Medical periocular skin sterile liquid dressing as well as preparation method and application thereof

Abstract

The invention discloses a medical periocular skin sterile liquid dressing as well as a preparation method and application thereof. The medical periocular skin sterile liquid dressing is prepared from the following components in parts by weight: 5 to 10 parts of glycerol, 5 to 10 parts of propylene glycol, 0.25 to 1 part of luteoloside, 0.5 to 2 parts of polyvinyl alcohol, 2 to 5 parts of carbomer, 1 to 2.5 parts of kaempferol, 0.5 to 2 parts of sodium carboxymethyl cellulose and the balance of purified water. The medical periorbital skin sterile liquid dressing can deeply clean eyelids, remove demodicid mites, secretions and grease at eyelid margins and eyelash roots, relieve meibomian gland blepharitis, accelerate the healing speed of periorbital skin non-chronic wounds and shorten the healing time. Through the anti-inflammatory effect, local inflammation can be relieved, formation of new tissues of skin around eyes can be promoted, and the wound healing quality is improved; the growth of bacteria can be effectively inhibited, the possibility of wound infection of skin around eyes is reduced, and the safety of a patient is improved.

Description

Technical Field

[0001] The invention relates to the technical field of skin care, and in particular to a medical periocular skin sterile liquid dressing, a preparation method and application thereof. Background Art

[0002] Blepharitis is the most common clinical eye inflammation, which may be caused by bacterial infection, Demodex infection, viral infection, allergic reaction, seborrheic dermatitis, rosacea, atopic dermatitis, and meibomian gland dysfunction. Among them, Demodex blepharitis accounts for about 60% to 80% of all blepharitis cases. Demodex blepharitis is a chronic inflammation of the eyelid margin, secondary to Demodex infection of the eyelash follicles and meibomian glands. Patients affected by this disease experience a series of symptoms that may reduce their quality of life, including eyelid itching, dryness, eye irritation, and blurred vision. At present, eyelid cleansers such as 0.01% hypochlorous acid eye wash and cleaning cotton balls / swabs, but any of the above cleaning methods can cause corneal epithelial damage if not properly operated. Therefore, there is an urgent need for a new, safe and effective dressing to deeply clean the periocular skin, especially the eyelid margin, to remove Demodex mites, secretions and oils at the eyelid margin and eyelash roots, and to relieve meibomian gland blepharitis.

[0003] Effective treatment and healing of wounds are important links in clinical treatment. Non-chronic wounds refer to wounds formed during the normal healing process, usually caused by trauma, surgery or other acute injuries. With the advancement of medical technology, the treatment of non-chronic wounds has received increasing attention. Modern medicine emphasizes the wound management principles of "timely, effective and safe". For these wounds, timely debridement, disinfection and correct application of dressings are the key to ensuring healing.

[0004] Traditional wound dressings are mostly made of materials such as gauze or tape. Although they can provide certain protection, they have obvious deficiencies in antibacterial, anti-inflammatory and healing promotion. At the same time, the skin around the eyes is very thin and fragile, and the traditional dressings on the market have poor healing effects on periocular skin wounds. With the development of biomedical material technology, new dressings with specific functions have gradually attracted attention due to their superior characteristics. New medical liquid dressings can form a protective film to keep the wound moist, which helps cell regeneration and wound healing. However, some new dressings have some defects in actual application: they have weak ability to inhibit pathogenic microorganisms and cannot effectively prevent wound infection, resulting in patients facing a higher risk of infection during the healing process and prolonging the recovery time; they may contain irritating ingredients, resulting in skin redness, swelling, itching and other discomfort reactions after use, which is particularly unfriendly to patients with sensitive skin and may affect the continuity and effect of treatment; they only focus on a single function (such as antibacterial or moisturizing), which limits their application effect in clinical practice.

[0005] Therefore, it is particularly important to develop a safe and effective medical sterile liquid dressing for periocular skin with excellent antibacterial and anti-inflammatory effects, which can meet the clinical needs for deep eyelid cleaning and periocular skin trauma treatment and improve the treatment effect. Summary of the invention

[0006] In view of the defects in the prior art, the present invention proposes a medical periocular skin sterile liquid dressing and a preparation method and application thereof. The medical periocular skin sterile liquid dressing of the present invention has excellent antibacterial and anti-inflammatory effects, relieves meibomian gland blepharitis, and can also accelerate the healing speed of non-chronic wounds of periocular skin and reduce the healing time. The dressing is safe and non-toxic, does not contain allergens, has no skin irritation reaction, does not cause skin allergic reactions, and has good biological safety.

[0007] The present invention provides a medical periocular skin sterile liquid dressing, which comprises the following components in parts by weight:

[0008] 5-10 parts of glycerol, preferably 7-9 parts; 5-10 parts of propylene glycol, preferably 7-9 parts; glycerol and propylene glycol as moisturizers can keep the wound area of ​​the skin around the eyes moist, promote the regeneration and healing of the skin cells around the eyes, and have a certain antibacterial effect to prevent infection.

[0009] Luteolin 0.25-1 part, within a certain range of addition, can relieve eyelid inflammation and reduce the inflammatory response in the periocular skin wound area, and promote the healing process. When luteolin is excessive, a dose-dependent effect is likely to occur, resulting in a weakened cell response and reduced overall dressing effectiveness. In addition, high concentrations of luteolin may cause local irritation or allergic reactions, which have a negative impact on the healing process.

[0010] 0.5 to 2 parts of polyvinyl alcohol, preferably 0.8 to 1.5 parts, polyvinyl alcohol as a film-forming agent can form a protective film to reduce external stimulation, while providing a moist environment for the eyelids, which is conducive to deep cleaning of the eyelids and migration and regeneration of skin cells around the eyes.

[0011] 2 to 5 parts of Carbomer, preferably 2.5 to 4 parts; Carbomer as a thickener can improve the adhesion of the dressing, can adhere to the eyelid secretions, oils and mite corpses, so that the eyelids can be deeply cleaned and blepharitis can be relieved. At the same time, it can also maintain its stability on the periocular skin wound and prevent liquid leakage. In addition, Carbomer can also promote the healing of periocular skin wounds to a certain extent.

[0012] 1-2.5 parts of kaempferol. Kaempferol has good anti-inflammatory, antioxidant and antibacterial properties. It can effectively inhibit bacterial growth, reduce inflammatory reactions of the skin around the eyes, relieve blepharitis and help accelerate the healing of skin wounds around the eyes. The combination of kaempferol and luteolin improves the antibacterial and anti-inflammatory effects of the dressing. The anti-inflammatory effect of luteolin can reduce cell damage, while the antioxidant effect of kaempferol can protect cells from oxidative stress damage, effectively enhancing the healing ability of tissues through a dual protection mechanism. In addition, kaempferol can improve the stability of luteolin in medical sterile liquid dressings. The strong antioxidant property and good chemical stability can significantly reduce the oxidative degradation of luteolin, thereby extending the shelf life of the dressing.

[0013] 0.5-2 parts of sodium carboxymethyl cellulose. As a lubricant and protective agent, sodium carboxymethyl cellulose not only has a mild and lasting lubricating effect on the skin around the eyes, relieving discomfort such as dry eyes and itching caused by blepharitis, but also has a protective and moisturizing effect on the wounds around the eyes, helping the dressing to remain on the surface of the wounds around the eyes and promote healing of the wounds around the eyes.

[0014] Make up to 100 parts of purified water.

[0015] The medical sterile liquid dressing for periocular skin of the present application can provide a suitable moist environment, inhibit the growth of pathogenic microorganisms, remove eyelid secretions, oil and demodex mites, reduce inflammatory response, thereby effectively alleviating blepharitis and accelerating the healing of periocular skin wounds.

[0016] In some embodiments, the luteolin is 0.5 to 0.8 parts by weight.

[0017] In some embodiments, the compounding ratio of luteolin to kaempferol is 1:(1-2).

[0018] In some embodiments, the pH of the medical periocular skin sterile liquid dressing is 4.5 to 6.5. This pH range is close to the pH value of normal periocular skin, which helps to maintain the physiological balance of the skin, reduce irritation and discomfort, and ingredients such as carbomer and polyvinyl alcohol are more likely to maintain the stability of their physical and chemical properties, thereby ensuring the effectiveness and safety of the dressing.

[0019] The present invention also provides a method for preparing the medical sterile liquid dressing for periocular skin, comprising the following steps:

[0020] (i) Weighing each component by weight, dissolving polyvinyl alcohol, carbomer and sodium carboxymethyl cellulose respectively in purified water at 60 to 80° C., and mixing to obtain a solution I;

[0021] (ii) mixing glycerol, propylene glycol, luteolin and kaempferol, and stirring to obtain a solution II;

[0022] (iii) mixing solution I and solution II, adjusting the pH of the solution, supplementing with purified water to 100 parts by weight, and performing 0.22 μm sterile filtration to obtain the medical sterile liquid dressing.

[0023] The present invention also provides medical equipment, medical supplies or medical drugs comprising the medical sterile liquid dressing for periocular skin.

[0024] The present invention also provides application of the medical periocular skin sterile liquid dressing in preparing a dressing for treating blepharitis and non-chronic wounds.

[0025] In some embodiments, the blepharitis is caused by any one of bacterial infection, demodex infection, viral infection, allergic reaction, dermatitis, meibomian gland dysfunction, etc.

[0026] In some embodiments, the non-chronic wound is any one of acute trauma, surgical incision, burn, and mildly infected wound.

[0027] In summary, compared with the prior art, the present invention achieves the following technical effects:

[0028] 1. The medical periocular skin sterile liquid dressing of the present invention provides a suitable moist environment and nutrients, helps to deeply clean the periocular skin, especially the eyelids, removes Demodex mites, secretions and oils on the eyelid margins and eyelash roots, relieves meibomian gland blepharitis and the dry eyes caused by it, and promotes the proliferation and migration of periocular skin cells, accelerates the healing speed of non-chronic periocular skin wounds, and reduces the healing time.

[0029] 2. The medical sterile liquid dressing for periocular skin of the present invention reduces inflammation of the periocular skin through anti-inflammatory effect, helps promote the formation of new tissue, and improves the quality of wound healing; it can effectively inhibit bacterial growth, relieve blepharitis and reduce the possibility of infection of the periocular skin wound, thereby improving the safety of patients.

[0030] 3. The medical sterile liquid dressing for periocular skin of the present invention is safe and non-toxic, does not contain allergens, has no eye skin irritation reaction, does not cause eye skin allergic reaction, and has good biological safety.

[0031] 4. The medical sterile liquid dressing for periocular skin of the present invention is more convenient to apply and cover, and is suitable for deep cleaning of periocular skin and various periocular skin wounds, especially those that are difficult to bandage. It can be used for blepharitis caused by bacterial infection, demodex infection, viral infection, allergic reaction, dermatitis, meibomian gland dysfunction, etc., and various types of eye wounds, including postoperative wounds, trauma and burns, etc., to provide all-round protection and support. DETAILED DESCRIPTION

[0032] In order to enable those skilled in the art to better understand the solutions of the present invention, the technical solutions in the embodiments of the present invention will be clearly and completely described below in combination with the solutions in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work should fall within the scope of protection of the present invention.

[0033] The experimental methods used in the following examples are conventional methods unless otherwise specified. The materials and reagents used are all commercially available unless otherwise specified.

[0034] Example 1

[0035] The components and preparation of the medical periocular skin sterile liquid dressing of this embodiment are as follows:

[0036] Weigh 5 parts of glycerol, 5 parts of propylene glycol, 0.25 parts of luteolin, 0.5 parts of polyvinyl alcohol, 2 parts of carbomer, 1 part of kaempferol, 0.5 parts of sodium carboxymethylcellulose, and 85.75 parts of purified water;

[0037] On a heated stirrer, add an appropriate amount of purified water, heat to 60-80°C, slowly add polyvinyl alcohol, carbomer and sodium carboxymethyl cellulose, and stir until completely dissolved; in another container, mix glycerol, propylene glycol, luteolin and kaempferol, continue stirring, then mix the two and stir, add the remaining purified water, adjust the pH to 4.5 with boric acid, sterile filter with a 0.22 μm filter membrane, put into a sterile plastic bottle, and seal for storage.

[0038] Example 2

[0039] The components of the medical periocular skin sterile liquid dressing of this embodiment are as follows:

[0040] 5 parts of glycerin, 5 parts of propylene glycol, 0.8 parts of luteolin, 1 part of polyvinyl alcohol, 3 parts of carbomer, 2 parts of kaempferol, 1 part of sodium carboxymethylcellulose, 82.2 parts of purified water;

[0041] The preparation method is as in Example 1.

[0042] Example 3

[0043] The components of the medical periocular skin sterile liquid dressing of this embodiment are as follows:

[0044] 8 parts of glycerin, 8 parts of propylene glycol, 0.5 parts of luteolin, 0.5 parts of polyvinyl alcohol, 2 parts of carbomer, 1 part of kaempferol, 0.5 parts of sodium carboxymethylcellulose, 79.5 parts of purified water;

[0045] The preparation method is as in Example 1.

[0046] Example 4

[0047] The components of the medical periocular skin sterile liquid dressing of this embodiment are as follows:

[0048] 10 parts of glycerin, 10 parts of propylene glycol, 1 part of luteolin, 2 parts of polyvinyl alcohol, 2.5 parts of carbomer, 2.5 parts of kaempferol, 2 parts of sodium carboxymethylcellulose, 70 parts of purified water;

[0049] The preparation method is as in Example 1.

[0050] Example 5

[0051] The components of the medical periocular skin sterile liquid dressing of this embodiment are as follows:

[0052] 8 parts of glycerin, 8 parts of propylene glycol, 0.3 parts of luteolin, 0.5 parts of polyvinyl alcohol, 2 parts of carbomer, 1.2 parts of kaempferol, 0.5 parts of sodium carboxymethylcellulose, 79.5 parts of purified water;

[0053] The preparation method is as in Example 1.

[0054] Example 6

[0055] The difference between this embodiment and embodiment 2 is that disodium hydrogen phosphate is used to adjust the pH to 6.5.

[0056] Comparative Example 1

[0057] The components of the medical sterile liquid dressing for periocular skin of this comparative example are as follows:

[0058] 5 parts glycerin, 5 parts propylene glycol, 1 part polyvinyl alcohol, 3 parts carbomer, 2 parts kaempferol, 1 part sodium carboxymethylcellulose, 83 parts purified water;

[0059] The preparation method is as in Example 1.

[0060] Comparative Example 2

[0061] The components of the medical periocular skin sterile liquid dressing of this embodiment are as follows:

[0062] 5 parts of glycerin, 5 parts of propylene glycol, 0.8 parts of luteolin, 1 part of polyvinyl alcohol, 3 parts of carbomer, 1 part of sodium carboxymethylcellulose, 84.2 parts of purified water;

[0063] The preparation method is as in Example 1.

[0064] Comparative Example 3

[0065] The components of the medical periocular skin sterile liquid dressing of this embodiment are as follows:

[0066] 5 parts glycerin, 5 parts propylene glycol, 1 part polyvinyl alcohol, 3 parts carbomer, 1 part sodium carboxymethyl cellulose, 85 parts purified water;

[0067] The preparation method is as in Example 1.

[0068] Comparative Example 4

[0069] The components of the medical periocular skin sterile liquid dressing of this embodiment are as follows:

[0070] 5 parts of glycerin, 5 parts of propylene glycol, 5 parts of luteolin, 1 part of polyvinyl alcohol, 3 parts of carbomer, 2 parts of kaempferol, 1 part of sodium carboxymethylcellulose, 78 parts of purified water;

[0071] The preparation method is as in Example 1.

[0072] Comparative Example 5

[0073] The components of the medical periocular skin sterile liquid dressing of this embodiment are as follows:

[0074] 5 parts of glycerin, 5 parts of propylene glycol, 0.8 parts of luteolin, 1 part of polyvinyl alcohol, 3 parts of carbomer, 5 parts of kaempferol, 1 part of sodium carboxymethylcellulose, 79.2 parts of purified water;

[0075] The preparation method is as in Example 1.

[0076] Effect Example 1 Cytotoxicity Test of Sterile Liquid Dressing for Periocular Skin

[0077] The medical periocular skin sterile liquid dressings prepared in Examples 1 to 5 were selected for biological evaluation, and the in vitro toxicity of the dressings on cells was evaluated by measuring the inhibitory effect of the dressings on cell growth.

[0078] The specific steps are as follows:

[0079] (1) Culture mouse fibroblasts ATCC CCL-1 (NCTC clone 929) until the end of the logarithmic growth phase when the cells tend to be confluent. Use cell digestion solution to disperse the cells and use cell culture medium to prepare 1×10 4 Take a 96-well culture plate, add 100 μL of cell suspension to each well, gently rotate the culture plate horizontally to evenly disperse the cells on the surface of the wells, and culture at 5% CO2 and 37°C for 24 hours.

[0080] (2) The cells were divided into a control group and an experimental sample group. The blank control group was added with 200 μL of culture medium, and the experimental group was added with 50 μL of medical sterile liquid dressing, and the culture medium was used as a diluent to make up to 200 μL. The cells were cultured for another 24 h.

[0081] (3) The cell morphology was observed using a fluorescence microscope and it was found that the cell morphology in each group was normal.

[0082] (4) Add 10 μL of CCK-8 solution to each well and continue culturing for 4 h.

[0083] (5) The absorbance was measured using an ELISA instrument with a wavelength of 450 nm and a reference wavelength of 630 nm.

[0084] (6) Test results: as shown in Table 1.

[0085] Table 1 Cytotoxicity test results (Mean±SD, n=4)

[0086] Example 1 Example 2 Example 3 Example 4 Example 5 Control group Survival rate (%) 97.12±0.14 96.87±0.21 97.66±0.25 98.19±0.31 98.23±0.11 97.24±0.19

[0087] From the cell survival rate results in Table 1, it can be seen that the cell proliferation rate of the medical periocular skin sterile liquid dressing prepared in the embodiment is not significantly different from that of the control group (P>0.05), indicating that the medical periocular skin sterile liquid dressing of the present application has no obvious cytotoxicity and good cell compatibility.

[0088] Effect Example 2: Sensitization Test of Sterile Liquid Dressing for Periocular Skin

[0089] The medical periocular skin sterile liquid dressings prepared in Example 2 and Comparative Example 1 were subjected to a skin sensitization test, and the specific test steps are as follows:

[0090] 1. Animals: 24 white guinea pigs weighing 300±30 g and aged 2.5 months were selected as experimental subjects.

[0091] 2. Processing:

[0092] Divide them into a blank control group, a first treatment group (200 μL of Example 2 dressing treatment), a second treatment group (200 μL of Comparative Example 1 dressing treatment), and a positive control group, with 6 animals in each group. Among them, the blank control group was coated with 200 μL of purified water, and the positive control group was coated with 200 μL of 0.5% formaldehyde. Each coating lasted for 6 hours, and was repeated once on the 7th and 14th days. Use barium sulfide for depilation 24 hours before coating, and the depilation area is 10% of the body surface area. After the last coating on the 14th day, feed normally for 14 days, then depilate the opposite side of the original test area of ​​each guinea pig, apply 200 μL of each of the above solutions, seal and fix for 6 hours, and compare the local skin erythema, edema, and blisters immediately and at 24, 48, and 72 hours after the test animals are eluted with physiological saline to determine the sensitization intensity.

[0093] Mean response value = (total score of erythema formation + total score of edema formation) / number of animals;

[0094] Skin sensitization reaction scoring is carried out according to the standards in Table 2:

[0095] Table 2 Scoring criteria for skin sensitization

[0096]

[0097]

[0098] After the skin reaction was scored according to the standard, the skin irritation was evaluated according to the difference in reaction between the experimental group and the control group guinea pigs according to the following standards: 0.00-0.49, no irritation; 0.50-2.99, slight irritation; 3.00-5.99, moderate irritation; 6.00-8.00, severe irritation.

[0099] 3. The results are shown in Table 3:

[0100] Table 3 Effects of dressings on guinea pig skin allergic reactions (n=6)

[0101]

[0102] It can be seen from the results in Table 3 that the dressings prepared in this embodiment and the comparative example do not contain allergens, have no skin irritation reaction, do not cause skin allergic reaction, and have good biological safety.

[0103] Effect Example 3: In vitro antibacterial test of sterile liquid dressing for periocular skin

[0104] Experimental materials: medical sterile liquid dressings for periocular skin prepared in Examples 1 to 6 and Comparative Examples 1 to 5.

[0105] The specific steps are as follows:

[0106] (1) Pick 4 to 5 Escherichia coli, Staphylococcus aureus, Pseudomonas aeruginosa, and Streptococcus from the blood plate culture incubated for 18 to 24 hours and make 1 to 2 × 10 8 cfu / mL bacterial suspension. Use a cotton swab to apply the bacterial suspension on the MH plate in three directions (rotate 60 degrees) to ensure that the inoculum is evenly distributed. Finally, apply the cotton swab around the edge of the plate. Cover the plate and dry it at room temperature for 5 minutes.

[0107] (2) Pipette 20 μL of sterile dressing and place the sterilized dressing in a counterclockwise direction starting from the upper right corner of the MH plate. Place the plate in a 37°C constant temperature incubator and incubate for 16 to 18 hours. Use a vernier caliper to measure the size of the inhibition zone.

[0108] (3) The experimental results are shown in Table 4.

[0109] Table 4 Inhibition zone of medical sterile liquid dressing for periocular skin (mm)

[0110]

[0111]

[0112] As shown in Table 4, the dressings of Examples 1 to 6 of the present invention have obvious antibacterial zones, have good antibacterial properties against Escherichia coli, Staphylococcus aureus, Pseudomonas aeruginosa and Streptococcus, and can effectively inhibit the growth of microorganisms. In Example 2, the antibacterial zone of Escherichia coli can reach 15.36 mm, the antibacterial zone of Staphylococcus aureus can reach 13.25 mm, the antibacterial zone of Pseudomonas aeruginosa can reach 12.16 mm, and the antibacterial zone of Streptococcus can reach 12.97 mm.

[0113] Each comparative example has a single variable compared with Example 2, wherein, in Comparative Example 1, no luteolin was added, and the antibacterial ability of the dressing was significantly reduced; in Comparative Example 2, no kaempferol was added, and the antibacterial ability of the dressing was significantly reduced; in Comparative Example 3, no luteolin and kaempferol were added, and the antibacterial ability of the dressing was the lowest; in Comparative Example 4, too much luteolin was added, which was toxic to bacteria through a non-specific mechanism, affecting its inhibitory effect on specific microorganisms; in Comparative Example 5, too much kaempferol was added, which destroyed the synergistic effect with luteolin, resulting in the antibacterial effect being inferior to that of the example.

[0114] Effect Example 4: Anti-inflammatory Effect Test of Medical Periocular Sterile Liquid Dressing

[0115] Experimental materials: medical sterile liquid dressings for periocular skin prepared in Examples 1 to 6 and Comparative Examples 1 to 5.

[0116] Experimental subjects: Mouse macrophages RAW264.7.

[0117] The specific steps are as follows:

[0118] (1) Take mouse macrophages in good growth condition and adjust the cell density to 1×10 6 / mL was inoculated into a 24-well culture plate, and after the cells grew to 80% confluence, 50 μL of the dressing prepared in different embodiments and comparative examples was added, and the LPS group was stimulated by adding 50 μL of DMEM medium and incubating for 2 hours, and then LPS (final concentration of 1 μg / mL) was added, and the control group was not treated with LPS. After stimulation, the culture was continued for 24 hours, and the cell culture supernatant of each group was collected, and the cytokine content in the supernatant was detected using TNF-α and IL-6 Elisa kits.

[0119] (2) The test results are shown in Table 5.

[0120] Table 5 Effects of sterile liquid dressing treatment on the expression of TNF-α and IL-6 in periocular skin

[0121] Group TNF-α(pg / mL) IL-6 (pg / mL) Control group 314.74±15.93 105.94±26.17 LPS group 5294.05±140.84 786.49±33.36 Example 1 4150.42±158.93** 647.38±24.72* Example 2 3943.33±243.28** 593.84±22.81** Example 3 4311.95±293.82** 623.85±52.76** Example 4 4762.46±265.96** 701.92±43.92* Example 5 4513.74±153.95** 693.86±56.43* Example 6 3971.19±425.93** 700.43±14.80* Comparative Example 1 5049.35±204.36 723.81±37.94 Comparative Example 2 4935.82±318.95 738.55±36.97 Comparative Example 3 5167.93±351.82 747.99±44.94 Comparative Example 4 4583.14±276.92* 713.25±15.62* Comparative Example 5 4487.93±382.32* 703.82±25.94*

[0122] Data Indicates, * indicates P<0.05, ** indicates P<0.01.

[0123] The results in Table 5 show that under normal circumstances, the content of TNF-α and IL-6 is low. After LPS stimulation, the expression levels of TNF-α and IL-6 are significantly increased, and after the cells are treated with the dressings prepared by Examples 1 to 6, the expression levels of TNF-α and IL-6 are significantly reduced compared with the LPS group (P<0.01). There is no significant difference in TNF-α and IL-6 treated with the dressings of Comparative Examples 1 to 3, and in Comparative Examples 4 and 5, although the content of TNF-α and IL-6 is reduced, it is not as good as the effect of the embodiment (P<0.05).

[0124] Effect Example 5: The therapeutic effect of sterile liquid dressing for periocular skin on mechanical trauma

[0125] (1) Experimental animals: SD rats, half male and half female, weighing 180-220 g, were housed in a conventional manner at a temperature of 26-28°C.

[0126] (2) Preparation of periocular skin injury model: After SD rats were adaptively fed for 1 day, they were anesthetized by intraperitoneal injection of chloral hydrate (300 mg / kg), and the periocular skin was depilated with 5% sodium sulfide. After disinfection with 75% alcohol cotton balls, two wounds with a diameter of approximately 1 cm were made at the same site around the eyes on both sides of the rats using a special puncher. The circular full-thickness skin was excised and hemostasis was performed. All SD rats were housed in individual cages and had free access to plenty of water.

[0127] (3) Experimental grouping: The SD rats with successful modeling were randomly divided into 5 groups, with 5 rats in each group. 0.5 mL of the dressings of Examples 1 and 2 and Comparative Examples 1 and 2 were applied to the wound surface of each group of rats, respectively. The control group was given normal saline. The dressing was slowly immersed into the wound by dropwise addition with a syringe. After the dressing was applied, the wound surface was repeatedly and gently rubbed to allow the drug to be fully absorbed. Each group was given the dressing once a day for one week.

[0128] (4) Wound healing index: The transparent sulfuric acid film recording method was used to record the wound area at different times after injury. That is, the wound was graphed on translucent paper at 0d, 3d, 5d, and 7d after wound preparation. The graph was then traced onto small square paper. The number of small squares represented the wound area. The wound healing percentage of each wound of each animal at different times was calculated by comparing it with that before the application of the dressing (0d), and the final healing time was recorded.

[0129] Wound healing percentage = [(area before dressing - area after dressing) / area before dressing] × 100%.

[0130] (5) The experimental results are shown in Table 6.

[0131] Table 6 Results of wound healing percentage after treatment with medical sterile liquid dressings

[0132]

[0133]

[0134] Data Indicates, * indicates P<0.05, ** indicates P<0.01.

[0135] As shown in Table 6, 3 days after surgery, the healing rate of the liquid dressing prepared by coating the embodiment was significantly higher than that of the control group (P<0.05), and the wound healing rate gradually increased over time. There was no statistical difference in the healing rate of the liquid dressing prepared by coating the comparative example 3 days after surgery, and the dressing of comparative example 2 had a significant difference after 5 days after surgery, but the healing effect was significantly lower than that of the embodiment. It shows that in the liquid dressing of the embodiment, the treatment of the periocular skin wound of rats by adding luteolin and kaempferol can promote the synthesis of fibroblasts and stimulate angiogenesis, thereby achieving the purpose of not producing scabs, alleviating wound pain, promoting wound healing, and rapidly repairing the dermis. In addition, the liquid dressing of the present application can make the periocular skin wound tissue tend to be moisturized, and can easily infiltrate the injured part in the early stage of wound healing, thereby avoiding unnecessary mechanical damage.

[0136] Effect Example 6 Clinical Treatment Effect of Medical Periocular Skin Sterile Liquid Dressing

[0137] A total of 60 patients with Demodex blepharitis were selected as the research subjects. The patients were diagnosed with Demodex blepharitis through ocular surface symptom examination, slit lamp observation of the eyelid margin and ocular surface, and Demodex examination. The patients were randomly divided into a control group (20 cases) and an experimental group (20 cases in each group). There was no significant difference in the general data between the two groups (P>0.05), which was comparable.

[0138] During the treatment, all patients were forbidden to eat spicy food, and hot compress was applied to the eyes according to the condition. The treatment of the patients in the control group was as follows: 0.915g of metronidazole disodium phosphate injection was added to 43mL of normal saline to prepare a liquid, and an appropriate amount was applied to a cotton swab to scrub the upper and lower eyelid margins and eyelash roots, 2 times / d, 10 times back and forth each time. The experimental group used the dressings prepared in Examples 1 to 2 to scrub the upper and lower eyelid margins and eyelash roots, 2 times / d, 10 times back and forth each time. The treatment cycle was 4 weeks.

[0139] Efficacy criteria:

[0140] Markedly effective: After treatment, the patient's clinical symptoms such as itchy eyes, dry eyes, red eyes, and foreign body sensation in the eyes completely disappeared or improved significantly;

[0141] Effective: After treatment, the patient's clinical symptoms and signs such as itchy eyes, dry eyes, red eyes, and foreign body sensation in the eyes were alleviated;

[0142] Ineffective: After treatment, the patient's clinical symptoms and signs such as itchy eyes, dry eyes, red eyes, and foreign body sensation in the eyes did not improve, and even tended to worsen.

[0143] Total effective rate = (markedly effective + effective) / total number of cases × 100%.

[0144] The results are shown in Table 7. Compared with the control group, *P<0.05.

[0145] Table 7 Comparison of clinical efficacy in patients with blepharitis (%)

[0146]

[0147] As shown in Table 7, compared with the control group, the total effective rate of the dressing prepared in the embodiment was as high as 100%, which was significantly higher than that in the control group. This indicates that the medical periocular skin sterile liquid dressing of the present application has a significant effect on Demodex blepharitis, can remove Demodex mites at the eyelid margin and eyelash root, and relieve blepharitis.

[0148] In summary, the present invention provides a medical periocular skin sterile liquid dressing. According to the results of cytotoxicity tests and animal sensitization tests, the medical sterile liquid dressing of the present invention is safe and non-toxic, does not contain allergens, has no skin irritation reaction, does not cause skin allergic reactions, and has good biosafety. According to the results of in vitro antibacterial and anti-inflammatory tests, the dressing of the present application can effectively inhibit bacterial growth, relieve blepharitis and reduce the possibility of infection of periocular skin wounds, improve the safety of patients, and reduce the incidence of complications. Through anti-inflammatory effects, inflammation of the periocular skin is reduced, the formation of new tissues is promoted, and the quality of wound healing is improved. The sterile liquid dressing of the present application can help deep cleaning of the periocular skin by providing a suitable moist environment and nutrients, remove Demodex mites, secretions and grease at the eyelid margin and eyelash roots, relieve blepharitis and symptoms such as dry eyes caused by it, and promote the proliferation and migration of periocular skin cells, accelerate the healing speed of non-chronic wounds of periocular skin, and reduce the healing time.

[0149] The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. Any modifications, equivalent substitutions, improvements, etc. made within the spirit and principle of the present invention should be included in the protection scope of the present invention.

Claims

1. A medical sterile liquid dressing for periocular skin, characterized in that: In parts by weight, it includes the following components:

2. The medical sterile liquid dressing for periocular skin according to claim 1, characterized in that: The luteolin is 0.5 to 0.8 parts by weight.

3. The medical sterile liquid dressing for periocular skin according to claim 2, characterized in that: The compounding ratio of luteolin to kaempferol is 1:(1-2).

4. The medical sterile liquid dressing for periocular skin according to any one of claims 1 to 3, characterized in that: The pH of the medical sterile liquid dressing for periocular skin is 4.5-6.

5.

5. The method for preparing the medical sterile liquid dressing for periocular skin according to any one of claims 1 to 4, characterized in that: The steps include: (i) Weighing each component by weight, dissolving polyvinyl alcohol, carbomer and sodium carboxymethyl cellulose respectively in purified water at 60 to 80° C., and mixing to obtain solution I; (ii) mixing glycerol, propylene glycol, luteolin and kaempferol, and stirring to obtain a solution II; (iii) mixing solution I and solution II, adjusting the pH of the solution, supplementing with purified water to 100 parts by weight, and performing 0.22 μm sterile filtration to obtain the medical periocular skin sterile liquid dressing.

6. A medical device, medical product or medical drug comprising the medical sterile liquid dressing for periocular skin according to any one of claims 1 to 4.

7. Use of the medical sterile liquid dressing for periocular skin according to any one of claims 1 to 4 in the preparation of dressings for treating blepharitis or non-chronic wounds.

8. The use according to claim 7, characterized in that: The blepharitis is caused by any one of bacterial infection, demodex infection, viral infection, allergic reaction, dermatitis, meibomian gland dysfunction, etc.

9. The use according to claim 7, characterized in that: The non-chronic wound surface is any one of acute trauma, surgical incision, burn, and slightly infected wound.

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