Medical antibacterial gel for preventing and treating gynecological vagina inflammation and preparation method thereof

Abstract

The antibacterial gel is prepared from the following substances in percentage by mass: 1% of carbomer, 1% of honeysuckle flower, 0.5% of astragalus polysaccharide, 2% of herba houttuyniae and the balance of purified water. The invention further discloses a method for preparing the antibacterial gel. According to the antibacterial gel prepared by the invention, the carbomer is used as a basis, the traditional Chinese medicine extract and the monoclonal antibody are combined, the components are simple, the preparation process is simple, and the finished gel has the advantages of safety, effectiveness and small use amount, and has a good curative effect on human papilloma virus (HPV) positive vagina inflammation and human papilloma virus (HPV) negative vagina inflammation.

Description

Technical Field

[0001] The invention belongs to the field of biotechnology, and specifically relates to a medical antibacterial gel for preventing and treating gynecological vaginal inflammation and a preparation method thereof. Background Art

[0002] Gynecological inflammation refers to a series of diseases caused by bacterial, fungal and other pathogenic infections in the organs of the female reproductive system, also known as gynecological infection. Gynecological inflammatory diseases are diverse and are more common in adult women. They are mostly caused by pathogenic infection, decreased hormone levels and other reasons. The clinical symptoms are complex and varied, such as vaginal burning sensation, vaginal itching, pain and strong odor. Among them, vaginitis is one of the common diseases of gynecological inflammation. Common pathogens that cause vaginal inflammation include bacteria, protozoa, fungi, viruses, etc., which are described as follows:

[0003] 1. Bacteria: Bacterial infection is the most common type of infection in the female reproductive tract. Common bacteria include Staphylococcus, Streptococcus, anaerobic bacteria, Escherichia coli, Neisseria gonorrhoeae, Mycobacterium tuberculosis, etc. Symptoms of bacterial infection generally include fever, back pain, lower abdominal pain, increased leucorrhea, odor, etc.

[0004] 2. Protozoa: Trichomonas vaginalis is the most common protozoa in the female reproductive tract, which can cause symptoms such as vaginitis and vulvar itching. In addition, amoeba is also a common pathogen of protozoan infection;

[0005] 3. Fungus: Candida albicans is the most common pathogen of fungal infection in the female reproductive tract. Symptoms of fungal infection include vaginal itching, increased leucorrhea, vaginitis, etc.

[0006] 4. Viruses: Human papillomavirus is one of the most common viral infection pathogens in the female reproductive tract. Infection can cause symptoms such as genital warts or cervical cancer. In addition, herpes virus is also a common viral infection pathogen;

[0007] 5. Others: Chlamydia trachomatis, mycoplasma, spirochetes, etc. may also cause female reproductive tract infections. The symptoms of these pathogens include fever, lower abdominal pain, increased leucorrhea, odor, etc.

[0008] At present, the treatment for vaginal inflammation can be physical therapy and drug therapy, which are mainly divided into Western medicine, Chinese medicine and a combination of Chinese and Western medicine. However, most drugs mainly use the efficacy of antibiotics and hormone components, and the disadvantages are incomplete treatment, high recurrence rate and large side effects. Summary of the invention

[0009] In order to make up for the deficiencies of the prior art, the object of the present invention is to provide a medical antibacterial gel for preventing and treating gynecological vaginal inflammation and a preparation method thereof.

[0010] Therefore, the present invention discloses an antibacterial gel on one hand, which is composed of the following substances in terms of mass fraction: 1% carbomer, 1% honeysuckle, 0.5% astragalus polysaccharide, 2% houttuynia cordata, and the rest is purified water.

[0011] Preferably, the antibacterial gel of the present invention further contains anti-HPV monoclonal antibodies, and the mass fraction of the anti-HPV monoclonal antibodies in the antibacterial gel is 0.5%.

[0012] Preferably, the amino acid sequences of the heavy chain variable region and the light chain variable region of the anti-HPV monoclonal antibody of the present invention are shown as SEQ ID NO.1 and SEQ ID NO.2.

[0013] In another aspect, the present invention also discloses a method for preparing the antibacterial gel, the method comprising the following steps:

[0014] (1) Preparation of carbomer gel matrix: 1 g of carbomer dry powder was placed in a 100 ml dry beaker, and 25 ml of purified water was added while stirring to allow the carbomer to fully absorb water and swell; then the mixture was sterilized at 121° C. and 0.15 MPa for 20 min to obtain the carbomer gel matrix;

[0015] (2) Preparation of other aqueous solutions: weigh 1g honeysuckle, 0.5g astragalus polysaccharide, and 2g houttuynia cordata, add 25ml purified water, decoct for 2-3 times, each time for 1 hour, filter and combine the filtrates; then add purified water twice the volume of the filtrate, filter with a 0.45μm organic filter membrane to obtain a filtrate; then sterilize the filtrate at 121°C and 0.15Mpa for 20min to obtain an aqueous solution containing various components;

[0016] (3) under sterile conditions, adding the aqueous solution prepared in step (2) to the carbomer gel matrix prepared in step (1), and then adding sterilized triethanolamine dropwise with a dropper, stirring while adding, measuring the pH value, and adjusting the pH value to about 7.2;

[0017] (4) Under sterile conditions, add 0.5 g of anti-HPV monoclonal antibody;

[0018] (5) Under aseptic conditions, add sterilized purified water to make the total volume 100 ml, and stir evenly to obtain the antibacterial gel.

[0019] In another aspect, the present invention also discloses a use of the anti-HPV monoclonal antibody in the preparation of a medical antibacterial gel for preventing and treating gynecological vaginal inflammation.

[0020] Carbomer in the present invention is a natural medicinal ingredient, and its effects are mainly reflected as follows:

[0021] (1) Thickening effect: Carbomer is a highly effective thickener that can produce a thickening effect at very low dosages (conventional dosage is 0.25-0.5%), thereby preparing gels with different viscosity ranges and rheological properties.

[0022] (2) Suspension effect: Carbomer helps stabilize the active ingredients in the gel, making them evenly dispersed and enhancing product stability.

[0023] (3) Protective effect: Carbomer has a certain affinity with the skin and can reduce the irritation and damage of irritants to the skin and mucous membranes.

[0024] (4) Anti-inflammatory and antibacterial effects: Carbomer itself is a natural medicinal ingredient with antibacterial and anti-inflammatory effects.

[0025] (5) Promote repair and healing: In gynecological gel, carbomer can promote the repair and healing of cervical erosion and alleviate the symptoms of cervicitis.

[0026] (6) Alleviate symptoms: Carbomer gynecological gel can reduce and relieve abnormal leucorrhea such as blood and purulent discharge, and relieve pain symptoms.

[0027] (7) Anti-inflammatory effect: Carbomer gel has certain anti-inflammatory effects and can improve the symptoms of leucorrhea, such as excessive leucorrhea, bloody leucorrhea, and odor.

[0028] The honeysuckle in the present invention is a herbal medicine widely used in traditional Chinese medicine, and its effects are mainly reflected in the following aspects:

[0029] (1) Antibacterial effect: Honeysuckle contains a variety of antibacterial active ingredients, such as organic acids, flavonoids, triterpenoid saponins and volatile oils. These ingredients have inhibitory effects on a variety of pathogenic bacteria, including Staphylococcus aureus and Escherichia coli.

[0030] (2) Antiviral effect: Honeysuckle also has antiviral effects and can inhibit a variety of viruses.

[0031] (3) Anti-inflammatory effect: Honeysuckle has anti-inflammatory effects and can relieve inflammatory responses, which in antibacterial gel helps reduce skin inflammation and discomfort.

[0032] (4) Enhance immunity: Honeysuckle can enhance immunity and improve the body's resistance to pathogens.

[0033] (5) Clearing heat and detoxifying: Honeysuckle is believed to have the effect of clearing heat and detoxifying, helping to eliminate heat and toxins in the body.

[0034] (6) Antioxidant effect: Some components in honeysuckle have antioxidant properties and can scavenge free radicals. The astragalus polysaccharide of the present invention is a natural active ingredient extracted from astragalus, and its main effects are as follows:

[0035] (1) Enhance immune function: Astragalus polysaccharides can enhance the body's immune function and improve the body's resistance to pathogens.

[0036] (2) Antiviral effect: Astragalus polysaccharide, as an interferon inducer, can stimulate the function of macrophages and T cells, promote the induction of interleukins, and thus produce endogenous interferons to achieve the purpose of antiviral.

[0037] (3) Antibacterial effect: Astragalus polysaccharide has antibacterial effect and can inhibit a variety of bacteria such as Shigella dysenteriae, anthrax bacteria, Streptococcus, Pneumococcus, Staphylococcus aureus, Escherichia coli and Salmonella.

[0038] (4) Antioxidant effect: Astragalus polysaccharide has an antioxidant effect, which can scavenge free radicals and protect cells from oxidative damage.

[0039] (5) Anti-tumor effect: Astragalus polysaccharide also has anti-tumor effect and can resist the growth of tumor cells.

[0040] The herb Houttuynia cordata of the present invention is a herb widely used in traditional Chinese medicine and has multiple pharmacological effects, the effects of which are mainly reflected in the following aspects:

[0041] (1) Antibacterial effect: Houttuynia cordata contains a variety of antibacterial ingredients that can inhibit the growth of a variety of bacteria, such as Staphylococcus aureus, Escherichia coli, Shigella dysenteriae, and Salmonella typhi.

[0042] (2) Antiviral effect: Houttuynia cordata decoction has an inhibitory effect on influenza virus and can delay the growth of certain viruses.

[0043] (3) Anti-inflammatory effect: Houttuynia cordata decoction has significant anti-inflammatory effect and can alleviate inflammatory response.

[0044] (4) Enhance immunity: Houttuynia cordata can improve the body's immunity, enhance the phagocytic ability of white blood cells, and increase serum properdin levels.

[0045] (5) Promote tissue regeneration: Houttuynia cordata can also promote tissue regeneration and help wound healing.

[0046] (6) Analgesic effect: Houttuynia cordata has a certain analgesic effect and can relieve pain.

[0047] (7) Hemostatic effect: Houttuynia cordata also has a hemostatic effect, which helps reduce bleeding.

[0048] (8) Anti-tumor effect: Some studies have shown that certain components in Houttuynia cordata have anti-tumor effects.

[0049] (9) Synergistic effect: When Houttuynia cordata is used in combination with other drugs, it may have a synergistic effect and enhance the antibacterial effect.

[0050] The antibacterial gel prepared by the present invention is based on carbomer and combined with traditional Chinese medicine extracts and monoclonal antibodies. It has simple ingredients and a simple preparation process. The finished gel has the advantages of being safe, effective, and having a small usage amount. It has a good therapeutic effect on both human papillomavirus (HPV)-positive vaginitis and human papillomavirus (HPV)-negative vaginitis.

[0051] The various components in the present invention complement each other and work synergistically, and together provide a good basis for the clinical application of the antibacterial gel of the present invention. At the same time, the anti-HPV monoclonal antibody added in the present invention can specifically and directly bind to HPV, providing a targeted therapeutic effect for HPV-positive vaginal inflammation, and further enhancing the therapeutic effect of HPV-positive vaginal inflammation. DETAILED DESCRIPTION

[0053] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as those generally understood by those skilled in the art of the present invention. The terms used herein in the specification of the present invention are only for the purpose of describing specific embodiments and are not intended to limit the present invention. The term "and / or" used herein includes any and all combinations of one or more related listed items.

[0054] Unless otherwise specified, the reagents, methods and equipment used in the present invention are conventional reagents, methods and equipment in the art. Unless otherwise specified, the reagents and materials used in the following examples are commercially available.

[0055] Example 1: An antibacterial gel

[0056] It is composed of the following substances in order of mass fraction: 1% of carbomer, 1% of honeysuckle, 0.5% of astragalus polysaccharide, 2% of houttuynia cordata, and the rest is purified water.

[0057] Example 2: An antibacterial gel

[0058] It is composed of the following substances in order of mass fraction: 1% carbomer, 1% honeysuckle, 0.5% astragalus polysaccharide, 2% houttuynia cordata, 0.5% anti-HPV monoclonal antibody, and the rest is purified water.

[0059] The amino acid sequences of the heavy chain variable region and the light chain variable region of the anti-HPV monoclonal antibody are shown in SEQ ID NO. 1 and SEQ ID NO. 2. The monoclonal antibody is a mouse monoclonal antibody against HPV L1 protein, and its expression level in CHO cells can reach 10g / L, with a high expression yield. Therefore, when it is used as a component in the antibacterial gel, the cost is low.

[0060] Example 3: Preparation of antibacterial gel

[0061] (1) Preparation of carbomer gel matrix: 1 g of carbomer dry powder was placed in a 100 ml dry beaker, and 25 ml of purified water was added while stirring to allow the carbomer to fully absorb water and swell; then the mixture was sterilized at 121° C. and 0.15 MPa for 20 min to obtain the carbomer gel matrix;

[0062] (2) Preparation of other aqueous solutions: weigh 1g honeysuckle, 0.5g astragalus polysaccharide, and 2g houttuynia cordata, add 25ml purified water, decoct for 2-3 times, each time for 1 hour, filter and combine the filtrates; then add purified water twice the volume of the filtrate, filter with a 0.45μm organic filter membrane to obtain a filtrate; then sterilize the filtrate at 121°C and 0.15Mpa for 20min to obtain an aqueous solution containing various components;

[0063] (3) under sterile conditions, adding the aqueous solution prepared in step (2) to the carbomer gel matrix prepared in step (1), and then adding sterilized triethanolamine dropwise with a dropper, stirring while adding, measuring the pH value, and adjusting the pH value to about 7.2;

[0064] (4) Under sterile conditions, add 0.5 g of anti-HPV monoclonal antibody (this step is not required in Example 1);

[0065] (5) Under aseptic conditions, add sterilized purified water to make the total volume 100 ml, and stir evenly to obtain the antibacterial gel.

[0066] Example 4: Application of medical antibacterial gel

[0067] (1) In vitro antibacterial test: Standard Staphylococcus aureus, Escherichia coli, Candida albicans, and Neisseria gonorrhoeae were selected and cultured in culture medium respectively. The antibacterial effect was calculated by broth dilution method. The MIC (minimum inhibitory concentration) was used as the standard to measure the antibacterial effect. A single chitosan quaternary ammonium salt aqueous solution was used as the reference substance. Antibacterial rate (%) = (positive control value - test value) / (positive control value - negative control value) × 100%.

[0068] The results show that the antibacterial gels prepared in Examples 1 and 2 have good antibacterial effects, as shown in the following table:

[0069] Group Staphylococcus aureus Escherichia coli Candida albicans Gonorrhea Example 1 99.56％ 99.68％ 99.87％ 99.89％ Example 2 99.65％ 99.72％ 99.81％ 99.82％

[0070] (2) Comparison of clinical application: The gels prepared in Examples 1 and 2 were used on clinical personnel. The results showed that the gels in Examples 1 and 2 had a good effect on gynecological vaginal inflammation, especially on vaginal inflammation caused by HPV mixed infection, as shown in the following table (Example 1 and Example 2 were used once a day, 2 g each time, for 7 consecutive days, and the other two products were also used for 7 consecutive days according to the instructions):

[0071]

[0072] The above results show that the antibacterial gel prepared in Example 1 and Example 2 of the present invention is safe and effective, and has good therapeutic effects on both human papillomavirus (HPV)-positive vaginitis and human papillomavirus (HPV)-negative vaginitis, achieving the purpose of solving the pain of patients and effectively improving the quality of life of patients.

[0073] The above embodiments are preferred implementation modes of the present invention, but the implementation modes of the present invention are not limited to the above embodiments. Any other changes, modifications, substitutions, combinations, and simplifications that do not deviate from the spirit and principles of the present invention should be equivalent replacement methods and are included in the protection scope of the present invention.

Claims

1. An antibacterial gel, characterized in that: The antibacterial gel is composed of the following substances according to mass fractions: 1% of carbomer, 1% of honeysuckle, 0.5% of astragalus polysaccharide, 2% of houttuynia cordata, and the rest is purified water.

2. The antibacterial gel according to claim 1, characterized in that The antibacterial gel also contains anti-HPV monoclonal antibodies, and the mass fraction of the anti-HPV monoclonal antibodies in the antibacterial gel is 0.5%.

3. The antibacterial gel according to claim 2, characterized in that The amino acid sequences of the heavy chain variable region and the light chain variable region of the anti-HPV monoclonal antibody are shown in SEQ ID NO.1 and SEQ ID NO.

2.

4. A method for preparing the antibacterial gel according to any one of claims 1 to 3, characterized in that: The method comprises the following steps: (1) Preparation of carbomer gel matrix: 1 g of carbomer dry powder was placed in a 100 ml dry beaker, and 25 ml of purified water was added while stirring to allow the carbomer to fully absorb water and swell; then the mixture was sterilized at 121° C. and 0.15 MPa for 20 min to obtain the carbomer gel matrix; (2) Preparation of other aqueous solutions: weigh 1g honeysuckle, 0.5g astragalus polysaccharide, and 2g houttuynia cordata, add 25ml purified water, decoct for 2-3 times, each time for 1 hour, filter and combine the filtrates; then add purified water twice the volume of the filtrate, filter with a 0.45μm organic filter membrane to obtain a filtrate; then sterilize the filtrate at 121°C and 0.15Mpa for 20min to obtain an aqueous solution containing various components; (3) under sterile conditions, adding the aqueous solution prepared in step (2) to the carbomer gel matrix prepared in step (1), and then adding sterilized triethanolamine dropwise with a dropper, stirring while adding, measuring the pH value, and adjusting the pH value to about 7.2; (4) Under sterile conditions, add 0.5 g of anti-HPV monoclonal antibody; (5) Under aseptic conditions, add sterilized purified water to make the total volume 100 ml, and stir evenly to obtain the antibacterial gel.

5. Use of the anti-HPV monoclonal antibody according to claim 3 in the preparation of a medical antibacterial gel for preventing and treating gynecological vaginal inflammation.

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