Vagina tightening bacteriostatic preparation and preparation method thereof

Abstract

The invention relates to the technical field of medicine, in particular to a vagina tightening bacteriostatic preparation and a preparation method thereof.The vagina tightening bacteriostatic preparation is prepared from, by mass, 0%-0.5% of carbomer, 5%-13% of galactomannan, 1%-6% of transient pink regulator, 0.1% of tetrahydropiperine, 4% of physalis alkekengi extracting solution and 10% of composite plant fungicide; the amount of the neutralizer is the amount which enables the pH value of the preparation to be 6.0-6.5. According to the invention, the galactomannan instantly forms a film to tighten and shrink vagina, the instant plicatin rapidly thickens vagina mucosa, the plant penetrant tetrahydropiperine promotes permeation of effective components and increases the mucosa absorbance of the effective components, so that the vagina shrinking effect is multiplied, and the plant penetrant tetrahydropiperine cooperates with other various components to achieve a synergistic effect, so that the vagina shrinking effect is improved. And a rapid and efficient vagina contracting effect is achieved.

Description

Technical Field

[0001] This invention relates to the field of pharmaceutical technology, and in particular to a vaginal tightening and antibacterial preparation and its preparation method. Background Technology

[0002] Due to factors such as miscarriage, frequent sexual intercourse, postpartum childbirth, or increasing age, a woman's vagina can become noticeably wider and stretched. Simultaneously, due to the relaxation of surrounding muscles, the vagina may also experience laxity, urinary incontinence, and dryness. This is a natural physiological phenomenon in women, but it can lead to a series of problems, including dissatisfaction in personal life and a weakening of marital relationships. This issue troubles many women both domestically and internationally.

[0003] Vaginal tightening and vaginal tightening have become methods for women to improve the quality of their sex lives. Common methods include Kegel exercises, vaginal tightening surgery, and the use of related care products. However, vaginal tightening surgery carries significant risks, potentially causing vaginal laxity and dilation again, bleeding, or damage to the vaginal interior, and recurrence is common. Kegel exercises are time-consuming and require perseverance. As for vaginal tightening care products, they often take a long time to show results and may not be as effective as initially advertised. Summary of the Invention

[0004] To address the above technical problems, this invention provides a vaginal tightening and antibacterial preparation and its preparation method.

[0005] To achieve the technical effects of this invention, the following technical solution is adopted: A vaginal tightening and antibacterial preparation, wherein the raw materials for preparation include the following components by mass percentage: carbomer 0-0.5%, galactomannan 5-13%, instant wrinkle smoothing agent 1-6%, tetrahydropiperine 0.1%, berry extract 4%, compound plant bactericide 10%; the balance is a neutralizing agent and water, wherein the amount of the neutralizing agent is such that the pH of the preparation is 6.0-6.5.

[0006] As a further improvement, the galactomannan is a C1-5 alkyl galactomannan, the mass fraction of the berry extract in the berry extract is 9.7-10.3%; the water is purified water, the neutralizing agent is lactic acid / sodium lactate buffer; and the amount of the neutralizing agent is 0.2-0.5% of the total mass of the preparation.

[0007] As a further improvement, the trade name of the compound plant fungicide is RyanCOM-8011; the raw materials for preparing the instant wrinkle smoothing agent include the following components by mass percentage: 70-80% hydrolyzed collagen, 0.7% sodium hydroxymethylglycinate and 20.0-30.0% glucosamine.

[0008] As a further improvement, the formulation is a gel or an essence; the compound plant fungicide includes rosemary leaf extract, American ginseng root extract, fucus vesiculosus extract, chamomile extract and Satsuma mandarin peel extract; the mass of the rosemary leaf extract, American ginseng root extract, fucus vesiculosus extract, chamomile extract and Satsuma mandarin peel extract is 7.5-16.5% of the total mass of the compound plant fungicide.

[0009] As a further improvement, the compound plant fungicide comprises the following components by mass percentage: 0.5-2% rosemary leaf extract, 0.5-2.5% American ginseng root extract, 5.0-8.0% fucus veitchii extract, 0.5-1.5% chamomile extract, 1.0-2.5% Satsuma mandarin orange peel extract, 5-15% butylene glycol, 10-50% propylene glycol, 0.1-0.5% 1,2-pentanediol, 1-10% sodium cocamidopropyl PG-dimethylammonium chloride phosphate, 1-10% dichlorobenzyl alcohol, 0.1-0.2% p-hydroxyacetophenone, and 10-50% water.

[0010] The present invention also provides a method for preparing the above-described formulation, the method comprising the following steps: 1) Add water, carbomer, and galactomannan to a stirring apparatus, stir, homogenize, heat to 85-90℃, and stir until dissolved; 2) Cool to 40-45℃, add instant wrinkle smoothing agent, tetrahydropiperine, berry extract and compound plant fungicide to the stirring device and stir until dissolved; 3) Add the neutralizing agent to the stirring device while stirring; 4) After adding, continue stirring until well combined; 5) Filter and discharge.

[0011] As a further improvement, in step 1), water, carbomer, and galactomannan are added to the stirring device sequentially; the stirring speed is 600 rpm; the homogenization speed is 3000 rpm; and the homogenization time is 1 minute; in step 3), the stirring speed is 200-300 rpm; in step 4), the stirring speed is 300-500 rpm; and the stirring time is 20 minutes; and in step 5), filtration is performed using a 200-mesh filter cloth.

[0012] As a further improvement, after filtering and discharging in step 5), the steps of sampling and testing, settling and filling are also included.

[0013] The present invention also has the following beneficial effects: This invention utilizes galactomannan to instantly form a film that tightens and firms the vagina, an instant wrinkle-smoothing agent to rapidly thicken the vaginal mucosa, and a plant-based penetrant, tetrahydropiperine, to promote the penetration of active ingredients and increase their absorption by the mucosa, thus significantly enhancing the vaginal tightening effect. In conjunction with other ingredients, these components work synergistically to achieve a rapid and highly effective vaginal tightening effect. Detailed Implementation

[0014] Example 1 A vaginal tightening and antibacterial preparation, wherein the raw materials for preparation are composed of the following components by mass percentage: 0.5% carbomer, 5% galactomannan, 1% instant wrinkle smoothing agent, 0.1% tetrahydropiperine, 4% berry extract, and 10% compound plant bactericide; the balance being a neutralizing agent and water, wherein the amount of neutralizing agent is such that the pH of the preparation is 6.0-6.5.

[0015] Example 2 A vaginal tightening and antibacterial preparation, wherein the raw materials for preparation include the following components by mass percentage: 0.5% carbomer, 8% galactomannan, 3% instant wrinkle smoothing agent, 0.1% tetrahydropiperine, 4% berry extract, and 10% compound plant bactericide; the balance is a neutralizing agent and water, wherein the amount of neutralizing agent is such that the pH of the preparation is 6.0-6.5.

[0016] Example 3 A vaginal tightening and antibacterial preparation, wherein the raw materials for preparation include the following components by mass percentage: 0.5% carbomer, 10% galactomannan, 5% instant wrinkle smoothing agent, 0.1% tetrahydropiperine, 4% berry extract, and 10% compound plant bactericide; the balance being a neutralizing agent and water, wherein the amount of neutralizing agent is such that the pH of the preparation is 6.0-6.5.

[0017] Example 4 A vaginal tightening and antibacterial preparation, the raw materials for which the preparation is made include the following components by mass percentage: 0.5% carbomer, 13% galactomannan, 6% instant wrinkle smoothing agent, 0.1% tetrahydropiperine, 4% berry extract, and 10% compound plant bactericide; the balance is a neutralizing agent and water, wherein the amount of the neutralizing agent is such that the pH of the preparation is 6.0-6.5.

[0018] Example 5 A vaginal tightening and antibacterial preparation, wherein the raw materials for preparation include the following components by mass percentage: 10% galactomannan, 5% instant wrinkle smoothing agent, 0.1% tetrahydropiperine, 4% berry extract, and 10% compound plant bactericide; the balance is a neutralizing agent and water, wherein the amount of neutralizing agent is such that the pH of the preparation is 6.0-6.5.

[0019] Comparative Example 1 Compared with the formulation of Example 3, the difference is that galactomannan is not added, but purified water of the same mass is used instead of galactomannan. The other components and amounts are the same as in Example 3.

[0020] Comparative Example 2 Compared with the formulation of Example 3, the difference is that the instant wrinkle smoothing agent is not added, but the same mass of purified water is used instead of the instant wrinkle smoothing agent. The other components and amounts are the same as in Example 3.

[0021] Comparative Example 3 Compared with the formulation of Example 3, the difference is that tetrahydropiperine is not added, but purified water of the same mass is used instead of tetrahydropiperine. The other components and amounts are the same as in Example 3.

[0022] Comparative Example 4 Compared with the formulation of Example 3, the difference is that galactomannan, transient wrinkle-reducing agent and tetrahydropiperine are not added, and the same mass of purified water is used to replace these substances (galactomannan, transient wrinkle-reducing agent and tetrahydropiperine), while the other components and amounts are the same as in Example 3.

[0023] The preparation methods of the vaginal tightening and antibacterial preparations of Examples 1-5 and Comparative Examples 1-4 include the following steps: 3) Add water, carbomer, and galactomannan to a stirring apparatus, stir, homogenize, and heat until dissolved; 4) Cool down to 40-45℃, add instant wrinkle smoothing agent, tetrahydropiperine, berry extract and compound plant fungicide to the stirring device and stir until dissolved; 3) Add the neutralizing agent to the stirring device while stirring; 4) After adding all the ingredients, continue stirring until well combined; 5) Filter and discharge.

[0024] It can be that, in step 1), water, carbomer, and galactomannan are added to the stirring device in sequence; the stirring speed is 600 rpm; the homogenization speed is 3000 rpm; and the homogenization time is 1 minute; in step 3), the stirring speed is 200-300 rpm; in step 4), the stirring speed is 300-500 rpm; and the stirring time is 20 minutes; and in step 5), filtration is performed using a 200-mesh filter cloth.

[0025] After filtering and discharging the material in step 5), the process also includes sampling and testing (to check whether the prepared formulation is qualified), settling, and filling.

[0026] The products prepared in Examples 1-4 are gels with a viscosity between 23,000 and 26,000 mPas at 25°C; the product prepared in Example 5 is an essence with a viscosity of 368 mPas at 25°C.

[0027] In Examples 1-5 and Comparative Examples 1-4: The galactomannan is a C1-5 alkyl galactomannan; the mass fraction of the berry extract in the berry extract solution is 10% (or between 9.7% and 10.3%); the neutralizing agent is a lactic acid / sodium lactate buffer solution; in Examples 1-4, the amount of neutralizing agent is 0.5% of the total mass of the preparation; in Example 5, the amount of neutralizing agent is 0.2% of the total mass of the preparation. The remainder is water.

[0028] For example, in Example 3, the raw materials for the preparation of the formulation include the following components by mass percentage: 0.5% carbomer, 10% galactomannan, 5% instant wrinkle smoothing agent, 0.1% tetrahydropiperine, 4% berry extract, 10% compound plant fungicide; 0.5% neutralizer; and the balance is water.

[0029] The lactic acid / sodium lactate buffer solution can be prepared by mixing 60% lactic acid and 60% sodium lactate in a mass ratio of 2:3.

[0030] The compound plant fungicide includes rosemary leaf extract, American ginseng root extract, fucus vesiculosus extract, chamomile extract, and Satsuma mandarin orange peel extract; the mass of the rosemary leaf extract, American ginseng root extract, fucus vesiculosus extract, chamomile extract, and Satsuma mandarin orange peel extract is 7.5-16.5% of the total mass of the compound plant fungicide. Specifically, the compound plant fungicide may include the following components by mass percentage (or the raw materials may include the following components by mass percentage): rosemary leaf extract 0.5-2%, American ginseng root extract 0.5-2.5%, fucus vesiculosus extract 5.0-8.0%, chamomile extract 0.5-1.5%, Satsuma mandarin orange peel extract 1.0-2.5%, butylene glycol 5-15%, propylene glycol 10-50%, 1,2-pentanediol 0.1-0.5%, cocamidopropyl PG-dimethylammonium chloride phosphate sodium 1-10%, dichlorobenzyl alcohol 1-10%, p-hydroxyacetophenone 0.1-0.2%, and water 10-50%; the total mass percentage of each component is 100%.

[0031] The compound plant fungicide can be marketed under the name RyanCOM-8011 and may be sold by Guangzhou Baoyi Biotechnology Co., Ltd.

[0032] The trade name for the instant wrinkle smoothing agent is DSP-N527. It can be sold by Guangzhou Deshipu New Material Technology Co., Ltd.

[0033] The raw materials for preparing the instant wrinkle-smoothing agent comprise the following components by mass percentage: 70-80% hydrolyzed collagen, 0.7% sodium hydroxymethylglycinate, and 20.0-30.0% glucosamine; the total mass percentage of each component is 100%. The INCI name of the hydrolyzed collagen is HYDROLYZED COLLAGEN; the INCI name of the glucosamine is GLYCOSAMINOGLYCANS.

[0034] The berry extract can be marketed under the name "Red Groundcherry Anti-inflammatory No. 4" and can be sold by Jilin Ruijin Haoye Biotechnology Co., Ltd.

[0035] The physalis extract may include the following components by mass percentage: 9.7-10.3% Physalis alkekengi fruit extract, 87.7-88.3% glycerin, and 2% 1,2-hexanediol; the total mass percentage of each component is 100%.

[0036] The water is purified water.

[0037] In Examples 1-5, if a certain example does not include one or more substances, then that substance will not be added in the preparation method.

[0038] In Comparative Examples 1-4, if a certain comparative example does not add one or more substances, then the preparation method does not add that or these substances; if the same mass of purified water is used to replace the substances that are not added, then the time and amount of purified water added are the same as the time and amount of the substance being replaced.

[0039] Performance and effectiveness testing

[0040] The formulations in Examples 1-5 of this invention are pale yellow.

[0041] The formulations in Examples 1-5 of this invention were placed at 45℃±2℃ and -20℃±2℃ for 10 days respectively, and the samples were restored to normal at room temperature.

[0042] The formulations in Examples 1-5 of this invention were observed at room temperature for 24 months, and the samples remained normal.

[0043] The formulations in Examples 1-5 of this invention each have a pH of 6.0-6.5 (tested at 25°C).

[0044] The preparations prepared in Examples 1-5 were centrifuged at 3000 rpm for 30 minutes (each centrifuge tube contained 10 mL of liquid). After centrifugation, it was found that the substances in the centrifuge tubes did not separate into layers, which is normal.

[0045] 2.1 Antibacterial effect test Antibacterial rate: The samples in Examples 1-5 were tested according to Appendix C of GB 15979-2002 "Hygienic Standard for Disposable Sanitary Products". The original samples were left to act for 2 min, 5 min, 10 min and 20 min respectively. The test results are shown in Table 1. Test conditions: Ambient temperature: 20-25℃, relative humidity: 46-51%RH.

[0046] Table 1

[0047] Generally speaking, the better the antibacterial effect, the better the anti-inflammatory effect. As can be seen from the data in Table 1, the embodiments of the present invention have a strong antibacterial effect against Escherichia coli, Staphylococcus aureus and Candida albicans, with an antibacterial rate of >99.9%, which meets the requirements of Appendix C of GB15979-2002 "Hygienic Standard for Disposable Sanitary Products".

[0048] Examples 1-5 and Comparative Examples 1-4 were prepared by placing the original samples in a 37°C constant temperature chamber for 108 days at a relative humidity of 55%. The test method for the antibacterial rate is described in section 2.1, "Test Method for Antibacterial Effect Detection." The results showed that the decrease in antibacterial rate was less than 10%, indicating that the product's antibacterial effect lasts for at least 2 years at room temperature.

[0049] Female Japanese White rabbits (approximately 2 kg) were used to test samples from Examples 1-5 and Comparative Examples 1-4. According to the vaginal mucosal irritation intensity grading for vaginal mucosal irritation testing in Section 2.3.5 of the "Disinfection Technical Specifications" (2002 edition), all samples were found to be non-irritating and met the requirements of the "Disinfection Technical Specifications" (2002 edition).

[0050] Film-forming and tightening effect test: 20 female volunteers (aged 25-50) were selected for the experiment. Examples 1-5, Comparative Examples 1-4 and commercially available vaginal tightening products were applied to the skin surface of each person's arm, and the effects were observed. The experimental results are shown in Table 2.

[0051] The feeling of firmness and plumpness on the skin is rated on a scale of 1 to 5, with 1 being the lowest and 5 being the highest. This is the feeling after applying the product to the skin of each person's arm for 30 minutes.

[0052] Table 2

[0053] As can be seen from Table 1, Example 3 has superior effects in terms of film formation and adhesion. Comparative Examples 1 and 4 could not form films because they did not use galactomannan. Although Comparative Examples 2 and 3 could form films, the time was either too long or the time was short, but the fullness was not good, and the increase in effect was not as great as that of Example 3.

[0054] One hundred female patients aged 25-49 who had given birth vaginally to one or more children and all experienced vaginal laxity were randomly divided into 10 groups of 10 patients each. These patients all had vaginal laxity issues (weak or atrophied vaginal muscles; some patients frequently experienced urinary incontinence when laughing, coughing, exercising, running, jumping, or feeling stressed). Instructions for use: Insert one formulation (each formulation prepared in each example or comparative example constitutes one formulation) into the patient's vagina using a pusher. Use 3 mL once every other day per person. In Examples 1-5 and Comparative Examples 1-4, each formulation prepared in each example or comparative example is used by one group (10 people).

[0055] Criteria for judging treatment effectiveness: 1) The condition of the pelvic floor muscle tissue was assessed using a biofeedback instrument assessment system before and after treatment. A reference value of 35-45uv for fast muscle fibers and 30-40uv for slow muscle fibers were considered to be in line with the standard and to be considered as normal postpartum recovery.

[0056] Cure: Symptoms have completely disappeared and the target has been met.

[0057] Effective: Symptoms are relieved.

[0058] Ineffective: No change in symptoms.

[0059] 2) The feeling of vaginal tightening effect If we divide the degree of noticeability of vaginal tightening effect into no feeling, 1 degree, 2 degree and 3 degree (1 degree has a slight feeling of tightness and fullness, 2 degree has a strong feeling of tightness and fullness, and 3 degree has a very strong feeling of tightness and fullness).

[0060] The statistics on the firming and plumping effects are shown in Table 3.

[0061] Table 3

[0062] Examples 1-5 above illustrate that the formulation of the present invention has a good immediate vaginal tightening and plumping effect, as well as a long-term vaginal tightening, plumping and anti-aging effect.

[0063] In Examples 1-5, after 30 minutes of use, all participants experienced varying degrees of tightening and contraction of the smooth muscle of the vaginal mucosa. After consistent use for 3 months, all participants felt a significant thickening and increased elasticity of the vaginal wall. This demonstrates that the product of this invention has excellent vaginal tightening and fullness-enhancing effects.

[0064] Based on the trial results, as the amount of galactomannan and instant wrinkle-smoothing agent added increased, the effect of vaginal tightening and plumping also increased. Example 3 had the best cost performance, while although the amount of galactomannan and instant wrinkle-smoothing agent added in Example 4 was greater than that in Example 3, the effect of vaginal tightening and plumping was not improved.

[0065] After three months of use, Example 3 showed that the number of people who recovered was significantly higher than the sum of Comparative Examples 1-3, producing an unexpected technical effect.

[0066] Galactomannan film-forming tightening agent has a very obvious effect on tightening the vagina quickly (within 30 minutes) and has a synergistic effect with instant wrinkle smoothing agent; at the same time, it also has a synergistic effect on improving the long-lasting effect of vaginal wall plumping and anti-aging with instant wrinkle smoothing agent.

[0067] In this invention, the samples remain normal, including no product layering, discoloration, pH shift (±0.5), and viscosity change (≤10%).

[0068] This invention relates to a vaginal tightening and antibacterial preparation, which is a vaginal instant tightening and lubrication preparation and also a vaginal antibacterial preparation.

[0069] In the embodiments and comparative examples of this invention, 200 grams or 500 grams of formulation can be prepared at a time, or other quantities of formulation can be prepared.

[0070] The total mass percentage of all raw materials used in the preparation of the vaginal tightening and antibacterial preparation of this invention is 100%.

[0071] In this invention, the functions of the various components can be described as follows:

[0072] The above description is merely a preferred embodiment of the present invention and should not be construed as limiting the scope of the invention. Any simple equivalent changes and modifications made in accordance with the claims and specification of the present invention shall still fall within the scope of the claims. Furthermore, the abstract and headings are merely for assisting in patent document searching and are not intended to limit the scope of the present invention.

Claims

1. A vaginal tightening and antibacterial preparation, characterized in that, The raw materials for preparing this formulation include the following components by mass percentage: Carbomer 0-0.5%, galactomannan 5-13%, instant wrinkle smoothing agent 1-6%, tetrahydropiperine 0.1%, berry extract 4%, compound plant fungicide 10%; the balance is neutralizing agent and water, wherein the amount of neutralizing agent is such that the pH of the preparation is 6.0-6.

5.

2. The vaginal tightening and antibacterial preparation as described in claim 1, characterized in that, The galactomannan is a C1-5 alkyl galactomannan, and the mass fraction of the berry extract in the berry extract solution is 9.7-10.3%; the water is purified water, and the neutralizing agent is lactic acid / sodium lactate buffer; the amount of the neutralizing agent is 0.2-0.5% of the total mass of the preparation.

3. The vaginal tightening and antibacterial preparation as described in claim 1, characterized in that, The trade name of the compound plant fungicide is RyanCOM-8011; the raw materials for preparing the instant wrinkle smoothing agent include the following components by mass percentage: 70-80% hydrolyzed collagen, 0.7% sodium hydroxymethylglycinate, and 20.0-30.0% glucosamine.

4. The vaginal tightening and antibacterial preparation as described in claim 1, characterized in that, The preparation is a gel or essence; the compound plant fungicide includes rosemary leaf extract, American ginseng root extract, fucus vesiculosus extract, chamomile extract and Wenzhou mandarin orange peel extract; the mass of the rosemary leaf extract, American ginseng root extract, fucus vesiculosus extract, chamomile extract and Wenzhou mandarin orange peel extract is 7.5-16.5% of the total mass of the compound plant fungicide.

5. The vaginal tightening and antibacterial preparation as described in claim 1, characterized in that, The compound plant fungicide comprises the following components by mass percentage: rosemary leaf extract 0.5-2%, American ginseng root extract 0.5-2.5%, fucus vesiculosus extract 5.0-8.0%, chamomile extract 0.5-1.5%, Satsuma mandarin orange peel extract 1.0-2.5%, butylene glycol 5-15%, propylene glycol 10-50%, 1,2-pentanediol 0.1-0.5%, cocamidopropyl PG-dimethylammonium chloride phosphate sodium 1-10%, dichlorobenzyl alcohol 1-10%, p-hydroxyacetophenone 0.1-0.2%, and water 10-50%.

6. The method for preparing the vaginal tightening and antibacterial preparation according to any one of claims 1-5, characterized in that, The preparation method of the formulation includes the following steps: 1) Add water, carbomer, and galactomannan to a stirring apparatus, stir, homogenize, heat to 85-90℃, and stir until dissolved; 2) Cool down to 40-45℃, add instant wrinkle smoothing agent, tetrahydropiperine, berry extract and compound plant fungicide to the stirring device and stir until dissolved; 3) Add the neutralizing agent to the stirring device while stirring; 4) After adding, continue stirring until well combined; 5) Filter and discharge.

7. The method for preparing the vaginal tightening and antibacterial preparation as described in claim 6, characterized in that, In step 1), water, carbomer, and galactomannan are added to the stirring device sequentially; the stirring speed is 600 rpm; the homogenization speed is 3000 rpm; and the homogenization time is 1 minute. In step 3), the stirring speed is 200-300 rpm. In step 4), the stirring speed is 300-500 rpm; and the stirring time is 20 minutes. In step 5), filtration is performed using a 200-mesh filter cloth.

8. The method for preparing the vaginal tightening and antibacterial preparation as described in claim 6, characterized in that, After filtering and discharging the material in step 5), the process also includes sampling and testing, settling, and filling.

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