Anti-HPV (human papillomavirus) gel and preparation method thereof

By improving the components and preparation methods of anti-HPV virus gel, especially the use of nanoliposome encapsulation and traditional Chinese medicine fermentation extracts, the existing gel permeability and retention problems are solved, and a long-term retention and high cure rate therapeutic effect is achieved.

CN120585984APending Publication Date: 2025-09-05TIANJIN AIKE TECH DEV
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Patent Information

Application Number
CN202510765911.1
Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Filing Date
2025-06-10
Publication Date
2025-09-05

AI Technical Summary

Technical Problem

Existing anti-HPV gels have poor transdermal/mucosal permeability and retention, are easily diluted and washed away by body fluids, and are unable to maintain effective drug concentrations at the infected site, resulting in poor efficacy.

Method used

An anti-HPV virus gel containing components A and B is used. Component A includes water, hydroxypropyl methylcellulose, glycerol, and propylene glycol. Component B includes preservatives, Tween-20, Centella asiatica, plant soothing agents, and traditional Chinese medicine fermentation extracts. The traditional Chinese medicine fermentation extracts are composed of Hedyotis diffusa, Kochia scoparia, Equisetum arvense, Sophora flavescens root, Phellodendron chinense bark, Smilax glabra, Glycyrrhiza glabra, and brewer's yeast extracts. The retention and therapeutic effect of the gel are improved through the synergistic effect of nanoliposome encapsulation and traditional Chinese medicine fermentation extracts.

Benefits of technology

The gel stays in the vagina for a long time and works effectively. The plant soothing agent interacts with the fermented extract of traditional Chinese medicine to increase the cure rate to 93.33%, and has a multiple mechanism of prevention and treatment effect on HPV virus.

✦ Generated by Eureka AI based on patent content.

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Abstract

The invention relates to the field of gynecological gel, in particular to anti-HPV (human papillomavirus) gel and a preparation method thereof. The anti-HPV gel comprises a component A and a component B, the component A is prepared from the following raw materials in parts by weight: 75 to 80 parts of water, 1 to 3 parts of hydroxypropyl methyl cellulose, 3 to 6 parts of glycerol and 3 to 6 parts of propylene glycol; the component B is prepared from the following raw materials in parts by weight: 0.3 to 0.6 part of preservative, 0.5 to 1.2 parts of tween-20, 0.6 to 1.3 parts of herba centellae, 0.6 to 1.2 parts of plant soothing agent, 3 to 6 parts of traditional Chinese medicine fermentation extract and 0.005 to 0.015 part of citric acid. The obtained gel is applied to HPV patients, and the cure rate is high.
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Description

Technical Field

[0001] The present application relates to the technical field of gynecological gels, and in particular to an anti-HPV virus gel and a preparation method thereof. Background Art

[0002] Human papillomavirus (HPV) is a spherical DNA virus belonging to the genus Papillomatovirus A of the family Papovaviridae. It can cause proliferation of the squamous epithelium of the human skin and mucous membranes. Symptoms include common warts and genital warts (condyloma acuminata). With the rapid increase in the incidence of genital warts among STDs and the rise in cervical and anal cancers, HPV infection is attracting increasing attention.

[0003] HPV gel is a popular treatment in my country: HPV gel blocks high-risk HPV infection and prevents high-risk cervical lesion infection. Bioprotein dressings also inhibit recurrence of genital warts. The anti-HPV bioprotein gel dressing consists of a bioprotein gel and a gel delivery device. The bioprotein gel is composed of hydroxyethyl cellulose (excipient), biofunctional protein, glycerin, and purified water. The gel delivery device is a packing device suitable for reducing local HPV viral load. HPV gel introduces a new concept in physical therapy. HPV is a positively charged product. Its main ingredients are bioprotein and 980 carbomer. The negative charges of the modified bioprotein and carbomer molecules attract the positive charge of HPV to block and eliminate the HPV virus, thereby achieving negative results.

[0004] The applicant found that the gels commonly used on the market have poor transdermal / mucosal permeability and poor retention, are easily diluted and washed away by body fluids, and are unable to maintain effective drug concentrations at the site of infection, resulting in poor effects. Summary of the Invention

[0005] In order to improve the effect of anti-HPV virus gel, the present application provides an anti-HPV virus gel and a preparation method thereof.

[0006] In a first aspect, the present application provides an anti-HPV virus gel, which adopts the following technical solution.

[0007] An anti-HPV virus gel, comprising component A and component B; The component A comprises the following raw materials in parts by weight: 75-80 parts of water, 1-3 parts of hydroxypropyl methylcellulose, 3-6 parts of glycerol, and 3-6 parts of propylene glycol; The component B comprises the following raw materials in parts by weight: 0.3-0.6 parts of preservatives, 0.5-1.2 parts of Tween-20, 0.6-1.3 parts of asiatica, 0.6-1.2 parts of plant soothing agents, 3-6 parts of traditional Chinese medicine fermentation extracts, and 0.005-0.015 parts of citric acid.

[0008] By adopting the above technical solution, the obtained gel stays in the vagina for a long time and can play an effective role. The plant soothing agent interacts with the traditional Chinese medicine fermentation extract to improve the curative effect on HPV.

[0009] Furthermore, the Chinese medicine fermentation extract includes Hedyotis diffusa extract, Kochia scoparia fruit extract, Equisetum arvense extract, Sophora flavescens root extract, Phellodendron chinense bark extract, Smilax glabra extract, Glycyrrhiza glabra extract, and Brewer's yeast extract.

[0010] Furthermore, based on the weight of the traditional Chinese medicine fermentation extract, the traditional Chinese medicine fermentation extract includes the following raw materials in parts by weight: 1-1.5 parts of Hedyotis diffusa extract, 7-9 parts of Kochia scoparia extract, 1-1.5 parts of Equisetum arvense extract, 1-1.5 parts of Sophora flavescens root extract, 3-4 parts of Phellodendron chinense bark extract, 0.06-0.07 parts of Smilax glabra extract, 1-2 parts of Glycyrrhiza glabra extract, and 4-5 parts of brewer's yeast extract.

[0011] By adopting the above-mentioned technical solutions, the Houttuynia cordata extract has a wide range of targets and can target multiple key links of HPV infection, such as virus adsorption, immune escape, and inflammatory response. Through the synergistic effect of multiple mechanisms, mainly immune regulation and supplemented by direct antiviral and anti-inflammatory, it helps the body eliminate HPV infection, while improving the vaginal microenvironment and repairing mucosal damage.

[0012] The core value of Kochia scoparia extract in anti-HPV gel lies in the trinity of "prevention + clearance + repair". In the prevention stage, it reduces the risk of infection by physically blocking viral adsorption and regulating the microecology; in the clearance stage, it activates the Th1 immune response, directly inhibits viral gene expression and induces apoptosis of infected cells; in the repair stage, it reduces inflammatory damage and promotes the reconstruction of the mucosal barrier.

[0013] Equisetum arvense extract physically blocks viral adsorption through flavonoid components, and phenolic acids inhibit viral replication; activates Th1 immune response, enhances CTL and NK cell function; repairs mucosal barriers, regulates microecology, and has anti-inflammatory and antioxidant effects, reducing the risk of recurrence and lesions.

[0014] The alkaloids in Sophora flavescens root extract directly inhibit viral adsorption and replication, and flavonoids have anti-inflammatory and antioxidant effects; they activate immune cells through the IFN-α / IL-12 pathway and reverse immune escape; polysaccharides and flavonoids repair the mucosal barrier and regulate the microecology to prevent recurrence.

[0015] Alkaloids such as berberine in the bark extract of the yellow-peeled tree directly block viral adsorption and replication, and flavonoids have anti-inflammatory and antioxidant effects; they enhance immune cell function through the IFN-α / IL-8 pathway and reverse HPV-mediated immune escape; polysaccharides promote mucin secretion and tight junction repair, restoring the balance of the vaginal microecology.

[0016] The steroidal saponins and flavonoids in Smilax glabra extract directly interfere with viral adsorption, replication and oncogenic protein expression; polysaccharides and flavonoids activate immune cells through the IFN-γ / IL-12 pathway and reverse immune escape; they rebuild the vaginal defense barrier by inhibiting bacteria, promoting lactobacillus proliferation and repairing tight junctions.

[0017] Glycyrrhiza glabra extract reduces the persistent infection rate of HPV and promotes viral clearance by physically blocking viral adsorption, activating local immunity, inhibiting inflammation and oxidative damage, and interfering with the viral life cycle.

[0018] Brewer's yeast extract activates immune cells through β-glucan, competitively adsorbs viruses through mannan, and repairs mucosa and regulates bacterial flora through peptides and polysaccharides, thereby reducing the risk of HPV infection and promoting virus clearance in multiple ways.

[0019] Furthermore, the preparation method of the Chinese medicine fermentation extract is: 1) Raw material preparation Dry and crush Hedyotis diffusa, Kochia scoparia, Equisetum arvense, Sophora flavescens root, Phellodendron chinense bark, Smilax glabra, and Glycyrrhiza glabra; 2) Segmented extraction The barks of Equisetum arvense and Phellodendron chinense were soaked and steam distilled for 3 hours to collect the volatile oil, which was then included with β-cyclodextrin. Dynamic countercurrent extraction was performed on Sophora flavescens, Smilax glabra and Glycyrrhiza glabra respectively, and the extracts were combined to obtain an alcohol extract; The herb Hedyotis diffusa and Kochia scoparia were subjected to enzyme-assisted water extraction, and the enzymatic hydrolysis conditions were: cellulase + pectinase, pH 4-5, and enzymatic hydrolysis at 45-55°C for 1.5 hours; and water extraction was performed after enzymatic hydrolysis to obtain a water extract; 3) Purification The alcohol extract obtained in 2) is combined with the water extract, concentrated to a density of 1.1-1.2 g / mL, and then ethanol is added to a final concentration of 55-60%. The mixture is allowed to stand at 3-5°C for 24 hours, followed by centrifugation to collect the supernatant. Ethanol is added to the supernatant to a final concentration of 80-90%, the mixture is allowed to stand at 3-5°C for 12 hours, and the filtrate is collected by filtration. The filtrate is then subjected to ultrafiltration to obtain an extract. 4) Nanoliposome encapsulation Encapsulation of the extract using a molecular layer membrane; 5) Concentration and drying Obtain freeze-dried powder; 6) Mixing the freeze-dried powder, brewer's yeast extract, and the volatile oil obtained in 2) to obtain a traditional Chinese medicine fermentation extract.

[0020] Furthermore, the specific method of nanoliposome encapsulation is: The lipid component was dissolved in a mixed solvent of chloroform and methanol, and rotary evaporated to form a film at 40-45°C and (-0.09)-(-0.10) MPa. The temperature was then raised to 60-65°C, and the extract obtained in 3) was added. The mixture was vortexed for 30 minutes and then homogenized.

[0021] Furthermore, the lipid component includes hydrogenated soybean lecithin, cholesterol, and functional phospholipid-polymer conjugate in a weight ratio of (6-7): (2-3): 1.

[0022] Furthermore, the volume ratio of the volatile oil to β-cyclodextrin is 1:6.

[0023] Furthermore, based on the total weight of the plant soothing agent, the plant soothing agent includes the following raw materials in parts by weight: 50-60 parts of water, 30-40 parts of butylene glycol, 2-4 parts of Sophora flavescens extract, 2-5 parts of Glycyrrhiza inflata root extract, and 3-6 parts of Scutellaria baicalensis extract.

[0024] In a second aspect, the present application provides a method for preparing an anti-HPV virus gel, which adopts the following technical solution.

[0025] A method for preparing an anti-HPV gel comprises the following steps: S1. Mix the ingredients of component A, heat to 90°C with stirring, and stir until the ingredients are completely melted; S2. Cool down while stirring until the temperature drops to 45°C, add component B raw materials in sequence, and stir for 30 minutes; S3. Stop stirring, take samples for testing, and filter out the material after all physical and chemical indicators are qualified.

[0026] In summary, this application has the following beneficial effects: The gel obtained in this application has a long residence time in the vagina, and can stay in the rabbit vagina for up to 6 hours, ensuring its effective function. The plant soothing agent interacts with the fermented extract of traditional Chinese medicine, and the cure rate for HPV in rabbit experiments can reach 93.33%. DETAILED DESCRIPTION

[0027] The present application is further described in detail below with reference to the embodiments.

[0028] Preparation examples of raw materials and intermediates raw material The raw materials in the examples of this application can be obtained commercially: Hydroxypropyl methylcellulose, pharmaceutical grade; Glycerol, analytical grade; Propylene glycol, analytical grade; Preservatives, preservative CAP; Brewer's yeast extract, spray-dried powder meeting FCC V standard, protein content ≥45%; Take the dried whole herb of Hedyotis diffusa, remove impurities, dry it in hot air circulation at 60℃ for 2 hours, and grind it through an 80-mesh sieve; Remove the shell of Kochia scoparia fruit, take out the kernel, dry it at 45℃, and grind it into 100 mesh; For Equisetum arvense, cut the stem into sections (length ≤ 5 mm), steam-finish (100°C / 3 min), and then dry-dry. Sophora flavescens roots were washed, cut into 2 mm slices, and microwave-dried (power 3 kW, time 15 min); Scrape off the outer rough bark of the yellow bark tree, moisten it with 60% ethanol for 24 hours, and then cut it into strips; Smilax glabra, steamed to soften (102℃ / 0.2MPa / 30min), sliced ​​to 1mm thickness; Glycyrrhiza glabra, peeled and split radially, quick-frozen in liquid nitrogen and crushed into particles; Functional phospholipid-polymer conjugate, DSPE-PEG2000.

[0029] Preparation Example Preparation Example 1 A method for preparing a traditional Chinese medicine fermentation extract is as follows: 1) Raw material preparation Dry Hedyotis diffusa, Kochia scoparia, Equisetum arvense, Sophora flavescens root, Phellodendron chinense bark, Smilax glabra, and Glycyrrhiza glabra to a moisture content of ≤8% and grind to 80 mesh; 2) Segmented extraction The barks of horsetail and kumquat were soaked in 8 times water, and then extracted separately: steam distilled for 3 hours, volatile oils were collected respectively, and the volatile oils were included with β-cyclodextrin at a volume ratio of volatile oil to β-cyclodextrin of 1:6, and the inclusion was carried out by stirring at 45°C for 2 hours; the volatile oils of horsetail and kumquat were obtained; Sophora flavescens, Smilax glabra, and Glycyrrhiza glabra were subjected to dynamic countercurrent extraction, respectively. Sophora flavescens extraction: solvent is 70% ethanol, solid-liquid ratio is 1:8, temperature is 80℃, time is 1.5h, to obtain Sophora flavescens extract; Smilax glabra extraction: solvent is 50% ethanol, solid-liquid ratio is 1:6, temperature is 70℃, time is 2h, to obtain Smilax glabra extract; Glycyrrhiza glabra extraction: solvent is 30% ethanol, solid-liquid ratio is 1:5, temperature is 60℃, time is 1h, to obtain Glycyrrhiza glabra extract; 1.3kg of Sophora flavescens extract, 0.065kg of Smilax glabra extract, and 1.5kg of Glycyrrhiza glabra extract were combined to obtain an alcohol extract; The Hedyotis diffusa and Kochia scoparia were subjected to enzyme-assisted water extraction, respectively. The enzymatic hydrolysis conditions were: cellulase + pectinase, the weight ratio of cellulase to pectinase was 5:3, pH 4, and enzymatic hydrolysis was performed at 50°C for 1.5 hours. After enzymatic hydrolysis, water extraction was performed by adding 10 times the amount of purified water and extracting at 90°C twice, each time for 1 hour. The Hedyotis diffusa extract and Kochia scoparia extract were obtained respectively. 1.2 kg of the Hedyotis diffusa extract and 8 kg of the Kochia scoparia extract were combined and coarsely filtered through a 100-mesh filter to obtain an aqueous extract. 3) Purification The alcohol extract obtained in 2) was combined with the water extract, concentrated to a density of 1.2 g / mL, and then ethanol was added to a final concentration of 55%. The mixture was allowed to stand at 4°C for 24 hours, followed by centrifugation, and the supernatant was collected. Ethanol was added to the supernatant to a final concentration of 85%, and the mixture was allowed to stand at 4°C for 12 hours. The filtrate was collected by filtration, and the filtrate was subjected to ultrafiltration to obtain an extract. 4) Nanoliposome encapsulation 6.5 kg of hydrogenated soybean lecithin, 2.5 kg of cholesterol, and 1 kg of the lipid component of the functional phospholipid-polymer conjugate were dissolved in a 2:1 volume ratio of chloroform and methanol. The mixture was rotary evaporated at 40°C and -0.09 MPa to form a film. The temperature was then raised to 65°C, and the extract obtained in 3) was added. The mixture was vortexed for 30 minutes and then homogenized: first homogenization: 800 bar, 3 cycles; second homogenization: 1500 bar, 5 cycles (temperature controlled ≤ 45°C). The average particle size of the resulting liposomes was 80 nm. 5) Concentration and drying The liposomes obtained in 4) were desalted using a nanofiltration membrane (molecular weight cut-off 200 Da), then concentrated under reduced pressure at 40°C to a solid content of 25%; then quickly frozen at -40°C for 3 hours, and maintained at -20°C / 50 Pa for 24 hours; then the temperature was increased in steps from 0°C to 25°C (each 5°C for 2 hours) until the final moisture content was ≤3%, thereby obtaining a lyophilized powder; 6) The freeze-dried powder obtained in 5), 4.5 kg of brewer's yeast extract, 1.3 kg of horsetail volatile oil obtained in 2), and 3.5 kg of phellodendron chinense bark volatile oil were mixed to obtain a traditional Chinese medicine fermentation extract.

[0030] Preparation Example 2 Different from Preparation Example 1, Preparation Example 2 includes the following raw materials: 1 kg of Sophora flavescens extract, 0.07 kg of Smilax glabra extract, 1 kg of Glycyrrhiza glabra extract, 1.5 kg of Hedyotis diffusa extract, 7 kg of Kochia scoparia extract, 5 kg of brewer's yeast extract, 1 kg of Equisetum arvense volatile oil and 4 kg of Phellodendron chinense bark volatile oil.

[0031] Preparation Example 3 Different from Preparation Example 1, Preparation Example 3 includes the following raw materials: 1.5 kg of Sophora flavescens extract, 0.06 kg of Smilax glabra extract, 2 kg of Glycyrrhiza glabra extract, 1 kg of Hedyotis diffusa extract, 9 kg of Kochia scoparia extract, 4 kg of brewer's yeast extract, 1.5 kg of Equisetum arvense volatile oil and 3 kg of Phellodendron chinense bark volatile oil.

[0032] Preparation Example 4 Different from Preparation Example 1, in Preparation Example 4, 6.5 kg of hydrogenated soybean lecithin and 1 kg of lipid component of the functional phospholipid-polymer conjugate were dissolved in a mixed solvent of chloroform and methanol in a volume ratio of 2:1.

[0033] Preparation Example 5 Different from Preparation Example 1, in Preparation Example 5, 6.5 kg of hydrogenated soybean lecithin, 2.5 kg of cholesterol, and other components were dissolved in a mixed solvent of chloroform and methanol in a volume ratio of 2:1.

[0034] Preparation Example 6 The difference from Preparation Example 1 is that in Preparation Example 6, an equal amount of Sophora flavescens extract is used to replace the Smilax glabra extract.

[0035] Preparation Example 7 The difference from Preparation Example 1 is that in Preparation Example 7, an equal amount of Glycyrrhiza glabra extract is used to replace the Smilax glabra extract.

[0036] Preparation Example 8 The difference from Preparation Example 1 is that in Preparation Example 7, an equal amount of Equisetum arvense extract was used to replace the Phellodendron chinense bark extract.

[0037] Preparation Example 9 A Sophora flavescens extract, the preparation method of which is as follows: Dynamic countercurrent extraction was performed with 70% ethanol as the solvent, a solid-liquid ratio of 1:8, a temperature of 80°C, and a time of 1.5 h to obtain the Sophora flavescens extract; the extract was then concentrated to a density of 1.2 g / mL, and then ethanol was added to a final concentration of 55%, and the mixture was allowed to stand at 4°C for 24 h, followed by centrifugation to collect the supernatant; ethanol was added to the supernatant to a final concentration of 85%, and the mixture was allowed to stand at 4°C for 12 h, and the filtrate was collected by filtration, and the filtrate was ultrafiltered to obtain the Sophora flavescens extract.

[0038] Preparation Example 10 A Glycyrrhiza inflata root extract, the preparation method of which is as follows: Dynamic countercurrent extraction was performed with 30% ethanol as solvent, a solid-liquid ratio of 1:5, a temperature of 60°C, and a time of 1 hour to obtain the Glycyrrhiza inflata root extract; the extract was then concentrated to a density of 1.2 g / mL, and then ethanol was added to a final concentration of 55%. The mixture was allowed to stand at 4°C for 24 hours, and then centrifuged to collect the supernatant; ethanol was added to the supernatant to a final concentration of 85%, and the mixture was allowed to stand at 4°C for 12 hours. The filtrate was collected by filtration, and the filtrate was subjected to ultrafiltration to obtain the Glycyrrhiza inflata root extract.

[0039] Preparation Example 11 A scutellaria baicalensis extract, the preparation method of which is as follows: Dynamic countercurrent extraction was performed with 50% ethanol as the solvent, a solid-liquid ratio of 1:6, a temperature of 70°C, and a time of 2 hours to obtain the Scutellaria baicalensis extract; the extract was then concentrated to a density of 1.2 g / mL, and then ethanol was added to a final concentration of 55%. The mixture was allowed to stand at 4°C for 24 hours, and then centrifuged to collect the supernatant; ethanol was added to the supernatant to a final concentration of 85%, and the mixture was allowed to stand at 4°C for 12 hours. The filtrate was collected by filtration, and the filtrate was ultrafiltered to obtain the Scutellaria baicalensis extract.

[0040] Preparation Examples 12-14 A plant soothing agent, the preparation method of which is: Mix the raw materials according to the raw material ratio in Table 1.

[0041] Table 1 Raw material ratio table of preparation examples 12-14 (kg)

[0042] The Sophora flavescens extract, Glycyrrhiza inflata root extract, and Scutellaria baicalensis extract are from Preparation Examples 9-11, respectively.

[0043] Example Examples 1-3 An anti-HPV virus gel, the preparation method of which is: S1. According to the ratio in Table 2, mix the materials of component A, stir and heat to 90 ° C, and stir until the materials are completely melted; S2. Cool down while stirring until the temperature drops to 45°C, add component B raw materials in sequence, and stir for 30 minutes; S3. Stop stirring, take samples for testing, and filter out the material after all physical and chemical indicators are qualified.

[0044] Table 2 Raw material ratios for Examples 1-3 (kg)

[0045] Among them, the plant soothing agent comes from Preparation Example 12, and the Chinese medicine fermentation extract comes from Preparation Example 1.

[0046] Examples 4-10 Different from Example 2, the Chinese medicinal fermentation extracts in Examples 4-10 are from Preparation Examples 2-8.

[0047] Examples 11-12 The difference from Example 2 is that the plant soothing agents in Examples 11-12 are respectively from Preparation Examples 13-14.

[0048] Comparative Example Comparative Example 1 The difference from Example 1 is that in Comparative Example 1, an equal amount of plant soothing agent is used to replace the traditional Chinese medicine fermentation extract.

[0049] Comparative Example 2 Different from Example 1, in Comparative Example 2, an equal amount of a fermented Chinese medicine extract was used to replace the plant soothing agent.

[0050] Performance testing Retention time test: The gel of the present invention was added with blue ink and injected into the rabbit vagina. The rabbits were sacrificed and dissected at 3, 4, 5, 6, 7, and 8 hours. The time when no fluorescent marker was first observed in the rabbit vagina was taken as the retention time. The results are shown in Table 3.

[0051] HPV cure rate test: SPF female rabbits were pretreated with hormones. 20 rabbits were not treated and served as the control group. The experimental group was administered with the examples of the present invention and the comparative example drugs, and the blank group was not administered with drugs. Each experimental group and blank group were divided into 3 groups, with 10 rabbits in each group. The HPV16 virus was inoculated and the drugs were administered 3 times a day, with an interval of 4 hours each time, for 7 consecutive days. After the last administration, the rabbits were killed and dissected. The cure rate was calculated based on the basic recovery of the rabbit's vagina to normal, and the presence of papules in the rabbit's vagina was considered uncured. The results are shown in Table 3.

[0052] Table 3 Performance test results

[0053] Combining Examples 1-12 with Comparative Examples 1-2 and Table 3, it can be seen that the cure rates of the gels obtained in Examples 1-10 for HPV are better than those in Comparative Examples 1-2, which indicates that the gels obtained in the present application have better effects on HPV viruses.

[0054] Combining Example 1 with Comparative Examples 1-2 and Table 3, it can be seen that the cure rate of the gel obtained in Example 1 for HPV is better than that of Comparative Examples 1-2. This may be because the plant soothing agent and the traditional Chinese medicine fermentation extract synergize with each other to improve the therapeutic effect on HPV virus.

[0055] Combining Examples 1-3 and Table 3, it can be seen that the gels obtained in Examples 1-3 have a better cure rate for HPV, among which the ratio in Example 2 is more excellent.

[0056] Combining Example 2 with Examples 4-5 and Examples 8-10, and Table 3, it can be seen that the differences in Chinese herbal fermentation extracts will affect the therapeutic effect on HPV, among which the Chinese herbal fermentation extract in Example 2 is more superior.

[0057] This specific embodiment is merely an explanation of the present application and is not a limitation of the present application. After reading this specification, those skilled in the art may make non-creative modifications to the present embodiment as needed, but as long as they are within the scope of the claims of the present application, they are protected by the patent law.

Claims

1. An anti-HPV virus gel, characterized in that: It includes component A and component B; The component A comprises the following raw materials in parts by weight: 75-80 parts of water, 1-3 parts of hydroxypropyl methylcellulose, 3-6 parts of glycerol, and 3-6 parts of propylene glycol; The component B comprises the following raw materials in parts by weight: 0.3-0.6 parts of preservatives, 0.5-1.2 parts of Tween-20, 0.6-1.3 parts of asiatica, 0.6-1.2 parts of plant soothing agents, 3-6 parts of traditional Chinese medicine fermentation extracts, and 0.005-0.015 parts of citric acid.

2. The anti-HPV gel according to claim 1, characterized in that: The traditional Chinese medicine fermentation extract includes Hedyotis diffusa extract, Kochia scoparia extract, Equisetum arvense extract, Sophora flavescens root extract, Phellodendron chinense bark extract, Smilax glabra extract, Glycyrrhiza glabra extract and Brewer's yeast extract.

3. The anti-HPV gel according to claim 2, characterized in that: Calculated by weight of the traditional Chinese medicine fermentation extract, the traditional Chinese medicine fermentation extract includes the following raw materials in parts by weight: 1-1.5 parts of Hedyotis diffusa extract, 7-9 parts of Kochia scoparia extract, 1-1.5 parts of Equisetum arvense extract, 1-1.5 parts of Sophora flavescens root extract, 3-4 parts of Phellodendron chinense bark extract, 0.06-0.07 parts of Smilax glabra extract, 1-2 parts of Glycyrrhiza glabra extract, and 4-5 parts of brewer's yeast extract.

4. The anti-HPV gel according to claim 2, characterized in that: The preparation method of the traditional Chinese medicine fermentation extract is: 1) Raw material preparation Dry and crush Hedyotis diffusa, Kochia scoparia, Equisetum arvense, Sophora flavescens root, Phellodendron chinense bark, Smilax glabra, and Glycyrrhiza glabra; 2) Segmented extraction The barks of Equisetum arvense and Phellodendron chinense were soaked and steam distilled for 3 hours to collect the volatile oil, which was then included with β-cyclodextrin. Sophora flavescens, Smilax glabra and Glycyrrhiza glabra were subjected to dynamic countercurrent extraction respectively, and the extracts were combined to obtain an alcohol extract; The herb Hedyotis diffusa and Kochia scoparia were subjected to enzyme-assisted water extraction, and the enzymatic hydrolysis conditions were: cellulase + pectinase, pH 4-5, and enzymatic hydrolysis at 45-55°C for 1.5 hours; and water extraction was performed after enzymatic hydrolysis to obtain a water extract; 3) Purification The alcohol extract obtained in 2) is combined with the water extract, concentrated to a density of 1.1-1.2 g / mL, and then ethanol is added to a final concentration of 55-60%. The mixture is allowed to stand at 3-5°C for 24 hours, followed by centrifugation to collect the supernatant. Ethanol is added to the supernatant to a final concentration of 80-90%, the mixture is allowed to stand at 3-5°C for 12 hours, and the filtrate is collected by filtration. The filtrate is then subjected to ultrafiltration to obtain an extract. 4) Nanoliposome encapsulation Encapsulation of the extract using a molecular layer membrane; 5) Concentration and drying Obtain freeze-dried powder; 6) Mixing the freeze-dried powder, brewer's yeast extract, and the volatile oil obtained in 2) to obtain a traditional Chinese medicine fermentation extract.

5. The anti-HPV gel according to claim 4, characterized in that: The specific method of the nanoliposome encapsulation is: The lipid component was dissolved in a mixed solvent of chloroform and methanol, and rotary evaporated to form a film at 40-45°C and (-0.09)-(-0.10) MPa. The temperature was then raised to 60-65°C, and the extract obtained in 3) was added. The mixture was vortexed for 30 minutes and then homogenized.

6. The anti-HPV gel according to claim 5, characterized in that: The lipid component includes hydrogenated soybean lecithin, cholesterol, and a functional lecithin-polymer conjugate in a weight ratio of (6-7): (2-3):

1.

7. The anti-HPV gel according to claim 4, characterized in that: The volume ratio of the volatile oil to β-cyclodextrin is 1:

6.

8. The anti-HPV gel according to claim 1, characterized in that: Based on the total weight of the plant soothing agent, the plant soothing agent includes the following raw materials in parts by weight: 50-60 parts of water, 30-40 parts of butylene glycol, 2-4 parts of Sophora flavescens extract, 2-5 parts of Glycyrrhiza inflata root extract, and 3-6 parts of Scutellaria baicalensis extract.

9. A method for preparing the anti-HPV gel according to any one of claims 1 to 8, characterized in that: The following steps are involved: S1. Mix the ingredients of component A, heat to 90°C with stirring, and stir until the ingredients are completely melted; S2. Cool down while stirring until the temperature drops to 45°C, add component B raw materials in sequence, and stir for 30 minutes; S3. Stop stirring, take samples for testing, and filter out the material after all physical and chemical indicators are qualified.

Citation Information

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