A kind of implant gel for improving vaginal elasticity and its preparation method and application

Abstract

This invention provides a plant-based gel for improving vaginal elasticity, its preparation method, and its application, belonging to the field of biomedical technology. The plant-based gel comprises: Evodia rutaecarpa fruit extract, Paeonia lactiflora root extract, Myrtol extract, Cornus officinalis extract, Citrus aurantium peel extract, Dryopteris crassirhizoma extract, Curcuma zedoaria oil, Melaleuca alternifolia leaf oil, Rosmarinus officinalis leaf oil, matrine, and excipients. The Evodia rutaecarpa fruit extract of this invention increases the thickness, moisture, and elasticity of the vaginal wall by mimicking the function of estrogen; the Paeonia lactiflora root extract has anti-inflammatory and antioxidant effects. The Myrtol extract can immediately tighten tissue, the Cornus officinalis extract improves microcirculation and provides nutrition, and the Citrus aurantium peel extract protects elastic fibers from oxidative damage. The components in the plant-based gel complement each other, working together to achieve a comprehensive effect of restoring and maintaining vaginal elasticity. The plant-based gel of this invention is significantly effective in balancing vaginal flora and improving vaginal elasticity.

Description

Technical Field

[0001] This invention relates to the field of biomedical technology, specifically to a plant-based gel for improving vaginal elasticity, its preparation method, and its application. Background Technology

[0002] Various physiological and pathological factors can lead to a decrease in vaginal tissue elasticity, causing a range of problems. The main causes of weakened vaginal elasticity include natural aging and perimenopausal changes, the effects of childbirth, certain surgical procedures, radiation therapy, and unhealthy lifestyle habits. Decreased vaginal elasticity can not only affect sexual satisfaction but may also be accompanied by problems such as stress urinary incontinence and recurrent urinary tract infections, severely damaging women's self-confidence and quality of life.

[0003] Currently, existing methods for improving vaginal elasticity each have their limitations. Drug therapy: Topical estrogen ointments or creams are a routine clinical approach to improving vaginal atrophy, effectively increasing vaginal thickness and elasticity. However, hormone therapy has potential side effects and contraindications (such as increased risk of certain cancers), causing some patients, especially women with a history of hormone dependence, to hesitate and have low adherence. Physical therapy: Physical methods such as laser therapy, radiofrequency technology, and pelvic floor muscle exercises (Kegel exercises) are also widely used. However, these methods often require specialized equipment, multiple visits to medical institutions, and are expensive, or require long-term adherence to see results, lacking convenience and accessibility. Lubricants and moisturizers: Most products on the market only temporarily relieve dryness, treating the symptoms but not the root cause, and cannot fundamentally improve the elasticity and health of the tissue.

[0004] Therefore, there is an urgent need for a safe, effective, convenient, and readily acceptable non-hormonal solution. In recent years, plant extracts have attracted much attention due to their diverse biological activities and good safety profile, providing a solid theoretical basis and broad application prospects for developing a plant-based gel product that can effectively and safely improve vaginal elasticity through topical administration. Summary of the Invention

[0005] The purpose of this invention is to provide a plant extract gel that improves vaginal elasticity, its preparation method, and its application. The plant extract gel provided by this invention has the effect of balancing vaginal flora and improving vaginal elasticity.

[0006] To achieve the above-mentioned objectives, the present invention provides the following technical solution:

[0007] This invention provides a plant extract composition for improving vaginal elasticity, comprising the following raw materials in parts by weight: 1-2 parts of Evodia rutaecarpa fruit extract, 1-2 parts of Paeonia lactiflora root extract, 0.05-0.1 parts of Myrtula sylvestris fruit extract, 0.1-0.3 parts of Cornus officinalis extract, 0.03-0.06 parts of Citrus aurantium peel extract, 3-6 parts of Dryopteris crassirhizoma extract, 3-6 parts of Curcuma zedoaria oil, 0.4-0.8 parts of Melaleuca alternifolia leaf oil, 0.5-0.9 parts of Rosmarinus rosifolia leaf oil, and 0.1-0.5 parts of Matrine.

[0008] Preferably, the Evodia fruit extract is obtained by extracting Evodia fruit by heating and reflux with an ethanol solution.

[0009] Preferably, the peony root extract is obtained by ultrasonic extraction of peony root using a deep eutectic solvent.

[0010] Preferably, the myrtle fruit extract is obtained by enzymatic hydrolysis of myrtle fruit using a compound enzyme.

[0011] Preferably, the Cornus officinalis extract is obtained by ultrasonic extraction of Cornus officinalis with an ethanol solution.

[0012] Preferably, the lime peel extract is obtained by supercritical CO2 extraction of lime peel.

[0013] The present invention also provides the use of the above-described plant extract composition in the preparation of products that improve vaginal elasticity.

[0014] Preferably, the dosage form of the product includes suppositories, tablets, ointments, gels, and sprays.

[0015] The present invention also provides a plant extract gel comprising the above-mentioned plant extract composition, comprising the following raw materials in parts by weight: 7-22 parts of plant extract composition, 10-20 parts of glycerin, 15-20 parts of poloxamer 407, 0.06-0.3 parts of chlorhexidine gluconate and 0.1-0.5 parts of lactic acid.

[0016] The present invention also provides a method for preparing the above-mentioned plant extract gel, comprising: adding glycerol, poloxamer 407, plant extract composition, chlorhexidine gluconate and lactic acid to deionized water to obtain the plant extract gel.

[0017] Compared with the prior art, the present invention has the following beneficial effects:

[0018] This invention provides a plant-based composition for improving vaginal elasticity, comprising: Evodia rutaecarpa fruit extract, Paeonia lactiflora root extract, Myrtol extract, Cornus officinalis extract, Citrus aurantium peel extract, Dryopteris crassirhizoma extract, Curcuma zedoaria oil, Melaleuca alternifolia leaf oil, Rosmarinus officinalis leaf oil, and matrine. This invention uses Evodia rutaecarpa fruit extract and Paeonia lactiflora root extract as its core components. Evodia rutaecarpa fruit extract, by mimicking the function of estrogen, directly stimulates the proliferation of vaginal epithelial cells and promotes the synthesis of collagen, elastin, and hyaluronic acid by fibroblasts, thereby fundamentally increasing the thickness, moisture, and elasticity of the vaginal wall. Paeonia lactiflora root extract exerts anti-inflammatory and antioxidant effects, reducing the damage of inflammation to collagen fibers and providing a healthy environment for collagen synthesis. Myrtol extract tightens tissues instantly through its polyphenols, Cornus officinalis extract improves microcirculation and provides nutrition, and Citrus aurantium peel extract protects elastic fibers from oxidative damage. Furthermore, the extracts of Dryopteris crassirhizoma, Curcuma zedoaria oil, Melaleuca alternifolia oil, Rosmarinus officinalis leaf oil, and matrine collectively provide broad-spectrum antibacterial, antiviral, and antifungal effects, preventing inflammation caused by infection and protecting vaginal tissue health from the source. The components of this plant extract composition work synergistically to achieve a comprehensive effect of restoring and maintaining vaginal elasticity.

[0019] The present invention prepares the above-mentioned plant extract composition into a gel. Experimental results show that the plant extract gel of the present invention has significant effects in balancing vaginal flora and improving vaginal elasticity. Detailed Implementation

[0020] This invention provides a plant extract composition for improving vaginal elasticity, comprising the following raw materials in parts by weight: 1-2 parts of Evodia rutaecarpa fruit extract, 1-2 parts of Paeonia lactiflora root extract, 0.05-0.1 parts of Myrtula sylvestris fruit extract, 0.1-0.3 parts of Cornus officinalis extract, 0.03-0.06 parts of Citrus aurantium peel extract, 3-6 parts of Dryopteris crassirhizoma extract, 3-6 parts of Curcuma zedoaria oil, 0.4-0.8 parts of Melaleuca alternifolia leaf oil, 0.5-0.9 parts of Rosmarinus rosifolia leaf oil, and 0.1-0.5 parts of Matrine.

[0021] The Evodia rutaecarpa fruit extract of the present invention is preferably obtained by extracting Evodia rutaecarpa fruit by heating and reflux with an ethanol solution. More preferably, it includes: pulverizing dried Evodia rutaecarpa fruit through an 80-120 mesh sieve, adding an ethanol solution with a volume fraction of 60%-70% at a ratio of 1:(8-12) g / mL, and heating and refluxing at 78-82℃ and pH 4-4.5 for 1-3 times, each time for 40-80 min, filtering, combining the filtrates, and freeze-drying under vacuum to obtain the Evodia rutaecarpa fruit extract.

[0022] The extract of Evodia rutaecarpa fruit obtained by the extraction method of this invention can efficiently extract alkaloids from Evodia rutaecarpa. These alkaloids can bind to estrogen receptors in the vaginal wall tissue, mimicking the function of endogenous estrogen, directly stimulating the proliferation of vaginal epithelial cells, increasing the number of cell layers, and promoting the synthesis of collagen, elastin and hyaluronic acid by fibroblasts. This can fundamentally increase the thickness, moisture and elasticity of the vaginal wall.

[0023] The peony root extract of the present invention is preferably obtained by ultrasonic extraction of peony root using a deep eutectic solvent. More preferably, the deep eutectic solvent is prepared by mixing choline chloride and lactic acid in a molar ratio of 1:1.5-2.5, stirring at 60-80℃ and 300-500rpm for 2-4 hours, adding deionized water, and stirring at 300-500rpm for 8-12 minutes to obtain a deep eutectic solvent solution with a water content of 20wt%-30wt%. The dried peony root is pulverized and passed through a 40-60 mesh sieve, and added to the deep eutectic solvent solution at a ratio of 1:(18-22)g / mL. The extract is ultrasonically extracted at 200-300W and 50-60℃ for 30-50 minutes, filtered, and freeze-dried under vacuum to obtain the peony root extract.

[0024] This invention innovatively employs a deep eutectic solvent ultrasonic extraction method to efficiently extract the active ingredients from peony root, which have anti-inflammatory and antioxidant effects, reducing the damage to collagen fibers caused by inflammatory factors; at the same time, it scavenge free radicals and protects fibroblasts from oxidative stress damage, thereby providing a healthy environment for collagen synthesis and indirectly maintaining and enhancing tissue elasticity.

[0025] The myrtle fruit extract of the present invention is preferably obtained by enzymatic hydrolysis of myrtle fruit with a compound enzyme, and more preferably includes: pulverizing dried myrtle fruit through a 200-300 mesh sieve, adding water at a material-to-liquid ratio of 1:(5-10) g / mL, adding 1%-3% of the weight of the myrtle fruit compound enzyme, enzymatically hydrolyzing at 50-55℃ and pH 5-5.5 for 1-2 hours, inactivating the enzyme, filtering, and freeze-drying the filtrate under vacuum to obtain the myrtle fruit extract; the compound enzyme is composed of cellulase and fig protease at a mass ratio of (1-3):1, more preferably 2:1, the cellulase activity is 100,000 U / g, purchased from Nanjing Jingchang Biotechnology Co., Ltd., and the fig protease activity is 100,000 U / g, purchased from Changsha Shenghe Bioengineering Co., Ltd.

[0026] This invention employs a compound enzymatic hydrolysis method, which can completely destroy cell walls and release polyphenolic substances such as ellagic acid and gallic acid with extremely high efficiency, yielding a variety of active ingredients. These ingredients can bind to proteins (such as collagen), making them slightly denser and stronger, thereby instantly increasing the feeling of tissue firmness. Furthermore, their antioxidant properties can protect existing collagen from damage.

[0027] The Cornus officinalis extract of the present invention is preferably obtained by ultrasonic extraction of Cornus officinalis with ethanol solution, and more preferably by: pulverizing dried Cornus officinalis, passing it through an 80-120 mesh sieve, adding 55%-65% ethanol solution at a material-to-liquid ratio of 1:(10-15) g / mL, ultrasonically extracting it 1-3 times at 300-400W and 40-50℃, each time for 20-40 min, filtering, and freeze-drying the filtrate under vacuum to obtain the Cornus officinalis extract.

[0028] The extraction method of this invention effectively preserves iridoid glycosides and organic acids, which can improve microcirculation, increase local blood oxygen supply, provide nutrition for tissue repair, and have an astringent effect, which helps to improve the relaxed state.

[0029] The sour orange peel extract of the present invention is obtained by supercritical CO2 extraction of sour orange peel, and more preferably includes: crushing dried sour orange peel through a 40-80 mesh sieve, placing it in a supercritical extraction vessel, and extracting it for 1-2 hours at 40-50℃, 25-35MPa, and CO2 flow rate of 15-25L / h, and collecting the sour orange peel extract.

[0030] The supercritical CO2 extraction method of this invention perfectly preserves volatile oils such as limonene and flavonoids in lime peel, which are natural antioxidants. They can eliminate free radicals that cause skin aging, protect the elastic fibers and collagen fibers of the vaginal wall from oxidative degradation, and alleviate mucosal damage, thereby maintaining their elasticity and youthful state.

[0031] The Dryopteris crassirhizoma extract described in this invention can effectively inhibit viral replication (such as HPV) and the growth of various pathogens, preventing infection-induced inflammation from the source.

[0032] The Curcuma zedoaria oil described in this invention has a significant inhibitory effect on fungi such as Candida albicans; the Melaleuca alternifolia oil not only has the effect of mucosal repair, but also has extremely strong penetrability, which can destroy bacterial cell membranes and has a good killing effect on Gardnerella vaginalis, Escherichia coli, and other bacteria that cause bacterial vaginosis; the rosemary leaf oil has antibacterial properties and can also produce synergistic effects with other essential oils, enhancing the overall antibacterial effect and delaying the development of antibacterial resistance.

[0033] The matrine described in this invention can alter the cell membrane permeability of pathogens (such as trichomonas and bacteria) and inhibit their respiration.

[0034] The present invention also provides the use of the above-described plant extract composition in the preparation of products that improve vaginal elasticity.

[0035] The dosage forms of the products described in this invention preferably include suppositories, tablets, ointments, gels, and sprays.

[0036] The present invention also provides a plant extract gel containing the above-mentioned plant extract composition, comprising the following raw materials in parts by weight: 7-22 parts of plant extract composition, 10-20 parts of glycerin, 15-20 parts of poloxamer 407, 0.06-0.3 parts of chlorhexidine gluconate and 0.1-0.5 parts of lactic acid.

[0037] The present invention also provides a method for preparing the above-mentioned plant extract gel, comprising: adding glycerol, poloxamer 407, plant extract composition, chlorhexidine gluconate and lactic acid to deionized water to obtain the plant extract gel.

[0038] The preferred method of using the plant extract gel of this invention is as follows: After cleaning the vulva, lie down naturally with knees bent, open the sterile applicator packaging, gently push the pusher to expel a small amount of gel to remove air, then gently insert the applicator deep into the vagina, reaching the vaginal fornix or the area around the cervix, slowly push the pusher to make the gel evenly cover the cervix and surrounding mucosa, after removing the applicator, rest in a lying position for 10 to 20 minutes. In the first month, use once a day before bedtime, and in the second month, use twice a week.

[0039] The technical solutions of this invention will be clearly and completely described below with reference to the embodiments thereof. Obviously, the described embodiments are only a part of the embodiments of this invention, and not all of them. All other embodiments obtained by those skilled in the art based on the embodiments of this invention without creative effort are within the scope of protection of this invention.

[0040] Unless otherwise specified, the following embodiments are all conventional methods.

[0041] Unless otherwise specified, all materials and reagents used in the following examples are commercially available.

[0042] Dryopteris crassirhizoma extract was purchased from Xi'an Ruiying Biotechnology Co., Ltd.; Curcuma zedoaria oil was purchased from Ji'an Xiangyuan Natural Fragrance Co., Ltd.; Melaleuca alternifolia oil was purchased from Hubei Yamaide Biomedical Co., Ltd.; Rosemary leaf oil was purchased from Ji'an Xiangyuan Natural Fragrance Co., Ltd.; Cellulase activity 100,000 U / g was purchased from Nanjing Jingchang Biotechnology Co., Ltd.; Fig protease activity 100,000 U / g was purchased from Changsha Shenghe Bioengineering Co., Ltd.; Hemicellulase 100,000 U / g was purchased from Qingdao Haiweisen Biotechnology Co., Ltd.; Papain activity 100,000 U / g was purchased from Henan Anrui Biotechnology Co., Ltd.

[0043] Example 1

[0044] Plant extract composition to improve vaginal elasticity

[0045] (1) Evodia fruit extract

[0046] The dried Evodia fruit was pulverized and passed through a 100-mesh sieve. A 65% ethanol solution was added at a ratio of 1:10 g / mL. The mixture was heated and refluxed twice at 80℃ and pH 4.3 for 60 min each time. The mixture was filtered, and the filtrates were combined. The filtrate was concentrated to 1 / 4 of its volume and then freeze-dried under vacuum until the water content was 3 wt% to obtain the Evodia fruit extract.

[0047] (2) Peony root extract

[0048] Choline chloride and lactic acid were mixed at a molar ratio of 1:2 and stirred at 70℃ and 400 rpm for 3 h. Deionized water was then added and stirred at 400 rpm for 10 min to obtain a deep eutectic solvent solution with a water content of 25 wt%. Dried peony root was pulverized and passed through a 50-mesh sieve. The deep eutectic solvent solution was added at a ratio of 1:20 g / mL, and the mixture was ultrasonically extracted at 250 W and 55℃ for 40 min. The mixture was filtered, and the filtrate was adsorbed onto a D101 macroporous adsorption resin. The filtrate was then eluted sequentially with water and 65% ethanol solution. The ethanol eluent was collected and concentrated to 1 / 3 of its volume. The eluent was then freeze-dried under vacuum to a water content of 2 wt% to obtain the peony root extract.

[0049] (3) Myrtle fruit extract

[0050] The compound enzyme consists of cellulase and fig protease in a mass ratio of 2:1. Dried myrtle fruit was pulverized and passed through a 250-mesh sieve. Water was added at a material-to-liquid ratio of 1:8 g / mL, followed by 2% of the compound enzyme by weight of the myrtle fruit. The mixture was enzymatically hydrolyzed at 52℃ and pH 5.2 for 1.5 h to inactivate the enzyme. After filtration, the filtrate was freeze-dried under vacuum to a water content of 4 wt% to obtain the myrtle fruit extract.

[0051] (4) Cornus officinalis extract

[0052] The dried Cornus officinalis was pulverized and passed through a 100-sieve. A 60% ethanol solution was added at a material-to-liquid ratio of 1:12 g / mL. The mixture was ultrasonically extracted twice at 350 W and 45 °C for 30 min each time. After filtration, the filtrate was concentrated to 1 / 5 of its volume and then freeze-dried under vacuum until the water content was 2 wt% to obtain the Cornus officinalis extract.

[0053] (5) Lime peel extract

[0054] The dried lime peel was crushed and passed through a 50-mesh sieve, then placed in a supercritical extraction vessel and extracted for 1.5 hours at 45℃, 30MPa, and a CO2 flow rate of 20L / h. The lime peel extract was then collected in a separation vessel.

[0055] (6) Plant extract composition

[0056] Weigh out 1.5 parts by weight of Evodia rutaecarpa fruit extract, 1.5 parts by weight of Paeonia lactiflora root extract, 0.08 parts by weight of Myrtella syriacus fruit extract, 0.2 parts by weight of Cornus officinalis extract, 0.04 parts by weight of Citrus aurantium peel extract, 5 parts by weight of Dryopteris crassirhizoma extract, 4 parts by weight of Curcuma zedoaria oil, 0.6 parts by weight of Melaleuca alternifolia leaf oil, 0.7 parts by weight of Rosmarinus rosifolia leaf oil, and 0.3 parts by weight of Matrine. Mix the above-weighed components at 200 rpm for 15 min to obtain the plant extract composition.

[0057] Example 2

[0058] Plant extract composition to improve vaginal elasticity

[0059] (1) Evodia fruit extract

[0060] The dried Evodia fruit was pulverized and passed through an 80-mesh sieve. A 60% ethanol solution was added at a ratio of 1:8 g / mL. The mixture was heated and refluxed three times at 78℃ and pH 4, for 40 min each time. The mixture was filtered, and the filtrates were combined. The filtrate was concentrated to 1 / 3 of its volume and then freeze-dried under vacuum until the water content was 4 wt% to obtain the Evodia fruit extract.

[0061] (2) Peony root extract

[0062] Choline chloride and lactic acid were mixed at a molar ratio of 1:1.5 and stirred at 60℃ and 300rpm for 4 hours. Deionized water was then added, and the mixture was stirred at 300rpm for 12 minutes to obtain a deep eutectic solvent solution with a water content of 20wt%. Dried peony root was pulverized and passed through a 40-mesh sieve. The deep eutectic solvent solution was added at a ratio of 1:18 g / mL, and the mixture was ultrasonically extracted at 200W and 50℃ for 50 minutes. The mixture was filtered, and the filtrate was adsorbed onto a D101 macroporous adsorption resin. The filtrate was then eluted sequentially with water and a 63% (v / v) ethanol solution. The ethanol eluent was collected, concentrated to half its volume, and freeze-dried under vacuum to a water content of 2wt% to obtain the peony root extract.

[0063] (3) Myrtle fruit extract

[0064] The compound enzyme consists of cellulase and fig protease in a mass ratio of 1:1. Dried myrtle fruit is pulverized and passed through a 200-mesh sieve. Water is added at a material-to-liquid ratio of 1:5 g / mL, followed by 3% of the compound enzyme by weight of the myrtle fruit. The mixture is enzymatically hydrolyzed at 50℃ and pH 5 for 2 hours to inactivate the enzyme. After filtration, the filtrate is freeze-dried under vacuum to a water content of 5 wt% to obtain myrtle fruit extract.

[0065] (4) Cornus officinalis extract

[0066] The dried Cornus officinalis was pulverized and passed through an 80-mesh sieve. A 55% ethanol solution was added at a material-to-liquid ratio of 1:10 g / mL. The mixture was ultrasonically extracted three times at 300W and 40℃ for 20 minutes each time. After filtration, the filtrate was concentrated to 1 / 4 of its volume and then freeze-dried under vacuum until the water content was 3wt% to obtain the Cornus officinalis extract.

[0067] (5) Lime peel extract

[0068] The dried lime peel was crushed and passed through a 40-mesh sieve, then placed in a supercritical extraction vessel and extracted for 2 hours at 40℃, 25MPa, and a CO2 flow rate of 15L / h. The lime peel extract was then collected in a separation vessel.

[0069] (6) Plant extract composition

[0070] Weigh out 1 part of Evodia rutaecarpa fruit extract, 2 parts of Paeonia lactiflora root extract, 0.05 parts of Myrtula sylvestris fruit extract, 0.3 parts of Cornus officinalis extract, 0.03 parts of Citrus aurantium peel extract, 6 parts of Dryopteris crassirhizoma extract, 3 parts of Curcuma zedoaria oil, 0.8 parts of Melaleuca alternifolia leaf oil, 0.5 parts of Rosmarinus rosifolia leaf oil, and 0.5 parts of Matrine according to the weight ratio. Mix the above-weighed components at 150 rpm for 20 min to obtain the plant extract composition.

[0071] Example 3

[0072] Plant extract composition to improve vaginal elasticity

[0073] (1) Evodia fruit extract

[0074] The dried Evodia fruit was pulverized and passed through a 120-mesh sieve. A 70% ethanol solution was added at a ratio of 1:12 g / mL. The mixture was heated and refluxed at 82℃ and pH 4.5 for 80 min. After filtration, the filtrate was concentrated to 1 / 4 of its volume and then freeze-dried under vacuum to a water content of 2 wt% to obtain the Evodia fruit extract.

[0075] (2) Peony root extract

[0076] Choline chloride and lactic acid were mixed at a molar ratio of 1:2.5 and stirred at 80℃ and 500rpm for 2 hours. Deionized water was then added, and the mixture was stirred at 500rpm for 8 minutes to obtain a deep eutectic solvent solution with a water content of 30wt%. Dried peony root was pulverized and passed through a 60-mesh sieve. The deep eutectic solvent solution was added at a ratio of 1:22g / mL, and the mixture was ultrasonically extracted at 300W and 60℃ for 30 minutes. The mixture was filtered, and the filtrate was adsorbed onto a D101 macroporous adsorption resin. The filtrate was then eluted sequentially with water and a 68% (v / v) ethanol solution. The ethanol eluent was collected, and the volume of the ethanol eluent was reduced to 1 / 5 of its original volume. The eluent was then freeze-dried under vacuum to a water content of 3wt% to obtain the peony root extract.

[0077] (3) Myrtle fruit extract

[0078] The compound enzyme is composed of cellulase and fig protease in a mass ratio of 3:1. The dried myrtle fruit was crushed and passed through a 300-mesh sieve. Water was added at a material-to-liquid ratio of 1:10 g / mL, and then 1% of the weight of the compound enzyme of myrtle fruit was added. The mixture was enzymatically hydrolyzed at 50℃ and pH 5 for 1 hour to inactivate the enzyme. After filtration, the filtrate was freeze-dried under vacuum to a water content of 4 wt% to obtain the myrtle fruit extract.

[0079] (4) Cornus officinalis extract

[0080] The dried Cornus officinalis was pulverized and passed through a 120-mesh sieve. A 65% ethanol solution was added at a material-to-liquid ratio of 1:15 g / mL. The mixture was ultrasonically extracted at 400 W and 40 °C for 40 min. After filtration, the filtrate was concentrated to 1 / 6 of its volume and then freeze-dried under vacuum until the water content was 2 wt% to obtain the Cornus officinalis extract.

[0081] (5) Lime peel extract

[0082] The dried lime peel was crushed and passed through an 80-mesh sieve, then placed in a supercritical extraction vessel and extracted for 1 hour at 50℃, 35MPa, and a CO2 flow rate of 25L / h. The lime peel extract was then collected in a separation vessel.

[0083] (6) Plant extract composition

[0084] Weigh out 2 parts by weight of Evodia rutaecarpa fruit extract, 1 part of Paeonia lactiflora root extract, 0.1 part of Myrtella syriacus fruit extract, 0.1 part of Cornus officinalis extract, 0.06 parts of Citrus aurantium peel extract, 3 parts of Dryopteris crassirhizoma extract, 6 parts of Curcuma zedoaria oil, 0.4 parts of Melaleuca alternifolia leaf oil, 0.9 parts of Rosmarinus rosifolia leaf oil, and 0.1 parts of Matrine. Mix the weighed components at 250 rpm for 12 min to obtain the plant extract composition.

[0085] Example 4

[0086] Plant-based gel to improve vaginal elasticity

[0087] (1) Weighing

[0088] Based on 100 parts by weight, weigh 18 parts of the plant extract composition of Example 1, 15 parts of glycerin, 18 parts of poloxamer 407, 0.18 parts of chlorhexidine gluconate, and 0.3 parts of lactic acid, and make up to 100 parts with deionized water.

[0089] (2) Plant extract gel

[0090] Poloxamer 407 was added to deionized water and refrigerated at 4°C for 12 hours to obtain a gel matrix. Glycerin was mixed with the plant extract composition to obtain a paste. The paste was added to the gel matrix and stirred for 20 minutes at a stirring speed of 250 rpm. Then, chlorhexidine gluconate and lactic acid were added and stirred for another 15 minutes to obtain the plant extract gel.

[0091] Example 5

[0092] Plant-based gel to improve vaginal elasticity

[0093] (1) Weighing

[0094] Based on 100 parts by weight, weigh 10 parts of the plant extract composition of Example 2, 20 parts of glycerin, 15 parts of poloxamer 407, 0.3 parts of chlorhexidine gluconate and 0.1 parts of lactic acid, and make up to 100 parts with deionized water.

[0095] (2) Plant extract gel

[0096] Poloxamer 407 was added to deionized water and refrigerated at 3°C ​​for 11 hours to obtain a gel matrix. Glycerin was mixed with the plant extract composition to obtain a paste. The paste was added to the gel matrix and stirred for 25 minutes at a stirring speed of 200 rpm. Then, chlorhexidine gluconate and lactic acid were added and stirred for another 20 minutes to obtain the plant extract gel.

[0097] Example 6

[0098] Plant-based gel to improve vaginal elasticity

[0099] (1) Weighing

[0100] Weigh 20 parts by weight of the plant extract composition of Example 3, 10 parts by weight of glycerin, 20 parts by weight of poloxamer 407, 0.06 parts by weight of chlorhexidine gluconate and 0.5 parts by weight of lactic acid, and make up to 100 parts by weight with deionized water.

[0101] (2) Plant extract gel

[0102] Poloxamer 407 was added to deionized water and refrigerated at 5°C for 14 hours to obtain a gel matrix. Glycerin was mixed with the plant extract composition to obtain a paste. The paste was added to the gel matrix and stirred for 15 minutes at 300 rpm. Then, chlorhexidine gluconate and lactic acid were added and stirred for another 12 minutes to obtain the plant extract gel.

[0103] Comparative Example 1

[0104] The specific implementation method is the same as in Example 1, except that the extract of Evodia rutaecarpa fruit is discarded and the weight of the peony root extract is adjusted to 3 parts.

[0105] Comparative Example 2

[0106] The specific implementation method is the same as in Example 1, except that the peony root extract is discarded and the weight of the Evodia fruit extract is adjusted to 3 parts.

[0107] Comparative Example 3

[0108] The specific implementation method is the same as in Example 1, except that the deep eutectic solvent solution in step (2) is replaced with a 65% volume fraction ethanol solution.

[0109] Comparative Example 4

[0110] The specific implementation method is the same as in Example 1, except that the complex enzyme in step (3) is composed of hemicellulase and papain in a mass ratio of 2:1.

[0111] Comparative Example 5

[0112] The specific implementation method is the same as that in Example 1, except that the 60% volume fraction ethanol solution in step (4) is replaced with deionized water.

[0113] Comparative Example 6

[0114] The specific implementation method is the same as that in Example 1. The difference is that the preparation method of step (5) of the sour orange peel extract is as follows: the dried sour orange peel is crushed and passed through a 50-mesh sieve. Deionized water is added at a material-to-liquid ratio of 1:10 g / mL. The mixture is extracted by distillation at 105°C for 2 hours to obtain the distillate. After standing for 30 minutes, the lower aqueous phase is released and the upper liquid is collected as the sour orange peel extract.

[0115] Comparative Example 7

[0116] The specific implementation method is the same as that in Example 4, except that the plant extract is the plant extract of Comparative Example 1.

[0117] Comparative Example 8

[0118] The specific implementation method is the same as that in Example 4, except that the plant extract is the plant extract of Comparative Example 2.

[0119] Comparative Example 9

[0120] The specific implementation method is the same as that in Example 4, except that the plant extract is the plant extract of Comparative Example 3.

[0121] Comparative Example 10

[0122] The specific implementation method is the same as that in Example 4, except that the plant extract is the plant extract of Comparative Example 4.

[0123] Comparative Example 11

[0124] The specific implementation method is the same as that in Example 4, except that the plant extract is the plant extract of Comparative Example 5.

[0125] Comparative Example 12

[0126] The specific implementation method is the same as that in Example 4, except that the plant extract is the plant extract of Comparative Example 6.

[0127] Experimental Example 1

[0128] Antibacterial test

[0129] (1) The carrier immersion quantitative antibacterial test of the test samples (plant extract gels of Examples 4-6 and Comparative Examples 7-12) against Escherichia coli was tested using the test method of bactericidal performance, antibacterial performance and stability test method of products in Appendix E of GB 15979-2024. Escherichia coli 8099, Staphylococcus aureus Staphylococcus aureus ATCC6538 and Candida albicans Candida albicans Antibacterial properties of ATCC 10231.

[0130] Evaluation criteria: If the antibacterial rate in each test is greater than or equal to 50% and less than 90%, it is judged to have antibacterial effect; if the antibacterial rate in each test is greater than or equal to 90%, it is judged to have strong antibacterial effect.

[0131] The inhibition rates of each sample against Escherichia coli, Staphylococcus aureus, and Candida albicans are shown in Table 1.

[0132] Table 1. Antibacterial rate (%) of different plant extract gels

[0133]

[0134] Table 1 shows that Examples 4-6 and Comparative Examples 7-12 all exhibited varying degrees of inhibitory effects against *Escherichia coli*, *Staphylococcus aureus*, and *Candida albicans*. The plant extract gels of Examples 4-6 all showed an inhibition rate greater than 90%, indicating that the plant extract gels of this invention have a strong antibacterial effect. Data from Comparative Examples 7-8 and Example 4 show that the combination of *Evodia rutaecarpa* fruit extract and *Paeonia lactiflora* root extract can enhance the antibacterial effect. Data from Comparative Examples 9-12 and Comparative Example 4 show that changes in the extraction solvent, enzyme type, and extraction method all affect the antibacterial effect of the plant extract gel.

[0135] (2) Effects on probiotics

[0136] The plate method was used to determine whether the plant extract gels of Examples 4-6 had an inhibitory effect on Lactobacilli crispatus CGMCC6469.

[0137] Lactobacillus curvature was inoculated onto slant agar and incubated at 37°C for 24 hours. Suitable single colonies were then screened and inoculated into NB nutrient broth medium, and incubated at 37°C until the bacterial concentration reached 10⁻⁶.6 CFU / mL was used to obtain bacterial suspension. 0.1 mL of bacterial suspension was spread on broth agar plates, dried for 5 min, and then injected into the plant extract gels of Examples 4-6 through the large wells of a sterile steel tube. The gels were incubated at 37°C for 24 h. The diameter of the inhibition zone was measured with a ruler after 24 h. 0.1 mL of distilled water was used as a negative control. The specific results are shown in Table 2.

[0138] Table 2. Diameter of the inhibition zone (mm) of the plant extract gels in Examples 4-6

[0139]

[0140] The results in Table 2 show that the diameter of the antibacterial zone of the plant extract gel of the present invention is less than 7 mm, indicating that the plant extract gel of the present invention has no antibacterial effect on the probiotic Lactobacillus curvatureis.

[0141] As shown in Tables 1 and 2, the plant extract gel of the present invention has a significant antibacterial effect against harmful microorganisms, but no significant antibacterial effect against beneficial vaginal bacteria, indicating that the plant extract gel of the present invention can effectively maintain the balance of vaginal flora.

[0142] Experimental Example 2

[0143] vaginal smooth muscle test

[0144] SPF-grade 10-week-old SD mice were euthanized using CO2 asphyxiation. The entire vaginal tissue was dissected and removed, surrounding connective tissue and excess fat were removed, and the tissue was transversely cut into 1-2 mm wide rings. Using a vascular ring hook, the tissue rings were suspended in a thermostatic perfusion system bath, one end fixed and the other end connected to a tension sensor. KH solution was added, and the system was maintained at 37°C with a mixed gas (95% O2 and 5% CO2) purging. A pre-tension of 5 mN was applied to the vaginal smooth muscle tissue rings, and the system was allowed to equilibrate for 30 min. After equilibration, 1 μM carbacholine was used to induce a smooth muscle contraction response. When the response reached a plateau, 5 mg of the plant extract gels from Examples 4 and 7-12 were added, respectively, with an equal mass of physiological saline as a blank control. Changes in smooth muscle were observed, and the maximum smooth muscle contraction force was recorded. Finally, the positive control drug NaHS was applied to achieve a maximum relaxation response.

[0145] The maximum smooth muscle tension before and after using the plant extract gels of Example 4 and Comparative Examples 7-12 was statistically analyzed, and the specific results are shown in Table 3.

[0146] Table 3. Maximum smooth muscle contractility (g) of different plant extract gels

[0147]

[0148] Table 3 shows that the smooth muscle contractility of the blank control group did not change significantly, indicating that physiological saline itself has no promoting effect on smooth muscle contraction. The plant extract gels of Example 4 and Comparative Examples 7-12 both promoted smooth muscle contraction. The smooth muscle contractility of Example 4 was significantly higher than that of Comparative Examples 7-12 and the blank control group, indicating that it can effectively enhance the contractile function of vaginal smooth muscle, thereby improving vaginal elasticity. A comparison of the data from Comparative Examples 7-8 and Example 4 shows that Evodia rutaecarpa fruit extract and Paeonia lactiflora root extract have a synergistic effect in improving smooth muscle contraction; their combination can significantly improve smooth muscle contraction. The results of Comparative Examples 9-12 and Comparative Example 4 show that changes in solvent substitution for Paeonia lactiflora root extract, extraction method of Citrus aurantium peel, and enzyme types in Myrtle fruit extract all affect the contractile effect of the plant extract gel on smooth muscle. The plant extract gel of this invention can significantly enhance the maximum contractile force of vaginal smooth muscle and has a positive effect on improving vaginal elasticity. However, when the composition or preparation process of the plant extract composition is changed, the effect of the gel in enhancing vaginal smooth muscle contractility will be significantly weakened. Therefore, it is evident that the plant extract composition formulation and the extraction and preparation methods of each component of the present invention are crucial to the gel's core function of improving vaginal elasticity.

[0149] Experimental Example 3

[0150] The effect of plant extract gel on vaginal laxity

[0151] 1. Source of subjects

[0152] 250 postpartum women diagnosed with vaginal laxity between May 2024 and May 2025 were selected as subjects.

[0153] 2. Diagnostic criteria

[0154] (1) Western medicine diagnostic criteria

[0155] The diagnostic criteria for postpartum vaginal laxity are based on the "Expert Consensus on the Diagnosis and Treatment of Vaginal Laxity (2020 Edition)" and are determined by professional digital rectal examination: In the lithotomy position, at rest, and with adequate lubrication, a finger is inserted into the vagina, ensuring the subject does not experience pain or discomfort. The diagnostic criteria for grading vaginal laxity are as follows:

[0156] 1) Normal: The vagina is considered normal if it can accommodate two fingers (less than two finger widths) side by side; the circumference is 10 cm.

[0157] 2) Mild laxity: The vagina can accommodate 2-3 fingers side by side without resistance, which is considered mild laxity. There may be no obvious discomfort during sexual intercourse.

[0158] 3) Moderate laxity: The vagina can accommodate 3-4 fingers side by side without resistance, indicating moderate laxity, which increases discomfort during intercourse;

[0159] 4) Severe laxity: Severe laxity is defined as the vagina being able to accommodate more than 4 fingers side by side without any resistance, resulting in decreased sexual satisfaction for both partners.

[0160] (2) Inclusion criteria

[0161] 1) Women aged 20-40 who have given birth to a singleton, full-term vaginal primiparous woman 2 to 12 months after delivery;

[0162] 2) Meets the Western medical diagnostic criteria for mild or moderate vaginal laxity;

[0163] 3) Voluntarily participate in this study and sign an informed consent form;

[0164] 4) No serious gynecological inflammation (such as acute vaginitis, cervicitis, etc.) or skin / mucous membrane damage;

[0165] 5) Has not received pelvic floor rehabilitation treatment or related drug / surgical treatment within the past month;

[0166] 6) Demonstrates good adherence to treatment, is able to use the gel as required, and complete follow-up visits.

[0167] (3) Exclusion criteria

[0168] 1) Individuals with severe systemic diseases such as heart, liver, and kidney, or those with immune dysfunction;

[0169] 2) Those who are pregnant, breastfeeding, or planning to become pregnant again;

[0170] 3) Individuals allergic to or with a history of allergies to the gel ingredients;

[0171] 4) Patients with pelvic floor dysfunction (such as grade III or higher pelvic organ prolapse, stress urinary incontinence, etc.) who require surgical treatment;

[0172] 5) Individuals with a history of mental illness or who are unable to cooperate in completing the research;

[0173] 6) Individuals who have recently (within 3 months) participated in other clinical trials.

[0174] (4) Elimination criteria

[0175] 1) If a serious adverse reaction or allergic reaction occurs during the use of the gel, the trial must be terminated;

[0176] 2) Poor adherence during the trial, failure to use the gel as prescribed, or loss to follow-up;

[0177] 3) Those who self-medicate with other medications or treatments that affect pelvic floor function;

[0178] 4) Those who voluntarily withdrew or lost contact during the research process;

[0179] 5) Incomplete data records affect the validity or security assessment.

[0180] (5) Determination of subjects

[0181] Subjects were screened according to the above criteria, 10 subjects were excluded, and the remaining subjects were divided into 8 groups on average. There were no significant differences in health status and vaginal laxity among the groups.

[0182] (6) Treatment evaluation criteria

[0183] The treatment evaluation criteria are as follows:

[0184] 1) Significant effect: Vaginal laxity grade decreased by 2 levels;

[0185] 2) Effective: The grade of vaginal laxity decreased by 1 level;

[0186] 3) Ineffective: No change in the degree of vaginal laxity;

[0187] Overall effectiveness (%) = (Number of cases with significant effect + Number of cases with effect) / Total number of cases × 100%.

[0188] 3. Treatment methods

[0189] Each group will perform Kegel exercises (lie flat on your back with knees bent and feet flat on the ground, relax your body, contract your pelvic floor muscles as much as possible, hold the contraction for 5-10 seconds, and then relax your muscles for 10 seconds. This is one repetition. Do 10 repetitions as one set, and do 8 sets each in the morning, noon and evening).

[0190] The plant extract gels of Example 4 and Comparative Examples 7-12 were used respectively, with physiological saline as the blank group, for 2 months.

[0191] The method of using the plant extract gel is as follows: After cleaning the vulva, lie down naturally with your knees bent. Open the sterile applicator packaging, gently push the pusher to expel a small amount of gel to remove air, and then gently insert the applicator deep into the vagina, reaching the vaginal fornix or the area around the cervix. Slowly push the pusher to make the gel evenly cover the cervix and surrounding mucosa. After removing the applicator, rest in the lying position for 10 to 20 minutes. In the first month, use it once a day before bedtime. In the second month, use it twice a week.

[0192] 4. Therapeutic effects

[0193] Two months later, the number of people with vaginal laxity before and after treatment in each group was compared, and the treatment effect was statistically analyzed according to the treatment evaluation criteria. The specific results are shown in Tables 4 and 5.

[0194] Table 4. Number of people with vaginal laxity before and after treatment in each group

[0195]

[0196] Table 5. Therapeutic effects of each group

[0197]

[0198] The data in Tables 4 and 5 show that the control group still mainly experienced mild to moderate vaginal laxity after treatment, with only 8 cases recovering to normal, indicating limited improvement. Both the examples and comparative examples showed varying degrees of improvement in vaginal laxity, with Example 4 showing the most significant improvement. A comparison of the data from Comparative Examples 7-8 and Example 4 reveals that the extracts of Evodia rutaecarpa and Paeonia lactiflora root have a synergistic effect in improving vaginal laxity and enhancing vaginal elasticity. A comparison of the data from Comparative Examples 9-12 and Comparative Example 4 demonstrates that the extraction process of this invention (such as deep eutectic solvent extraction, compound enzymatic hydrolysis, and supercritical CO2 extraction) is crucial for preserving active ingredients, improving vaginal elasticity, and alleviating vaginal laxity.

[0199] During the use of the medication, no obvious local skin and mucous membrane irritation symptoms (such as vulvar redness, swelling, itching, burning, stinging, etc.) were observed in any of the subjects, nor were any adverse reactions such as increased abnormal vaginal discharge, odor, bleeding, or pelvic discomfort.

[0200] The plant extract gel of this invention has good clinical application prospects and can effectively improve postpartum vaginal laxity, which is superior to simple physical training or traditional therapy.

[0201] The above description is only a preferred embodiment of the present invention. It should be noted that for those skilled in the art, several improvements and modifications can be made without departing from the principle of the present invention, and these improvements and modifications should also be considered within the scope of protection of the present invention.

Claims

1. A plant extract composition for improving vaginal elasticity, characterized in that, It is made from the following raw materials in parts by weight: 1-2 parts of Evodia rutaecarpa fruit extract, 1-2 parts of Paeonia lactiflora root extract, 0.05-0.1 parts of Myrtula spp. fruit extract, 0.1-0.3 parts of Cornus officinalis extract, 0.03-0.06 parts of Citrus aurantium peel extract, 3-6 parts of Dryopteris crassirhizoma extract, 3-6 parts of Curcuma zedoaria oil, 0.4-0.8 parts of Melaleuca alternifolia leaf oil, 0.5-0.9 parts of Rosmarinus rosifolia leaf oil, and 0.1-0.5 parts of Matrine; Evodia fruit extract was obtained by heating and reflux extraction of Evodia fruit with 65% ethanol solution (v / v). Peony root extract was obtained by ultrasonic extraction of peony root using a deep eutectic solvent; the deep eutectic solvent was obtained by mixing choline chloride and lactic acid in a molar ratio of 1:

2. Myrtle fruit extract is obtained by enzymatic hydrolysis of myrtle fruit using a compound enzyme; the compound enzyme consists of cellulase and fig protease in a mass ratio of 2:

1. Cornus officinalis extract was obtained by ultrasonic extraction of Cornus officinalis with a 60% (v / v) ethanol solution; The lime peel extract is obtained by supercritical CO2 extraction of lime peel.

2. The use of the plant extract composition according to claim 1 in the preparation of a plant extract gel that improves vaginal elasticity.

3. A plant extract gel comprising the plant extract composition of claim 1, characterized in that, It is made from the following raw materials in parts by weight: 7-22 parts of plant extract composition, 10-20 parts of glycerin, 15-20 parts of poloxamer 407, 0.06-0.3 parts of chlorhexidine gluconate and 0.1-0.5 parts of lactic acid.

4. A method for preparing the plant extract gel according to claim 3, characterized in that, include: Glycerin, poloxamer 407, plant extract composition, chlorhexidine gluconate and lactic acid were added to deionized water to obtain plant extract gel.

Images