Medical wound surface disinfectant and preparation method thereof

Abstract

The invention belongs to the field of medical disinfectants, and discloses a medical wound surface disinfectant and a preparation method thereof. According to the disinfectant, hydrogen peroxide and silver ions are combined to construct a dual synergistic sterilization system, decomposition of hydrogen peroxide is inhibited through polyvinylpyrrolidone and a sodium citrate stabilizer, and a polyvinyl alcohol-acrylic acid copolymer or a carbomer slow-release carrier is introduced to realize long-acting sterilization for 12 hours; meanwhile, hydroxypropyl methyl cellulose, glycerol or urea is adopted to adjust the viscosity so as to ensure wound coverage and permeation, and a repairing agent is matched to promote epithelium regeneration. The disinfectant can quickly and efficiently sterilize pathogenic bacteria, has no irritation to skin and oral mucosa, is mild and reliable in effect, and can accelerate wound healing.

Description

TECHNICAL FIELD

[0001] The present application belongs to the field of medical disinfectant, and particularly relates to a medical wound surface disinfectant and a preparation method thereof. BACKGROUND

[0002] With the continuous improvement of medical level and the increasingly prominent problem of antibiotic resistance, the importance of medical wound surface disinfectant in preventing wound infection and promoting wound healing is increasingly prominent. The existing medical disinfectant is mainly alcohol, iodophor and single hydrogen peroxide, which can reduce the bacterial load in a short time, but has the limitations of strong concentration dependence, insufficient penetration of anaerobic bacteria and biofilm, easy irritation of new tissues, and short effective duration; silver ions and their derivative preparations have good bactericidal spectrum, but are difficult to be used alone due to fast ion inactivation, photosensitive discoloration, high cost and potential pigmentation problems. Especially in the environment of diabetic foot ulcers, burns and scalds, radiation dermatitis and oral mucosal ulcers, pathogenic bacteria show diversification and drug resistance, and the local microcirculation is poor, the pH is alkaline, and the immune factors are insufficient, so that the traditional single-target disinfectant is difficult to achieve rapid sterilization and sustained bacteriostasis. Hydrogen peroxide and silver salt have been tried to be compounded at home and abroad, but there is generally a lack of stable-controlled release system: hydrogen peroxide is rapidly decomposed by temperature and metal ion catalysis, Ag + In the physiological chloride and protein environment, it is precipitated or complexed to be inactivated, resulting in short shelf life of the preparation, great irritation during use, and lack of systematic study on the promotion of collagen maturity and re-epithelialization. On the other hand, although the new wet dressing has the effect of promoting healing, it generally does not have high-efficiency and broad-spectrum bactericidal capacity, and needs to be used in steps with traditional disinfectants, which is complicated in operation, increases the cost, and also increases the risk of secondary infection. SUMMARY

[0003] To solve the problems mentioned in the background, the present application aims to provide a medical wound surface disinfectant and a preparation method thereof. The disinfectant realizes broad-spectrum and efficient inactivation of aerobic bacteria, anaerobic bacteria, fungi and Helicobacter pylori in a very short time through the dual synergistic bactericidal effect of hydrogen peroxide and silver ions; the high-molecular slow-release carrier and the viscosity regulator in the formula synergistically act to significantly prolong the residence and penetration of the disinfectant on the wound surface, and also realize continuous and stable release of the active ingredients for 12 hours, ensuring the sustained bactericidal effect; the polyvinylpyrrolidone and sodium citrate stable system effectively inhibits the spontaneous decomposition of hydrogen peroxide, maintaining the high activity of the product during storage; the added tissue repair factor promotes the proliferation of epithelial cells and the reconstruction of collagen fibers, and combines the disinfection and healing functions organically.

[0004] The purpose of the present application can be achieved by the following technical solutions:

[0005] A medical wound disinfectant and a preparation method thereof. The disinfectant is a water-soluble solution, comprising the following main effective components: hydrogen peroxide 0.1-5.0 wt%; silver ion 0.1-10 mg / L; tissue repair agent 0.01-0.2 wt%; slow-release carrier 0.5-3.0 wt%; viscosity regulator 0.01-1.0 wt%; and carrier water and conventional adjuvants.

[0006] Further preferably, the disinfectant further comprises a stabilizer, and the stabilizer is polyvinylpyrrolidone and sodium citrate, the content of polyvinylpyrrolidone being 0.05-0.2 wt%, and the content of sodium citrate being 0.03-0.1 wt%.

[0007] Further preferably, the disinfectant further comprises 0.01-0.5 wt% of phosphoric acid or phosphate as a buffer to control the pH value of the system within 5.5-6.5.

[0008] Further preferably, the disinfectant further comprises one of phosphoric acid, citric acid and triethanolamine to further enhance the stability of hydrogen peroxide.

[0009] Further preferably, the slow-release carrier is one of polyvinyl alcohol-acrylic acid copolymer or carbomer to achieve the sustained release of hydrogen peroxide and silver ion within 12 h.

[0010] Further preferably, the viscosity regulator is one of hydroxypropyl methylcellulose (HPMC), glycerol or urea.

[0011] Further preferably, the tissue repair agent is one of hyaluronic acid and recombinant human epidermal growth factor to promote wound healing and mucosal repair.

[0012] Further preferably, the raw materials further comprise 0.5-2.0 wt% of propylene glycol, 0.01-0.05 wt% of EDTA, 0.5-2.0 wt% of polysorbate-407 and 0.05-0.2 wt% of ascorbate.

[0013] A preparation method of a medical wound disinfectant, comprising the following steps:

[0014] S1. Adding silver nitrate into deionized water, stirring to dissolve and adding polyvinylpyrrolidone and sodium citrate to obtain a silver ion stable solution;

[0015] S2. In another container, slowly adding 30% hydrogen peroxide stock solution into deionized water to stir and dilute, while adding the buffer, surfactant, viscosity regulator, tissue repair agent, slow-release carrier, propylene glycol, EDTA, polysorbate-407 and ascorbate, stirring to obtain an active oxygen carrier mixture;

[0016] S3. Slowly add the silver ion solution in step S1 to the active oxygen carrier mixture in step S2, stir the mixture, and then adjust the pH to 5.5-6.5;

[0017] S4. Filter under sterile conditions using a 0.22 μm microfiltration membrane, and then distribute into dark containers, seal, and obtain the product.

[0018] Further preferably, the step S3 dropwise adding speed is 0.5-2.0 mL / min, the stirring speed is 200-400 rpm, and the duration is 10-30 min.

[0019] The beneficial effects of the present application are:

[0020] The medical wound disinfectant prepared by the present application is through the "hydrogen peroxide-silver ion" dual pathway synergy, so that the active oxygen destroys the cell wall and cell membrane and oxidizes nucleic acid in seconds, and then the free Ag + binds to the key thiol proteins and respiratory enzymes of microorganisms, blocks the metabolic chain, and thus achieves a broad-spectrum killing of bacteria, fungi, anaerobes, and spores >99.99% in one minute. The polyvinyl alcohol-acrylic acid copolymer or carbomer three-dimensional gel and the PVP-sodium citrate complex system together construct an "oxygen-silver" micro-acid slow-release microenvironment, which can stably control the hydrogen peroxide and Ag + 12h gradual release, which not only inhibits active self-consumption but also maintains a long-acting sterile barrier on the wound surface; the viscosity regulator ensures that the liquid medicine uniformly covers and deeply penetrates the wound surface; and the tissue repair factor promotes epithelial cell proliferation and collagen reconstruction, organically fusing the disinfection and healing functions; and the product has no irritation to the skin and mucous membrane, does not contain alcohol or organic solvents, and is mild and safe; the process only needs four steps of simple stirring, pH regulation, and sterile filtration, which is convenient for large-scale production and quality control, and has multiple advantages of quick-acting, long-acting, low irritation, and repair promotion, thereby providing an ideal solution for various wound disinfection and nursing in hospitals, communities, and families. BRIEF DESCRIPTION OF DRAWINGS

[0021] In order to more clearly illustrate the technical solutions in the embodiments of the present application or the prior art, the following will briefly introduce the drawings needed to be used in the embodiment or prior art description. Obviously, for those skilled in the art, other drawings can also be obtained without creative labor based on these drawings.

[0022] Figure 1 is a representative photo of the wound surface under the treatment of different disinfectants in the performance test 6 of the present application, i.e., the diabetic foot ulcer healing test. DETAILED DESCRIPTION

[0023] The technical solutions in the embodiments of the present application will be clearly and completely described below with reference to the embodiments of the present application. Obviously, the described embodiments are only part of the embodiments of the present application, rather than all the embodiments of the present application. Based on the embodiments of the present application, all other embodiments obtained by a person of ordinary skill in the art without creative work fall within the protection scope of the present application.

[0024] Embodiment 1

[0025] A medical wound surface disinfectant, and a preparation method thereof are disclosed.

[0026] The medical wound surface disinfectant comprises the following raw materials in the following amounts: hydrogen peroxide (30% stock solution diluted): 2.0 wt%; silver nitrate: 0.008 wt%; polyvinylpyrrolidone (PVP): 0.10 wt%; sodium citrate: 0.05 wt%; polyvinyl alcohol-acrylic acid copolymer: 1.00 wt%; hydroxypropyl methyl cellulose (HPMC): 0.50 wt%; hyaluronic acid: 0.10 wt%; propylene glycol: 0.50 wt%; EDTA: 0.01 wt%; polysorbate-407: 0.50 wt%; ascorbate: 0.05 wt%; and deionized water: the balance to 100%.

[0027] The preparation method of the medical wound surface disinfectant comprises the following steps.

[0028] 40 mL of deionized water was taken in a reaction kettle, 0.008 g of silver nitrate was added under 4°C ice bath, and stirred at 300 rpm for 10 min; 0.10 g of PVP and 0.05 g of sodium citrate were added in sequence, and stirred at 300 rpm for 20 min.

[0029] In a 80°C water bath, 1.00 g of copolymer was added to 20 mL of deionized water, and stirred at 500 rpm for 30 min; after cooling to 25°C, 0.50 g of HPMC, 0.10 g of hyaluronic acid, 0.50 g of propylene glycol, 0.01 g of EDTA, 0.50 g of polysorbate-407 and 0.05 g of ascorbate were added, and stirred at 300 rpm for 15 min to prepare a multifunctional sustained-release matrix.

[0030] 6.67 mL of 30% hydrogen peroxide was slowly added to the above sustained-release matrix, and stirred at 200 rpm for 10 min; then the silver ion stabilizing solution was added to the mixing system at a speed of 1.0 mL / min, and stirred at 250 rpm for 30 min; the pH was adjusted to 6.0 with 0.1M NaOH or HCl. The mixture was sterile filtered with a 0.22μm PES microfiltration membrane under sterile conditions, and was divided into 50 mL dark glass bottles, and sealed to obtain the medical wound surface disinfectant.

[0031] Embodiment 2

[0032] The preparation method of the medical wound surface disinfectant is as follows:

[0033] The medical wound surface disinfectant comprises the following ingredients: hydrogen peroxide (30% stock solution diluted): 2.00wt%; silver nitrate: 0.012wt%; polyvinylpyrrolidone (PVP): 0.20wt%; polysorbate-80 (Tween-80): 0.05wt%; triethanolamine: 0.02wt%; carbomer 934: 2.00wt%; glycerol: 0.30wt%; recombinant human epidermal growth factor (rhEGF): 0.05wt%; propylene glycol: 2.0wt%; EDTA: 0.05wt%; polysorbate-407: 2.0wt%; ascorbate: 0.2wt%; deionized water: the balance to 100%.

[0034] The preparation method of the medical wound surface disinfectant comprises the following steps:

[0035] Prepare 20mL deionized water in a glass beaker, and place it in a 60°C water bath; accurately weigh 0.05mL Tween-80 and 0.02g triethanolamine, add them to the beaker, and stir at 400rpm for 10min until completely dissolved; add 2.00g carbomer 934 and 0.30g glycerol to the same beaker in sequence, and continue stirring at 400rpm for 20min to obtain a uniform emulsion colloid.

[0036] Cool the above emulsion base to 25°C, accurately weigh 0.012g silver nitrate and 0.20g PVP, and add them to the emulsion colloid, and stir at 300rpm for 30min; then add 0.05g rhEGF, 2.0g propylene glycol, 0.05g EDTA, 2.0g polysorbate-407, and 0.2g ascorbate, and continue stirring at 300rpm for 10min to obtain a silver ion-protein composite emulsion.

[0037] In another clean container, take 20mL deionized water, and slowly add 6.67mL 30% hydrogen peroxide stock solution to make the system reach a hydrogen peroxide concentration of 2.00wt%; add the silver ion-protein composite emulsion to the hydrogen peroxide solution at a rate of 0.8mL / min, and stir at 350rpm for 25min; adjust the pH to 5.8 with 0.1M HCl or NaOH. Sterile filter with a 0.22μm PES microfiltration membrane, and divide into 50mL dark glass bottles, and seal to obtain the medical wound surface disinfectant.

[0038] Example 3

[0039] The preparation method of the medical wound surface disinfectant is as follows:

[0040] The medical wound surface disinfectant liquid comprises the following raw materials in the following amounts: hydrogen peroxide: 2.0 wt%; silver nitrate: 0.006 wt%; hydroxypropyl methyl cellulose (HPMC): 1.00 wt%; urea: 0.50 wt%; glycerol: 0.10 wt%; polyvinyl alcohol-acrylic acid copolymer: 1.50 wt%; citric acid: 0.02 wt%; propylene glycol: 1.25 wt%; EDTA: 0.03 wt%; polysorbate-407: 1.25 wt%; ascorbate ester: 0.125 wt%; deionized water: the balance to 100%.

[0041] The preparation method of the medical wound surface disinfectant liquid comprises the following steps:

[0042] Take 30 mL of deionized water in a beaker, add 0.30 g of hydroxypropyl methyl cellulose (HPMC), 0.15 g of urea and 0.03 g of glycerol, stir at 360 rpm for 30 min until completely dissolved and form a uniform viscous solution. Then add 0.45 g of polyvinyl alcohol-acrylic acid copolymer, stir at 300 rpm for 20 min to obtain a viscous matrix.

[0043] Add 0.006 g of silver nitrate to the above viscous matrix, stir at 300 rpm for 15 min until it is completely dissolved. Add 0.02 g of citric acid, then add 1.25 g of propylene glycol, 0.03 g of EDTA, 1.25 g of polysorbate-407 and 0.125 g of ascorbate ester, continue to stir at 300 rpm for 5 min to stabilize the system and adjust the pH.

[0044] Slowly add 6.67 mL of 30% hydrogen peroxide stock solution to the viscous matrix, stir at 250 rpm for 30 min to ensure uniform dispersion. Adjust to pH 6.2 using 0.1 M NaOH or HCl. Sterile filter with 0.22 μm PES microfiltration membrane, and store in 50 mL dark glass bottles, seal, and the medical wound surface disinfectant liquid is obtained.

[0045] Comparative Example 1

[0046] The medical wound surface disinfectant liquid comprises the following raw materials in the following amounts: hydrogen peroxide: 2.0 wt%; triethanolamine: 0.05 wt%; propylene glycol: 1.25 wt%; EDTA: 0.03 wt%; polysorbate-407: 1.25 wt%; ascorbate ester: 0.125 wt%; deionized water: the balance to 100%.

[0047] Take 100 mL of sterile deionized water in a clean stainless steel container, keep room temperature (25℃); use a graduated pipette to take 6.00 g (corresponding to 1.8 wt%) of 30% hydrogen peroxide stock solution, slowly drop into the deionized water; gently stir for 5 min, make the hydrogen peroxide evenly dispersed, then add 1.25 g of propylene glycol, 0.03 g of EDTA, 1.25 g of polysorbate-407 and 0.125 g of ascorbate, continue stirring at 300 rpm for 5 min, measure the pH of the mixture with a calibrated pH meter; if the pH > 6.2, slowly add 0.1 M triethanolamine solution until the pH is 6.0 ± 0.2, if the pH < 5.8, then titrate with a small amount of 0.1 M hydrochloric acid to pH 6.0 ± 0.2; gently stir again for 2 min. Sterile filter with 0.22 μm PES microfiltration membrane, dispense into 50 mL dark glass bottles, seal, and the medical wound disinfectant is obtained.

[0048] Performance test

[0049] The medical wound disinfectant prepared in Examples 1-3 and Comparative Example 1 was tested as follows:

[0050] 1. Hydrogen peroxide content and stability test

[0051] The disinfectant prepared in Examples 1-3 and Comparative Example 1 was tested according to the test standard of “Disinfection Technical Specification” (2002 edition), and the results are shown in Table 1.

[0052] (2002 edition), and the results are shown in Table 1.

[0053] Table 1: Hydrogen peroxide content and stability results of disinfectant

[0054]

[0055] As shown in Table 1, the hydrogen peroxide content of the disinfectant of the three examples decreased by 7.8%, 6.5% and 5.9% respectively after being stored at 37℃ for 90 days, which was significantly lower than the 19.2% decrease rate of Comparative Example 1. Specifically, the hydrogen peroxide content of Example 1 decreased from 2.17% to 2.00%; Example 2 decreased from 2.155% to 2.015%; and Example 3 decreased from 2.185% to 2.055%, all of which remained above 92% of the initial content; while Comparative Example 1 decreased from 1.80% to 1.455%, with less than 81% of the remaining activity. This result fully proves that PVP and sodium citrate form a complex with silver ions and hydrogen peroxide, reducing the self-catalytic decomposition rate, and the three-dimensional gel network gradually releases active oxygen, reducing the inactivation of molecules caused by excessive exposure. Compared with the traditional single hydrogen peroxide formula, the examples of the present application have a significant advantage in formulation stability, ensuring the high and lasting effect of the product in actual storage and use.

[0056] 2. Residual bactericidal activity test at 12 hours

[0057] A suspension of 1 x 106CFU / mL of S. aureus was uniformly coated on sterilized stainless steel pieces, and the disinfectant solutions of Examples 1-3 and Comparative Example 1 were sprayed thereon. After air-drying at room temperature, samples were taken at 1 h, 4 h, 8 h, and 12 h, respectively, and inoculated into culture medium after being swabbed with sterile cotton swabs. The number of colonies (CFU) was counted, and the results are shown in Table 2 below:

[0058] Table 2. Results of residual bactericidal activity test at 12 hours

[0059]

[0060] The disinfectant solutions of Examples 1-3 can rapidly reduce the number of colonies to

[0061] <10 CFU within 1 h, and maintain a significantly low level of bacterial concentration throughout the 12 h monitoring period, exhibiting excellent long-acting bactericidal performance. The initial release of high-concentration active oxygen and silver ions achieves instant killing, and the remaining components are gradually released by the reticular gel to continuously inhibit bacterial growth. In contrast, the disinfectant solution of Comparative Example 1 rapidly loses its bacteriostatic efficacy due to the lack of a stable and controlled-release design, and the active ingredients are rapidly volatilized or degraded.

[0062] 3. Broad-spectrum antibacterial performance test

[0063] Suspensions of common pathogenic bacteria S. aureus, P. aeruginosa, C. albicans, H. pylori, and C. difficile (all at a density of 1 x 10^6 CFU / mL) were mixed with the disinfectant solutions at a volume ratio of 1:10, and after 1 min of action, a neutralizing agent was added, gradient dilution was performed, and plate counting was carried out to calculate the number of residual pathogenic bacteria. The results are shown in Table 3 below:

[0064] Table 3. Results of broad-spectrum antibacterial performance test

[0065] pathogenic bacteria Example 1 Example 2 Example 3 Comparative Example 1 Staphylococcus aureus 8 12 7 150 Pseudomonas aeruginosa 10 14 9 180 Candida albicans 20 25 18 200 Helicobacter pylori 30 35 28 240 Clostridium difficile 50 60 45 260

[0066] From the surviving bacterial colony counts of each strain after 1 min of the above Table 1, it can be seen that the Examples 1-3 achieve ultra-high efficient sterilization of five common aerobic, microaerophilic and anaerobic pathogens, Staphylococcus aureus, Pseudomonas aeruginosa, Candida albicans, Helicobacter pylori and Clostridium difficile, with sterilization rates exceeding 99.99%. In contrast, the traditional single hydrogen peroxide disinfectant still has a residual bacterial count of more than 150 CFU / mL under the same conditions, with a sterilization rate of about 99.98%, and a lower sterilization rate for Helicobacter pylori and Clostridium difficile. This shows that the disinfectant prepared in the examples can ensure rapid synergy of high peak active oxygen and silver ions, and form a slightly acidic environment and controlled release layer in a very short time, enhancing the sustained inhibition of various pathogens, producing rapid and persistent broad-spectrum killing of bacteria, fungi and anaerobes in a short time, providing strong protection for high-risk infection scenarios such as surgical wounds, oral cavity and diabetic foot.

[0067] 4. Wound healing test

[0068] Select 80 SPF Kunming mice (22±2g), randomly divided into Examples 1, 2, 3, and Comparative Example 1, a total of 4 groups, 20 in each. Full-thickness incision (deep to subcutaneous fascia) was made on the back of the mice, local anesthesia during operation, and single antibiotic after operation to prevent infection. Quickly drop and apply 0.2 mL of corresponding disinfectant for each group; then treat the same amount once a day until the wound is completely covered by new epithelium. Record the number of days required for each animal to heal the wound, and calculate the shortest, longest and average healing time, the results of which are shown in Table 4 below.

[0069] Table 4 Wound healing test results

[0070] Group Shortest time (d) Longest time (d) Average time (d) Example 1 4 7 5±1 Example 2 5 8 6±1 Example 3 5 9 6±2 Comparative Example 1 8 14 11±2

[0071] As can be seen from Table 4, the average healing time of Examples 1-3 is 5-6 days, and that of Comparative Example 1 is 11 days; the slowest healing of the Example group is 9 days, while the longest healing of the comparative example is 14 days. This shows that the disinfectant of the examples significantly accelerates tissue repair on the basis of antibacterial activity, shortening the wound healing period by about 40-50%, and embedding tissue repair factors, promoting cell migration and matrix remodeling, accelerating epithelial cell coverage, fully embodying its dual effects of long-acting sterilization and wound healing promotion.

[0072] 5. Oral mucosa wound healing test

[0073] A three-dimensional oral mucosa model was constructed using TR146 cells, laser drilling was used to create a standardized ulcer with a diameter of 2 mm and a depth of 200 μm, and the disinfectants prepared in Examples 1-3 and Comparative Example 1 and normal saline (control group) were used to treat the wound and determine the real-time cell analysis of the ulcer wound and the mucosal protective mucin content (MUC5AC) and active oxygen clearance rate (ROS). The results are shown in Table 5 below.

[0074] Table 5 Results of oral mucosa wound healing test

[0075]

[0076] From the comprehensive results of the TR146 oral mucosa wound model, it can be seen that the disinfectant prepared in Examples 1-3 is significantly better than Comparative Example 1 and the negative control in terms of wound repair, barrier reconstruction, and antioxidant protection in three dimensions.

[0077] The amount of MUC5AC secretion is a key indicator of mucosal protective layer reconstruction. Example 2 secreted 14.3±1.5 μg / mL at 24 h, with an increase of more than 130% compared to the comparative group, indicating that the PVP-sodium citrate stable system and slow-release carrier not only maintains the safe bactericidal effect of active oxygen-silver ions, but also stimulates the secretion of goblet cells through a wet matrix and growth factors, improving mucosal lubrication and barrier function.

[0078] The 24-hour re-epithelialization rate (up to 72±5%) and 48-hour trans-epithelial electrical resistance (TEER) recovery value (up to 310±12 Ω·cm 2 ) of the disinfectant treatment group of the application are much higher than those of the comparative example and the negative control, indicating that the disinfectant of the examples can efficiently promote the physical healing of the wound and quickly restore the integrity of the barrier function of the oral mucosa. The disinfectant prepared in the examples can stimulate the secretion of protective mucin and efficiently remove active oxygen (with a removal rate of up to 88±2%), indicating that the disinfectant of the examples not only can repair existing physical damage, but also can accelerate the healing process by enhancing the defense mechanism of the mucosa itself and providing an antioxidant environment.

[0079] 6. Diabetic foot ulcer healing test

[0080] Inoculate multiple drug-resistant Staphylococcus aureus (1×10 6 CFU / wound) on the wound of mice, and use the disinfectants prepared in Examples 1-3 and Comparative Example 1 and normal saline (control group) to treat the wound of mice. Before changing the dressing at 0, 3, 5, 7, and 14 days, take photos of the wound using a digital camera with a ruler and measure and calculate the wound area and healing rate using ImageJ software. At 1, 3, 7, 10, and 14 days, use the IVIS Spectrum near-infrared imaging system to perform in vivo imaging of the wound of mice, and non-invasively monitor the intensity and distribution of bacterial load in the wound by detecting the fluorescence of MRSA itself or exogenous probe signals. At 14 days, analyze the healing quality (collagen proportion) of the wound, and the results are shown in Table 6 below.

[0081] Table 6 Results of diabetic foot ulcer healing

[0082]

[0083] From the above table, it can be seen that in terms of wound healing, the effect of the example group is better than that of the comparative example and the control group. By the 14th day, the healing rate of the example group is more than 92%, and the wound is basically completely closed, while the healing rate of the comparative example and the control group is only 75% and 65%, indicating that the disinfectant solution of the example can effectively accelerate the closure of the wound and shorten the healing period by at least one week. And the MRSA light flux value of the wound of the example 1-3 group is maintained at a low level, indicating that it can effectively eliminate drug-resistant bacteria and control wound infection. In terms of healing quality, the collagen type I / III ratio of the example group is significantly higher than that of the comparative example and the control group, which means that the newly generated tissue of the wound is more mature, has less scar, better mechanical strength and higher healing quality. In summary, the disinfectant solution prepared by the example can more efficiently resist infection, rapidly promote wound healing and has high-quality tissue regeneration ability.

[0084] The above description is only a preferred specific embodiment of the present application, but the protection scope of the present application is not limited thereto, any person skilled in the art can make equivalent replacement or change according to the technical solution and the inventive concept of the present application within the technical range disclosed by the present application, which should be covered in the protection scope of the present application.

Claims

1. A medical wound disinfectant, characterized in that, The disinfectant solution is a water-soluble solution comprising raw materials in the following weight ratios: hydrogen peroxide 0.1-5.0 wt%; silver ions 0.1-10 mg / L; tissue repair agent 0.01-0.2 wt%; sustained-release carrier 0.5-3.0 wt%; viscosity regulator 0.01-1.0 wt%; carrier water; and conventional adjuvants.

2. The medical wound and burn disinfectant solution according to claim 1, characterized in that, The disinfectant solution further comprises a stabilizer, and the stabilizer is polyvinylpyrrolidone and sodium citrate, the content of polyvinylpyrrolidone being 0.05-0.2 wt%, and the content of sodium citrate being 0.03-0.1 wt%.

3. The medical wound and burn disinfectant solution according to claim 1, characterized in that, The disinfectant solution further comprises 0.01-0.5 wt% of phosphoric acid or phosphate as a buffer to control the pH of the system to 5.5-6.

5.

4. The medical wound and burn disinfectant solution according to claim 1, characterized in that, The disinfectant solution further comprises one of phosphoric acid, citric acid, and triethanolamine.

5. The medical wound and burn disinfectant solution according to claim 1, wherein The sustained-release carrier is one of polyvinyl alcohol-acrylic acid copolymer or carbomer.

6. The medical wound and burn disinfectant solution according to claim 1, wherein The viscosity regulator is one of hydroxypropyl methylcellulose (HPMC), glycerol, or urea.

7. The medical wound and burn disinfectant solution according to claim 1, wherein The tissue repair agent is one of hyaluronic acid and recombinant human epidermal growth factor (rhEGF).

8. The medical wound and burn disinfectant solution according to claim 1, wherein The raw materials further comprise 0.5-2.0 wt% of propylene glycol, 0.01-0.05 wt% of EDTA, 0.5-2.0 wt% of polysorbate-407, and 0.05-0.2 wt% of ascorbate.

9. A method for the preparation of a medical wound and surface disinfectant solution as claimed in any one of claims 1 to 8, characterized in that The method comprises the following steps: S1. Silver nitrate is added to deionized water, stirred and dissolved, and polyvinylpyrrolidone and sodium citrate are added to obtain a silver ion stable solution; S2. In another container, 30% hydrogen peroxide stock solution is slowly added to deionized water under stirring and dilution, and the buffer, surfactant, viscosity regulator, tissue repair agent, sustained-release carrier, propylene glycol, EDTA, polysorbate-407, and ascorbate are added and stirred uniformly to obtain an active oxygen carrier mixture; S3. The silver ion solution in step S1 is slowly added dropwise to the active oxygen carrier mixture in step S2, and after stirring and mixing, the pH is adjusted to 5.5-6.5; S4. Under sterile conditions, the solution is filtered using a 0.22 μm microfiltration membrane, and is then divided and packaged into dark containers, and is sealed to obtain the product.

10. The method of claim 9, wherein the medical wound surface disinfectant is prepared by adding 0.1 to 0.3 parts by weight of the surfactant to 100 parts by weight of the alcohol. The dropwise addition rate in step S3 is 0.5-2.0 mL / min, the stirring rate is 200-400 rpm, and the duration is 10-30 min.

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