Traditional Chinese medicine composition with vagina tightening effect as well as preparation method and application of traditional Chinese medicine composition

Abstract

The invention provides a traditional Chinese medicine composition with a vaginal tightening effect and a preparation method thereof, and further provides application of the traditional Chinese medicine composition in preparation of products for preventing or treating vaginal relaxation. According to the pharmaceutical composition with the vagina tightening effect, ten Chinese herbal medicines are combined with a special microbial fermentation technology, and effective active ingredients, which cannot be directly utilized after entering a human body, in the Chinese herbal medicines are degraded into small-molecule active substances through microbial fermentation, so that the efficacy of the ten Chinese herbal medicines is greatly improved; the micromolecular active ingredients in the fermentation product have a relatively strong transdermal permeation effect, and the content of fibroblast growth factors of vaginal cells can be increased, so that the content of collagen of the vaginal cells is increased, and the purpose of improving the contractility of vaginal muscle fiber cells is achieved.

Description

Technical Field

[0001] The invention belongs to the technical field of female reproductive care, and specifically relates to a traditional Chinese medicine composition with vaginal tightening effect and a preparation method thereof, and also relates to the application of the composition in preparing a product for preventing or treating vaginal relaxation. Background Art

[0002] As women age, their estrogen levels in the vagina decrease. Or due to factors such as childbirth and disease, the vaginal mucosal folds decrease, collagen fibers decrease, and muscle fibers tear, leading to changes in the surrounding connective tissue and pelvic floor muscle structure, which in turn leads to vaginal relaxation. Vaginal relaxation not only causes urinary incontinence and a decline in the quality of life of couples, which in turn affects women's quality of life, self-confidence and sexual desire, but also causes gynecological diseases such as bacterial infection and inflammation, which brings pain to women both psychologically and physically.

[0003] Currently, the main methods to solve vaginal relaxation include exercise, surgical treatment, drug treatment, etc., but exercise is slow to take effect, surgical treatment has a high risk and a long recovery period. Therefore, it is of great significance to obtain an external resident product or raw material that can effectively promote the regeneration of vaginal collagen fibers, restore vaginal elasticity, and promote vaginal firmness.

[0004] There are two types of care products for women on the market to solve vaginal relaxation. One type is chemical synthetic medicines, and the dosage forms and methods include vaginal injection, drug filling, etc. The advantage of this type of medicine is that it works quickly, but the disadvantage is that the effect is not long-lasting. Once the drug is stopped, the vagina becomes loose again, and it is also harmful to the human body; the other type is Chinese herbal medicine products, and the dosage forms and methods are mostly douching agents or suppositories. Since natural Chinese herbal medicine ingredients are used, they are less harmful to the human body, have no side effects, and are safe and reliable. However, for example, Chinese patent document CN1939518A discloses a herbal care solution for contracting the vagina, sterilizing and relieving itching for women during menstruation and daily use, and CN101934033A discloses a natural ingredient vaginal tightening liquid and a preparation method thereof. Since the natural ingredients of Chinese herbal medicines used in these patented technologies are all water extracts, the effective ingredients extracted from each Chinese herbal medicine ingredient are very limited. In order to increase the content of the effective ingredients, natural water such as well water is used for soaking and extraction, and the preparation process is relatively harsh. Summary of the invention

[0005] In view of the defects of the prior art, the purpose of the present invention is to provide a traditional Chinese medicine composition with vaginal tightening effect and a preparation method thereof, as well as an application of the composition in the preparation of products for preventing or treating vaginal relaxation.

[0006] To achieve the above purpose, the solution adopted by the present invention is as follows:

[0007] In a first aspect, the present invention provides a traditional Chinese medicine composition with a vaginal tightening effect, comprising a fermentation product formed by fermenting 10 kinds of Chinese herbal medicine preparations and inositol through probiotics, wherein the raw materials of the 10 kinds of Chinese herbal medicine preparations and their weight proportions are: 5-25 parts of ginseng, 1-15 parts of scutellaria baicalensis, 10-30 parts of white peony root, 5-25 parts of sanguisorba officinalis, 5-25 parts of fructus aurantii, 5-25 parts of terminalia chebula, 5-20 parts of siler, 5-20 parts of ligusticum chuanxiong, 5-25 parts of tangerine peel, and 5-25 parts of cimicifuga.

[0008] Preferably, the 10 Chinese herbal medicine preparations are powders of the raw materials, or water or organic solvent extracts of the raw materials; the probiotics are selected from one or more of lactic acid bacteria (Lactobacillus acidophilus, Lactobacillus bulgaricus, Streptococcus faecalis), Bacillus (Bacillus licheniformis, Bacillus subtilis, Bacillus cereus), and yeast fungi (Saccharomyces cerevisiae, petroleum yeast), preferably Bacillus subtilis.

[0009] Preferably, the mass percentage content of the inositol is 1%-10% of the total mass of the 10 Chinese herbal medicine preparations.

[0010] In a second aspect, the present invention further provides a method for preparing the above-mentioned traditional Chinese medicine composition having vaginal tightening effect, comprising the following steps:

[0011] Weigh ginseng, scutellaria, white peony root, sanguisorba officinalis, fructus aurantii, terminalia chebula, siler, ligusticum chuanxiong, tangerine peel, and cimicifuga according to the formula ratio, grind, and pass through a 40-mesh sieve to obtain a mixed Chinese herbal medicine preparation;

[0012] Weigh a certain amount of mixed Chinese herbal medicine preparation, add 5-10 times of water and inositol, soak and sterilize at 121°C;

[0013] After cooling, inoculate the probiotic seed solution in a clean bench and ferment at 30℃-38℃ for 48-96h;

[0014] After the fermentation is completed, sterilization and filtration are carried out, and the filtrate is the fermentation product.

[0015] Preferably, the mixed Chinese herbal medicine preparation is the powder of each raw material medicine, or the water or organic solvent extract of each raw material medicine; the probiotics are selected from one or more of lactic acid bacteria (Lactobacillus acidophilus, Lactobacillus bulgaricus, Streptococcus faecalis), Bacillus (Bacillus licheniformis, Bacillus subtilis, Bacillus cereus), yeast fungi (Saccharomyces cerevisiae, petroleum yeast), preferably Bacillus subtilis.

[0016] Preferably, the inoculated bacterial concentration of the probiotic seed solution is 10 6 -10 8 CFU / mL, and the solution volume of the probiotic seed solution is 20-50mL.

[0017] In a third aspect, the present invention also provides a use of the above-mentioned traditional Chinese medicine composition having vaginal tightening effect in the preparation of a product for preventing or treating vaginal relaxation.

[0018] In a fourth aspect, the present invention further provides an external preparation having a vaginal tightening effect, comprising the traditional Chinese medicine composition having a vaginal tightening effect as described above.

[0019] Preferably, the dosage form of the external agent with vaginal tightening effect includes cream, gel, spray, douche or suppository, preferably cream or gel.

[0020] Preferably, the external preparation having vaginal tightening effect further comprises at least one of an excipient, a bactericide, a moisturizer, an anti-allergic agent, a chelating agent and a flavor.

[0021] Compared with the prior art, the present invention has the following beneficial effects:

[0022] The pharmaceutical composition with vaginal tightening effect prepared by the present invention combines 10 kinds of Chinese herbal medicines with microbial fermentation technology, and degrades the effective active ingredients in the Chinese herbal medicines that cannot be directly utilized after entering the human body into small molecular active substances through microbial fermentation, thereby greatly improving the efficacy of the 10 kinds of Chinese herbal medicines, and the small molecular active ingredients in the fermentation products and the inositol added during the fermentation have a strong transdermal permeation effect, which can increase the content of vaginal cell fibroblast growth factor, thereby increasing the content of vaginal cell collagen, and achieving the purpose of improving the contractility of vaginal muscle fiber cells. DETAILED DESCRIPTION

[0023] The invention provides a traditional Chinese medicine composition with vaginal tightening effect, comprising a fermentation product formed by fermenting 10 kinds of traditional Chinese medicine preparations and inositol through probiotics, wherein the raw materials of the 10 kinds of traditional Chinese medicine preparations and their weight proportions are: 5-25 parts of ginseng, 1-15 parts of scutellaria baicalensis, 10-30 parts of white peony root, 5-25 parts of sanguisorba officinalis, 5-25 parts of fructus aurantii, 5-25 parts of terminalia chebula, 5-20 parts of siler, 5-20 parts of ligusticum chuanxiong, 5-25 parts of dried tangerine peel and 5-25 parts of cimicifuga.

[0024] In the process of fermenting the above 10 kinds of Chinese herbal medicine preparations with probiotics, the 10 kinds of Chinese herbal medicine preparations used can be the powder of each raw material medicine, or can be the water or organic solvent extract of each raw material medicine. The probiotics used include but are not limited to lactic acid bacteria (Lactobacillus acidophilus, Lactobacillus bulgaricus, Streptococcus faecalis), Bacillus (Bacillus licheniformis, Bacillus subtilis, Bacillus cereus), yeast fungi (Saccharomyces cerevisiae, petroleum yeast), and Bacillus subtilis is used as an example to illustrate the technical solution of the present invention in the embodiment of the present invention.

[0025] In the Chinese medicine composition with vaginal tightening effect provided by the present invention, the mass percentage content of inositol is 1%-10% of the total mass of 10 Chinese herbal medicine preparations, such as 2%, 3%, 4%, 5%, 6%, 7%, 8%, 9%. The inositol used in the present invention, also known as cyclohexane hexol, is widely distributed in animals and plants, and is a growth factor for animals and microorganisms. It was first isolated from the myocardium and liver. Inositol is a "bioactive element" that participates in the metabolic activities in the body and has multiple functions such as immunity, prevention and treatment of certain diseases. In the fermentation and food industry, it can be used to cultivate multiple strains, promote the growth of yeast, promote the growth of Bacillus subtilis, etc. In addition, inositol is also a transdermal permeation agent that can help other small molecular components in the fermentation liquid penetrate into the deep layer of the vaginal mucosa, thereby achieving a synergistic effect.

[0026] Furthermore, the present invention also provides a method for preparing the above-mentioned traditional Chinese medicine composition having vaginal tightening effect, comprising the following steps:

[0027] Step (1), weighing ginseng, scutellaria, white peony root, sanguisorba officinalis, fructus aurantii, terminalia chebula, siler, ligusticum chuanxiong, tangerine peel, and cimicifuga according to the formula ratio, crushing, and passing through a 40-mesh sieve to obtain a mixed Chinese herbal medicine preparation;

[0028] In this step, when the mixed Chinese herbal medicine preparation obtained is the powder of each raw material medicine, each raw material medicine is crushed and passed through a 40-mesh sieve, and mixed evenly to obtain the preparation; when the mixed Chinese herbal medicine preparation obtained is the water or organic solvent extract of each raw material medicine, a conventional Chinese herbal medicine water or organic solvent (such as ethanol) extraction method is adopted, for example, the crushed Chinese herbal medicine mixed powder is placed in a 70% ethanol solution, heated to reflux, filtered, and the crude extract is then distilled under reduced pressure to remove the ethanol therein, concentrated, and sterilized to obtain the preparation.

[0029] Step (2), weighing a certain amount of the mixed Chinese herbal medicine preparation, adding 5-10 times of water and inositol, soaking and sterilizing at 121° C. for 15-30 minutes;

[0030] Step (3), after cooling, inoculating the probiotic seed solution in a clean bench and fermenting at 30° C. to 38° C. for 48 to 96 hours;

[0031] In this step, the bacterial concentration of the inoculated probiotic seed solution is 10 6 -10 8 CFU / mL, the solution volume of the inoculated probiotic seed solution is 20-50mL.

[0032] Step (4), sterilization and filtration are performed after the fermentation is completed, and the filtrate is the fermentation product.

[0033] The present invention also provides a product for preventing or treating vaginal relaxation, comprising the traditional Chinese medicine composition.

[0034] In the present invention, the "Chinese medicine composition" and "product for preventing or treating vaginal relaxation" are generally compositions comprising a composition having an active ingredient component (referred to as active ingredient) and pharmaceutically acceptable excipients.

[0035] In the present invention, the active ingredient components are fermentation products obtained by fermenting the above 10 Chinese herbal medicine preparations and inositol with probiotics.

[0036] In the present invention, the "pharmaceutically acceptable excipients" include inert diluents, dispersants and / or granulating agents, surfactants and / or emulsifiers, disintegrants, binders, preservatives, buffers, lubricants and / or lubricating oils.

[0037] The product provided by the present invention, which includes the above-mentioned Chinese medicine composition and is used for preventing or treating vaginal relaxation, has a dosage form of ointment, gel, spray, douche or suppository. This can be achieved by adding at least one of an excipient, a bactericide, a moisturizer, an anti-allergic agent, a chelating agent and a flavor to the composition to prepare a vaginal external preparation such as an ointment or a gel. When applying, the vaginal external preparation is applied to the affected part of the female vagina.

[0038] In the traditional Chinese medicine composition with vaginal tightening effect provided by the present invention, each raw material component as an active ingredient has the following expected functions:

[0039] Ginseng:

[0040] Aliases: Renjie, Guigai, Huangshen, Yujing, Xueshen, Tujing, Dijing, Jinjing Yulan, Haiershen, Bangchui, the root of the Araliaceae plant Panax ginseng, which contains a variety of ginsenosides, of which ginsenosides and polysaccharides are the main active ingredients, warm in nature, sweet, slightly bitter, slightly warm, and enter the spleen and lung meridians. Efficacy: greatly replenishes vital energy, restores pulse and consolidates the body, replenishes the spleen and lungs, promotes fluid production and quenches thirst, calms the mind and improves intelligence. Indications: fatigue, loss of appetite, fatigue, nausea and vomiting, loose stools, cough and shortness of breath, spontaneous sweating and sudden loss of body fluids, palpitations, forgetfulness, dizziness and headache, impotence, frequent urination, thirst, metrorrhagia in women, slow shock in children and long-term deficiency, all symptoms of insufficient qi, blood and body fluids. Ginseng can regulate the balance of the excitation and inhibition processes of the central nervous system, which is manifested as small doses of excitation of the central nervous system and large doses of inhibition of the central nervous system. Ginseng or its extract has a stimulating and protective effect on the hematopoietic function of the bone marrow, and has the effect of enhancing the hematopoietic function. Ginseng saponins have the effect of inhibiting platelet aggregation. Ginseng extract concentrate has an inhibitory effect on Shigella flexneri type Ia, beta-hemolytic Streptococcus, and purple-producing Penicillium. Higher concentrations have an inhibitory effect on Staphylococcus aureus, Escherichia coli, Bacillus anthracis, Pneumococcus, Aspergillus niger, and chrysogenycetes. In addition, ginseng still has certain effects of promoting gonadal function, promoting protein synthesis, anti-tumor, anti-oxidation, anti-aging, anti-liver damage, anti-gastric ulcer, anti-fatigue, anti-stress, anti-radiation, anti-mutation, and hemostasis.

[0041] Scutellaria baicalensis:

[0042] Aliases: Rotten intestines, Huangwen, Dumb woman, Hongsheng, Jingqin, Yintou, Neixu, Jejun, Ziqin, Suqin, Tiaoqin, Yuanqin, Tujinchagen, Shanchagen, Huangjintiaogen. It tastes bitter and is cold in nature. It enters the lungs, gallbladder, and spleen. It has the effects of clearing away heat and dampness, purging fire and detoxifying, stopping bleeding, and calming the fetus. It is mainly used to treat damp-heat, summer dampness, chest tightness and nausea, damp-heat fullness, jaundice and diarrhea, lung heat cough, high fever and thirst, blood heat vomiting and epistaxis, and fetal movement disorder. Huangqin root contains flavonoid compounds such as baicalin, baicalin, wogonin, wogonin, oroxylin A, 7-methoxybaicalin, baicalin, dihydrooroxylin, and chrysin. In vitro, the decoction of Scutellaria baicalensis has different degrees of inhibitory effects on Shigella dysenteriae, Corynebacterium diphtheriae, Pseudomonas aeruginosa, Salmonella typhi, Salmonella paratyphi, Proteus, Staphylococcus aureus, hemolytic Streptococcus, Pneumococcus, meningococcus, Vibrio cholerae, etc.; baicalin and baicalein have a relieving effect on the allergic contraction of the isolated trachea of ​​guinea pigs and allergic asthma in whole animals, and have a synergistic effect with ephedrine to reduce the permeability of mouse ear capillaries; this product also has antipyretic, antihypertensive, sedative, liver-protecting, choleretic, intestinal motility inhibition, lipid-lowering, anti-oxidation, cAMP level regulation, and anti-tumor effects; the water extract of Scutellaria baicalensis has an inhibitory effect on the biosynthesis of prostaglandins.

[0043] White Peony Root:

[0044] Alias: Golden Peony, the root of white peony contains paeoniflorin, peony phenol, and peony flower glycoside. It tastes bitter and sour, and is slightly cold in nature; it enters the liver. White peony contains paeoniflorin, peony phenol paeoniflorin, as well as paeoniflorin, benzoic acid, etc. In addition, it also contains volatile oil, fatty oil, resin sugar, starch, mucus, protein and triterpenoid components. Another Sichuan-produced one contains an acidic substance that has an inhibitory effect on Staphylococcus aureus. The flower contains astragaloside, kaempferol 3,7-diglucoside, a large amount of gallic tannin (more than 10%), pyrethrin 0.13%, 13-methyltetradecanoic acid, β-sitosterol, pentacone, etc. The leaves contain tannin. It has the effects of nourishing blood and restraining yin, softening the liver and relieving pain, and calming liver yang. Indications: Liver blood deficiency, menstrual disorders, liver-spleen disharmony, chest and flank abdominal pain, cramps and pain in the limbs, hyperactivity of liver yang, headache and dizziness. Paeoniflorin has strong sedative, anticonvulsant and antipyretic effects. Total glucosides of white peony (TGP) has a dose-dependent analgesic effect. Paeoniflorin has an inhibitory effect on the gastrointestinal tract and uterine smooth muscle, and antagonizes the contraction caused by oxytocin. White peony decoction has an antibacterial effect on Shigella dysenteriae. It can also inhibit Staphylococcus aeruginosa, Pseudomonas aeruginosa, pyogenic cocci, digestive tract pathogens and conditional pathogens. The infusion also has an inhibitory effect on certain pathogenic fungi. Total glucosides of white peony (TGP) has an antiviral effect. White peony, total glucosides of white peony and benzoyl paeoniflorin have the effect of inhibiting platelet aggregation. In addition, white peony has the effects of lowering blood sugar, enhancing learning and memory function, antitussive, scavenging free radicals, anti-oxidation and anti-hypoxia.

[0045] 1. Sanguisorba officinalis

[0046] Other names: white burdock, water betel nut, mountain jujube ginseng, rat tail burdock, astringent burdock, red burdock, red burdock, is a hemostatic drug, which is the dried root of burdock or long-leaved burdock of the Rosaceae family. The latter is commonly known as "cotton burdock". The medicinal properties of burdock are bitter, sour, astringent, and slightly cold. It enters the liver and large intestine meridians. Burdock is bitter and purgative, sour and astringent, slightly cold and clear, and enters the liver, stomach, and large intestine meridians. It can relieve heat and toxicity, cool blood and stop bleeding, reduce swelling and relieve pain. It is suitable for people with blood heat and bleeding; because it sinks into the lower part of the body, it is good at treating various symptoms of blood heat in the lower part of the body, and is a good product for treating hemorrhoids, bloody stools, and metrorrhagia. It is good at detoxification and swelling, astringing sores and relieving pain in external use, and is an important medicine for treating burns caused by water and fire. The root of burdock contains burdock glycosides I, II, A, B, E, etc. and phenolic acid compounds, and also contains a small amount of vitamin A. The main component of hemostasis is tannin. Sanguisorba officinalis preparations have a significant effect on the healing of burns, scalds and wounds. They can reduce the permeability of capillaries, reduce exudation, and relieve tissue edema. The drug forms a protective film on the wound surface, which has a convergence effect, can reduce skin abrasions and prevent infection. Sanguisorba officinalis can inhibit formaldehyde-induced swelling of the foot and swelling of the mouse ear shell induced by croton oil mixture. It has a strong inhibitory effect on the enhancement of skin microvascular permeability caused by prostaglandin E, and can inhibit the proliferation of cotton ball granulomas, promote wound healing, and has anti-inflammatory and detumescent effects. Sanguisorba officinalis has an inhibitory effect on Staphylococcus aureus, beta-hemolytic streptococci, pneumococci, meningococci, diphtheria, dysentery, large intestine, typhoid fever, paratyphoid fever, Pseudomonas aeruginosa and human tuberculosis bacteria, and also has varying degrees of inhibitory effect on certain pathogenic fungi.

[0047] Citrus aurantium:

[0048] It is a medicine for promoting qi, and is the dried unripe fruit of the plant sour orange and its cultivated varieties of the Rutaceae family. Citrus aurantium is bitter, pungent, slightly cold, and enters the spleen, stomach, and large intestine meridians. Citrus aurantium is bitter, purgative, pungent, dispersing, slightly cold but not warm, and enters the spleen, stomach, and large intestine meridians. Indications: breaking qi, promoting phlegm, and eliminating accumulation. It is used to treat chest phlegm stagnation, chest distension, flank distension, food accumulation, belching, vomiting, heaviness after diarrhea, rectal prolapse, and uterine prolapse. The N-methyltyramine contained in Citrus aurantium increases coronary blood flow and renal blood flow, reduces myocardial oxygen consumption, and has a significant diuretic effect. Intravenous injection of 0.02-0.5mg / kg in anesthetized dogs all showed a pressor effect, and the dose was large and the pressor was obvious. Intravenous infusion of 0.2mg / kg per minute increased renal blood flow by 75% and doubled urine volume. It has a strong effect of inducing myocardial rhythm, which is equivalent to adrenaline, but stronger than dopamine and synephrine. Synephrine contained in Citrus aurantium is an adrenaline α-receptor stimulant, and also has a certain excitatory effect on cardiac β-receptors. It has the effect of constricting blood vessels and raising blood pressure. Its diuretic effect may be produced by inhibiting other effects such as renal tubular reabsorption. Other studies believe that Citrus aurantium exerts a sodium excretion and diuretic effect by strengthening the heart and constricting renal blood vessels, increasing filtration pressure. Citrus aurantium decoction has a significant excitatory effect on the isolated and in vivo uterus of rabbits, whether pregnant or not, and uterine fistula, which can make it contract strongly, increase tension and even produce tonic contraction. However, it has an inhibitory effect on the isolated uterus of mice, whether pregnant or not.

[0049] Terminalia chebula:

[0050] Alias: chebula, chebula, and fengzi. It is bitter, sour, astringent, and flat in nature and flavor. It belongs to the lung and large intestine meridians. Indications: astringent to the intestines and lungs, reducing fire and relieving sore throat. It is used for chronic diarrhea and dysentery, blood in the stool and prolapse of the anus, lung deficiency, wheezing and coughing, chronic cough, sore throat and hoarseness. The fruit contains 23.60-37.36% tannin, and its components are chebulic acid, chebulic acid, 1,3,6-trigalloyl glucose and 1,2,3,4,6-pentagalloyl glucose, tannin, original chebulic acid, glucose gallotannin, gallic acid and gallic acid. It also contains shikimic acid, dehydroshikimic acid, quinic acid, arabinose, fructose, glucose, sucrose, rhamnose and amino acids. It also contains sennoside A, chebula, tannase, polyphenol oxidase, peroxidase, ascorbic acid oxidase, etc. The bark contains β-sitosterol, tannin, gallic acid, gallic acid and pyrocatechol. The water decoction of Terminalia chebula (100%) is effective against various Shigella dysenteriae, and has a strong effect on Pseudomonas aeruginosa and Corynebacterium diphtheriae. It also has an effect on Staphylococcus aureus, Escherichia coli, Pneumococcus, hemolytic Streptococcus, Proteus and Salmonella typhimurium (paper strip method); the effective concentrations for Shigella dysenteriae, Staphylococcus aureus and Pseudomonas aeruginosa are 1:32, 1:128 and 1:64 respectively (test tube method). Terminalia chebula has a good effect against Salmonella typhi in vitro. The ethanol extract extracted with hydrochloric acid and ether has a higher antibacterial and antifungal effect. In addition, Terminalia chebula has certain antispasmodic, astringent and antioxidant effects.

[0051] Windproof:

[0052] Other names: Tongyun, Huiyun, Huicao, Baizhi, etc. It tastes spicy and sweet, is slightly warm in nature, and enters the bladder, lung, spleen, and liver meridians. It enters the Taiyang bladder, Jueyin liver, and Taiyin spleen meridians, and is mainly used for strong winds. It has the effects of dispelling wind and cold, overcoming dampness, relieving pain, and relieving spasms. It is often used clinically for rheumatic pain and external symptoms. Fangfeng contains volatile oils, mannitol, β-sitosterol, bitter glycosides, phenols, polysaccharides, and organic acids. Fangfeng has antipyretic, anti-inflammatory, sedative, analgesic, anticonvulsant, and anti-allergic effects. The fresh juice of Fangfeng has a certain antibacterial effect on Pseudomonas aeruginosa and Staphylococcus aureus. The decoction has different degrees of inhibitory effect on Shigella dysenteriae, hemolytic streptococci, etc., and has the effect of enhancing the phagocytic function of peritoneal macrophages in mice.

[0053] Chuanxiong:

[0054] Alias: Chuanxiong, small-leaf Chuanxiong, Shanjuqiong, Xiangguo, Hujing, Maxian Chuanxiong, Quenaoxiong, Jingxiong, Guanxiong, Fuxiong, Taixiong, Xixiong, Maxian. Spicy, warm. Enter the liver, gallbladder, and pericardium meridians. Indications: Promote blood circulation and qi, dispel wind and relieve pain, used to soothe nerves, correct headaches caused by wind, abdominal pain caused by masses, stabbing pain in the chest and ribs, swelling and pain caused by falls, headaches, and rheumatic pain. Promote qi and relieve depression, eliminate wind and dampness, promote blood circulation and relieve pain. Treat headaches caused by wind and cold, dizziness, rib pain and abdominal pain, cold arthralgia and muscle spasms, amenorrhea, dystocia, postpartum blood stasis and pain, carbuncle and ulcers. Used for irregular menstruation, amenorrhea and dysmenorrhea, abdominal pain caused by masses, stabbing pain in the chest and ribs, swelling and pain caused by falls, headaches, and rheumatic pain. Chuanxiong contains alkaloids (such as ligustrazine), volatile oils (mainly ligustilide, fennel, etc.), phenolic substances (such as ferulic acid), visfatin, vitamin A, folic acid, sucrose, sterols, fatty oils, etc. Ligustrazine can dilate coronary arteries, increase coronary blood flow, improve myocardial blood oxygen supply, and reduce myocardial oxygen consumption; ligustrazine can dilate cerebral blood vessels, reduce vascular resistance, significantly increase brain and limb blood flow, and improve microcirculation; it can reduce platelet surface activity, inhibit platelet aggregation, and prevent the formation of thrombus; the neutral component of ferulic acid contained in it promotes uterine smooth muscle in small doses and inhibits it in large doses; the decoction has a sedative effect on the central nervous system of animals and has a significant and lasting antihypertensive effect; it can accelerate the absorption of local hematoma of fractures and promote bone callus formation; it has an anti-vitamin E deficiency effect; it can inhibit a variety of bacilli; it has anti-histamine and choleretic effects.

[0055] Tangerine peel:

[0056] Alias: orange peel, noble old, yellow orange peel, red peel, is the dried mature peel of Citrus reticulata Blanco and its cultivated varieties. It tastes pungent and bitter, warm in nature; it enters the spleen and lung meridians. It has the effects of regulating qi and strengthening the spleen, drying dampness and resolving phlegm. It is mainly used to treat spleen and stomach qi stagnation, vomiting, hiccups, damp phlegm, cold phlegm cough, and chest pain. Tangerine peel contains nobiletin, hesperidin, neohesperidin, hesperidin, parahydroxyforin, flavonoid compounds, etc. The volatile oil content of tangerine peel is 1.5%-2.0%, and the volatile oil content of Guang tangerine peel is 1.2%-3.2%, and its components include α-thujacene, limonene, etc. Tangerine peel extract has the effects of scavenging oxygen free radicals and resisting lipid peroxidation; fresh tangerine peel decoction has the effect of dilating the trachea; the volatile oil has a stimulating and expectorant effect, and the main active ingredient is limonene; tangerine peel decoction has an inhibitory effect on the isolated uterus of mice, and high concentrations make it completely relaxed. Intravenous injection of the decoction can cause tonic contraction of the uterus in situ of anesthetized rabbits; it has the effects of promoting choleresis and lowering serum cholesterol.

[0057] Cimicifuga:

[0058] Alias: Longan root, cave tooth root, is the rhizome of Cimicifuga heracleifolia Kom, Cimicifuga dahurica (Turez.) maxim. or Cimicifuga foetida L. of the Ranunculaceae family. It has the effects of relieving the surface and clearing away rashes, clearing away heat and detoxifying, and raising Yang Qi. It tastes spicy and slightly sweet, and is slightly cold in nature; it enters the lungs. It is mainly used to treat external symptoms, measles that does not break out, toothache and mouth sores, sore throat, fever and rashes, qi deficiency and sinking, organ prolapse, and metrorrhagia. Cimicifuga has different degrees of inhibitory effects on skin fungi such as Trichophyton schrenckii, Trichophyton audouinii, Trichophyton ferrugineum, Epidermophyton rubrum, as well as Mycobacterium tuberculosis, Staphylococcus aureus, and Catarrhalis. It has an inhibitory effect on simian HIV virus SIV. Cimicifuga decoction has an excitatory effect on the normal isolated rabbit uterus, which is manifested as increased frequency and short-term increased tension. It has an excitatory effect on the bladder and non-pregnant uterus, and an inhibitory effect on the isolated intestine and pregnant uterus.

[0059] The present invention prepares a plant composition with vaginal tightening effect by rationally combining Chinese herbal medicines including ginseng, scutellaria, white peony root, sanguisorba officinalis, fructus aurantii, terminalia chebula, siler, rhizoma ligustici, tangerine peel and cimicifuga. Meanwhile, the plant composition is combined with microbial fermentation technology and 10 kinds of Chinese herbal medicines to achieve a synergistic effect on vaginal tightening effect and bring the following advantages:

[0060] (1) The microbial fermentation preparation process adopted in the present invention is a biotransformation carried out under relatively mild conditions such as room temperature and pressure, which can protect the active ingredients in Chinese herbal medicines from destruction to the greatest extent possible, especially heat-sensitive aromatic volatile oils, vitamins and other active ingredients, and can more effectively protect them. It can also solve the problem that the active ingredients of traditional Chinese herbal medicines are difficult to extract to the greatest extent possible in traditional processes such as decocting, boiling, simmering, refining, steaming and soaking.

[0061] (2) The microbial fermentation preparation process adopted in the present invention allows the effective active ingredients in Chinese herbal medicines that cannot be directly utilized after entering the human body to be degraded into small molecular active substances through microbial fermentation, thereby promoting the absorption of the active ingredients of Chinese herbal medicines in the human body, greatly improving the efficacy of Chinese medicines, and improving the therapeutic effect; during the fermentation process, the Chinese herbal medicines change the content of their active ingredients under the action of microorganisms, and make the composition of the fermentation product different from that of the raw material medicine, and break the cell wall of the Chinese herbal medicine to dissolve the effective substances, thereby increasing the concentration of the active ingredients, and also improving the water solubility of the active ingredients of the Chinese herbal medicines, further promoting the absorption of the active ingredients of the Chinese herbal medicines in the human body.

[0062] (3) According to the microbial fermentation preparation process adopted by the present invention, some Chinese herbal medicines may produce new active substances, new functions and efficacy after being fermented by probiotics.

[0063] (4) The microbial fermentation preparation process adopted by the present invention can promote the growth of some Chinese herbal medicines, further increase the content of active ingredients, and play a synergistic role in the efficacy of the medicine.

[0064] (5) In the microbial fermentation preparation process adopted by the present invention, the biotransformation and decomposition action of the microorganisms can also decompose the toxic substances in the Chinese herbal medicines, or perform structural modification on the toxic active ingredients of the Chinese herbal medicines, thereby reducing the toxic side effects of the Chinese herbal medicines.

[0065] The present invention is further described below in conjunction with examples, the purpose of which is to better understand the content of the present invention and reflect the essential characteristics of the present invention, so the examples cited should not be regarded as limiting the scope of protection of the present invention. It is also particularly pointed out here that the specific experimental methods and equipment involved in the examples are conventional methods or implemented under the conditions recommended by the manufacturer's instructions unless otherwise specified, and the reagents involved are commercially available unless otherwise specified.

[0066] Example 1

[0067] Take 10 parts of ginseng, 5 parts of scutellaria, 15 parts of white peony root, 15 parts of sanguisorba officinalis, 10 parts of fructus aurantii, 10 parts of terminalia chebula, 15 parts of siler, 15 parts of ligusticum, 15 parts of ligusticum, 10 parts of tangerine peel, 10 parts of cimicifuga, grind, pass through a 40-mesh sieve, weigh 30g of the mixed powder, add 10 times of water, and then add 2.0wt.% of inositol based on the total plant mass, stir and mix evenly. After mixing, sterilize at 121℃ for 15min. After cooling, inoculate 40mL of Bacillus subtilis seed solution (1×10 8 CFU / mL), fermented at 37°C and 200r / min for 72h, sterilized after the fermentation, filtered with a 0.22μm filter membrane, and the filtrate was the fermented plant composition.

[0068] Example 2

[0069] 15 parts of ginseng, 10 parts of scutellaria, 8 parts of white peony root, 12 parts of sanguisorba officinalis, 10 parts of fructus aurantii, 10 parts of terminalia chebula, 5 parts of siler, 10 parts of ligusticum, 8 parts of dried orange peel, 5 parts of cimicifuga, crushed, passed through a 40-mesh sieve, weighed 30g of mixed powder, added 10 times of water, and then added 2.0wt.% of inositol based on the total plant mass, stirred and mixed evenly. After mixing, sterilized at 121℃ for 15min, cooled, inoculated with 30mL of Bacillus subtilis seed solution (1×10 8 CFU / mL), fermented at 37°C and 200r / min for 96h, sterilized after the fermentation, filtered with a 0.22μm filter membrane, and the filtrate was the fermented plant composition.

[0070] Example 3

[0071] Take 15 parts of ginseng, 10 parts of scutellaria, 8 parts of white peony root, 5 parts of sanguisorba officinalis, 15 parts of fructus aurantii, 5 parts of terminalia chebula, 10 parts of siler, 10 parts of ligusticum, 8 parts of dried orange peel, 10 parts of cimicifuga, crush, pass through a 40-mesh sieve, weigh 30g of mixed powder, add 10 times of water, and then add 2.0wt.% of inositol based on the total plant mass, stir and mix evenly. After mixing, sterilize at 121℃ for 15min, cool, and inoculate 50mL of Bacillus subtilis seed solution (1×10 8 CFU / mL), fermented at 35°C and 200r / min for 48h, sterilized after the fermentation, filtered with a 0.22μm filter membrane, and the filtrate was the fermented plant composition.

[0072] Example 4

[0073] Take 10 parts of ginseng, 5 parts of scutellaria, 15 parts of white peony root, 15 parts of sanguisorba officinalis, 10 parts of fructus aurantii, 10 parts of terminalia chebula, 15 parts of siler, 15 parts of ligusticum, 15 parts of ligusticum, 10 parts of tangerine peel, 10 parts of cimicifuga, crush them, and pass through a 40-mesh sieve. Take 50g of the crushed Chinese herbal medicine in 500ml of 70% ethanol solution, heat and reflux for 3h, cool it slightly and filter it to obtain a crude extract; remove the ethanol by vacuum distillation, concentrate it to 100ml, sterilize it at 121℃ for 25min, and store it in a refrigerator at 4℃ for use. This is 1 / 2 of the 70% ethanol extraction liquid. Weigh 30g of ethanol extraction liquid, add 10 times of water, and then add 2.0wt.% of inositol based on the total plant mass, and stir to mix evenly. After mixing, sterilize at 121℃ for 15min. After cooling, inoculate 40mL of Bacillus subtilis seed liquid (1×10 8 CFU / mL), fermented at 37°C and 200r / min for 72h, sterilized after the fermentation, filtered with a 0.22μm filter membrane, and the filtrate was the fermented plant composition.

[0074] Comparative Example 1 (Chinese herbal medicine decoction group)

[0075] Take 10 parts of ginseng, 5 parts of scutellaria, 15 parts of white peony root, 15 parts of sanguisorba officinalis, 10 parts of fructus aurantii, 10 parts of terminalia chebula, 15 parts of siler, 15 parts of ligusticum, 15 parts of ligusticum, 10 parts of tangerine peel, 10 parts of cimicifuga, crush them, and pass through a 40-mesh sieve. Take 50g of the crushed Chinese herbal medicine in 500ml of distilled water, soak at room temperature for 30min, boil for 10min, cool slightly and filter to obtain a decoction; add 500ml of distilled water to the remaining medicinal residue and boil for 10min, repeat twice; combine the two decoctions, concentrate to 100ml by vacuum distillation, sterilize at 121℃ for 25min, and store in a refrigerator at 4℃ for standby use, which is 100% decoction.

[0076] Comparative Example 2 (group without inositol addition)

[0077] Take 10 parts of ginseng, 5 parts of scutellaria, 15 parts of white peony root, 15 parts of sanguisorba officinalis, 10 parts of fructus aurantii, 10 parts of terminalia chebula, 15 parts of siler, 15 parts of ligusticum, 15 parts of ligusticum, 10 parts of tangerine peel, 10 parts of cimicifuga, grind, pass through a 40-mesh sieve, weigh 30g of the mixed powder, add 10 times of water, and stir to mix evenly. After mixing, sterilize at 121℃ for 15min. After cooling, inoculate 40mL of Bacillus subtilis seed solution (1×10 8 CFU / mL), fermented at 37°C and 200r / min for 72h, sterilized after the fermentation, filtered with a 0.22μm filter membrane, and the filtrate was the fermented plant composition.

[0078] Efficacy test:

[0079] 1. Effect of Chinese medicine combination on the expression of zebrafish elastin gene protein:

[0080] Test method: This test uses zebrafish as a model organism, aiming to evaluate the effects of the Chinese medicine compositions of Examples 1-4 and Comparative Examples 1-2 on their elastin gene expression. Elastin is the main component of elastic fibers in skin tissue, which can provide structural support for the skin and protect the skin from aging and sagging. Elastin is composed of two types of short peptide segments arranged alternately. Eln1 and eln2 are responsible for encoding different peptide segments of elastin. The two genes are jointly responsible for regulating the expression level of elastin, making the skin firm and elastic. Zebrafish have elastin (eln1, eln2) genes similar to those of humans. Therefore, by detecting the relative expression of eln1 and / or eln2 genes, it can be shown whether the test sample has a firming effect.

[0081] Experimental steps: a blank control group, a positive drug group (0.8 g / L), and sample groups of Examples 1-4 and Comparative Examples 1-2 (detection concentration 0.1%) were set up respectively, with 3 biological replicates in each group, 10 fish in each replicate, and 5 mL of the working solution corresponding to each concentration group was added to each well; each test group was placed in a constant temperature incubator at 28.5±0.5°C for 24 hours and then sampled; total RNA of each group of zebrafish was extracted, reverse transcribed and amplified by fluorescence quantitative PCR, and the β-actin gene was used as the internal reference gene, using 2 -△△Ct Methods The relative expression of elastin gene in each group was calculated, and the gene expression promotion rate of the test group relative to the control group was calculated. The relative expression of elastin in each group of zebrafish is shown in Table 1.

[0082] Table 1

[0083]

[0084] As can be seen from Table 1, compared with the control group, the Chinese medicine composition samples of Examples 1-4 at a concentration of 0.1% promoted the expression of zebrafish elastin gene (Elastin 1) by more than 42%, with significant differences (p<0.05), indicating that the Chinese medicine composition of the present invention has the effect of vaginal tightening.

Claims

1. A Chinese medicine composition having a vaginal tightening effect, characterized in that: The invention comprises a fermentation product formed by fermenting 10 kinds of Chinese herbal medicine preparations and inositol through probiotics. The raw materials of the 10 kinds of Chinese herbal medicine preparations and their weight proportions are: 5-25 parts of ginseng, 1-15 parts of scutellaria baicalensis, 10-30 parts of white peony root, 5-25 parts of sanguisorba officinalis, 5-25 parts of fructus aurantii, 5-25 parts of terminalia chebula, 5-20 parts of siler, 5-20 parts of ligusticum chuanxiong, 5-25 parts of dried tangerine peel and 5-25 parts of cimicifuga.

2. The Chinese medicinal composition having vaginal tightening effect according to claim 1, characterized in that: The 10 Chinese herbal medicine preparations are powders of the raw materials, or water or organic solvent extracts of the raw materials; the probiotics are selected from one or more of lactic acid bacteria (Lactobacillus acidophilus, Lactobacillus bulgaricus, Streptococcus faecalis), Bacillus (Bacillus licheniformis, Bacillus subtilis, Bacillus cereus), and yeast fungi (Saccharomyces cerevisiae, petroleum yeast), preferably Bacillus subtilis.

3. The Chinese medicinal composition having vaginal tightening effect according to claim 1, characterized in that: The mass percentage content of the inositol is 1%-10% of the total mass of the 10 Chinese herbal medicine preparations.

4. A method for preparing the traditional Chinese medicine composition having vaginal tightening effect as claimed in any one of claims 1 to 3, characterized in that: The steps include: Weigh ginseng, scutellaria, white peony root, sanguisorba officinalis, fructus aurantii, terminalia chebula, siler, ligusticum chuanxiong, tangerine peel, and cimicifuga according to the formula ratio, grind, and pass through a 40-mesh sieve to obtain a mixed Chinese herbal medicine preparation; Weigh a certain amount of mixed Chinese herbal medicine preparation, add 5-10 times of water and inositol, soak and sterilize at 121°C; After cooling, inoculate the probiotic seed solution in a clean bench and ferment at 30℃-38℃ for 48-96h; After the fermentation is completed, sterilization and filtration are carried out, and the filtrate is the fermentation product.

5. The preparation method according to claim 4, characterized in that: The mixed Chinese herbal medicine preparation is the powder of each raw material medicine, or the water or organic solvent extract of each raw material medicine; the probiotics are selected from one or more of lactic acid bacteria (Lactobacillus acidophilus, Lactobacillus bulgaricus, Streptococcus faecalis), Bacillus (Bacillus licheniformis, Bacillus subtilis, Bacillus cereus), yeast fungi (Saccharomyces cerevisiae, petroleum yeast), preferably Bacillus subtilis.

6. The preparation method according to claim 4, characterized in that: The inoculated bacterial concentration of the probiotic seed solution is 10 6 -10 8 CFU / mL, and the solution volume of the probiotic seed solution is 20-50mL.

7. Use of the traditional Chinese medicine composition having vaginal tightening effect as claimed in any one of claims 1 to 3 and the traditional Chinese medicine composition prepared by the preparation method as claimed in any one of claims 4 to 6 in preparing products for preventing or treating vaginal relaxation.

8. An external preparation having a vaginal tightening effect, characterized in that: The invention comprises the traditional Chinese medicine composition having vaginal tightening effect as claimed in any one of claims 1 to 3 and the traditional Chinese medicine composition prepared by the preparation method as claimed in any one of claims 4 to 6.

9. The external preparation having vaginal tightening effect according to claim 8, characterized in that: The dosage form of the external preparation with vaginal tightening effect includes cream, gel, spray, douche or suppository, preferably cream or gel.

10. The external preparation having vaginal tightening effect according to claim 8, characterized in that: The external preparation with vaginal tightening effect also includes at least one of an excipient, a bactericide, a moisturizer, an anti-allergic agent, a chelating agent and a fragrance.

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