A detoxification and repair medical dressing for treating and relieving stubborn vulva leukoplakia and a preparation method thereof

Abstract

The application provides a detoxification and repair medical dressing for treating and relieving stubborn vulvar leukoplakia and a preparation method thereof, and relates to the technical field of gel dressings. The medical dressing is composed of a gel component and a composite antibacterial repair component, and the composite antibacterial repair component is composed of modified corn starch, anise camphene, eugenol, algal polysaccharide and Gynura japonica fermented inactivated extract. The Gynura japonica fermented inactivated extract is obtained by fermenting Gynura japonica with Bacillus subtilis and lactic acid bacteria and then inactivating. The application overcomes the shortcomings of the prior art, can effectively relieve itching during the treatment of vulvar leukoplakia under the premise of having an antibacterial effect, shortens the overall treatment cycle, and improves the comfort of treatment.

Description

Technical Field

[0001] This invention relates to the field of gel dressing technology, specifically to a detoxifying and repairing medical dressing for treating and alleviating stubborn vulvar leukoplakia and its preparation method. Background Technology

[0002] Vulvar dystrophy, also known as vulvar leukoplakia, vulvar intraepithelial non-neoplastic lesion, or vulvar leukoplakia, is a chronic and common disease in women, characterized by degeneration and pigmentation changes in the skin and mucous membranes of the vulva. It has a long course, is difficult to cure, and is prone to recurrence. Furthermore, the pathogenesis of vulvar dystrophy remains unclear.

[0003] Currently, clinical treatments for vulvar leukoplakia include medication, ultrasound therapy, microwave therapy, hyperbaric oxygen therapy, laser therapy, warm acupuncture, and surgery. Considering comfort, convenience, and safety, most patients choose medication. Common medications for vulvar leukoplakia include corticosteroids, immunomodulators, antitumor drugs, sex hormones, and traditional Chinese medicine. During medication treatment, the affected area undergoes a certain repair period, during which peeling and itching may occur. This period is known as the detoxification period. During this time, itching intensifies, and discomfort increases significantly, causing considerable disruption to daily life and treatment. Therefore, alleviating these symptoms during the detoxification period is a major research focus in vulvar leukoplakia treatment. Summary of the Invention

[0004] To address the shortcomings of existing technologies, this invention provides a detoxifying and repairing medical dressing for treating and alleviating stubborn vulvar leukoplakia, and its preparation method. It can effectively relieve itching during the treatment of vulvar leukoplakia while having antibacterial effects, and shorten the overall treatment cycle and improve the comfort of treatment.

[0005] To achieve the above objectives, the technical solution of the present invention is implemented through the following technical solution:

[0006] A detoxifying and repairing medical dressing for treating and alleviating stubborn vulvar leukoplakia, the medical dressing being composed of a gel component and a compound antibacterial and repairing component in a mass ratio of 1:0.1-0.4; the compound antibacterial and repairing component is composed of the following substances in parts by weight: 4-6 parts modified corn starch, 0.8-1.2 parts anethole, 0.2-0.6 parts eugenol, 1-3 parts seaweed polysaccharide, and 1-1.6 parts Centella asiatica fermentation inactivated extract; the modified corn starch is obtained by completely gelatinizing corn starch and then modifying it by steam explosion; the Centella asiatica fermentation inactivated extract is obtained by fermenting Centella asiatica with Bacillus subtilis and lactic acid bacteria and then inactivating it; the gel component is made of xanthan gum, lithium chloride, hydroxypropyl carboxymethyl cellulose, chitosan carbomer, and glycerin.

[0007] Preferably, the specific preparation method of the modified corn starch includes the following steps:

[0008] S1-1. Mix corn starch with deionized water and stir at 75-85℃ for 30-60 minutes to obtain a fully gelatinized slurry for later use.

[0009] S1-2. After freeze-drying the above fully gelatinized slurry, grind and pulverize it through a 40-mesh sieve, then steam-explode it at 119°C for 60-80 seconds, and then dry it to obtain modified corn starch.

[0010] Preferably, the preparation method of the Centella asiatica fermentation inactivated extract includes the following steps:

[0011] S2-1. Add Centella asiatica to 3-5 times the amount of deionized water and grind it into a slurry. Then, repeatedly freeze and thaw 2-3 times to obtain a preliminary slurry for later use.

[0012] S2-2. Add Bacillus subtilis and lactic acid bacteria to the initial slurry and ferment at 38±2℃ for 2-4 days. Then press and filter. Add 2-3 times the amount of deionized water to the filter residue, ultrasonically vibrate, and press and filter again. Combine the two filtrates for later use.

[0013] Preferably, in step S2-3, the above filtrate is concentrated by rotary evaporation to 20-40% of its original volume, then sterilized at 121°C for 15-20 minutes, and then freeze-dried to obtain the Centella asiatica fermentation inactivated extract.

[0014] Preferably, in step S2-2, the amount of Bacillus subtilis and lactic acid bacteria added is 0.2%-0.5% of the total mass of the initial slurry.

[0015] Preferably, the ultrasonic oscillation power in step S2-2 is 400-600W, and the oscillation time is 10-20min.

[0016] The preparation method of medical dressings includes the following steps:

[0017] (1) Add xanthan gum to lithium chloride solution and stir in a water bath to dissolve it. Then add hydroxypropyl carboxymethyl cellulose, chitosan, carbomer and glycerol and continue stirring to dissolve to obtain a mixed gel solution for later use.

[0018] (2) Add modified corn starch to 10-20 times the volume of deionized water and stir to dissolve. Then add anethole, eugenol and Centella asiatica fermentation inactivated extract, stir and mix evenly, then pour into the above mixed gel solution, stir and disperse to obtain the mixture for later use.

[0019] (3) Add seaweed polysaccharide to the above mixture and stir and mix evenly under a pressure of 0.4-0.6 MPa to obtain a gel dressing.

[0020] Preferably, in step (1), the mass ratio of xanthan gum, hydroxypropyl carboxymethyl cellulose, chitosan, carbomer and glycerol is 6:3-6:4-6:0.5-1.2:1-1.4.

[0021] Preferably, the concentration of the lithium chloride solution in step (1) is 0.2%-0.5%, and the mass of the lithium chloride solution is 80-100 times the total mass of xanthan gum. The water bath temperature is maintained at 50-60°C throughout the stirring and dissolving process.

[0022] Preferably, in step (2), the stirring speed is 120-160 r / min, the stirring temperature is 50-60℃, and the stirring time is 15-20 min.

[0023] Preferably, the stirring speed in step (3) is 600-800 r / min, and the stirring time is 15-30 min.

[0024] This invention provides a detoxifying and repairing medical dressing for treating and alleviating stubborn vulvar leukoplakia and its preparation method. Compared with existing technologies, its advantages are:

[0025] This invention uses anethole, eugenol, seaweed polysaccharide, and Centella asiatica fermentation inactivated extract as the main functional ingredients. When mixed with gel components under starch coating, it can effectively relieve itching during the treatment of vulvar leukoplakia. Furthermore, when used in combination with other drugs for the treatment of vulvar leukoplakia, it can effectively shorten the treatment cycle, improve the treatment effect, and further enhance the patient's comfort. Detailed Implementation

[0026] To make the objectives, technical solutions, and advantages of the embodiments of the present invention clearer, the technical solutions of the embodiments of the present invention will be clearly and completely described below in conjunction with the embodiments of the present invention. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0027] Example 1:

[0028] Preparation of medical dressings:

[0029] 1. Preparation of modified corn starch:

[0030] (1) Mix corn starch with 10 times the volume of deionized water and stir at 80°C for 40 minutes to obtain a fully gelatinized slurry for later use.

[0031] (2) The above fully gelatinized slurry was freeze-dried, ground and pulverized and passed through a 40-mesh sieve. Then it was steam-exploded at 119°C for 70 seconds and then dried to obtain modified corn starch.

[0032] 2. Preparation of Centella Asiatica extract:

[0033] 2-1. Extract A

[0034] (1) Grind the Centella asiatica into a paste by adding 4 times the amount of deionized water, and then freeze and thaw it 3 times to obtain a preliminary paste for later use.

[0035] (2) Add 0.3% of the total mass of the initial slurry of Bacillus subtilis and lactic acid bacteria to the initial slurry, keep it warm and ferment at 38±2℃ for 3 days, then press and filter, add 3 times the amount of deionized water to the filter residue, and continue to press and filter after ultrasonic vibration at 600W power for 15 minutes. Combine the two filtrates for later use.

[0036] (3) The above filtrate was concentrated by rotary evaporation to 30% of its original volume, then sterilized at 121°C for 15 min, and then freeze-dried to obtain extract A.

[0037] 2-2, Extract B

[0038] (1) Grind the Centella asiatica into a paste by adding 4 times the amount of deionized water, and then freeze and thaw it 3 times to obtain a preliminary paste for later use.

[0039] (2) Add 0.3% of the total mass of the initial slurry of Bacillus subtilis and lactic acid bacteria to the initial slurry, keep it warm and ferment at 38±2℃ for 3 days, then press and filter, add 3 times the amount of deionized water to the filter residue, and continue to press and filter after ultrasonic vibration at 600W power for 15 minutes. Combine the two filtrates for later use.

[0040] (3) The above filtrate was concentrated by rotary evaporation to 30% of its original volume, and then freeze-dried to obtain extract B.

[0041] 3. Preparation of the mixed gel solution:

[0042] (1) Preparation of materials: Xanthan gum, hydroxypropyl carboxymethyl cellulose, chitosan, carbomer and glycerin are prepared in a mass ratio of 6:4:5:0.8:1.2;

[0043] (2) Add xanthan gum to 90 times its mass of a 0.4% lithium chloride solution and stir to dissolve it at a water bath temperature of 55°C. Then add hydroxypropyl carboxymethyl cellulose, chitosan, carbomer and glycerol and continue stirring to dissolve to obtain a mixed gel solution.

[0044] 4. Preparation of gel dressing:

[0045] (1) Preparation of materials: Modified corn starch, anethole, eugenol, seaweed polysaccharide and extract are selected as compound antibacterial and repairing ingredients, and the mass ratio of mixed gel liquid and compound antibacterial and repairing ingredients is controlled to be 1:0.1.

[0046] (2) Add 15 times the volume of deionized water to the modified corn starch and stir to dissolve. Then add anethole, eugenol and extract, stir and mix evenly, and pour into the mixed gel solution. At a water bath temperature of 55℃, stir and disperse at a speed of 140r / min for 20min to obtain the mixture for later use.

[0047] (3) Add seaweed polysaccharide to the above mixture and mix evenly at a stirring speed of 700 r / min under a pressure of 0.5 MPa to obtain a gel dressing.

[0048] Furthermore, according to Table 1 below, following the above preparation method, select the types of extracts and the weight parts of each component to set up different groups:

[0049] Table 1

[0050]

[0051]

[0052] Comparative Example 1:

[0053] Following the preparation method and ingredients of Experiment 1 above, different gel dressings were prepared by changing only the mass ratio of the mixed gel solution and the composite antibacterial repair component. The specific mass ratios are shown in Table 2 below:

[0054] Table 2

[0055] Group The mass ratio of the mixed gel liquid and the compound antibacterial repair ingredients Experimental group 6 1∶0.4 Experimental group 7 1:0 (No added compound antibacterial and repairing ingredients) Experimental group 8 1∶0.5

[0056] Detection:

[0057] 1. Test the antibacterial effect of each group of gel dressings:

[0058] Staphylococcus aureus was inoculated into PBS solution at pH 7 and incubated at 37°C for 18 h. After dilution, 1×10⁻⁶ cells were obtained for each group. 6 CFU / ml bacterial suspension was used to coat each group of gel dressings to a thickness of 1-2 mm, then dried and cut into 19 mm diameter films. 0.1 ml of each diluted bacterial suspension was injected into agar medium, and the films were then placed onto the agar medium. The cultures were then incubated at 37℃ for 24 h, 48 h, and 72 h. The diameter of the inhibition zone for each bacterial species was then observed. The specific results are shown in Table 3 below.

[0059] Table 3

[0060]

[0061]

[0062] As shown in the table above, the gel dressings prepared in experimental groups 1, 6 and 8 all have good antibacterial effects.

[0063] 2. Skin irritation test of each group of gel dressings during the treatment of vulvar leukoplakia: (Eucerin hydrocortisone butyrate cream was selected as the experimental treatment drug, with a hydrocortisone content of 0.1%)

[0064] Adult white rabbits were used as experimental animals. The fur was shaved off from both sides of the back of the adult rabbits, within a 5cm x 5cm area. A 3cm x 3cm area was marked in the center of the shaved area as the drug administration zone. The rabbits were kept in a suitable environment for 48 hours. Rabbits without erythema or edema at the shaved area were selected for testing.

[0065] Eight groups of shaved rabbits were selected, with three rabbits in each group. Every 8 hours, 0.5g of hydrocortisone butyrate cream was applied to one side of the treatment area of ​​each rabbit. After standing for 10-15 minutes, a 1g gel dressing was applied. Every 8 hours, 0.5g of hydrocortisone butyrate cream was applied to the other side of the control area. Before each administration, both the treatment and control areas were cleaned with warm water. The treatment was continued for 72 hours, and the condition of the treatment sites in each group was observed. The details are shown in Table 4 below.

[0066] Table 4

[0067] Group gel dressing Drug administration area control area 1 Experimental group 1 No erythema, no edema A few spots of erythema and mild edema 2 Experimental group 2 Extensive erythema, mild edema A few spots of erythema and mild edema 3 Experimental group 3 No erythema, no edema A few spots of erythema and mild edema 4 Experimental group 4 No erythema, no edema A few spots of erythema and mild edema 5 Experimental group 5 A few erythematous spots, no edema A few spots of erythema and mild edema 6 Experimental group 6 No erythema, no edema A few spots of erythema and mild edema 7 Experimental group 7 A few spots of erythema and mild edema A few spots of erythema and mild edema 8 Experimental group 8 A few spots of erythema and mild edema A few spots of erythema and mild edema

[0068] As shown in Table 4 above, experimental groups 1, 3, 4 and 6 all have good soothing effects. In combination with Table 3, the gel dressings prepared in experimental groups 1 and 6 have the best effect.

[0069] 3. Clinical testing:

[0070] Sixty-three patients (aged 42-65 years) diagnosed with vulvar dystrophy (mixed type) by pathological examination between June and December 2022 were selected. Of these, 27 patients were treated with corticosteroid ointment (13 patients applied a layer of the gel dressing prepared in Experimental Group 1 3-10 minutes after applying the corticosteroid ointment), 20 patients were treated with tacrolimus ointment (10 patients applied a layer of the gel dressing prepared in Experimental Group 1 3-10 minutes after applying the corticosteroid ointment), and 16 patients were treated with testosterone propionate cod liver oil ointment (8 patients applied a layer of the gel dressing prepared in Experimental Group 1 3-10 minutes after applying the corticosteroid ointment). The treatment results for each group under conventional drug treatment and combined gel dressing treatment were recorded and observed at 5, 10, and 20 weeks of treatment, as shown in Table 5 below.

[0071] Table 5

[0072]

[0073] As shown in the table above, the gel dressing prepared in experimental group 1, when used in combination with therapeutic drugs, can effectively relieve itching, shorten the treatment cycle, and improve treatment comfort.

[0074] The above embodiments are only used to illustrate the technical solutions of the present invention, and are not intended to limit it. Although the present invention has been described in detail with reference to the foregoing embodiments, those skilled in the art should understand that modifications can still be made to the technical solutions described in the foregoing embodiments, or equivalent substitutions can be made to some of the technical features. Such modifications or substitutions do not cause the essence of the corresponding technical solutions to deviate from the spirit and scope of the technical solutions of the embodiments of the present invention.

Claims

1. A detoxifying and repairing medical dressing for treating and alleviating stubborn vulvar leukoplakia, characterized in that, The medical dressing is composed of a gel component and a compound antibacterial and repairing component in a mass ratio of 1:0.1-0.4; the compound antibacterial and repairing component is composed of the following substances in parts by weight: 4-6 parts modified corn starch, 0.8-1.2 parts anethole, 0.2-0.6 parts eugenol, 1-3 parts seaweed polysaccharide, and 1-1.6 parts Centella asiatica fermentation inactivated extract; The modified corn starch is obtained by steam explosion modification of corn starch after complete gelatinization. The preparation method of the Centella asiatica fermentation inactivated extract includes the following steps: S2-1. Add Centella asiatica to 3-5 times the amount of deionized water and grind it into a slurry. Then, repeatedly freeze and thaw 2-3 times to obtain a preliminary slurry for later use. S2-2. Add Bacillus subtilis and lactic acid bacteria to the initial slurry, and ferment at 38±2℃ for 2-4 days. Then press and filter. Add 2-3 times the volume of deionized water to the filter residue, ultrasonically vibrate, and continue pressing and filtering. Combine the two filtrates for later use. The amount of Bacillus subtilis and lactic acid bacteria added is 0.2%-0.5% of the total mass of the initial slurry. S2-3. The above filtrate is concentrated by rotary evaporation to 20-40% of its original volume, then sterilized at 121°C for 15-20 min, and then freeze-dried to obtain Centella asiatica fermentation inactivated extract. The gel component is made of xanthan gum, lithium chloride, hydroxypropyl carboxymethyl cellulose, chitosan carbomer, and glycerin.

2. The detoxifying and repairing medical dressing for treating and alleviating stubborn vulvar leukoplakia according to claim 1, characterized in that, The specific preparation method of the modified corn starch includes the following steps: S1-1. Mix corn starch with deionized water and stir at 75-85℃ for 30-60 minutes to obtain a fully gelatinized slurry for later use. S1-2. After freeze-drying the above fully gelatinized slurry, grind and pulverize it through a 40-mesh sieve, then steam-explode it at 119°C for 60-80 seconds, and then dry it to obtain modified corn starch.

3. The detoxifying and repairing medical dressing for treating and alleviating stubborn vulvar leukoplakia according to claim 1, characterized in that: In step S2-2, the power of ultrasonic oscillation is 400-600W, and the oscillation time is 10-20min.

4. A method for preparing a detoxifying and repairing medical dressing for treating and alleviating refractory vulvar leukoplakia as described in any one of claims 1-3, characterized in that, The preparation method includes the following steps: (1) Add xanthan gum to lithium chloride solution and stir in a water bath to dissolve it. Then add hydroxypropyl carboxymethyl cellulose, chitosan, carbomer and glycerol and continue stirring to dissolve to obtain a mixed gel solution for later use. (2) Add 10-20 times the volume of deionized water to the modified corn starch and stir to dissolve. Then add anethole, eugenol and Centella asiatica fermentation inactivated extract, stir and mix evenly, and pour into the above mixed gel solution. Stir to disperse and obtain the mixture for later use. (3) Add seaweed polysaccharide to the above mixture and stir and mix evenly under a pressure of 0.4-0.6 MPa to obtain a gel dressing.

5. The preparation method according to claim 4, characterized in that: In step (1), the mass ratio of xanthan gum, hydroxypropyl carboxymethyl cellulose, chitosan, carbomer, and glycerol is 6:3-6:4-6:0.5-1.2:1-1.

4.

6. The preparation method according to claim 4, characterized in that: In step (1), the concentration of the lithium chloride solution is 0.2%-0.5%, and the mass of the lithium chloride solution is 80-100 times the total mass of xanthan gum. The water bath temperature is maintained at 50-60℃ throughout the stirring and dissolving process.

7. The preparation method according to claim 4, characterized in that: In step (2), the stirring speed is 120-160 r / min, the stirring temperature is 50-60℃, and the stirring time is 15-20 min.

8. The preparation method according to claim 4, characterized in that: In step (3), the stirring speed is 600-800 r / min and the stirring time is 15-30 min.

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