Traditional Chinese medicine composition for preventing and treating climacteric insomnia and preparation method thereof

Abstract

The invention discloses a traditional Chinese medicine composition for preventing and treating climacteric insomnia. The traditional Chinese medicine composition is mainly prepared from cortex moutan, mantis egg-case, poria cocos, rhizoma anemarrhenae, pericarpium citri reticulatae, folium apocyni veneti, cortex albiziae, polygala tenuifolia, roses, herba lycopi, pericarpium arecae, fructus liquidambaris and the like according to a certain weight ratio. The traditional Chinese medicine can be prepared into any common oral dosage form. The whole formula has the effects of nourishing blood and soothing liver, activating blood and removing stasis, promoting qi circulation and inducing diuresis, and nourishing yin and clearing heat, and has an exact curative effect on preventing and treating climacteric insomnia.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of traditional Chinese medicine, in particular to a traditional Chinese medicine composition for preventing and treating menopausal insomnia and a preparation method thereof. The composition is composed of various traditional Chinese medicine raw materials in a specific ratio, has the effects of nourishing blood and soothing liver, promoting blood circulation to remove blood stasis, regulating qi and water, and nourishing yin and clearing heat, and is suitable for preventing and treating insomnia and related accompanying symptoms caused by yin-yang imbalance, liver stagnation and blood stasis, and restlessness of heart spirit in menopausal women. BACKGROUND

[0002] Insomnia refers to a disease syndrome characterized by frequent inability to obtain normal sleep due to external evil disturbing or deficiency of vital energy leading to spirit not resting. The nervous function syndrome, post-concussion syndrome, and high blood pressure, liver disease, hyperthyroidism, anemia, cerebral arteriosclerosis, chronic poisoning, and early stage of schizophrenia patients in western medicine all belong to the treatment category of insomnia. The drugs for treating insomnia in western medicine include benzodiazepine receptor agonists (such as estazolam, diazepam, alprazolam, etc.), non-benzodiazepine receptor agonists (such as zopiclone, zaleplon, etc.), melatonin receptor agonists (such as melatonin, agomelatine, etc.), antidepressants (such as mirtazapine, trazodone, etc.), antipsychotic drugs (olanzapine, quetiapine, etc.), antiepileptic drugs (gabapentin), etc.

[0003] The above-mentioned chemical drugs can relieve insomnia symptoms to a great extent, but cannot treat insomnia from the root. Long-term taking will not only cause body tolerance and increase liver and kidney burden, but also stimulate the gastrointestinal tract and harm various human tissues and organs to different degrees. Traditional Chinese medicine believes that a person's sleep is controlled by the heart and spirit, and the normal operation of the Ying and Wei and Yin and Yang is the basis for the heart and spirit to regulate sleep. The "Lingshu Ying Weisheng Hui" says: "Yin and Yang are connected, like a ring with no end …… Ying and Wei operate normally, so they are clear during the day and sleep at night." Any factor that affects the normal operation of Ying and Wei, blood, Yin and Yang, and makes the spirit restless will become the cause and mechanism of insomnia. Traditional Chinese medicine believes that the causes of insomnia mainly include the following five aspects: First, the invasion of external evils. The "Lingshu Xieke" says: "Evil spirits are guests, or they can make people's eyes not closed and not sleep out." Among the external evils, fire and heat are the direct causes, and others such as cold, dampness, and wind are indirect causes of insomnia. Second, emotional disorders. Emotional disorders such as excessive joy, anger, worry, thought, sadness, fear, and surprise are common direct causes of insomnia, and long-term mental strain is an important cause of long-term insomnia. Third, improper diet. Overeating and overdrinking are the primary causes of insomnia. "Suwen Nijiao Lun" says: "Yangming is the stomach meridian …… If the stomach is not harmonious, it will not sleep peacefully"; long-term eating of fatty and sweet foods can also indirectly cause insomnia; some beverages such as wine, coffee, and strong tea are direct causes of insomnia. Fourth, physical deficiency. It may be due to insufficient inheritance and heart and gallbladder deficiency, or due to aging and body weakness, such as the Ming Dynasty "Zhenzhi Zhunlun·Zhabing·Not Sleeping" says: "Old people, Yang deficiency, not sleeping". Fifth, people with chronic diseases. Insomnia often occurs during the course of various diseases or after the disease, and it may be due to body deficiency caused by long-term illness or internal damage caused by internal disturbance of phlegm and fire, resulting in insomnia. Traditional Chinese medicine believes that the pathogenesis of this disease is: any factor that directly affects the heart and spirit, such as external invasion of fire and heat, drinking strong tea, or excessive joy, sadness, fear, and surprise, will cause acute disease; any factor that mainly causes internal damage, such as body deficiency or other diseases, will generally cause slow disease.

[0004] Traditional Chinese medicine believes that this disease is that the heart does not contain the spirit, and the spirit is not at ease in its residence. The treatment is to eliminate evil and support the right, supplement deficiency and drain excess, and regulate blood to calm the heart and spirit.

[0005] Menopausal insomnia is one of the common diseases of middle-aged and elderly women. Menopausal insomnia is caused by the gradual decrease of ovarian estrogen secretion and the increase of pituitary gonadotropin, resulting in temporary neuroendocrine disorder, hypothalamic-pituitary-ovarian axis feedback system disorder, and autonomic nervous system dysfunction, and insomnia.

[0006] Menopausal insomnia is one of a series of somatic and neuropsychological symptoms caused by sex hormone fluctuation of women before and after menopause, often accompanied by other symptoms such as hot flashes, fever, self-sweating, night sweats, etc.; in addition, some autonomic nervous dysfunction symptoms such as palpitation, dizziness, headache, insomnia, tinnitus, etc. may also occur; insomnia is easy to cause symptoms such as inattention, emotional fluctuation, easy to excite, irritable, anxious, low mood, depression, unable to control emotions, memory decline, etc. SUMMARY

[0007] The present inventors have engaged in clinical work of menopausal syndrome for many years, and through screening of diagnosis and treatment of a large number of menopausal insomnia patients, and through clinical experiment verification, a traditional Chinese medicine composition with definite curative effect is determined, thereby creating the present application.

[0008] The purpose of the present application is to provide a traditional Chinese medicine composition for preventing and treating menopausal insomnia with definite curative effect.

[0009] Another purpose of the present application is to provide a preparation method of the traditional Chinese medicine composition.

[0010] The present application selects 15 kinds of traditional Chinese medicines, including cortex moutan, ground beetle, poria cocos, anemarrhena, dried tangerine or orange peel, roxburgh rose leaf, albizzia, polygala, rose flower, lamiophlomis, large belly skin, cantharis, cypress seed, motherwort, and mint, to play a synergistic role.

[0011] Cortex moutan is the dried root bark of Paeonia suffruticosa Andr. of Ranunculaceae. It is mainly produced in Anhui, Sichuan, Hunan, Hubei and Shaanxi. The root part is dug in autumn, the fine roots are removed, the root bark is peeled off, dried or the rough bark is scraped off, the wood core is removed, and then dried. The product has a fragrant aroma and a bitter and astringent taste; the good ones have thick bark, white and powdery cross section, strong aroma and sufficient powder; it is used raw or wine-fried. The medicinal property is bitter, pungent and cold; it belongs to heart, liver and kidney channels. The function is to clear heat and cool blood, and activate blood and resolve stasis. The product is bitter and cold, enters the heart and liver blood, and is good at clearing the heat of the blood system; it is used for treating fever caused by warm disease, forcing blood to run, causing rash, hematemesis and metrorrhagia, often used with water buffalo horn, radix rehmanniae, radix paeoniae rubra, etc.; it is used for treating warm disease rash, often used with gardenia, rhubarb, radix scutellariae, etc.; if used for treating blood heat hematemesis, it is often used with radix paeoniae rubra, radix mori, radix rubiae, etc. The product is bitter, pungent and cold, enters the blood system and is good at clearing the heat of the yin system, and is the main drug for treating bone steaming without sweating; it is often used with carapax trionycis, radix anemarrhenaeh, radix rehmanniae, etc. for treating warm disease in the late stage, evil hiding in the yin system, night fever and early cooling, heat subsiding without sweating; if there is bone steaming without sweating due to yin deficiency and internal heat, it is often used with radix rehmanniae, radix ophiopogonis, etc. The product is pungent and bitter, has the function of activating blood and resolving stasis, and is used for treating blood stasis, amenorrhea and dysmenorrhea, often used with peach kernel, chuanxiong, cassia twig, etc.; it is used for treating contusion and sprain, often used with safflower, frankincense, myrrh, etc. The product is bitter and cold, among clearing heat and cooling blood, and is good at resolving stasis and eliminating carbuncle, and is used for treating heat and toxic carbuncle, often used with rhubarb, radix angelicae sinensis, radix bupleuri, etc.; if used with rhubarb, peach kernel and mirabilite, it can be used for treating intestinal abscess caused by stasis and heat.

[0012] Chemical ingredients mainly contain peony phenol (paeonol), peony phenol glycoside, peony phenol proglycoside, peony phenol neoglycoside, paeoniflorin, oxidized paeoniflorin, benzoyl paeoniflorin, benzoyl oxidized paeoniflorin, etc., also contains gallic acid, volatile oil, etc. Pharmacological action: Paeonol has significant inhibitory effect on various experimental animal inflammations, has antipyretic effect on fever caused by cholera, typhoid, paratyphoid triple bacteria, and has sedative effect; total paeony glycoside also has significant anticonvulsant effect; peony water decoction has inhibitory effect on pathogenic bacteria such as dysentery bacillus, typhoid bacillus, and microbacterium testaceum, and various skin fungi. Peony extract, paeonol, paeoniflorin, benzoyl paeoniflorin, and benzoyl oxidized paeoniflorin can inhibit platelet aggregation and have antithrombotic effect; in addition, it also has analgesic, anti-allergic, anti-cardiac and cerebral ischemia, anti-atherosclerosis, anti-arrhythmia, antihypertensive, immune regulation, liver protection, kidney protection, and antitumor effects.

[0013] Peony has the dual effects of cooling blood and promoting blood circulation, and is used as the monarch drug in this prescription in large doses.

[0014] Sangpaojia is the dried egg case of the insects of the family Mantidae, such as Tenodera aridifolia, Mantis religiosa or Hierodula patruela. It is produced in most parts of the country. It is collected from late autumn to early spring, removed from impurities, steamed until the eggs are dead, and then dried. It has a slight fishy odor and a bland or slightly salty taste. The best product is complete, yellowish-brown, and with un-hatched eggs. It is used after being cut into pieces. The drug has a sweet and salty taste and is neutral in nature. It belongs to the liver and kidney channels. It has the functions of consolidating essence and urine, and tonifying the kidney and assisting yang.

[0015] The sweet flavor of the product can tonify and the salty flavor can enter the kidney and have astringent effect. It can tonify kidney qi, consolidate essence, and reduce urination. It is a good herb for treating spermatorrhea, enuresis, frequent urination, and leukorrhea due to kidney deficiency. It is often used with dragon bone, schisandra fruit, and processed aconite to treat spermatorrhea and ozoospermia due to kidney deficiency. It can be used alone as powder for treating enuresis in children. It can be used with polygala root, dragon bone, and turmeric to treat mental confusion, enuresis, frequent urination, and leukorrhea. The product has the function of tonifying the kidney and assisting yang, and can be used with deer horn, cistanche, and milkvetch seed to treat impotence due to kidney deficiency.

[0016] The chemical components mainly include proteins, fats, amino acids, vitamins, and trace elements. Pharmacological action: Sangpaojia alcohol extract can reduce the urine volume of rats with ethanol anesthesia and polyuria, has certain antidiuretic effect, can prolong the normal pressure anoxia time of mice, and prolong the swimming time of mice, has anti-anoxia and anti-fatigue effects, and can significantly reduce the content of malondialdehyde in liver tissue, has antioxidant effect.

[0017] Sangpaojia acts as a ministerial drug in this prescription, assisting the monarch drug to tonify the kidney and consolidate essence.

[0018] Poria is the dried sclerotium of Poria cocos (Schwein.) Wolf, mainly produced in Anhui, Yunnan and Hubei. It is usually collected from July to September, removed of dirt and sand, piled up for "sweating", spread out and dried until the surface is dry, then "sweated" repeatedly for several times until wrinkles appear and most of the internal moisture is lost, and dried in the shade, which is called "Poria individual". Or fresh Poria is cut into different parts and dried in the shade, which are called "Poria block" and "Poria slice", respectively. Poria has a slight odor and a bland taste. The best one is white and fine in section, with strong adhesion. It is used raw. Poria has sweet and bland flavor, and is neutral in nature. It is associated with the heart, lung, spleen and kidney meridians. Poria has the functions of promoting water metabolism, removing dampness, invigorating the spleen and calming the heart and soothing the nerves.

[0019] Poria has sweet and bland flavor, and is neutral in nature. It can both expel pathogenic factors and support the healthy qi. It can promote water metabolism without damaging healthy qi. It is the main herb for promoting water metabolism and reducing edema. It is used for treating edema of various types of cold, heat, deficiency and excess, and for treating edema and dysuria caused by internal retention of water-dampness, often combined with Alisma orientalis (Sam.) Juzep, Sclerotium of Wolfiporia sagittata (Fr.) Ryvarden, and Atractylodes macrocephala Koidz et Nob. It is used for treating edema due to deficiency of the spleen and kidney, often combined with Aconitum carmichaeli Debx, and Rhizoma Zingiberis recens. It is used for treating edema due to retention of water and heat, and for treating edema due to deficiency of the yin, often combined with Natrii sulfas, Colla Corii Asini, and Alisma orientalis (Sam.) Juzep. Poria is good at promoting water metabolism and removing dampness, so that dampness is not accumulated and phlegm is not generated. It is used for treating dizziness and palpitation due to phlegm-dampness, often combined with Ramulus Cinnamomi, Atractylodes macrocephala Koidz et Nob, and Glycyrrhizae Radix. If the patient has vomiting due to retention of fluid in the stomach, Poria is often combined with Rhizoma Pinelliae and Rhizoma Zingiberis recens. Poria has sweet flavor and enters the spleen meridian. It can invigorate the spleen and supplement the center, remove dampness and stop diarrhea, make the middle-jiao clear and ascending and the turbid descending, especially for treating diarrhea due to dampness and spleen deficiency. It is often combined with Radix Dioscoreae, Atractylodes macrocephala Koidz et Nob, and Coix lachryma-jobi L. var. ma-yuen (Roman.) Stapf. It is used for treating spleen-stomach deficiency, lassitude, debility, poor appetite and loose stools, often combined with Radix et Rhizoma Ginseng, Atractylodes macrocephala Koidz et Nob, and Glycyrrhizae Radix. Poria can invigorate the heart and spleen, calm the heart and soothe the nerves. It is often used for treating palpitation, insomnia and amnesia due to deficiency of the heart and spleen, often combined with Radix Astragali seu Hedysari, Angelica sinensis (Oliv.) Diels, and Polygalae Radix. If the patient has insomnia due to deficiency of the heart qi, Poria is often combined with Radix et Rhizoma Ginseng, Radix et Rhizoma Gastrodiae, and Polygalae Radix.

[0020] The chemical constituents of Poria mainly include polysaccharides, triterpenoids, sterols, and others. The content of β-pachyman is the highest. The triterpenoids include pachymic acid, pachymic acid, and fomesone. The sterols include ergosterol. Poria also contains protein, fat, lecithin, and adenine. Poria decoction, syrup, alcohol extract, and ether extract have the functions of diuresis, sedation, anti-tumor, and increasing the contractility of myocardium. Pachymic acid has the function of enhancing immune function.

[0021] Poria is a ministerial herb in this formula, which assists the monarch herbs to invigorate the heart and spleen, calm the heart and soothe the nerves.

[0022] Anemarrhena asphodeloides Bunge is the dried rhizome of Anemarrhena asphodeloides Bunge, mainly produced in Hebei, Shanxi, Shaanxi and Inner Mongolia. It is usually collected in spring and autumn, removed of roots and dirt, dried in the sun, and called "Mao Anemarrhena asphodeloides Bunge". Or the skin is removed, dried in the sun, and cut into slices. Anemarrhena asphodeloides Bunge has a slight odor and a sweet and slightly bitter taste, with adhesion when chewed. The best one is yellowish white in section. It is used raw or fried with salt water. Anemarrhena asphodeloides Bunge has bitter and sweet flavors, and is cold in nature. It is associated with the lung, stomach and kidney meridians. Anemarrhena asphodeloides Bunge has the functions of clearing heat and purging fire, and nourishing yin and moistening dryness.

[0023] It enters the kidney channel, can nourish kidney yin, purge kidney fire and relieve bone dryness. It is used to treat kidney yin deficiency, yin deficiency with excessive fire, bone dryness with tidal fever, spermatorrhea and night sweat. It has the functions of clearing heat, purging fire, nourishing yin and moistening dryness, and is often used to treat internal heat and dryness, polydipsia and polyuria. It can also nourish yin and moisten dryness to relieve constipation.

[0024] The chemical components mainly include saponins (zizyphi wilsonii A-I, A-II, zizyphi wilsonii B-I, B-II, etc.), zizyphi wilsonii polysaccharides, mangiferin, isomangiferin, alkaloids and organic acids, etc. Pharmacological effects: Zizyphi wilsonii extract has antipyretic effect, can prevent high fever caused by E. coli in rabbits and has long-lasting effect; it can inhibit platelet aggregation, lower blood sugar, anti-inflammatory, diuretic, expectorant, antibacterial, anticancer, anti-ulcer, improve learning and memory ability, protect brain ischemic injury, etc.; the saponins contained can significantly reduce the increased oxygen consumption rate caused by thyroid hormone, inhibit Na+, K+-ATPase activity; and can also adjust the relationship between β-adrenergic receptors and M-cholinergic receptors.

[0025] Zizyphi wilsonii acts as a ministerial herb in this prescription, assisting the monarch herb to tonify the kidney and nourish yin.

[0026] Pericarpium Citri Reticulatae is the dried mature pericarp of Citrus reticulata Blanco and its cultivated varieties, mainly produced in Guangdong, Guangxi, Fujian, Sichuan and Jiangxi. The mature fruits are picked, the pericarp is peeled off and dried or dried at low temperature. The medicinal material is divided into "pericarpium citri reticulatae" and "Guangdong pericarpium citri reticulatae", with bright color and strong aroma being the best. It is used raw after being cut into shreds. It has a fragrant aroma, bitter and pungent taste, warm nature, and enters the spleen and lung channels. It has the functions of regulating qi and invigorating the spleen, drying dampness and reducing phlegm.

[0027] It has the functions of regulating qi, relieving distension, drying dampness and relieving constipation. It is used to treat abdominal distension, poor appetite, vomiting and diarrhea caused by qi stagnation and dampness accumulation in the spleen and stomach. It is most suitable for cold-dampness accumulation in the middle-jiao. It can be used alone for mild qi stagnation, or combined with Aucklandia, Fructus Aurantii Immaturus, etc. for severe qi stagnation. It can be combined with Atractylodes, Magnolia officinalis, etc. for cold-dampness accumulation in the spleen and stomach. It can be combined with Hovenia dulcis, Massa Medicata Fermentata, etc. for food accumulation and qi stagnation. It can be combined with Radix et Rhizoma Ginseng, Atractylodes Macrocephala, Poria, etc. for spleen deficiency, poor appetite and abdominal distension after eating. It has the property of bitter descending, and can be used to treat vomiting and hiccup. It is the best herb for treating vomiting and hiccup. It can be used alone or combined with ginger for cold types, combined with bamboo shoots and gardenia for heat types, and combined with Radix et Rhizoma Ginseng, bamboo shoots and jujube for complex types. It has bitter and warm properties, and is good at drying dampness and reducing phlegm, and can regulate qi and relieve chest stuffiness. It is used to treat damp-phlegm cough, combined with Pinellia ternata, Poria, etc. It is used to treat cold-phlegm cough, combined with dried ginger, Herba et Radix Sargentodoxae, Pinellia ternata, etc. It has a pungent aroma, enters the lung and moves through the chest, and can regulate qi, relieve obstruction and stop pain. It is used to treat chest obstruction and shortness of breath caused by phlegm and qi accumulation, combined with Fructus Aurantii Immaturus, ginger, etc.

[0028] Chemical ingredients mainly contain volatile oil, flavones or flavone ingredients, organic amine and trace elements, etc.; volatile oil mainly contains limonene, γ-terpinene, etc.; flavone ingredients mainly contain hesperidin, neohesperidin, citropten, naringin, neohesperidin, etc. Pharmacological action: Chenpi decoction has obvious promoting effect on salivary amylase activity, can inhibit the spontaneous activity of isolated duodenum of rabbits, and make contraction and tonicity decrease; has direct inhibitory effect on isolated and in-vivo stomach and intestinal movement. Volatile oil can relax isolated bronchial smooth muscle of guinea pigs, and water extract and volatile oil can block the contraction spasm of bronchial smooth muscle caused by chloroacetylcholine and histamine, have the effects of relieving asthma and relieving cough; volatile oil has stimulating expectorant effect, and the main effective component is limonene; the product also has the effects of increasing blood pressure, resisting platelet aggregation, resisting oxidation, resisting aging, strengthening heart, resisting shock, resisting allergy, resisting tumor, inhibiting bacteria, contraception, resisting ultraviolet radiation, insect killing, etc.

[0029] Chenpi is used as a ministerial drug in the prescription, and assists the monarch drug to play the role of promoting qi and resolving phlegm, removing stagnation and regulating stomach; traditional Chinese medicine believes that "if stomach is not harmonious, sleep will be uneasy", and Chenpi indirectly helps sleep by regulating stomach.

[0030] Apocynaceae Rubus suavissimus leaf is the dried leaf of Rubus suavissimus, mainly produced in Inner Mongolia, Gansu and Xinjiang; it is collected in summer, impurities are removed, and then dried. The product has slight odor and tastes bland; the better one is green in color, complete in leaf blade and free of ash; it is used in segments. The medicine tastes bitter and sweet, is cool in nature, and belongs to liver meridian; it has the effects of calming liver and soothing nerves, clearing heat and promoting diuresis.

[0031] The product tastes bitter and is cool in nature, and enters liver meridian; it has the effects of calming liver yang and clearing liver heat, and can be used to treat dizziness, restlessness and insomnia caused by hyperactivity of liver yang and attack of liver fire; it can be used alone or combined with oyster, concha murex, red ochre, etc. to treat the syndrome of hyperactivity of liver yang; or combined with Gouteng, Xihucuo, Yekewa, etc. to treat the syndrome of attack of liver fire. If there is palpitation and insomnia, it can be combined with Longgu, Cishan, Ruzhizhi, etc. to calm the nerves. The product can clear heat and promote diuresis, and can be used alone or combined with Fuling, Zexie, Cheqianzi, etc. to treat edema, oliguria and heat.

[0032] Chemical ingredients mainly contain flavone ingredients: hyperoside, rutin, kaempferol, quercetin, etc.; organic acid ingredients: fumaric acid, succinic acid, chlorogenic acid, etc.; and tannin, anthraquinone, amino acid, etc. Pharmacological action: the product has the effects of dilating blood vessels, reducing blood pressure, resisting atherosclerosis, slowing heart rate, calming, resisting convulsions, resisting depression, diuresis, reducing blood lipids, regulating immunity, resisting aging, resisting influenza virus, etc.

[0033] In the present application, Rubus suavissimus leaf is used as a ministerial drug, and assists the monarch and ministerial drugs to play the effects of calming liver yang and clearing heat and soothing nerves.

[0034] Melia toosendan is the dried bark of Melia toosendan, which is produced in most parts of China. It is peeled off in summer and autumn, and dried. The product has a slight fragrance, a mild, bitter taste, and a slightly astringent and slightly pungent aftertaste. The bark is tender and has obvious pores. It is used raw. The drug has a sweet taste and a neutral nature, and is related to the heart, liver, and lung meridians. It has the functions of relieving depression and soothing the liver, and is used to treat emotional depression, irritability, and insomnia caused by emotional depression, restlessness, and other symptoms.

[0035] The product has a sweet and neutral nature, and enters the heart and liver meridians. It is good at soothing the liver and relieving depression, and is suitable for treating emotional depression, irritability, and insomnia caused by emotional depression, restlessness, and other symptoms. It can make the five internal organs harmonious and the heart happy, and has the effect of relieving depression and soothing the liver. It is a key drug for soothing the liver and relieving depression, and can be used alone or combined with other drugs such as Suanzaoren, Shouwuteng, and Yujin to relieve depression and soothe the liver. The product has the functions of promoting blood circulation and reducing swelling, and can dissipate internal and external abscesses. It is used to treat lung abscess and chest pain, and can be combined with Yuxingcao, Dongguaren, and Lugen to clear heat, reduce abscesses, and discharge pus. It is also used to treat sores and abscesses, and is often combined with Pugongying, Zihua Diding, and Lianqiao to clear heat and relieve toxicity. The product enters the heart and liver blood, and can promote blood circulation and remove blood stasis. It is used to treat sprains and pains, and is often combined with Ru Xiang, Muyan, and Gushugubao to promote blood circulation and treat injuries.

[0036] The main chemical components of the product include lignans: syringaresinol-4-O-β-D-glucopyranosyl-(1→2)-β-D-glucopyranoside, syringaresinol-4-O-β-D-glucopyranosyl-(1→2)-β-D-glucopyranosyl-4, glucopyranoside; terpenes, saponins, and tannins. The pharmacological effects of the product include: decoction of Melia toosendan, alcohol extract, and total saponins of Melia toosendan have a sedative effect, saponins of Melia toosendan have an anti-fertility effect, methanol extract of Melia toosendan, polysaccharides of Melia toosendan, and ethanol extract of Melia toosendan have an anti-tumor effect, and ethanol extract of Melia toosendan and water extract have an immune-enhancing effect.

[0037] In the present application, Melia toosendan is used as an auxiliary drug to assist the monarch and minister drugs, and has the functions of soothing the liver and relieving depression, and soothing the liver and relieving depression. Menopausal insomnia has its particularity. Menopausal women have imbalance of yin and yang, irritability, and other symptoms. Melia toosendan can relieve menopausal insomnia and other symptoms at the same time.

[0038] Polygala is the dried root of Polygalaceae Polygala or Ovate Polygala, which is mainly produced in Shanxi, Shaanxi, Hebei, and Henan. It is harvested in spring and autumn, and is dried after removing the roots and mud. The product has a slight smell and a bitter and slightly pungent taste. It has a throat-irritating effect when chewed. The product is grayish yellow, thick, and has a clean core. It is used raw or roasted. The drug has a bitter and pungent taste, and a warm nature. It is related to the heart, kidney, and lung meridians, and has the functions of soothing the heart and kidney, removing phlegm and opening the orifices, and dissipating abscesses.

[0039] This herb is bitter, pungent, and warm in nature, with a strong ability to promote circulation and open up the mind. It can both open the heart qi and calm the mind, and also invigorate the kidney qi and strengthen the will and memory. It is an excellent herb for harmonizing the heart and kidneys, stabilizing the mind, and improving intelligence and memory. It is suitable for restlessness, insomnia, dreaminess, forgetfulness, palpitations, and mental confusion caused by disharmony between the heart and kidneys. It is often used with calming herbs such as Poria cocos, fossilized teeth, and cinnabar. For forgetfulness, it is often used with ginseng, Poria cocos, and Acorus tatarinowii. If Poria cocos is added to the formula, it becomes the "Forgetfulness Powder". This herb is pungent and unblocking, and can benefit the heart orifices and expel phlegm. Therefore, it can be used to treat epilepsy, convulsions, and mania caused by phlegm obstructing the heart orifices. For epilepsy with fainting spells and convulsions, it can be combined with phlegm-resolving and wind-calming herbs such as Pinellia ternata, Gastrodia elata, and Scorpion. For mania caused by convulsions, it is often used with phlegm-resolving and orifice-opening herbs such as Acorus tatarinowii, Curcuma longa, and Alum. This herb is bitter, warm, and drying in nature, entering the lung meridian. It can resolve phlegm and stop coughing, so it can be used to treat excessive, sticky phlegm and difficulty expectorating. It is often used in combination with other expectorant, cough-suppressing, and asthma-relieving herbs such as bitter almond, fritillaria cirrhosa, and platycodon grandiflorus. This herb is pungent, bitter, and warm, which can clear stagnation of qi and blood and dissipate carbuncles and swellings. It is used for sores, boils, and breast swelling and pain, and can be taken internally or externally. For internal use, it can be powdered and taken with rice wine. For external use, it can be steamed until soft, mashed with a small amount of rice wine, and applied to the affected area.

[0040] The main chemical components include saponins, ketones (also known as benzovinone), phenolic glycosides such as 3,6-disinoyl sucrose; it also contains alkaloids, 3,4,5-trimethoxycinnamic acid, polygalactoside, polygalactoside alkaloid, fatty oil, resin, tetrahydrotetrahydrofenamic acid, etc. Pharmacological effects: Polygala tenuifolia has sedative, hypnotic and anticonvulsant effects; polygala saponins have expectorant, antitussive and hypotensive effects; polygala alcohol has analgesic effects; polygala decoction has antioxidant and anti-aging effects; polygala water extract has a protective effect on the brain; polygala root water extract has a preventive effect on various inflammatory encephalopathy; polygala saponins have immune-enhancing, myocardial contractility-reducing, heart rate-slowing, antibacterial, antiviral and hemolytic effects; the methanol extract of polygala tenuifolia has hypoglycemic and hypolipidemic effects; the crude extract of polygala tenuifolia has choleretic, diuretic and anti-edema effects; the decoction and water-soluble extract of polygala tenuifolia have anti-aging, anti-mutagenic and anti-cancer effects, respectively.

[0041] In this invention, Polygala tenuifolia is used as an adjuvant to assist the principal and assistant drugs, and plays a role in calming the mind and improving intelligence, harmonizing the heart and kidneys, clearing phlegm and opening the orifices, and regulating yin and yang.

[0042] Roses are the dried flower buds of the rose plant (Rosa rugosa), a member of the Rosaceae family. They are mainly produced in Jiangsu and Zhejiang provinces. They are harvested in batches in late spring and early summer when the flowers are about to bloom and dried at low temperatures in a timely manner. The product has a strong and fragrant aroma and a slightly bitter taste. The best quality roses are purplish-red in color, large in size, and have a strong fragrance. They are used raw. The medicinal taste is sweet and slightly bitter, and the nature is warm. It enters the liver and spleen meridians and has the functions of regulating qi and relieving depression, harmonizing blood, and relieving pain.

[0043] It has the functions of soothing liver, regulating qi and relieving pain, and can be used to treat distending pain in chest, hypochondrium, abdomen and stomach caused by liver-stomach disharmony, and can be used in combination with rhizoma cyperi, fructus citri sarcodactylis and fructus amomi etc. It can also be used to treat irregular menstruation and premenstrual breast distending pain, and can be used in combination with angelica sinensis, ligusticum wallichii and radix paeoniae alba etc. It has the functions of soothing liver, regulating qi and relieving pain, and can be used to treat irregular menstruation and premenstrual breast distending pain, and can be used in combination with angelica sinensis, ligusticum wallichii and radix paeoniae alba etc. It has the functions of soothing liver, regulating qi and relieving pain, and can be used to treat irregular menstruation and premenstrual breast distending pain, and can be used in combination with angelica sinensis, ligusticum wallichii and radix paeoniae alba etc.

[0044] The chemical components mainly include volatile oil (rose oil, citronellol, geraniol, nerol, eugenol, phenethyl alcohol, etc.), quercitrin, tannin, fatty oil, organic acid, etc. Pharmacological action: rose oil has the effect of promoting bile secretion in rats.

[0045] In the present application, rose is used as an auxiliary medicine to assist the monarch and minister medicines, and has the effects of regulating qi and blood, relieving depression and soothing the nerves.

[0046] Lamiophlomis rotata is the dried aerial part of Lamiophlomis rotata (Benth.) Kudo of Labiatae, which is produced in most areas of China. The stems and leaves are harvested in summer and autumn when they are in full growth, and then dried. The product has a slight odor and a mild taste. The best product is gray-green in color, tender in quality, and has more leaves. It is used in sections and used raw. The medicine has a bitter and pungent taste, and is slightly warm in nature. It is related to the liver and spleen meridians, and has the functions of activating blood and regulating menstruation, removing blood stasis and resolving abscess, and promoting water excretion and reducing swelling.

[0047] The product has the functions of dispersing and removing, warming and unblocking, and is good at activating blood and regulating menstruation. It is often used for treating gynecological diseases caused by blood stasis. It can be used to treat blood stasis and irregular menstruation, and is often used in combination with angelica sinensis, radix paeoniae rubra and herba schizonepetae etc. It can also be used to treat irregular menstruation caused by blood stasis and blood deficiency, and is often used in combination with angelica sinensis and radix paeoniae alba etc. It can activate blood and remove blood stasis to reduce swelling and relieve pain, and can be used to treat traumatic injury, sore and abscess. It can be used to treat traumatic injury and swelling and pain, and can be used alone or in combination with angelica sinensis, safflower and semen persicae etc. It can be used to treat chest and hypochondrium injury and pain, and is often used in combination with salvia miltiorrhiza, rhizoma curcumae and rhizoma corydalis etc. It can be used to treat sore and abscess, and can be used alone or in combination with honeysuckle, rhizoma coptidis and radix paeoniae rubra etc. It can activate blood and remove blood stasis, and can also promote water excretion and reduce swelling. It is especially suitable for treating edema caused by blood stasis and water stasis. It can be used to treat postpartum edema, and is often used in combination with radix stephaniae tetrandrae etc. It can be used to treat abdominal edema, and is often used in combination with rhizoma atractylodis, poria cocos and radix stephaniae tetrandrae etc.

[0048] The chemical components mainly include volatile oil, glucoside, tannin, resin, flavonoid glycoside, phenol, amino acid, organic acid, saponin, lamiophlomis rotata sugar, stachyose, galactose and fructose etc. Pharmacological action: lamiophlomis rotata decoction can reduce blood viscosity, fibrinogen content, hematocrit and erythrocyte electrophoresis time, reduce red blood cell aggregation, inhibit platelet aggregation, prevent blood clotting and thrombosis, improve microcirculation, and regulate blood lipid metabolism. Lamiophlomis rotata whole herb preparation has the effect of strengthening heart, and lamiophlomis rotata water extraction and alcohol precipitation liquid has the effect of promoting bile secretion and protecting liver. Lamiophlomis rotata and different polar parts have the effect of removing free radicals.

[0049] In this invention, Lycopus lucidus is used as an adjuvant to assist the principal and assistant drugs in promoting blood circulation, removing blood stasis, reducing swelling, aiding blood circulation, and restoring yin-yang balance.

[0050] Areca peel is the dried pericarp of the areca palm (Areca catechu), a plant in the palm family. It is mainly produced in Indonesia, India, and the Philippines abroad; and in Hainan, Guangdong, Yunnan, and Taiwan domestically. The immature fruits are harvested from winter to the following spring, boiled, dried, and then split lengthwise in half to remove the pericarp, commonly known as "areca peel." It has a faint odor and a slightly astringent taste; the best quality is yellowish-white in color and pliable in texture, and is used raw. Its medicinal properties are pungent and slightly warm, and it enters the spleen, stomach, large intestine, and small intestine meridians. Its functions include regulating qi, relieving chest congestion, and promoting diuresis to reduce swelling.

[0051] This herb is pungent and dispersing, entering the spleen, stomach, and large intestine meridians. It can promote qi circulation, relieve stagnation, and relieve abdominal distension caused by dampness and qi stagnation. It can be used with agastache, tangerine peel, and magnolia bark. It can also be used with hawthorn, malt, and immature bitter orange to treat abdominal distension, constipation, or incomplete diarrhea caused by food stagnation and qi stagnation. This herb can promote qi circulation, diuresis, and reduce swelling. It can be used with poria peel and eleutherococcus peel to treat edema and difficulty urinating. It can also be used with mulberry bark, areca nut, and papaya to treat beriberi with swelling and difficulty urinating.

[0052] The main chemical components include arecoline, arecoside, α-catechin, etc. Pharmacological effects: This product has the effects of stimulating gastrointestinal smooth muscle, promoting gastrointestinal motility, promoting fibrinolysis, and killing tapeworms.

[0053] In this invention, Areca peel is used as an adjuvant to assist the principal and assistant drugs in exerting their effects of promoting qi circulation, diuresis, eliminating stagnation, relieving depression, and calming the mind.

[0054] *Liquidambar formosana*, a plant in the Hamamelidaceae family, is the dried, mature fruit cluster of the *Liquidambar formosana*. It is mainly produced in Jiangsu, Zhejiang, Anhui, Jiangxi, and Fujian provinces. The fruit is harvested in winter after ripening, impurities are removed, and then it is dried. This product has a slight odor and a bland taste; the best quality is yellow in color and large in size. It is used raw. The medicinal taste is bitter, and the nature is neutral; it enters the liver and kidney meridians, and its functions include dispelling wind and activating collaterals, promoting diuresis, and regulating menstruation.

[0055] This herb can dispel wind and dampness, relax muscles and tendons, and unblock meridians. It is effective in treating rheumatic pain, numbness, and contractures, and is often combined with herbs such as *Lycopodium clavatum*, *Trachelospermum jasminoides*, and *Gentiana macrophylla*. For stagnation of qi and blood, obstruction of meridians, and hemiplegia after stroke, it can be used with herbs such as *Astragalus membranaceus*, *Ligusticum chuanxiong*, and *Carthamus tinctorius*. This herb is bitter and has a descending and purging effect, and can promote diuresis and reduce swelling, treating edema and abdominal distension, often used with herbs such as *Poria cocos*, *Polyporus umbellatus*, and *Alisma plantago-aquatica*. This herb can unblock meridians and disperse blood stasis and relieve pain, treating traumatic injuries, swelling, and pain, often... It can be used in combination with peach kernel, safflower, sappanwood, etc.; this product can soothe the liver and regulate qi and promote menstruation, and treat menstrual disorders or amenorrhea caused by qi stagnation and blood stasis, as well as lower abdominal distension and pain. It is often used in combination with angelica, chuanxiong, leonurus japonicus, etc.; this product can promote menstruation and lactation, and is often used in combination with pangolin scales, vaccaria segetalis, green tangerine peel, etc.; it can treat insufficient lactation, breast distension and pain, or insufficient milk production; this product can dispel wind and relieve itching, and is used for urticaria and itching. It can be used in combination with kochia scoparia, tribulus terrestris, sophora flavescens, etc., for internal use or external washing.

[0056] Chemical ingredients mainly contain labdanum acid, stigmasterol, suhe xiang acid, caryophyllene, birch ketone acid, etc. Pharmacological action: labdanum has inhibitory effect on egg albumen arthritis swelling, and its methanol extract birch ketone acid has obvious anti-hepatocyte toxicity activity.

[0057] In the application, labdanum as a medicinal auxiliary, auxiliary monarch drug, minister drug, play through the channel, active water, and the effect of eliminating accumulation, and the effect of nourishing yin and blood.

[0058] Platycladus orientalis is the dried mature seed of Platycladus orientalis of Cupressaceae, mainly produced in Shandong, Henan and Hebei. The mature seeds are collected in autumn and winter, dried, and the seed coat is removed. The product has a slight fragrance, a mild taste, and is better with full grains, yellowish white color and high oiliness. It is used raw or made into cream. The medicine has a sweet taste, a neutral nature, and is related to the heart, kidney and large intestine channels. It has the effects of nourishing the heart, calming the nerves, moistening the intestines, and relieving constipation.

[0059] The product has a sweet and moist taste, a neutral nature, and is mainly related to the heart channel. It has the effect of nourishing the heart and calming the nerves. It is often used for heart palpitations, restlessness, insomnia, dizziness and forgetfulness due to deficiency of heart yin and blood, and is often used with ginseng, schisandra chinensis, and jujube kernel. It is often used with ophiopogon japonicus, rehmannia glutinosa and acorus gramineus for treating heart palpitations, insomnia and forgetfulness due to heart-kidney disharmony, and dream and forgetfulness. The product is rich in oil and has the effect of moistening the intestines and relieving constipation. It is often used with yuliuren, pine kernel and apricot kernel for treating constipation due to yin deficiency and blood deficiency, such as old age and postpartum. The product has a sweet and moist taste, and can also tonify yin to stop sweating. It can also be used to treat yin deficiency and night sweat, and is often used with jujube kernel, oyster and ephedra root to stop sweating.

[0060] Chemical ingredients mainly contain cypress alcohol, sitosterol and diterpene components, also contain fatty oil, and contain a small amount of volatile oil, saponin, vitamin A and protein, etc. Pharmacological action: Platycladus orientalis extract has the effect of prolonging slow wave sleep period, and the petroleum ether extract of Platycladus orientalis has a mild promoting effect on the growth of chicken embryo dorsal root ganglion sprouts, and the ethanol extract of Platycladus orientalis has an improving effect on passive avoidance learning of mice with basal forebrain damage.

[0061] In the application, Platycladus orientalis as a medicinal auxiliary, auxiliary monarch drug, minister drug, play through the channel, active water, and the effect of eliminating accumulation, and the effect of nourishing yin and blood.

[0062] Motherwort is the fresh or dried aboveground parts of Motherwort of Labiatae, which is produced in most parts of China. Fresh products are harvested in spring from young seedlings to early summer before flowering, dried products are harvested in summer when stems and leaves are lush and flowers are not yet open or are just opening, dried or cut and dried, fresh or raw; the drinking pieces are irregular segments, the stem is square, the four sides are concave into longitudinal grooves, gray-green or yellow-green, the cross section has white pith in the middle, the leaf blade is gray-green, and is mostly shriveled; the corymb inflorescence is axillary, the flowers are yellow-brown, the calyx is tubular, the corolla is labiate, the smell is slight, and the taste is slightly bitter. The medicine has a bitter taste, a slightly cold nature, and is related to the heart, liver and bladder channels; it has the effects of activating blood, regulating menstruation, promoting water and eliminating swelling, and clearing heat and resolving toxins.

[0063] This herb is pungent and bitter, primarily entering the blood level. It excels at invigorating blood circulation, regulating menstruation, removing blood stasis, and promoting menstruation, making it an essential medicine for gynecological and obstetric diseases. For treating dysmenorrhea and amenorrhea due to blood stasis, it can be used alone as a decoction, such as motherwort extract or motherwort paste. For treating postpartum lochia retention, abdominal pain due to blood stasis, difficult labor, or fetal death in utero, it can be used alone as a decoction or as a paste, or combined with other herbs such as angelica, chuanxiong, and frankincense. This herb can both promote diuresis and reduce swelling, and invigorate blood circulation and remove blood stasis, making it particularly suitable for edema caused by water retention and blood stasis. It can be used alone or combined with herbs such as imperata root and eupatorium. For treating hematuria and urinary tract infections due to blood heat and blood stasis, it is often combined with herbs such as plantain seed, pyrrosia, and akebia. This product is pungent and bitter, cold in nature and clears heat. It can both promote blood circulation and remove blood stasis to relieve pain, and clear heat and detoxify to reduce swelling. It is used for traumatic injuries, blood stasis and swelling. It can be used with Chuanxiong, Danggui and other herbs. For treating carbuncles and boils, it can be used alone for external washing or application, or it can be combined with Huangbai, Pugongying, Kushen and other herbs to make a decoction for internal use.

[0064] The main chemical components include alkaloids such as leonurine, stachydrine, and leonuridine, as well as diterpenoids and volatile oils. Pharmacological effects: Leonurus japonicus decoction, ethanol extract, and leonurine have uterine-stimulating effects and exhibit some anti-implantation and anti-early pregnancy effects in mice; Leonurus japonicus injection can protect against myocardial ischemia-reperfusion injury, inhibit platelet aggregation, and reduce blood viscosity; crude extract of Leonurus japonicus can dilate blood vessels and has a transient hypotensive effect; leonurine has a significant diuretic effect.

[0065] In this formula, motherwort is used as an adjuvant to assist the principal and assistant herbs, exerting the effects of promoting blood circulation and diuresis, clearing heat and relieving irritability, and calming the mind and soothing the nerves.

[0066] Peppermint is the dried aerial part of the plant *Mentha haplocalyx*, belonging to the Lamiaceae family. It is mainly produced in Jiangsu and Zhejiang provinces. Harvesting is done in stages during the summer and autumn when the stems and leaves are lush or when the flowers have bloomed three times. The peppermint is then sun-dried or shade-dried and cut into sections. When rubbed, it has a unique cool aroma and a pungent, cool taste. The best quality peppermint has abundant leaves, a green color, and a strong aroma. It is used raw. Medicinally, it is pungent and cool in nature, entering 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.

[0067] This herb is pungent and dispersing, cool and clearing heat. Its pungent and dispersing properties are relatively strong, making it the most effective diaphoretic among pungent-cool exterior-releasing herbs in dispersing external pathogens. It also has a certain diaphoretic effect, making it a commonly used herb for dispersing wind-heat. Therefore, it is frequently used for wind-heat colds and febrile diseases in the Wei level. When used to treat wind-heat colds or the initial stage of febrile diseases, with pathogens in the Wei level, symptoms such as fever, slight aversion to wind and cold, and headache, it is often combined with honeysuckle, forsythia, and burdock fruit, as in Yinqiao Powder. This herb is light and ascending, aromatic and clearing the orifices, effectively dispersing wind-heat in the upper burner, clearing the head and eyes, and benefiting the throat. When used to treat wind-heat attacking upwards, causing headache and dizziness, it should be combined with wind-dispelling, heat-clearing, and pain-relieving herbs such as chuanxiong, gypsum, and angelica. For treating red and watery eyes due to wind-heat attacking upwards, it can be used with mulberry leaves, chrysanthemum, and vitex fruit. For treating wind-heat accumulation and sore throat, it is often combined with platycodon, licorice root, and silkworm. This herb is light and dispersing, possessing the functions of dispersing wind-heat, promoting detoxification and rash eruption, and relieving itching. It is used to treat wind-heat binding the exterior and measles that fail to erupt, often combined with cicada slough, burdock fruit, and tamarisk, as in the Bamboo Leaf and Burdock Decoction. For treating itchy rashes, it can be used with schizonepeta, saposhnikovia, and silkworm, among other wind-dispelling and itching-relieving herbs. This herb also enters the liver meridian, soothing the liver and regulating qi. It is often combined with bupleurum, white peony root, and angelica root, among other liver-soothing, qi-regulating, and menstruation-regulating herbs, to treat liver qi stagnation, chest and rib pain, and irregular menstruation, as in the Xiaoyao Powder. This herb is aromatic and dispels foul odors, and can also resolve dampness and harmonize the middle jiao. It can also be used to treat summer heat and dampness, abdominal distension and pain, vomiting and diarrhea, often combined with sesame, magnolia bark, and honeysuckle.

[0068] The main chemical components include volatile oils such as menthol, menthone, isomenthone, menthol, α-pinene, and limonene. Pharmacological effects: When taken internally, peppermint oil stimulates the central nervous system, dilates skin capillaries, promotes sweat gland secretion, and increases heat dissipation, thus inducing sweating and relieving fever. Peppermint oil can inhibit gastrointestinal smooth muscle contraction and antagonize acetylcholine, exhibiting an antispasmodic effect. Menthol has a choleretic effect. When applied externally, peppermint oil stimulates cold receptors in nerve endings, producing a cooling sensation, and reflexively causes changes in deep tissue blood vessels, resulting in anti-inflammatory, analgesic, antipruritic, local anesthetic, and anti-irritant effects. This product also has expectorant, antitussive, anti-implantation, anti-early pregnancy, and antimicrobial effects.

[0069] In this invention, peppermint is used as an adjuvant to soothe the liver, regulate qi, clear the head and eyes, calm the mind and soothe the nerves, and guide the other herbs upwards.

[0070] The dosage of each Chinese herbal medicine in this invention was determined through long-term clinical trials and experiments by the inventors. Each component exhibits good therapeutic effects within the following weight ranges:

[0071] 32-48 parts of peony bark, 18-28 parts of mantis egg case, 18-28 parts of poria cocos, 18-28 parts of anemarrhena asphodeloides, 18-28 parts of tangerine peel, 14-24 parts of apocynum venetum leaf, 14-24 parts of albizia bark, 14-24 parts of polygala tenuifolia, 14-24 parts of rose, 12-22 parts of eupatorium fortunei, 12-22 parts of areca peel, 12-22 parts of luffa cylindrica, 12-22 parts of arborvitae seed, 12-22 parts of leonurus japonicus, and 8-16 parts of peppermint.

[0072] The further proportions are as follows: 36-42 parts of peony bark, 22-26 parts of mantis egg case, 22-26 parts of poria cocos, 22-26 parts of anemarrhena asphodeloides, 22-26 parts of tangerine peel, 18-22 parts of apocynum venetum leaf, 18-22 parts of albizia bark, 18-22 parts of polygala tenuifolia, 18-22 parts of rose, 14-18 parts of lycopus lucidus, 14-18 parts of areca peel, 14-18 parts of luffa cylindrica, 14-18 parts of arborvitae seed, 14-18 parts of leonurus japonicus, and 10-14 parts of peppermint.

[0073] The preferred ingredients are: 38 parts peony bark, 24 parts mantis egg case, 24 parts poria cocos, 24 parts anemarrhena asphodeloides, 24 parts tangerine peel, 20 parts apocynum venetum leaf, 20 parts albizia bark, 20 parts polygala tenuifolia, 20 parts rose, 16 parts eupatorium fortunei, 16 parts areca peel, 16 parts luffa cylindrica, 16 parts arborvitae seed, 16 parts leonurus japonicus, and 12 parts mint.

[0074] The drug of this invention can be prepared into any conventional oral preparation using conventional methods of traditional Chinese medicine preparations. In order to better exert the efficacy of each component, the motherwort in the raw materials is preferably specially extracted, and the volatile oils of peony bark, tangerine peel, rose, eupatorium, cypress seed, and peppermint are extracted by steam distillation. However, these special processes should not be used to limit the scope of protection of this invention.

[0075] Preferably, the preparation method of the active pharmaceutical ingredient of the present invention is as follows:

[0076] a) Weigh out the raw materials: peony bark, mantis egg case, poria cocos, anemarrhena rhizome, tangerine peel, apocynum venetum leaf, albizia bark, polygala root, rose flower, lycopus lucidus, areca peel, luffa fruit, cypress seed, motherwort, and peppermint for later use.

[0077] b) Add water to the eight Chinese herbs (Mantis Egg Case, Poria Cocos, Anemarrhena Rhizome, Apocynum Venetum Leaf, Albizia Bark, Polygala Root, Areca Peel, and Liquidambar Formosa) in the specified weight ratio and decoct twice. For the first decoction, add water to cover the herbs by 3 cm, and simmer over low heat for 30 minutes after boiling. For the second decoction, add water to cover the herbs by 2 cm, and simmer over low heat for 20 minutes after boiling. Combine the two decoctions, filter, and obtain filtrate 1.

[0078] c) Collect the volatile oils from the specified weight ratio of peony bark, dried tangerine peel, rose petals, eupatorium, arborvitae seed, and peppermint using steam extraction for later use. Combine the aqueous decoction of peony bark, dried tangerine peel, rose petals, eupatorium, arborvitae seed, and peppermint (obtained using the same method as in step b) with filtrate 1, concentrate it to form an extract with a specific gravity of 1.35, add 90%-95% ethanol for alcohol precipitation, recover the ethanol and concentrate it, and dry it at 45℃-50℃ to obtain dry extract 1.

[0079] d) The motherwort in the specified weight ratio is refluxed with 90%-95% ethanol for extraction. The ethanol is recovered from the extract, and the extract is dried at 45℃-50℃ to obtain dry extract 2.

[0080] e) Combine dry extract 1 and dry extract 2, grind them into powder, mix them evenly, grind them into fine powder, spray in peony bark, dried tangerine peel, rose petals, eupatorium, cypress seed, and peppermint volatile oil, and stir evenly.

[0081] The active components of the drug of this invention can be added to various conventional excipients required for the preparation of different dosage forms, such as disintegrants, binders, lubricants, etc. It can be prepared into any commonly used oral dosage form, such as pills, powders, tablets, capsules, oral liquids, etc., using conventional traditional Chinese medicine preparation methods.

[0082] The drug of this invention is used to prevent and treat menopausal insomnia by exerting the effects of nourishing blood and soothing the liver, promoting blood circulation and removing blood stasis, regulating qi and promoting diuresis, and nourishing yin and clearing heat. Detailed Implementation

[0083] The following experimental examples further illustrate the beneficial effects of the drug described in this invention. These examples include pharmacological experiments and clinical efficacy observation experiments of the drug of this invention (referred to as "Gynopsis Sweet Dream," abbreviated as GNTM).

[0084]

Experimental Example

[0085] Clinical observation of the drug of the present invention for the treatment of menopausal insomnia and its complications

[0086] 1. Case Information:

[0087] Seventy-six outpatients and recruited subjects from January 2021 to December 2023 were selected and randomly divided into a treatment group (n=38) and a control group (n=38) using a random number table. The mean age of the treatment group was 48.72±1.25 years (female) and the mean duration of disease was 2.36±0.25 years. The mean age of the control group was 49.03±0.98 years (female) and the mean duration of disease was 2.53±0.68 years. There were no statistically significant differences in baseline data such as age, duration of disease, and disease condition between the two groups (P>0.05), making them comparable.

[0088] 2 Diagnostic criteria

[0089] 2.1 Diagnostic criteria for menopausal syndrome

[0090] Based on the diagnostic criteria of the International Menopause Association (2011) and the North American Menopause Association (2001), combined with works such as *Internal Medicine*, *Traditional Chinese Medicine Internal Medicine*, *Physiology*, *Pathology*, and *Guiding Principles for Clinical Research of New Traditional Chinese Medicine Drugs*, and taking into account expert opinions, the diagnostic criteria are as follows:

[0091] (1) Irregular menstruation ≥ 3 times, or amenorrhea, but the duration of amenorrhea is ≤ 12 months;

[0092] (2) Presence of related symptoms (at least one primary symptom, and at least one secondary symptom or tongue / pulse symptom):

[0093] Main symptoms: flushed face, hot flashes, low-grade fever, spontaneous sweating, night sweats, irritability, mood swings, anxiety, depression.

[0094] Secondary symptoms: vaginal dryness, painful or uncomfortable intercourse, decreased libido, frequent and / or urgent urination and / or urinary tract infections, joint and / or muscle pain or discomfort, fatigue, headache, palpitations, weight gain and / or changes in body shape despite normal diet, dry and / or itchy skin, significantly increased wrinkles, dry and / or easily falling hair, low interest in things, decreased memory, and poor concentration.

[0095] Tongue and pulse: Red tongue with little or no coating, pale tongue and / or enlarged tongue and / or teeth marks on the edges, white and slippery or white and greasy tongue coating, red tongue with little coating at the edges and tip, red tongue with thin yellow coating, deep and thready pulse, deep and slow, thready and rapid, wiry and rapid, soft and slow pulse. The combination and severity of various symptoms vary from person to person.

[0096] 2.2 Diagnostic criteria for sleep disorders

[0097] The diagnostic criteria are based on the "Guidelines for the Diagnosis and Treatment of Insomnia in Chinese Adults" formulated by the Sleep Disorders Group of the Neurology Branch of the Chinese Medical Association in 2011, as follows:

[0098] (1) Having one of the following symptoms: difficulty falling asleep, sleep maintenance disorder, early awakening, decreased sleep quality or no sense of recovery after waking up in the morning;

[0099] (2) The above symptoms still occur even when there are conditions for sleep and the environment is suitable for sleep;

[0100] (3) The patient complains of at least one of the following sleep-related daytime functional impairments:

[0101] ① Fatigue or general discomfort;

[0102] ② Decreased attention, attention maintenance ability, or memory;

[0103] ③ A decline in learning, work, and / or social skills;

[0104] ④ Mood swings or irritability;

[0105] ⑤ Feeling sleepy during the day;

[0106] ⑥ Decreased interest and energy;

[0107] ⑦ An increased tendency to make mistakes while working or driving;

[0108] ⑧ Tension, headache, dizziness, or other physical symptoms related to sleep deprivation;

[0109] 9. Excessive focus on sleep.

[0110] 3. Case inclusion criteria

[0111] (1) Meets the diagnostic criteria for sleep disorders as described above.

[0112] (2) Meets the diagnostic criteria for menopausal syndrome in women as described above.

[0113] 4 Exclusion Criteria

[0114] (1) Those suffering from insomnia due to severe neurosis;

[0115] (2) Those with primary hypertension, hypotension, or anemia;

[0116] (3) Patients who have undergone bilateral oophorectomy, have ovarian lesions, or have premature ovarian failure;

[0117] (4) Individuals with allergic constitutions or allergies to the drugs used in this study;

[0118] (5) Patients with serious primary diseases of the cardiovascular, cerebrovascular, liver, kidney, or hematopoietic systems, as well as those with mental illness;

[0119] (6) Those who fail to take medication as prescribed or whose data is incomplete and cannot be used to determine the efficacy.

[0120] 5 Experimental Methods

[0121] 5.1 Sample size estimation and grouping

[0122] A randomized, controlled trial design was adopted. The required sample size was calculated using the R language pwr packages. The pre-set effect size d=0.80 (Cohen criterion), the pre-set statistical power 1-β=0.9, and the significance level α=0.05. The results showed that approximately 32 cases were needed in each group. Considering the maximum allowable dropout rate of 15%, the final sample size for this study was determined to be 76 cases, which were randomly divided into a treatment group and a control group, with 38 cases in each group.

[0123] 5.2 Intervention methods

[0124] The treatment group received capsules of GNTM Example 1 (48g of peony bark, 28g of mantis egg case, 28g of poria cocos, 28g of anemarrhena asphodeloides, 28g of tangerine peel, 24g of apocynum venetum leaf, 24g of albizia bark, 24g of polygala tenuifolia, 24g of rose, 22g of eupatorium fortunei, 22g of areca peel, 22g of luffa cylindrica, 22g of arborvitae seed, 22g of leonurus japonicus, and 16g of peppermint), taken orally with warm water after meals, 10 capsules each time, once in the morning, noon, and evening; 7 days constituted one course of treatment, and 10 courses were taken consecutively. The control group received estazolam tablets (Shanghai Xinyi Pharmaceutical Co., Ltd., National Drug Approval Number H31021534), at the maximum dose specified in the drug instructions, 2mg daily, taken 30 minutes before bedtime, 7 days constituted one course of treatment, and 10 courses were taken consecutively.

[0125] 5.3 Observation Indicators

[0126] (1) Pittsburgh Sleep Quality Index (PSQI): Used to assess patients’ sleep conditions, mainly including sleep onset time, sleep quality, total sleep time, sleep efficiency, daytime dysfunction, etc. The score range is 0-21 points, and the score is inversely correlated with the sleep quality of the test subject.

[0127] (2) HAMD-24 item score: This scale can well reflect the severity of depression in the research subjects, and the score is positively correlated with the severity of depression.

[0128] (3) Insomnia Severity Index (ISI): This scale is a tool for quantifying the severity of insomnia and has been proven to have extremely high reliability and validity. It is also more closely related to daytime sleepiness, anxiety, and depression. The lower the score, the better the sleep quality.

[0129] (4) Evaluation of sleep quality and cognitive function: The Montreal Cognitive Assessment Scale (MoCA) was used to evaluate the patient's cognitive function. The assessment consisted of 8 items with a total score of 30 points. The higher the score, the better the cognitive function.

[0130] (5) Evaluation of negative emotions: The Self-Rating Depression Scale (SDS) and the Self-Rating Anxiety Scale (SAS) were used to evaluate depression and anxiety. Each scale has 20 items, with a score of 1 to 4 for each item. The higher the score, the more severe the patient's depression and anxiety.

[0131] (6) Before and after treatment, the menopausal symptoms and TCM syndrome changes were observed using a scoring method. The observation items included all the symptoms and tongue and pulse as described in point (2) of the diagnostic criteria for menopausal syndrome in 2.1 above. The scoring method referred to the relevant standards in "Internal Medicine", "Traditional Chinese Medicine Internal Medicine", "Physiology", "Pathology" and "Guiding Principles for Clinical Research of New Chinese Medicines". Symptoms were scored as 0, 2, 4 and 6 points respectively for none, mild, moderate and severe, and 2 points for abnormal tongue coating and pulse. Normal was 0 points.

[0132] (7) Serum-related indicators: 8 mL of fasting venous blood was collected from both groups of patients before and after treatment, centrifuged (centrifugation radius 10 cm, speed 3000 r / min, centrifugation time 15 min), and stored at -70℃ for later analysis. Neurotransmitter indicators, including norepinephrine (NE), excitatory amino acids (EAA), and acetylcholine (Ach) levels, were detected by radioimmunoassay; neurotrophic factors, including nerve growth factor (NGF) and brain-derived neurotrophic factor (BDNF) levels, were detected by chemiluminescence immunoassay; and inflammatory factor indicators, including tumor necrosis factor-α (TNF-α) and interleukin-1β (IL-1β) levels, were detected by enzyme-linked immunosorbent assay (ELISA).

[0133] (8) Clinical efficacy: The criteria for judging clinical efficacy were based on the relevant content in the "Guidelines for the Diagnosis and Treatment of Insomnia in Chinese Adults" and the "Guiding Principles for Clinical Research of New Traditional Chinese Medicine" formulated by the Sleep Disorders Group of the Neurology Branch of the Chinese Medical Association in 2011.

[0134] Clinically cured: Sleep duration returns to normal or nighttime sleep duration is more than 6 hours, sleep is deep, and one feels refreshed upon waking;

[0135] Significant effects: Sleep is noticeably improved, with sleep time increasing by more than 3 hours and sleep depth increasing;

[0136] Effective: Symptoms were relieved, and sleep time increased by less than 3 hours compared to before;

[0137] Ineffective: Insomnia shows no significant improvement or worsens.

[0138] (9) Safety: Blood routine, urine routine, serum alanine aminotransferase (ALT), creatinine (Cr), blood urea nitrogen (BUN), blood glucose and electrocardiogram were measured before and after treatment. Adverse reactions were observed and recorded during the trial.

[0139] 6 Statistical Methods

[0140] Excel 2021 was used for data preparation, and SPSS 26.0 was used to analyze the prepared data; the mean ± standard deviation was used for measurement data. For data that conforms to a normal distribution and has homogeneous variances, an independent samples t-test is used; for data with unequal variances, a corrected t-test is used. For comparisons within groups before and after treatment, paired samples t-tests are used for data that conforms to a normal distribution, and Wilcoxon signed-rank tests are used for data that do not conform to a normal distribution. For ordinal data and non-normally distributed measurement data, nonparametric rank-sum tests are used. For count data, chi-square tests are used. P < 0.05 indicates a statistically significant difference.

[0141] 7. Efficacy Standards

[0142] The evaluation was conducted in accordance with the relevant standards in the "Guidelines for the Diagnosis and Treatment of Insomnia in Chinese Adults" and the "Guiding Principles for Clinical Research of New Traditional Chinese Medicine Drugs" formulated by the Sleep Disorders Group of the Neurology Branch of the Chinese Medical Association in 2011.

[0143] Recovery: Sleep duration returns to normal, or nighttime sleep duration is more than 6 hours, sleep is deep, and one feels refreshed upon waking;

[0144] Significant effects: Sleep is noticeably improved, with sleep time increasing by more than 3 hours and sleep depth increasing;

[0145] Effective: Symptoms were relieved, and sleep time increased by less than 3 hours compared to before;

[0146] Ineffective: Sleep does not improve significantly or worsens.

[0147] Overall effective rate = (Number of cured cases + Number of cases with significant improvement + Number of cases with improvement) / Total number of cases

[0148] 8 Results

[0149] During the clinical observation, two subjects withdrew from the study for personal reasons (1 in the control group and 1 in the treatment group), and four patients were excluded because they failed to strictly adhere to the medication contraindications during the study (3 in the control group and 1 in the treatment group). A total of 70 patients participated in this observation study, with an overall dropout rate of 7.9%. There were no statistically significant differences in the baseline general information (age, gender, and disease duration) between the two groups (P>0.05), making them comparable.

[0150] 8.1 Comparison of baseline data before treatment

[0151] Before treatment, there were no statistically significant differences in PSQI scores, ISI scores, HAMD-24 scores, and TCM syndrome scale scores between the two groups (P>0.05), indicating comparability (see Table 1).

[0152] Table 1. Comparison of PSQI score, ISI score, HAMD-24 score, and TCM syndrome scale between the two groups of patients.

[0153] 8.2 Comparison of clinical efficacy between the two groups of patients

[0154] 8.2.1 Evaluation of the efficacy of treatment for insomnia

[0155] As shown in Table 2, there was a statistically significant difference in the efficacy evaluation of insomnia treatment between the two groups (P<0.01), with the treatment group showing better results than the control group.

[0156] Table 2. PSQI score efficacy analysis

[0157] 8.2.2 Comparison of PSQI scores, ISI scores, HAMD-24 scores, and Traditional Chinese Medicine syndrome scale scores between the two groups

[0158] As shown in Table 3, there were statistically significant differences in the improvement of PSQI, ISI and HAMD-24 scores in the treatment group (P<0.05), with the treatment group showing better improvement than the control group.

[0159] Table 3 PSQI score, ISI score, HAMD-24 score

[0160] 8.2.3 Comparison of MoCA score, SDS score, and SAS score between the two groups of patients

[0161] After treatment, the SDS and SAS scores of the patients in the treatment group were significantly lower than those before treatment, while the MoCA score was higher. Moreover, the SDS and SAS scores of the treatment group were lower than those of the control group, while the MoCA score was higher than that of the control group, with statistical differences (P<0.05), as shown in Table 4.

[0162] Table 4 Comparison of MoCA scores, SDS scores, and SAS scores between the two groups (mean ± standard deviation)

[0163] ① Compared with the group before treatment: P < 0.05; ② Compared with the control group after treatment: P < 0.05;

[0164] 8.2.4 Comparison of neurotransmitter levels between the two groups

[0165] After treatment, the levels of NE and EAA decreased in both groups, while the level of Ach increased. The levels of NE and EAA in the treatment group were lower than those in the control group, while the level of Ach was higher than that in the control group, which showed statistical differences (P < 0.05), as shown in Table 5.

[0166] Table 5. Changes in neurotransmitter levels in the two groups (mean ± standard deviation)

[0167] ① Compared with the group before treatment: P < 0.05; ② Compared with the control group after treatment: P < 0.05

[0168] 8.2.5 Comparison of neurotrophic factor levels between the two groups

[0169] Before treatment, there was no statistically significant difference in serum NGF and BDNF levels between the two groups (P > 0.05). After treatment, serum NGF and BDNF levels increased in both groups (P < 0.05), and the serum NGF and BDNF levels in the treatment group were higher than those in the control group, with statistically significant differences (P < 0.05), as shown in Table 6.

[0170] Table 6 Comparison of neurotrophic factor levels between the two groups (mean ± standard deviation)

[0171] ① Compared with the group before treatment: P < 0.05; ② Compared with the control group after treatment: P < 0.05

[0172] 8.2.6 Comparison of inflammatory factor levels between the two groups

[0173] Before treatment, there was no statistically significant difference in TNF-α and IL-1β levels between the two groups (P > 0.05). After treatment, TNF-α and IL-1β levels decreased significantly in both groups (P < 0.05); the TNF-α and IL-1β levels in the treatment group were lower than those in the control group, with a statistically significant difference (P < 0.05), as shown in Table 7.

[0174] Table 7 Comparison of inflammatory factor levels between the two groups (mean ± standard deviation)

[0175] ① Compared with the same group before treatment: P < 0.05; ② Compared with the control group after treatment: P < 0.05.

[0176] 8.2.7 Comparison of TCM syndrome scores between the two groups

[0177] Before treatment, there were no statistically significant differences in the scores of primary and secondary symptoms between the two groups (P > 0.05). After 70 days of treatment, the scores of primary and secondary symptoms in the treatment group were lower than those before treatment, and the scores of primary and secondary symptoms in the treatment group were lower than those in the control group, with statistically significant differences (P < 0.05). See Table 8 for details.

[0178] Table 8 Comparison of clinical efficacy (mean ± standard deviation)

[0179] Note: ① Compared with the pre-treatment level in this group, P < 0.05; ② Compared with the post-treatment level in the control group, P < 0.05.

[0180] 8.3 Follow-up Results

[0181] One month after the end of treatment, follow-up telephone calls were made to patients in both groups who responded to the treatment. Data collected showed that the treatment group had a sustained effective rate of 89.19% in PSQI, which was better than the control group's 65.38%, and the difference was statistically significant (P<0.05); the treatment group had a sustained effective rate of 87.89% in HAMD, which was better than the control group's 63.98%, and the difference was statistically significant (P<0.05).

[0182] 8.4 Safety Evaluation

[0183] No serious adverse events occurred in either group during the experiment. The main adverse reactions that occurred during the experiment included dizziness, dry mouth, and constipation, which did not require special treatment after close observation. No abnormalities were found in blood routine tests, liver and kidney function tests, etc., indicating good safety.

[0184] [Example 1] Preparation of the drug capsule of the present invention

[0185] a) Weigh out the raw material drugs for later use. The dosage of the raw material drugs is as follows.

[0186]

[0187] b) Add water to the eight Chinese herbs (Mantis Egg Case, Poria Cocos, Anemarrhena Rhizome, Apocynum Venetum Leaf, Albizia Bark, Polygala Root, Areca Peel, and Liquidambar Formosa) in the specified weight ratio and decoct twice. For the first decoction, add water to cover the herbs by 3 cm, and simmer over low heat for 30 minutes after boiling. For the second decoction, add water to cover the herbs by 2 cm, and simmer over low heat for 20 minutes after boiling. Combine the two decoctions, filter, and obtain filtrate 1.

[0188] c) Collect the volatile oils from the specified weight ratio of peony bark, dried tangerine peel, rose petals, eupatorium, arborvitae seed, and peppermint using steam extraction for later use. Combine the aqueous decoction of peony bark, dried tangerine peel, rose petals, eupatorium, arborvitae seed, and peppermint (obtained using the same method as in step b) with filtrate 1, concentrate it to form an extract with a specific gravity of 1.35, add 90%-95% ethanol for alcohol precipitation, recover the ethanol and concentrate it, and dry it at 45℃-50℃ to obtain dry extract 1.

[0189] d) The motherwort in the specified weight ratio is refluxed with 90%-95% ethanol for extraction. The ethanol is recovered from the extract, and the extract is dried at 45℃-50℃ to obtain dry extract 2.

[0190] e) Combine dry extract 1 and dry extract 2, pulverize them into powder, mix them evenly, pulverize them again into fine powder, spray in volatile oils of peony bark, dried tangerine peel, rose petals, eupatorium, cypress seed, and peppermint, and stir evenly. Fill into gelatin hard capsules, each capsule containing approximately 2 grams of the compound active ingredients of this invention.

[0191] [Example 2] Preparation of the drug granules of the present invention

[0192] a) Weigh out the raw material drugs for later use. The dosage of the raw material drugs is as follows.

[0193]

[0194] b) Add water to the eight Chinese herbs (Mantis Egg Case, Poria Cocos, Anemarrhena Rhizome, Apocynum Venetum Leaf, Albizia Bark, Polygala Root, Areca Peel, and Liquidambar Formosa) in the specified weight ratio and decoct twice. For the first decoction, add water to cover the herbs by 3 cm, and simmer over low heat for 30 minutes after boiling. For the second decoction, add water to cover the herbs by 2 cm, and simmer over low heat for 20 minutes after boiling. Combine the two decoctions, filter, and obtain filtrate 1.

[0195] c) Collect the volatile oils from the specified weight ratio of peony bark, dried tangerine peel, rose petals, eupatorium, arborvitae seed, and peppermint using steam extraction for later use. Combine the aqueous decoction of peony bark, dried tangerine peel, rose petals, eupatorium, arborvitae seed, and peppermint (obtained using the same method as in step b) with filtrate 1, concentrate it to form an extract with a specific gravity of 1.35, add 90%-95% ethanol for alcohol precipitation, recover the ethanol and concentrate it, and dry it at 45℃-50℃ to obtain dry extract 1.

[0196] d) The motherwort in the specified weight ratio is refluxed with 90%-95% ethanol for extraction. The ethanol is recovered from the extract, and the extract is dried at 45℃-50℃ to obtain dry extract 2.

[0197] e) Combine dry extract 1 and dry extract 2, pulverize them into powder, mix them evenly, pulverize them again into fine powder, spray in volatile oils of peony bark, dried tangerine peel, rose petals, eupatorium, cypress seed, and peppermint, and stir evenly. Add ethanol as a binder and starch as a filler, and compress into granules. Each 15g granule contains 10g of the pharmaceutical ingredients of this invention.

[0198] [Example 3] Preparation of tablets of the drug of the present invention

[0199] a) Weigh out the raw material drugs for later use. The dosage of the raw material drugs is as follows.

[0200]

[0201] b) Add water to the eight Chinese herbs (Mantis Egg Case, Poria Cocos, Anemarrhena Rhizome, Apocynum Venetum Leaf, Albizia Bark, Polygala Root, Areca Peel, and Liquidambar Formosa) in the specified weight ratio and decoct twice. For the first decoction, add water to cover the herbs by 3 cm, and simmer over low heat for 30 minutes after boiling. For the second decoction, add water to cover the herbs by 2 cm, and simmer over low heat for 20 minutes after boiling. Combine the two decoctions, filter, and obtain filtrate 1.

[0202] c) Collect the volatile oils from the specified weight ratio of peony bark, dried tangerine peel, rose petals, eupatorium, arborvitae seed, and peppermint using steam extraction for later use. Combine the aqueous decoction of peony bark, dried tangerine peel, rose petals, eupatorium, arborvitae seed, and peppermint (obtained using the same method as in step b) with filtrate 1, concentrate it to form an extract with a specific gravity of 1.35, add 90%-95% ethanol for alcohol precipitation, recover the ethanol and concentrate it, and dry it at 45℃-50℃ to obtain dry extract 1.

[0203] d) The motherwort in the specified weight ratio is refluxed with 90%-95% ethanol for extraction. The ethanol is recovered from the extract, and the extract is dried at 45℃-50℃ to obtain dry extract 2.

[0204] e) Combine dry extract 1 and dry extract 2, grind them into powder, mix them evenly, then grind them into a fine powder. Spray in peony bark, dried tangerine peel, rose petals, eupatorium, cypress seed, and peppermint volatile oil, and stir evenly. Press into tablets, each tablet...

[0205] It contains 2 grams of the compound active ingredients of this invention.

[0206] [Example 4] Preparation of the oral liquid drug of the present invention

[0207] a) Weigh out the raw material drugs for later use. The dosage of the raw material drugs is as follows.

[0208]

[0209] b) Add water to the eight Chinese herbs (Mantis Egg Case, Poria Cocos, Anemarrhena Rhizome, Apocynum Venetum Leaf, Albizia Bark, Polygala Root, Areca Peel, and Liquidambar Formosa) in the specified weight ratio and decoct twice. For the first decoction, add water to cover the herbs by 3 cm, and simmer over low heat for 30 minutes after boiling. For the second decoction, add water to cover the herbs by 2 cm, and simmer over low heat for 20 minutes after boiling. Combine the two decoctions, filter, and obtain filtrate 1.

[0210] c) Collect the volatile oil from the specified weight ratio of peony bark, dried tangerine peel, rose petals, eupatorium, arborvitae seed, and mint using a steam extraction method for later use. The decoction of peony bark, dried tangerine peel, rose petals, eupatorium, arborvitae seed, and mint (water)

[0211] The decoction was obtained in the same way as in step b) and combined with filtrate 1. It was concentrated into an extract with a specific gravity of 1.35, precipitated with 90%-95% ethanol, the ethanol was recovered and concentrated, and dried at 45℃-50℃ to obtain dry extract 1.

[0212] d) The motherwort in the specified weight ratio is refluxed with 90%-95% ethanol for extraction. The ethanol is recovered from the extract, and the extract is dried at 45℃-50℃ to obtain dry extract 2.

[0213] e) Combine dry extract 1 and dry extract 2, pulverize them into powder, mix them evenly, pulverize them again into fine powder, and stir evenly. Add ethanol to the fine powder to make the ethanol content reach 55%, let it stand for 24 hours, filter, recover the ethanol, concentrate it into a thick paste with a relative density of 1.26-1.30 (60℃), add the volatile oils of peony bark, dried tangerine peel, rose, eupatorium, cypress seed, and peppermint obtained in step c), as well as 2g of sodium benzoate, 50g of sucrose, and distilled water (the amount of distilled water added should be such that each 10ml of the medicinal solution contains 10g of compound active ingredients), filter, sterilize, and fill into vials to obtain the final product.

[0214] [Example 5] Preparation of the drug pills of the present invention

[0215] a) Weigh out the raw material drugs for later use. The dosage of the raw material drugs is as follows.

[0216]

[0217] b) Add water to the eight Chinese herbs (Mantis Egg Case, Poria Cocos, Anemarrhena Rhizome, Apocynum Venetum Leaf, Albizia Bark, Polygala Root, Areca Peel, and Liquidambar Formosa) in the specified weight ratio and decoct twice. For the first decoction, add water to cover the herbs by 3 cm, and simmer over low heat for 30 minutes after boiling. For the second decoction, add water to cover the herbs by 2 cm, and simmer over low heat for 20 minutes after boiling. Combine the two decoctions, filter, and obtain filtrate 1.

[0218] c) Collect the volatile oils from the specified weight ratio of peony bark, dried tangerine peel, rose petals, eupatorium, arborvitae seed, and peppermint using steam extraction for later use. Combine the aqueous decoction of peony bark, dried tangerine peel, rose petals, eupatorium, arborvitae seed, and peppermint (obtained using the same method as in step b) with filtrate 1, concentrate it to form an extract with a specific gravity of 1.35, add 90%-95% ethanol for alcohol precipitation, recover the ethanol and concentrate it, and dry it at 45℃-50℃ to obtain dry extract 1.

[0219] d) The motherwort in the specified weight ratio is refluxed with 90%-95% ethanol for extraction. The ethanol is recovered from the extract, and the extract is dried at 45℃-50℃ to obtain dry extract 2.

[0220] e) Combine dry extract 1 and dry extract 2, pulverize them into powder, mix them evenly, then pulverize them into a fine powder. Spray in volatile oils from peony bark, dried tangerine peel, rose petals, eupatorium, cypress seed, and peppermint, and stir evenly. Add 30-50g of refined honey to every 100g of powder, form into pills, dry, polish, or coat with sugar. Each pill contains 10g of compound active ingredients.

[0221] [Typical Case]

[0222] Ms. Wang, female, 48 years old, first visited in early May 2022. Chief complaint: Difficulty falling asleep for more than 3 years, irritability, insomnia, vivid dreams and easy awakening, irregular menstruation for nearly 2 years, hot palms and soles, dry and bitter mouth, dizziness, fatigue, poor appetite, abdominal distension and pain, fever and irritability after 3 pm every day, body temperature above 37°C (normal body temperature 36°C), easily emotional, red tongue tip and edges, thin yellow and slightly greasy tongue coating, and thready and rapid pulse. Treatment with tablets as described in Example 3, 10 tablets orally after breakfast, lunch and dinner each time, for 10 days as one course of treatment. During her second consultation in August 2022, the patient reported improvement in her insomnia and excessive dreaming. Symptoms such as hot palms and soles, dry and bitter mouth, dizziness, fatigue, poor appetite, and abdominal distension and pain were all relieved. Her afternoon fever and irritability had also lessened. Before taking the medication, she often felt irritable, but after taking it, she felt less averse to people and things she previously disliked. Her former colleagues, who used to avoid her, now actively interacted with them, and she felt a significant increase in her happiness. After continuing the medication for six months, all symptoms disappeared. The dosage was adjusted to a preventative level, 10 tablets once daily. A one-year follow-up showed no recurrence.

[0223] Ms. Zhong, female, 50 years old, first visited in early March 2022. She reported poor sleep quality for the past 5 years, which had worsened in the last 3 months. She experienced prolonged periods of restlessness after lying down, tossing and turning for over 2 hours, frequent awakenings at night, especially around 3-4 AM, and difficulty falling back asleep. Her sleep was shallow and filled with vivid dreams, leaving her feeling "half-awake" throughout the night. She felt lethargic upon waking. Accompanying symptoms included hot flashes and night sweats, with sudden onset of facial and chest heat and sweating that disrupted her sleep. She also experienced occasional rapid heartbeat or inexplicable anxiety, joint pain, muscle aches, and increased urination at night. Irritability, depression, or excessive worry further exacerbated her insomnia. She also experienced daytime fatigue, poor concentration, and memory loss. Her chronic insomnia led to anxiety, creating a vicious cycle of "insomnia-anxiety." Visual examination revealed a rough, dull complexion, a red tongue with a yellow coating, and a wiry, thready, and rapid pulse. She was prescribed the granules of Example 2 of this invention, taken orally three times a day after breakfast, lunch, and dinner, 30 grams each time, for 10 days as one course of treatment. The patient had a second consultation in June 2022. They reported that the time from going to bed to falling asleep had shortened to less than one hour, the frequency of nighttime awakenings had significantly decreased, and they experienced deep sleep throughout the entire sleep process. They were awake after 5 AM, and sometimes could fall back asleep. They felt refreshed after waking up, and their accompanying symptoms such as vivid dreams, hot flashes, night sweats, rapid heartbeat, joint pain, muscle aches, increased nocturia, and unexplained anxiety had all significantly lessened. Their mood had improved considerably, with significant relief from symptoms of depression and excessive worry. They had abundant energy during the day, improved memory, and a significant increase in work efficiency. Visual examination revealed a more delicate and lustrous complexion than during the first consultation, a red tongue with a thin yellow coating, and a weak, thready, and rapid pulse. The patient continued to take the granules of Example 2 of this invention, 30 grams orally after breakfast, lunch, and dinner daily, for 10 days as one course of treatment. In December 2022, during the third consultation, the patient reported that the time from going to bed to falling asleep had shortened to less than half an hour. Occasionally, the patient would wake up during the night, but the entire sleep process was deep sleep. The symptom of waking up early in the morning had disappeared, and the patient felt energetic every morning after waking up. Accompanying symptoms such as vivid dreams, hot flashes, night sweats, rapid heartbeat, increased urination at night, and unexplained anxiety had all disappeared. Joint pain and muscle soreness had also ceased. The patient was able to cope with various situations with a positive attitude, experiencing a cheerful and pleasant mood. The patient had abundant energy, strong memory, high work efficiency, and increased happiness. The patient continued to take the granules from Example 2, but at a maintenance dose of 15 grams daily, taken before bedtime. No recurrence was observed during a two-year follow-up.

Claims

1. A traditional Chinese medicine composition for preventing and treating menopausal insomnia, characterized in that... It consists of the following parts by weight of active pharmaceutical ingredient:

2. The traditional Chinese medicine composition according to claim 1, characterized in that, The traditional Chinese medicine composition is made from the following raw materials in parts by weight:

3. The traditional Chinese medicine composition according to claim 1, characterized in that, The traditional Chinese medicine composition is made from the following raw materials in parts by weight:

4. The traditional Chinese medicine composition according to claim 1, 2 or 3, wherein the preparation method comprises the following steps: a) Weigh out the raw materials: peony bark, mantis egg case, poria cocos, anemarrhena rhizome, tangerine peel, apocynum venetum leaf, albizia bark, polygala root, rose flower, lycopus lucidus, areca peel, luffa cylindrica root, arborvitae seed, motherwort, and peppermint for later use; b) Add water to the eight Chinese herbs (Mantis Egg Case, Poria Cocos, Anemarrhena Rhizome, Apocynum Venetum Leaf, Albizia Bark, Polygala Root, Areca Peel, and Liquidambar Formosa) in the specified weight ratio and decoct twice. For the first decoction, add water to cover the herbs by 3 cm, bring to a boil, and simmer for 30 minutes. For the second decoction, add water to cover the herbs by 2 cm, bring to a boil, and simmer for 20 minutes. Combine the two decoctions and filter to obtain filtrate 1. c) Collect the volatile oils from the specified weight ratio of peony bark, dried tangerine peel, rose petals, eupatorium, arborvitae seed, and peppermint using steam extraction for later use. Combine the aqueous decoction of peony bark, dried tangerine peel, rose petals, eupatorium, arborvitae seed, and peppermint (obtained using the same method as in step b) with filtrate 1, concentrate it to form an extract with a specific gravity of 1.35, add 90%-95% ethanol for alcohol precipitation, recover the ethanol and concentrate it, and dry it at 45℃-50℃ to obtain dry extract 1; d) The motherwort in the specified weight ratio is refluxed with 90%-95% ethanol for extraction. The ethanol is recovered from the extract and dried at 45℃-50℃ to obtain dry extract 2. e) Combine dry extract 1 and dry extract 2, grind them into powder, mix them evenly, grind them into fine powder, spray in peony bark, dried tangerine peel, rose petals, eupatorium, cypress seed, and peppermint volatile oil, and stir evenly.

5. The method for preparing the drug according to claim 4, wherein the active component obtained in step e) is combined with commonly used excipients to prepare oral dosage forms such as pills, tablets, granules, capsules, and oral liquids.

6. The use of the traditional Chinese medicine composition according to any one of claims 1-3 in a medicine for preventing and treating menopausal insomnia and its complications.

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