Gynecological gel composition as well as preparation method and application thereof

Abstract

The invention discloses a gynecological gel composition as well as a preparation method and application thereof. The gynecological gel composition is prepared from the following components in percentage by weight: 10%-15% of isomaltooligosacharide, 22%-26% of lactic acid, 22%-26% of glycerol, 2%-6% of xanthan gum and the balance of purified water. The gel disclosed by the invention has a physical barrier effect: after the gel is dissolved in the vagina, the gel is attached to the surface of vaginal mucosa to form a protective film, so that a wound surface is isolated, secondary cross infection is avoided, repair and regeneration of erosive tissues are accelerated, and healing is promoted. Meanwhile, a layer of protective gel film can be formed on the vaginal wall, so that the vaginal wall is physically isolated from external bacteria, and pathogenic microorganisms are prevented from colonization.

Description

Technical Field

[0001] This invention relates to the field of pharmaceutical technology, and more particularly to the field of gynecological external medicine technology, specifically to a composition of a gynecological gel, its preparation method, and its application. Background Technology

[0002] Gynecological diseases refer to illnesses that affect the health of a woman's reproductive system, including but not limited to menstrual problems, vaginal inflammation, pelvic inflammatory disease, uterine fibroids, ovarian cysts, cervical diseases, endometriosis, and breast diseases. These diseases can impact a woman's quality of life and fertility.

[0003] In modern society, the incidence of gynecological diseases is gradually increasing, partly due to the following factors: Lifestyle factors: Unhealthy lifestyles, such as improper diet, lack of exercise, overwork, and high stress, can all increase the risk of gynecological diseases. Environmental factors: Environmental pollution, exposure to chemicals, and radiation can adversely affect the female reproductive system and increase the risk of disease. Genetic factors: Some gynecological diseases may have a hereditary tendency, and women with a family history of related diseases have an increased risk.

[0004] However, vaginal inflammation and its complications account for the highest proportion of gynecological diseases, and are highly recurrent, causing significant distress to women. Current technologies primarily control these conditions with oral anti-inflammatory drugs and antibiotics, combined with topical medications. These topical medications are often presented in solutions, suspensions, and gels. From an action perspective, contact therapy via gels is more effective. According to the medical device classification catalog, the intended use of gynecological gels is: to form a protective gel film on the vaginal wall, physically isolating the vaginal wall from external bacteria and thus preventing the colonization of pathogenic microorganisms. It is suitable for those with symptoms of cervicitis, vaginitis, and cervical erosion, promoting the healing of cervical erosion and other lesions. Summary of the Invention

[0005] To address the issue of isolating the vaginal wall from external bacteria, this application provides a gynecological gel composition, preparation method, and application, used to physically isolate the vaginal wall from external bacteria, thereby preventing the colonization of pathogenic microorganisms. It is suitable for patients with symptoms of cervicitis, vaginitis, and cervical erosion, promoting the healing of lesions such as cervical erosion.

[0006] To achieve the above objectives, the technical solution adopted in this application is as follows:

[0007] A composition of a gynecological gel, comprising 10%-15% isomaltooligosaccharide, 22%-26% lactic acid, 22%-26% glycerol, 2%-6% xanthan gum, and the remainder being purified water in weight ratios.

[0008] Preferably, the pH value of the composition is 3.4-4.5.

[0009] Preferably, the viscosity of the composition is not less than 3000 mPa·s.

[0010] Preferably, the heavy metal content of the composition is less than or equal to two parts per million.

[0011] Preferably, the isomaltooligosaccharide content of the composition should be between 90% and 110%.

[0012] Preferably, the total number of aerobic bacteria in the composition is ≤100 cfu / g, the total number of molds and yeasts is ≤10 cfu / g, and the levels of Staphylococcus aureus, Candida albicans, Pseudomonas aeruginosa, and Escherichia coli are below the minimum detectable standard.

[0013] The present invention also provides a preparation method for preparing the composition for obtaining the gynecological gel, comprising the following steps:

[0014] Step S1, mixing of main ingredients: Prepare the components according to the proportions of each component in Example 1 by weight, and then put all the components except lactic acid and glycerin into a mixing vessel and heat to 46℃-58℃. During the heating process, keep stirring at a constant speed, and then filter through a sieve with a mesh size of less than 20 mesh. The whole process should be carried out without solidification. If gel forms due to temperature drop during filtration, reheat until filtration is complete to remove large particles of foreign matter.

[0015] Step S2, test the pH. After adding the preset weight of glycerol to the mixture obtained in step S1 and stirring thoroughly, take a sample for pH value testing. When the actual pH value is higher than 4.5, gradually add lactic acid and stir again. Keep the temperature at 46℃ during the stirring process until the pH value reaches 4±0.2. Let it stand until it solidifies naturally at room temperature and then package it for later use.

[0016] The present invention also provides the use of a gynecological gel composition in the preparation of a medicament for the treatment / adjunctive treatment of bacterial vaginosis (BV), fungal vaginitis, trichomonal vaginitis, and abnormal vaginal bleeding.

[0017] Beneficial effects:

[0018] 1. This invention provides a physical barrier effect: After the gel melts in the vagina, it adheres to the vaginal mucosa surface, forming a protective film that isolates the wound, prevents secondary cross-infection, accelerates the repair and regeneration of eroded tissue, and promotes healing. Simultaneously, it forms a protective gel film on the vaginal wall, physically isolating the vaginal wall from external bacteria, thereby preventing the colonization of pathogenic microorganisms.

[0019] 2. This invention has a microecological maintenance effect: Isomaltooligosaccharide is a functional oligosaccharide, and its main functional components are isomaltose, isomalttriose, and panose, which can promote the proliferation of beneficial bacteria in the human body. By consuming itself, it provides the necessary restoration environment for the microecology of beneficial bacteria, promotes their growth, regulates the balance of the flora, and promotes the restoration of the self-cleaning function of the female reproductive system.

[0020] 3. Lactic acid is commonly used in vaginal douches and gels to help maintain the normal pH balance of the vagina and prevent and treat bacterial vaginosis and candidal vaginitis. Glycerin has good moisturizing and lubricating properties, which can keep the skin and mucous membranes moist, form a protective film, and prevent external irritation and infection. Detailed Implementation

[0021] Example 1:

[0022] This embodiment provides a composition of a gynecological gel, which is composed of 10%-15% isomaltooligosaccharide, 22%-26% lactic acid, 22%-26% glycerol, 2%-6% xanthan gum, and the remainder being purified water in a weight ratio.

[0023] In this embodiment, the pH value of the composition is 3.4-4.5, the viscosity of the composition is not less than 3000 mPa·s, the heavy metal content of the composition is less than or equal to 2 parts per million, the isomaltooligosaccharide content of the composition should be 90%-110%, the total number of aerobic bacteria in the composition is ≤100 cfu / g, the total number of molds and yeasts is ≤10 cfu / g, and Staphylococcus aureus, Candida albicans, Pseudomonas aeruginosa, and Escherichia coli are below the minimum detectable standard, that is, they cannot be detected or the detection is negative.

[0024] The isomaltooligosaccharide, lactic acid, glycerin, and xanthan gum used in this embodiment have wide applications in various fields, and their medicinal value in gynecology varies. The following are their functions and specific applications in the field of gynecology:

[0025] Isomaltooligosaccharide:

[0026] 1. Promotes gut health: Isomaltooligosaccharide is a prebiotic that can promote the growth of beneficial bacteria in the gut (such as bifidobacteria and lactobacilli) and improve the balance of the gut microbiota.

[0027] 2. Enhance immunity: By promoting the growth of beneficial bacteria, it indirectly enhances the body's immune function.

[0028] 3. Prevents constipation: Because it promotes intestinal peristalsis, it helps prevent and relieve constipation problems.

[0029] Gynecological applications: Vaginal microecological regulation: Isomaltooligosaccharide can indirectly regulate the balance of vaginal flora by improving intestinal health, and prevent or alleviate vaginal inflammation, such as bacterial vaginosis (BV).

[0030] Functions of lactic acid:

[0031] 1. Regulates pH: Lactic acid is a natural acidic substance that can regulate the pH of the local environment, maintaining the acidic environment of the vagina (pH value is approximately 3.8-4.5). 2. Antibacterial effect: The acidic environment can inhibit the growth of harmful bacteria, helping to maintain vaginal health.

[0032] Gynecological applications: Lactic acid is used in vaginal douches and gels to help maintain the normal pH balance of the vagina and prevent and treat bacterial vaginosis and candidal vaginitis.

[0033] Glycerin's functions: 1. Moisturizing and lubricating: Glycerin has good moisturizing and lubricating properties, which can keep the skin and mucous membranes moist.

[0034] 2. Protective function: Forms a protective film to prevent external irritants and infections.

[0035] Gynecological Applications: Lubricant: Glycerin is commonly used in vaginal lubricants to help relieve pain and dryness during intercourse. Suppository Base: Due to its excellent lubricating and moisturizing properties, glycerin is often used as a base material for gynecological suppositories.

[0036] Uses of xanthan gum:

[0037] 1. Thickener: Xanthan gum is a natural polysaccharide with good thickening and stability properties.

[0038] 2. Suspension and emulsifier: Xanthan gum can stabilize suspensions and emulsions.

[0039] Gynecological applications: Pharmaceutical preparations: Xanthan gum is used in gynecological pharmaceutical preparations as a thickener or suspending agent to help stabilize the physical properties of drug suspensions or emulsions, improve drug efficacy and patient compliance.

[0040] The application of these substances in gynecology is often based on their unique functions. For example, lactic acid and glycerin are commonly used in vaginal care products to help maintain vaginal health and comfort; isomaltooligosaccharides indirectly affect the vaginal microecological balance through the regulation of intestinal flora; and xanthan gum plays an important physical stabilizing role in pharmaceutical preparations. Combining the use of these ingredients can lead to the development of more effective gynecological health and treatment products.

[0041] When using it, simply insert the gel into the vagina using the delivery device. The delivery device can be an existing product, such as one similar to a syringe, with a tube for holding the gel, a push rod inside the tube to push the gel out, a dispensing port at the other end of the tube, and a cap structure to seal the dispensing port to ensure that the inside of the tube is not contaminated.

[0042] Example 2:

[0043] The present invention also provides a preparation method for preparing a composition to obtain the gynecological gel described in Example 1, comprising the following steps:

[0044] Step S1, mixing of main ingredients: Prepare the components according to the proportions of each component in Example 1 by weight, and then put all the components except lactic acid and glycerin into a mixing vessel and heat to 46℃-58℃. During the heating process, keep stirring at a constant speed, and then filter through a sieve with a mesh size of less than 20 mesh. The whole process should be carried out without solidification. If gel forms due to temperature drop during filtration, reheat until filtration is complete to remove large particles of foreign matter.

[0045] Step S2, test the pH. After adding the preset weight of glycerol to the mixture obtained in step S1 and stirring thoroughly, take a sample for pH value testing. When the actual pH value is higher than 4.5, gradually add lactic acid and stir again. Keep the temperature at 46℃ during the stirring process until the pH value reaches 4±0.2. Let it stand until it solidifies naturally at room temperature and then package it for later use.

[0046] The present invention also provides the use of a gynecological gel composition in the preparation of a medicament for the treatment / adjunctive treatment of bacterial vaginosis (BV), fungal vaginitis, trichomonal vaginitis, and abnormal vaginal bleeding.

[0047] The above description is merely a preferred embodiment of this application and is not intended to limit this application. Various modifications and variations can be made to this application by those skilled in the art. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of this application should be included within the protection scope of this application.

Claims

1. A composition of a gynecological gel, characterized in that: The composition is prepared by mixing 10%-15% of isomaltooligosaccharide, 22%-26% of lactic acid, 22%-26% of glycerol, 2%-6% of xanthan gum, and the rest of purified water.

2. A composition of a gynecological gel according to claim 1, characterized in that: The pH value of the composition is 3.4-4.

5.

3. A composition of a gynecological gel according to claim 1, characterized in that: The viscosity of the composition is not less than 3000 mPa.s.

4. A composition of a gynecological gel according to claim 1, characterized in that: The heavy metal content of the composition is less than or equal to 2 parts per million.

5. A composition of a gynecological gel according to claim 1, characterized in that: The isomaltooligosaccharide content of the composition should be 90%-110%.

6. A composition of a gynecological gel according to claim 1, characterized in that: The total number of aerobic bacteria in the composition is ≤100 cfu / g, the total number of mold and yeast is ≤10 cfu / g, and the number of Staphylococcus aureus, Candida albicans, Pseudomonas aeruginosa, and Escherichia coli is lower than the minimum detectable standard.

7. A process for the preparation of a composition for obtaining the gynaecological gel according to any one of claims 1 to 6, characterized in that, The method comprises the following steps: Step S1, mixing of main materials, the components in the proportions in Example 1 are prepared by weight parts, and the other components except lactic acid and glycerol are all put into a mixing vessel and heated to 46-58°C, uniform stirring is maintained during the heating process, then filtration is carried out through a sieve with a mesh size of less than 20, the whole process is suitable for not solidifying, if gel-like is produced due to temperature reduction during the filtration process, re-heating can be carried out until the filtration is completed, and large-particle impurities are filtered out; Step S2, testing of pH value, the mixture obtained in step S1 is added with a predetermined weight of glycerol, fully stirred, and then sampled for PH value detection, when the actual PH value is higher than 4.5, lactic acid is gradually added and stirred again, the stirring process maintains a temperature of 46°C; until the detected PH value reaches 4±0.2, and then it is packaged after standing at room temperature and natural solidification.

8. Use of the composition of the gynecological gel according to claim 1 in the preparation of a drug for treating / assisting in treating bacterial vaginosis (BV), mold vaginitis, trichomonas vaginitis, and abnormal vaginal bleeding.