or degradation of macromolecules such as proteins.
[0004] But there is no dressing that can reach and satisfy the above requirements so far. Summary of the invention
[0005] The present application provides a composition for the above skin problems: the composition is mainly composed of hyaluronic acid or its salts of different molecular weights, trehalose, phosphate buffer and sodium chloride. It can quickly act on damaged skin (wound surface), protect the extracellular water film of macromolecular substances in the dermis, thereby preventing the degradation or change of macromolecular substances in the dermis, and timely preventing the damage of the deeper barrier of the skin.
[0006] The composition containing trehalose and hyaluronic acid or its salt is directly brought into contact with the basal layer. Trehalose plays the role of water substitution theory and quickly forms hydrogen bonds with macromolecular substances through hydroxyl groups at the dehydrated sites, replacing the original water-molecule hydrogen bonds. In this way, the protein remains active in the state of water shortage, effectively protecting the protein from degradation.
[0007] Hyaluronic acid or its salts of different molecular weights can absorb, retain and lock water, reducing the transepidermal water loss rate of the skin; the guarantee of protein activity can enable the skin to quickly restore metabolism, ensure the skin's self-repair function, promote the growth of keratinized cells, and repair the skin barrier system.
[0008] The technical solution of this application is as follows:
[0009] 1. A dressing comprising trehalose, macromolecular hyaluronic acid or its salt, medium molecular hyaluronic acid or its salt, and small molecular hyaluronic acid or its salt; the molecular weight of the macromolecular hyaluronic acid or its salt is 2.00-2.30 MDa, the molecular weight of the medium molecular hyaluronic acid or its salt is 1.20-1.60 MDa, and the molecular weight of the small molecular hyaluronic acid or its salt is 0.50-0.70 MDa.
[0010] 2. The dressing according to claim 1, wherein
[0011] Calculated by mass percentage of the total mass of the dressing, the trehalose is 0.2% to 1.0%, the macromolecular hyaluronic acid or its salt is 0.1% to 0.5%, the medium molecular hyaluronic acid or its salt is 0.2% to 1.0%, and the small molecular hyaluronic acid or its salt is 0.3% to 1.0%.
[0012] 3. The dressing according to claim 1, wherein
[0013] The dressing also includes sodium chloride, disodium hydrogen phosphate, sodium dihydrogen phosphate and water;
[0014] Preferably, in terms of mass percentage of the total mass of the dressing, the sodium chloride is 0.2% to 1.0%, the disodium hydrogen phosphate is 0.05% to 0.8%, and the sodium dihydrogen phosphate is 0.01% to 0.03%.
[0015] 4. The dressing according to claim 1, wherein
[0016] The bacterial endotoxin content of the dressing does not exceed 0.5 EU / g.
[0017] 5. The dressing according to claim 1, wherein
[0018] The relative density of the dressing is 1.00-1.04, and the viscosity of the dressing is 850-1050 mPa.s.
[0019] The osmotic pressure of the dressing is 285-315 mOsmol / kg.
[0020] 6. The dressing according to claim 1, wherein
[0021] The sodium chloride is injectable sodium chloride, and the water is water for injection.
[0022] 7. A method for preparing a dressing according to any one of items 1 to 6, comprising:
[0023] The macromolecular hyaluronic acid or its salt, the medium molecular hyaluronic acid or its salt, and the small molecular hyaluronic acid or its salt are added into water, and stirred evenly after being soaked for 2 to 3 hours, and then trehalose is added to obtain a mixed solution;
[0024] Add the dissolved sodium chloride, disodium hydrogen phosphate and sodium dihydrogen phosphate into the mixed solution, stir until it is uniform and clear, to obtain a dressing.
[0025] 8. The preparation method according to item 7, wherein:
[0026] The dressing is sterilized by moist heat.
[0027] 9. Use of the dressing described in any one of items 1 to 6 or the dressing prepared by the method described in item 7 or 8 in the treatment of non-chronic wounds.
[0028] 10. The use according to item 9, which is for preventing the degradation of macromolecular substances in the dermis or preventing damage to the skin barrier.
[0029] This application has the following beneficial technical effects:
[0030] The present application provides a dressing for repairing basal tissue and barrier, which contains hyaluronic acid or its salts, phosphate buffer, trehalose and sodium chloride of different molecular weights. Hyaluronic acid or its salts of different molecular weights play different roles, and can simultaneously meet the effects of skin water absorption, water capture and water retention, skin barrier repair and soothing and anti-inflammatory, thereby providing a good microenvironment for wound healing.
[0031] The dressing of this application does not contain preservatives, adopts moist heat sterilization, is provided aseptically, and strictly controls the source and level of raw materials, production process and sterilization parameters to ensure the sterility, osmotic pressure and endotoxin of the composition before use; it can be directly used on non-chronic wounds to ensure the safety of contacting the dermis and promote the absorption of trehalose and hyaluronic acid or its salts; and ensure that it plays a role, is mild and non-irritating to non-chronic wounds, controls the endotoxin content of the composition, and ensures the safety and effectiveness of the composition contacting the dermis. Control the osmotic pressure of the composition to ensure the safety of the product on the wound and alleviate the discomfort during the use of the composition; direct contact with superficial wounds can maximize the absorption of trehalose and hyaluronic acid or its salts.
[0032] Trehalose used in this application can play a role in water substitution, quickly forming hydrogen bonds between hydroxyl groups and macromolecular substances at the site of water loss, replacing the original water-molecule hydrogen bonds, so that the protein remains active in a water-deficient state. It can effectively repair skin barrier damage caused by extreme environments or water light, photons, etc., and prevent the degradation and loss of proteins in barrier-damaged skin or non-chronic superficial wounds; hyaluronic acid or its salts penetrate deeply into the skin, absorb, retain and lock water, and reduce the transepidermal water loss rate of the skin; the microenvironment formed after film formation promotes the growth rate of epidermal cells towards keratinization.
[0033] The present application provides a safe and effective dressing for skin barrier repair, which increases the technical means of self-repair of the skin barrier; it can effectively solve the problem of synergistic absorption of trehalose and hyaluronic acid or its salts, so as to maximize their utilization and effectiveness; at the same time, it adds a new use of trehalose in skin, verifies its effectiveness in protecting macromolecular substances in the skin, and its effectiveness in soothing skin inflammation and removing redness; the composition of the present application, combined with its scope of application, will bring economic benefits of 30 to 50 million with clinical application. BRIEF DESCRIPTION OF THE DRAWINGS
[0034] Figure 1 This is a bar graph of the dressing barrier repair effect in Example 1;
[0035] Figure 2 This is a bar graph of the barrier repair effect of the dressing in Example 15. DETAILED DESCRIPTION
[0036] It should be noted that certain words are used in the specification and claims to refer to specific components. Those skilled in the art should understand that technicians may use different nouns to refer to the same component. This specification and claims do not use the difference in nouns as a way to distinguish components, but use the difference in the functions of the components as the criterion for distinction. As mentioned throughout the specification and claims, "including" or "comprising" is an open term, so it should be interpreted as "including but not limited to". The subsequent description of the specification is a preferred embodiment of the implementation of the present application, but the description is based on the general principles of the specification and is not used to limit the scope of the present application. The scope of protection of the present application shall be determined by the attached claims.
[0037] The present application provides a dressing, which includes trehalose, macromolecular hyaluronic acid or its salt, medium molecular hyaluronic acid or its salt, and small molecular hyaluronic acid or its salt; the molecular weight of the macromolecular hyaluronic acid or its salt is 2.00-2.30 MDa, the molecular weight of the medium molecular hyaluronic acid or its salt is 1.20-1.60 MDa, and the molecular weight of the small molecular hyaluronic acid or its salt is 0.50-0.70 MDa.
[0038] The molecular weight in the present application is a weight average molecular weight, and the testing method thereof is based on the test by gel permeation chromatography (GPC).
[0039] In some embodiments of the present application, the molecular weight of the macromolecular hyaluronic acid or its salt can be 2.00MDa, 2.01MDa, 2.02MDa, 2.03MDa, 2.04MDa, 2.05MDa, 2.06MDa, 2.07MDa, 2.08MDa, 2.09MDa, 2.10MDa, 2.11MDa, 2.12MDa, 2.13MDa, 2.14MDa, 2.15MDa, 2.16MDa, 2.17MDa, 2.18Mda, 2.19Mda, 2.20Mda, 2.21Mda, 2.22Mda, 2.23Mda, 2.24Mda, 2.25Mda, 2.26Mda, 2.27Mda, 2.28Mda, 2.29Mda, 2.30Mda or any range therebetween.
[0040] In some embodiments of the present application, the molecular weight of the medium molecular weight hyaluronic acid or its salt can be 1.20MDa, 1.21MDa, 1.22MDa, 1.23MDa, 1.24MDa, 1.25MDa, 1.26MDa, 1.27MDa, 1.28MDa, 1.29MDa, 1.30MDa, 1.31MDa, 1.32MDa, 1.33MDa, 1.34MDa, 1.35MDa, 1.36MDa, 1.37MDa, 1.38MDa, 1.39MDa, 1.40MDa, 1.41MDa, 1.42MDa, 1.43MDa, 1.44MDa, 1.45MDa, 1.46MDa, 1.47MDa, 1.48MDa, 1.49MDa, 1.50MDa, 1.51MDa, 1.52MDa, 1.53MDa, 1.54MDa, 1.55MDa, 1.56MDa, 1.57MDa, 1.58MDa, 1.59MDa, 1.60MDa, 1.61MDa, 1.62MDa, 1.63MDa, 1.64MDa, 1.65MDa, 1.66MDa, 1.67MDa, 1.68MDa, 1.69MDa, 1.70MDa, 1.71MDa, 1.72MDa, 1.73MDa, 1.74MDa 1.54MDa, 1.55MDa, 1.56MDa, 1.57MDa, 1.58MDa, 1.59MDa, 1.60MDa or any range therebetween.
[0041] In some embodiments of the present application, the molecular weight of the small molecule hyaluronic acid or its salt can be 0.50MDa, 0.51MDa, 0.52MDa, 0.53MDa, 0.54MDa, 0.55MDa, 0.56MDa, 0.57MDa, 0.58MDa, 0.59MDa, 0.60MDa, 0.61MDa, 0.62MDa, 0.63MDa, 0.64MDa, 0.65MDa, 0.66MDa, 0.67MDa, 0.68MDa, 0.69MDa, 0.70MDa or any range therebetween. In some embodiments of the present application, in terms of the mass percentage of the total mass of the dressing, trehalose is 0.2% to 1.0%, macromolecular hyaluronic acid or its salt is 0.1% to 0.5%, medium-molecular hyaluronic acid or its salt is 0.2% to 1.0%, and small-molecule hyaluronic acid or its salt is 0.3% to 1.0%; for example, trehalose can be 0.2%, 0.3%, 0.4%, 0.5%, 0.6%, 0.7%, 0.8%, 0.9%, 1.0% or any range therebetween; macromolecular hyaluronic acid or its salt is 0.1% to 0.5%, medium-molecular hyaluronic acid or its salt is 0.2% to 1.0%, and small-molecule hyaluronic acid or its salt is 0.3% to 1.0%; Hyaluronic acid or its salt can be 0.1%, 0.2%, 0.3%, 0.4%, 0.5% or any range therebetween; medium molecular hyaluronic acid or its salt can be 0.2%, 0.3%, 0.4%, 0.5%, 0.6%, 0.7%, 0.8%, 0.9%, 1.0% or any range therebetween; small molecular hyaluronic acid or its salt can be 0.3%, 0.4%, 0.5%, 0.6%, 0.7%, 0.8%, 0.9%, 1.0% or any range therebetween.
[0042] In some embodiments of the present application, the dressing further comprises sodium chloride, disodium hydrogen phosphate, sodium dihydrogen phosphate and water.
[0043] In some embodiments of the present application, based on the mass percentage of the total mass of the dressing, sodium chloride is 0.2% to 1.0%, disodium hydrogen phosphate is 0.05% to 0.8%, and sodium dihydrogen phosphate is 0.01% to 0.03%; for example, based on the mass percentage of the total mass of the dressing, sodium chloride can be 0.2%, 0.3%, 0.4%, 0.5%, 0.6%, 0.7%, 0.8%, 0.9%, 1.0% or any range therebetween; disodium hydrogen phosphate can be 0.05%, 0.1%, 0.2%, 0.3%, 0.4%, 0.5%, 0.6%, 0.7%, 0.8% or any range therebetween; sodium dihydrogen phosphate can be 0.01%, 0.02%, 0.03% or any range therebetween.
[0044] The hyaluronic acid salt is selected from any one or two or more of sodium hyaluronic acid, potassium hyaluronic acid, zinc hyaluronic acid, magnesium hyaluronic acid and calcium hyaluronic acid.
[0045] In some embodiments of the present application, the bacterial endotoxin content of the dressing does not exceed 0.5 EU / g.
[0046] In the present application, bacterial endotoxin is the lipopolysaccharide (LPS) component constituting the outermost layer of the outer membrane of the cell wall of Gram-negative bacteria, and its basic structure is highly conservative, consisting of O-specific side chains, core polysaccharides and lipid A (lipid A). Its active center is lipid A, which is one of the strongest known immunostimulants. It can stimulate monocytes and macrophages to produce inflammatory mediators and cytokines such as interleukin-1 (IL-1), tumor necrosis factor (TNF), interferon (IFN), macrophage inflammatory protein-1 (MIP-1), leukocyte pyrogen (LP). The biological activity of endotoxin is very extensive, mainly through inducing these cells to produce a series of inflammatory mediators and cytokines by acting on target cells, which can cause fever reaction, promote prostaglandin synthesis, promote the release of vasoactive substances, lower blood pressure, activate coagulation system and complement, cause local allergies, affect or participate in immune response, affect blood sugar and tumor necrosis, etc., and serious cases can cause death. The dressing product is in direct contact with the wound surface, so the applicant strictly controls the bacterial endotoxins in the product with reference to the requirements for water for injection and injection, and tests the bacterial endotoxins in the product according to the gel method in Article 1143 of the Bacterial Endotoxin Test Method of the Chinese Pharmacopoeia.
[0047] In this application, relative density refers to the ratio of the density of a substance to the density of a reference substance under respective specified conditions. It can reflect the purity and concentration of the substance in the product to a certain extent. Since the molecular weight and proportion of the main component hyaluronic acid or its salt have a great influence on the relative density, and its content and molecular weight determine the effectiveness of the product, the relative density of the product is limited. The dressing of this application is tested according to the pycnometer method in the relative density determination method of 0601 of the Chinese Pharmacopoeia.
[0048] In this application, viscosity refers to an indicator of the ability of a fluid to resist flow. Viscosity has a great influence on the feeling during the use of the product. Whether hyaluronic acid or its salt is used or not, it will have a great influence on the viscosity. Therefore, the viscosity of the product is controlled, and the dressing of this application is tested according to the rotational viscometer determination method in the viscosity determination method of 0633 of the "Chinese Pharmacopoeia".
[0049] In the present application, osmotic pressure is the pressure required to prevent the penetration of solvent from diffusing from low concentration to high concentration solution through a semipermeable membrane. In various biological processes involving diffusion of solutes or liquid transport through biological membranes, osmotic pressure plays an extremely important role. Too high or too low osmotic pressure will affect the feeling and effect of product use, so the osmotic pressure of the product is controlled, and the dressing of the present application is tested according to the osmotic pressure molar concentration determination method of 0632 of the Chinese Pharmacopoeia.
[0050] Based on this, the relative density of the dressing of the present application is controlled to be 1.00-1.04, the viscosity of the dressing is 850-1050 mPa.s, and the osmotic pressure of the dressing is 285-315 mOsmol / kg.
[0051] In some embodiments of the present application, the relative density of the dressing is 1.00-1.04; for example, the relative density of the dressing can be 1.00, 1.01, 1.02, 1.03, 1.04 or any range therebetween.
[0052] In some embodiments of the present application, the viscosity of the dressing is 850-1050 mPa.s; for example, the viscosity of the dressing may be 850 mPa.s, 860 mPa.s, 870 mPa.s, 880 mPa.s, 890 mPa.s, 900 mPa.s, 910 mPa.s, 920 mPa.s, 930 mPa.s, 940 mPa.s, 950 mPa.s, 960 mPa.s, 970 mPa.s, 980 mPa.s, 990 mPa.s, 1000 mPa.s, 1010 mPa.s, 1020 mPa.s, 1030 mPa.s, 1040 mPa.s, 1050 mPa.s or any range therebetween.
[0053] In some embodiments of the present application, the osmotic pressure of the dressing is 285 to 315 mOsmol / kg; for example, the osmotic pressure of the dressing may be 285 mOsmol / kg, 290 mOsmol / kg, 295 mOsmol / kg, 300 mOsmol / kg, 305 mOsmol / kg, 310 mOsmol / kg, 315 mOsmol / kg or any range therebetween.
[0054] In some embodiments of the present application, the sodium chloride is injectable sodium chloride, and the water is water for injection.
[0055] The present application provides a method for preparing the above-mentioned dressing, which comprises: adding the macromolecular hyaluronic acid or its salt, the medium molecular hyaluronic acid or its salt, and the small molecular hyaluronic acid or its salt into water, soaking for 2 to 3 hours and then stirring evenly, and then adding trehalose to obtain a mixed solution; adding dissolved sodium chloride, disodium hydrogen phosphate, and sodium dihydrogen phosphate into the mixed solution, stirring until uniform and clear, and obtaining a dressing.
[0056] In some embodiments of the present application, the dressing is sterilized by moist heat.
[0057] In some embodiments of the present application, the macromolecular hyaluronic acid or its salt, the medium molecular hyaluronic acid or its salt, and the small molecular hyaluronic acid or its salt are added to water (add while stirring, and try to disperse the materials in the water), soaked for 2 to 3 hours, heated (temperature not exceeding 50°C) and stirred until uniform, and then trehalose is added to obtain a mixed solution; the dissolved sodium chloride, disodium hydrogen phosphate, and sodium dihydrogen phosphate are added to the mixed solution, stirred until uniform and clear, to obtain a dressing, filled into a medium borosilicate glass bottle, sealed, sterilized with wet heat steam, labeled and outpackaged after sterilization.
[0058] The present application provides the use of the above-mentioned dressing in treating non-chronic wounds.
[0059] The present application provides the use of the above-mentioned dressing in preventing the degradation of macromolecular substances in the dermis or preventing damage to the skin barrier.
[0060] Example 1
[0061] A dressing comprises trehalose, macromolecular hyaluronic acid or its salt, medium-molecular hyaluronic acid or its salt, small-molecular hyaluronic acid or its salt, sodium chloride, disodium hydrogen phosphate, sodium dihydrogen phosphate and water for injection; the molecular weight of the macromolecular hyaluronic acid or its salt is 2.00-2.30 MDa, the molecular weight of the medium-molecular hyaluronic acid or its salt is 1.20-1.60 MDa, and the molecular weight of the small-molecular hyaluronic acid or its salt is 0.50-0.70 MDa.
[0062] Calculated by weight percentage of the total weight of the dressing, the trehalose is 0.5%, the macromolecular sodium hyaluronate is 0.1%, the medium-molecular sodium hyaluronate is 0.2%, the small-molecule sodium hyaluronate is 0.7%, the sodium chloride is 0.9%, the disodium hydrogen phosphate is 0.1%, and the sodium dihydrogen phosphate is 0.02%.
[0063] The macromolecular hyaluronic acid or its salt, the medium molecular hyaluronic acid or its salt, and the small molecular hyaluronic acid or its salt are added into water (adding while stirring, and try to disperse the materials in the water), soak for 2 to 3 hours, heat (temperature not exceeding 50 degrees), stir until uniform, and then add trehalose to obtain a mixed solution; add dissolved sodium chloride, disodium hydrogen phosphate, and sodium dihydrogen phosphate into the mixed solution, stir until uniform and clear, to obtain a dressing, fill it into a medium borosilicate glass bottle, seal it, sterilize it with wet heat steam, label it after sterilization, and outsource it.
[0064] Compared with Example 1, the difference between Examples 2 to 24 and Comparative Examples 1-4 is only in Table 1, and the rest is the same as Example 1.
[0065] The results of Examples 1 to 24 and Comparative Examples 1 to 4 are shown in Table 2.
[0066] Table 1
[0067]
[0068]
[0069] The relative density is tested according to the pycnometer method in the relative density determination method of Chinese Pharmacopoeia 0601.
[0070] The viscosity is tested according to the rotational viscometer method in the viscosity determination method of "Chinese Pharmacopoeia 0633", and the osmotic pressure is tested according to the osmotic pressure molar concentration determination method of "Chinese Pharmacopoeia 0632".
[0071] Table 2
[0072]
[0073]
[0074] The above dressings must meet the following requirements: relative density should be 1.00-1.04, viscosity should be 850-1050 mPa.s, osmotic pressure should be 285-315 mOsmol / kg, wherein the performance characteristics of Examples 1, 8, 11, 14-15, 18-19, 22-24 all meet the requirements.
[0075] Patch tests and skin tests were performed on the above embodiments and comparative examples, and the results of the patch tests and skin tests were shown in Table 3.
[0076] The patch test process is as follows:
[0077] Inclusion criteria: Volunteers aged 18 to 60 who meet the experimental requirements were selected as subjects.
[0078] Exclusion criteria: 1. Patients who have used antihistamines within the past week or immunosuppressants within the past month; 2. Patients who have used any anti-inflammatory drugs on the test site within the past two months; 3. Subjects with inflammatory skin diseases that have not been cured clinically; 4. Patients with insulin-dependent diabetes; 5. Patients who are undergoing treatment for asthma or other chronic respiratory diseases; 6. Patients who have received anti-cancer chemotherapy within the past six months; 7. Patients with immunodeficiency or autoimmune diseases; 8. Lactating or pregnant women; 9. Patients with bilateral mastectomy and bilateral axillary lymph node resection; 10. Those whose skin test sites have scars, pigmentation, atrophy, port-wine stains and other blemishes that affect the determination of the test results; 11. Participants in other clinical trial researchers; 12. Those with highly sensitive constitutions; 13. Non-voluntary participants or those who cannot complete the required content according to the test requirements.
[0079] Tested area: forearm.
[0080] The skin test process is as follows:
[0081] The product is prohibited for use by people who are allergic to its ingredients and is not suitable for use on chronic wounds. Therefore, skin tests are conducted on the user population based on the product's intended use and contraindications to verify the product's safety.
[0082] Skin test process:
[0083] Inclusion criteria: Volunteers aged 18 to 60 who meet the experimental requirements were selected as subjects.
[0084] Exclusion criteria: Volunteering to participate in the trial, normal perception, healthy skin at the injection site. Detailed inquiries on allergic reaction symptoms and allergy history, such as chest tightness, itching, facial numbness, fever, etc. Those with a history of allergies or allergies to product ingredients are prohibited from using the product.
[0085] Test site: The lower part of the palmar forearm or the lower 1 / 3 of the palmar forearm, because the skin is thinner, less keratinized, lighter in color, and easier to inject and identify local reactions.
[0086] Table 3
[0087]
[0088]
[0089]
[0090] The applicant will conduct internal clinical recruitment, and the recruited subjects are people with sensitive skin or dry and dehydrated skin. 30 volunteers will be treated with water light or rolling needle treatment using registered and marketed products. After the treatment, half of the face will be self-controlled. The dressings of Example 1 and Example 15 will be clinically tested and self-controlled. Before water light or microneedling, the patient's skin red area will be photographed with a skin testing instrument (6th generation visia), and the skin condition will be statistically analyzed and evaluated. After the treatment, half of the face will be immediately used with Example 1, and the other half of the face will be immediately applied with the dressing of Example 15. When the skin is dry, continue to use the corresponding dressing. Continue to use the corresponding dressing during the acute inflammation period and the repair period. The patient's skin condition will be tested after one week, and the patient's skin red area condition will be tested again after two weeks of use. The results are statistically analyzed, and the effectiveness data are shown as follows:
[0091] Table 3 shows the red zone improvement effect of Example 15 on 30 people, indicating that Example 15 has a significant improvement effect on the skin barrier repair of patients in 1 week, and the improvement effect after 2 weeks is very significant. Figure 2 .
[0092] Table 4 shows the red zone improvement effect of Example 1 on 30 people, which shows that Example 1 has a very significant improvement effect on the skin barrier repair of patients in one week, and the improvement effect after two weeks is extremely significant. Figure 1 .
[0093] Improvement of the red zone in Example 15
[0094] Table 3
[0095]
[0096]
[0097]
[0098] Table 4: Improvement of the red zone in Example 1
[0099]
[0100]
Claims
1. A dressing comprising trehalose, macromolecular hyaluronic acid or its salt, medium molecular hyaluronic acid or its salt, and small molecular hyaluronic acid or its salt; the molecular weight of the macromolecular hyaluronic acid or its salt is 2.00-2.30 MDa, the molecular weight of the medium molecular hyaluronic acid or its salt is 1.20-1.60 MDa, and the molecular weight of the small molecular hyaluronic acid or its salt is 0.50-0.70 MDa.
2. The dressing according to claim 1, wherein Calculated by mass percentage of the total mass of the dressing, the trehalose is 0.2% to 1.0%, the macromolecular hyaluronic acid or its salt is 0.1% to 0.5%, the medium molecular hyaluronic acid or its salt is 0.2% to 1.0%, and the small molecular hyaluronic acid or its salt is 0.3% to 1.0%.
3. The dressing according to claim 1, wherein The dressing also includes sodium chloride, disodium hydrogen phosphate, sodium dihydrogen phosphate and water; Preferably, in terms of mass percentage of the total mass of the dressing, the sodium chloride is 0.2% to 1.0%, the disodium hydrogen phosphate is 0.05% to 0.8%, and the sodium dihydrogen phosphate is 0.01% to 0.03%.
4. The dressing according to claim 1, wherein The bacterial endotoxin content of the dressing does not exceed 0.5 EU / g.
5. The dressing according to claim 1, wherein The relative density of the dressing is 1.00-1.04, and the viscosity of the dressing is 850-1050 mPa.s. The osmotic pressure of the dressing is 285-315 mOsmol / kg.
6. The dressing according to claim 1, wherein The sodium chloride is injectable sodium chloride, and the water is water for injection.
7. A method for preparing the dressing according to any one of claims 1 to 6, comprising: The macromolecular hyaluronic acid or its salt, the medium molecular hyaluronic acid or its salt, and the small molecular hyaluronic acid or its salt are added into water, and stirred evenly after being soaked for 2 to 3 hours, and then trehalose is added to obtain a mixed solution; Add the dissolved sodium chloride, disodium hydrogen phosphate and sodium dihydrogen phosphate into the mixed solution, stir until it is uniform and clear, to obtain a dressing.
8. The preparation method according to claim 7, wherein: The dressing is sterilized by moist heat.
9. Use of the dressing according to any one of claims 1 to 6 or the dressing prepared by the method according to claim 7 or 8 in treating non-chronic wounds.
10. The use according to claim 9, which is used for preventing the degradation of macromolecular substances in the dermis or preventing damage to the skin barrier.