Bacteriostatic soft capsule helpful for improving vaginal relaxation and preparation method thereof

Abstract

The invention provides a bacteriostatic soft capsule helpful for improving vaginal relaxation and a preparation method thereof. The soft capsule comprises a soft capsule content and a soft capsule shell, the soft capsule content is prepared from the following raw materials in parts by weight: 3 to 5 parts of fructus corni, 2 to 4 parts of fructus evodiae, 0.8 to 1.2 parts of herba violae, 1 to 3 parts of radix angelicae sinensis, 1 to 2 parts of saffron crocus, 1 to 3 parts of gallnut, 1 to 3 parts of fructus schisandrae chinensis, 0.8 to 1.0 part of sunflower seeds, 0.1 to 0.4 part of geranium, 2 to 4 parts of cortex phellodendri, 1 to 3 parts of folium artemisiae argyi, 0.8 to 1.0 part of pericarpium zanthoxyli and 1 to 3 parts of compound polysaccharide; the soft capsule shell comprises the following raw materials in parts by weight: 1-3 parts of gelatin, 1-3 parts of egg yolk lecithin, 2-4 parts of glycerol and 15-20 parts of deionized water. The soft capsule prepared by the invention integrates the functions of repairing, tightening, nourishing, lubricating, inhibiting bacteria and resisting inflammation, has no irritation to skin and mucous membrane, does not damage the acid-base balance in the body, has no side effect, can obviously improve the vaginal relaxation phenomenon, has strong sterilization and anti-inflammation effects, has a good curative effect on vaginal bacterial infection, eliminates peculiar smell, and has a good application prospect.

Description

Technical Field

[0001] The present invention relates to the technical field of traditional Chinese medicine, and particularly relates to an antibacterial soft capsule helpful for improving vaginal relaxation and a preparation method thereof. Background Art

[0002] Vaginal relaxation is one of the common conditions in gynecology. Due to the changes in the connective tissue around the vagina and the pelvic floor muscles, there is relaxation of the vaginal orifice and / or vaginal wall, as well as a decrease in the secretion of vaginal mucus. It is a female pelvic floor disorder. The occurrence and development of vaginal relaxation are mainly related to the traction of the vagina during vaginal delivery, the use of forceps, the delivery of macrosomia, age growth, and menopause, which may have an adverse impact on the rectum, uterus, bladder, etc. And this vaginal relaxation may worsen and cause serious problems, such as fecal incontinence, premature birth, and stillbirth.

[0003] At the present stage, the treatment for vaginal relaxation mainly includes self-therapy, vaginal tightening surgery, and drug treatment; self-therapy has the disadvantages of obvious ineffectiveness and long recovery time; vaginal tightening surgery has the disadvantages of patient pain, trauma, long recovery time, and low cure rate with high risk; there are several varieties of drug treatment, including vaginal injection, topical preparations, and oral medications, but they all have the problems of short-lasting drug efficacy requiring continuous use, large side effects on the human body, and treating the symptoms rather than the root cause. Summary of the Invention

[0004] In view of this, the present invention provides an antibacterial soft capsule helpful for improving vaginal relaxation and a preparation method thereof to solve the above-mentioned technical problems.

[0005] The technical solution of the present invention is realized as follows:

[0006] An antibacterial soft capsule helpful for improving vaginal relaxation, comprising a soft capsule content and a soft capsule shell;

[0007] The soft capsule content, calculated by weight, comprises the following raw materials: 3 - 5 parts of Cornus officinalis, 2 - 4 parts of Evodia rutaecarpa, 0.8 - 1.2 parts of vaginal tightening herb, 1 - 3 parts of Angelica sinensis, 1 - 2 parts of Crocus sativus, 1 - 3 parts of Chinese gallnut, 1 - 3 parts of Schisandra chinensis, 0.8 - 1.0 parts of sunflower seeds, 0.1 - 0.4 parts of Pelargonium graveolens, 2 - 4 parts of Phellodendron amurense, 1 - 3 parts of Artemisia argyi, 0.8 - 1.0 parts of Zanthoxylum bungeanum, 1 - 3 parts of complex polysaccharide;

[0008] The soft capsule shell, calculated by weight, comprises the following raw materials: 1 - 3 parts of gelatin, 1 - 3 parts of egg yolk lecithin, 2 - 4 parts of glycerol, 15 - 20 parts of deionized water.

[0009] Further, the complex polysaccharide is composed of Poria cocos polysaccharide, Polygonatum sibiricum polysaccharide, and Ganoderma lucidum polysaccharide with a mass ratio of 1:2 - 4:1 - 2.

[0010] Further, the preparation method of the soft capsule content includes:

[0011] (1) Grind cornel and evodia fruit, add deionized water, carry out ultrasonic treatment, then extract under medium temperature and high pressure, centrifuge, and concentrate under reduced pressure to obtain extract a;

[0012] (2) Mix sunflower seeds, Chinese prickly ash, and a composite solvent, carry out wet grinding, add the ground material to water, carry out microwave heating, centrifuge, and concentrate under reduced pressure to obtain extract b;

[0013] (3) Crush vaginal constriction grass, saffron, geranium, and mugwort, add absolute ethanol, carry out ethanol extraction, centrifuge, and concentrate under reduced pressure to obtain extract c;

[0014] (4) Crush angelica, Chinese gall, schisandra fruit, and phellodendron bark, add a composite enzyme solution, carry out enzymatic hydrolysis, retain the supernatant, and concentrate under reduced pressure to obtain extract d;

[0015] (5) Mix extract a, extract b, extract c, extract d, and composite polysaccharide evenly to obtain the soft capsule content.

[0016] Further, in step (1), the material-liquid ratio of cornel to deionized water is 1:10 - 12 g / mL; the ultrasonic treatment is carried out at 50 - 70 °C and 20 - 30 kHz for 20 - 30 min; the temperature of the medium temperature and high pressure is 95 - 105 °C, the pressure is 0.5 - 1.0 MPa, and the time is 5 - 10 min.

[0017] Further, in step (2), the material-liquid ratio of sunflower seeds to the composite solvent is 1:3 - 5 g / mL; the composite solvent is a 20wt% - 40wt% citric acid solution and a 5wt% - 10wt% glucose solution with a volume ratio of 1:2 - 4; the material-liquid ratio of the ground material to water is 1:6 - 8 g / mL; the power of the microwave heating is 200 - 300 W, the temperature is 60 - 80 °C, and the time is 20 - 30 min.

[0018] Further, in step (3), the material-liquid ratio of vaginal constriction grass to absolute ethanol is 1:5 - 7 g / mL; the ethanol extraction is carried out at 55 - 65 °C for 2 - 4 h.

[0019] Further, in step (4), the material-liquid ratio of angelica to the composite enzyme solution is 1:6 - 10 g / mL; the composite enzyme is pectinase, xylanase, and cellulase with a mass ratio of 2 - 4:1:1.5 - 1.8, and the enzyme activity is 100 u / g; the temperature of the enzymatic hydrolysis is 40 - 60 °C, and the time is 40 - 60 min.

[0020] A preparation method of an antibacterial soft capsule that helps improve vaginal relaxation, the specific steps include:

[0021] S1. Mix gelatin, egg yolk lecithin, glycerol and deionized water evenly, and defoam to obtain latex.

[0022] S2. Press and mold the soft capsule content and latex, and dry to obtain the target soft capsule.

[0023] Further, in step S1, the vacuum degree of defoaming is -0.04 to -0.02 MPa, and the time is 40 - 50 min.

[0024] Further, in step S2, the drying temperature is 25 - 30 °C, and the drying stops until the water content of the soft capsule shell is 8 - 10 wt%.

[0025] Compared with the prior art, the beneficial effects of the present invention are:

[0026] 1. The soft capsule prepared by the present invention integrates repair and firming, nourishing and lubricating, and antibacterial and anti-inflammatory functions. It has no irritation to the skin and mucous membranes, does not disrupt the acid-base balance in the body, and has no side effects. By promoting blood circulation and cell regeneration, it promotes the recovery of muscle elastic fibers and transverse wrinkles, thereby improving the phenomenon of vaginal relaxation, enabling the vagina to have the ability of autonomous contraction, improving the relaxed pelvic floor muscles and the connective tissues around the vagina, and enhancing the fast muscle pelvic floor muscle strength, which has an obvious therapeutic effect on patients with vaginal relaxation. The present invention has a strong bactericidal and anti-inflammatory effect, has a good curative effect on vaginal bacterial infections, and eliminates odors. In addition, it can also increase the secretion of estrogen, enhance immunity, and solve the problems of dysmenorrhea and cold uterus. The soft capsule of the present invention can nourish the vagina, improve vaginal dryness, and has good application prospects.

[0027] 2. By compounding shrubby sophora herb, Chinese gall, Asiatic cornelian cherry fruit and geranium, the present invention can strongly shrink the vagina and tighten it, significantly improve vaginal relaxation, and then combined with sunflower seeds, saffron, evodia fruit, angelica and complex polysaccharide, it can improve the phenomenon of vaginal dryness, promote the female reproductive tract to return to a tight state, and at the same time can warm the uterus and dispel cold, achieving the treatment of symptoms of cold uterus and dysmenorrhea. Moreover, phellodendron bark, Chinese prickly ash, Chinese mugwort and Chinese magnoliavine fruit have the function of sterilizing and anti-inflammatory, and can treat vaginal inflammation. Specific Embodiments

[0028] In order to better understand the technical content of the present invention, specific embodiments are provided below to further illustrate the present invention.

[0029] The experimental methods used in the embodiments of the present invention are all conventional methods unless otherwise specified.

[0030] The materials, reagents, etc. used in the embodiments of the present invention can be obtained from commercial channels unless otherwise specified.

[0031] Example 1

[0032] The antibacterial soft capsule for helping improve vaginal relaxation in this example includes a soft capsule content and a soft capsule shell;

[0033] Among them, the soft capsule content, by weight, includes the following raw materials: 4 parts of Cornus officinalis, 3 parts of Evodia rutaecarpa, 1 part of vaginal constricting herb, 2 parts of Angelica sinensis, 1.5 parts of saffron, 2 parts of Chinese gallnut, 2 parts of Schisandra chinensis, 0.9 part of sunflower seed, 0.3 part of geranium, 3 parts of Phellodendron amurense, 2 parts of Artemisia argyi, 0.9 part of Chinese prickly ash, 2 parts of complex polysaccharide, and the complex polysaccharide is Poria cocos polysaccharide, Polygonatum sibiricum polysaccharide and Ganoderma lucidum polysaccharide with a mass ratio of 1:3:1.5;

[0034] The soft capsule shell, by weight, includes the following raw materials: 2 parts of gelatin, 2 parts of egg yolk lecithin, 3 parts of glycerol, 18 parts of deionized water.

[0035] The preparation method of the above soft capsule content includes:

[0036] (1) Crush Cornus officinalis and Evodia rutaecarpa, add them into deionized water, the material-liquid ratio of Cornus officinalis to deionized water is 1:11 g / mL, perform ultrasonic treatment at 60 °C and 25 kHz for 25 min, then extract at 100 °C and a pressure of 0.8 MPa for 8 min, centrifuge, and concentrate under reduced pressure to obtain extract a;

[0037] (2) Mix sunflower seed, Chinese prickly ash and a composite solvent (a 30 wt% citric acid solution and an 8 wt% glucose solution with a volume ratio of 1:3), the material-liquid ratio of sunflower seed to the composite solvent is 1:4 g / mL, perform wet grinding, and add the ground material into water according to a material-liquid ratio of 1:7 g / mL, perform microwave heating at 250 W and 70 °C for 25 min, centrifuge, and concentrate under reduced pressure to obtain extract b;

[0038] (3) Crush vaginal constricting herb, saffron, geranium and Artemisia argyi, add them into absolute ethanol, the material-liquid ratio of vaginal constricting herb to absolute ethanol is 1:6 g / mL, extract at 60 °C for 3 h, centrifuge, and concentrate under reduced pressure to obtain extract c;

[0039] (4) Crush Angelica sinensis, Chinese gallnut, Schisandra chinensis and Phellodendron amurense, add them into a composite enzyme solution (the composite enzyme is pectinase, xylanase and cellulase with a mass ratio of 3:1:1.7, and the enzyme activity is 100 u / g), the material-liquid ratio of Angelica sinensis to the composite enzyme solution is 1:8 g / mL, perform enzymatic hydrolysis at 50 °C for 50 min, retain the supernatant, and concentrate under reduced pressure to obtain extract d;

[0040] (5) Mix extract a, extract b, extract c, extract d and complex polysaccharide evenly to obtain the soft capsule content.

[0041] The preparation method of the antibacterial soft capsule that helps to improve vaginal relaxation specifically includes the following steps:

[0042] S1. Mix gelatin, egg yolk lecithin, glycerol, and deionized water evenly, and defoam for 45 minutes under a vacuum degree of -0.03 MPa to obtain latex.

[0043] S2. Press and mold the soft capsule content and the latex, and dry at 28 °C until the water content of the soft capsule shell is 9 wt% to obtain the target soft capsule.

[0044] Example 2

[0045] The antibacterial soft capsule that helps to improve vaginal relaxation in this example includes a soft capsule content and a soft capsule shell.

[0046] Among them, the soft capsule content includes the following raw materials by weight: 3 parts of Cornus officinalis, 2 parts of Evodia rutaecarpa, 0.8 part of vagina tightening herb, 1 part of Angelica sinensis, 1 part of Crocus sativus, 1 part of Chinese gallnut, 1 part of Schisandra chinensis, 0.8 part of sunflower seeds, 0.1 part of Pelargonium graveolens, 2 parts of Phellodendron amurense, 1 part of Artemisia argyi, 0.8 part of Chinese prickly ash, 1 part of complex polysaccharide, and the complex polysaccharide is Poria cocos polysaccharide, Polygonatum sibiricum polysaccharide, and Ganoderma lucidum polysaccharide with a mass ratio of 1:2:1.

[0047] The soft capsule shell includes the following raw materials by weight: 1 part of gelatin, 1 part of egg yolk lecithin, 2 parts of glycerol, and 15 parts of deionized water.

[0048] The preparation method of the above soft capsule content includes:

[0049] (1) Grind Cornus officinalis and Evodia rutaecarpa, add them to deionized water, and the material-liquid ratio of Cornus officinalis to deionized water is 1:10 g / mL. Ultrasonically treat at 50 °C and 20 kHz for 20 minutes, then extract at 95 °C and a pressure of 0.5 MPa for 5 minutes, centrifuge, and concentrate under reduced pressure to obtain extract a.

[0050] (2) Mix sunflower seeds, Chinese prickly ash, and a composite solvent (a 20 wt% citric acid solution and a 5 wt% glucose solution with a volume ratio of 1:2), and the material-liquid ratio of sunflower seeds to the composite solvent is 1:3 g / mL. Perform wet grinding, and according to the material-liquid ratio of 1:6 g / mL, add the ground material to water, microwave heat at 200 W and 60 °C for 20 minutes, centrifuge, and concentrate under reduced pressure to obtain extract b.

[0051] (3) Crush vagina tightening herb, Crocus sativus, Pelargonium graveolens, and Artemisia argyi, add them to absolute ethanol, and the material-liquid ratio of vagina tightening herb to absolute ethanol is 1:5 g / mL. Extract at 55 °C for 2 hours, centrifuge, and concentrate under reduced pressure to obtain extract c.

[0052] (4) Crush Angelica sinensis, Chinese gall, Schisandra chinensis and Phellodendron amurense, add them to a composite enzyme solution (the composite enzyme is pectinase, xylanase and cellulase with a mass ratio of 2:1:1.5, and the enzyme activity is 100 u / g). The material-liquid ratio of Angelica sinensis to the composite enzyme solution is 1:6 g / mL. Enzymatically hydrolyze at 40 °C for 40 min, retain the supernatant, and concentrate under reduced pressure to obtain extract d;

[0053] (5) Mix extract a, extract b, extract c, extract d and the composite polysaccharide evenly to obtain the soft capsule content.

[0054] The preparation method of the above-mentioned antibacterial soft capsule that helps to improve vaginal relaxation specifically includes the following steps:

[0055] S1. Mix gelatin, egg yolk lecithin, glycerol and deionized water evenly, and defoam at a vacuum degree of -0.04 MPa for 40 min to obtain latex;

[0056] S2. Compress and form the soft capsule content and the latex, and dry at 25 °C until the water content of the soft capsule shell is 8 wt% to obtain the target soft capsule.

[0057] Example 3

[0058] The antibacterial soft capsule that helps to improve vaginal relaxation in this example includes a soft capsule content and a soft capsule shell;

[0059] Among them, the soft capsule content includes the following raw materials by weight: 5 parts of Cornus officinalis, 4 parts of Evodia rutaecarpa, 1.2 parts of vaginal constriction grass, 3 parts of Angelica sinensis, 2 parts of saffron, 3 parts of Chinese gall, 3 parts of Schisandra chinensis, 1.0 part of sunflower seeds, 0.4 part of Pelargonium graveolens, 4 parts of Phellodendron amurense, 3 parts of Artemisia argyi, 1.0 part of Chinese prickly ash, 3 parts of composite polysaccharide, and the composite polysaccharide is Poria cocos polysaccharide, Polygonatum sibiricum polysaccharide and Ganoderma lucidum polysaccharide with a mass ratio of 1:4:2;

[0060] The soft capsule shell includes the following raw materials by weight: 3 parts of gelatin, 3 parts of egg yolk lecithin, 4 parts of glycerol, and 20 parts of deionized water.

[0061] The preparation method of the above-mentioned soft capsule content includes:

[0062] (1) Grind Cornus officinalis and Evodia rutaecarpa, add them to deionized water. The material-liquid ratio of Cornus officinalis to deionized water is 1:12 g / mL. Ultrasonically treat at 70 °C and 30 kHz for 30 min, then extract at 105 °C and a pressure of 1.0 MPa for 10 min, centrifuge, and concentrate under reduced pressure to obtain extract a;

[0063] (2) Mix sunflower seeds, Chinese prickly ash, and a composite solvent (a 40 wt% citric acid solution and a 10 wt% glucose solution with a volume ratio of 1:4), with the material-liquid ratio of sunflower seeds to the composite solvent being 1:5 g / mL, and conduct wet grinding. Then, add the ground material to water according to a material-liquid ratio of 1:8 g / mL, heat it in a microwave at 300 W and 80 °C for 30 min, centrifuge, and concentrate under reduced pressure to obtain extract b;

[0064] (3) Crush Herba Sedi Sarmentosi, saffron, geranium, and mugwort, add them to absolute ethanol, with the material-liquid ratio of Herba Sedi Sarmentosi to absolute ethanol being 1:7 g / mL, extract at 65 °C for 4 h, centrifuge, and concentrate under reduced pressure to obtain extract c;

[0065] (4) Crush angelica, Chinese gall, Chinese magnoliavine fruit, and phellodendron bark, add them to a composite enzyme solution (the composite enzyme is pectinase, xylanase, and cellulase with a mass ratio of 4:1:1.8, and the enzyme activity is 100 u / g), with the material-liquid ratio of angelica to the composite enzyme solution being 1:10 g / mL, enzymolyze at 60 °C for 60 min, retain the supernatant, and concentrate under reduced pressure to obtain extract d;

[0066] (5) Mix extract a, extract b, extract c, extract d, and composite polysaccharide evenly to obtain the soft capsule content.

[0067] The preparation method of the above-mentioned antibacterial soft capsule that helps improve vaginal relaxation specifically includes the following steps:

[0068] S1. Mix gelatin, egg yolk lecithin, glycerol, and deionized water evenly, and defoam at a vacuum degree of -0.02 MPa for 50 min to obtain latex;

[0069] S2. Compress and mold the soft capsule content and the latex, and dry at 30 °C until the water content of the soft capsule shell is 10 wt% to obtain the target soft capsule.

[0070] Comparative Example 1

[0071] The difference from Example 1 is that the dosage of the soft capsule content is different, and the others are the same as in Example 1.

[0072] That is, the soft capsule content of this comparative example includes the following raw materials by weight: 2 parts of cornel, 5 parts of evodia fruit, 1.4 parts of Herba Sedi Sarmentosi, 4 parts of angelica, 0.5 part of saffron, 4 parts of Chinese gall, 0.5 part of Chinese magnoliavine fruit, 0.5 part of sunflower seeds, 0.5 part of geranium, 5 parts of phellodendron bark, 4 parts of mugwort, 0.6 part of Chinese prickly ash, and 4 parts of composite polysaccharide.

[0073] Comparative Example 2

[0074] The difference from Example 1 is that the content of the soft capsule lacks complex polysaccharides, and the missing substances are distributed according to the proportion of other substances. The rest is consistent with Example 1.

[0075] Comparative Example 3

[0076] The difference from Example 1 is that the soft capsule content lacks Cornus officinalis and Evodia rutaecarpa, and the missing substances are distributed according to the proportion of other substances. The rest is consistent with Example 1.

[0077] Comparative Example 4

[0078] The difference from Example 1 is that the extraction method of the raw material extract of the soft capsule content is water extraction, and the rest is consistent with Example 1.

[0079] That is, the preparation method of the soft capsule content of this comparative example comprises:

[0080] (1) Grind cornus officinalis, evodia rutaecarpa, herba sutchuenensis, angelica sinensis, saffron, gallnut, schisandra chinensis, sunflower seeds, geranium, phellodendron amurense, wormwood and Zanthoxylum bungeanum to form a mixture powder, add the mixture powder into deionized water at a solid-liquid ratio of 1:11 g / mL, extract at 60° C. for 2 h, centrifuge, and concentrate under reduced pressure to obtain an extract;

[0081] (2) The extract and the complex polysaccharide are mixed evenly to obtain the contents of the soft capsule.

[0082] Test Example 1 Animal Experiment

[0083] Modeling: 90 female SD rats weighing 200-250g were purchased and randomly divided into a blank control group of 10 and an experimental group of 80. The experimental group was anesthetized by injecting 2% lidocaine with a syringe. Under sterile conditions, an incision was made on the inside of the rat's vagina with a surgical instrument to create a vaginal defect. Then exogenous relaxin was given to promote the proliferation and relaxation of vaginal tissue. The drug was administered continuously for 7 days. After 7 days, the skin, tissues, and muscles near the vagina were observed with the naked eye to be relaxed. Due to the relaxation of the vaginal muscles, the vulva was open to a certain extent. The color of the vulva was slightly red and congested, and the vulva area was moist with secretions discharged.

[0084] Experimental grouping and administration method: 80 model rats were randomly divided into 8 groups again, each with 10 rats, namely the model group, the Example 1-3 group and the Comparative Example 1-4 group. The Example 1-3 group was treated with the soft capsule prepared in Example 1-3, and the Comparative Example 1-4 group was treated with the soft capsule prepared in Comparative Example 1-4, one capsule each time, and the model group was not treated. The above operation was repeated again after 24 hours, and the efficacy was evaluated after 7 days of treatment.

[0085] Evaluation indicators: 1. In vaginal relaxation, TNF-α (tumor necrosis factor-α) affects the structure and function of vaginal tissue by regulating inflammatory responses and apoptosis. In the vagina, the release of TNF-α can cause infiltration and activation of inflammatory cells, leading to inflammatory symptoms such as tissue edema, redness, and pain, which can affect the elasticity and contractile function of vaginal tissue, resulting in vaginal relaxation. In vaginal tissue, excessive TNF-α can cause apoptosis, leading to a reduction in vaginal tissue cells and structural damage. This can affect the muscle tone and elasticity of the vagina, thereby causing vaginal relaxation. TNF-α can also affect the synthesis and degradation of collagen, which is an important component for maintaining the structure and elasticity of vaginal tissue. Excessive TNF-α may inhibit collagen synthesis, leading to the relaxation and fragility of vaginal tissue. Therefore, the expression of TNF-α can be detected by taking vaginal tissue homogenate.

[0086] 2. In vaginal relaxation, VEGF (vascular endothelial growth factor) is a protein that promotes angiogenesis and repair, and it plays a key role in maintaining normal tissue blood supply and repairing damaged tissues. In vaginal relaxation, VEGF can promote the proliferation of vascular endothelial cells and stimulate the formation of new blood vessels, thereby increasing local blood flow, improving the nutritional status of tissues, and helping to restore the elasticity and function of tissues. Vaginal relaxation is usually caused by factors such as vascular atrophy, tissue malnutrition, and lack of elastic fibers. The increase in VEGF can promote the synthesis of collagen and elastic fibers, increase the elasticity and firmness of tissues, and help improve the condition of vaginal relaxation. Therefore, the expression of VEGF can be detected by taking vaginal tissue homogenate.

[0087] 3. In vaginal relaxation, collagen I (COL-1) is the main connective tissue protein in vaginal tissue. It forms a fibrous structural support network that maintains the overall structure and shape of vaginal tissue. The presence of COL-1 gives vaginal tissue a certain degree of tension and elasticity, contributing to the firmness and strength of the vagina. It can also promote cell proliferation and repair. In the case of vaginal damage or aging, COL-1 participates in the process of cell regeneration and repair, helping to restore the health of vaginal tissue and maintain the stability of the vaginal internal environment. The presence of COL-1 helps to maintain the integrity and barrier function of the vaginal mucosa, preventing the invasion of external harmful substances. Therefore, the expression of COL-1 can be detected by taking vaginal tissue homogenate.

[0088] 4. In vaginal relaxation, elastin is an elastic protein that helps maintain the elasticity and firmness of the vagina. Elastin provides support and elasticity in vaginal tissue. When its content decreases or its structure is damaged, the vaginal tissue loses its original elastic support, resulting in relaxation. In addition, elastin can also help with intercellular connections, maintaining the integrity and stability of tissues. It keeps the vaginal tissue in a hydrated state, making it firm and full. When elastin is damaged, the intercellular connections become weak, and vaginal tissue relaxation may occur. Lack of sufficient elastin leads to the loss of the water-hydrating ability of vaginal tissue, further exacerbating the relaxation. Elastin plays an important role in maintaining vaginal health and function, and its structure and function are crucial for the elasticity and firmness of vaginal tissue. Therefore, the expression of elastin can be detected after taking vaginal tissue homogenate.

[0089] The results are shown in Table 1.

[0090] Table 1

[0091]

[0092]

[0093] Note: *Compared with the control group, P < 0.05; ※Compared with the model group, P < 0.05.

[0094] As can be seen from Table 1, compared with the control group, the content of TNFα in the model group increased significantly, while the contents of VEGF, COL-1, and elastin decreased significantly. After intervention and treatment with the soft capsules prepared in Examples 1-3 of the present invention, the content of TNFα decreased, and the contents of VEGF, COL-1, and elastin increased. The TNFα reduction effect and the VEGF, COL-1, and elastin increase effects of Comparative Examples 1-4 were far inferior to those of Examples 1-3.

[0095] Test Example 2 Clinical Trial

[0096] 1. Diagnostic criteria: The degree of vaginal relaxation;

[0097] Normal: The transverse diameter of the vagina is 2.5 cm or less;

[0098] Mild relaxation: The transverse diameter of the vagina is 2.5 - 4 cm, the vaginal orifice is slightly enlarged, and the lubricating function decreases;

[0099] Moderate relaxation: The transverse diameter of the vagina is 4 - 5 cm, the vaginal muscle contractility and lubricating function decrease, the vagina is dry, and there are symptoms such as frequent urination and urinary incontinence;

[0100] Severe relaxation: The transverse diameter of the vagina is more than 5 cm, showing symptoms such as vaginal prolapse.

[0101] 2. Experimental procedure: 80 patients with moderate vaginal relaxation who had a history of vaginal delivery, aged 24 - 60 years old, were randomly divided into 8 groups (control group, Example 1 - 3 groups, and Comparative Example 1 - 4 groups), with 10 people in each group.

[0102] The Example 1 - 3 groups and Comparative Example 1 - 4 groups were treated with the soft capsules prepared in the corresponding examples and comparative examples of the present invention. One case was used vaginally before going to bed every night for 7 consecutive days. The control group used a commercially available vaginal tightening soft capsule (purchased from Guangzhou Yuzhan Biotechnology Co., Ltd.), one case was used vaginally before going to bed every night for 7 consecutive days.

[0103] After the treatment course ended, the patients were continuously monitored for 3 months to observe whether there were any side effects.

[0104] 3. Efficacy determination criteria: Cured: The transverse diameter of the vagina is 2.5 cm or less, the vaginal muscle contraction force and lubrication function return to normal, the vagina has a lubricating feeling, and frequent urination and urinary incontinence return to normal;

[0105] Markedly effective: The transverse diameter of the vagina is 2.6 - 3 cm, the vaginal muscle contraction force and lubrication function are restored, the vagina has no dryness feeling, and frequent urination and urinary incontinence are significantly improved;

[0106] Effective: The transverse diameter of the vagina is 3.1 - 4 cm, the lubrication function returns to normal, the vaginal dryness condition is improved, and frequent urination and urinary incontinence are improved;

[0107] Ineffective: There is no change, that is, the transverse diameter of the vagina is 4 - 5 cm, the vaginal muscle contraction force and lubrication function decline, the vagina is dry, and there is frequent urination and urinary incontinence.

[0108] The results are shown in Table 2.

[0109] Table 2

[0110] Group Total number of cases / case Cured / case Markedly effective / case Effective / case Ineffective / case Example 1 10 8 2 1 0 Example 2 10 6 3 1 0 Example 3 10 7 1 2 0 Comparative Example 1 10 4 2 3 1 Comparative Example 2 10 3 2 3 2 Comparative Example 3 10 2 3 3 2 Comparative Example 4 10 2 1 3 4 Control group 10 3 0 3 4

[0111] As can be seen from Table 2, the soft capsules prepared by the present invention can effectively treat vaginal relaxation, and the curative effect is better than that of Comparative Example 1 - 4 and the control group.

[0112] Test Example 3 Antibacterial experiment

[0113] Strains: Escherichia coli, Candida albicans, Gardnerella vaginalis.

[0114] Specific method: Take the soft capsule to measure its antibacterial effect. The minimum inhibitory concentration (MIC) is measured by the micro - dilution method. After dissolving the soft capsule with Mueller - Hinton broth and performing gradient dilution, it is added to a 96 - well culture plate. 0.2 mL of the diluted medicinal liquid is added to each well, and then 20 μL of a concentration of 10 6The bacterial solution with a concentration of cfu / mL was cultured at 5% CO2 and 37°C for 48 hours. The minimum drug administration concentration without bacterial growth was defined as the MIC. The results are shown in Table 3.

[0115] Table 3

[0116]

[0117] As can be seen from Table 3, the soft capsules prepared by the present invention have good antibacterial effects, indicating that they can treat vaginitis.

[0118] The above are only the preferred embodiments of the present invention and are not intended to limit the present invention. Any modifications, equivalent replacements, improvements, etc. made within the spirit and principles of the present invention shall be included within the protection scope of the present invention.

Claims

1. An antibacterial soft capsule that helps improve vaginal relaxation, characterized in that, It includes soft capsule contents and a soft capsule shell; The soft capsule contents, by weight, include the following raw materials: 3 - 5 parts of Cornus officinalis, 2 - 4 parts of Evodia rutaecarpa, 0.8 - 1.2 parts of Herba Hypoestes Phyllostachyae, 1 - 3 parts of Angelica sinensis, 1 - 2 parts of Crocus sativus, 1 - 3 parts of Galla chinensis, 1 - 3 parts of Schisandra chinensis, 0.8 - 1.0 parts of sunflower seeds, 0.1 - 0.4 parts of Pelargonium graveolens, 2 - 4 parts of Phellodendron amurense, 1 - 3 parts of Artemisia argyi, 0.8 - 1.0 parts of Zanthoxylum bungeanum, 1 - 3 parts of complex polysaccharide; The soft capsule shell, by weight, includes the following raw materials: 1 - 3 parts of gelatin, 1 - 3 parts of egg yolk lecithin, 2 - 4 parts of glycerol, 15 - 20 parts of deionized water.

2. The antibacterial soft capsule for helping improve vaginal relaxation according to claim 1, wherein The complex polysaccharide is composed of Poria cocos polysaccharide, Polygonatum sibiricum polysaccharide and Ganoderma lucidum polysaccharide with a mass ratio of 1:2 - 4:1 - 2.

3. The antibacterial soft capsule according to claim 1, which is helpful for improving vaginal relaxation, is characterized in that, The preparation method of the soft capsule contents includes: (1) Crush Cornus officinalis and Evodia rutaecarpa, add them into deionized water, carry out ultrasonic treatment, then extract under medium - temperature and high - pressure conditions, centrifuge, and concentrate under reduced pressure to obtain extract a; (2) Mix sunflower seeds, Zanthoxylum bungeanum and a composite solvent, carry out wet grinding, add the ground material into water, carry out microwave heating, centrifuge, and concentrate under reduced pressure to obtain extract b; (3) Crush Herba Hypoestes Phyllostachyae, Crocus sativus, Pelargonium graveolens and Artemisia argyi, add them into absolute ethanol, carry out alcohol extraction, centrifuge, and concentrate under reduced pressure to obtain extract c; (4) Crush Angelica sinensis, Galla chinensis, Schisandra chinensis and Phellodendron amurense, add them into a composite enzyme solution, carry out enzymatic hydrolysis, retain the supernatant, and concentrate under reduced pressure to obtain extract d; (5) Mix extract a, extract b, extract c, extract d and complex polysaccharide evenly to obtain the soft capsule contents.

4. The antibacterial soft capsule for helping to improve vaginal relaxation according to claim 3, characterized in that, In step (1), the material - liquid ratio of Cornus officinalis to deionized water is 1:10 - 12 g / mL; the ultrasonic treatment is carried out at 50 - 70 °C, 20 - 30 kHz for 20 - 30 min; the temperature of the medium - temperature and high - pressure is 95 - 105 °C, the pressure is 0.5 - 1.0 MPa, and the time is 5 - 10 min.

5. The antibacterial soft capsule for helping improve vaginal relaxation according to claim 3, characterized in that, In step (2), the material - liquid ratio of sunflower seeds to the composite solvent is 1:3 - 5 g / mL; the composite solvent is a 20wt% - 40wt% citric acid solution and a 5wt% - 10wt% glucose solution with a volume ratio of 1:2 - 4; the material - liquid ratio of the ground material to water is 1:6 - 8 g / mL; the power of the microwave heating is 200 - 300 W, the temperature is 60 - 80 °C, and the time is 20 - 30 min.

6. The antibacterial soft capsule for helping improve vaginal laxity according to claim 3, wherein, In step (3), the material - liquid ratio of Herba Hypoestes Phyllostachyae to absolute ethanol is 1:5 - 7 g / mL; the alcohol extraction is carried out at 55 - 65 °C for 2 - 4 h.

7. The antibacterial soft capsule for helping to improve vaginal relaxation according to claim 3, characterized in that, In step (4), the material - liquid ratio of Angelica sinensis to the composite enzyme solution is 1:6 - 10 g / mL; the composite enzyme is pectinase, xylanase and cellulase with a mass ratio of 2 - 4:1:1.5 - 1.8, and the enzyme activity is 100 u / g; the temperature of the enzymatic hydrolysis is 40 - 60 °C, and the time is 40 - 60 min.

8. The preparation method of an antibacterial soft capsule for helping to improve vaginal relaxation according to claim 1, characterized in that, The specific steps include: S1. Mix gelatin, egg yolk lecithin, glycerol and deionized water evenly, and defoam to obtain latex; S2. Press and form the soft capsule content and the latex, and dry them to obtain the target soft capsule.

9. The preparation method of an antibacterial soft capsule for helping to improve vaginal relaxation according to claim 8, characterized in that, In step S1, the vacuum degree for defoaming is -0.04 to -0.02 MPa, and the time is 40 - 50 min.

10. The preparation method of an antibacterial soft capsule for helping to improve vaginal relaxation according to claim 8, characterized in that, In step S2, the drying temperature is 25 - 30 °C, and the drying is stopped until the water content of the soft capsule shell is 8 - 10 wt%.

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