Traditional Chinese medicine composition for preventing and treating insomnia due to yang deficiency and preparation method thereof

Abstract

The invention discloses a traditional Chinese medicine composition for preventing and treating insomnia due to yang deficiency. The traditional Chinese medicine composition is mainly prepared from prepared rehmannia root, semen cuscutae, fructus psoraleae, radix aconiti carmichaeli, wine-processed radix bupleuri, rhizoma cimicifugae, cassia twig, herba taxilli, herba cistanche, pericarpium citri reticulatae, radix acanthopanacis senticosi 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 warming kidney to strengthen yang, boosting essence and filling marrow, raising yang and transforming qi, warming channel and strengthening spleen, regulating qi and Chong, nourishing heart and tranquilizing mind, and has an exact curative effect of preventing and treating insomnia due to yang deficiency.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine technology, specifically relating to a traditional Chinese medicine composition for preventing and treating insomnia due to Yang deficiency and its preparation method. The composition consists of eighteen traditional Chinese medicines in a specific weight ratio: Rehmannia glutinosa (processed), Cuscuta chinensis, Psoralea corylifolia, Aconitum carmichaelii, Bupleurum chinense (processed with wine), Cimicifuga foetida, Cinnamomum cassia, Taxillus chinensis, Cistanche deserticola, Citrus reticulata, Acanthopanax senticosus, Ganoderma lucidum, Saussurea involucrata, Citrus medica, Citrus medica var. sarcodactylis, Syzygium aromaticum, Citrus reticulata, and Mentha haplocalyx. It possesses the effects of warming the kidneys and tonifying Yang, nourishing essence and marrow, promoting Yang and transforming Qi, warming the meridians and strengthening the spleen, regulating Qi and harmonizing the Chong meridian, and nourishing the heart and calming the mind. It is suitable for the prevention and treatment of insomnia due to Yang deficiency and its related complications. Background Technology

[0002] Insomnia refers to a condition characterized by the inability to obtain normal sleep, caused by external pathogenic factors or deficiency of vital energy leading to restlessness of the mind. In Western medicine, neurosis, post-concussion syndrome, as well as hypertension, liver disease, hyperthyroidism, anemia, cerebral arteriosclerosis, chronic poisoning, and early-stage schizophrenia all fall under the category of insomnia.

[0003] Western medicine treatments for insomnia include benzodiazepine receptor agonists (such as estazolam, diazepam, alprazolam, etc.), non-benzodiazepine receptor agonists (such as eszopiclone, zaleplon, etc.), melatonin receptor agonists (such as melatonin, agomelatine), antidepressants (such as mirtazapine, trazodone, etc.), antipsychotics (such as olanzapine, quetiapine, etc.), and antiepileptics (such as gabapentin).

[0004] The aforementioned chemical drugs can alleviate insomnia symptoms to a great extent, but they cannot cure insomnia at its root. Long-term use can not only lead to tolerance and increase the burden on the liver and kidneys, but also irritate the gastrointestinal tract and cause varying degrees of damage to various tissues and organs. Traditional Chinese medicine believes that a person's sleep is controlled by the mind, and the normal functioning of the Ying and Wei (nutritive and defensive qi) and Yin and Yang is the foundation for the mind to regulate sleep. The *Ling Shu* (Spiritual Pivot) states, "Yin and Yang are interconnected, like a ring without end... the circulation of Ying and Wei does not deviate from its normal course, therefore one is energetic during the day and sleeps soundly at night." Anything that affects the normal functioning of Ying and Wei, Qi, blood, Yin and Yang, causing the mind to be restless, can become the cause and pathogenesis of insomnia. Traditional Chinese medicine believes that the causes of insomnia are mainly five aspects. First, exposure to external pathogens; the *Ling Shu* states, "The guest of pathogenic qi may cause one to be unable to close one's eyes and lie down." Among external pathogens, heat is the most common direct cause, while other factors such as cold, dampness, and wind are mostly indirect causes of insomnia. Second, emotional disturbances; extreme emotions such as joy, anger, worry, grief, fear, and fright are common direct causes of insomnia, while overthinking and fatigue are important causes of chronic insomnia. Third, irregular diet; overeating is a primary cause of insomnia. The *Suwen* (Plain Questions) states, "The Yangming meridian is the stomach meridian… if the stomach is not in harmony, one cannot sleep peacefully." A long-term diet rich in fatty and sweet foods can also be an indirect cause of insomnia; some beverages such as alcohol, coffee, and strong tea are also direct causes of insomnia. Fourth, physical weakness; this may be due to insufficient endowment, weakness of the heart and gallbladder, or old age and physical decline, resulting in yin and yang deficiency. For example, the Ming Dynasty text *Zhengzhi Zhunsheng* (Standards of Diagnosis and Treatment) states, "Old people, due to yang deficiency, suffer from insomnia." Fifth, insomnia in people with chronic illnesses often occurs during or after various diseases; prolonged illness may lead to physical weakness due to depletion of vital energy, or internal disturbance of phlegm and fire may cause the mind to wander, resulting in insomnia. Traditional Chinese medicine understands the pathogenesis of this disease as follows: when the mind is directly affected by external pathogenic heat, drinking strong tea, or extreme joy, sorrow, fright, or fear, the onset is usually rapid; when the disease is mainly caused by internal injury due to physical weakness or other illnesses, the onset is generally slower.

[0005] Traditional Chinese medicine believes that this disease is caused by the heart failing to store the spirit, and the spirit being restless in its dwelling place; the main treatment principle is to dispel pathogens and support the body's resistance, replenish deficiencies and purge excesses, regulate qi and blood to calm the mind and spirit.

[0006] The core pathogenesis of insomnia due to Yang deficiency is the failure of Yang to enter Yin. Traditional Chinese medicine believes that normal sleep depends on "Yin-Yang balance," that is, the harmony and coordination of Yin and Yang. Specifically, the key to sleep mechanism lies in Yang entering Yin. During the day, Yang Qi circulates externally, keeping a person awake; at night, Yang Qi is drawn back into Yin, and a person falls asleep.

[0007] The key to Yang deficiency leading to Yang not entering Yin is: (1) Yang Qi is weak and unable to enter Yin: Yang Qi itself is weak, just like insufficient power, unable to smoothly gather, sink and enter the Yin part; (2) Yin cold is excessive inside, hindering Yang from entering: Yang deficiency will generate internal cold, and the Yin cold Qi in the body is excessive, forming a layer of "cold Qi barrier", which hinders the weak Yang Qi from sinking to the Yin part. Yang Qi is rejected outside and cannot smoothly enter Yin; (3) Deficient Yang floats over (false heat): This is a mechanism that needs special attention in Yang deficiency insomnia. When Yang Qi is extremely weak and cannot hold its position, the weak Yang Qi will float over to the body surface or disturb the mind. This floating deficient Yang will disturb the mind and cause a special kind of insomnia. It seems to have "heat symptoms" (such as irritability, dry mouth and no desire to drink, flushed cheeks), but the essence is deficiency and cold (fear of cold, cold limbs, and preference for hot drinks).

[0008] The main organs and manifestations involved in Yang deficiency insomnia are:

[0009] (1) Heart Yang Deficiency; Core Influence: The heart governs the mind and is the master of sleep. When the heart yang is insufficient, the mind loses its warmth and consolidation, resulting in restlessness and agitation. Characteristics of insomnia: difficulty falling asleep, or waking up easily during sleep, and difficulty falling back asleep after waking up. It is often accompanied by palpitations, anxiety, shortness of breath, chest tightness, spontaneous sweating (especially in the chest area), lethargy, pale or sallow complexion, and fear of cold (especially in the chest area). The tongue is pale and swollen or purplish-dark with a white and slippery coating, and the pulse is deep, weak, or intermittent. Mechanism: When the heart yang is deficient, it is unable to warm and nourish the mind, causing the mind to become agitated. Yang deficiency cannot promote blood circulation, leading to blood stasis in the heart and malnourishment of the mind.

[0010] (2) Spleen Yang Deficiency; Core Impact: The spleen is the foundation of acquired constitution and the source of qi and blood production. Insufficient spleen yang leads to a lack of qi and blood production, which cannot nourish the heart and spirit. The spleen governs the transformation and transportation of water and dampness. Spleen yang deficiency results in the internal generation of phlegm and dampness, which disturbs the heart and spirit. Spleen deficiency leads to coldness and deficiency of the middle jiao, and disordered qi movement. Characteristics of insomnia: Insomnia with many dreams, shallow sleep and easy awakening, often accompanied by loss of appetite, abdominal distension (especially after meals), cold pain in the abdomen that is relieved by warmth and pressure, loose stools (even undigested food in stools), cold limbs, fatigue, sallow complexion, bland taste in the mouth and no thirst, pale and swollen tongue with teeth marks, white and greasy or slippery tongue coating, and deep, slow and weak pulse. Mechanism: Insufficient qi and blood leads to malnourishment of the heart and spirit. Phlegm and dampness obstruct the internal flow, clouding the sensory orifices. Coldness and deficiency of the middle jiao and disordered qi movement affect the peace of mind.

[0011] (3) Kidney Yang Deficiency; Core Impact: The kidney is the foundation of innate essence, containing primordial yin and primordial yang (true yin and true yang), which is the root of yang qi in the human body; Kidney yang deficiency cannot warm the whole body and nourish the heart fire to warm the mind (heart and kidney interact); the kidney governs water, and kidney yang deficiency leads to abnormal water metabolism, with cold water rising and attacking the heart; Kidney essence deficiency cannot generate marrow to nourish the brain. Characteristics of insomnia: early awakening (especially between 3-5 am), difficulty falling back asleep after waking up; often accompanied by soreness and coldness in the waist and knees, aversion to cold and cold limbs (especially the lower body), frequent and clear urination at night, decreased libido, diarrhea at dawn, lethargy, dizziness and tinnitus, pale or dark complexion, pale and swollen tongue with white coating, deep, thready and weak pulse, especially the cun pulse; Mechanism: Deficiency of the fire of the gate of life, disharmony between the heart and kidney (the kidney water is cold and cannot nourish the heart fire, which is actually a deficiency fire); cold water rises and disturbs the mind; the marrow sea is not nourished.

[0012] Insomnia due to Yang deficiency is essentially due to deficiency and cold. The core symptoms are fear of cold (cold limbs), preference for warmth, lethargy, and fatigue. Sleep disorders may manifest as difficulty falling asleep, but more commonly, it is characterized by shallow sleep, frequent awakenings (especially in the second half of the night), early awakening, and difficulty falling back asleep, often accompanied by a "false heat" phenomenon. Symptoms may include irritability, dry mouth (but often without desire to drink or with a preference for hot drinks), and flushed cheeks, which are manifestations of floating Yang deficiency. The tongue is often pale, swollen, and tender, or may have teeth marks, with a white, slippery, and moist coating. The pulse is often deep, slow, thready, weak, and feeble. Exposure to cold, fatigue, excessive thinking, and drinking too much water at night (which increases the burden on kidney Yang) often aggravate insomnia.

[0013] Treatment principles: The core of treating insomnia due to Yang deficiency is to warm and tonify Yang Qi. Depending on the specific organs involved, the treatments mainly include warming and tonifying heart Yang, warming and tonifying spleen Yang, warming and tonifying kidney Yang, guiding fire back to its source, and calming the mind and spirit. Summary of the Invention

[0014] The inventor has been engaged in health conditioning and prevention and treatment of insomnia for many years. Through the treatment of many patients with Yang deficiency insomnia and the screening of medications, it has been determined that Yang deficiency insomnia is a syndrome that has a significant impact on the physical and mental health of patients. After clinical trials, a Chinese herbal medicine composition with definite efficacy in preventing and treating Yang deficiency insomnia has been identified, thus establishing this invention.

[0015] The purpose of this invention is to provide a traditional Chinese medicine composition that is effective in preventing and treating insomnia caused by yang deficiency. Another purpose of this invention is to provide a method for preparing the traditional Chinese medicine composition. The present invention uses 18 traditional Chinese medicines, including Rehmannia glutinosa, Cuscuta chinensis, Psoralea corylifolia, Aconitum carmichaelii, Bupleurum chinense, Cimicifuga foetida, Cinnamomum cassia, Taxillus chinensis, Cistanche deserticola, Citrus reticulata, Acanthopanax senticosus, Ganoderma lucidum, Saussurea involucrata, Citrus medica, Citrus medica var. sarcodactylis, Cinnamomum cassia, Clove, Leonurus japonicus, and Mentha haplocalyx, to exert a synergistic effect.

[0016] Prepared Rehmannia root is the dried tuberous root of Rehmannia glutinosa, a plant in the Scrophulariaceae family, processed into a finished product. The preparation method involves taking raw Rehmannia root, stewing it in wine until the wine is absorbed, removing it, and sun-drying it until the outer skin's mucilage is slightly dry. Then, it is cut into thick slices or chunks and dried. Alternatively, it can be steamed in wine until it becomes black and glossy, removed, sun-dried until about 80% dry, cut into thick slices or chunks, and dried. This product is slightly warm in nature, has a faint odor, and a sweet taste. It enters the liver and kidney meridians. The best quality is characterized by large, plump tubers, a black cross-section, and a sweet taste. Its effects include nourishing blood and yin, and replenishing essence and marrow.

[0017] Applications: (1) Blood deficiency with chlorosis, palpitations, irregular menstruation, metrorrhagia, etc. This product is sweet and warm in nature, nourishes yin and replenishes essence to generate blood. It is a key medicine for treating blood deficiency syndrome. It is used to treat blood deficiency with chlorosis, dizziness, palpitations, insomnia, irregular menstruation, metrorrhagia, etc. It is often used with Angelica sinensis, Paeonia lactiflora, and Ligusticum chuanxiong, such as Siwu Decoction (Formulary of the Bureau of Imperial Physicians). If there is blood deficiency with palpitations, it can be used with calming medicines such as Polygala tenuifolia and Ziziphus jujuba. If there is blood deficiency with metrorrhagia, it can be used with blood-nourishing and hemostatic medicines such as donkey-hide gelatin and Artemisia argyi, such as Jiao Ai Decoction (Essentials from the Golden Cabinet). If there is deficiency of both qi and blood, it is often used with ginseng and Angelica sinensis, such as Bazhen Decoction (Essentials of Traditional Chinese Medicine). (2) For liver and kidney yin deficiency, soreness and weakness of the waist and knees, bone steaming fever, night sweats, seminal emission, internal heat and thirst, this herb is sweet and moistening, enters the liver and kidneys and is good at nourishing yin and blood. It is an essential medicine for treating liver and kidney yin deficiency. The ancients said that it "greatly nourishes the true yin of the five internal organs" and "greatly nourishes the true water". It can nourish the liver and kidneys and benefit the essence. It is used to treat soreness and weakness of the waist and knees, seminal emission, night sweats, tinnitus, deafness and thirst caused by liver and kidney yin deficiency. It is often used with Cornus officinalis, Dioscorea opposita and other herbs, such as Liuwei Dihuang Wan (Xiao'er Yaozheng Zhijue). It is used to treat liver and kidney yin deficiency, deficiency fire rising, bone steaming fever, flushed cheeks, night sweats, tinnitus and seminal emission. It is often used with Anemarrhena asphodeloides, Phellodendron chinense and Cornus officinalis and other herbs, such as Zhibai Dihuang Wan (Yifang Kao). (3) Liver and kidney deficiency, essence and blood deficiency, dizziness, tinnitus, premature graying of hair. This product has the effect of tonifying the liver and kidney, replenishing essence and marrow. It is used to treat essence and blood deficiency and premature graying of hair. It is often used with Polygonum multiflorum, Achyranthes bidentata, Cuscuta chinensis and other products to benefit essence and blood and blacken hair, such as Qibao Meiran Dan (Collection of Medical Prescriptions). It is used to treat the five delays and five weaknesses caused by liver and kidney deficiency and essence and blood deficiency. It can be used with tortoise shell, Cynomorium songaricum, Cibotium barometz and other products that tonify the kidney and strengthen bones.

[0018] Prepared Rehmannia glutinosa is a processed form of raw Rehmannia glutinosa. Its chemical composition is similar to that of raw Rehmannia glutinosa, mainly containing styrene glycosides (such as verbascoside), as well as monosaccharides, amino acids, vitamin A-like substances, etc.

[0019] Pharmacological effects: The aqueous decoction of this product can promote the recovery of erythrocytes and red blood cells in mice with hemorrhagic anemia. The decoction of Rehmannia glutinosa can antagonize the inhibitory effect of dexamethasone on the pituitary-adrenal cortex system and promote the synthesis of adrenocortical hormones. The alcoholic extract can enhance immune function, promote blood coagulation, and strengthen the heart. In addition, this product also has effects such as lowering blood sugar, preventing and treating osteoporosis, regulating immunity, anti-aging, anti-anxiety, and improving learning and memory.

[0020] In this invention, Rehmannia glutinosa is used as the principal ingredient in large doses to nourish yin and blood, replenish essence and marrow, provide a material basis for kidney essence, and ensure the source of yang qi generation.

[0021] Dodder seed is the dried, mature seed of *Cuscuta chinensis* or *Cuscuta spp.*, a plant in the Convolvulaceae family, and is produced in most parts of my country. The plants are harvested in autumn when the fruit is ripe, dried in the sun, the seeds are threshed, impurities are removed, washed, and dried again. This product has a slight odor and a bland taste; the best quality is grayish-yellow in color and with plump seeds. It can be used raw or processed with salt water. The medicinal taste is pungent and sweet, and the nature is neutral; it enters the liver, kidney, and spleen meridians. Its functions include tonifying the liver and kidneys, consolidating essence and reducing urination, calming the fetus, improving eyesight, and stopping diarrhea; externally, it is used to dispel wind and remove blemishes.

[0022] This herb is neutral in nature, pungent to moisten dryness, and sweet to replenish deficiency. It is a neutral tonic for both Yin and Yang, functioning to tonify kidney Yang, benefit kidney essence, and strengthen essence while reducing urination. For treating kidney deficiency and lower back pain, it can be combined with Eucommia ulmoides and Dioscorea opposita; for treating impotence and seminal emission, it can be used with Lycium barbarum, Rubus idaeus, and Plantago asiatica, as in the Five-Seed Progeny Pill; for treating excessive urination or incontinence, it can be used with Mantis egg case, Cistanche deserticola, and deer antler; for treating seminal emission, leukorrhea, and dribbling urination, it can be used with Astragalus complanatus, Euryale ferox, and Dioscorea hypoglauca. This herb can tonify the liver and kidneys and stabilize the fetus, treating kidney deficiency and unstable fetal development, fetal restlessness, and miscarriage. It is often used with Dipsacus asper, Taxillus chinensis, and donkey-hide gelatin, as in the Longevity Fetus Pill. This herb nourishes the liver and kidneys, benefits essence and blood, and improves eyesight. It is often used with Rehmannia glutinosa, Plantago asiatica, and Lycium barbarum, as in the Vision-Promoting Pill. This product can tonify the kidneys and spleen, and stop diarrhea. It treats loose stools and diarrhea caused by deficiency of both the spleen and kidneys, and can be combined with psoralea, atractylodes macrocephala, nutmeg, etc. Externally, it can dispel wind and remove blemishes; it can be used to treat vitiligo by soaking it in alcohol and applying it topically. Taking advantage of its kidney-tonifying and essence-boosting effects, it can also treat kidney deficiency and diabetes.

[0023] The main chemical components include flavonoids such as hyperoside and cuscuta glycoside; organic acids such as chlorogenic acid; and trace elements such as calcium, potassium, and phosphorus, as well as amino acids. Pharmacological effects: Cuscuta chinensis has a therapeutic effect on a hydrocortisone-induced "yang deficiency" model in mice, significantly increasing the mating frequency of Drosophila melanogaster; it has estrogen-like effects and anti-aging effects; it can enhance the contractility of isolated toad hearts, lower cholesterol, soften blood vessels, lower blood pressure, and promote hematopoietic function; it can inhibit intestinal motility; and it can delay the development of galactose-induced cataracts in rats.

[0024] In this invention, Cuscuta chinensis is used as an assistant herb to help the principal herb to nourish the liver and kidneys, replenish blood and strengthen essence, reflecting the therapeutic concept of seeking yang within yin.

[0025] Psoralea corylifolia is the dried, mature fruit of the legume Psoralea corylifolia. It is mainly produced in Henan, Sichuan, Anhui, and Shaanxi provinces. The fruit clusters are harvested in autumn when ripe, dried in the sun, and the fruits are rubbed out to remove impurities. This product has a fragrant aroma and a pungent, slightly bitter taste; the best quality is characterized by large, black, plump, firm grains free of impurities; it can be used raw or processed with salt water. The medicinal properties are pungent and bitter, and warm in nature; it enters the kidney and spleen meridians. Its functions include tonifying the kidneys and strengthening yang, consolidating essence and reducing urination, regulating qi and relieving asthma, warming the spleen and stopping diarrhea; externally, it is used to dispel wind and remove blemishes.

[0026] Applications: For kidney yang deficiency, impotence, infertility, and cold pain in the lower back and knees, this herb is bitter, pungent, warm, and drying. It can warm the kidneys and assist yang, treating impotence due to kidney deficiency. It is often used with dodder seed, walnut kernel, and agarwood. For kidney yang deficiency and cold pain in the lower back and knees due to wind-cold invasion, it can be used with eucommia bark and walnut kernel, such as in Qing'e Pill. This herb is tonifying and astringent, good at tonifying the kidneys and assisting yang, consolidating essence and reducing urination. It can be used alone or combined with other herbs according to the symptoms. For example, to treat spermatorrhea, it is stir-fried with equal parts of psoralea corylifolia and rock salt and then powdered and taken orally. To treat bedwetting in children, the "Supplement to Essential Pediatric Prescriptions" uses this herb alone, stir-fried and powdered, and taken orally. To treat kidney qi deficiency and coldness, and excessive urination, the "Wei Family Prescriptions" uses this herb with equal parts of fennel and made into pills for oral administration. This product tonifies the kidneys and strengthens yang, regulates qi and relieves asthma. It is effective for asthma due to kidney yang deficiency and the kidney's inability to regulate qi, addressing both the root cause and the symptoms. It can be used in combination with aconite, cinnamon, and agarwood, as in the formula Black Tin Pill. This product enters the spleen and kidney meridians, warming and tonifying the spleen and kidneys, astringing and stopping diarrhea. It treats early morning diarrhea caused by spleen and kidney deficiency and cold, often combined with evodia, schisandra, and nutmeg, as in the Four Gods Pill. Externally, this product can dispel wind and remove blemishes. It is used to treat vitiligo and alopecia areata. Grind this product into powder, soak it in wine to make a tincture, and apply it externally to the affected area.

[0027] The main chemical components include coumarins such as psoralen and isopsoralen; flavonoids such as astragaloside; and monoterpenoid phenols such as psoralen. It also contains stigmasterol, sitosterol, glucoside, and raffinose. Pharmacological effects: Psoralen has estrogen-like effects, enhancing vaginal keratinization and increasing uterine weight. It can dilate coronary arteries, stimulate the heart, and increase cardiac output. It can contract the uterus and shorten bleeding time, reducing bleeding volume. It has photosensitizing effects; when taken internally or applied topically to the skin, exposure to sunlight or ultraviolet radiation can cause local skin pigmentation.

[0028] In this invention, Psoralea corylifolia is used as an adjuvant to tonify the kidneys and strengthen yang, as well as to invigorate the spleen and replenish essence.

[0029] Aconite is a processed product of the lateral root of the Ranunculaceae plant *Aconitum carmichaelii*, mainly produced in Sichuan Province. It is harvested from late June to early August, after which the mother root, fibrous roots, and soil are removed; this is commonly known as "mud aconite." It is processed into salted aconite, black aconite slices (black aconite slices), and white aconite slices. Salted aconite has a slight odor, a salty and numbing taste, and a tingling sensation on the tongue; the best quality is characterized by its large size, heavy weight, grayish-black color, and salt frost on the surface. Black aconite slices (black aconite slices) have a slight odor and a bland taste; the best quality is characterized by its dark brown skin and oily, glossy cut surface. White aconite slices have a slight odor and a bland taste; the best quality is characterized by its large size, yellowish-white color, and oily, semi-transparent appearance. Processed aconite slices include black aconite slices, white aconite slices, light-colored aconite slices, and processed aconite slices. It is extremely hot in nature and toxic; its taste is pungent and sweet, and it enters the heart, kidney, and spleen meridians. Its functions include restoring yang and rescuing from collapse, tonifying fire and assisting yang, and dispelling cold and relieving pain.

[0030] Applications: (1) For collapse of yang, cold limbs and weak pulse, this product can help the heart yang, warm the spleen yang, and tonify the kidney yang. It is the "first-class medicine for restoring yang and rescuing from collapse". The Compendium of Materia Medica states that "for those who are in the extreme of yang deficiency and have no heat in the lungs and kidneys, taking this product has the special effect of reviving the dead". It is used to treat collapse of yang, cold limbs and weak pulse caused by prolonged illness, weakness, yang deficiency, internal cold, or excessive sweating, vomiting, or diarrhea. It is often used with dried ginger and licorice, such as in the Four Reversal Decoction (Treatise on Cold Damage). This product can restore yang and rescue from collapse. When used with ginseng, which greatly tonifies the original qi, it can treat collapse of yang and qi collapse, such as in the Ginseng and Aconite Decoction (Treatise on Cold Damage). (2) Kidney Yang deficiency, impotence, cold uterus, cold vomiting and diarrhea, cold pain in the stomach and abdomen, cold edema, heart Yang deficiency, chest pain, cold pain, cold yin deficiency and external pathogenic factors; This product is pungent, sweet and warm, and has the effect of tonifying the original Yang and benefiting the fire and eliminating Yin. The Compendium of Materia Medica calls it "the main medicine of the gate of life". It can be used for all cases where the Yang Qi of the kidney, spleen and heart is weak and the Yin cold is excessive; It is used to treat kidney Yang deficiency. For impotence, premature ejaculation, infertility due to cold uterus, cold pain in the lower back and knees, and frequent urination at night caused by deficiency of kidney yang, it is often combined with cinnamon, cornus officinalis, and prepared rehmannia root, as in Yougui Wan (from Jingyue Quanshu). For abdominal pain, vomiting, and loose stools caused by deficiency of spleen and kidney yang and internal accumulation of cold and dampness, it is often used with ginseng, atractylodes macrocephala, and dried ginger, as in Fuzi Lizhong Tang (from Heji Jufang). For urinary difficulty and edema of the limbs caused by deficiency of spleen and kidney yang and internal retention of water, it is often used with poria cocos and atractylodes macrocephala, as in Zhenwu Tang (from Shanghan Lun). For weakness of heart yang, palpitations, shortness of breath, chest pain, and heart pain, it can be combined with ginseng. , Cinnamon twig and others are used together; for those with yang deficiency and external wind-cold, it is often used with ephedra and asarum, such as Ephedra, Aconite and Asarum Decoction (Shang Han Lun); (3) Cold-dampness bi pain, this product is strong and vigorous, it moves without staying, it can warm the meridians and unblock the collaterals, and expel wind-cold-dampness evil in the meridians, so it has a strong effect of dispelling cold and relieving pain; "Compendium of Materia Medica" says it is "a strong medicine for opening the joints", "Correct Meaning of Materia Medica" says it is "an essential medicine for opening the twelve meridians and pure yang"; it can be used for all those with wind-cold-dampness bi pain in the whole body and joints, especially good for treating severe cold bi pain, often used with cinnamon twig, white atractylodes and licorice, such as licorice and aconite decoction (Shang Han Lun).

[0031] Chemical composition: It mainly contains diester-type alkaloids (aconitine, neoaconitine, hypoaconitine, noraconitine, noraconitine, tararaconine, isophorine, neoaconitine, etc.), and also contains monoester-type alkaloids (benzoylneoaconitine, benzoylaconitine, benzoylhypoaconitine, etc.). Diester-type alkaloids are the main active and toxic components of Aconitum carmichaelii. The Chinese Pharmacopoeia stipulates that this product contains benzoylneoaconitine (…). The total amount of benzoyl aconitine (C31H43NO10), benzoyl aconitine (C32H45NO10), and benzoyl hypoaconitine (C31H43NO9) in the medicinal slices shall not be less than 0.010%; the total amount of diester-type alkaloids in the medicinal slices, calculated as neoaconitine (C33H45NO11), hypoaconitine (C33H45NO10), and aconitine (C34H47NO11), shall not exceed 0.010%.

[0032] Pharmacological effects: Aconite decoction and its water-soluble fraction have significant cardiotonic effects on the hearts of frogs, toads, and warm-blooded animals; the water-soluble fraction of aconite can increase femoral artery blood flow, reduce vascular pressure, and has a mild vasodilatory effect on coronary arteries; its n-butanol extract, ethanol extract, and water extract have a preventive effect on chloroform-induced ventricular fibrillation in mice; aconite alkaloids can dilate blood vessels in the limbs, thus having a bidirectional effect on blood pressure; aconite decoction can reduce changes in blood pressure, heart rate, and myocardial contractility in animals, and significantly prolong the survival time of animals in shock; aconite decoction has anticoagulant and antithrombotic effects; aconite has anti-inflammatory and analgesic effects; aconite can enhance immunity and the body's antioxidant capacity, and has anti-aging effects.

[0033] Adverse reactions: Aconitum carmichaelii contains various aconitine compounds, which are highly toxic, especially to the heart. However, the toxicity of aconitine formed after hydrolysis is greatly reduced. Aconitine compounds belong to the diterpenoid alkaloid class and have curare-like effects, i.e., blocking neuromuscular transmission. They also have aconitine-like effects, manifesting as arrhythmia, hypotension, hypothermia, respiratory depression, muscle paralysis, and central nervous system dysfunction. Large doses of crude aconitine alkaloids can cause various systemic and respiratory paralysis symptoms in animals, with respiratory arrest preceding circulatory disturbances. The main causes of aconitine poisoning are accidental ingestion, improper use (such as excessive dosage, improper decoction, or inappropriate formulation), or individual differences.

[0034] In this invention, Aconitum carmichaelii is used as an assistant herb to help the principal herb exert its effects of restoring yang and rescuing from collapse, tonifying fire and assisting yang, and calming the mind and stabilizing the will.

[0035] Wine-processed Bupleurum is a wine-processed product of the dried roots of Bupleurum chinense or Bupleurum stenoptera, both belonging to the Apiaceae family. Bupleurum is commonly referred to as "Northern Bupleurum" and "Southern Bupleurum" based on its characteristics. Northern Bupleurum is mainly produced in Hebei, Henan, and Liaoning provinces, while Southern Bupleurum is mainly produced in Hubei, Jiangsu, and Sichuan provinces (this invention, through detailed experiments, proves that the different origins of "Northern Bupleurum" and "Southern Bupleurum" do not affect the efficacy of the herbal combination). It is harvested in spring and autumn, with stems, leaves, and dirt removed, then dried and cut into sections. This product has a slightly fragrant odor and a slightly bitter taste; the best quality is characterized by a dark brown outer skin and a yellowish-white cut surface. It can be used raw or processed with vinegar. It is slightly cold in nature, pungent and bitter in taste, and enters the liver, gallbladder, and lung meridians. Its functions include dispersing and reducing fever, soothing the liver and relieving depression, and raising yang qi.

[0036] Applications: (1) For colds with fever and alternating chills and fever, this product is pungent and bitter, slightly cold and reduces fever. It is good at dispelling evil, relieving exterior fever and dispersing evil in the half-exterior and half-interior of the Shaoyang meridian. For colds with fever, regardless of whether it is wind-heat or wind-cold exterior syndrome, it can be used to treat wind-cold colds with chills and fever, headache and body pain. It is often used with Fangfeng, ginger and other drugs, such as Zheng Chaihu Yin (Jingyue Quanshu). If the external wind-cold is invaded and the cold evil enters the interior and transforms into heat, the chills gradually lessen and the body fever increases. Chaihu is often used with Gegen, Huangqin, Shigao and other drugs to relieve the exterior and clear the interior, such as Chaihu Yin. Ge Jie Ji Tang (from *Shang Han Liu Shu*) is used to treat wind-heat colds, fever, headaches, etc. It can be used with pungent and cool exterior-releasing herbs such as chrysanthemum, mint, and cimicifuga. Modern single-herb or compound injections made from Bupleurum have a good exterior-releasing and fever-reducing effect for exogenous fever. If the pathogenic factor of typhoid fever is in the Shaoyang stage, with alternating chills and fever, fullness and discomfort in the chest and hypochondrium, bitter taste in the mouth, dry throat, and dizziness, this herb is most suitable and is an essential medicine for treating Shaoyang syndrome. It is often used with Scutellaria baicalensis to clear the heat in the half-exterior and half-interior, thus achieving the effect of harmonizing and relieving Shaoyang, as in Xiao Chai Hu Tang (from *Shang Han Lun*). (2) For liver qi stagnation, chest and rib pain, and menstrual disorders, this herb is pungent and bitter, and is good at regulating liver qi and relieving liver stagnation. It is used to treat chest and rib pain or lower abdominal pain, depression, menstrual disorders, and dysmenorrhea caused by liver qi stagnation and qi stagnation. It is often used with Cyperus rotundus, Ligusticum chuanxiong, and Paeonia lactiflora, such as in Chaihu Shugan San (from Jingyue Quanshu). If there is liver qi stagnation and blood deficiency, spleen deficiency, menstrual disorders, breast pain, rib pain, fatigue, poor appetite, and weak pulse, it is often combined with Angelica sinensis, Paeonia lactiflora, and Atractylodes macrocephala, such as in Xiaoyao San (from Jingyue Quanshu). (3) Qi deficiency and sinking, gastroptosis, kidney prolapse, uterine prolapse, chronic diarrhea and rectal prolapse. This product can raise the clear yang qi of the spleen and stomach. It can be used to treat the abdominal distension, poor appetite and fatigue, chronic diarrhea and rectal prolapse, uterine prolapse and kidney prolapse caused by insufficient middle qi and qi deficiency and sinking. It is often used with ginseng, astragalus, and cimicifuga to replenish qi and raise yang, such as Buzhong Yiqi Tang (Treatise on the Spleen and Stomach). In addition, this product can also reduce fever and stop malaria. It is also a commonly used medicine for treating malaria with chills and fever. It is often used with scutellaria, datura, and amomum.

[0037] Chemical composition: Primarily contains saponins (saikosaponins a, b, d, f, etc.), volatile oils (2-methylcyclopentanone, limonene, myrcene, carvone, valeric acid, hexanoic acid, heptanoic acid, octanoic acid, 2-octenic acid, nonanoic acid, γ-heptenic acid, etc.), as well as polysaccharides, organic acids, phytosterols, and flavonoids. The Chinese Pharmacopoeia stipulates that the total amount of saikosaponin a (C42H68O13) and saikosaponin d (C42H68O13) in this product, *Bupleurum chinense*, shall not be less than 0.30%.

[0038] Pharmacological effects: Bupleurum decoction, injection, alcohol extract, volatile oil, and crude saponins have significant antipyretic effects on experimental fever in animals caused by various reasons, and can also lower the body temperature of normal animals; Bupleurum and its effective component, saikosaponin, have anti-inflammatory effects, which are related to promoting the function of the adrenal cortex system; Bupleurum has sedative, tranquilizing, analgesic, antitussive, lipid-lowering, hepatoprotective, choleretic, intestinal smooth muscle stimulating, gastric acid secretion inhibiting, anti-ulcer, trypsin inhibitory, antimicrobial, uterine stimulating, metabolism-influencing, antitumor, antiepileptic, anti-radiation, and immune-promoting effects.

[0039] After being processed with wine, Bupleurum chinense enhances its effects of raising Yang and lifting prolapse, as well as soothing the liver and relieving depression. Simultaneously, it shifts the medicinal properties more towards the upper burner and the circulation of Qi, while mitigating its potential dryness. In this invention, wine-processed Bupleurum chinense serves as an assistant herb, assisting the principal herb in exerting its effects of soothing the liver and relieving depression, and raising Yang Qi, thereby achieving the therapeutic effect of emotional balance and restoring vitality throughout the day.

[0040] Cimicifuga rhizome is the dried rhizome of *Cimicifuga foetida*, *Cimicifuga dahurica*, or *Cimicifuga foetida*, all belonging to the Ranunculaceae family. It is mainly produced in Liaoning, Heilongjiang, Hebei, Shanxi, and Sichuan provinces. Harvested in autumn, the soil and sand are removed, and the rhizomes are sun-dried until the fibrous roots are dry. The roots are then singed off or removed, and the remaining roots are sun-dried and sliced. The product has a slight odor and a slightly bitter and astringent taste. The best quality is characterized by a dark brown outer skin and a yellowish-green cut surface. It can be used raw or honey-processed. It is slightly cold in nature, pungent and slightly sweet in taste, and enters the lung, spleen, stomach, and large intestine meridians. Its functions include releasing exterior pathogens and promoting rash eruption, clearing heat and detoxifying, and raising yang qi. It enters the spleen and stomach meridians and is good at... It draws the clear yang qi of the spleen and stomach upward, and its lifting power is stronger than that of Bupleurum. Therefore, it is often used to treat abdominal distension, poor appetite, fatigue, chronic diarrhea, rectal prolapse, uterine prolapse, kidney prolapse, and other organ prolapse caused by insufficient middle qi and qi deficiency and sinking. It is often used with Astragalus, Ginseng, Bupleurum, etc. to replenish qi and raise yang. If the qi in the chest sinks and there is shortness of breath, it is often used with Bupleurum, Astragalus, Platycodon, etc. For treating qi deficiency and sinking, heavy menstrual bleeding or metrorrhagia, it is used with Ginseng, Astragalus, Atractylodes macrocephala, etc. to replenish qi and boost the middle qi.

[0041] The main chemical components include phenolic acids (isoferric acid, cimicifugic acid A, B, C, D, E, triterpenoids and glycosides, xingan cimicifugol, 25-O-hydroxycimicifugol-3-O-β-D xyloside) and chromones (decimicifugin).

[0042] Pharmacological effects: Cimicifuga extract has antipyretic, anti-inflammatory, analgesic, anticonvulsant, leukocyte-increasing, and platelet aggregation and release-inhibiting effects. Cimicifuga has moderate antibacterial effects against Mycobacterium tuberculosis, Staphylococcus aureus, and Moraxella catarrhalis. Cimicifuga has a certain inhibitory effect on intestinal spasms induced by chloroacetylcholine, histamine, and barium chloride. It also has the effects of inhibiting the heart, slowing heart rate, lowering blood pressure, inhibiting intestinal spasms, and inhibiting uterine spasms during pregnancy. Both crude and charred versions of Cimicifuga can shorten clotting time.

[0043] In this invention, both Cimicifuga and Bupleurum chinense are used as assistant herbs, working together to lift and promote the flow of Qi and clear Yang.

[0044] Cinnamon twigs are the dried tender branches of the cinnamon tree (Cinnamomum cassia), a plant in the Lauraceae family. They are mainly produced in Guangdong and Guangxi provinces. Harvested in spring and summer, the leaves are removed, and the twigs are sun-dried or sliced ​​and sun-dried. This product has a distinctive aroma, a sweet and slightly spicy taste, with a stronger flavor in the bark. The best quality twigs are tender, reddish-brown in color, and have a strong aroma. They are used raw. The medicinal properties are warm, with a pungent and sweet taste, and they enter the heart, lung, and bladder meridians. Their functions include inducing sweating and relieving muscle tension, warming and unblocking the meridians, assisting yang qi, and calming the rebellious qi.

[0045] The main chemical components include volatile oils (cinnamaldehyde, camphene, benzaldehyde, β-elemene, β-piperine, etc.), as well as phenols, organic acids, polysaccharides, glycosides, coumarins, and tannins.

[0046] The cinnamon oil contained in this product can dilate blood vessels, improve blood circulation, and promote blood flow to the body surface, thereby facilitating sweating and heat dissipation. Cinnamon twig decoction and cinnamaldehyde have antipyretic and cooling effects. Cinnamon twig alcohol extract has inhibitory effects on Staphylococcus aureus, Escherichia coli, Streptococcus pneumoniae, Bacillus anthracis, Vibrio cholerae, and influenza virus. Cinnamon oil and cinnamaldehyde have inhibitory effects on Mycobacterium tuberculosis and Proteus vulgaris. Cinnamaldehyde can promote gastrointestinal smooth muscle peristalsis, enhance digestive function, and has a choleretic effect. In addition, cinnamon twig has analgesic, anti-inflammatory, anti-allergic, coronary blood flow increasing, cardiac function improving, sedative, anticonvulsant, and antitumor effects.

[0047] In this invention, cinnamon twig is used as an adjuvant to assist the principal and assistant herbs in warming and unblocking the meridians and promoting yang and qi circulation.

[0048] Mistletoe is the dried leafy stem and branches of the plant *Taxillus chinensis*, belonging to the Loranthaceae family. It is mainly produced in Guangxi and Guangdong provinces. Harvesting takes place from winter to the following spring. The coarse stems are removed, and the stems are cut into sections and dried; alternatively, they can be steamed, dried, and sliced ​​into thick pieces. This product has a slight odor and astringent taste. The best quality is characterized by thin branches, tender texture, and abundant leaves. It is used raw. Its medicinal properties are neutral, with a bitter and sweet taste. It enters the liver and kidney meridians, and its functions include dispelling wind-dampness, tonifying the liver and kidneys, strengthening muscles and bones, and calming the fetus.

[0049] This herb is bitter and sweet, nourishing and tonifying. It can dispel wind and dampness, and is also good at tonifying the liver and kidneys, and strengthening tendons and bones. It is especially suitable for those with long-term arthralgia that has damaged the liver and kidneys, resulting in soreness and weakness of the lower back and knees, and weakness of tendons and bones. It is often used with Angelica pubescens, Eucommia ulmoides, and Achyranthes bidentata, such as in the Angelica pubescens and Loranthus Decoction. This herb can tonify the liver and kidneys, nourish blood, strengthen the Chong and Ren meridians, and stabilize the fetus. It is used to treat liver and kidney deficiency, metrorrhagia, menorrhagia, bleeding during pregnancy, and threatened abortion. It is often combined with donkey-hide gelatin, Dipsacus asper, and Cyperus rotundus; or with donkey-hide gelatin, Dipsacus asper, and Cuscuta chinensis. This herb can also tonify the liver and kidneys to calm the liver and lower blood pressure. It is used for dizziness and vertigo in patients with hypertension due to liver and kidney deficiency. It can be combined with Eucommia ulmoides and Achyranthes bidentata.

[0050] The main chemical components include flavonoids (such as parasitic glycoside, quercetin, hyperoside, and quercitrin) and volatile oils (such as benzoyl, phenyladiene, aromatic curcumin, and eucalyptol).

[0051] Pharmacological effects: Loranthus parasiticus has a hypotensive effect; the injection has a coronary vasodilatory effect and can slow the heart rate; the decoction or infusion has a significant inhibitory effect on poliovirus and various enteroviruses in vitro, and can inhibit the growth of Salmonella typhi and Staphylococcus aureus; the extract has inhibitory activity against hepatitis B virus surface antigen.

[0052] In this invention, mulberry mistletoe is used as an adjuvant to tonify the liver and kidneys, nourish blood, and strengthen the Chong and Ren meridians, thus demonstrating the therapeutic effect of seeking yang within yin.

[0053] Cistanche deserticola is the dried, fleshy stem with scaly leaves of Cistanche deserticola or Cistanche tubulosa, both belonging to the Orobanchaceae family. It is mainly produced in Inner Mongolia, Xinjiang, and Gansu. Harvesting takes place in spring when the seedlings just emerge or in autumn before the ground freezes. The stem tips are removed, and the stems are cut into sections and sun-dried. This product has a faint odor and a sweet, slightly bitter taste. The best quality is characterized by thick, robust stems densely covered with scales, a brownish-red color, and a soft, moist texture. It is cut into thick slices and used raw or stewed (or steamed) with wine. It is warm in nature and has a sweet and salty taste; it enters the kidney and large intestine meridians; its functions include tonifying kidney yang, nourishing essence and blood, and moistening the intestines to relieve constipation.

[0054] This herb is sweet and warm, invigorating yang, moist and nourishing. Its salty nature enters the kidneys, tonifying kidney yang and replenishing essence and blood. However, its effects are gradual and slow, with no immediate results. For treating male weakness and impotence, dribbling urination, it is often used with Cuscuta chinensis, Dipsacus asper, and Eucommia ulmoides. For treating kidney deficiency and bone weakness, unable to move, it can be used with Eucommia ulmoides, Morinda officinalis, and Placenta hominis. This herb is sweet and salty, moistening the large intestine and promoting bowel movements. For treating constipation due to excessive sweating and depletion of body fluids, it can be used with Aquilaria sinensis and Hemp seed, as in Run Chang Wan (a traditional Chinese medicine formula). For treating kidney qi deficiency, constipation, clear and copious urination, lower back pain and coldness, it can be used with Angelica sinensis, Achyranthes bidentata, and Alisma plantago-aquatica, as in Ji Chuan Jian (another traditional Chinese medicine formula).

[0055] The main chemical components include phenylethanol glycosides such as echinacoside and verbascoside, iridoids such as epistrylinic acid, lignin components such as pinoresinol, as well as alkaloids, sugars, sugar alcohols, sterols, and various trace elements.

[0056] Pharmacological effects: Cistanche deserticola has a regulatory effect on the decrease and increase of liver and spleen nucleic acid content in animals with yang deficiency and yin deficiency. It can activate the adrenal gland and release corticosteroids, enhance the luteinizing function of the hypothalamus-pituitary-ovarian axis, and improve the responsiveness of the pituitary gland to LRH and the responsiveness of the ovary to LH, without affecting the endocrine balance of the natural reproductive cycle. The ethanol extract of Cistanche deserticola can significantly inhibit the production of lipid peroxides in rat brain, liver, heart, kidney and testis tissue homogenates in an in vitro incubation system, and shows a good dose-effect relationship.

[0057] In this invention, Cistanche deserticola is used as an adjuvant to assist the principal and assistant herbs in tonifying the kidneys, strengthening yang, replenishing essence, and calming the mind.

[0058] Chenpi (dried tangerine peel) is the dried, mature peel of the citrus fruit and its cultivated varieties, belonging to the Rutaceae family. It is mainly produced in Guangdong, Guangxi, Fujian, Sichuan, and Jiangxi provinces. Mature fruits are harvested, the peel is removed, and then dried in the sun or at low temperature. The medicinal material is divided into "Chenpi" and "Guangdong Chenpi". This product has a fragrant aroma and a pungent and bitter taste. Those with bright color and strong aroma are considered the best. It is cut into strips and used raw. It is warm in nature, bitter and pungent in taste, and enters the spleen and lung meridians. Its functions include regulating qi and strengthening the spleen, drying dampness and resolving phlegm.

[0059] This herb is pungent and aromatic, warm and bitter, and enters the spleen and stomach meridians. It has the functions of regulating qi, relieving bloating, and drying dampness, making it an excellent remedy for abdominal distension, poor appetite, vomiting, and diarrhea caused by qi stagnation and dampness in the spleen and stomach. It is most suitable for those with cold-dampness obstructing the middle jiao. For mild cases of qi stagnation in the spleen and stomach, it can be used alone; for severe cases, it can be used with costus root and immature bitter orange. For those with cold-dampness obstructing the spleen and stomach, it can be used with atractylodes and magnolia bark. For those with food stagnation and qi stagnation, abdominal distension and pain, it can be combined with hawthorn and medicated leaven. For those with spleen deficiency and qi stagnation, poor appetite, and abdominal distension after meals, it can be used with ginseng, atractylodes macrocephala, and poria. This herb has a bitter and descending nature. The "Mingyi Bielu" states that it "lowers qi and stops vomiting," and the "Compendium of Materia Medica" states that it "treats vomiting, regurgitation, and nausea, with occasional vomiting of clear water," making it an excellent remedy for vomiting and hiccups. For those with cold constitution, it can be used alone as a powder or combined with ginger; for those with heat constitution, it can be combined with bamboo shavings, gardenia, etc.; for those with mixed deficiency and excess with heat, it can be combined with ginseng, bamboo shavings, jujube, etc. This herb is bitter and warm, and excels at drying dampness and resolving phlegm, as well as regulating qi and relieving chest tightness, making it an essential medicine for treating damp phlegm and cold phlegm. For treating cough with damp phlegm, it is often used with pinellia, poria, etc.; for treating cough with cold phlegm, it can be used with dried ginger, asarum, pinellia, etc. This herb is pungent, warm, and enters the lungs and chest, promoting qi circulation, relieving pain, and treating chest pain due to phlegm and qi stagnation, chest tightness, and shortness of breath, which can be combined with immature bitter orange, ginger, etc.

[0060] The chemical composition mainly includes volatile oils, flavonoids or flavonoid compounds, organic amines, and trace elements. The volatile oils are mainly limonene and γ-terpinene, while the flavonoid compounds are mainly hesperidin, neohesperidin, tangeretin, naringin, and neonaringin.

[0061] Pharmacological effects: The decoction of dried tangerine peel significantly promotes salivary amylase activity, inhibits spontaneous activity of isolated rabbit duodenum, reducing contraction and tension; it also directly inhibits the motility of isolated and in vivo stomach and intestines. The volatile oil relaxes isolated guinea pig bronchial smooth muscle; both the water extract and the volatile oil can block bronchial smooth muscle contraction and spasm induced by chloroacetylcholine and histamine phosphate, exhibiting anti-asthmatic and antitussive effects; the volatile oil has an irritating expectorant effect, with limonene as the main active ingredient. This product also has effects such as raising blood pressure, inhibiting platelet aggregation, antioxidation, anti-aging, cardiotonic, anti-shock, anti-allergy, anti-tumor, antibacterial, contraceptive, anti-ultraviolet radiation, and insecticidal activity.

[0062] In this invention, tangerine peel is used as an adjuvant to regulate qi and resolve phlegm. On the one hand, it prevents the retention of phlegm and turbidity caused by yang deficiency and weak qi transformation, and on the other hand, it enhances qi and prevents the tonifying drugs in the formula from stagnating in the spleen and stomach.

[0063] Acanthopanax senticosus is the dried root, rhizome, or stem of Acanthopanax senticosus, a plant in the Araliaceae family. It is mainly produced in Heilongjiang Province and is harvested in spring and autumn. After being washed, dried, and cut into thick slices, it has a unique aroma and a slightly pungent, bitter, and astringent taste. The one with a strong aroma is the best. It is used raw. It is warm in nature and has a sweet and slightly bitter taste. It enters the spleen, lung, kidney, and heart meridians and has the functions of invigorating qi, strengthening the spleen, tonifying the kidneys, and calming the mind.

[0064] Applications (1) Spleen and lung qi deficiency, physical weakness and fatigue, loss of appetite. This product is sweet and warm, enters the spleen and lung meridians, and functions to tonify spleen qi and benefit lung qi. It can be used with Astragalus membranaceus, Codonopsis pilosula, Atractylodes macrocephala, etc. (2) Lung and kidney deficiency, chronic cough and wheezing. This product can benefit the lungs and kidneys, and has a slight expectorant and antiasthmatic effect. It can be used with ginseng, gecko, Schisandra chinensis, etc. (3) Kidney deficiency and soreness of waist and knees. This product can be used with Astragalus membranaceus, Codonopsis pilosula, Atractylodes macrocephala, etc. (4) Kidney deficiency and soreness of waist and knees. This product can be used with Astragalus membranaceus, Codonopsis pilosula, Atractylodes macrocephala, etc. (5) Kidney deficiency and soreness of waist and knees. It enters the kidney meridian and has the function of warming the kidney and assisting yang, strengthening tendons and bones. It is used to treat those with kidney yang deficiency and tendons and bones that are not warmed and nourished, resulting in soreness in the waist and knees. It can be used alone or with Eucommia ulmoides, Loranthus parasiticus and other drugs. It can also be used for impotence, delayed walking in children and rheumatic arthralgia with liver and kidney deficiency. (4) Heart and spleen deficiency, insomnia and dreaminess. This product enters the heart and spleen meridians and can replenish the qi of the heart and spleen, and calm the mind and benefit the will. It is used to treat insomnia, dreaminess and forgetfulness caused by deficiency of both heart and spleen and malnourishment of the mind. It can be combined with jujube seed, polygala tenuifolia, acorus tatarinowii and other heart-nourishing and mind-calming products.

[0065] Chemical composition: It mainly contains various glycosides (such as eleutheroside, syringin, and liriodendronin), coumarins (such as isoflavones), lignans (such as sesamin), as well as sugars, fatty acids, and quinones.

[0066] Pharmacological effects: Aqueous extracts and total glycosides of Acanthopanax senticosus have anti-fatigue effects. Acanthopanax senticosus powder and injection can regulate the excitation and inhibition processes of the central nervous system, improve cerebral blood supply, promote brain cell metabolism and repair, and improve sleep. Alcoholic and water extracts of Acanthopanax senticosus, sesamin, glycosides, and polysaccharides can improve nervous system function and enhance learning and memory abilities. In addition, Acanthopanax senticosus has anti-tumor, anti-radiation, anti-myocardial ischemia, antioxidant, anti-aging, hypoglycemic, immune-enhancing, nucleic acid and protein synthesis-promoting, antibacterial, and antiviral effects, and can improve the body's tolerance to hypoxia and adaptability to temperature changes.

[0067] In this invention, Acanthopanax senticosus is used as an adjuvant to assist the principal and assistant drugs in exerting the effects of invigorating qi and strengthening the spleen, tonifying the kidneys and calming the mind.

[0068] Reishi mushroom is the dried fruiting body of the fungus Ganoderma lucidum or Ganoderma sinense of the Polyporaceae family. It is produced in most parts of China. It is harvested year-round, impurities are removed, and the lower part of the stipe attached to rotten wood, mud, or culture medium is cut off. It is then air-dried or dried at 40℃~50℃. It has a slightly fragrant odor and a bitter taste. The best quality is characterized by a robust, thick fruiting body with a glossy outer shell. It is used raw. It is neutral in nature and sweet in taste. It enters the heart, lung, liver, and kidney meridians. Its functions include tonifying qi and calming the mind, relieving cough and asthma.

[0069] Applications: (1) Restlessness, insomnia and palpitations. This herb is sweet and neutral in nature. It enters the heart meridian and can nourish heart blood, benefit heart qi, and calm the mind. It is suitable for those with restlessness, insomnia, palpitations, dreaminess, forgetfulness, fatigue, and poor appetite due to insufficient qi and blood and malnourishment of the mind. It can be used alone or with Angelica sinensis, Paeonia lactiflora, Ziziphus jujuba var. spinosa, etc. (2) Cough and asthma due to lung deficiency. This herb is sweet and enters the lung meridian. It can nourish the qi of the lung and kidney, stop cough and relieve asthma. It is suitable for cough and asthma due to lung deficiency. It can be used alone or with Astragalus membranaceus, Codonopsis pilosula, Schisandra chinensis, etc. (3) Shortness of breath and loss of appetite due to deficiency. This herb is sweet and nourishes qi. It is used to treat shortness of breath and loss of appetite due to deficiency. It is often combined with ginseng, Cornus officinalis, Dioscorea opposita, etc.

[0070] Chemical composition: It mainly contains polysaccharides (glucan A-G, Ganoderma lucidum polysaccharides), triterpenoids (ganoderic acids A, B, C, C2, D, E, F, K, M, oleanolic acid, etc.), alkaloids (betaine, ganoderic acid A, ganoderic acid B), sterols (ergosterol, ergosterol palmitate, ergosterol 4, 6, 8, (14) 22-tetraen-3-one, etc.), nucleosides (adenosine, adenine), as well as various amino acids, polypeptides and organic acids.

[0071] Pharmacological effects: Ganoderma lucidum polysaccharides have broad immunomodulatory activity and can enhance the body's immune activity; triterpenoids isolated from Ganoderma lucidum fruiting bodies, polysaccharides, and spores all have anti-tumor effects; proteoglycans in Ganoderma lucidum have antiviral activity, and acid-bound Ganoderma lucidum polysaccharides (APBP) have anti-HSV-1 and HSV-2 activity; Ganoderma lucidum triterpenoids can also fight HIV. Phenolic compounds and Ganoderma lucidum aminopolysaccharide G009 obtained by methanol extraction of Ganoderma lucidum have antioxidant and anti-aging effects; Ganoderma lucidum polysaccharides have hepatoprotective effects and can improve hypoxia tolerance. In addition, Ganoderma lucidum can reduce blood viscosity, increase myocardial contractility, increase coronary blood flow and cardiac output, and improve heart rhythm; it can also resist the damage of radiation and toxic chemicals to the body, has sedative and analgesic effects, prolongs sleep time and improves sleep quality, and can relieve asthma, stop cough, expectorate phlegm, and treat chronic bronchitis.

[0072] In this invention, Ganoderma lucidum is used as an adjuvant to assist the principal and assistant herbs in exerting the effects of tonifying qi and yang, calming the mind and stabilizing the will.

[0073] Snow lotus refers to the whole flowering plant of various species in the Asteraceae family, including Saussurea involucrata, Saussurea involucrata, and Saussurea medusa. It is mainly produced in Sichuan, Yunnan, Tibet, Xinjiang, Gansu, and Qinghai. The whole plant is harvested in June and July when the flowers are in bloom, the soil is removed, it is dried, and then cut into sections. This product has a light aroma and a slightly bitter and astringent taste. The best quality is the one with more leaves. It is used raw. The medicinal properties are warm, the taste is sweet and slightly bitter, and it enters the liver and kidney meridians. Its functions are to dispel wind and dampness, strengthen tendons and bones, tonify kidney yang, and regulate the Chong and Ren meridians.

[0074] Applications: (1) Rheumatic arthralgia: This product is bitter, dry, warm and invigorating, sweet and nourishing. It can dispel wind and dampness, nourish the liver and kidneys, and strengthen tendons and bones. It is especially suitable for rheumatic arthralgia with predominance of cold and dampness, and for those with long-term rheumatism, deficiency of liver and kidneys, and weakness of waist and knees. It can be used alone to make wine, or used with Acanthopanax senticosus, Taxillus chinensis, Cibotium barometz, etc. (2) Kidney deficiency and impotence: This product can nourish the kidneys and assist yang. It can treat kidney deficiency and impotence, soreness of waist and knees, and weakness of tendons and bones. It can be used alone or soaked in wine with Cordyceps sinensis. (3) Menstrual disorders, amenorrhea, dysmenorrhea, metrorrhagia and leukorrhea: This product can nourish kidney yang, regulate the Chong and Ren meridians, and stop bleeding. It can treat menstrual disorders, amenorrhea, dysmenorrhea, metrorrhagia and leukorrhea caused by deficiency and coldness of the lower body and cold stagnation of blood vessels. It can be used alone to make steamed food, or stewed with Codonopsis pilosula and other ingredients.

[0075] Chemical composition: This product contains scopolamine, umbelliferone, arctiin, emodin methyl ether, rutin, etc.

[0076] Pharmacological effects: Snow lotus decoction, ethanol extract, total flavonoids, and total alkaloids have significant anti-inflammatory and hypotensive effects. The injection and total flavonoids have strong analgesic effects. The decoction has immune and antioxidant effects, significant inhibitory effect on the central nervous system of mice, excitatory effect on the uterus, and can terminate pregnancy. The decoction can enhance cardiac contractility and increase cardiac output, but has no significant effect on heart rate. The total alkaloids have an inhibitory effect on the heart, weakening myocardial contractility and slowing heart rate. The decoction and total alkaloids have an inhibitory effect on the intestine and can significantly counteract intestinal muscle tonic spasm.

[0077] In this invention, snow lotus is used as an adjuvant to assist the principal and assistant drugs in exerting the effects of tonifying kidney yang, regulating the Chong and Ren meridians, and calming the mind.

[0078] Buddha's Hand (Citrus medica var. sarcodactylis) is the dried fruit of the Buddha's Hand plant, belonging to the Rutaceae family. It is mainly produced in Sichuan and Guangdong provinces. The fruit is harvested in autumn before it turns yellow or just begins to turn yellow. It is then sliced ​​lengthwise into thin slices and sun-dried or dried at low temperature. It has a fragrant aroma and a slightly sweet taste followed by a bitter aftertaste. The best quality is characterized by large slices, green skin, white flesh, and a strong aroma. It is sliced ​​and used raw. The medicinal properties are pungent, bitter, and sour, and warm in nature. It enters the liver, spleen, stomach, and lung meridians. Its functions include soothing the liver and regulating qi, harmonizing the stomach and relieving pain, and drying dampness and resolving phlegm.

[0079] This herb is pungent and aromatic, dispersing and purging, and is good at soothing the liver, relieving depression, regulating qi, and alleviating pain. It treats chest and rib pain, abdominal distension, and other symptoms caused by liver qi stagnation and liver-stomach disharmony, and can be used with Bupleurum, Cyperus, and Curcuma. This herb enters the spleen and stomach meridians, regulating qi, harmonizing the stomach, and relieving pain. It treats abdominal distension, nausea, and poor appetite caused by spleen and stomach qi stagnation, and can be used with Aucklandia, Cyperus, and Amomum. This herb is bitter and warm, drying dampness and resolving phlegm; its pungent and aromatic nature also promotes qi circulation, making it effective for treating coughs with damp phlegm and chest tightness with excessive phlegm. It can be combined with Luffa, Trichosanthes peel, and Citrus reticulata peel.

[0080] The main chemical components include volatile oils (limonene, γ-terpinene, etc.), flavonoids (hesperidin, geraniol, etc.), coumarins (bergamot lactone, limonol), and terpenoids (limonene, etc.). It also contains polysaccharides and organic acids. Pharmacological effects: Bergamot alcohol extract has a significant inhibitory effect on intestinal smooth muscle; it dilates coronary vessels and increases coronary blood flow; at high concentrations, it inhibits myocardial contractility, slows heart rate, lowers blood pressure, and protects against experimental myocardial ischemia; Bergamot has certain anti-asthmatic and expectorant effects; in addition, it has anti-stress, immunomodulatory, and anti-tumor effects.

[0081] In this invention, Buddha's Hand is used as an adjuvant to assist the principal and assistant drugs, exerting the effects of soothing the liver and regulating qi, drying dampness and resolving phlegm, and opening the orifices and refreshing the mind.

[0082] Citron is the dried, ripe fruit of the citron plant (Citrus medica), belonging to the Rutaceae family. Both citron and citron (Citrus reticulata) have the same medicinal properties and are collectively referred to as citron. It is mainly produced in Sichuan, Yunnan, Fujian, Jiangsu, and Zhejiang provinces. The fruit is harvested in autumn when ripe, sliced ​​while fresh, and then sun-dried or dried at low temperature. Citron balls can also be dried whole or halved before sun-drying or low-temperature drying. Citron has a fragrant aroma and a slightly sweet and bitter-pungent taste; citron balls have a fragrant aroma and a sour and bitter taste. The best quality citron balls are large, with rough skin, dark green color, and a strong aroma. It is used raw. The medicinal properties are pungent, bitter, and sour, and it is warm in nature. It enters the liver, spleen, and lung meridians. Its functions include soothing the liver and relieving depression, regulating qi and relieving chest tightness, and drying dampness and resolving phlegm. Its pungent nature promotes dispersion, and its bitter nature helps to drain. Entering the liver meridian, it can soothe the liver, regulate qi, and relieve pain; it can be used with Bupleurum chinense, Curcuma longa, and Citrus medica to treat liver stagnation and chest and rib pain. This herb has a fragrant aroma that invigorates the spleen, and its pungent and bitter properties promote circulation and drain excess energy. It enters the spleen and stomach to regulate qi and relieve chest congestion, and is used to treat abdominal distension and pain, belching, acid reflux, nausea, and poor appetite caused by qi stagnation in the spleen and stomach. It can be used in combination with costus root, amomum villosum, and agastache rugosa. This herb is bitter and drying, and its descending and draining properties help resolve phlegm and stop coughing. Its pungent properties enter the lungs to regulate qi and relieve chest congestion. It is used to treat cough with damp phlegm, excessive phlegm, and chest tightness, and can be combined with ginger, pinellia ternata, and poria cocos.

[0083] The main chemical components include volatile oils (d-limonene, phellandrene, citral, geraniol acetate, etc.), flavonoids (naringin, hesperidin, etc.), as well as diterpenoid lactones and tannins. Pharmacological effects: This product promotes gastrointestinal motility, strengthens the stomach, and has expectorant effects; it also has anti-inflammatory and antiviral effects.

[0084] Both Buddha's Hand and Citron can soothe the liver, regulate qi, relieve chest congestion, and resolve dampness and phlegm. They are used to treat liver qi stagnation, spleen and stomach qi stagnation, liver and stomach disharmony, and cough with damp phlegm, and are often used together. Among them, Buddha's Hand is slightly stronger in soothing the liver, regulating qi, and relieving pain, while Citron is slightly better at drying dampness and resolving phlegm. In this invention, Citron and Buddha's Hand are used together to exert the effects of regulating qi, relieving chest congestion, resolving phlegm, and relieving stagnation, preventing qi stagnation and phlegm obstruction caused by insufficient yang qi and weak qi transformation, thus preventing obstruction of the sensory orifices.

[0085] Cloves are the dried flower buds of the clove tree (Syzygium aromaticum), a plant in the Myrtaceae family. They are commonly known as male cloves. They are mainly produced in Zanzibar, Madagascar, Sri Lanka, and Indonesia, and also in Guangdong and Hainan provinces of my country. The buds are harvested when they turn from green to red and then dried. This product has a strong, aromatic fragrance and a pungent, numbing taste. The best quality cloves are large, brownish-red, highly aromatic, and oily. They are used raw. The medicinal properties are pungent and warm; they enter the spleen, stomach, and kidney meridians, and their functions include warming the middle jiao (spleen and stomach), dispelling cold and relieving pain, and warming the kidneys and tonifying yang.

[0086] This herb is pungent, warm, and aromatic, warming the spleen and stomach while promoting the flow of qi, especially effective in relieving nausea and vomiting. Therefore, it has the functions of warming the middle jiao, dispelling cold, relieving nausea and vomiting, and stopping hiccups. It is an essential medicine for treating vomiting and hiccups due to stomach cold, as stated in *Ben Cao Zheng* (Corrective Materia Medica): "It warms the middle jiao, promotes qi flow, and treats hiccups in the upper jiao." For vomiting due to deficiency and cold, it is often used with persimmon calyx, ginseng, and ginger. For vomiting and diarrhea due to spleen and stomach deficiency and cold, and poor appetite, it is often used with atractylodes macrocephala and amomum villosum. For morning sickness during pregnancy, *Zheng Zhi Zhun Sheng* (Standards of Diagnosis and Treatment) uses it in combination with agastache rugosa. This herb is pungent, dispersing, and warming, with the function of warming the middle jiao, dispelling cold, and relieving pain. It can be used to treat cold pain in the heart and abdomen. For chest pain due to cold in the heart, it can be used in combination with aconite, allium macrostemon, and chuanxiong. For cold pain in the stomach and abdomen due to stomach cold, it can be used with dried ginger, galangal, and corydalis yanhusuo. This herb is pungent and warm in nature, enters the kidney meridian, and has the function of warming the kidney, assisting yang, and treating impotence. For treating kidney deficiency, impotence, and infertility due to cold uterus, it can be used in combination with aconite, cinnamon, and epimedium.

[0087] The main chemical components include volatile oils (eugenol, acetyleugenol, β-eugenol, methyl n-pentyl ketone, methyl salicylate, etc.), as well as oleanolic acid, rhamnine, kaempferol, etc. Pharmacological effects: Oral administration of this product can promote gastric juice secretion, enhance digestion, reduce nausea and vomiting, and relieve abdominal bloating, making it an aromatic stomachic. Its water and ether extracts have analgesic and anti-inflammatory effects; eugenol has anticonvulsant effects; its decoction has inhibitory effects on Staphylococcus aureus, Streptococcus, Corynebacterium diphtheriae, Proteus, Pseudomonas aeruginosa, Escherichia coli, Shigella dysenteriae, and Salmonella typhi, and also has good acaricidal effects; it also has antiplatelet aggregation, anticoagulant, antithrombotic, antidiarrheal, choleretic, and anti-hypoxic effects.

[0088] In this invention, cloves are used as an adjuvant to assist the principal and assistant herbs in exerting their function of warming the kidneys and tonifying yang.

[0089] Yang Hong Tan is the root or whole herb of the plant *Illicium verum*, which belongs to the Apiaceae family. It is mainly produced in North China, Northeast China and Shaanxi Province. It is warm in nature, pungent and sweet in taste, and enters the heart, kidney, lung and spleen meridians. Its main functions and effects are: (1) warming the kidney and assisting yang, which is suitable for impotence, cold sperm, low sperm count and infertility, decreased sexual function, and soreness of the waist and knees caused by insufficient kidney yang. Its mechanism of action is to promote gonadal function and improve the vitality of the reproductive system; (2) promoting blood circulation and removing blood stasis, which is suitable for chest pain and heart pain caused by obstruction of the heart vessels (such as angina pectoris in coronary heart disease) and qi stagnation and blood stasis syndrome. Its mechanism of action is to dilate the coronary arteries, reduce myocardial oxygen consumption, inhibit thrombus formation and improve microcirculation; (3) nourishing the heart and calming the mind, which is suitable for palpitations, insomnia, shortness of breath and weakness, and chest tightness caused by insufficient heart qi (such as Keshan disease and neurasthenia); (4) warming the lungs and dispelling cold, which is suitable for colds caused by wind and cold and coughs caused by cold phlegm (with clear and thin phlegm, fear of cold and cold back).

[0090] The main chemical components include volatile oils (γ-nonanolide, aldehyde, terpenoids, etc.), flavonoids (quercetin and its glycosides, kaempferol and its glycosides, apigenin, luteolin, tannin A, B, C, D, etc.), coumarins (simple coumarins such as umbelliferone, furanocoumarins such as psoralen, pyranocoumarins, etc.), sterols (β-sitosterol, stigmasterol, campesterol), and fatty acids (palmitic acid, linoleic acid, oleic acid, linolenic acid, etc.).

[0091] Pharmacological effects: Cardiovascular protection (lowering blood pressure, lowering blood lipids, resisting myocardial ischemia, reducing coronary artery resistance), metabolic regulation (inhibiting the rise of triglycerides, reducing fatty liver, and promoting protein turnover), immune regulation (enhancing cellular immunity and improving immune function in patients with coronary heart disease), anticoagulation and antihyperxia (inhibiting thrombus formation and improving tissue tolerance to hypoxia).

[0092] In this invention, mutton is used as an adjuvant to assist the principal and assistant herbs in exerting the effects of warming the kidneys and tonifying yang, nourishing the heart and calming the mind.

[0093] Peppermint is the dried aerial part of the peppermint plant (Mentha haplocalyx), belonging to the Lamiaceae family. It is mainly produced in Jiangsu and Zhejiang provinces. Harvesting takes place in summer and autumn when the stems and leaves are lush or when the flowers have bloomed to their third whorl. The peppermint is then sun-dried or shade-dried and cut into sections. When rubbed, it has a distinctive cool aroma and a pungent, cool taste. The best quality peppermint has abundant leaves, a green color, and a strong aroma, and is used raw. Medicinally, it is pungent and cool, and enters the lung and liver meridians. It has the functions of dispersing wind-heat, clearing the head and eyes, relieving sore throat, promoting rash eruption, and soothing the liver and regulating qi.

[0094] This product enters the liver meridian, can soothe the liver and regulate qi, and treat liver qi stagnation, chest and rib pain, and irregular menstruation. This product is aromatic and can dispel foul odors, and can also resolve dampness and harmonize the middle jiao. It can be used to treat abdominal distension, vomiting and diarrhea caused by exposure to summer heat, dampness and foul odors.

[0095] The main chemical components include volatile oils (menthol, menthol, menthone, isomenthone, menthone, α-pinene, limonene, etc.). 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. In addition, this product has expectorant, antitussive, anti-implantation, anti-early pregnancy, and antimicrobial effects.

[0096] In this invention, peppermint is used as an adjuvant to clear the head and eyes, relieve depression and dispel evil, and at the same time carry the medicine upward to the head and eyes.

[0097] The dosage of each traditional Chinese medicine in this invention was determined through long-term clinical and animal experiments by the inventors. Each component exhibits good therapeutic effects within the following weight ranges:

[0098] Prepared Rehmannia Root 32-40 parts, Cuscuta Seed 22-30 parts, Psoralea Root 22-30 parts, Aconite Root 22-30 parts, Bupleurum Root (processed with wine) 22-30 parts, Cimicifuga Root 22-30 parts, Cinnamon Twig 16-24 parts, Mulberry Taxillus Root 16-24 parts, Cistanche Root 16-24 parts, Tangerine Peel 16-24 parts, Acanthopanax Root 16-24 parts, Ganoderma Lucidum 12-20 parts, Snow Lotus Root 12-20 parts, Buddha's Hand Root 12-20 parts, Citron Root 8-16 parts, Clove Root 8-16 parts, Mutton Red Root 8-16 parts, Peppermint Root 2-10 parts.

[0099] The further proportions are as follows: 34-38 parts Rehmannia glutinosa (processed), 24-28 parts Cuscuta chinensis, 24-28 parts Psoralea corylifolia, 24-28 parts Aconitum carmichaelii, 24-28 parts Bupleurum chinense (processed with wine), 24-28 parts Cimicifuga foetida, 18-22 parts Cinnamomum cassia, 18-22 parts Taxillus chinensis, 18-22 parts Cistanche deserticola, 18-22 parts Citrus reticulata peel, 18-22 parts Acanthopanax senticosus, 14-18 parts Ganoderma lucidum, 14-18 parts Saussurea involucrata, 14-18 parts Citrus medica, 10-14 parts Citronella foenum-graecum, 10-14 parts Syzygium aromaticum, 10-14 parts mutton, and 4-8 parts Mentha haplocalyx.

[0100] The preferred ingredients are: 36 parts Rehmannia glutinosa, 26 parts Cuscuta chinensis, 26 parts Psoralea corylifolia, 26 parts Aconitum carmichaelii, 26 parts Bupleurum chinense (processed with wine), 26 parts Cimicifuga foetida, 20 parts Cinnamomum cassia, 20 parts Taxillus chinensis, 20 parts Cistanche deserticola, 20 parts Citrus reticulata peel, 20 parts Acanthopanax senticosus, 16 parts Ganoderma lucidum, 16 parts Saussurea involucrata, 16 parts Citrus medica, 12 parts Citronella foenum-graecum, 12 parts Syzygium aromaticum, 12 parts mutton, and 6 parts Mentha haplocalyx.

[0101] 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 prepared Rehmannia glutinosa in the raw materials is preferably extracted using special methods, and the volatile oils of Bupleurum chinense, Cinnamomum cassia, Taxillus chinensis, Citrus reticulata peel, Citrus medica, Citrus medica, Clove, Leonurus japonicus, and Mentha haplocalyx are extracted by steam distillation. However, these special processes should not be used to limit the scope of protection of this invention.

[0102] Preferably, the preparation method of the active pharmaceutical ingredient of the present invention is as follows:

[0103] a) Weigh out the raw medicinal materials: Rehmannia glutinosa (processed), Cuscuta chinensis, Psoralea corylifolia, Aconitum carmichaelii, Bupleurum chinense (processed with wine), Cimicifuga foetida, Cinnamomum cassia, Taxillus chinensis, Cistanche deserticola, Citrus reticulata peel, Acanthopanax senticosus, Ganoderma lucidum, Saussurea involucrata, Citrus medica, Citrus medica var. sarcodactylis, Syzygium aromaticum, mutton, and Mentha haplocalyx, and set aside;

[0104] b) Add water to the eight Chinese herbs (Cuscuta chinensis, Psoralea corylifolia, Aconitum carmichaelii, Cimicifuga foetida, Cistanche deserticola, Acanthopanax senticosus, Ganoderma lucidum, and Saussurea involucrata) 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 then simmer for 30 minutes. For the second decoction, add water to cover the herbs by 2 cm, bring to a boil, and then simmer for 20 minutes. Combine the two decoctions and filter to obtain filtrate 1.

[0105] c) Collect the volatile oils from the specified weight ratio of Bupleurum chinense, Cinnamomum cassia, Taxillus chinensis, Citrus reticulata peel, Citrus medica, Citrus aurantium, Syzygium aromaticum, and Mentha haplocalyx using steam extraction for later use. Combine the decoction of Bupleurum chinense, Cinnamomum cassia, Taxillus chinensis, Citrus reticulata peel, Citrus medica, Citrus aurantium, Syzygium aromaticum, and Mentha haplocalyx (obtained by the same method as in step b) with filtrate 1, concentrate it into 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.

[0106] d) Extract the prepared Rehmannia root in the specified weight ratio by reflux with 90%-95% ethanol, and recover the ethanol from the extract.

[0107] The alcohol was dried at 45℃-50℃ to obtain dry extract 2.

[0108] e) Combine dry extract 1 and dry extract 2, pulverize them into powder, mix them evenly, pulverize them again into fine powder, spray in the volatile oils of Bupleurum chinense, Cinnamomum cassia, Taxillus chinensis, Citrus reticulata peel, Citrus medica, Citronella arvense, Clove, mutton, and peppermint, and stir evenly. This prepares the active component of the drug of this invention.

[0109] 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.

[0110] The medicine of this invention has the effects of warming the kidney and assisting yang, nourishing essence and replenishing marrow, raising yang and transforming qi, warming the meridians and strengthening the spleen, regulating qi and harmonizing the kidneys, and nourishing the heart and calming the mind. It is used for the prevention and treatment of yang deficiency insomnia and its complications. Detailed Implementation

[0111] 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 "Yang Deficiency Insomnia Relief," abbreviated as YXSMA).

[0112] 1. Case Information:

[0113] Eighty outpatients (from TCM clinics, TCM health centers, etc.) and recruited subjects were selected from January 2022 to December 2024. They were randomly divided into a treatment group (n=40) and a control group (n=40) using a random number table. The mean age of the treatment group was 42.35±2.18 years (22 males and 18 females), and the mean duration of disease was 3.78±0.36 years. The mean age of the control group was 43.15±2.36 years (20 males and 20 females), and the mean duration of disease was 3.92±0.51 years. There were no statistically significant differences in baseline data such as age, duration of disease, and severity of disease between the two groups (P>0.05), making them comparable.

[0114] 2 Diagnostic criteria

[0115] 2.1 Diagnostic criteria for Yang deficiency

[0116] Based primarily on references to literature such as *Internal Medicine of Traditional Chinese Medicine*, *Guiding Principles for Clinical Research of New Traditional Chinese Medicine Drugs*, and *Guidelines for Clinical Practice of Traditional Chinese Medicine in Insomnia (WHO / WPO)*, the diagnostic criteria for Yang deficiency are as follows:

[0117] 2.1.1 Main symptoms (one or more of the following symptoms are present)

[0118] (1) Feeling cold and afraid of cold, with cold limbs and cold hands and feet;

[0119] (2) Decreased function, lethargy, fatigue, listlessness, and preference for lying down;

[0120] (3) Lack of vitality, slow movement, decreased libido, reduced metabolism, and slowed down of various physiological functions of the body;

[0121] 2.1.2 Accompanying symptoms (0, 1, or more accompanying symptoms)

[0122] (1) Abnormal complexion: pale (pale and lacking in color and luster) or dark (dull and smoky, with obvious lower eyelid blemishes)

[0123] (2) Abnormalities in urination and defecation: clear and copious urine, frequent urination at night, diarrhea in the early morning, and undigested food in stool.

[0124] (3) Reproductive system problems: male impotence, premature ejaculation, low sperm count and infertility; female infertility due to cold uterus, thin and copious leukorrhea, delayed menstruation, scanty and pale menstruation, dysmenorrhea with preference for warmth.

[0125] (4) Local cold pain: soreness and cold pain in the lower back and knees, cold pain in the stomach and abdomen, relieved by warmth and pressure.

[0126] 2.1.3 Tongue pulse

[0127] Tongue appearance: The tongue is large and tender, pale in color, with a white and moist coating. If there is yang deficiency with dampness, the coating may be white and greasy.

[0128] Pulse characteristics: The pulse is deep, slow, weak, or deep, thready, weak, especially the cun pulse.

[0129] 2.2 Diagnostic criteria for sleep disorders

[0130] 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:

[0131] (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;

[0132] (2) The above symptoms still occur even when there are conditions for sleep and the environment is suitable for sleep;

[0133] (3) The patient complains of at least one of the following sleep-related daytime functional impairments:

[0134] ① Fatigue or general discomfort;

[0135] ② Decreased attention, attention maintenance ability, or memory;

[0136] ③ A decline in learning, work, and / or social skills;

[0137] ④ Mood swings or irritability;

[0138] ⑤ Feeling sleepy during the day;

[0139] ⑥ Decreased interest and energy;

[0140] ⑦ An increased tendency to make mistakes during work or other tasks;

[0141] ⑧ Tension, headache, dizziness, or other physical symptoms related to sleep deprivation;

[0142] 9. Excessive focus on sleep.

[0143] 3. Case inclusion criteria

[0144] (1) Meets the diagnostic criteria for insomnia in the Chinese Classification and Diagnostic Criteria for Mental Disorders.

[0145] (2) Meets the above diagnostic criteria for Yang deficiency and sleep disorders.

[0146] 4 Exclusion Criteria

[0147] (1) Those suffering from insomnia due to severe neurosis;

[0148] (2) Those with primary hypertension, hypotension, or anemia;

[0149] (3) Individuals with organ dysfunction;

[0150] (4) Individuals with allergic constitutions or allergies to the drugs used in this study;

[0151] (5) Patients with serious primary diseases of the cardiovascular, cerebrovascular, liver, kidney, or hematopoietic systems, as well as those with mental illness;

[0152] (6) Those who fail to take medication as prescribed or whose data is incomplete and cannot be used to determine the efficacy.

[0153] 5 Experimental Methods

[0154] 5.1 Sample size estimation and grouping

[0155] A randomized controlled experimental 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 80 cases, which were randomly divided into a treatment group and a control group, with 40 cases in each group.

[0156] 5.2 Intervention methods

[0157] The treatment group received YXSMA granules (38g Rehmannia glutinosa, 28g Cuscuta chinensis, 28g Psoralea corylifolia, 28g Aconitum carmichaelii, 28g Bupleurum chinense, 28g Cimicifuga foetida, 22g Cinnamomum cassia, 22g Taxillus chinensis, 22g Cistanche deserticola, 22g Citrus reticulata, 22g Acanthopanax senticosus, 18g Ganoderma lucidum, 18g Saussurea involucrata, 18g Citrus medica, 14g Citronella foenum-graecum, 14g Syzygium aromaticum, 14g Leonurus japonicus, 8g Mentha haplocalyx) orally, 30g each time, taken with warm water after meals, three times a day (morning, noon, and evening); one course of treatment was 7 days, and 10 courses were administered 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, one course of treatment was 7 days, and 10 courses were administered consecutively.

[0158] 5.3 Observation Indicators

[0159] (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.

[0160] (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.

[0161] (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.

[0162] (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.

[0163] (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.

[0164] (6) Before and after treatment, the changes in TCM syndrome were observed using a scoring method. The observation items included the main symptoms (fear of cold, cold limbs, cold hands and feet; decreased function, lethargy, fatigue, listlessness, preference for lying down; insufficient vitality, slow movement, decreased libido, decreased metabolism, slowed physiological functions), and accompanying symptoms (see the above diagnostic criteria for details). The scoring method was based on the relevant standards in Internal Medicine, Traditional Chinese Medicine Internal Medicine, Physiology, Pathology, Clinical Practice Guidelines for Insomnia in Traditional Chinese Medicine (WHO / WPO), Clinical Research Guidelines for New Chinese Medicine Drugs, and Clinical Practice Guidelines for Insomnia in Traditional Chinese Medicine (WHO / WPO). Symptoms were scored as follows: 0, 2, 4, and 6 points for none, mild, moderate, and severe, respectively. Abnormal tongue coating and pulse were scored as 2 points, and normal was scored as 0 points.

[0165] (7) Clinical efficacy: The criteria for judging clinical efficacy were based on the relevant standards in the "Guidelines for the Diagnosis and Treatment of Insomnia in Chinese Adults", "Guidelines for Clinical Practice of Traditional Chinese Medicine in Insomnia (WHO / WPO)" and "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.

[0166] 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;

[0167] Significant effects: Sleep is noticeably improved, with sleep time increasing by more than 3 hours and sleep depth increasing;

[0168] Effective: Symptoms were relieved, and sleep time increased by less than 3 hours compared to before;

[0169] Ineffective: Insomnia shows no significant improvement or worsens.

[0170] Overall effective rate = (Number of cured cases + Number of cases with significant improvement + Number of cases with improvement) / Total number of cases

[0171] (8) 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).

[0172] (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 experiment.

[0173] 6 Statistical Methods

[0174] Excel 2021 was used for data preparation, and SPSS 26.0 was used for data analysis. Quantitative data were expressed as mean ± standard deviation (x̄ ± s). For data conforming to a normal distribution and with homogeneous variances, an independent samples t-test was used; for data with unequal variances, a corrected t-test was used. For comparisons within groups before and after treatment, paired samples t-tests were used for data conforming to a normal distribution, and Wilcoxon signed-rank tests were used for data not conforming to a normal distribution. For ordinal data or non-normally distributed quantitative data, a nonparametric rank-sum test was used. For categorical data, a chi-square test was used. P < 0.05 indicated a statistically significant difference.

[0175] 7 Results

[0176] 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 three patients were excluded because they failed to strictly adhere to the medication contraindications during the study (1 in the control group and 2 in the treatment group). In the end, a total of 75 patients (37 in the treatment group and 38 in the control group) participated in this study, with an overall dropout rate of 6.25%. 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.

[0177] 7.1 Comparison of baseline data before treatment

[0178] 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).

[0179] Table 1. Comparison of PSQI score, ISI score, HAMD-24 score, and TCM syndrome score between the two groups of patients.

[0180]

[0181] 7.2 Comparison of clinical efficacy between the two groups of patients

[0182] 7.2.1 Evaluation of Insomnia Treatment

[0183] 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.

[0184] Table 2. PSQI score efficacy analysis

[0185]

[0186] 7.2.2 Comparison of PSQI scores, ISI scores, and HAMD-24 scores between the two groups

[0187] 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.

[0188] Table 3 Comparison of PSQI score, ISI score, and HAMD-24 score

[0189]

[0190] 7.2.3 Comparison of TCM syndrome scores between the two groups

[0191] 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 4 for details.

[0192] Table 4 Comparison of clinical efficacy (mean ± standard deviation)

[0193]

[0194] 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.

[0195] 7.2.4 Comparison of MoCA scores, SDS scores, and SAS scores between the two groups

[0196] 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 5.

[0197] Table 5 Comparison of MoCA scores, SDS scores, and SAS scores between the two groups (mean ± standard deviation)

[0198]

[0199] Note: ① Compared with the same group before treatment: P < 0.05; ② Compared with the control group after treatment: P < 0.05;

[0200] 7.2.5 Comparison of neurotransmitter levels between the two groups

[0201] 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 6.

[0202] Table 6. Changes in neurotransmitter levels in the two groups (mean ± standard deviation)

[0203]

[0204] Note: ① Compared with the group before treatment: P < 0.05; ② Compared with the control group after treatment: P < 0.05

[0205] 7.2.6 Comparison of neurotrophic factor levels between the two groups

[0206] 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 7.

[0207] Table 7 Comparison of neurotrophic factor levels between the two groups (mean ± standard deviation)

[0208]

[0209] Note: ① Compared with the group before treatment: P < 0.05; ② Compared with the control group after treatment: P < 0.05

[0210] 7.2.7 Comparison of inflammatory factor levels between the two groups

[0211] 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 in both groups decreased significantly (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 8.

[0212] Table 8 Comparison of inflammatory factor levels between the two groups (mean ± standard deviation)

[0213]

[0214] Note: ① Compared with the same group before treatment: P<0.05; ② Compared with the control group after treatment: P<0.05.

[0215] 7.3 Follow-up Results

[0216] 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).

[0217] 7.4 Safety Evaluation

[0218] 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.

[0219] [Example 1] Preparation of the drug capsule of the present invention

[0220] a) Weigh out the raw material drug for later use. The dosage of the raw material drug is as follows:

[0221]

[0222] b) Add water to the eight Chinese herbs (Cuscuta chinensis, Psoralea corylifolia, Aconitum carmichaelii, Cimicifuga foetida, Cistanche deserticola, Acanthopanax senticosus, Ganoderma lucidum, and Saussurea involucrata) 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 then simmer for 30 minutes. For the second decoction, add water to cover the herbs by 2 cm, bring to a boil, and then simmer for 20 minutes. Combine the two decoctions and filter to obtain filtrate 1.

[0223] c) Collect the volatile oils from the specified weight ratio of Bupleurum chinense, Cinnamomum cassia, Taxillus chinensis, Citrus reticulata peel, Citrus medica, Citrus aurantium, Syzygium aromaticum, and Mentha haplocalyx using steam extraction for later use. Combine the decoction of Bupleurum chinense, Cinnamomum cassia, Taxillus chinensis, Citrus reticulata peel, Citrus medica, Citrus aurantium, Syzygium aromaticum, and Mentha haplocalyx (obtained by the same method as in step b) with filtrate 1, concentrate it into 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.

[0224] d) Extract the prepared Rehmannia root in the specified weight ratio by reflux with 90%-95% ethanol, and recover the ethanol from the extract.

[0225] The alcohol was dried at 45℃-50℃ to obtain dry extract 2.

[0226] e) Combine dry extract 1 and dry extract 2, pulverize them into powder, mix them evenly, pulverize them into fine powder, spray in Bupleurum chinense, Cinnamomum cassia, Taxillus chinensis, Citrus reticulata peel, Citrus medica, Citronella arvense, Clove, mutton, and peppermint volatile oil, stir evenly; fill into gelatin hard capsules, each capsule containing about 2 grams of the compound active ingredients of this invention.

[0227] [Example 2] Preparation of the drug granules of the present invention

[0228] a) Weigh out the raw material drug for later use. The dosage of the raw material drug is as follows:

[0229]

[0230] b) Add water to the eight Chinese herbs (Cuscuta chinensis, Psoralea corylifolia, Aconitum carmichaelii, Cimicifuga foetida, Cistanche deserticola, Acanthopanax senticosus, Ganoderma lucidum, and Saussurea involucrata) 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 then simmer for 30 minutes. For the second decoction, add water to cover the herbs by 2 cm, bring to a boil, and then simmer for 20 minutes. Combine the two decoctions and filter to obtain filtrate 1.

[0231] c) Collect the volatile oils from the specified weight ratio of Bupleurum chinense, Cinnamomum cassia, Taxillus chinensis, Citrus reticulata peel, Citrus medica, Citrus aurantium, Syzygium aromaticum, and Mentha haplocalyx using steam extraction for later use. Combine the decoction of Bupleurum chinense, Cinnamomum cassia, Taxillus chinensis, Citrus reticulata peel, Citrus medica, Citrus aurantium, Syzygium aromaticum, and Mentha haplocalyx (obtained by the same method as in step b) with filtrate 1, concentrate it into 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.

[0232] d) Extract the prepared Rehmannia root in the specified weight ratio by reflux with 90%-95% ethanol, and recover the ethanol from the extract.

[0233] The alcohol was dried at 45℃-50℃ to obtain dry extract 2.

[0234] e) Combine dry extract 1 and dry extract 2, pulverize them into powder, mix them evenly, pulverize them into fine powder, spray in the volatile oils of Bupleurum chinense, Cinnamomum cassia, Taxillus chinensis, Citrus reticulata, Citrus medica, Citronella arvense, Clove, mutton, and peppermint, and stir evenly again; add ethanol as a binder, add starch as a filler, and compress into granules. Each 15g granule contains 10g of the effective ingredients of the traditional Chinese medicine composition of the present invention.

[0235] [Example 3] Preparation of tablets for the drug of the present invention

[0236] a) Weigh out the raw material drug for later use. The dosage of the raw material drug is as follows:

[0237]

[0238] b) Add water to the eight Chinese herbs (Cuscuta chinensis, Psoralea corylifolia, Aconitum carmichaelii, Cimicifuga foetida, Cistanche deserticola, Acanthopanax senticosus, Ganoderma lucidum, and Saussurea involucrata) 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 then simmer for 30 minutes. For the second decoction, add water to cover the herbs by 2 cm, bring to a boil, and then simmer for 20 minutes. Combine the two decoctions and filter to obtain filtrate 1.

[0239] c) Collect the volatile oils from the specified weight ratio of Bupleurum chinense, Cinnamomum cassia, Taxillus chinensis, Citrus reticulata peel, Citrus medica, Citrus aurantium, Syzygium aromaticum, and Mentha haplocalyx using steam extraction for later use. Combine the decoction of Bupleurum chinense, Cinnamomum cassia, Taxillus chinensis, Citrus reticulata peel, Citrus medica, Citrus aurantium, Syzygium aromaticum, and Mentha haplocalyx (obtained by the same method as in step b) with filtrate 1, concentrate it into 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.

[0240] d) Extract the prepared Rehmannia root in the specified weight ratio by reflux with 90%-95% ethanol, and recover the ethanol from the extract.

[0241] The alcohol was dried at 45℃-50℃ to obtain dry extract 2.

[0242] e) Combine dry extract 1 and dry extract 2, pulverize them into powder, mix them evenly, pulverize them into fine powder, spray in the volatile oils of Bupleurum chinense, Cinnamomum cassia, Taxillus chinensis, Citrus reticulata, Citrus medica, Citronella arvense, Clove, mutton, and peppermint, and stir evenly again; compress into tablets, each tablet containing 2 grams of the compound active ingredients of this invention.

[0243] [Example 4] Preparation of the oral liquid drug of the present invention

[0244] a) Weigh out the raw material drug for later use. The dosage of the raw material drug is as follows:

[0245]

[0246] b) Add water to the eight Chinese herbs (Cuscuta chinensis, Psoralea corylifolia, Aconitum carmichaelii, Cimicifuga foetida, Cistanche deserticola, Acanthopanax senticosus, Ganoderma lucidum, and Saussurea involucrata) 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 then simmer for 30 minutes. For the second decoction, add water to cover the herbs by 2 cm, bring to a boil, and then simmer for 20 minutes. Combine the two decoctions and filter to obtain filtrate 1.

[0247] c) Collect the volatile oils from the specified weight ratio of Bupleurum chinense, Cinnamomum cassia, Taxillus chinensis, Citrus reticulata peel, Citrus medica, Citrus aurantium, Syzygium aromaticum, and Mentha haplocalyx using steam extraction for later use. Combine the decoction of Bupleurum chinense, Cinnamomum cassia, Taxillus chinensis, Citrus reticulata peel, Citrus medica, Citrus aurantium, Syzygium aromaticum, and Mentha haplocalyx (obtained by the same method as in step b) with filtrate 1, concentrate it into 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.

[0248] d) Extract the prepared Rehmannia root in the specified weight ratio by reflux with 90%-95% ethanol, and recover the ethanol from the extract.

[0249] The alcohol was dried at 45℃-50℃ to obtain dry extract 2.

[0250] e) Combine dry extract 1 and dry extract 2, pulverize them into powder, mix them evenly, and then pulverize them into fine powder. Add ethanol to the fine powder to make the ethanol content reach 55%. Let it stand for 24 hours, filter, recover the ethanol, and concentrate it into a thick paste with a relative density of 1.26-1.30 (60℃). Add the volatile oils of Bupleurum chinense, Cinnamomum cassia, Taxillus chinensis, Citrus reticulata, Citrus medica, Citronella arvense, Clove, Mutton, and Peppermint obtained in step c), 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 the compound active ingredients). Filter, sterilize, and fill into a container to obtain the final product.

[0251] [Example 5] Preparation of the drug pill of the present invention

[0252] a) Weigh out the raw material drug for later use. The dosage of the raw material drug is as follows:

[0253]

[0254] b) Add water to the eight Chinese herbs (Cuscuta chinensis, Psoralea corylifolia, Aconitum carmichaelii, Cimicifuga foetida, Cistanche deserticola, Acanthopanax senticosus, Ganoderma lucidum, and Saussurea involucrata) 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 then simmer for 30 minutes. For the second decoction, add water to cover the herbs by 2 cm, bring to a boil, and then simmer for 20 minutes. Combine the two decoctions and filter to obtain filtrate 1.

[0255] c) Collect the volatile oils from the specified weight ratio of Bupleurum chinense, Cinnamomum cassia, Taxillus chinensis, Citrus reticulata peel, Citrus medica, Citrus aurantium, Syzygium aromaticum, and Mentha haplocalyx using steam extraction for later use. Combine the decoction of Bupleurum chinense, Cinnamomum cassia, Taxillus chinensis, Citrus reticulata peel, Citrus medica, Citrus aurantium, Syzygium aromaticum, and Mentha haplocalyx (obtained by the same method as in step b) with filtrate 1, concentrate it into 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.

[0256] d) Extract the prepared Rehmannia root in the specified weight ratio by reflux with 90%-95% ethanol, and recover the ethanol from the extract.

[0257] The alcohol was dried at 45℃-50℃ to obtain dry extract 2.

[0258] e) Combine dry extract 1 and dry extract 2, pulverize them into powder, mix them evenly, then pulverize them into fine powder. Spray in the volatile oils of Bupleurum chinense, Cinnamomum cassia, Taxillus chinensis, Citrus reticulata peel, Citrus medica, Citronella arvense, Clove, mutton shavings, and peppermint, and stir evenly again. Add 30-50g of refined honey to every 100g of powder, make into pills, dry, polish or coat with sugar, and the product is ready. Each pill contains 10g of compound active ingredients.

[0259] [Typical Case]

[0260] Ms. Chen, 38 years old, has suffered from intractable insomnia for over two years. She reports sleeping only 3-4 hours per night, unable to fall asleep for a long time in bed, feeling mentally alert, and experiencing light sleep, easily awakened by slight noises or light. She wakes easily in the early morning and finds it difficult to fall back asleep, feeling tired upon waking, sometimes even more tired than before bed. Her dreams are numerous and varied. She is particularly sensitive to cold while sleeping: even under thick blankets, her feet and lower abdomen feel cold. She needs to curl up to fall asleep. Although she feels irritable, she has no desire to drink water or only drinks a small amount of hot water; she is sensitive to cold, with cold extremities, especially the lower back, abdomen, and limbs. During the day, she is listless, fatigued, and lethargic, showing little interest in various activities. Her complexion is pale and lacks luster; her tongue is pale, swollen, with teeth marks on the edges, and a white, slippery coating; her pulse is deep, slow, and weak. The capsules of Example 1 of this invention are taken orally three times a day after meals, 10 capsules each time, for 10 days as one course of treatment. After 2 months, the sleep condition has significantly improved. The time to fall asleep each night has been shortened from 2-3 hours to less than 1 hour, and the sleep duration can reach more than 5 hours. Sleep gradually becomes deeper, and slight sounds or light will not wake the patient. The patient's morning energy has improved, and symptoms such as excessive dreaming, fear of cold, and cold limbs have been relieved. The patient's daytime energy has improved, and the patient gradually develops interest in activities that were previously uninteresting. Upon inspection, the patient's complexion is more rosy than before, the tongue is pale red, the teeth marks on the tongue edges have been reduced, and the tongue coating is white. The pulse is deep and slow. Continue taking the capsules of Example 1 of this invention, 10 capsules orally three times a day after meals (morning, noon, and evening), for 10 days as one course of treatment. After 4 months, the patient was able to sleep for more than 7 hours each night, falling asleep within half an hour of going to bed, and only needing an alarm clock to wake up in the morning. The patient felt energetic upon waking, and symptoms of excessive dreaming and cold intolerance disappeared. The patient felt refreshed during the day, and resumed activities such as painting, calligraphy, and outdoor sports that had been neglected for a long time. Work and social abilities improved. Visual examination revealed a rosy and lustrous complexion, a pale tongue with a white coating, and a slow pulse. The patient continued taking the capsules of Example 1 of this invention at a maintenance dose of 10 capsules daily before bedtime. A two-year follow-up showed no recurrence.

[0261] Mr. Wu, male, 41 years old; reported that he has had poor sleep quality for the past 3 years, tossing and turning in bed and having difficulty falling asleep, sometimes even all night. Even when he does fall asleep, his sleep is very light and he is easily awakened by the slightest noise or movement. He wakes up very early in the morning and has difficulty falling back asleep. He feels exhausted and weak after waking up, but he cannot fall back asleep. He also has poor concentration and memory loss. He is sensitive to cold, especially his lower back, abdomen, knees, hands and feet, which is difficult to relieve even with thick blankets or a warm environment. This is more pronounced at night. He also feels cold, sore, and weak in his lower back, and his knees feel sore, cold, painful, and weak. The patient experienced difficulty falling asleep due to lower back discomfort while in bed; lack of interest in various activities; decreased libido; occasional nocturnal emissions; frequent urination with clear urine; and frequent urination at night, affecting sleep continuity. Self-administered sedatives and traditional Chinese medicine preparations such as Bai Zi Yang Xin Wan and Bu Xin Dan were ineffective. Visual examination revealed a dull, lackluster complexion; a pale, swollen tongue with teeth marks; a white, slippery tongue coating; and a weak, thready pulse. The patient was prescribed the tablets described in Example 3 of this invention, taken orally three times daily after meals, 10 tablets each time, for 10 days as one course of treatment. Two months later, during the second consultation, the patient reported a significant improvement in sleep. The time from going to bed to falling asleep had decreased from over two hours to less than one hour. Sleep had deepened, and the symptoms of early morning awakenings had significantly improved. The patient felt refreshed upon waking, and symptoms such as chills, lower back and knee pain and weakness had significantly improved. Symptoms such as nocturnal emission, spermatorrhea, frequent urination, and nocturia had also lessened. The patient continued to take the tablets of Example 3 of this invention, 10 tablets three times a day after meals, for 10 days as one course of treatment. Four months later, the patient could fall asleep within half an hour of going to bed, and slept deeply. An alarm clock was needed to wake the patient in the morning. The patient felt refreshed upon waking, and work efficiency had doubled. The lower back, abdomen, knees, hands, and feet felt warm, and the symptoms of coldness, soreness, and weakness in the lower back had disappeared. There were no symptoms of knee weakness, coldness, pain, or weakness. Symptoms such as nocturnal emission, spermatorrhea, frequent urination, and nocturia had also disappeared. The patient actively participated in various activities organized by the workplace, which were fulfilling and enjoyable, and had a harmonious sex life. Continue taking the tablets of Example 3 of this invention, changed to a maintenance dose of 10 tablets daily, taken before bedtime. After 3 months, the patient reported excellent efficacy. The dose was adjusted to 5 tablets daily, taken before bedtime. After 3 months, a follow-up showed excellent efficacy. The medication was discontinued for observation, and a follow-up one year later showed no recurrence.

Claims

1. A traditional Chinese medicine composition for preventing and treating yang deficiency insomnia, characterized in that It is composed of the following weight parts of raw medicinal materials:

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

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

4. The traditional Chinese medicine composition according to claim 1, 2 or 3, the preparation method comprising the following steps: a) weigh raw medicinal materials Radix Rehmanniae Preparata, Semen Leonuri, Fructus Aurantii Immaturus, Radix Ledebouriellae, Radix Aconiti, Radix Angelicae Pubescentis, Ramulus Cinnamomi, Taxillus Sessilifolius, Herba Cistanche, Pericarpium Citri Reticulatae, Radix et Rhizoma Astragali, Ganoderma lucidum, Saussurea involucrata, Citrus medica, Syzygium aromaticum, and Herba Mentholis, and reserve; b) decoct the following 8 traditional Chinese medicines with water for 2 times: Semen Leonuri, Fructus Aurantii Immaturus, Radix Ledebouriellae, Radix Aconiti, Radix Angelicae Pubescentis, Herba Cistanche, Ganoderma lucidum, and Saussurea involucrata; the first time, the water is added to 3 cm above the medicine surface, and after boiling, the medicine is decocted for 30 minutes on a low heat; the second time, the water is added to 2 cm above the medicine surface, and after boiling, the medicine is decocted for 20 minutes on a low heat; the decoctions of the two times are combined, and the filtrate 1 is obtained by filtration; c) collect the volatile oil of the following 9 traditional Chinese medicines by water vapor extraction method: Radix Angelicae Pubescentis, Taxillus Sessilifolius, Pericarpium Citri Reticulatae, Citrus medica, Syzygium aromaticum, and Herba Mentholis, and reserve; combine the water decoction of Radix Angelicae Pubescentis, Taxillus Sessilifolius, Pericarpium Citri Reticulatae, Citrus medica, Syzygium aromaticum, and Herba Mentholis (obtained by the method of step b) with the filtrate 1, and concentrate to the extract with a specific gravity of 1.35; alcohol precipitation is performed by adding 90%-95% ethanol, the ethanol is recovered, and the dry extract 1 is obtained by drying at 45-50℃; d) reflux extraction is performed on Radix Rehmanniae Preparata by adding 90%-95% ethanol, the ethanol of the extraction liquid is recovered, the dry extract 2 is obtained by drying at 45-50℃; e) combine the dry extract 1 and the dry extract 2, crush them into powder, mix them uniformly, crush them into fine powder again, and spray the volatile oil of Radix Angelicae Pubescentis, Taxillus Sessilifolius, Pericarpium Citri Reticulatae, Citrus medica, Syzygium aromaticum, and Herba Mentholis, and mix them uniformly.

5. The preparation method of the medicine of claim 4, wherein the active component obtained in step e) is combined with common auxiliary materials to prepare pills, tablets, granules, capsules, oral liquids, and other oral dosage forms.

6. The traditional Chinese medicine composition according to any one of claims 1-3, for use in the prevention and treatment of insomnia due to yang deficiency.

Images