Female gel with vagina tightening effect as well as preparation method and application thereof

Abstract

The invention belongs to the technical field of gynecological external medicines, and particularly relates to a gynecological gel with a vagina tightening effect as well as a preparation method and application thereof. The gel is prepared from the following components in parts by weight: 0.1 to 1 part of gallic acid and 0.2 to 1 part of dimethyl sulfone. The gel for women is prepared by compounding gallic acid and dimethyl sulfone in a specific ratio, and the antioxidant and antibacterial effects of gallic acid and the deep repair and permeation characteristics of dimethyl sulfone can play a synergistic effect, so that the problem of vaginal relaxation can be efficiently solved, a mild, safe and long-acting nursing scheme is provided for women, and the gel has a good application prospect. Meanwhile, the micro-ecological balance of the vagina is maintained, and the requirements of modern women for health and nursing are met.

Description

Technical Field

[0001] The invention belongs to the technical field of gynecological external medicines, and in particular relates to a gynecological gel with vaginal tightening effect, and a preparation method and application thereof. Background Art

[0002] Vaginal relaxation is a common problem for women due to various factors such as aging, poor postpartum recovery, and hormonal changes. Existing vaginal tightening products mainly rely on physical means to achieve short-term effects, which is difficult to fundamentally solve the relaxation problem, and some products may have a negative impact on the vaginal microecology, leading to infection or dysbacteriosis.

[0003] Most vaginal tightening products currently on the market rely on short-term physical contraction techniques, such as topical creams and laser / radiofrequency treatments. These methods achieve a tightening effect by locally stimulating vaginal tissue, temporarily increasing muscle tension or contracting the mucosa. However, such effects are usually short-lived, and the tightening sensation quickly disappears with local metabolism or tissue recovery, and cannot fundamentally improve the problem of vaginal relaxation.

[0004] The vaginal water light injection (firming injection) in medical beauty technology moisturizes and enhances elasticity by injecting active ingredients such as hyaluronic acid and collagen, promoting collagen production and tissue regeneration in the short term, and providing a more significant firming effect. However, the effect of this method is also limited, and it usually requires regular injections to maintain, and the cost is high, and it cannot cure the problem of vaginal relaxation in the long term.

[0005] Patent CN202320573371.3 claims that its vaginal tightening rehabilitation device with electric shock and vibration function can quickly stimulate vaginal muscles through a combination of electric shock and vibration, help restore tightness, and is harmless to the body. However, there is a lack of sufficient evidence to verify its safety and effectiveness, and it cannot be guaranteed that the device is suitable for all people, and it may have side effects on users with sensitive constitutions. In addition, the complexity of the device and the electric shock function may cause discomfort, and its clinical application value is still unclear.

[0006] Patent CN201922078575.6 discloses a vaginal tightening ball, which is connected to the sphere by a soft handle, with diamond-shaped convex patterns on the sphere and a steel ball with replaceable weight inside. It claims to achieve a firming effect by physical means and alleviate the problem of dryness. It is easy to use and suitable for vaginal tightening exercises at any time. However, the vaginal tightening ball requires correct insertion, weight adjustment and regular use. The operation is relatively complicated and difficult for users to master. Secondly, the vaginal tightening ball requires regular cleaning and maintenance, and is not easy to use in public places. In addition, the vaginal tightening ball is an invasive physical vaginal tightening method, which may cause discomfort or potential harm to women with sensitive constitutions. For women with certain health conditions or sensitive constitutions, there may be potential risks of use.

[0007] Patent CN202311623430.4 discloses a vaginal tightening lubricating gel, which mainly forms a protective biogel layer on the vaginal wall through ingredients such as xanthan gum, trehalose, glycerin, gelatin alginate complex, etc., claiming to be able to prevent the colonization of pathogenic microorganisms and improve symptoms such as vaginal itching and erosion. However, this patent focuses on physical barriers and lubrication functions, and does not provide an effective solution for vaginal tightening.

[0008] Therefore, the existing technologies for vaginal contraction and tightening still have the following disadvantages: (1) Short-term effect: physical contraction products can only provide a short-term tightening effect, usually requiring frequent use to maintain the effect, and cannot solve the problem of vaginal relaxation in the long term; (2) Destruction of the microecological environment: some physical tightening products contain chemical ingredients that may destroy the natural acid-base balance of the vagina, leading to dysbiosis, thereby causing discomfort, itching, odor in the private parts, and even increasing the risk of infection; (3) Lack of repair function: most traditional physical tightening products are emergency products that cannot effectively repair vaginal mucosal damage caused by relaxation or aging, and it is difficult to promote tissue regeneration and elasticity recovery. Therefore, the market is in urgent need of a product that can repair in a long-term, gentle and safe manner. Summary of the invention

[0009] The purpose of the present invention is to overcome the deficiencies of the above-mentioned prior art and provide a female gel with vaginal tightening effect and its preparation method and application, aiming to fundamentally solve the problem of vaginal relaxation.

[0010] To achieve the above objectives, the technical solutions adopted by the present invention include:

[0011] In a first aspect, the present invention provides a female gel having a vaginal tightening effect, the gel comprising the following components in parts by weight: 0.1-1 part of gallic acid and 0.2-1 part of dimethyl sulfone.

[0012] Gallic acid is a natural polyphenol with antioxidant, antibacterial and tissue repair functions. Introducing it into vaginal care products can help restore the elasticity of the mucosa and provide long-lasting firming and repair effects.

[0013] MSM (Methylsulfonylmethane) has a molecular formula of C 2 H 6 O 2S is a natural organic sulfur compound that is widely found in animals and plants and is often used as a dietary supplement and skin care ingredient. Its excellent bioavailability and permeability enable it to quickly penetrate the skin barrier and accelerate the absorption of active ingredients such as gallic acid, thereby enhancing the overall product efficacy. In addition, dimethyl sulfone has good anti-inflammatory and antioxidant properties, which can effectively relieve local inflammation and reduce tissue damage. It is especially suitable for repairing tissues in sensitive areas. At the same time, it can promote the synthesis of collagen and keratin, help repair and strengthen tissue structure, which is crucial for improving the firmness and elasticity of the vaginal mucosa. The cell regeneration promoting effect of dimethyl sulfone can not only accelerate tissue repair, but also maintain the moisture balance of the mucosa, thereby improving the local moisturizing effect and further enhancing the overall firmness.

[0014] Experimental research has found that the antioxidant and antibacterial effects of gallic acid and the deep repair and penetration properties of dimethyl sulfone can play a synergistic role. The combination of the two can not only effectively solve the problem of vaginal relaxation, but also provide women with a gentle, safe and long-lasting care plan to help restore vaginal health and firmness while maintaining the microecological balance of the vagina. When either of the two components is missing or replaced, the repair and firming effect of the gel will be significantly reduced.

[0015] Moreover, when the inventors explored the dosage ratio of the two components, they found that when the ratio of gallic acid and dimethyl sulfone exceeded the preferred range of the present invention, the synergistic effect between the components was not obvious and even produced an antagonistic effect, which led to a significant deterioration in the firming and repairing effect of the gel. This shows that the above two components have an ideal synergistic effect within the specified range of the present invention.

[0016] Preferably, the gel comprises the following components in parts by weight: 0.1-0.4 parts of gallic acid and 0.2-0.5 parts of dimethyl sulfone.

[0017] Preferably, the gel comprises the following components in parts by weight: 0.2 parts of gallic acid and 0.4 parts of dimethyl sulfone.

[0018] Experimental research found that when gallic acid and dimethyl sulfone were compounded using the above-mentioned optimal dosage ratio, in the zebrafish experiment, the elastin expression rate of the prepared gel was greatly improved, which can effectively restore the elasticity of the mucosa, provide long-lasting firming and repair effects, and effectively improve the problem of vaginal relaxation from the root, with the best synergistic effect.

[0019] Preferably, based on 100 parts by weight, the gel further comprises the following components in parts by weight: 1-5 parts of a moisturizer, 0.1-1 parts of a thickener, 0.2-0.5 parts of a neutralizer, and the balance of water.

[0020] Preferably, based on 100 parts by weight, the gel further comprises the following components in parts by weight: 3 parts of moisturizer, 0.5 parts of thickener, 0.2-0.5 parts of neutralizer and the balance of water.

[0021] Preferably, the moisturizing agent comprises glycerol and 1,2-hexanediol, and the mass ratio of the glycerol to 1,2-hexanediol is (1.5-2.5):1.

[0022] Preferably, the moisturizing agent comprises glycerol and 1,2-hexanediol, and the mass ratio of the glycerol to 1,2-hexanediol is (1.8-2.2):1.

[0023] More preferably, the moisturizing agent comprises glycerol and 1,2-hexanediol, and the mass ratio of the glycerol to 1,2-hexanediol is 2:1.

[0024] The present invention further adds a specific amount of glycerin and 1,2-hexanediol to the gel, and the two as moisturizers can further enhance the moisturizing effect of the gel, fully achieve the moisture balance of the mucous membrane, and thus enhance the overall firming and repairing effect of the gel to a certain extent.

[0025] Preferably, the thickener comprises Carbomer U30; and / or the neutralizer comprises sodium hydroxide.

[0026] In a second aspect, the present invention provides a method for preparing the feminine gel, the method comprising the following steps:

[0027] S1, adding a thickener into water for swelling to obtain a swelling solution;

[0028] S2, mixing the moisturizer, gallic acid, dimethyl sulfone and water to obtain a mixed solution, then adding the mixed solution to the swelling solution and stirring for 10-30 minutes;

[0029] S3, adding a neutralizing agent and adjusting the pH value to 5.0-6.2 to obtain the feminine gel.

[0030] In a third aspect, the present invention provides use of the feminine gel in the preparation of vaginal tightening or repairing products.

[0031] Preferably, the mass percentage of the female gel in the vaginal tightening or repairing product is 0.05-0.15%. It is found that the gel has the best effect in enhancing elastin gene expression when used at a dosage of 0.1%, and its expression promotion rate is close to that of the positive drug group.

[0032] Compared with the prior art, the present invention has the following beneficial effects:

[0033] The present invention adopts gallic acid and dimethyl sulfone in a specific ratio to prepare a gel for women. The antioxidant and antibacterial effects of gallic acid and the deep repair and penetration characteristics of dimethyl sulfone can play a synergistic role, which can not only effectively solve the problem of vaginal relaxation, but also provide women with a gentle, safe and long-lasting care plan, help restore vaginal health and firmness, maintain the microecological balance of the vagina, and meet the health and care needs of modern women. BRIEF DESCRIPTION OF THE DRAWINGS

[0034] Figure 1 This is a comparison chart of the chicken embryo mucosal stimulation test results of the negative control (NC) in Effect Example 2, the left picture is before adding the sample, and the right picture is after adding the sample;

[0035] Figure 2 This is a comparison chart of the chicken embryo mucosal irritation test results of the negative control (PC) in Effect Example 2, the left picture is before adding the sample, and the right picture is after adding the sample;

[0036] Figure 3 This is a comparison chart of the chicken embryo mucosal stimulation test results of the test sample (Example 1) in Effect Example 2, the left picture is before sample addition, and the right picture is after sample addition. DETAILED DESCRIPTION

[0037] To better illustrate the purpose, technical solutions and advantages of the present invention, the present invention will be further described below in conjunction with specific embodiments. It should be understood by those skilled in the art that the specific embodiments described herein are only used to explain the present invention and are not intended to limit the present invention.

[0038] Unless otherwise specified, all raw materials involved in the following examples and comparative examples are commercially available general raw materials.

[0039] Examples 1-5

[0040] This embodiment 1-5 provides a female gel with vaginal tightening effect, and the specific formula is shown in Table 1 (total weight parts are 100 parts). The preparation method of the female gel comprises the following steps:

[0041] S1, adding a thickener into water for swelling to obtain a swelling solution;

[0042] S2, mixing the moisturizer, gallic acid, dimethyl sulfone and water to obtain a mixed solution, then adding the mixed solution to the swelling solution and stirring for 10-30 minutes;

[0043] S3, adding a neutralizing agent and adjusting the pH value to 5.0-6.2 to obtain the feminine gel.

[0044] Table 1 Formula of the female gel described in Examples 1-5 (parts by weight)

[0045]

[0046] Comparative Examples 1-5

[0047] The present invention also provides the formula of the female gel of comparative examples 1-5, as shown in Table 2 (total weight parts is 100 parts). The preparation method of the female gel provided by comparative examples 1-5 is similar to that of embodiments 1-5, except that the formula is different.

[0048] Table 2 Formula of the female gel described in Comparative Examples 1-5 (parts by weight)

[0049]

[0050]

[0051] Comparative Example 6

[0052] This comparative example provides a gel for women, which differs from Example 1 only in that hyaluronic acid replaces gallic acid, and the other components and contents are the same.

[0053] Comparative Example 7

[0054] This comparative example provides a gel for women, which is different from Example 1 only in that α-lipoic acid replaces dimethyl sulfone, and the other components and contents are the same.

[0055] Effect Example 1

[0056] This effect example tests the tightening effect of the sample on the vagina through a zebrafish tightening effect experiment, and the specific method is as follows.

[0057] The female gel prepared in Examples 1-5 and Comparative Examples 1-7 was used as a sample for testing. The concentration of the sample in the working solution was 0.1%, and a blank control group and a positive drug group (0.8 g / L) were added. Three biological replicates were set in each group, and 10 fish were set in each replicate. 5 mL of working solution was added to each well. Each test group was placed in a constant temperature incubator at 28.5±0.5℃ for 24 hours and then sampled. Total RNA was extracted, reverse transcribed and amplified by fluorescence quantitative PCR from each group of zebrafish. The β-actin gene was used as the internal reference gene, and 2 -△△Ct Methods The relative expression of elastin gene in each group was calculated, and the gene expression promotion rate of the test group relative to the control group was calculated. The final result of each group was averaged. The results are shown in Table 3.

[0058] Table 3 Relative expression of zebrafish elastin

[0059]

[0060]

[0061] From the results in Table 3, it can be seen that the gel prepared by the technical solution of the present invention can significantly promote the expression of elastin gene, thereby helping to improve the firmness and elasticity of the vaginal mucosa and achieve vaginal tightening effect. In particular, the gel prepared in Example 1 has the highest gene expression promotion rate, that is, the best tightening effect.

[0062] When gallic acid and dimethyl sulfone were missing in Comparative Examples 1-2, the relative expression amount and promotion rate of the prepared gel for elastin gene were significantly lower than those in the embodiment, indicating that the synergistic effect of gallic acid and dimethyl sulfone played an important role in the expression of elastin gene. When any component was missing, the gene expression promotion rate of the gel was significantly reduced. When the two components were replaced with other components with similar effects in Comparative Examples 6-7, the relative expression amount of elastin gene in the prepared gel was also significantly reduced, indicating that the synergistic effect of gallic acid and dimethyl sulfone played an important role in the expression of elastin gene. The two components cooperate with each other to synergistically enhance the firming effect of the gel, while when other components are conventionally replaced, the synergistic effect is not obvious; when the dosage ratio of gallic acid and dimethyl sulfone in comparative example 4-5 exceeds the specified range of the present invention, the gene expression promotion rate of the gel is also significantly reduced, that is, the imbalance in the ratio of the two components will lead to a weakening of the firming effect of the gel; the above results all show that gallic acid and dimethyl sulfone can better play a synergistic role within a specific dosage range, significantly improving the vaginal repair and firming effect of the gel, thereby efficiently solving the problem of vaginal relaxation.

[0063] Effect Example 2

[0064] In this effect example, the gel prepared in Example 1 was used as a sample, and the irritation of the sample to the vaginal mucosa was tested by a chicken embryo mucosal stimulation experiment. The specific method is as follows.

[0065] Preparation of chorioallantoic membrane (CAM): Purchase chicken embryos of appropriate age, and when incubated to 9 days old, check and discard defective chicken embryos. Mark the position of the air cell on the surface of the eggshell of a normal chicken embryo, peel off part of the eggshell to expose the white egg membrane; carefully remove the inner membrane with tweezers to ensure that the vascular membrane is not damaged.

[0066] Stimulation scoring method: 6 chicken embryos in each group, take 0.3mL of sample and add it directly to the CAM surface, observe the reaction of CAM, record the time of bleeding, coagulation and vascular melting within 5 minutes, and record the degree of reaction.

[0067] Endpoint evaluation method: For each group of 6 chicken embryos, 0.3 mL of the prepared sample was directly added to the CAM surface, and the CAM reaction was observed. After 3 minutes of action, the test substance was gently rinsed with physiological saline to remove it, and the three reactions and degrees of bleeding, coagulation and vascular melting were observed within 30 seconds after rinsing. If the observation shows that at least one reaction of all 6 chicken embryos is scored as moderate or above (total score ≥12), the experiment should be repeated once.

[0068] Positive and negative controls were added (negative control (NC): 0.9% NaCl; positive control (PC): 0.1 mol / LNaOH). The positive and negative controls were operated using the stimulation scoring method. The samples were operated using the endpoint scoring method. The results are shown in Table 4-5 and Figure 1-3 shown.

[0069] Table 4 Scoring results of the control group

[0070]

[0071] Table 5 Test sample scoring results

[0072]

[0073] The experimental results show that the firming and repairing gel of the present invention did not cause obvious irritation reaction in the chicken embryo mucosal irritation test, proving that it is mild and non-irritating to mucosal tissues.

[0074] Finally, it should be noted that the above embodiments are intended to illustrate the technical solution of the present invention rather than to limit the scope of protection of the present invention. Although the present invention has been described in detail with reference to the preferred embodiments, those skilled in the art should understand that the technical solution of the present invention may be modified or replaced by equivalents without departing from the essence and scope of the technical solution of the present invention.

Claims

1. A female gel having vaginal tightening effect, characterized in that: The gel comprises the following components in parts by weight: 0.1-1 part of gallic acid and 0.2-1 part of dimethyl sulfone.

2. The female gel according to claim 1, characterized in that: The gel comprises the following components in parts by weight: 0.1-0.4 parts of gallic acid and 0.2-0.5 parts of dimethyl sulfone.

3. The female gel according to claim 2, characterized in that: The gel comprises the following components in parts by weight: 0.2 parts of gallic acid and 0.4 parts of dimethyl sulfone.

4. The female gel according to any one of claims 1 to 3, characterized in that: Based on 100 parts by weight, the gel further comprises the following components in parts by weight: 1.5-5 parts of a moisturizer, 0.1-1 parts of a thickener, 0.2-0.5 parts of a neutralizer, and the balance of water.

5. The female gel according to claim 4, characterized in that: Based on 100 parts by weight, the gel further comprises the following components in parts by weight: 3 parts of moisturizer, 0.5 parts of thickener, 0.2-0.5 parts of neutralizer and the balance of water.

6. The female gel according to claim 4 or 5, characterized in that: The moisturizing agent includes glycerol and 1,2-hexanediol; the mass ratio of the glycerol to 1,2-hexanediol is (1.5-2.5):

1.

7. The female gel according to claim 4 or 5, characterized in that: The thickener comprises Carbomer U30; and / or the neutralizer comprises sodium hydroxide.

8. The method for preparing the feminine gel according to any one of claims 4 to 7, characterized in that: The preparation method comprises the following steps: S1, adding a thickener into water for swelling to obtain a swelling solution; S2, mixing the moisturizer, gallic acid, dimethyl sulfone and water to obtain a mixed solution, then adding the mixed solution to the swelling solution and stirring for 10-30 minutes; S3, adding a neutralizing agent and adjusting the pH value to 5.0-6.2 to obtain the feminine gel.

9. Use of the feminine gel according to any one of claims 1 to 7 in the preparation of vaginal tightening or repairing products.

10. The use according to claim 9, characterized in that The mass percentage of the female gel in the vagina tightening or repairing product is 0.05-0.15%.

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