A traditional Chinese medicine composition for treating vaginal itching and a preparation method thereof

Abstract

The application discloses a traditional Chinese medicine composition for treating vaginitis and a preparation method thereof. The traditional Chinese medicine composition mainly comprises 12 Chinese herbal medicines, i.e. Sophora flavescens, Phellodendron chinense, Dictamnus dasycarpus, Herba Artemisiae Scopariae, Herba Taraxaci, Chrysanthemum indicum, Herba Portulacae, Cnidium monnieri, Angelica polymorpha, Herba Verbena, Herba Menthae and Saposhnikovia divaricata, and further comprises Salix viminalis, Eucalyptus, Ephedra sinica, anthocyanin quaternary ammonium salt, Ocimum basilicum, Houttuynia cordata, polysialic acid, polydopamine, antibacterial polypeptide modified chitosan hydrochloride and artemether. The traditional Chinese medicine composition is prepared by mixing traditional Chinese medicines and bactericidal and bacteriostatic biocompatible materials to prepare various medicaments. The traditional Chinese medicine composition is used for treating pruritus and leukorrhagia caused by endogenous insect poison and burning of yin fluid, and is used for treating bacterial vaginitis, mycotic vaginitis, trichomonal vaginitis and vulvitis. In clinical tests, the traditional Chinese medicine composition has remarkable treatment effect, and the cure rate is more than 95%.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine technology, specifically relating to a traditional Chinese medicine composition using Chinese herbal medicines as raw materials and having the function of treating vulvar pruritus, and its preparation method. Background Technology

[0002] Vulvar pruritus is a common gynecological condition that can occur at any age. It refers to itching of the vulva in women, sometimes severe and painful, causing restlessness, and may be accompanied by increased vaginal discharge. It is also known as vulvar pruritus. Ge Hong of the Jin Dynasty, in his *Elbow-Side Emergency Prescriptions*, stated, "For vulvar pruritus with discharge, chew raw soybeans and apply the liquid; this also treats urinary eczema," thus first introducing the term "vulvar pruritus," specifically referring to the symptom of vulvar itching, and included a treatment method. Later physicians followed this view. For example, Chao Yuanfang of the Sui Dynasty, in his *Treatise on the Causes and Symptoms of Various Diseases*, recorded "vulvar pruritus," referring to the symptom of "vulvar pruritus in women," and pointed out that this disease was caused by "insect infestation." Chen Ziming of the Song Dynasty, in his *Complete Collection of Effective Prescriptions for Women*, dedicated a chapter to "vulvar pruritus in women," treating it as an independent gynecological disease. In Western medicine, vulvar pruritus, vulvitis, vaginitis, and vulvar hypopigmentation disorders are associated with vulvar pruritus symptoms. The causes of vulvar pruritus are complex, including contact allergies, chemical irritation, and systemic chronic diseases. Vulvar pruritus has a serious impact on women's physical and mental health, causing not only local discomfort but also a series of complications, harming their physical health, and, more importantly, causing anxiety. Traditional Chinese medicine believes that vulvar pruritus is related to dysfunction of the liver, kidneys, and spleen. The liver meridian runs around the genitals, stores blood, and is associated with the element of wind and wood; the spleen governs the transformation and transportation of fluids. Xue Ji summarized that vulvar pruritus in women is related to the liver meridian, with symptoms such as liver and spleen stagnation, liver and spleen qi deficiency, and damp-heat accumulation. Treatment methods include modified versions of Longdan Xiegan Tang, Xiaoyao San, Guipi Tang, and Xiao Chaihu Tang, with external application of peach kernel paste and realgar for insecticidal purposes. The kidneys store essence and govern reproduction, opening to the two genitals (urethra and anus). The "Treatise on the Causes and Symptoms of Various Diseases - Miscellaneous Diseases of Women" states: "The kidneys nourish the genitals. When the kidney qi is deficient, it is susceptible to wind-evil. The evil invades the skin and muscles, while the body's vital energy is not released. The interaction between the evil and the body's vital energy causes itching on the skin." Modern medicine believes that irritating vaginal discharge is an important cause of vaginal itching.

[0003] Currently, the treatment of vulvar pruritus mainly focuses on antibacterial and anti-inflammatory methods, aiming to improve the vaginal microecological environment. However, long-term use of antibacterial and anti-inflammatory drugs can easily lead to drug dependence and has a high incidence of adverse reactions. Clinically, the pathogenesis of vulvar pruritus is often complex, involving both deficiency and excess, particularly liver and kidney yin deficiency, damp-heat accumulation, and the proliferation of dampness and parasites. Treatment targeting a single pathogenesis has limited effectiveness. Therefore, finding a treatment method or drug with good therapeutic effect and low toxicity has become a research focus in this field. Traditional Chinese medicine (TCM) has significant advantages through internal and external treatments. Chinese herbs and their compound preparations have the characteristics of multi-pathway and multi-target action. Based on the TCM diagnostic and treatment methods, this invention is based on the principle of combining disease differentiation and syndrome differentiation in the treatment of vulvar pruritus. It takes a holistic approach, following the principle of "treating the external by addressing the internal," combining systemic and local treatment to achieve the goal of treating the root cause. Summary of the Invention

[0004] The technical problem to be solved by the present invention is to overcome the above-mentioned shortcomings and provide a traditional Chinese medicine composition for treating vulvar pruritus with significant efficacy, low cost and few side effects, and its preparation method.

[0005] The technical problem to be solved by this invention is achieved by the following technical solution:

[0006] Through continuous practice, we have gradually developed a core prescription for treating vulvar pruritus, which includes 12 kinds of Chinese herbal medicines: Sophora flavescens, Phellodendron chinense, Dictamnus dasycarpus, Polygonum cuspidatum, Taraxacum mongolicum, Chrysanthemum indicum, Portulaca oleracea, Cnidium monnieri, Angelica dahurica, Verbena officinalis, Mentha haplocalyx, and Saposhnikovia divaricata.

[0007] The core prescription of the traditional Chinese medicine composition for treating vulvar pruritus of this invention includes 20-30 parts of Sophora flavescens, 20-30 parts of Phellodendron chinense, 20-30 parts of Dictamnus dasycarpus, 20-30 parts of Polygonum cuspidatum, 20-30 parts of Taraxacum mongolicum, 20-30 parts of Chrysanthemum indicum, 20-30 parts of Portulaca oleracea, 20-30 parts of Cnidium monnieri, 30-40 parts of Angelica dahurica, 20-30 parts of Verbena officinalis, 10-20 parts of Mentha haplocalyx, and 6-15 parts of Saposhnikovia divaricata.

[0008] The core prescription of the traditional Chinese medicine composition for treating vulvar pruritus of this invention is as follows: 24 parts of Sophora flavescens, 24 parts of Phellodendron chinense, 24 parts of Dictamnus dasycarpus, 24 parts of Polygonum cuspidatum, 24 parts of Taraxacum mongolicum, 24 parts of Chrysanthemum indicum, 24 parts of Portulaca oleracea, 24 parts of Cnidium monnieri, 32 parts of Angelica dahurica, 24 parts of Verbena officinalis, 16 parts of Mentha haplocalyx, and 8 parts of Saposhnikovia divaricata.

[0009] The traditional Chinese medicine composition for treating vulvar pruritus of the present invention also includes 3-8 parts of willow, 2-5 parts of eucalyptus leaves, 2-6 parts of ephedra, 1-4 parts of anthocyanin quaternary ammonium salt, 2-4 parts of basil leaves, 2-7 parts of houttuynia cordata, 5-18 parts of polysialic acid, 10-30 parts of polydopamine, 2-5 parts of antibacterial polypeptide modified chitosan hydrochloride, and 1-1.5 parts of artesunate hydrochloride.

[0010] A method for preparing a traditional Chinese medicine composition for treating vulvar pruritus as described above includes the following steps:

[0011] (1) Weigh out the following ingredients according to the formula: Sophora flavescens, Phellodendron chinense, Dictamnus dasycarpus, Polygonum cuspidatum, Taraxacum mongolicum, Chrysanthemum indicum, Portulaca oleracea, Cnidium monnieri, Angelica dahurica, Verbena officinalis, Mentha haplocalyx, and Saposhnikovia divaricata. Soak in 5-10 times the amount of water for 0.5-1.5 hours and decoct twice. The first decoction is for 0.5-3.0 hours, and the second decoction is for 0.5-2.0 hours with 3-8 times the amount of water to obtain decoction A.

[0012] (2) Weigh out the following ingredients according to the formula: willow, eucalyptus leaves, ephedra, basil leaves, and houttuynia cordata. Soak in 3-7 times the amount of water for 0.5-1.5 hours and decoct twice. The first decoction is for 0.5-1.5 hours, and the second decoction is for 0.5-1.0 hours with 2-4 times the amount of water. After cooling to room temperature, add anthocyanin quaternary ammonium salt, polysialic acid, and polydopamine and stir well to obtain decoction B.

[0013] (3). Combine decoction A and decoction B, filter to obtain filtrate, rinse the filter residue with 1-2 times the amount of water of the filtrate and then filter, mix the filtrate and the washing liquid, and concentrate the mixture under low temperature and reduced pressure to 1 / 5-1 / 2 of the original filtrate volume;

[0014] (4) Add 0.3-0.8% sodium benzoate to the concentrate and stir until homogeneous. Then mix the antibacterial peptide modified chitosan hydrochloride and artesunate hydrochloride and add them to the concentrate. Stir until homogeneous again and filter. The filtrate can then be bottled.

[0015] Another object of the present invention is to provide a preparation containing the traditional Chinese medicine composition described in the present invention, wherein the preparation is a topical preparation - a lotion.

[0016] Another object of the present invention is the use of the traditional Chinese medicine composition described herein in the preparation of a medicine for treating vulvar pruritus.

[0017] Another object of the present invention is the use of the traditional Chinese medicine composition described herein in the preparation of a drug for treating vaginitis.

[0018] The present invention provides a traditional Chinese medicine composition for treating vulvar itching, which is mainly used to treat vulvar itching caused by the internal accumulation of insect venom and burning of vulvar fluid.

[0019] The pharmacological effects and efficacy of the traditional Chinese medicines in the raw materials of this invention are as follows:

[0020] Sophora flavescens is bitter and cold in nature. It enters the heart, liver, stomach, large intestine, and bladder meridians. Its functions include clearing heat and drying dampness, killing parasites, and promoting diuresis. Modern pharmacological studies have shown that this herb mainly possesses antimicrobial, antipyretic, anti-inflammatory, anti-allergic, antitumor, and antiarrhythmic effects.

[0021] Xianghuangbai (Huangbai), a traditional Chinese medicine from Hunan Province, is bitter and cold in nature. It enters the kidney and bladder meridians. Its functions include clearing heat and drying dampness, purging fire and eliminating steaming heat, and detoxifying and healing sores. Modern pharmacological studies have shown that this herb has antimicrobial, anti-inflammatory, immunosuppressive, antihypertensive, antioxidant, anti-gout, and energy metabolism-improving effects.

[0022] Dictamnus dasycarpus root bark is bitter and cold in nature. It enters the spleen, stomach, and bladder meridians. Its functions include clearing heat and drying dampness, dispelling wind and detoxifying. Modern pharmacological studies have shown that this herb possesses antimicrobial, anti-endotoxin, anti-inflammatory, immunosuppressive, and hepatoprotective effects.

[0023] Polygonum cuspidatum: Slightly bitter, slightly cold. It enters the liver, gallbladder, and lung meridians. Its functions include promoting diuresis and relieving jaundice, clearing heat and detoxifying, dispersing blood stasis and relieving pain, and stopping cough and resolving phlegm. Modern pharmacological studies have shown that this herb has a wide range of pharmacological effects, including stabilizing blood pressure and anti-shock, anti-myocardial ischemia and arteriosclerosis, anti-thrombosis, improving cerebral ischemia and protecting against brain damage, anti-lung injury and fibrosis, lowering lipids, promoting bile secretion, protecting the liver, anti-inflammation, antioxidant effects, antibacterial, antiviral, and antitumor effects.

[0024] Dandelion is bitter, sweet, and cold in nature. It enters the liver and stomach meridians. Its functions include clearing heat and detoxifying, reducing swelling and dissipating nodules, and promoting urination. Modern pharmacological studies have shown that this herb has antimicrobial, anti-inflammatory, and anti-ulcer effects.

[0025] Wild chrysanthemum is bitter, pungent, and slightly cold in nature. It enters the liver and heart meridians. Its functions include clearing heat and detoxifying, purging fire and calming the liver. Modern pharmacological research shows that this product has antimicrobial, anti-inflammatory, and hepatoprotective effects.

[0026] Purslane is sour and cold in nature. It enters the liver and large intestine meridians. Its functions include clearing heat and detoxifying, cooling the blood and stopping bleeding, and stopping dysentery. Modern pharmacological studies have shown that this product has antimicrobial, anti-inflammatory, hypoglycemic, and hypolipidemic effects.

[0027] Cnidium monnieri is pungent, bitter, and warm in nature; it is slightly toxic. It enters the kidney meridian. Its functions include drying dampness and dispelling wind, killing parasites and relieving itching, and warming the kidneys and strengthening yang. Modern pharmacological studies have shown that this product has antimicrobial, antipruritic, anti-allergic, anti-inflammatory, analgesic, and anti-tumor effects.

[0028] Xiang Baizhi (Radix Angelicae Sinensis), a traditional Chinese medicine from Hunan Province, is pungent and warm in nature. It enters the stomach, large intestine, and lung meridians. Its functions include relieving exterior syndromes and dispelling cold, dispelling wind and relieving pain, clearing nasal passages, drying dampness and stopping leukorrhea, and reducing swelling and draining pus. Modern pharmacological studies have shown that this herb has antipyretic, analgesic, anti-inflammatory, pathogenic microbial inhibitory, antioxidant, and antitumor effects.

[0029] Verbena officinalis is bitter and cool in nature. It enters the liver and spleen meridians. Its functions include promoting blood circulation and removing blood stasis, detoxifying, promoting diuresis, relieving jaundice, and treating malaria. Modern pharmacological studies have shown that this herb has anti-early pregnancy, anti-tumor, anti-inflammatory, and analgesic effects.

[0030] Peppermint is pungent and cool in nature. It enters the lung and liver meridians. Its functions include dispersing wind-heat, clearing the head and eyes, relieving sore throat, promoting rash eruption, and soothing the liver and regulating qi. Modern pharmacological studies have shown that this product has diaphoretic, antipyretic, analgesic, sedative, antipathogenic, antispasmodic, choleretic, and litholytic effects.

[0031] Saposhnikovia divaricata (Fang Feng) is pungent, sweet, and slightly warm in nature. It enters the bladder, liver, and spleen meridians. Its functions include dispelling wind and releasing the exterior, eliminating dampness and relieving pain, and stopping spasms. Modern pharmacological studies have shown that this herb has antipyretic, analgesic, anti-inflammatory, anti-allergic, antitumor, antioxidant, immunomodulatory, and anticoagulant effects.

[0032] Willow bark, bitter and cold in nature. It enters the liver, gallbladder, and bladder meridians, clearing heat, promoting bile secretion, diuresis, and detoxification. Modern pharmacological studies have shown that this herb is effective in treating acute and chronic hepatitis, cholecystitis, gallstones, bladder stones, gonorrhea, syphilis, hemorrhoids, traumatic injuries, burns, and other diseases.

[0033] Eucalyptus leaves are pungent, bitter, and cold in nature. They enter the lung, stomach, spleen, and liver meridians. Modern pharmacological studies have shown that this herb has the effects of dispelling wind and releasing the exterior, clearing heat and detoxifying, resolving phlegm and regulating qi, and killing parasites and relieving itching. It is mainly used to treat colds, high fever with cough and wheezing, whooping cough, abdominal distension and pain, diarrhea, dysentery, hookworm and filariasis, malaria, rheumatic pain, eczema, scabies, burns, and external bleeding.

[0034] Ephedra, pungent, slightly bitter, and warm in nature. It enters the Lung and Bladder meridians. Modern pharmacological studies show that it has diaphoretic, antiasthmatic, and diuretic effects. It is mainly used to treat typhoid fever with exterior excess, fever and chills without sweating, headache, nasal congestion, and joint pain; cough and asthma; edema due to wind-dampness, difficulty urinating; stubborn wind-evil numbness, skin numbness, and itchy rashes.

[0035] Basil leaves are pungent and sweet in taste, and warm in nature. They enter the lung, spleen, stomach, and large intestine meridians. Modern pharmacological studies have shown that this herb has the effects of dispelling wind and releasing the exterior, resolving dampness and harmonizing the middle jiao, promoting qi and blood circulation, and detoxifying and reducing swelling. It is commonly used for colds with headaches, fever and cough, heatstroke, indigestion, loss of appetite, abdominal distension and pain, vomiting and diarrhea, rheumatic pain, seminal emission, irregular menstruation, toothache and halitosis, pterygium covering the eyes, eczema, itchy rashes, traumatic injuries, and snake and insect bites.

[0036] Houttuynia cordata, pungent and cold in nature. It enters the liver and lung meridians. Modern pharmacological studies show that it has the effects of clearing heat and detoxifying, promoting diuresis and reducing swelling. It is mainly used to treat pneumonia, lung abscess, dysentery, malaria, edema, gonorrhea, leukorrhea, carbuncles, hemorrhoids, rectal prolapse, eczema, tinea capitis, and scabies.

[0037] Anthocyanin quaternary ammonium salts contain anthocyanins, a powerful antioxidant that protects the body from damage caused by harmful substances called free radicals. Anthocyanin quaternary ammonium salts also enhance blood vessel elasticity, improve the circulatory system, and increase skin smoothness. They inhibit inflammation and allergies, improve joint flexibility, and have anti-aging, joint protection, anti-inflammatory, and allergy-preventing effects. Through quaternary ammonium salt derivatization, they also exhibit significant antibacterial and bacteriostatic effects.

[0038] Polysialic acid is a more promising protein drug modification material than polyethylene glycol. In addition to having better biocompatibility, biodegradability and high hydrophilicity, it also has the function of resisting recognition by the human immune system, and has the functions of preventing pathogen invasion, promoting digestion, promoting nervous system development and promoting wound healing.

[0039] Polydopamine is a highly stable substance obtained by polymerizing dopamine, and it has multiple properties such as antioxidant properties, photothermal conversion properties, adhesion, biocompatibility, and biodegradability.

[0040] Antimicrobial peptide-modified chitosan hydrochloride, with chitosan as the matrix of natural polysaccharide chitin after partial removal of acetyl groups, has multiple physiological functions such as biodegradability, biocompatibility, non-toxicity, antibacterial, anticancer, lipid-lowering, and immune enhancement. After modification with antimicrobial peptides, its antibacterial effect is significantly improved, and its water solubility is significantly improved after hydrochlorination.

[0041] Artesunate hydrochloride has artemisinin as its antibacterial matrix. To improve the water solubility of artemisinin, scientists replaced the hydroxyl group at the 10-carbon position of dihydroartemisinin with an ester group, obtaining artemisinin ester derivatives. Among these ester derivatives, the sodium salt of artesunate is the earliest water-soluble artemisinin derivative. Artesunate hydrochloride possesses a variety of pharmacological effects, including antitumor activity, treatment of pulmonary hypertension, antidiabetic activity, embryotoxicity, antifungal activity, immunomodulatory activity, antiviral activity, anti-inflammatory activity, anti-pulmonary fibrosis activity, antibacterial activity, and cardiovascular effects.

[0042] The term "vaginal itching" originates from Volume 5 of *Elbow-Side Emergency Prescriptions*. Also known as vulvar pruritus or vulvar pruritus, this condition refers to itching of the vulva and genital area in children and women. The itching can even affect the anus, causing intense itching and pain around the anus, leading to a strong urge to scratch. In severe cases, it can cause restlessness and significantly impact daily life. The primary causes are dysfunction of the liver, kidneys, and spleen. The liver meridian passes around the genitals, and the liver itself is a blood-storing organ, making the liver meridian susceptible to invasion by pathogenic factors such as wind, fire, dampness, and heat. The kidneys store essence, and the spleen is responsible for the transformation and transportation of fluids throughout the body. When the liver meridian is invaded by pathogenic factors of dampness and heat, or when liver stagnation and spleen deficiency lead to the generation of fire and dampness in the body, the damp-heat pathogen, being heavy and prone to descending, accumulates in the vulva. Alternatively, infection with parasites can also cause vulvar itching. Furthermore, deficiency of essence and blood in the liver and kidneys, and depletion of vital energy, easily leads to wind-related ailments. Traditional Chinese medicine theory states that when the body is diseased, pain arises from obstruction and lack of nourishment; deficiency of essence and blood results in itching of the vulva due to lack of nourishment. Clinically, this disease is most commonly caused by two factors: damp-heat in the liver and spleen, and yin deficiency in the liver and kidneys. The main mechanisms can be discussed from two aspects: deficiency and excess. Deficiency of essence and blood in the liver and kidneys, and depletion of vital energy, easily leads to wind-related ailments, causing itching of the vulva, which is a deficiency syndrome. Excess syndrome arises from invasion of the liver meridian by damp-heat pathogens, or from liver stagnation and spleen deficiency leading to internal heat and dampness. This damp-heat pathogen descends along the meridian, accumulating in the vulva; infection of the vulva by damp parasites causes itching. The primary cause of this disease is the accumulation of damp-heat toxins in the vulva. Unhygienic living habits can also lead to this condition. Damp-heat toxins reside in the liver meridian and accumulate in the vulva, causing poor local blood and qi circulation. "When blood and qi circulation is obstructed, it transforms into heat and fire over time. This heat scorches the yin essence, leading to sores in the vulva. Excessive heat causes flesh to rot, and over time, this rot leads to suppuration. Therefore, local redness and swelling, heat, pain, and even ulceration and pus discharge are observed. If damp-heat toxins accumulate in the vulva for a long time, the vulva, being a damp and congested area, is easily infected by parasites. These parasites can invade the vulva, leading to ulceration. Cold congeals phlegm and blood stasis. Even in cases of underlying yang deficiency or liver and kidney insufficiency, cold-damp toxins can invade the vulva, and "weak individuals are more prone to developing this condition." If the body's vital energy is insufficient or the disease is prolonged and the body is weak with lingering pathogens, the damp toxins cannot be expelled from the body, leading to further ulceration of the swelling, even with profuse pus discharge, and prolonged illness, or even death. The ulcers in the vulva fail to heal for a long time. Poor vulvar hygiene, or prolonged exposure to damp environments, can lead to the breeding of parasites that erode the vulva, causing itching. The formula contains bitter and cold herbs, including *Sophora flavescens* and *Phellodendron chinense*, both from Hunan Province. *Phellodendron chinense* is a traditional Chinese medicine from Hunan Province, known for its ability to clear damp-heat in the lower burner and purge kidney deficiency fire. The combination of these two herbs clears heat, dries dampness, kills parasites, and relieves itching, targeting the main pathogenesis, and is therefore used as the principal herb. *Dictamnus dasycarpus* is also bitter and cold, clearing heat, drying dampness, dispelling wind, and relieving itching; it works synergistically with the principal herb, *Sophora flavescens*. The effects of drying dampness and relieving itching are enhanced; Polygonum cuspidatum is bitter and cold, drains damp heat, and clears the water passages, making it an excellent medicine for clearing damp heat; Taraxacum mongolicum and Chrysanthemum indicum are bitter and cold, and when used together, their effects of clearing heat and detoxifying are enhanced; Purslane is cold in nature, clears heat and detoxifies, and clears damp heat; Cnidium monnieri is pungent, bitter, and drying, dries dampness, dispels wind, kills parasites, and relieves itching, making it a commonly used medicine for gynecological conditions such as vulvar itching. The above six medicines clear heat and resolve dampness, dispel wind and detoxify, kill parasites, and relieve itching, thus assisting the effects of the principal medicine and are used as assistant medicines.Angelica dahurica, a native medicinal herb of Hunan Province, is used to dry dampness, stop leukorrhea, dispel wind, and relieve itching. When used with heat-clearing and dampness-drying herbs, it can enhance the effect of removing dampness and stopping leukorrhea. Verbena officinalis is bitter and cool in nature, enters the blood, invigorates blood circulation and unblocks menstruation to prevent damp-heat from causing blood stasis over time. It is also good at clearing heat and detoxifying, thus assisting the effects of the principal and assistant herbs. Mentha haplocalyx and Saposhnikovia divaricata dispel wind and relieve itching. The above four herbs clear heat and remove dampness, dispel wind and relieve itching, invigorate blood circulation and remove blood stasis, and are used as adjuvant herbs. Salix babylonica, Eucalyptus leaves, Ephedra sinica, Basil leaves, and Houttuynia cordata are also bitter and cold in nature, and have anti-inflammatory, antibacterial, heat-clearing and detoxifying effects. Anthocyanin quaternary ammonium salt, polysialic acid, polydopamine, antibacterial polypeptide modified chitosan hydrochloride, and artesunate hydrochloride are used as adjuvant herbs in traditional Chinese medicine. They have functions such as anti-oxidation, antibacterial and bacteriostatic properties, promoting wound healing, good biocompatibility and biodegradability.

[0043] Overall, the formula primarily uses bitter and cold herbs, employing both drying and dampness-removing properties. The combined effects of these herbs clear heat and detoxify, eliminate dampness, kill parasites, and relieve itching. It is used for vulvar itching caused by internal parasite toxins burning the vaginal fluids, with symptoms including vulvar itching, profuse yellow and thick vaginal discharge; also for bacterial, fungal, and trichomonal vaginitis, and vulvitis with the above symptoms.

[0044] Compared with the prior art, the beneficial effects of the present invention are as follows:

[0045] 1) This invention is based on the theory and clinical experience of traditional Chinese medicine. It selects raw materials and their proportions, and the combination conforms to the theory of "principal, assistant, adjuvant and guide". The combination is appropriate and it hits the pathogenesis of vulvar itching caused by the internal accumulation of insect toxins and the burning of yin fluid. Symptoms include vulvar itching, excessive vaginal discharge, yellow and thick.

[0046] 2) This invention is mainly for the prescription of medicine for vulvar pruritus caused by the internal accumulation of insect venom and burning of vaginal fluid, which is common in modern clinical practice. It conforms to the basic theory of traditional Chinese medicine, the combination is appropriate, and the clinical application of the prescription for many years has shown that the prescription is effective, safe and has no toxic side effects.

[0047] 3) This invention adds biocompatible and biodegradable polysialic acid, polydopamine and antibacterial peptide modified chitosan hydrochloride to the traditional Chinese medicine ingredients, which can promote wound healing and effectively kill and inhibit bacteria, significantly improving its efficacy. It is non-toxic, harmless and has no side effects, and has high safety.

[0048] 4) Patients cured using the traditional Chinese medicine composition provided by this invention have not experienced any recurrence of their condition after recovery. Detailed Implementation

[0049] To enable those skilled in the art to better understand the technical solution of the present invention, the present invention will be further described below with reference to specific embodiments, but the embodiments are not intended to limit the present invention.

[0050] All the Chinese herbal raw materials used in this invention can be purchased from Chinese medicine stores. Other ingredients can be obtained as pharmaceutical-grade products from relevant suppliers such as national chemical reagents or food additives, and their specifications meet national pharmaceutical standards.

[0051] The present invention will be further described below with reference to specific embodiments:

[0052] Example 1

[0053] This product is used in a wash for treating vulvar pruritus. A traditional Chinese medicine composition for treating vulvar pruritus includes Sophora flavescens, Phellodendron chinense, Dictamnus dasycarpus, Polygonum cuspidatum, Taraxacum mongolicum, Chrysanthemum indicum, Portulaca oleracea, Cnidium monnieri, Angelica dahurica, Verbena officinalis, Mentha haplocalyx, and Saposhnikovia divaricata. The components and their proportions by weight are as follows: Sophora flavescens 20-30 parts, Phellodendron chinense 20-30 parts, Dictamnus dasycarpus 20-30 parts, Polygonum cuspidatum 20-30 parts, Taraxacum mongolicum 20-30 parts, Chrysanthemum indicum 20-30 parts, Portulaca oleracea 20-30 parts, Cnidium monnieri 20-30 parts, Angelica dahurica 30-40 parts, Verbena officinalis 20-30 parts, Mentha haplocalyx 10-20 parts, and Saposhnikovia divaricata 6-15 parts.

[0054] The preferred formulation consists of the following components in parts by weight:

[0055] Sophora flavescens 24 parts, Phellodendron chinense 24 parts, Dictamnus dasycarpus 24 parts, Polygonum cuspidatum 24 parts, Taraxacum mongolicum 24 parts, Chrysanthemum indicum 24 parts, Portulaca oleracea 24 parts, Cnidium monnieri 24 parts, Angelica dahurica 32 parts, Verbena officinalis 24 parts, Mentha haplocalyx 16 parts, Saposhnikovia divaricata 8 parts.

[0056] Preparation method examples

[0057] This is a wash for treating vulvar itching. The wash is prepared according to the following proportions by weight: 24 parts of Sophora flavescens, 24 parts of Phellodendron chinense, 24 parts of Dictamnus dasycarpus, 24 parts of Polygonum cuspidatum, 24 parts of Taraxacum mongolicum, 24 parts of Chrysanthemum indicum, 24 parts of Portulaca oleracea, 24 parts of Cnidium monnieri, 32 parts of Angelica dahurica, 24 parts of Verbena officinalis, 16 parts of Mentha haplocalyx, and 8 parts of Saposhnikovia divaricata. Soak these ingredients in 8 times the amount of water for 0.5 hours, then decoct twice. The first decoction is for 1.5 hours, and the second decoction is for 1 hour with 6 times the amount of water. Combine the decoctions, filter, and concentrate the filtrate under reduced pressure at 55℃. The concentration relative density should be ≥1.05. Add 0.3% sodium benzoate, stir well, fill, and bottle.

[0058] Example 2

[0059] A traditional Chinese medicine composition for treating vulvar pruritus includes: Sophora flavescens, Phellodendron chinense, Dictamnus dasycarpus, Polygonum cuspidatum, Taraxacum mongolicum, Chrysanthemum indicum, Portulaca oleracea, Cnidium monnieri, Angelica dahurica, Verbena officinalis, Mentha haplocalyx, and Saposhnikovia divaricata. The components and their proportions by weight are as follows: Sophora flavescens 24 parts, Phellodendron chinense 24 parts, Dictamnus dasycarpus 24 parts, Polygonum cuspidatum 24 parts, Taraxacum mongolicum 24 parts, Chrysanthemum indicum 24 parts, Portulaca oleracea 24 parts, Cnidium monnieri 24 parts, Angelica dahurica 32 parts, Verbena officinalis 24 parts, Mentha haplocalyx 16 parts, Saposhnikovia divaricata 8 parts, Salix babylonica 4 parts, Eucalyptus globulus 3 parts, Ephedra sinica 4 parts, anthocyanin quaternary ammonium salt 2 parts, Basil leaf 3 parts, Houttuynia cordata 5 parts, polysialic acid 12 parts, polydopamine 25 parts, antibacterial polypeptide modified chitosan hydrochloride 4 parts, and artesunate hydrochloride 1 part.

[0060] A method for preparing a traditional Chinese medicine composition for treating vulvar pruritus, comprising the following steps:

[0061] (1). Weigh out the following ingredients according to the formula: Sophora flavescens, Phellodendron chinense, Dictamnus dasycarpus, Polygonum cuspidatum, Taraxacum mongolicum, Chrysanthemum indicum, Portulaca oleracea, Cnidium monnieri, Angelica dahurica, Verbena officinalis, Mentha haplocalyx, and Saposhnikovia divaricata. Soak in 8 times the amount of water for 0.5 hours and decoct twice. The first decoction is for 1.5 hours, and the second decoction is for 1.0 hour with 6 times the amount of water to obtain decoction A.

[0062] (2). Weigh out the following ingredients according to the formula: willow, eucalyptus leaves, ephedra, basil leaves, and houttuynia cordata. Soak them in 6 times the amount of water for 0.5 hours and decoct them twice. The first decoction is for 1.5 hours, and the second decoction is for 1.0 hour with 4 times the amount of water. After cooling to room temperature, add anthocyanin quaternary ammonium salt, polysialic acid, and polydopamine and stir evenly to obtain decoction B.

[0063] (3). Combine decoction A and decoction B, filter to obtain filtrate, rinse the filter residue with 1-2 times the amount of water of the filtrate and then filter, mix the filtrate and the washing liquid, and concentrate the mixture under low temperature and reduced pressure to 1 / 2 of the original filtrate volume;

[0064] (4) Add 0.8% sodium benzoate to the concentrate and stir until homogeneous. Then mix the antibacterial peptide-modified chitosan hydrochloride and artesunate hydrochloride and add them to the concentrate. Stir until homogeneous again and filter. The filtrate can then be bottled.

[0065] The beneficial effects of this invention are as follows: It primarily targets vulvar pruritus caused by internal insect venom and burns to vaginal fluids, a common clinical condition in modern medicine. The prescription conforms to basic Traditional Chinese Medicine theory, is well-matched, and years of clinical application have shown its efficacy, good safety, and the absence of any toxic side effects. The product is prepared as a wash from prepared Chinese herbal medicine slices, making it convenient to store and use, fast-acting, and easy to carry, thus improving patient compliance and achieving a cure rate of over 94%. Pharmaceutical research results indicate that the preparation process is feasible, the quality is controllable, and the product is stable. Furthermore, a search of marketed products revealed no identical prescriptions, indicating that this product has good market competitiveness.

[0066] The present invention will be further described below with reference to specific embodiment 1:

[0067] Clinical trials

[0068] 1. Clinical Data

[0069] 1.1 From December 2022 to December 2023, female patients with vaginal itching (due to internal insect venom and burning of vaginal fluid) admitted to the gynecology outpatient clinic who were sexually active were randomly divided into an observation group and a control group, with 50 cases in each group. The age of the observation group was 23-58 years, with a mean age of (36.5±7.5) years. The age of the control group was 23-58 years, with a mean age of (35.9±6.4) years. There were no statistically significant differences in general characteristics between the two groups (P>0.05), making them comparable. In addition, female patients with vaginal itching (damp-heat type) who were sexually active were also admitted and randomly divided into an observation group and a control group, with 50 cases in each group. The age of the observation group was 23-50 years, with a mean age of (30.5±4.5) years. The age of the control group was 23-50 years, with a mean age of (29.5±5.4) years. All patients underwent rigorous examination and diagnosis, had no contraindications to this medication, and met the relevant diagnostic criteria: Results ① The patients experienced a large amount of abnormal vaginal discharge, along with pain and burning sensations, vulvar itching symptoms resembling insect bites, or even unbearable itching, whitening, thickening, or atrophy of the vulvar skin, and even cracking and ulceration, and experienced dyspareunia during normal intercourse; ② The abnormal vaginal discharge was yellowish-green in color, viscous and foul-smelling, foamy or cottage cheese-like, and accompanied by an unpleasant fishy odor.

[0070] 1.2 Diagnostic criteria

[0071] All patients underwent rigorous examination and diagnosis, had no contraindications to this medication, and met the relevant diagnostic criteria. ① Medical history: Poor hygiene habits, excessive vaginal discharge, long-term irritation of the vulva, or a history of vulvitis or vaginitis; ② Clinical manifestations: Intermittent vulvar itching, sometimes unbearable, causing restlessness, and may also affect the perianal area or inner thighs; ③ Gynecological examination: Rough vulvar skin with scratch marks, hypopigmentation, and even fissures, with yellow discharge; ④ Laboratory tests: Normal vaginal discharge microscopy or positive results for Candida, Trichomonas, bacterial vaginosis, etc.

[0072] 1.3 Inclusion Criteria

[0073] ① Women aged 18 to 50 years; ② Complaint of increased discharge, odor, or accompanied by vulvar itching or burning; ③ Meet the diagnostic criteria for vulvitis or vaginitis based on clinical and laboratory examinations; ④ Have no serious systemic or chronic diseases; ⑤ Understand the purpose of this study and sign an informed consent form.

[0074] 1.4 Exclusion Criteria

[0075] ① Women who are pregnant or breastfeeding; ② Women who are menstruating; ③ Women with diabetes or other serious chronic diseases in the acute phase; ⑤ Those who cannot be followed up; ⑥ Patients with vaginal inflammation caused by sexually transmitted diseases such as mycoplasma, chlamydia, and gonorrhea.

[0076] 2. Treatment methods

[0077] Bacterial and trichomonal vaginitis: Patients in the control group received metronidazole alone, twice daily, 0.4g each time, for one week as one course of treatment. Patients in the observation group received vaginal washes; 80ml of the wash solution was diluted 1:1 with warm water for vulvar and vaginal irrigation once daily; alternatively, the solution was diluted with hot water at home for fumigation followed by washing, once daily; one week constituted one course of treatment. Other medications and sexual intercourse were prohibited during treatment.

[0078] For fungal vaginitis: The control group used clotrimazole suppositories, one suppository once daily for 7 days, administered vaginally. The observation group used a vaginal wash; 80ml of the wash solution was diluted 1:1 with warm water for vulvar and vaginal irrigation once daily; the wash was also prepared at home with hot water, first steaming then washing, once daily. One week constituted one course of treatment. Other medications and sexual intercourse were prohibited during treatment.

[0079] 3. Efficacy criteria

[0080] Significant effect was defined as the complete elimination of all clinical symptoms and a negative pathogen test result; effective was defined as the near elimination of clinical symptoms and a negative pathogen test result; ineffective was defined as the failure to achieve any of the above indicators. The total effective rate was calculated as (significantly effective + effective) / total number of cases × 100%. The vaginal health and inflammation scores before and after treatment were compared between the two groups. Vaginal inflammation scores ranged from 0 to 8, with higher scores indicating more severe inflammation (0-3 for mild, 4-6 for moderate, and 7-8 for severe). Vaginal health scores were out of 24, with higher scores indicating better health (0-8 for low health, 9-16 for moderate health, and >16 for good health). The recurrence rate and adverse reactions were also compared between the two groups.

[0081] 4. Statistical methods

[0082] Data were processed using SPSS 24.0 statistical software. Quantitative data were expressed as mean ± standard deviation (x ± s) and analyzed using t-tests; categorical data were expressed as rates (%) and analyzed using chi-square tests. 2 Test. P < 0.05 indicates that the difference is statistically significant.

[0083] 5. The results of the clinical trial are shown in Table 1.

[0084] Table 1 Comparison of treatment effects between the two groups (n, %) (Damp-heat type)

[0085]

[0086] Note: Compared with the control group, * P<0.05

[0087] Table 2 Comparison of vaginal health and inflammation scores before and after treatment in the two groups (x±s, points) (Damp-heat type)

[0088]

[0089] Table 3 Comparison of treatment effects between the two groups (n, %) (Insect venom retention, burn-induced yin fluid type)

[0090]

[0091]

[0092] Note: Compared with the control group, * P<0.05

[0093] Table 4 Comparison of vaginal health and inflammation scores before and after treatment in the two groups (x±s, points) (Liver and Kidney Yin Deficiency Type)

[0094]

[0095] Table 1 shows the comparison of treatment effects between the two groups for vulvar itching (damp-heat type): the total effective rate of treatment in the observation group was higher than that in the control group, and the difference was statistically significant (P<0.05).

[0096] Vaginal itching (damp-heat type) was compared with the vaginal health and inflammation scores of the two groups before and after treatment in Table 2: Before treatment, there was no statistically significant difference in vaginal health and inflammation scores between the two groups (P>0.05); after treatment, the vaginal health and inflammation scores of the observation group were better than those of the control group, and the differences were statistically significant (P<0.05).

[0097] A comparison of disease recurrence and adverse reactions between the two groups showed that, 4 weeks after drug withdrawal, the recurrence rate in the observation group (4.0%, 2 / 50) was significantly lower than that in the control group (16.0%, 8 / 50). The difference was statistically significant (χ²). 2 =4.000, P<0.05). No significant adverse reactions were observed in either group of patients during treatment.

[0098] Comparison of treatment effects for vulvar itching (insect venom retention, scalding of vaginal fluid type): The total effective rate of treatment in the observation group was higher than that in the control group, and the difference was statistically significant (P<0.05). See Table 3.

[0099] Comparison of vaginal health and inflammation scores before and after treatment for vulvar itching (insect venom retention, scalding of vaginal fluid type): Before treatment, there was no statistically significant difference in vaginal health and inflammation scores between the two groups (P>0.05); after treatment, the vaginal health and inflammation scores in the observation group were significantly better than those in the control group (P<0.05). See Table 4.

[0100] Comparison of recurrence and adverse reactions of vulvar itching (insect venom retention, scalding of vaginal fluid type): After 4 weeks of drug withdrawal, the recurrence rate in the observation group was 4.0% (2 / 50), which was lower than that in the control group (16.0% (8 / 50), and the difference was statistically significant (χ²). 2 =4.000, P<0.05). No significant adverse reactions were observed in either group of patients during treatment.

[0101] Typical Cases

[0102] (1) Ms. Kuang, 32 years old, from Chenzhou. For the past week, she experienced unbearable itching of the vulva and vagina, copious, yellow, thick, and foul-smelling vaginal discharge, general weakness, loose, sticky stools, yellow urine, a slightly red tongue with a yellow, greasy coating, and a slippery pulse. Gynecological examination: normal vulva with a small amount of white discharge, unobstructed vagina, smooth cervix, no tenderness or rebound tenderness in the bilateral adnexa. Vaginal microecological testing: N-acetyl-β-aminogalactoside glycoside (+), leukocyte esterase (+), pH 5.4, fungus detected. Traditional Chinese medicine diagnosis: vulvar itching, internal accumulation of insect toxins, burning of vaginal fluid. Western medicine diagnosis: fungal vaginitis. The drug composition for treating vaginitis in Example 1 of this invention was used externally. 80ml of the wash solution was mixed with warm water at a 1:1 ratio and used for vulvar and vaginal irrigation once daily for one week as one course of treatment. After one course of treatment, the symptoms completely disappeared, and the disease was cured.

[0103] (2) Ms. Li, 32 years old, from Suxian District, Chenzhou. She had been experiencing vulvar itching and excessive, yellowish-green vaginal discharge for four days after swimming in a public swimming pool recently. Her bowel movements and urination were normal. Her tongue was red with a greasy coating, and her pulse was wiry and slippery. Gynecological examination revealed vulvar redness, a patent vagina with yellowish-green discharge of a fishy odor, mild cervical erosion, and no tenderness or rebound tenderness in the bilateral adnexa. Vaginal microecological testing showed hydrogen peroxide (+), pH 5.1, white blood cells (+), cleanliness grade III, and clue cells detected. Traditional Chinese medicine diagnosis: vulvar itching, internal accumulation of parasite toxins, and burning of vaginal fluid. Western medicine diagnosis: bacterial vaginosis. The medicated composition of Example 1 of this invention for treating vaginitis was applied externally. 80ml of the wash solution was mixed with warm water at a 1:1 ratio and used for vulvar and vaginal irrigation once daily for one week as one course of treatment. After one course of treatment, the symptoms completely disappeared, and the disease was cured.

[0104] (3) Ms. Ou, 27 years old, from Chenzhou. She had experienced recurrent vaginal itching for nearly a year, accompanied by vulvar itching. She reported minimal, white, odorless vaginal discharge, occasional lower back pain, sticky and uncomfortable bowel movements, normal urination, a red tongue with a greasy coating, and a wiry, slippery pulse. Gynecological examination: Vulva and vagina were flushed, the vagina was patent, and there was copious white, cottage cheese-like discharge. The cervix was smooth. There was tenderness in the left adnexa without rebound tenderness, while the right adnexa was negative. Vaginal microecological testing: N-acetyl-β-aminogalactoside (+), hydrogen peroxide (+), pH 5.3, and fungi were detected. Traditional Chinese medicine diagnosis: Vaginal itching, internal accumulation of insect toxins, and burning of vaginal fluid. Western medicine diagnosis: Vulvovaginal candidiasis. For external use of the drug composition for treating vaginitis according to Example 1 of this invention, take 80ml of the wash solution, add warm water at a ratio of 1:1, and rinse the vulva and vagina once a day. One week is one course of treatment. After two courses of external washing, the symptoms completely disappear and the disease is cured.

[0105] (4) Ms. Peng, female, 41 years old, from Chenzhou. For the past six months, she had experienced excessive, yellow, foul-smelling vaginal discharge, accompanied by mild vulvar itching, fatigue, drowsiness, sticky stools, yellow urine, a dark red tongue with a slightly greasy coating, and a wiry, slippery pulse. Gynecological examination revealed mild vulvar redness and swelling, an unobstructed vagina with copious cottage cheese-like discharge, grade I cervical erosion, mild tenderness in the left adnexa without rebound tenderness, and negative right adnexa. Vaginal microecological testing showed hydrogen peroxide (+), pH 5.1, detection of fungi and hyphae. The TCM diagnosis was: vulvar itching, internal accumulation of insect toxins, and burning of vaginal fluid. The Western medicine diagnosis was: fungal vaginitis. The drug composition for treating vaginitis in Example 1 of this invention was used externally. 80 ml of the wash solution was mixed with warm water at a 1:1 ratio and used for vulvar and vaginal irrigation once daily for one week as one course of treatment. After two courses of external washing, the symptoms completely disappeared, and the disease was cured. A follow-up vaginal microecological test one month later was normal.

[0106] (5) Ms. Liu, 28 years old. She usually had excessive, white, and foul-smelling vaginal discharge. For the past two weeks, she experienced unbearable vaginal itching, especially at night, accompanied by burning sensation in the vagina, chest tightness, and poor appetite. Her tongue was red with a white, greasy coating, and her pulse was wiry and slippery. Gynecological examination revealed slight redness and swelling of the vulva with white discharge and a foul odor. The vagina was unobstructed, the cervix was smooth, and there was no tenderness or rebound tenderness in the bilateral adnexa. Vaginal microecological testing at another hospital showed the presence of fungi. Traditional Chinese medicine diagnosis: Vaginal itching, internal accumulation of parasite toxins, and burning of vaginal fluid. Western medicine diagnosis: Fungal vaginitis. The drug composition for treating vaginitis in Example 1 of this invention was used externally. 80ml of the wash solution was mixed with warm water at a 1:1 ratio and used for vulvar and vaginal irrigation once daily for one week as one course of treatment. After two courses of external washing, the symptoms completely disappeared, and the disease was cured.

[0107] (6) Ms. Liu, female, 20 years old, from Chongqing, a student, with a history of sexual activity. She experienced vulvar itching for the past 3 days, reported normal amount of white, odorless vaginal discharge, accompanied by dry mouth, bitter taste, lower abdominal pain, loose stools, scanty yellow urine, red tongue with a yellow, greasy coating, and a wiry, slippery pulse. Gynecological examination revealed redness and swelling of the vulva and vagina, a small amount of white discharge in the vagina, unobstructed vagina, grade I cervical erosion, and no tenderness or rebound tenderness in the bilateral adnexa. Vaginal microecological testing showed a pH of 4.8, cleanliness grade III, and clue cells detected. Traditional Chinese medicine diagnosis: vulvar itching, internal accumulation of parasite toxins, and burning of vaginal fluid. Western medicine diagnosis: bacterial vaginosis. The drug composition for treating vaginitis in Example 1 of this invention was used externally. 80ml of the wash solution was mixed with warm water at a 1:1 ratio and used for vulvar and vaginal irrigation once daily for one week as one course of treatment. After one course of treatment, the symptoms completely disappeared, and the disease was cured.

[0108] (7) Ms. Cao, 35 years old, from Chenzhou. She had experienced frequent episodes of fungal vaginitis for the past two years. In the past 10 days, her vulvar itching worsened, accompanied by copious, yellow, cottage cheese-like vaginal discharge with an odor. She also had athlete's foot, sticky and difficult bowel movements, and normal urination. Her tongue was slightly red with a thick, greasy coating, and her pulse was wiry and slippery. Gynecological examination: normal vulva, unobstructed vagina, smooth cervix, no tenderness or rebound tenderness in the bilateral adnexa. Vaginal microecological testing: pH 4.8, fungus detected. Traditional Chinese medicine diagnosis: vulvar itching, internal accumulation of parasite toxins, burning of vaginal fluid. Western medicine diagnosis: fungal vaginitis. She was treated externally with the drug composition for treating vaginitis described in Example 1 of this invention. 80ml of the wash solution was mixed with warm water at a 1:1 ratio and used for vulvar and vaginal irrigation once daily for one week as one course of treatment. After one course of treatment, the symptoms completely disappeared, and the disease was cured.

[0109] (8) Ms. Deng, female, 39 years old. Two weeks after returning to Chenzhou from a trip out of town, she experienced vulvar itching and burning pain, a sensation like ants crawling on her skin, copious frothy white vaginal discharge with a foul odor, general weakness and fatigue, loose stools, frequent urination, slightly red tongue with a thick, greasy coating, and a slippery pulse. Gynecological examination: vulva was flushed with a small amount of yellowish-green discharge, vagina was unobstructed, cervix was smooth, and there was no tenderness or rebound tenderness in the bilateral adnexa. Vaginal microecological test: N-acetyl-β-aminogalactoside glycoside (+), pH 5.2, Trichomonas vaginalis detected, cleanliness grade IV. Traditional Chinese medicine diagnosis: vulvar itching, internal accumulation of parasite toxins, burning of vaginal fluid. Western medicine diagnosis: trichomonal vaginitis. External application of the drug composition for treating vaginitis in Example 1 of this invention: 80ml of the wash solution was mixed with warm water at a 1:1 ratio and used for vulvar and vaginal irrigation, once daily, for one week as one course of treatment. After two courses of external washing, the symptoms completely disappeared, and the disease was cured.

[0110] (9) Ms. Li, 45 years old, teacher. For the past half month, she had experienced excessive, yellowish vaginal discharge, burning sensation, frequent vulvar itching, slight odor, dry mouth and bitter taste, dry stools, scanty and yellow urine, red tongue with a thin yellow coating, and a slippery pulse. Gynecological examination: vulva and vagina were flushed, vagina was unobstructed, cervical erosion was grade II, mild tenderness without rebound tenderness in the left adnexa, and no tenderness or rebound tenderness in the right adnexa. Vaginal microecological testing: leukocyte esterase (+), pH 5.2, cleanliness grade IV, clue cells detected. Traditional Chinese medicine diagnosis: vulvar itching, internal accumulation of insect toxins, burning of vaginal fluid. Western medicine diagnosis: bacterial vaginosis. The drug composition for treating vaginitis in Example 1 of this invention was used externally. 80ml of the wash solution was mixed with warm water at a 1:1 ratio and used for vulvar and vaginal irrigation, once daily for one week as one course of treatment. After one course of treatment, the symptoms completely disappeared, the disease was cured, and there was no recurrence during a one-month follow-up after stopping the medication.

[0111] (10) Ms. Li, female, 36 years old, from Leiyang, office worker. For the past 10 days, she has experienced frequent vulvar itching, burning sensation, watery leukorrhea without odor, fatigue, heaviness, and a slightly obese physique. Her stools are sticky, and her urination is normal. Her tongue is red with a thin yellow coating, and her pulse is wiry and slippery. Gynecological examination: Vulvar redness with slight swelling, unobstructed vagina, smooth cervix, no tenderness or rebound tenderness in the bilateral adnexa. Vaginal microecological test: pH 4.6, epithelial cells +. Traditional Chinese medicine diagnosis: Vulvar itching, internal accumulation of insect toxins, burning of vaginal fluid. Western medicine diagnosis: Vulvitis. External application of the drug composition for treating vulvitis in Example 1 of this invention: Take 80ml of the wash solution, add warm water at a ratio of 1:1, and rinse the vulva once a day. One week is one course of treatment. After one course of external washing, the symptoms completely disappeared, and the disease was cured. During the period, she was advised to wear loose cotton pants.

[0112] In this invention, the traditional Chinese medicine composition is formulated under the guidance of traditional Chinese medicine theory and clinical experience. The raw materials and their proportions are carefully selected, and the combination conforms to the theory of "principal, assistant, adjuvant, and guide," demonstrating precise compatibility. It effectively addresses the pathogenesis of vulvar itching caused by internal insect venom and burning of vaginal fluids, manifested as vulvar itching, profuse yellow and thick vaginal discharge. This invention primarily targets vulvar itching caused by internal insect venom and burning of vaginal fluids, a common clinical condition in modern medicine. The formula conforms to basic TCM theory, is precisely formulated, and years of clinical application have shown that the prescription is effective, safe, and has not shown any toxic side effects. This invention adds biocompatible and biodegradable polysialic acid, polydopamine, and antibacterial peptide-modified chitosan hydrochloride to the traditional Chinese medicine components, promoting wound healing and effectively killing and inhibiting bacteria. This significantly enhances its efficacy, making it non-toxic, harmless, and without side effects, with high safety. Patients cured using the traditional Chinese medicine composition provided by this invention have not experienced recurrence of their condition after treatment.

[0113] Although embodiments of the invention have been shown and described, it will be understood by those skilled in the art that various changes, modifications, substitutions and alterations can be made to these embodiments without departing from the principles and spirit of the invention, the scope of which is defined by the appended claims and their equivalents.

Claims

1. A traditional Chinese medicine composition for treating vaginal itching, characterized in that, The traditional Chinese medicine composition is prepared from the following components in parts by weight: Sophora flavescens 20-30 parts, Phellodendri chinensis Cortex 20-30 parts, Dictamnus dasycarpus 20-30 parts, Polygonum cuspidatum 20-30 parts, Taraxacum mongolicum 20-30 parts, Chrysanthemum indicum 20-30 parts, Herba Portulacae 20-30 parts, Cnidium monnieri 20-30 parts, Angelica dahurica var. formosana 30-40 parts, Verbena officinalis 20-30 parts, Mentha haplocalyx 10-20 parts, Saposhnikovia divaricata 6-15 parts; and the traditional Chinese medicine composition is an external preparation.

2. The traditional Chinese medicine composition for treating pruritus vulvae according to claim 1, characterized in that, The traditional Chinese medicine composition includes Sophora flavescens 24 parts, Phellodendri chinensis Cortex 24 parts, Dictamnus dasycarpus 24 parts, Polygonum cuspidatum 24 parts, Taraxacum mongolicum 24 parts, Chrysanthemum indicum 24 parts, Herba Portulacae 24 parts, Cnidium monnieri 24 parts, Angelica dahurica var. formosana 32 parts, Verbena officinalis 24 parts, Mentha haplocalyx 16 parts, and Saposhnikovia divaricata 8 parts.

3. A lotion preparation for treating vaginal itching prepared from the traditional Chinese medicine composition according to any one of claims 1-2.

4. Use of the traditional Chinese medicine composition according to any one of claims 1-2 in the preparation of a medicine for treating vaginitis.

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