Traditional Chinese medicine composition for preventing and treating insomnia due to deficiency of qi and preparation method of traditional Chinese medicine composition

Abstract

The invention discloses a traditional Chinese medicine composition for preventing and treating insomnia due to qi deficiency. The traditional Chinese medicine composition is mainly prepared from the following medicines according to a certain weight ratio: pericarpium citri reticulatae, acanthopanax, lucid ganoderma, poria cocos, cassia twig, angelica sinensis, rhizoma cimicifugae, longan aril, lily, rhizoma polygonati, rose and the like. The traditional Chinese medicine can be prepared into any common oral dosage form. The whole formula has the effects of regulating qi-flowing for strengthening spleen, reinforcing qi and nourishing yin, promoting qi to activate blood, warming channels and transforming qi, eliminating dampness and phlegm, clearing away heart-fire and restoring consciousness, and calming heart and tranquilizing mind, and has a definite curative effect on preventing and treating insomnia due to qi deficiency.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine technology, specifically to a traditional Chinese medicine composition for preventing and treating insomnia caused by qi deficiency and its preparation method. The composition is composed of various traditional Chinese medicine raw materials in a specific ratio, and has the effects of regulating qi and strengthening the spleen, tonifying qi and nourishing yin, promoting qi circulation and blood flow, warming the meridians and transforming qi, drying dampness and resolving phlegm, clearing the mind and refreshing the brain, and calming the mind and soothing the nerves. It is suitable for the prevention and treatment of insomnia and its accompanying symptoms caused by qi deficiency, and the invention also relates to the preparation method and dosage form application of the composition. Background Technology

[0002] Insomnia refers to a condition characterized by the persistent inability to obtain normal sleep, caused by external pathogenic factors or deficiency of vital energy, leading to restlessness of the mind. Western medicine treatments for insomnia include benzodiazepine receptor agonists (such as estazolam, diazepam, alprazolam, etc.), non-benzodiazepine receptor agonists (eszopiclone, zaleplon, etc.), melatonin receptor agonists (such as melatonin, agomelatine), antidepressants (such as mirtazapine, trazodone, etc.), antipsychotics (olanzapine, quetiapine, etc.), and antiepileptic drugs (gabapentin). While these chemical drugs can significantly alleviate insomnia symptoms, they do not cure the underlying cause. Long-term use may lead to tolerance, increase the burden on the liver and kidneys, and irritate the gastrointestinal tract. Traditional Chinese medicine believes that a person's sleep is controlled by the mind, and the normal functioning of the body's vital energy and the balance of Yin and Yang is fundamental to regulating sleep. The *Ling Shu* (Spiritual Pivot), in its chapter "The Meeting of Ying and Wei Qi," states: "Yin and Yang are interconnected, like a ring without end... The circulation of Ying and Wei Qi does not deviate from its normal course, therefore one is energetic during the day and sleeps soundly at night." Anything that affects the normal circulation of Ying, Wei Qi, blood, Yin, and Yang, causing restlessness of the spirit, can become a cause of insomnia.

[0003] In Traditional Chinese Medicine (TCM) theory, there is a close relationship between Qi deficiency and insomnia (insomnia). Qi deficiency is one of the common syndromes leading to insomnia, and its main mechanism lies in the weakened role of Qi in maintaining the functions of the mind and internal organs. This is mainly manifested in the following aspects:

[0004] First, the function of Qi in consolidating and nourishing the mind is weakened. The heart governs the mind, and the mind needs sufficient Qi and blood to nourish it in order to settle down, fall asleep normally, and maintain sleep. When Qi is deficient, the mind is not nourished. When the heart Qi is deficient, it is unable to propel and consolidate the blood to nourish the mind, leading to malnourishment and restlessness of the mind, resulting in symptoms such as insomnia, excessive dreaming, easy awakening, and shallow sleep. This type of insomnia is often accompanied by palpitations, forgetfulness, mental fatigue, weakness, pale complexion, pale tongue with white coating, and weak pulse, which are all manifestations of heart Qi deficiency.

[0005] Secondly, the vital energy's driving effect on the functions of the internal organs weakens. The spleen is the source of qi and blood production; spleen qi deficiency prevents the effective transformation and transportation of food essence, leading to insufficient qi and blood production. Deficiency of both the heart and spleen: spleen qi deficiency leads to insufficient qi and blood, which in turn affects heart blood. The heart governs blood; blood deficiency prevents nourishment of the heart, resulting in insomnia due to malnourishment of the heart spirit. Other organ influences: lung qi deficiency (affecting the generation of ancestral qi), kidney qi deficiency (essence deficiency preventing the transformation of qi and blood to nourish the heart), and liver qi deficiency (abnormal qi flow, indirectly affecting the heart spirit), can all affect the generation and circulation of qi and blood, ultimately leading to malnourishment of the heart spirit and insomnia. Manifestations: In addition to insomnia, it is often accompanied by symptoms of qi deficiency in corresponding organs, such as loss of appetite, abdominal distension and loose stools (spleen qi deficiency), shortness of breath and reluctance to speak (lung qi deficiency), and soreness and weakness of the lower back and knees (kidney qi deficiency), as well as dizziness, blurred vision, and sallow complexion, indicating blood deficiency.

[0006] Third, deficiency of Wei Qi and disharmony between Ying and Wei Qi. Wei Qi governs wakefulness and sleep. The *Ling Shu* (Spiritual Pivot) states, "Wei Qi circulates in the Yang during the day and in the Yin at night... When Yang Qi is exhausted and Yin Qi is abundant, the eyes close; when Yin Qi is exhausted and Yang Qi is abundant, the eyes awaken." The normal functioning of Wei Qi is crucial for ensuring the sleep-wake cycle. Deficiency of Wei Qi leads to abnormal functioning: Wei Qi has the functions of consolidating the exterior, warming, defending, and regulating wakefulness and sleep. When Wei Qi is deficient, its function weakens, and it cannot smoothly enter the Yin aspect (body) at night, or after entering the Yin aspect, it lacks the ability to consolidate and easily floats out of the Yin aspect. This leads to a state of "Yang not entering Yin" or "Wei Yang floating out," thus causing insomnia symptoms such as difficulty falling asleep, shallow sleep, and frequent awakenings; symptoms of Wei Qi deficiency manifest as daytime lethargy, susceptibility to colds, spontaneous sweating, aversion to wind, and decreased immunity.

[0007] Fourth, the core pathogenesis of insomnia caused by Qi deficiency includes: malnourishment of the mind and spirit (Qi deficiency → insufficient production of Qi and blood / weak propulsion → deficiency of heart blood → malnourishment of the mind and spirit → insomnia), dysfunction of the internal organs (Qi deficiency of each organ → affecting the production, circulation, and consolidation of Qi and blood → ultimately affecting the mind and spirit → insomnia), disharmony between Ying and Wei, and failure of Yang to enter Yin (defensive Qi → disordered circulation of defensive Qi → failure of Yang to enter Yin or floating of defensive Yang → insomnia).

[0008] Common types of insomnia due to Qi deficiency include: insomnia due to heart Qi deficiency (insomnia, palpitations, shortness of breath, fatigue, spontaneous sweating, worsening symptoms after activity, pale tongue with white coating, and weak pulse); insomnia due to deficiency of both heart and spleen (insomnia with excessive dreaming, palpitations, forgetfulness, dizziness, fatigue, poor appetite, abdominal distension, loose stools, sallow complexion, pale tongue with thin white coating, and weak pulse); insomnia due to deficiency of lung and spleen Qi (insomnia, shortness of breath, fatigue, low voice, poor appetite, abdominal distension, loose stools, susceptibility to colds, spontaneous sweating, pale and swollen tongue with teeth marks, white coating, and weak pulse); and insomnia due to deficiency of Wei Qi (insomnia, easy awakening, shallow sleep, aversion to wind, susceptibility to colds, spontaneous sweating, daytime lethargy, pale tongue with white coating, and floating and weak pulse). Summary of the Invention

[0009] The inventor has been engaged in health conditioning and prevention and treatment of insomnia for many years. Through the treatment of many patients with Qi deficiency insomnia and the screening of medications, it has been determined that Qi 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 has been identified, thus establishing this invention.

[0010] The purpose of this invention is to provide a traditional Chinese medicine composition that is effective in preventing and treating insomnia caused by qi deficiency. Another purpose of this invention is to provide a method for preparing the traditional Chinese medicine composition. The present invention uses 15 traditional Chinese medicines, namely, tangerine peel, Acanthopanax senticosus, Ganoderma lucidum, Poria cocos, cinnamon twig, Angelica sinensis, Cimicifuga foetida, longan pulp, lily bulb, Polygonatum sibiricum, rose, litchi seed, citronella, Eupatorium fortunei, and peppermint, to exert a synergistic effect.

[0011] 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 Zhuang Autonomous Region, Fujian, Sichuan, and Jiangxi provinces. Mature fruits are harvested, the peel is removed, and then sun-dried or dried at low temperature. The medicinal material is classified as "Chenpi" and "Guangdong Chenpi" (detailed experiments have proven that Chenpi from different origins has no effect on the efficacy of the herbal composition of this invention). This product has a fragrant aroma and a pungent, bitter taste. Those with a bright color and strong aroma are preferred. It is sliced ​​and used raw. The medicinal taste is bitter and pungent, and the properties are warm. It enters the spleen and lung meridians, and its functions are to regulate qi, strengthen the spleen, dry dampness, and resolve phlegm.

[0012] This herb is pungent and aromatic, warm and bitter, and enters the spleen and stomach meridians. It has the functions of promoting qi circulation, relieving bloating, and drying dampness. Therefore, it is an excellent remedy for abdominal distension, poor appetite, vomiting, and diarrhea caused by qi stagnation and dampness obstruction 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." The "Compendium of Materia Medica" states that it "treats vomiting, regurgitation, heartburn, and occasional vomiting of clear water." Therefore, it is 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, excelling at drying dampness and resolving phlegm, and also 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, able to promote qi circulation, relieve pain, and alleviate stagnation. For treating chest pain due to phlegm and qi stagnation, chest tightness, and shortness of breath, it can be combined with immature bitter orange, ginger, etc.

[0013] 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; the flavonoid compounds are mainly hesperidin, neohesperidin, tangeretin, naringin, and neonaringin. 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 has a direct inhibitory effect on isolated and in vivo gastric and intestinal motility. The volatile oil can relax 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, thus having 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 effects.

[0014] Dried tangerine peel is widely distributed, readily available, has few toxic side effects, and a good taste, making it a traditional Chinese medicine that is both food and medicine. In this invention, it is used as the principal ingredient in large doses to exert the effects of regulating qi, strengthening the spleen, drying dampness, and resolving phlegm. It is effective in preventing and treating insomnia caused by qi deficiency, where qi is unable to transport and transform nutrients, leading to the accumulation of dampness and phlegm, which over time affects the normal functioning of the spleen and stomach, resulting in spleen and stomach weakness, deficiency leading to excess, and deficiency of vital energy with excess of pathogenic factors.

[0015] Eleutherococcus senticosus is the dried root, rhizome, and stem of the plant Eleutherococcus senticosus, belonging to the Araliaceae family. It is mainly produced in Heilongjiang Province, harvested in spring and autumn, washed, dried, and sliced ​​into thick pieces. This product has a distinctive aroma and a slightly pungent, bitter, and astringent taste; those with a strong aroma are considered superior. It is used raw. The medicinal taste is sweet and slightly bitter, and its nature is warm. It enters the spleen, lung, kidney, and heart meridians, and its functions include invigorating qi and strengthening the spleen, tonifying the kidneys, and calming the mind.

[0016] This herb is sweet and warm in nature, and enters the spleen and lung meridians. Its functions include tonifying spleen qi and benefiting lung qi; it treats spleen and lung qi deficiency, physical weakness and fatigue, loss of appetite, loose stools, shortness of breath and reluctance to speak, and can be used with Astragalus membranaceus, Codonopsis pilosula, and Atractylodes macrocephala. This herb also benefits the lungs and kidneys, and has a slight expectorant and asthma-relieving effect; it treats lung and kidney deficiency, chronic cough and wheezing, and can be combined with ginseng, gecko, and Schisandra chinensis. This herb enters the kidney meridian, and has the functions of warming the kidneys, assisting yang, and strengthening muscles and bones. It is effective in treating kidney yang deficiency and weakness of tendons and bones, resulting in soreness and pain in the lower back and knees. It can be used alone or in combination with Eucommia ulmoides, Taxillus chinensis, and other herbs. It can also be used for impotence, delayed walking in children, and rheumatic arthralgia with concurrent liver and kidney deficiency. This herb enters the heart and spleen meridians, and can replenish the qi of the heart and spleen, as well as calm the mind and strengthen the will. It can be 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 herbs that nourish the heart and calm the mind, such as Ziziphus jujuba var. spinosa, Polygala tenuifolia, and Acorus tatarinowii.

[0017] The chemical composition mainly contains various glycosides (such as eleutherococcal glycoside, syringin, and liriodendrone), coumarins (such as isoflavone), and lignans (such as sesamin), as well as sugars, fatty acids, and quinones. 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.

[0018] In this invention, Acanthopanax senticosus is used as an assistant herb to help the principal herb exert its effects of invigorating qi and strengthening the spleen, tonifying the kidneys and calming the mind.

[0019] Reishi mushroom is the dried fruiting body of the fungus *Ganoderma lucidum* or *Ganoderma sinense*, belonging to the Polyporaceae family. It is produced in most parts of China. Harvested year-round, impurities are removed, and the lower part of the stipe attached to rotten wood, mud, or culture medium is trimmed. It is then air-dried in the shade or baked at 40℃–50℃. It has a slightly fragrant odor and a bitter, astringent taste; the best quality is characterized by a robust, thick fruiting body with a glossy outer shell; it is used raw. The medicinal properties are sweet and neutral; it enters the heart, lung, liver, and kidney meridians. Its functions include tonifying qi and calming the mind, relieving cough and asthma.

[0020] This herb is sweet and neutral in nature, entering the Heart Meridian. It nourishes Heart Blood, benefits Heart Qi, and calms the mind. It is suitable for those with insufficient Qi and Blood, malnourishment of the Heart and Spirit, resulting in restlessness, insomnia, palpitations, excessive dreaming, forgetfulness, fatigue, and poor appetite. It can be used alone or in combination with Angelica sinensis, Paeonia lactiflora, and Ziziphus jujuba var. spinosa. This herb is sweet and enters the Lung Meridian. It nourishes Lung and Kidney Qi, stops cough and relieves asthma, suitable for cough and asthma due to Lung deficiency. It can be used alone or in combination with Astragalus membranaceus, Codonopsis pilosula, and Schisandra chinensis. This herb is sweet and tonifies Qi, used to treat weakness, shortness of breath, and loss of appetite, often in combination with ginseng, Cornus officinalis, and Dioscorea opposita.

[0021] The chemical composition mainly includes 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.

[0022] Pharmacological effects: Ganoderma lucidum polysaccharides possess broad immunomodulatory activity, enhancing the body's immune activity. Triterpenoids isolated from Ganoderma lucidum fruiting bodies, polysaccharides, and spores all exhibit antitumor effects. Ganoderma lucidum proteoglycans possess antiviral activity; acid-bound Ganoderma lucidum polysaccharides (APBP) exhibit anti-HSV-1 and HSV-2 activity, and Ganoderma lucidum triterpenoids can also fight HIV. Phenolic compounds obtained from methanol extraction of Ganoderma lucidum and Ganoderma lucidum aminopolysaccharide G009 possess antioxidant and anti-aging effects. Ganoderma lucidum polysaccharides can protect the liver and improve hypoxia tolerance. Furthermore, Ganoderma lucidum can reduce blood viscosity, increase myocardial contractility, increase coronary blood flow and cardiac output, and improve heart rhythm; it can also protect against damage from radiation and toxic chemicals, possessing sedative and analgesic effects, prolonging sleep time and improving sleep quality, and can relieve asthma, cough, and phlegm, as well as treat chronic bronchitis.

[0023] In this invention, Ganoderma lucidum is used as an assistant ingredient to help the principal ingredient exert its function of replenishing qi and calming the mind.

[0024] Poria cocos is the dried sclerotium of the fungus Poria cocos, belonging to the Polyporaceae family. It is mainly produced in Anhui, Yunnan, and Hubei provinces, and is harvested primarily from July to September. After being dug up, the soil and sand are removed, and the fungus is piled up to "sweat," then spread out to dry until the surface is dry. This process of "sweating" is repeated several times until wrinkles appear and most of the internal moisture is lost. It is then air-dried, and this product is called "Poria cocos pieces." Alternatively, fresh Poria cocos can be cut into different parts and air-dried, resulting in "Poria cocos chunks" and "Poria cocos slices," respectively. This product has a slight odor and a bland taste. The best quality is characterized by a white, fine surface and strong stickiness. It is used raw. The medicinal taste is sweet and bland, and the nature is neutral. It enters the heart, lung, spleen, and kidney meridians, and its functions include promoting diuresis and eliminating dampness, strengthening the spleen, and calming the mind.

[0025] This herb has a sweet and bland taste. Sweetness nourishes, while blandness promotes drainage. Its medicinal properties are mild, capable of both dispelling pathogens and supporting the body's vital energy. It promotes urination without harming the body's constitution, making it a key herb for reducing swelling and edema. It can be used to treat various types of edema, including those caused by cold, heat, deficiency, and excess. For edema and difficulty urinating caused by internal retention of dampness, it is often used with Alisma plantago-aquatica, Polyporus umbellatus, and Atractylodes macrocephala. For edema due to spleen and kidney yang deficiency, it is often used with Aconitum carmichaelii and Zingiber officinale. For edema due to water-heat accumulation, yin deficiency, difficulty urinating, and Alisma plantago-aquatica, it is often used in combination with Talcum, Colla corii asini, and Alisma plantago-aquatica. This herb excels at draining dampness, preventing its accumulation and phlegm formation. It can treat dizziness and palpitations caused by phlegm retention, often combined with Cinnamomum cassia, Atractylodes macrocephala, and Glycyrrhiza uralensis. If vomiting occurs due to fluid retention in the stomach, it is often used with Pinellia ternata and Zingiber officinale. This herb has a sweet taste and enters the spleen meridian. It can strengthen the spleen and replenish the middle jiao, eliminate dampness and stop diarrhea, and promote the ascending of clear qi and the descending of turbid qi in the middle jiao. It is especially suitable for diarrhea caused by spleen deficiency and dampness. It can be used with yam, atractylodes macrocephala, and coix seed. For treating spleen and stomach weakness, fatigue, poor appetite and loose stools, it is often combined with ginseng, atractylodes macrocephala, and licorice. This herb nourishes the heart and spleen and calms the mind. It is often used to treat palpitations, insomnia, and forgetfulness caused by deficiency of both heart and spleen and insufficient qi and blood. It is often used with astragalus, angelica, and polygala. If the heart qi is deficient and unable to store the spirit, causing fright and restlessness, it is often used with ginseng, fossilized teeth, and polygala.

[0026] The main chemical components include polysaccharides (with β-pachyman being the most abundant), triterpenoids (pachymic acid, pachymic acid, pachymannic acid, etc.), and sterols (ergosterol, etc.), as well as proteins, fats, lecithin, adenine, etc. Pharmacological effects: Poria cocos decoction, syrup, alcohol extract, and ether extract have diuretic, sedative, antitumor, and myocardial contractility-enhancing effects, respectively; Poria cocos polysaccharides have an immune-enhancing effect.

[0027] In this invention, Poria cocos is used as an assistant herb to assist the principal herb in exerting the functions of promoting diuresis and eliminating dampness, strengthening the spleen and harmonizing the stomach, and calming the mind and soothing the nerves.

[0028] 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 Zhuang Autonomous Regions. 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 pungent and sweet, and warm in nature; it enters the heart, lung, and bladder meridians; its functions include inducing sweating and relieving muscle tension, warming and unblocking the meridians, assisting yang and transforming qi, and calming the rebellious qi.

[0029] The main chemical components include volatile oils (cinnamaldehyde, camphene, benzaldehyde, β-elemene, β-piperazine, etc.), as well as phenols, organic acids, polysaccharides, glycosides, coumarins, and tannins. The cinnamon oil in this product can dilate blood vessels, improve blood circulation, and promote blood flow to the body surface, thus 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.

[0030] In this invention, cinnamon twig is used as an assistant herb to help the principal herb exert its effects of warming and unblocking the meridians, promoting yang and transforming qi, and nourishing the heart and calming the mind.

[0031] Angelica sinensis is the dried root of the plant Angelica sinensis, belonging to the Apiaceae family, and is mainly produced in Gansu Province. It is harvested in late autumn, with the fibrous roots and soil removed. After the moisture has slightly evaporated, it is bundled into small bunches, placed on a rack, and slowly dried with smoke before being sliced ​​thinly. This product has a rich aroma and a sweet, pungent, and slightly bitter taste. The best quality is characterized by its soft texture, yellowish-white cut surface, and strong fragrance. It can be used raw or processed with wine. The medicinal properties are sweet and pungent, warm in nature, and it enters the liver, heart, and spleen meridians. Its functions include nourishing and invigorating blood, regulating menstruation and relieving pain, and moistening the intestines and promoting bowel movements.

[0032] Applications: (1) Blood deficiency and chlorosis, dizziness and palpitations; This product is sweet and warm in nature and is good at nourishing blood. It is a holy medicine for nourishing blood. For blood deficiency and chlorosis, palpitations and insomnia, it is often combined with Rehmannia glutinosa, Paeonia lactiflora and Ligusticum chuanxiong, such as Siwu Decoction (from the Imperial Pharmacy). If there is deficiency of both qi and blood, it is often combined with Astragalus membranaceus, Ginseng and other herbs to nourish qi and generate blood, such as Danggui Buxue Decoction (from the Secret Collection of Orchid Chamber) and Renshen Yangrong Decoction (from the Treatise on Epidemic Diseases). (2) Menstrual disorders, amenorrhea, and dysmenorrhea due to blood deficiency and blood stasis; This herb is sweet and pungent, good at both nourishing and activating blood, "truly a qi-regulating medicine and a holy medicine for blood"; because it excels at activating blood circulation, removing stagnation, and relieving pain, it is an essential medicine for nourishing and activating blood, regulating menstruation, and relieving pain in gynecology. Furthermore, due to its warm nature, it is especially suitable for those with blood deficiency, blood stasis, and coldness; when used to treat menstrual disorders, amenorrhea, and dysmenorrhea in women with blood deficiency, it is often combined with blood-nourishing and blood-activating herbs such as Rehmannia glutinosa, Paeonia lactiflora, and Ligusticum chuanxiong, as in Siwu Tang (from *Heji Jufang*); if there is also blood stasis, blood-activating and menstruation-regulating herbs such as Prunus persica and Carthamus tinctorius can be added, such as... Taohong Siwu Decoction (from *Yizong Jinjian*); for menstrual disorders, amenorrhea, and dysmenorrhea, if the symptoms are due to deficiency and cold in the Chong and Ren meridians and blood stasis, it can be combined with white peony root, cinnamon twig, and evodia fruit, as in Wenjing Decoction (from *Jinkui Yaolue*); if the symptoms are due to liver qi stagnation, it can be combined with bupleurum root, white peony root, and atractylodes macrocephala, as in Xiaoyao Powder (from *Heji Jufang*); if the symptoms are due to liver qi stagnation transforming into fire and heat forcing blood to flow, it can be combined with peony bark, gardenia fruit, and bupleurum root, as in Danzhi Xiaoyao Powder (from *Jiaozhu Furen Liangfang*); if the symptoms are due to deficiency of both qi and blood, it can be combined with ginseng, atractylodes macrocephala, and prepared rehmannia root, as in Bazhen Decoction (from *Zhengti Leiyao*). (3) Abdominal pain due to deficiency and cold, rheumatic arthralgia, traumatic injuries, carbuncles and sores; This herb is pungent and warm, making it an excellent medicine for promoting blood circulation and removing blood stasis; This herb nourishes and invigorates blood, dispels cold and relieves pain. It is used to treat abdominal pain due to blood deficiency, blood stasis and cold coagulation. It can be used with cinnamon twig, ginger, white peony root, etc., such as Angelica sinensis and ginger mutton soup (from *Synopsis of Prescriptions of the Golden Chamber*) and Angelica sinensis Jianzhong Decoction (from *Prescriptions Worth a Thousand Gold*); It is used to treat wind-cold arthralgia and numbness of limbs. It is often used with notopterygium root, saposhnikovia root, gentian root, etc., such as Juanbi Decoction (from *Selected Prescriptions*); This herb invigorates blood and relieves pain. It is used to treat traumatic injuries and pain caused by blood stasis. When used with frankincense, myrrh, peach kernel, etc., it can be used in formulas such as Fuyuan Huoxue Tang (Medical Inventions) and Huoluo Xiaoling Dan (Medical Records of Integrating Chinese and Western Medicine). When used to treat early-stage sores with swelling and pain, it can be used with honeysuckle, red peony root, trichosanthes root, etc., as in Xianfang Huoming Yin (Women's Prescriptions). When used to treat carbuncles that do not heal after ulceration, it can be used with astragalus, ginseng, cinnamon, etc., as in Shiquan Dabu Tang (Formulary of the Bureau of Imperial Pharmacy). When used to treat gangrene with ulceration and damage to yin and blood, it can also be used with honeysuckle, scrophularia, licorice, as in Simiao Yong'an Tang (New Compilation of Effective Prescriptions). (4) Blood deficiency and intestinal dryness constipation: This product nourishes blood and moistens the intestines to relieve constipation. It is used to treat blood deficiency and intestinal dryness constipation. It is often used with Cistanche deserticola, Achyranthes bidentata, Cimicifuga foetida, etc., such as Jichuan Decoction (Jingyue Quanshu). It can also be used with raw Polygonum multiflorum, hemp seed, peach kernel and other laxatives.

[0033] Chemical composition: It mainly contains volatile oils (ligusticum chuanxiong, n-butenylfuran lactone, carawayol, verbenatenone, safrole, p-ethylbenzaldehyde, etc.), organic acid components (ferulic acid, vanillic acid, nicotinic acid, succinic acid), as well as polysaccharides, vitamins, amino acids, etc.

[0034] Pharmacological effects: The volatile oil of this product can counteract the excitatory effects of adrenaline-posterior pituitary hormone or histamine on the uterus; water- or alcohol-soluble non-volatile substances have an excitatory effect on isolated uterus, with alcohol-soluble substances having a stronger effect than water-soluble substances; the aqueous extract can significantly promote the production of hemoglobin and erythrocytes in mice, and Angelica sinensis and its sodium ferulate have significant antithrombotic effects; the extract of this product can dilate isolated guinea pig coronary arteries and increase coronary blood flow, and has a significant protective effect against experimental myocardial ischemia; this product has the effects of enhancing the body's immunity, inhibiting the proliferation of granulation tissue in the later stage of inflammation, anti-lipid peroxidation, anti-tumor, antibacterial, and anti-radiation.

[0035] In this invention, Angelica sinensis is used as an adjuvant to assist the principal and assistant herbs in exerting the effects of nourishing and promoting blood circulation.

[0036] Cimicifuga rhizome is the dried rhizome of *Cimicifuga foetida*, *Cimicifuga dahurica*, or *Cimicifuga foetida*, 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 fibrous roots are then singed off or removed, and the product is dried and sliced. It 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. The medicinal taste is pungent and slightly sweet, and the nature is slightly cold; it 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.

[0037] Applications: (1) Wind-heat cold, fever and headache; This product is pungent, sweet and slightly cold, and has the function of dispersing and releasing the exterior and reducing fever; It can be used with mulberry leaves, chrysanthemum, mint and other herbs to treat wind-heat cold, the initial stage of febrile disease, fever, headache and other symptoms; If it is wind-cold cold, aversion to cold and fever, no sweating, headache and cough, it can be combined with ephedra, perilla leaves, angelica and other herbs; If it is wind-heat with dampness in the Yangming meridian, headache, frontal pain, vomiting, heart irritability and fullness, it can be combined with atractylodes, kudzu root, fresh lotus leaf and other herbs, such as Qingzhen Decoction (Zheng Yin Mai Zhi). (2) Measles not fully erupted; This product can disperse and release the exterior, and promote the eruption of measles. It is used to treat the initial stage of measles when the eruption is not smooth. It is often used with kudzu root, white peony root, licorice root, etc., such as Shengma Gegen Tang (Yan's Pediatric Formulas); If the measles is about to erupt but cannot, with fever without sweating, cough, sore throat, thirst and dark urine, it is often combined with kudzu root, peppermint, burdock fruit and other medicines. (3) Toothache, oral ulcers, sore throat, and rashes caused by yang toxin; This product is sweet and cold, and is known for its heat-clearing and detoxifying effects. It is a good medicine for clearing heat and detoxifying and can be used to treat various diseases caused by heat toxin. Because it is particularly good at clearing heat toxin in the Yangming channel, it is especially used for toothache, oral ulcers, sore throat, and skin sores caused by excessive stomach fire; For the treatment of toothache and oral ulcers, it is often used with gypsum, coptis, etc., such as Qingwei San (Lan Shi Mi Cang); For the treatment of mumps caused by wind-heat epidemic toxin attacking the head, with redness and swelling of the face and sore throat, it is often combined with scutellaria, scrophularia, and isatis root, such as Puji Xiaodu Yin (Dong Yuan Shi Xiao Fang); For the treatment of mumps, it can be combined with coptis, forsythia, and burdock; For the treatment of rashes caused by yang toxin, it is often used with gypsum, indigo leaves, and gromwell. (4) Qi deficiency and sinking, gastroptosis, chronic diarrhea and rectal prolapse, uterine prolapse, nephroptosis, metrorrhagia and menorrhagia; This product enters the spleen and stomach meridians and is good at guiding the clear yang qi of the spleen and stomach to rise. Its lifting power is stronger than that of Bupleurum. Therefore, it is often used to treat the abdominal distension, poor appetite and fatigue, chronic diarrhea and rectal prolapse, uterine prolapse, nephroptosis and other organ prolapse caused by insufficient middle qi and qi deficiency and sinking. It is often used with Astragalus, Ginseng, Bupleurum and other herbs to replenish qi and raise yang, such as Buzhong Yiqi Tang (Treatise on the Spleen and Stomach); If the qi in the chest sinks and the breath is short and not enough to breathe, this product is often used with Bupleurum, Astragalus, Platycodon and other herbs, such as Shengxian Tang (Record of Medicine Combining Chinese and Western Medicine); For the treatment of qi deficiency and sinking, heavy menstrual flow or metrorrhagia, this product is combined with Ginseng, Astragalus, Atractylodes and other herbs to replenish middle qi, such as Juyuan Decoction (Complete Works of Jingyue).

[0038] Chemical composition: Primarily contains phenolic acids (isoferric acid, cimicifugic acid A, B, C, D, E), triterpenoids and glycosides (cicadaenin, 25-O-hydroxycicadae epoxyol-3-O-β-D xyloside), and chromones (nocicadaenin). Pharmacological effects: Cimicifuga extract possesses antipyretic, anti-inflammatory, analgesic, anticonvulsant, leukocyte-increasing, and platelet aggregation and release-inhibiting effects. Cimicifuga has moderate antibacterial activity against Mycobacterium tuberculosis, Staphylococcus aureus, and Moraxella catarrhalis. It also has inhibitory effects on intestinal spasms induced by chloroacetylcholine, histamine, and barium chloride, and has cardiotonic, heart rate-slowing, blood pressure-lowering, and intestinal and uterine spasm-inhibiting effects.

[0039] In this invention, Cimicifuga rhizome is used as an adjuvant to assist the principal and assistant herbs in raising Yang energy, restoring the body's Yin-Yang balance, eliminating symptoms of lethargy and lack of concentration, and achieving a good state of being energetic and refreshed when studying and working, and peaceful and quiet when sleeping at night.

[0040] Longan pulp is the aril of the longan tree, a plant in the Sapindaceae family. It is mainly produced in Guangdong, Guangxi Zhuang Autonomous Region, and Fujian. Mature fruits are harvested in summer and autumn, dried, the shell and seed removed, and then sun-dried until smooth and non-sticky. This product has a slightly fragrant aroma and a sweet taste; the best quality is characterized by thick flesh, large slices, brownish-yellow color, and sweetness, and is used raw. Medicinally, it is sweet and warm in nature; it enters the heart and spleen meridians, and its functions include tonifying the heart and spleen, nourishing blood, and calming the mind.

[0041] This product nourishes the heart and spleen, replenishes qi and blood, and calms the mind. It is neither greasy nor stagnant, making it an excellent tonic. It treats deficiency of both heart and spleen, insufficiency of qi and blood, palpitations, forgetfulness, insomnia, and anemia with a sallow complexion. It is often used in combination with ginseng, angelica, and jujube seed, such as in Gui Pi Tang (Spleen-Nourishing Decoction). For those who are elderly and frail, postpartum, or recovering from a serious illness, with deficiency of qi and blood, this product can be used alone, steamed with white sugar, and taken with boiling water, such as in Yu Ling Gao (Jade Spirit Paste).

[0042] The main chemical components include glucose, fructose, sucrose, adenine, and choline, as well as protein, organic acids, fats, and vitamins B1, B2, P, and C. Pharmacological effects: This product can prolong the survival time of mice under normobaric hypoxia and reduce mortality under low temperature; it also has anti-stress, anti-anxiety, antibacterial, and anti-aging effects.

[0043] Longan pulp is neither greasy nor cloying. As a nourishing medicine, it serves as an adjuvant in this invention, playing the role of tonifying the heart and spleen, nourishing blood, and calming the mind.

[0044] Lily is the dried, fleshy scale-like leaf of the lily plant (Lilium lancifolium). It has a sweet taste and slightly cold nature, and enters the lung and heart meridians. It nourishes yin and moistens the lungs, clears the heart and calms the mind, making it a commonly used yin-nourishing herb in Traditional Chinese Medicine. Its dual nature as both food and medicine makes it widely used in both dietary therapy and medicinal applications.

[0045] Main Efficacy and Clinical Applications. **Lung Nourishment and Cough Relief:** Lily nourishes lung yin and clears lung heat, suitable for symptoms such as dry cough due to yin deficiency, hemoptysis, and persistent cough, including conditions like tuberculosis and chronic bronchitis. It is often combined with Rehmannia glutinosa and Ophiopogon japonicus (e.g., Lily Bulb Decoction for Strengthening the Lungs). Fresh lily contains mucilage, which can relieve dry cough with little phlegm; the effect is better when combined with coltsfoot flower or honey. **Calming the Mind and Soothing the Nerves:** Used for lingering fever after febrile diseases, restlessness, palpitations, insomnia, and excessive dreaming. For insomnia, it is combined with Ziziphus jujuba seed and Ophiopogon japonicus, such as in lily porridge or lily, lotus seed, and jujube seed soup. Lily and Rehmannia Decoction can relieve symptoms such as mental confusion and anxiety. **Metabolic and Immune Regulation:** The dietary fiber and colchicine in lily can regulate blood sugar and assist in the treatment of gout; polysaccharides can increase white blood cell count, reduce the side effects of radiotherapy and chemotherapy, and inhibit tumor growth. **Beauty and Skin Repair:** Fresh lily is rich in vitamins and mucilage, which can promote skin metabolism. External application can treat sores and eczema.

[0046] In this invention, lily is used as an adjuvant to assist the principal and assistant herbs in exerting the effects of nourishing yin, clearing the mind, calming the nerves, and soothing the nerves.

[0047] Polygonatum is the dried rhizome of *Polygonatum yunnanense*, *Polygonatum sibiricum*, or *Polygonatum multiflorum*, all belonging to the Liliaceae family. Depending on its shape, it is commonly known as "Large Polygonatum," "Chicken Head Polygonatum," or "Ginger-shaped Polygonatum." It is mainly produced in Guizhou, Hunan, Hubei, Sichuan, and Anhui provinces. Harvested in spring and autumn, the fibrous roots are removed, the rhizomes are washed, and the rhizomes are briefly blanched in boiling water or steamed until thoroughly cooked, then dried. This product has a slight odor, a sweet taste, and is sticky when chewed. The best quality is characterized by large, plump, yellow pieces with a transparent cross-section. It is sliced ​​thickly and used raw, or processed using methods such as stewing or steaming with wine. The medicinal properties are sweet and neutral, and it enters the spleen, lung, and kidney meridians; its functions include tonifying qi and nourishing yin, strengthening the spleen and moistening the lungs, and benefiting the kidneys.

[0048] Applications: (1) For spleen and stomach qi deficiency, fatigue, stomach yin deficiency, dry mouth and poor appetite, this product tonifies both spleen qi and spleen yin. It is mainly used for fatigue, poor appetite and weak pulse due to spleen and stomach qi deficiency. It can be used with other qi-tonifying and spleen-strengthening herbs such as Codonopsis pilosula and Atractylodes macrocephala. If there is spleen and stomach yin deficiency with dry mouth and poor appetite, red tongue without coating, it can be used with other stomach-nourishing and fluid-generating herbs such as Dendrobium nobile, Ophiopogon japonicus and Dioscorea opposita. (2) For lung deficiency, dry cough, cough with blood, this product is sweet and neutral. It can nourish lung yin and benefit lung qi. It can treat lung qi and yin deficiency, dry cough with little phlegm. It can be used alone as a decoction or taken with other herbs such as Adenophora stricta, Fritillaria cirrhosa and Anemarrhena asphodeloides. When used with other medicines, this product can also benefit kidney yin and is used for chronic cough due to lung and kidney yin deficiency. It can be used with other products that nourish the lung and kidney, resolve phlegm and stop cough, such as Rehmannia glutinosa, Asparagus cochinchinensis, and Stemona japonica. (3) For deficiency of essence and blood, soreness of waist and knees, premature graying of hair, internal heat and thirst, this product can replenish kidney essence, delay aging, and improve symptoms of premature aging such as deficiency of liver and kidney, deficiency of essence and blood, dizziness, soreness of waist and knees, and premature graying of hair. In the "Essential Prescriptions for Emergencies", this product can be used alone to make a paste. It can also be combined with other products such as Lycium barbarum, Eclipta prostrata, and Ligustrum lucidum to treat internal heat and thirst. It can be combined with other products that nourish yin and generate fluids, such as Rehmannia glutinosa, Ophiopogon japonicus, and Trichosanthes kirilowii.

[0049] This product is sticky and can easily cause dampness and stagnation of qi, so it is not suitable for those with spleen deficiency and dampness obstruction, phlegm and dampness stagnation, or qi stagnation and abdominal distension.

[0050] Chemical composition: It mainly contains polysaccharides (Polygonatum oligosaccharides A, B, C, etc.), saponins (Polygonatum saponins A, B, diosgenin, digitoxin, etc.), and flavonoids (apigenin, etc.). The Chinese Pharmacopoeia stipulates that the content of Polygonatum polysaccharides in Polygonatum, calculated as anhydrous glucose (C6H12O6), shall not be less than 7.0%; the content of Polygonatum sibiricum containing gold polysaccharides, calculated as anhydrous glucose (C6H12O6), shall not be less than 4.0%.

[0051] Pharmacological effects: Polygonatum polysaccharides can increase lymphocyte transformation rate, increase protein kinase activity, increase the level of cAMP in cardiomyocytes, improve learning and memory ability, improve brain function to delay aging, and prevent and treat arteriosclerosis (AS) and hepatic steatosis; Polygonatum aqueous extract can significantly reduce triglycerides and total cholesterol; Polygonatum can inhibit hepatic glycogenolysis and lower blood sugar; Polygonatum polysaccharides can counteract the reduction of peripheral blood leukocytes and platelets induced by Co60 in mice; Polygonatum can inhibit the generation of malondialdehyde, a product of spontaneous and induced lipid peroxidation in vitro, and directly scavenge oxygen free radicals; Polygonatum aqueous extract has inhibitory effects on Salmonella typhi, Staphylococcus aureus and various pathogenic fungi in vitro.

[0052] In this invention, Polygonatum is used as an adjuvant to assist the principal and assistant drugs in exerting the effects of nourishing yin, strengthening the spleen, benefiting the kidneys, and calming the mind.

[0053] Roses are the dried flower buds of the rose plant (Rosa rugosa), a member of the Rosaceae family. They are mainly produced in Jiangsu and Zhejiang provinces. They are harvested in batches in late spring and early summer when the flowers are about to bloom and dried at low temperatures in a timely manner. The product has a strong and fragrant aroma and a slightly bitter taste. The best quality roses are purplish-red in color, large in size, and have a strong fragrance. They are used raw. The medicinal taste is sweet and slightly bitter, and the nature is warm. It enters the liver and spleen meridians and has the functions of regulating qi and relieving depression, harmonizing blood, and relieving pain.

[0054] This herb is aromatic and promotes qi circulation, bitter and dispersing, and enters the liver and stomach meridians. It can soothe the liver and harmonize the stomach. It can treat chest, rib, and abdominal distension and pain, nausea, and poor appetite caused by liver and stomach disharmony. It can be combined with Cyperus rotundus, Citrus medica, and Amomum villosum. This herb is good at soothing the liver, promoting qi circulation, and relieving pain. It can treat menstrual disorders and premenstrual breast distension and pain caused by liver qi stagnation. It can be combined with Angelica sinensis, Ligusticum chuanxiong, and Paeonia lactiflora. This herb is bitter and dispersing, warm and unblocking, and has the effect of promoting blood circulation and relieving pain. It can treat traumatic injuries, swelling and pain caused by bruises. It can be combined with Angelica sinensis, Ligusticum chuanxiong, and Paeonia lactiflora.

[0055] The main chemical components include volatile oils (rose oil, citronellol, geraniol, nerol, eugenol, phenylethyl alcohol, etc.), as well as quercetin, tannins, fatty oils, and organic acids. Pharmacological effects: Rose oil promotes bile secretion in rats.

[0056] In this invention, rose is used as an adjuvant to assist the principal and assistant herbs in promoting blood circulation, relieving depression, and calming the mind.

[0057] Litchi seeds are the dried, mature seeds of the litchi plant (Litchi chinensis), a member of the Sapindaceae family. They are mainly produced in Fujian, Guangdong, and Guangxi Zhuang Autonomous Regions. Mature fruits are harvested in summer, the pericarp and fleshy aril are removed, and the seeds are washed and sun-dried. The product has a faint odor and a slightly sweet, bitter, and astringent taste. Large, plump, and shiny seeds are considered the best quality. They are crushed and used raw or roasted with salt water. The medicinal properties are sweet and slightly bitter, and warm in nature; it enters the liver and kidney meridians, and its functions include promoting qi circulation, dispersing stagnation, dispelling cold, and relieving pain.

[0058] This herb is pungent and bitter, warm in nature and dispels cold. It primarily enters the liver meridian, and has the functions of soothing the liver and regulating qi, dispersing stagnation and reducing swelling, and relieving pain caused by cold. For hernia pain and testicular swelling due to cold stagnation and qi stagnation, it can be used with fennel, green tangerine peel, and lindera root. For testicular swelling due to damp-heat, it can be used with gentian, Sichuan pepper, and phellodendron bark. This herb also has the effects of soothing the liver and stomach, dispelling cold, and relieving pain. For stomach distension and pain due to liver qi stagnation and liver-stomach disharmony, it can be used with costus root and citron. For dysmenorrhea and postpartum abdominal pain due to liver qi stagnation and blood stasis, it can be used with cyperus rhizome and angelica root.

[0059] The main chemical components include polysaccharides, total saponins, and flavonoids. Pharmacological effects: Litchi seeds possess pharmacological effects such as lowering blood sugar, regulating blood lipids, antioxidation, inhibiting viruses, antitumor activity, and protecting against liver damage. Among these, flavonoids can inhibit viruses and have antitumor effects, while total saponins can inhibit viral activity and lower blood sugar, regulate blood lipids, and enhance insulin sensitivity. Flavonoids, total saponins, and polysaccharides all have antioxidant effects, and polysaccharides can also improve immune function.

[0060] In this invention, litchi seeds are used as an adjuvant to assist the principal and assistant drugs in soothing the liver and relieving depression, promoting qi circulation and dispersing stagnation, and harmonizing the stomach and relieving pain. While preventing and treating insomnia due to qi deficiency, they also soothe emotions, increase appetite, and improve physical fitness.

[0061] Buddha's Hand is the dried fruit of the Buddha's Hand plant (Citrus medica var. sarcodactylis), 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. This product 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; it is warm in nature and 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.

[0062] This herb is pungent and aromatic, with a bitter and dispersing taste. It is good at soothing the liver and relieving depression, promoting qi circulation and relieving pain. It can treat chest and rib pain, abdominal distension and fullness caused by liver qi stagnation and liver-stomach disharmony. It can be used with Bupleurum, Cyperus, Curcuma, etc. This herb enters the spleen and stomach meridians, can regulate qi and harmonize the stomach and relieve pain. It can treat abdominal distension and pain, nausea and vomiting and poor appetite caused by spleen and stomach qi stagnation. It can be used with Aucklandia, Cyperus, Amomum. This herb is bitter and warm, dries dampness and resolves phlegm. Its pungent and aromatic nature can also promote qi circulation. Therefore, it is good at treating cough with damp phlegm and chest tightness with excessive phlegm. It can be combined with Luffa sponge, Trichosanthes peel, and Citrus reticulata peel.

[0063] The main chemical components include volatile oils (limonene, γ-terpinene, etc.), flavonoids (hesperidin, geraniol, etc.), coumarins (bergamot lactone, limonene), terpenoids (limonene, etc.), as well as polysaccharides and organic acids. Pharmacological effects: Bergamot alcohol extract has a significant inhibitory effect on intestinal smooth muscle, dilates coronary vessels, increases coronary blood flow, and at high concentrations inhibits myocardial contractility, slows heart rate, lowers blood pressure, and protects against experimental myocardial ischemia. Bergamot also has certain anti-asthmatic and expectorant effects, as well as anti-stress, immunomodulatory, and anti-tumor effects.

[0064] In this invention, Buddha's Hand is used as an adjuvant to assist the principal and assistant drugs in exerting the effects of soothing the liver and regulating qi, drying dampness and harmonizing the stomach, resolving phlegm and eliminating stagnation, and calming the mind and soothing the nerves.

[0065] Eupatorium fortunei is the dried aerial part of the plant Eupatorium fortunei, belonging to the Asteraceae family. It is mainly produced in Jiangsu, Zhejiang, and Hebei provinces. It is harvested twice a year, in summer and autumn, and after removing impurities, it is sun-dried. This product has a fragrant aroma and a slightly bitter taste. The best quality is characterized by abundant leaves, a green color, tender texture, and a strong aroma. It is cut into sections and used raw. Its medicinal properties are neutral, and its taste is pungent. It enters the spleen, stomach, and lung meridians, and its functions include aromatically resolving dampness, invigorating the spleen and stomach, and relieving summer heat.

[0066] This herb has a fragrant aroma, and its dampness-resolving and stomach-harmonizing effects are similar to those of agastache. It is often used in combination with other herbs to treat dampness obstructing the middle jiao, such as Atractylodes lancea, Magnolia officinalis, and Amomum villosum, to enhance its aromatic dampness-resolving properties. This herb is neutral in nature, aromatically resolving dampness and turbidity, invigorating the spleen and stomach, and removing stale substances. It is used to treat spleen-related symptoms such as damp-heat in the spleen meridian, a sweet and greasy taste in the mouth, excessive salivation, and halitosis. It can be used alone as a decoction or combined with Scutellaria baicalensis, Paeonia lactiflora, and Glycyrrhiza uralensis. This herb can both resolve dampness and relieve summer heat, treating summer-dampness syndrome. It is often used with agastache, lotus leaf, and Artemisia annua. If damp-heat is in its early stages, it can be used with talc, Coix lacryma-jobi, and agastache.

[0067] The main chemical components include volatile oils (such as p-cymene, nerol acetate, and thymol methyl ether), alkaloids (such as phenoxybenzidine and squalene), sterols and their esters (such as taraxasterol and taraxasterol acetate), and organic acids (such as fumaric acid and succinic acid). Pharmacological effects: Aqueous decoction of *Eupatorium fortunei* has inhibitory effects on *Corynebacterium diphtheriae*, *Staphylococcus aureus*, *Micrococcus occulta*, *Proteus*, and *Salmonella typhi*; its volatile oil and the cymene and nerol acetate contained in the oil have direct inhibitory effects on influenza viruses; the volatile oil and its effective monomers of *Eupatorium fortunei* have a significant expectorant effect when administered via gavage to cymene.

[0068] In this invention, Eupatorium fortunei is used as an adjuvant to assist the principal and assistant drugs, exerting the effects of aromatically resolving dampness, invigorating the spleen and calming the mind, removing water and blood stasis, and maximizing the effects of lightening the body, opening the orifices, invigorating the brain and calming the mind.

[0069] Peppermint is the dried aerial part of the plant *Mentha haplocalyx*, belonging to the Lamiaceae family. It is mainly produced in Jiangsu and Zhejiang provinces. Harvesting is done in stages during the summer and autumn when the stems and leaves are lush or when the flowers have bloomed three times. The peppermint is then sun-dried or shade-dried and cut into sections. When rubbed, it has a unique cool aroma and a pungent, cool taste. The best quality peppermint has abundant leaves, a green color, and a strong aroma. It is used raw. Medicinally, it is pungent and cool in nature, entering the lung and liver meridians. Its functions include dispersing wind-heat, clearing the head and eyes, relieving sore throat, promoting rash eruption, and soothing the liver and regulating qi.

[0070] This herb is pungent and dispersing, cool and clearing heat. Its pungent and dispersing properties are relatively strong, making it the most effective diaphoretic among pungent-cool exterior-releasing herbs in dispersing external pathogens. It also has a certain diaphoretic effect, making it a commonly used herb for dispersing wind-heat. Therefore, it is frequently used for wind-heat colds and febrile diseases in the Wei level. When used to treat wind-heat colds or the initial stage of febrile diseases, with pathogens in the Wei level, symptoms such as fever, slight aversion to wind and cold, and headache, it is often combined with honeysuckle, forsythia, and burdock fruit, as in Yinqiao Powder. This herb is light and ascending, aromatic and clearing the orifices, effectively dispersing wind-heat in the upper burner, clearing the head and eyes, and benefiting the throat. When used to treat wind-heat attacking upwards, causing headache and dizziness, it should be combined with wind-dispelling, heat-clearing, and pain-relieving herbs such as chuanxiong, gypsum, and angelica. For treating red and watery eyes due to wind-heat attacking upwards, it can be used with mulberry leaves, chrysanthemum, and vitex fruit. For treating wind-heat accumulation and sore throat, it is often combined with platycodon, licorice root, and silkworm. This herb is light and dispersing, possessing the functions of dispersing wind-heat, promoting detoxification and rash eruption, and relieving itching. It is used to treat wind-heat affecting the exterior and measles that fail to erupt, often combined with cicada slough, burdock fruit, and tamarisk, as in the Bamboo Leaf and Burdock Decoction. For treating itchy rashes, it can be used with schizonepeta, saposhnikovia, and silkworm, among other wind-dispelling and itching-relieving herbs. This herb also enters the liver meridian, soothing the liver and regulating qi. It is often combined with bupleurum, white peony root, and angelica root, among other liver-soothing, qi-regulating, and menstruation-regulating herbs, to treat liver qi stagnation, chest and rib pain, and irregular menstruation, as in the Xiaoyao Powder. This herb is aromatic and dispels foul odors, and can also resolve dampness and harmonize the middle jiao. It can also be used to treat summer heat and dampness, abdominal distension and pain, vomiting and diarrhea, often combined with sesame, magnolia bark, and honeysuckle.

[0071] The main chemical components include volatile oils such as menthol, menthone, isomenthone, menthol, α-pinene, and limonene. Pharmacological effects: When taken internally, peppermint oil stimulates the central nervous system, dilates skin capillaries, promotes sweat gland secretion, and increases heat dissipation, thus inducing sweating and relieving fever. Peppermint oil can inhibit gastrointestinal smooth muscle contraction and antagonize acetylcholine, exhibiting an antispasmodic effect. Menthol has a choleretic effect. When applied externally, peppermint oil stimulates cold receptors in nerve endings, producing a cooling sensation, and reflexively causes changes in deep tissue blood vessels, resulting in anti-inflammatory, analgesic, antipruritic, local anesthetic, and anti-irritant effects. This product also has expectorant, antitussive, anti-implantation, anti-early pregnancy, and antimicrobial effects.

[0072] In this invention, peppermint is used as an adjuvant to soothe the liver, regulate qi, clear the head and eyes, calm the mind and soothe the nerves, and guide the other herbs upwards.

[0073] 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:

[0074] 28-44 parts dried tangerine peel, 18-28 parts Acanthopanax senticosus, 18-28 parts Ganoderma lucidum, 18-28 parts Poria cocos, 18-28 parts cinnamon twig, 14-26 parts Angelica sinensis, 14-26 parts Cimicifuga foetida, 14-26 parts longan pulp, 14-26 parts lily bulb, 12-22 parts Polygonatum sibiricum, 12-22 parts rose, 12-22 parts litchi seed, 12-22 parts Buddha's hand, 12-22 parts Eupatorium fortunei, 4-12 parts peppermint.

[0075] The further proportions are as follows: 32-40 parts dried tangerine peel, 22-26 parts Acanthopanax senticosus, 22-26 parts Ganoderma lucidum, 22-26 parts Poria cocos, 22-26 parts cinnamon twig, 18-22 parts Angelica sinensis, 18-22 parts Cimicifuga foetida, 18-22 parts longan pulp, 18-22 parts lily bulb, 14-18 parts Polygonatum sibiricum, 14-18 parts rose, 14-18 parts litchi seed, 14-18 parts Buddha's hand, 14-18 parts Eupatorium fortunei, and 6-10 parts peppermint.

[0076] The preferred ingredients are: 36 parts dried tangerine peel, 24 parts Acanthopanax senticosus, 24 parts Ganoderma lucidum, 24 parts Poria cocos, 24 parts cinnamon twig, 20 parts Angelica sinensis, 20 parts Cimicifuga foetida, 20 parts longan pulp, 20 parts lily bulb, 16 parts Polygonatum sibiricum, 16 parts rose, 16 parts litchi seed, 16 parts Buddha's hand, 16 parts Eupatorium fortunei, and 8 parts peppermint.

[0077] 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, it is preferable to perform special extraction on Ganoderma lucidum in the raw materials, and to extract the volatile oils of Citrus reticulata peel, Cinnamomum cassia twig, Angelica sinensis, Rosa rugosa, Citrus medica, Eupatorium fortunei, and Mentha haplocalyx by steam distillation. However, these special processes should not be used to limit the scope of protection of this invention.

[0078] Preferably, the preparation method of the active pharmaceutical ingredient of the present invention is as follows:

[0079] a) Weigh out the raw medicinal materials: dried tangerine peel, Acanthopanax senticosus, Ganoderma lucidum, Poria cocos, cinnamon twig, Angelica sinensis, Cimicifuga foetida, longan pulp, lily bulb, Polygonatum sibiricum, rose, litchi seed, citron, Eupatorium fortunei, and peppermint, and set aside.

[0080] b) Add water to the seven Chinese herbs (Acanthopanax senticosus, Poria cocos, Cimicifuga foetida, Longan aril, Lilium brownii, Polygonatum sibiricum, and Litchi chinensis seed) in the weight ratio mentioned above and decoct twice. For the first decoction, add water to cover the herbs by 3 cm and simmer for 30 minutes after boiling. For the second decoction, add water to cover the herbs by 2 cm and simmer for 20 minutes after boiling. Combine the two decoctions and filter to obtain filtrate 1.

[0081] c) Collect the volatile oils from the specified weight ratio of dried tangerine peel, cinnamon twig, angelica root, rose, bergamot, agastache, and peppermint using steam extraction for later use; combine the decoction of dried tangerine peel, cinnamon twig, angelica root, rose, bergamot, agastache, and peppermint (the decoction is obtained in the same way 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.

[0082] d) The Ganoderma lucidum in the specified weight ratio is refluxed with 90%-95% ethanol for extraction. The ethanol is recovered from the extract and dried at 45℃-50℃ to obtain dry extract 2.

[0083] e) Combine dry extract 1 and dry extract 2, grind them into powder, mix them evenly, grind them into fine powder, spray in volatile oils of dried tangerine peel, cinnamon twig, angelica, rose, bergamot, agastache, and peppermint, and stir evenly.

[0084] 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.

[0085] The medicine of this invention has the effects of regulating qi and strengthening the spleen, replenishing qi and nourishing yin, promoting qi and blood circulation, warming the meridians and transforming qi, drying dampness and resolving phlegm, clearing the mind and refreshing the brain, and calming the mind and soothing the nerves. It is used for the prevention and treatment of qi deficiency insomnia and its complications. Detailed Implementation

[0086] 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 "Qi-deficiency Insomnia Relief," abbreviated as QXSMA).

[0087] [Experimental Example] Clinical observation of the drug of the present invention in treating insomnia due to Qi deficiency and its complications.

[0088] 1. Case Information:

[0089] Eighty outpatients and recruited subjects from January 2022 to December 2024 were selected and 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 40.67±1.12 years (22 males and 18 females), and the mean duration of disease was 2.58±0.36 years. The mean age of the control group was 41.18±0.67 years (19 males and 21 females), and the mean duration of disease was 2.76±0.45 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.

[0090] 2 Diagnostic criteria

[0091] 2.1 Diagnostic criteria for Qi deficiency

[0092] Based primarily on references to literature such as *Internal Medicine*, *Traditional Chinese Medicine Internal Medicine*, *Physiology*, *Pathology*, and *Guiding Principles for Clinical Research of New Traditional Chinese Medicine Drugs*, the diagnostic criteria for Qi and Blood are as follows:

[0093] 2.1.1 Main symptoms (one or more symptoms present)

[0094] (1) Fatigue and weakness: Patients often feel weak all over, listless, easily tired, and lethargic.

[0095] (2) Shortness of breath: There is not enough breath to breathe, the breathing is short and rapid, the shortness of breath is aggravated after mild activity, and one prefers to rest quietly; in severe cases, one will feel short of breath even when sitting or lying flat.

[0096] (3) Spontaneous sweating: sweating that occurs naturally without being caused by physical exertion, hot weather, excessive clothing, or the use of diaphoretic drugs (especially when awake during the day), and sweating is more pronounced after activity.

[0097] 2.1.2 Accompanying symptoms (0, 1, or more of the following symptoms appear in addition to the main symptoms)

[0098] (1) Complexion: pale or sallow complexion.

[0099] (2) Dizziness: a feeling of lightheadedness or vertigo.

[0100] (3) Low voice: speaking in a soft voice, feeling like it takes effort.

[0101] (4) Loss of appetite: poor appetite, no desire to eat.

[0102] (5) Abdominal distension: The feeling of abdominal distension is obvious after meals.

[0103] (6) Abnormal bowel movements: loose stools are common, or there is a feeling of needing to defecate but no strength to do so, or the feeling of weakness worsens after defecation.

[0104] (7) Decreased immunity: prone to catching colds, and the colds are difficult to cure.

[0105] (8) Tongue appearance: The tongue is plump and tender, and looks relatively large with teeth marks on the edges.

[0106] (9) Pulse: The pulse feels weak overall, and feels empty and weak when pressed; the pulse amplitude is narrow and feels relatively thin and weak; the pulse beats with insufficient force.

[0107] 2.1.3 Location of Qi Deficiency of Zang-Fu Organs (based on the main symptoms, or the appearance of corresponding symptoms of Qi deficiency of Zang-Fu organs)

[0108] (1) Lung Qi deficiency: weak cough and wheezing, clear and thin white sputum; weak voice; afraid of wind, prone to colds; pale tongue with white coating, weak or thready pulse.

[0109] (2) Heart Qi deficiency: palpitations, anxiety, chest tightness, palpitations and shortness of breath are significantly aggravated after activity, pale complexion, and weak or intermittent pulse.

[0110] (3) Spleen deficiency: obvious fatigue, poor appetite, abdominal distension after meals, loose stools, sallow complexion, thin or bloated body.

[0111] (4) Kidney Qi deficiency: soreness and weakness in the lower back and knees, hearing loss, tinnitus, frequent and clear urination, or nocturia, or incomplete urination, or bedwetting, or premature ejaculation in men, and clear and thin vaginal discharge and easy miscarriage in women.

[0112] 2.2 Diagnostic criteria for sleep disorders

[0113] 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:

[0114] (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;

[0115] (2) The above symptoms still occur even when there are conditions for sleep and the environment is suitable for sleep;

[0116] (3) The patient complains of one or more of the following sleep-related daytime functional impairments:

[0117] ① Fatigue or general discomfort;

[0118] ② Decreased attention, attention maintenance ability, or memory;

[0119] ③ A decline in learning, work, and / or social skills;

[0120] ④ Mood swings or irritability;

[0121] ⑤ Feeling sleepy during the day;

[0122] ⑥ Decreased interest and energy;

[0123] ⑦ An increased tendency to make mistakes during work or other tasks;

[0124] ⑧ Tension, headache, dizziness, or other physical symptoms related to sleep deprivation;

[0125] 9. Excessive focus on sleep.

[0126] 3. Case inclusion criteria

[0127] (1) Meets the diagnostic criteria for insomnia in the Chinese Classification and Diagnostic Criteria for Mental Disorders;

[0128] (2) Meets the above diagnostic criteria for Qi deficiency and sleep disorders

[0129] 4 Exclusion Criteria

[0130] (1) Those suffering from insomnia due to severe neurosis;

[0131] (2) Those with primary hypertension, hypotension, or anemia;

[0132] (3) Individuals with allergic constitutions or allergies to the drugs used in this study;

[0133] (4) Patients with serious primary diseases of the cardiovascular, cerebrovascular, liver, kidney, or hematopoietic systems, as well as those with mental illness;

[0134] (5) Those who fail to take medication as prescribed or whose data is incomplete and cannot be used to determine the efficacy.

[0135] 5 Experimental Methods

[0136] 5.1 Sample size estimation and grouping

[0137] 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.

[0138] 5.2 Intervention methods

[0139] The treatment group received QXSMA pills (Example 5, Formula 5) containing 36g dried tangerine peel, 20g Acanthopanax senticosus, 20g Ganoderma lucidum, 20g Poria cocos, 20g cinnamon twig, 18g Angelica sinensis, 18g Cimicifuga foetida, 18g longan pulp, 18g lily bulb, 14g Polygonatum sibiricum, 14g rose, 14g litchi seed, 14g Citrus medica, 14g Eupatorium fortunei, and 4g peppermint, taken orally with warm water after meals, 2 pills each time, once in the morning, noon, and evening; 7 days constituted one course of treatment, 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, 7 days constituted one course of treatment, and 10 courses were administered consecutively.

[0140] 5.3 Observation Indicators

[0141] (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.

[0142] (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.

[0143] (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.

[0144] (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.

[0145] (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.

[0146] (6) The changes in TCM syndrome were observed before and after treatment using a scoring method. The observation items included fatigue, shortness of breath, spontaneous sweating, and accompanying symptoms. The scoring method referred to the relevant standards in "Internal Medicine", "Traditional Chinese Medicine Internal Medicine", "Physiology", "Pathology" and "Guiding Principles for Clinical Research of New Chinese Medicines". Symptoms were scored as 0, 2, 4 and 6 points respectively for none, mild, moderate and severe. Abnormal tongue coating and pulse were scored as 2 points, and normal was scored as 0 points.

[0147] (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" and the "Guiding Principles for Clinical Research of New Traditional Chinese Medicine" formulated by the Sleep Disorders Group of the Neurology Branch of the Chinese Medical Association in 2011.

[0148] 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;

[0149] Significant effects: Sleep is noticeably improved, with sleep time increasing by more than 3 hours and sleep depth increasing;

[0150] Effective: Symptoms were relieved, and sleep time increased by less than 3 hours compared to before;

[0151] Ineffective: Insomnia shows no significant improvement or worsens.

[0152] Overall effective rate = (Number of cured cases + Number of cases with significant improvement + Number of cases with improvement) / Total number of cases

[0153] (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).

[0154] (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.

[0155] 6 Statistical Methods

[0156] 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.

[0157] 7 Results

[0158] During the clinical observation, 3 subjects withdrew from the study for personal reasons (1 in the control group and 2 in the treatment group), and 2 patients were excluded because they failed to strictly adhere to the medication contraindications during the study (1 in the control group and 1 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.

[0159] 7.1 Comparison of baseline data before treatment

[0160] 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).

[0161] Table 1. Comparison of PSQI score, ISI score, HAMD-24 score, and TCM syndrome scale between the two groups of patients.

[0162]

[0163] 7.2 Comparison of clinical efficacy between the two groups of patients

[0164] 7.2.1 Evaluation of Insomnia Treatment Efficacy

[0165] 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.

[0166] Table 2. PSQI score efficacy analysis

[0167]

[0168] 7.2.2 Comparison of PSQI scores, ISI scores, and HAMD-24 scores between the two groups

[0169] 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.

[0170] Table 3 Comparison of PSQI score, ISI score, and HAMD-24 score

[0171]

[0172] 7.2.3 Comparison of TCM syndrome scores between the two groups

[0173] 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.

[0174] Table 4 Comparison of clinical efficacy (mean ± standard deviation)

[0175]

[0176] 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.

[0177] 7.2.4 Comparison of MoCA scores, SDS scores, and SAS scores between the two groups

[0178] 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.

[0179] Table 5 Comparison of MoCA scores, SDS scores, and SAS scores between the two groups (mean ± standard deviation)

[0180]

[0181] ① Compared with the group before treatment: P < 0.05; ② Compared with the control group after treatment: P < 0.05;

[0182] 7.2.5 Comparison of neurotransmitter levels between the two groups

[0183] 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.

[0184] Table 6. Changes in neurotransmitter levels in the two groups (mean ± standard deviation)

[0185]

[0186] ① Compared with the group before treatment: P < 0.05; ② Compared with the control group after treatment: P < 0.05

[0187] 7.2.6 Comparison of neurotrophic factor levels between the two groups

[0188] 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.

[0189] Table 7 Comparison of neurotrophic factor levels between the two groups (mean ± standard deviation)

[0190]

[0191] ① Compared with the group before treatment: P < 0.05; ② Compared with the control group after treatment: P < 0.05

[0192] 7.2.7 Comparison of inflammatory factor levels between the two groups

[0193] 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.

[0194] Table 8 Comparison of inflammatory factor levels between the two groups (mean ± standard deviation)

[0195]

[0196] ① Compared with the same group before treatment: P < 0.05; ② Compared with the control group after treatment: P < 0.05.

[0197] 7.3 Follow-up Results

[0198] 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).

[0199] 7.4 Safety Evaluation

[0200] 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.

[0201] [Example 1] Preparation of the drug capsule of the present invention

[0202] a) Weigh out the raw material drug for later use. The dosage of the raw material drug is as follows:

[0203]

[0204] b) Add water to the seven Chinese herbs (Acanthopanax senticosus, Poria cocos, Cimicifuga foetida, Longan aril, Lilium brownii, Polygonatum sibiricum, and Litchi chinensis seed) in the specified weight ratio and decoct twice. For the first decoction, add water to cover the herbs by 3 cm, bring to a boil, and simmer for 30 minutes. For the second decoction, add water to cover the herbs by 2 cm, bring to a boil, and simmer for 20 minutes. Combine the two decoctions and filter to obtain filtrate 1.

[0205] c) Collect the volatile oils from the specified weight ratio of dried tangerine peel, cinnamon twig, angelica root, rose, bergamot, agastache, and peppermint using steam extraction for later use; combine the aqueous decoction of dried tangerine peel, cinnamon twig, angelica root, rose, bergamot, agastache, and peppermint (obtained using the same method as in step b) with filtrate 1, concentrate to a specific gravity of 1.35, add 90%-95% ethanol for alcohol precipitation, recover the ethanol and concentrate, and dry at 45℃-50℃ to obtain dry extract 1;

[0206] d) The Ganoderma lucidum in the specified weight ratio is refluxed with 90%-95% ethanol for extraction. The ethanol is recovered from the extract, and the extract is dried at 45℃-50℃ to obtain dry extract 2;

[0207] 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 dried tangerine peel, cinnamon twig, angelica, rose, bergamot, agastache, and peppermint, and stir evenly again; fill into gelatin hard capsules, each capsule containing about 2 grams of the compound active ingredients of this invention.

[0208] [Example 2] Preparation of the drug granules of the present invention

[0209] a) Weigh out the raw material drug for later use. The dosage of the raw material drug is as follows:

[0210]

[0211] b) Add water to the seven Chinese herbs (Acanthopanax senticosus, Poria cocos, Cimicifuga foetida, Longan aril, Lilium brownii, Polygonatum sibiricum, and Litchi chinensis seed) in the specified weight ratio and decoct twice. For the first decoction, add water to cover the herbs by 3 cm, bring to a boil, and simmer for 30 minutes. For the second decoction, add water to cover the herbs by 2 cm, bring to a boil, and simmer for 20 minutes. Combine the two decoctions and filter to obtain filtrate 1.

[0212] c) Collect the volatile oils from the specified weight ratio of dried tangerine peel, cinnamon twig, angelica root, rose, bergamot, agastache, and peppermint using steam extraction for later use; combine the aqueous decoction of dried tangerine peel, cinnamon twig, angelica root, rose, bergamot, agastache, and peppermint (obtained using the same method as in step b) with filtrate 1, concentrate to a specific gravity of 1.35, add 90%-95% ethanol for alcohol precipitation, recover the ethanol and concentrate, and dry at 45℃-50℃ to obtain dry extract 1;

[0213] d) The Ganoderma lucidum in the specified weight ratio is refluxed with 90%-95% ethanol for extraction. The ethanol is recovered from the extract, and the extract is dried at 45℃-50℃ to obtain dry extract 2;

[0214] 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 dried tangerine peel, cinnamon twig, angelica, rose, bergamot, agastache, 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 this invention.

[0215] [Example 3] Preparation of tablets for the drug of the present invention

[0216] a) Weigh out the raw material drug for later use. The dosage of the raw material drug is as follows:

[0217]

[0218] b) Add water to the seven Chinese herbs (Eleutherococcus senticosus, Poria cocos, Cimicifuga foetida, Longan aril, Lilium brownii, Polygonatum sibiricum, and Litchi chinensis seed) in the specified weight ratio and decoct twice. For the first decoction, add water to cover the herbs by 3cm, bring to a boil, then simmer for 30 minutes. For the second decoction, add water to cover the herbs by 2cm, bring to a boil, then simmer for 20 minutes. Combine the two decoctions.

[0219] The decoction was filtered to obtain filtrate 1.

[0220] c) Collect the volatile oils from the specified weight ratio of dried tangerine peel, cinnamon twig, angelica root, rose, bergamot, agastache, and peppermint using steam extraction for later use; combine the decoction of dried tangerine peel, cinnamon twig, angelica root, rose, bergamot, agastache, and peppermint (the decoction is obtained in the same way 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;

[0221] d) The Ganoderma lucidum in the specified weight ratio is refluxed with 90%-95% ethanol for extraction. The ethanol is recovered from the extract, and the extract is dried at 45℃-50℃ to obtain dry extract 2.

[0222] e) Combine dry extract 1 and dry extract 2, grind them into powder, mix them evenly, grind them into fine powder again, spray in the volatile oils of dried tangerine peel, cinnamon twig, angelica, rose, bergamot, agastache, and peppermint, and stir evenly again; press into shape.

[0223] Each tablet contains 2 grams of the compound active ingredients of this invention.

[0224] [Example 4] Preparation of the oral liquid drug of the present invention

[0225] a) Weigh out the raw material drug for later use. The dosage of the raw material drug is as follows:

[0226]

[0227] b) Add water to the seven Chinese herbs (Acanthopanax senticosus, Poria cocos, Cimicifuga foetida, Longan aril, Lilium brownii, Polygonatum sibiricum, and Litchi chinensis seed) in the specified weight ratio and decoct twice. For the first decoction, add water to cover the herbs by 3 cm and simmer over low heat for 30 minutes after boiling. For the second decoction, add water to cover the herbs by 2 cm and simmer over low heat for 20 minutes after boiling. Combine the two decoctions and filter to obtain filtrate 1.

[0228] c) Collect the volatile oils from the specified weight ratio of dried tangerine peel, cinnamon twig, angelica root, rose, bergamot, agastache, and peppermint using steam extraction for later use; combine the decoction of dried tangerine peel, cinnamon twig, angelica root, rose, bergamot, agastache, and peppermint (the decoction is obtained in the same way 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;

[0229] d) The Ganoderma lucidum in the specified weight ratio is refluxed with 90%-95% ethanol for extraction. The ethanol is recovered from the extract, and the extract is dried at 45℃-50℃ to obtain dry extract 2.

[0230] 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℃). Spray it into the volatile oils of dried tangerine peel, cinnamon twig, angelica, rose, bergamot, agastache, 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 compound active ingredients). Filter, sterilize, and fill into a container to obtain the final product.

[0231] [Example 5] Preparation of the pharmaceutical pills of the present invention

[0232] a) Weigh out the raw material drug for later use. The dosage of the raw material drug is as follows:

[0233]

[0234] b) Add water to the seven Chinese herbs (Acanthopanax senticosus, Poria cocos, Cimicifuga foetida, Longan aril, Lilium brownii, Polygonatum sibiricum, and Litchi chinensis seed) in the specified weight ratio and decoct twice. For the first decoction, add water to cover the herbs by 3 cm and simmer over low heat for 30 minutes after boiling. For the second decoction, add water to cover the herbs by 2 cm and simmer over low heat for 20 minutes after boiling. Combine the two decoctions and filter to obtain filtrate 1.

[0235] c) Collect the volatile oils from the specified weight ratio of dried tangerine peel, cinnamon twig, angelica root, rose, bergamot, agastache, and peppermint using steam extraction for later use; combine the decoction of dried tangerine peel, cinnamon twig, angelica root, rose, bergamot, agastache, and peppermint (the decoction is obtained in the same way 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;

[0236] d) The Ganoderma lucidum in the specified weight ratio is refluxed with 90%-95% ethanol for extraction. The ethanol is recovered from the extract, and the extract is dried at 45℃-50℃ to obtain dry extract 2.

[0237] 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 dried tangerine peel, cinnamon twig, angelica, rose, bergamot, agastache, 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.

[0238] [Typical Case]

[0239] Ms. Zhang, female, 30 years old, first visit in early August 2022. Chief complaint: Insomnia accompanied by headache and dizziness for nearly 3 years, worsening in the past two weeks. The patient reported feeling fatigued and preferring to stay in bed. Two years ago, due to a significant increase in work pressure and prolonged periods of high-intensity mental work, she gradually developed anxiety, difficulty falling asleep, and restless sleep. Initially, she experienced difficulty falling asleep, needing to toss and turn for 1-2 hours to achieve light sleep, with frequent dreams and easy awakening, making it difficult to fall back asleep. Her sleep duration was approximately 3 hours per night, accompanied by morning headache, dizziness, weakness, palpitations, shortness of breath, and a lack of interest in anything. Western medicine prescribed eszopiclone tablets, 1 mg each time, orally once nightly before bedtime. Initially, sleep duration was maintained for 4-5 hours, but tolerance developed, and even increasing the dose to 2 mg did not improve the effect, and daytime drowsiness worsened. In the past two weeks, her difficulty falling asleep has worsened, requiring nearly 2 hours of tossing and turning to achieve light sleep, and difficulty falling back asleep after waking, resulting in only 3-4 hours of actual sleep per night. Symptoms: Difficulty falling asleep, frequent dreams and easy awakening, headache and dizziness upon waking, dry mouth, loss of appetite, palpitations and shortness of breath, early menstruation, scanty and pale menstrual flow, pale red tongue with a thin yellow coating, and a deep and thready pulse. Western medicine diagnosis: Insomnia; Traditional Chinese medicine diagnosis: Insomnia (Qi deficiency syndrome). Treatment with tablets as described in Example 3: 10 tablets orally after breakfast, lunch, and dinner daily for 10 days as one course of treatment. Second visit in October 2022: After taking the medication, sleep significantly improved, with sleep onset time shortened to about 50 minutes, and 6 hours of restful sleep per night without dreams. Morning dizziness and headache had largely disappeared, fatigue was significantly reduced, appetite was fair, the tongue was pale red with a thin yellow coating, and the deep and thready pulse was less severe than before. Continue treatment with tablets as described in Example 3: 10 tablets orally after breakfast, lunch, and dinner daily for 10 days as one course of treatment. In a follow-up visit in April 2023, the patient reported that insomnia had not recurred, the time to fall asleep had shortened to within 30 minutes, nighttime awakenings had disappeared, headaches and dizziness had not recurred, and symptoms such as fatigue, palpitations, and shortness of breath had all disappeared. Appetite was good, bowel movements were normal, sleep was sound, and the patient enjoyed exercise in their spare time and had plenty of energy. No recurrence was observed during the two-year follow-up.

[0240] Chen, female, 38 years old, has suffered from stubborn insomnia for more than five years. She only sleeps for 3 - 4 hours every night. Sometimes, it is difficult to fall asleep throughout the night. She has dizziness, fatigue, memory loss, a decreasing appetite, sallow complexion, emotional upset, discomfort in the abdomen and chest, occasional hiccups, a pale tongue, a thin yellow coating on the tongue, and a deep and slow pulse. She often uses sedatives and the traditional Chinese medicine Baizi Yangxin Pills, but there is no obvious effect. She takes the granules of Example 2 for treatment, orally after breakfast, lunch, and dinner every day, 30 grams each time, and 10 days as a course of treatment. After 2 months, the insomnia symptoms improved significantly. She can sleep for more than 6 hours every night, and the situation of being unable to fall asleep throughout the night no longer occurs. Symptoms such as dizziness, fatigue, and memory loss improved, her appetite increased, and her spirit improved. After continuing to take the granules of Example 2 for treatment for 4 months, her daily sleep time reached 8 hours, and she could fall asleep within 20 minutes after lying in bed. Symptoms such as dizziness and fatigue disappeared, her memory improved, and she participated in 3 professional examinations and passed all of them smoothly. Her complexion became rosy, and she said that she looked much younger and more beautiful. She was in a good mood and actively participated in various social activities, and her quality of life was significantly improved. After follow-up for two years, there was no recurrence.

[0241] Li, male, 42 years old, was initially diagnosed in early February 2022; Chief complaint: Insomnia for more than 5 years, aggravated for 1 month; Current medical history: The patient had repeated insomnia more than 5 years ago, which occurred every time he was overworked or emotionally anxious. Due to greater work pressure, in the past 1 month, he had difficulty falling asleep,多梦, light sleep, easy to wake up, fatigue, palpitation, shortness of breath, dry mouth, spontaneous sweating, dizziness and blurred vision, forgetfulness, loss of appetite, abdominal distension and loose stools. After taking Zhusha Anshen Pills, there was no obvious improvement; Tongue manifestation: The tongue body was light red, with a thin white coating; Pulse condition: The pulse was deep and thin. Western medicine diagnosis: Chronic insomnia; Traditional Chinese medicine diagnosis: Insomnia, qi deficiency type. He took the capsules of Example 1 for treatment, orally after breakfast, lunch, and dinner every day, 10 capsules each time, and 10 days as a course of treatment. Second diagnosis in April 2022: After taking the medicine, the patient's difficulty in falling asleep improved, the number of awakenings at night decreased, and symptoms such as fatigue, palpitation, shortness of breath, dry mouth, spontaneous sweating, dizziness and blurred vision, forgetfulness, loss of appetite, abdominal distension and loose stools were alleviated. The stool was formed once a day. The tongue was red, with a thin coating, and the pulse was deep and thin. After continuing to take it for 6 months, all symptoms were cured. It was adjusted to the preventive dose, once before going to bed every day, 10 capsules each time. The patient was advised to regulate his emotions, have a balanced diet, regular work and rest, and combine work with rest. There was no recurrence after follow-up for 1 year.

Claims

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

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

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

4. The traditional Chinese medicine composition according to claim 1, 2 or 3, wherein the preparation method comprises the following steps: a) Weigh out the raw medicinal materials: dried tangerine peel, Acanthopanax senticosus, Ganoderma lucidum, Poria cocos, cinnamon twig, Angelica sinensis, Cimicifuga foetida, longan pulp, lily bulb, Polygonatum sibiricum, rose, litchi seed, citron, Eupatorium fortunei, and peppermint, and set aside. b) Add water to the seven Chinese herbs (Acanthopanax senticosus, Poria cocos, Cimicifuga foetida, Longan aril, Lilium brownii, Polygonatum sibiricum, and Litchi chinensis seed) in the specified weight ratio and decoct twice. For the first decoction, add water to cover the herbs by 3 cm and simmer over low heat for 30 minutes after boiling. For the second decoction, add water to cover the herbs by 2 cm and simmer over low heat for 20 minutes after boiling. Combine the two decoctions and filter to obtain filtrate 1. c) Collect the volatile oils from the specified weight ratio of dried tangerine peel, cinnamon twig, angelica root, rose, bergamot, agastache, and peppermint using steam extraction for later use; combine the decoction of dried tangerine peel, cinnamon twig, angelica root, rose, bergamot, agastache, and peppermint (the decoction is obtained in the same way 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; d) The Ganoderma lucidum in the specified weight ratio is refluxed with 90%-95% ethanol for extraction. The ethanol is recovered from the extract, and the extract is dried at 45℃-50℃ to obtain dry extract 2. e) Combine dry extract 1 and dry extract 2, grind them into powder, mix them evenly, grind them into fine powder, spray in volatile oils of dried tangerine peel, cinnamon twig, angelica, rose, bergamot, agastache, and peppermint, and stir evenly.

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

6. The application of the traditional Chinese medicine composition according to any one of claims 1-3 in a medicine for preventing and treating insomnia in people with qi deficiency.

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