Traditional Chinese medicine composition for treating hyperhidrosis and preparation method and application thereof

Abstract

The invention discloses a traditional Chinese medicine composition for treating hyperhidrosis and a preparation method and application thereof. The traditional Chinese medicine composition is prepared from the following raw material medicines in parts by weight: 10-50 parts of astragalus membranaceus, 3-30 parts of radix ophiopogonis, 1-15 parts of schisandra chinensis, 6-30 parts of angelica sinensis, 6-30 parts of prepared rehmannia root, 6-30 parts of radix rehmanniae recen, 3-20 parts of divaricate saposhnikovia root, 6-30 parts of bighead atractylodes rhizome, 3-20 parts of scutellaria baicalensis, 1-15 parts of coptis chinensis and 3-20 parts of golden cypress. The traditional Chinese medicine is prepared from the following raw materials in parts by weight: 10-50 parts of gypsum, 3-30 parts of rhizoma anemarrhenae, 10-50 parts of light wheat, 3-20 parts of cassia twig and 3-30 parts of radix paeoniae alba. The traditional Chinese medicine composition disclosed by the invention positively exerts the advantage of overall differentiation and treatment of traditional Chinese medicine, is scientific in formula compared with other medicines, improves the medication safety, has a treatment effect on spontaneous perspiration and night sweat, and can make up for the deficiency of treatment measures for the clinical common hyperhidrosis disease.

Description

Technical Field

[0001] The invention belongs to the technical field of traditional Chinese medicines, and in particular relates to a traditional Chinese medicine composition for treating hyperhidrosis and a preparation method and application of the traditional Chinese medicine composition. Background Art

[0002] Sweat is one of the five fluids in the human body, which comes from the yang qi steaming the body fluid. The heart governs blood, and sweat is the fluid of the heart. Yang is the defensive qi, and yin is the blood. When yin and yang are balanced and the defense and defense are in harmony, the body fluid is retained. On the contrary, if the yin and yang organs are out of balance, the qi and blood, the defense and defense are not harmonious, the defense yang is not solid, and the opening and closing of the pores are not smooth, the sweat will leak out. Sweating syndrome is mostly a deficiency syndrome. Spontaneous sweating is mainly caused by qi deficiency and yang deficiency; night sweating is mainly caused by yin deficiency and blood deficiency. In the syndrome of lung defense failure, the head, neck, chest and back are sweating; in the syndrome of defense and defense imbalance, the sweat is sweating but not warm; in the syndrome of qi and yin deficiency, the whole body is sweating with signs of deficiency heat; in the syndrome of damp-heat forced steaming, the skin is hot due to sweating. Sweating syndrome is mainly caused by deficiency, and tonifying deficiency is its basic treatment principle. In the case of lung defense failure, the qi is strengthened to consolidate the defense; in the case of defense and defense imbalance, the defense and defense are harmonized; in the case of qi and yin deficiency, the qi is strengthened to nourish the yin; in the case of damp-heat forced steaming, the damp-heat is cleared. In addition to oral medication, external treatments such as umbilical therapy can also be used.

[0003] Western medicine classifies spontaneous sweating and night sweats as hyperhidrosis. Hyperhidrosis is a chronic autonomic nervous system disease, which refers to the phenomenon of abnormal increase in local or systemic skin sweating, mainly occurring in areas where eccrine sweat glands are densely distributed. The nerves that control the eccrine sweat glands are sympathetic nerves, with acetylcholine as the main neurotransmitter. Nerve damage or emotional impulses cause increased nerve impulses, increased acetylcholine secretion, and thus increased sweating. Among them, the increased tension of the sweat gland nerves can cause an increase in its sweating response to normal intensity neural and non-neural stimuli, which can also lead to an abnormal increase in sweating.

[0004] At present, the Western medicine treatment of hyperhidrosis mainly focuses on drug therapy and surgical treatment. Drug therapy is divided into topical drugs and oral agents. Aluminum salts are the main topical drugs for hyperhidrosis, but they are only effective in mild cases of hyperhidrosis, and the duration of effect is usually limited to 48 hours. Because aluminum salts expose the skin to a high salt concentration environment, side effects such as skin itching are more common. Botulinum neurotoxin inhibitors are more effective than aluminum salts, but they have problems such as a small range of popularization and many contraindications. Anticholinergic drugs (such as glycopyrrolate) and α-adrenergic agonists (such as clonidine) are the most common oral agents for the treatment of hyperhidrosis in clinical practice. Because they work by competitively inhibiting acetylcholine at muscarinic receptors, they may cause dry mouth, blurred vision, urination disorders, dizziness, tachycardia, and confusion during treatment. The contraindications of oral agents are quite wide, including myasthenia gravis, pyloric stenosis, narrow-angle glaucoma, etc.; in terms of surgical treatment, iontophoresis is relatively popular, but there are still problems such as high price, invasive harm, and poor patient compliance.

[0005] In recent years, traditional Chinese medicine has shown certain advantages in the treatment of spontaneous sweating and night sweats due to its comprehensive regulatory effects of multiple components, multiple pathways, and multiple targets.

[0006] At present, the commonly used Chinese patent medicine Yupingfeng Granule is developed based on Yupingfeng Powder in combination with modern pharmaceutical technology, but its components, including Astragalus, Angelica, and Atractylodes, are all warming and tonic herbs, and long-term use may cause symptoms such as dryness and internal heat. In addition, some Chinese medicines can also relieve the symptoms of spontaneous sweating and night sweats, but there are certain deficiencies or room for improvement.

[0007] For example, in Chinese patent application CN101890136A, the Chinese medicine composition includes Codonopsis pilosula, oyster, ephedra root, floating wheat, and Schisandra chinensis. The Chinese medicine composition introduced in the patent has a significant effect on spontaneous sweating symptoms, but the effect on night sweating symptoms is not as good as spontaneous sweating.

[0008] For another example, in Chinese patent application CN113577224A, the Chinese medicine composition includes 10-20 parts of polygonatum, 5-15 parts of angelica, 5-10 parts of cooked rehmannia, 5-10 parts of chuanxiong, 5-10 parts of codonopsis, 5-10 parts of donkey-hide gelatin, 5-10 parts of white peony root, 5-10 parts of astragalus, 5-10 parts of euryale, 5-10 parts of fenugreek, 5-10 parts of spinach seed, 5-10 parts of lotus seeds, and 5-10 parts of turmeric. According to the principle that medicine and food are of the same origin, it can replenish qi, blood, and deficiency, and has a significant effect on symptoms such as spontaneous sweating and night sweating in women during the puerperal period. The drug components described in this patent are mainly for women during the puerperal period, and the scope of indications is relatively narrow. Summary of the invention

[0009] In view of the shortcomings and deficiencies in the prior art, the object of the present invention is to provide a Chinese medicine composition for treating hyperhidrosis.

[0010] At present, there are few clinical drugs for treating hyperhidrosis with traditional Chinese medicine that are safe to use and have definite efficacy. On this basis, the Chinese medicine composition of the present invention actively exerts the advantages of overall diagnosis and treatment of traditional Chinese medicine, and has a scientific formulation compared with other drugs, improves the safety of medication, and has a therapeutic effect on spontaneous sweating and night sweats, which can make up for the shortcomings of treatment measures for this type of common clinical hyperhidrosis. In view of this, the present invention provides a Chinese medicine composition with good efficacy and high safety for patients with hyperhidrosis.

[0011] The present invention also aims to provide a method for preparing the above-mentioned Chinese medicine composition.

[0012] The present invention also aims to provide the use of the above-mentioned Chinese medicine composition in the preparation of a drug for treating hyperhidrosis.

[0013] The technical solution of the present invention is as follows: A traditional Chinese medicine composition for treating hyperhidrosis is prepared from raw materials in the following proportions: 10-50 parts of astragalus, 3-30 parts of ophiopogon, 1-15 parts of schisandra, 6-30 parts of angelica, 6-30 parts of prepared rehmannia, 6-30 parts of raw rehmannia, 3-20 parts of siler, 6-30 parts of atractylodes, 3-20 parts of scutellaria, 1-15 parts of coptis, 3-20 parts of phellodendron, 10-50 parts of gypsum, 3-30 parts of anemarrhena, 10-50 parts of floating wheat, 3-20 parts of cassia twig and 3-30 parts of white peony root.

[0014] Furthermore, the Chinese medicine composition is prepared by raw materials including the following proportions: 20-40 parts of Astragalus, 6-20 parts of Ophiopogon japonicus, 3-12 parts of Schisandra chinensis, 10-20 parts of Angelica sinensis, 10-20 parts of Rehmannia root, 10-20 parts of Rehmannia root, 5-15 parts of Saposhnikovia divaricata, 10-20 parts of Atractylodes macrocephala, 6-15 parts of Scutellaria baicalensis, 3-10 parts of Coptis chinensis, 6-15 parts of Phellodendron chinense, 20-40 parts of Gypsum, 10-20 parts of Anemarrhena asphodeloides, 20-40 parts of Triticum tiliaceum, 5-12 parts of Cinnamomum cassia, and 5-12 parts of White Peony Root.

[0015] Furthermore, the Chinese medicine composition is prepared by raw materials including the following proportions: 30-35 parts of Astragalus, 10-15 parts of Ophiopogon japonicus, 5-10 parts of Schisandra chinensis, 12-15 parts of Angelica sinensis, 12-15 parts of Rehmannia root, 12-15 parts of Rehmannia root, 6-10 parts of Saposhnikovia divaricata, 12-15 parts of Atractylodes macrocephala, 10-12 parts of Scutellaria baicalensis, 5-8 parts of Coptis chinensis, 10-12 parts of Phellodendron chinense, 30-35 parts of Gypsum, 12-15 parts of Anemarrhena asphodeloides, 30-35 parts of Triticum tiliaceum, 6-10 parts of Cassia twig, and 6-10 parts of White Peony Root.

[0016] Furthermore, the dosage form of the Chinese medicine composition is any one of a decoction, a Chinese medicine ointment, and a pill.

[0017] Furthermore, the dosage form of the Chinese medicine composition is a decoction.

[0018] A method for preparing a Chinese medicine composition for treating hyperhidrosis, comprising decocting the raw medicine with water and taking a filtrate; the decocting comprises the following steps: The raw gypsum is mixed with water and then pre-decocted, and then the remaining raw materials and water are added to perform a first decoction to obtain a first filter residue and a first filtrate; The first filter residue is mixed with water and then subjected to a second decoction to obtain a second filter residue and a second filtrate; The first filtrate and the second filtrate are combined to obtain a filtrate.

[0019] Furthermore, in the pre-decoction, the mass ratio of gypsum to water is 1:(8-10), and the pre-decoction time is 0.5h.

[0020] In the first decoction, the mass ratio of the total mass of the raw materials to the mass of the water added again is 1:(8-10), and the first decoction time is 1.25-1.5h.

[0021] In the second decoction, the mass ratio of the first filter residue to water is 1:(6-8), and the time of the second decoction is 0.5-1.0h.

[0022] Use of any of the above-mentioned Chinese medicine compositions in the preparation of a medicament for treating hyperhidrosis, wherein the hyperhidrosis includes spontaneous sweating and / or night sweating.

[0023] Furthermore, the location of the hyperhidrosis includes the whole body or a part.

[0024] Furthermore, the local parts include the head and face or the palms and soles of feet.

[0025] Compared with the prior art, the advantages of the present invention are as follows:

[0026] (1) The Chinese medicine composition of the present invention uses Radix Ophiopogonis and Fructus Schisandrae Chinensis as the main ingredients, which can nourish qi, nourish yin and promote the production of body fluid. Astragalus is used to strengthen the already weak surface and to calm the unstable yin. Angelica is used to nourish the body fluid and Rehmannia is used to nourish the yin, so that the yin fluid can be nourished. Scutellaria is used to purge the upper Jiao fire, Coptis chinensis purges the middle Jiao fire, and Phellodendron chinense purges the lower Jiao fire, so that the three fires can be lowered and the yin blood can be calmed. Saposhnikovia divaricata and Atractylodes macrocephala are used together to dispel the external evil, nourish qi and strengthen the spleen; Anemarrhena asphodeloides nourishes yin and promotes the production of body fluid, and the effect of clearing heat and purging fire is further enhanced when used together with Gypsum Fibrosum; Wheat is used to clear heat and stop sweating; Cinnamon twig and White Peony Root are used together to disperse and collect, and they are pungent and sweet to transform yang, stop sweating while inducing sweating, and stop sweating while inducing sweating. Sweating can reach the evil without damaging the Ying Yin, stop sweating and nourish the Yin without leaving evil qi, and play the role of harmonizing the Ying and Wei, and regulating yin and yang.

[0027] The Chinese medicine composition of the present invention treats sweating caused by deficiency of both qi and yin and accumulation of dampness and heat, and has the following characteristics: first, nourishing blood and nourishing yin and purging fire and heat go hand in hand, taking both the symptoms and the root into consideration, so that yin is solid and water can control fire, and heat clearing will not consume yin; second, invigorating qi and consolidating the exterior are matched with nourishing yin and purging fire, nourishing yin and purging fire as the root, and invigorating qi and consolidating the exterior as the symptom, so that the Ying yin is guarded inside and the Wei is solid outside, and fever and night sweats are cured accordingly. The compatibility of the various medicines plays the functions of invigorating qi and nourishing yin, clearing heat and drying dampness, and harmonizing Ying and Wei. Clinically verified, the Chinese medicine composition of the present invention has significant therapeutic effects in treating hyperhidrosis of different types (including spontaneous sweating and / or night sweats), and is suitable for clinical promotion and application.

[0028] in:

[0029] Astragalus: sweet in taste, slightly warm in nature, it has the effects of replenishing qi and raising yang, strengthening the body's defense system, promoting diuresis and reducing swelling, and removing toxins and promoting tissue regeneration. Modern pharmacological studies have shown that the main active ingredients of Astragalus are astragaloside IV, astragalus polysaccharides, calycosin isoflavones, formononetin, quercetin, etc., and its pharmacological effects include enhancing immunity, anti-virus and anti-cancer, anti-oxidation, anti-aging, improving memory, promoting body metabolism, enhancing the body's tolerance to hypoxia and stress, lowering blood sugar, and strengthening the heart. Astragalus can increase the content of cAMP in plasma tissues, increase immune function, and thus enhance disease resistance, thereby achieving the effect of replenishing qi and strengthening the body's defense system.

[0030] Atractylodes macrocephala: bitter and sweet, warm in nature, enters the spleen and stomach meridians, and has the effects of strengthening the spleen and replenishing qi, drying dampness and promoting diuresis, stopping sweating and stabilizing pregnancy. The classics say "the spleen suffers from dampness, so eat bitter food to dry it out immediately." Strengthening the spleen and drying dampness are the most prominent characteristics of Atractylodes macrocephala. The spleen governs the muscles. If the spleen is strong, the defensive qi is tight and solid, while if it is weak, the water vapor is trapped inside and the spleen qi is not reached. There is a prescription in Qianjin that uses Atractylodes macrocephala alone to stop sweating, or it can be used with oysters to achieve the effect of stopping sweating. Modern pharmacological studies have shown that Atractylodes macrocephala has pharmacological effects such as anti-inflammatory, anti-tumor, regulating the gastrointestinal tract, antibacterial, antioxidant, liver protection, protection of the cardiovascular and nervous systems, and immune regulation.

[0031] Angelica: Sweet and spicy, warm in nature, it enters the liver, heart and spleen meridians, and has the effects of nourishing blood and activating blood circulation, regulating menstruation and relieving pain, and moistening the intestines and relieving constipation. The active ingredients of Angelica are mainly Angelica polysaccharides, ferulic acid and Angelica volatile oil, which have pharmacological activities such as immune enhancement, regulating blood circulation, lowering blood pressure and lipids, analgesia and anti-inflammatory, anti-tumor, anti-tissue fibrosis, anti-asthma, anti-depression, liver and kidney protection.

[0032] Raw Rehmannia root: sweet in taste, cold in nature, enters the heart and liver meridians, has the effects of clearing heat and cooling blood, nourishing yin and promoting body fluid. Iridoids, phenylethanol and sugar are the main active substances of Rehmannia root. It has pharmacological effects such as lowering blood sugar, anti-aging, enhancing immunity, anti-tumor, protecting the nervous system, anti-depression, anti-inflammatory, and improving osteoporosis. Raw Rehmannia root exerts its anti-drug-induced Yin deficiency effect by inhibiting the secretion of corticosterone and restoring the function of the suppressed corticosterone synthase.

[0033] Rehmannia root: sweet in taste, slightly warm in nature, belongs to the liver and kidney meridians, and is known as the "extreme yin medicine". It has the effects of nourishing blood and yin, replenishing essence and filling marrow. Rehmannia root mainly contains iridoids, ionones and phenylethanol compounds, as well as sugars, nucleosides, alkaloids, phenolic acids, isoflavone glycosides and other compounds, which play a variety of pharmacological effects such as lowering blood sugar, anti-tumor, anti-aging, anti-oxidation, improving liver fat, anti-depression, improving memory, improving cognitive impairment, having estrogen-like activity, promoting hematopoiesis, and enhancing immunity.

[0034] Saposhnikovia divaricata: Spicy and sweet, warm in nature, it enters the bladder, liver and spleen meridians, can dispel wind and relieve exterior symptoms, overcome dampness and stop spasms. The main active ingredients are chromones, coumarins, volatile oils and polysaccharides. It has multiple pharmacological effects such as antipyretic, anti-inflammatory and analgesic, anti-thrombotic, anti-atherosclerotic, anti-tumor and immunomodulatory. The chromone compounds in Saposhnikovia divaricata have significant antioxidant effects, and Saposhnikovia divaricata extract also has a certain therapeutic effect on relieving lung tissue fibrosis.

[0035] Ophiopogon japonicus: sweet, slightly bitter, slightly cold, enters the heart, lung, and stomach meridians, and has the effects of nourishing yin, promoting fluid production, clearing the heart and relieving restlessness. The main chemical components of Ophiopogon japonicus are steroidal saponins, high isoflavones, polysaccharides, amino acids, etc. It has pharmacological effects such as lowering blood sugar, lowering blood lipids, protecting the cardiovascular system, enhancing immunity, anti-inflammatory, anti-tumor, anti-aging, and antioxidant. Ophiopogon japonicus polysaccharides reduce myocardial damage by increasing endogenous antioxidant factors. The natural active ingredients of steroidal saponins extracted from Ophiopogon japonicus have the activity of inhibiting oxidative stress and inflammatory factors. The components of Ophiopogon japonicus, ruscosaponin Lm-3 and its aglycone ruscosaponin, improve liver and lung damage. Ophiopogon japonicus saponin D weakens the excitability of tracheal parasympathetic ganglion neurons and reduces airway choline release. Ophiopogon japonicus hot water extract has a certain inhibitory effect on Gram-negative bacteria Escherichia coli and fungus Candida.

[0036] Schisandra: sour, sweet, warm in nature, with the effects of astringency, invigorating qi and promoting fluid, tonifying the kidney and calming the mind. The main ingredients are lignans, polysaccharides, volatile oils, terpenes, organic acids, flavonoids, etc. It has the effects of improving immunity, anti-tumor, anti-oxidation, anti-inflammation, anti-oxidation, anti-dementia, anti-aging, sedation, hypnosis, cardiovascular and liver protection, etc. Schisandra extract is also often processed into pieces, powders, pills, etc., for the treatment of chronic cough, asthma, internal heat and thirst, spontaneous sweating, night sweats, palpitations and insomnia, etc. Schisandra B SchB has many pharmacological effects such as sedation and hypnosis, scavenging oxygen free radicals, anti-oxidation and anti-aging, and lipid-lowering and liver protection. Ingredients such as schisandrin acid and flavonoids have been found to have anti-inflammatory effects. Lignans and triterpenes in Schisandra have good sedative and hypnotic effects. The hepatoprotective effect of lipopolysaccharide active ingredients is particularly obvious. Schisandra ethanol extract and polyphenols have antibacterial effects. The "Ophiopogon japonicus-Schisandra chinensis" drug pair exerts its anti-cardiovascular disease effects through mechanisms such as inhibiting cell apoptosis, promoting angiogenesis, anti-inflammation, and anti-oxidation; it mainly exerts its anti-cerebrovascular disease effects through mechanisms such as anti-oxidation, correcting acidosis, promoting astrocyte proliferation, sedation and hypnosis, and delaying brain aging.

[0037] Scutellaria: bitter, cold, enters the lung, gallbladder, spleen, large intestine, small intestine meridians. It has the effects of clearing away heat and dampness, purging fire and detoxifying, stopping bleeding, and calming the fetus. It mainly contains baicalin, baicalein, wogonin, baicalin, norwogonin, etc. It has the effects of anti-pathogenic microorganisms, anti-endotoxin, detoxification, anti-inflammatory, anti-allergic, anti-tumor, liver protection, detoxification, and antioxidant. It also has strong effects of inhibiting platelet aggregation, preventing and treating cataracts, and lowering blood sugar. Baicalein can inhibit the decrease in cardiomyocyte viability and increase in apoptosis rate induced by tert-butyl hydroperoxide, and inhibit the decrease in superoxide dismutase and glutathione peroxidase activities. At the same time, it can also improve myocardial hypertrophy, myocardial cell disorder and myocardial interstitial fibrosis, and reduce lipopolysaccharide-induced cardiomyocyte damage and apoptosis. Baicalin can significantly improve cardiac function and myocardial fibrosis in rats with myocardial infarction; total flavonoids from the stems and leaves of Scutellaria baicalensis can inhibit myocardial remodeling in rats with essential hypertension; current research results all indicate that Scutellaria baicalensis and its components improve myocardial damage and hypertrophy mainly through pathways such as anti-oxidative stress.

[0038] Coptis chinensis: bitter, cold. Tends to settle. Enters the heart, spleen, stomach, liver, gallbladder, and large intestine meridians. Has the effects of clearing away heat and dampness, purging fire and detoxifying. Mainly contains alkaloid components such as berberine, coptis chinensis, methyl coptis chinensis, palmatine, jatrorrhizine, african pine, epiberberine, tetrandrine, and magnolia alkaloids. Among them, berberine has anti-atherosclerosis, anti-myocardial ischemia, anti-hyperhidrosis and anti-cerebral thrombosis effects.

[0039] Phellodendron: bitter, cold. Tends to settle. Enters the kidney and small intestine meridians. It has the effects of clearing away heat and dampness, purging fire and removing steam, detoxifying and curing sores. It mainly contains alkaloids such as berberine, bamipine, jatrorrhizine, magnolia alkaloids, and phellodendron alkaloids. It has the effects of pathogenic microorganisms, anti-influenza virus, anti-inflammatory, anti-allergic, anti-hypertensive, and anti-gout. The "Scutellaria baicalensis-Coptis chinensis-Phellodendron chinense" drug pair can purge the heat of the three energizers, so that the heat can be cleared and calmed.

[0040] Anemarrhena: bitter, sweet, cold. Tends to settle. Enters the lung, stomach, and kidney meridians. Has the effects of clearing heat and purging fire, nourishing yin and moistening dryness. Mainly contains saponins, flavonoids, polysaccharides, alkaloids, organic acids, etc. It has the effects of resisting pathogenic microorganisms, relieving fever, anti-inflammatory, and lowering blood sugar. The "Anemarrhena-Phellodendron" drug pair is widely used in both Chinese and Western medicine. Li Shizhen's "Compendium of Materia Medica" says: "Anemarrhena is bitter, cold and cool in nature. It nourishes yin and moisturizes dryness from below, and clears the lung metal and purges fire from above. It is a medicine for the qi of the two meridians; Phellodendron is also a medicine for the blood of the kidney meridian, so the two medicines must be used together." Modern medicine has proved that this drug pair has the effects of lowering blood sugar and lipids, and can resist inflammation, anti-oxidation, reverse muscle atrophy, and has a certain protective effect on the nervous system.

[0041] Gypsum: Gypsum is bitter, pungent and extremely cold. It has a dual tendency. It enters the lung and stomach meridians and has the effects of clearing away heat and purging fire, relieving restlessness and quenching thirst. The main ingredients are hydrated calcium sulfate, as well as trace amounts of iron and magnesium. It has the effects of relieving fever, calming, enhancing phagocytosis, shortening water coagulation time, and lowering blood sugar. Gypsum can remove heat, restore body fluids and stop thirst. In "Treatise on Febrile Diseases", Ma Xing Shi Gan Tang and Yue Pi Tang both use a large amount of gypsum to treat patients with no fever and sweating symptoms. Modern medical research shows that the content of calcium and magnesium increases greatly during the formation of gypsum, which plays a role in reducing fever and stopping sweating by participating in the regulation of calcium ions in the body.

[0042] Floating wheat: sweet, cool. Dual tendency. Return to the heart meridian. It has the effects of strengthening the exterior and stopping sweating, invigorating qi, and removing heat. It mainly contains rich starch and enzyme proteins, fat, calcium, phosphorus, iron, vitamins, etc. It participates in the metabolism of the three major nutrients in the body and has the effect of inhibiting sweat gland secretion. Modern medicine has identified a total of 180 metabolites through component analysis of floating wheat and common wheat, and screened out 17 differential metabolites through metabolomics analysis. Based on further analysis of network pharmacology, it was found that kaempferol, asiatic acid, claretol, glycyrrhetinic acid, (-)-decantangisopine resin alcohol have high degree values, which may be potential effective ingredients of floating wheat; protein targets ESR1, ESR2 and MAP2K1 may be potential targets of floating wheat for the treatment of menopausal hyperhidrosis. Through the study of signal pathways such as prolactin signaling pathway, thyroid cancer pathway, endocrine resistance pathway, gonadotropin secretion pathway, and estrogen signaling pathway, the efficacy analysis and mechanism of action of floating wheat are revealed.

[0043] Cinnamon twig: pungent, sweet, warm, tends to rise and float, and enters the heart, lung, and bladder meridians. It has the effects of sweating and relieving muscles, warming and unblocking meridians, assisting yang and transforming qi, and balancing and descending qi. It mainly contains volatile oils, mainly cinnamaldehyde, which have antipyretic and cooling effects, inhibit bacteria and viruses, and promote coronary blood flow.

[0044] White peony root: bitter, sour, slightly cold, tends to settle. Enters the liver and spleen meridians. It has the effects of nourishing blood and softening the liver, relieving pain, and astringing yin and stopping sweating. It contains a variety of chemical components such as monoterpenes and their glycosides, triterpenes, flavonoids, tannins, etc., and has pharmacological effects such as anti-inflammatory, liver protection, analgesia, and blood nourishment. White peony root has the effect of astringing yin and stopping sweating. When used together with cinnamon twig, it harmonizes the Ying and Wei, one disperses and the other collects, and transforms yang with pungent and sweet properties. It stops sweating while sweating, and sweats while stopping sweating. It can sweat to eliminate evil without hurting Ying Yin, and stop sweating and nourish yin without leaving evil qi. When used together with astragalus and white atractylodes, it can treat spontaneous sweating due to asthenia. When used together with floating wheat, it can treat night sweats due to yin deficiency.

[0045] (2) The Chinese medicine composition of the present invention is based on Danggui Liuhuang Decoction and is modified. Modern pharmacological studies have shown that the present invention, on the basis of broad-spectrum treatment of hyperhidrosis, also has certain cardiovascular protective effects such as improving myocardial cell metabolism, resisting myocardial hypoxia and ischemia, and regulating autonomic nerve function. Compared with Danggui Liuhuang Decoction, the present invention, after modification, has more obvious effects of invigorating qi and nourishing yin, clearing away heat and drying dampness, and harmonizing Ying and Wei. In addition to the antiperspirant effect, it also has the effects of effectively anti-inflammatory, anti-liver fibrosis, and immunosuppressive.

[0046] Specifically, the Chinese medicine composition of the present invention is based on Danggui Liuhuang Decoction, which is composed of only 16 Chinese medicines after addition and subtraction. It has the effects of invigorating qi and nourishing yin, clearing away heat and drying dampness, and harmonizing the Ying and Wei. Modern pharmacological studies on drug pairs and single drugs have shown that the Chinese medicine composition can reduce the secretion of sweat gland cells and lower serum cholinesterase to stop sweating. It also has the advantages of anti-liver fibrosis, improvement of sex hormone levels, anti-inflammatory, and anti-oxidation.

[0047] (3) The Chinese medicine composition of the present invention is used for the treatment of hyperhidrosis and has the characteristics of combining traditional Chinese medicine prescriptions, safe formula, low cost and convenient administration.

[0048] (4) After the patient takes the Chinese medicine composition of the present invention, the patient's spontaneous sweating and night sweating symptoms can be effectively reduced or eliminated. It is a standardized and standard Chinese medicine composition for hyperhidrosis. DETAILED DESCRIPTION

[0049] The present invention will be further described below in conjunction with the embodiments and drawings. Example 1

[0050] The Chinese medicine composition of this embodiment is a decoction, and its preparation method is as follows: The raw materials of the Chinese medicine composition in this embodiment are prepared according to the following mass parts (g): 30 parts of Astragalus, 15 parts of Ophiopogon, 6 parts of Schisandra, 15 parts of Angelica, 15 parts of Rehmannia glutinosa, 15 parts of Radix Rehmanniae, 10 parts of Saposhnikovia, 15 parts of Atractylodes, 10 parts of Scutellaria, 6 parts of Coptis, 10 parts of Phellodendron, 30 parts of Gypsum, 15 parts of Anemarrhena, 30 parts of Triticum tiliaceus, 10 parts of Cinnamon twig, and 10 parts of White Peony.

[0051] After boiling the above raw gypsum with 240g boiling water (pre-boiling) for 0.5h, the remaining raw materials and 2178g water were added and boiled for 1.5h (first boiling), and then the first filter residue and the first filtrate were separated; The first filter residue was mixed with 3520 g of water and then decocted (second decoction) for 1.0 h, and the second filter residue and the second filtrate were separated; The first filtrate and the second filtrate are combined to obtain a traditional Chinese medicine composition. Example 2

[0052] The Chinese medicine composition of this embodiment is a Chinese medicine ointment, and its preparation method is as follows: Prepare the raw materials according to the following mass parts (g): 50 parts of Astragalus, 30 parts of Ophiopogon, 12 parts of Schisandra, 18 parts of Angelica, 18 parts of Rehmannia glutinosa, 18 parts of Radix Rehmanniae, 18 parts of Saposhnikovia, 18 parts of Atractylodes, 15 parts of Scutellaria, 10 parts of Coptis, 15 parts of Phellodendron, 50 parts of Gypsum, 20 parts of Anemarrhena, 30 parts of Triticum tiliaceus, 15 parts of Cassia twig, and 15 parts of White Peony.

[0053] Remove impurities, wash, and sun dry or tumble dry.

[0054] The weighed raw materials are crushed into powder, filtered through a 100-mesh filter to obtain a mixture for later use.

[0055] Add 1500ml of drinking water and soak for 8 hours, boil over high heat, and then simmer for 2 hours; simmer twice, adding 1000ml and 800ml of water each time, and simmering for 2 hours and 1 hour respectively; filter after simmering, and combine the filtrate. Then add 10% of its weight of donkey-hide gelatin, sucrose and honey auxiliary materials, mix and concentrate to a thick paste with a density of 1.5-1.6.

[0056] Method of taking the prepared Chinese medicine ointment: take it once in the morning and evening, each time with 50-100 ml of warm water. Example 3

[0057] The Chinese medicine composition of this embodiment is a pill, and its preparation method is as follows: Prepare the raw materials according to the following mass parts (g): 10 parts of Astragalus, 6 parts of Ophiopogon, 6 parts of Schisandra, 6 parts of Angelica, 6 parts of Rehmannia glutinosa, 6 parts of Radix Rehmanniae, 6 parts of Saposhnikovia, 6 parts of Atractylodes, 3 parts of Scutellaria, 3 parts of Coptis, 3 parts of Phellodendron, 10 parts of Gypsum, 6 parts of Anemarrhena, 10 parts of Triticum tiliaceus, 6 parts of Cassia twig, and 6 parts of White Peony.

[0058] Remove impurities, wash, and sun dry or tumble dry.

[0059] The above weighed raw materials are crushed into powder, filtered through a 100-mesh filter to obtain a mixture for later use.

[0060] Add appropriate amount of adhesive or other auxiliary materials to make spherical or quasi-spherical dosage forms. The adhesive includes water, honey, wine, vinegar, and medicinal juice, and can be made into different types of pills, such as water pills, honey pills, water-honey pills, wax pills, etc.

[0061] Clinical trials:

[0062] 1. Case selection criteria: A total of 31 patients with clinical diagnosis of hyperhidrosis were randomly selected, of whom the youngest was 23 years old, the oldest was 83 years old, and the average age was 53 years old. There were 8 patients aged 20-40 years, 15 patients aged 41-60 years, 8 patients aged 61-80 years, and 1 patient aged >80 years, including 16 males and 15 females.

[0063] 2.Disease diagnostic criteria: The main symptoms are easy sweating and excessive sweating. Patients diagnosed with hyperhidrosis after excluding other secondary diseases.

[0064] 3. How to use: The patient takes the Chinese medicine composition provided in Example 1 of the present invention, 200 ml each time, once in the morning and once in the evening, 14 days as a course of treatment, and takes 1-3 courses of treatment.

[0065] 4. Criteria for judging efficacy: According to the improvement degree of TCM symptoms before and after treatment The total effective rate of treatment = (number of markedly effective cases + number of effective cases) / total number of patients × 100%.

[0066] 5. Statistics and results The data statistics are shown in Table 1.

[0067] Table 1 The therapeutic effect of the Chinese medicine composition of the present invention on hyperhidrosis in patients

[0068]

[0069]

[0070] Clinically confirmed, taking the Chinese medicine composition provided by the present invention can significantly alleviate or even eliminate the symptoms of spontaneous sweating and night sweats, and can also effectively alleviate the patient's fatigue, insomnia and other symptoms, improve the patient's quality of life, and no side effects occur.

[0071] The remarkable effects of the present invention are further illustrated below by three typical cases of hyperhidrosis.

[0072] Case 1: Xu, female, 67 years old, visited the outpatient department of the Department of Cardiology of our hospital on October 15, 2021. At present, she had facial flushing, easy sweating, day and night, fear of heat, loose stools, and was diagnosed with spontaneous sweating and night sweats. The syndrome was diagnosed as qi and yin deficiency and damp-heat accumulation. She was given the Chinese medicine composition of Example 1 orally for 12 weeks. During the follow-up, the patient reported that her appetite and fear of heat were improved compared with before, and she did not sweat much in her daily life.

[0073] Case 2: Zhang, female, 52 years old, had spontaneous sweating for more than 2 months, mainly on the head and face, aggravated after activities, aversion to wind, easy to catch cold, pale red tongue, thin yellow fur, and stringy pulse. On June 3, 2022, she was diagnosed with spontaneous sweating in the outpatient department of the Department of Cardiology of our hospital, and the syndrome was diagnosed as deficiency of both qi and yin, and accumulation of dampness and heat. After taking the Chinese medicine composition of Example 1 orally for 6 weeks, the spontaneous sweating completely disappeared, and the remaining symptoms were improved.

[0074] Case 3: Yu, female, 77 years old, had obvious night sweats and poor sleep at night. She visited our outpatient clinic on April 23, 2024. Considering that the patient was old, had deficiency of both qi and yin, weak spleen and stomach, internal dampness, and deficiency heat, after taking the Chinese medicine composition of Example 1 orally for 4 weeks, her night sweats improved significantly, her sleep improved, and her life experience improved significantly.

[0075] Comparative Example 1

[0076] Wang, female, 57 years old, visited our outpatient clinic on January 7, 2025. She complained of dizziness, excessive sweating at night, dry mouth and bitter taste, poor sleep, yellow urine, red tongue with yellow fur, and stringy pulse. The patient was nearly 60 years old, with insufficient yin fluid, hyperactivity of yang and internal heat, and was given Danggui Liuhuang Decoction orally. The follow-up effect was poor.

[0077] After the patient subsequently took the Chinese medicine composition of Example 1 for 2 weeks, sweating was significantly reduced, indicating that the clinical efficacy of Example 1 is better than that of Danggui Liuhuang Decoction.

[0078] It can be seen from the above embodiments and application examples that the Chinese medicine composition provided by the present invention has good therapeutic effect, high cure rate, and no toxic ingredients. It can reduce the symptoms of spontaneous sweating and night sweats, has the effects of invigorating qi and nourishing yin, clearing away heat and dampness, and harmonizing the Ying and Wei, can effectively inhibit the progression of the disease, improve the quality of life of patients, and is safe.

[0079] The above embodiments are only for illustrating the technical idea of ​​the present invention, and cannot be used to limit the protection scope of the present invention. Any changes made on the basis of the technical solution in accordance with the technical idea proposed by the present invention shall fall within the protection scope of the present invention.

Claims

1. A Chinese medicine composition for treating hyperhidrosis, characterized in that: The Chinese medicine composition comprises raw materials in the following proportions: 10-50 parts of astragalus, 3-30 parts of ophiopogon, 1-15 parts of schisandra, 6-30 parts of angelica, 6-30 parts of prepared rehmannia, 6-30 parts of raw rehmannia, 3-20 parts of siler, 6-30 parts of atractylodes, 3-20 parts of scutellaria, 1-15 parts of coptis, 3-20 parts of phellodendron, 10-50 parts of gypsum, 3-30 parts of anemarrhena, 10-50 parts of floating wheat, 3-20 parts of cinnamon twig, and 3-30 parts of white peony root.

2. A Chinese medicine composition for treating hyperhidrosis according to claim 1, characterized in that: The Chinese medicine composition comprises raw materials in the following proportions: 20-40 parts of astragalus, 6-20 parts of ophiopogon, 3-12 parts of schisandra, 10-20 parts of angelica, 10-20 parts of prepared rehmannia, 10-20 parts of raw rehmannia, 5-15 parts of siler, 10-20 parts of atractylodes, 6-15 parts of scutellaria, 3-10 parts of coptis, 6-15 parts of phellodendron, 20-40 parts of gypsum, 10-20 parts of anemarrhena, 20-40 parts of aconite, 5-12 parts of cassia twig, and 5-12 parts of white peony root.

3. A Chinese medicine composition for treating hyperhidrosis according to claim 1, characterized in that: The Chinese medicine composition comprises raw materials in the following proportions: 30-35 parts of astragalus, 10-15 parts of ophiopogon, 5-10 parts of schisandra, 12-15 parts of angelica, 12-15 parts of prepared rehmannia, 12-15 parts of raw rehmannia, 6-10 parts of siler, 12-15 parts of atractylodes, 10-12 parts of scutellaria, 5-8 parts of coptis, 10-12 parts of phellodendron, 30-35 parts of gypsum, 12-15 parts of anemarrhena, 30-35 parts of floating wheat, 6-10 parts of cinnamon twig, and 6-10 parts of white peony root.

4. A Chinese medicine composition for treating hyperhidrosis according to any one of claims 1 to 3, characterized in that: The dosage form of the Chinese medicine composition is any one of a decoction, a Chinese medicine ointment, and a pill.

5. A Chinese medicine composition for treating hyperhidrosis according to claim 4, characterized in that: The dosage form of the Chinese medicine composition is a water decoction.

6. A method for preparing a Chinese medicine composition for treating hyperhidrosis, characterized in that: The raw material medicine is decocted with water to obtain the filtrate; the decocting comprises the following steps: The raw gypsum is mixed with water and then pre-decocted, and then the remaining raw materials and water are added to perform a first decoction to obtain a first filter residue and a first filtrate; The first filter residue is mixed with water and then subjected to a second decoction to obtain a second filter residue and a second filtrate; The first filtrate and the second filtrate are combined to obtain a filtrate.

7. The preparation method according to claim 6, characterized in that: In the pre-decoction, the mass ratio of gypsum to water is 1:(8-10), and the pre-decoction time is 0.5h; In the first decoction, the mass ratio of the total mass of the raw materials to the mass of the water added again is 1:(8-10), and the first decoction time is 1.25-1.5h; In the second decoction, the mass ratio of the first filter residue to water is 1:(6-8), and the time of the second decoction is 0.5-1.0h.

8. Use of the Chinese medicine composition according to any one of claims 1 to 5 in the preparation of a medicament for treating hyperhidrosis, characterized in that: The hyperhidrosis includes hyperhidrosis of spontaneous sweating and / or night sweating.

9. The use according to claim 8, characterized in that The location of the hyperhidrosis includes whole body or local.

10. The use according to claim 8 or 9, characterized in that: The local parts include the head and face or the palms and soles of feet.

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