Traditional Chinese medicine composition and traditional Chinese medicine decoction for treating insomnia

Abstract

The invention belongs to the technical field of traditional Chinese medicines, and discloses a traditional Chinese medicine composition and a traditional Chinese medicine decoction for treating insomnia, which have obvious curative effects and low toxic and side effects and have obvious curative effects on insomnia and dreaminess, palpitation and restlessness, anxiety and depression, chest and hypochondrium fullness and stuffiness and other symptoms. The traditional Chinese medicine composition is prepared from the following raw medicinal materials in parts by weight: 10-20 parts of radix bupleuri, 5-10 parts of scutellaria baicalensis, 15-20 parts of codonopsis pilosula, 9-15 parts of rhizoma pinelliae preparata, 20-30 parts of poria cocos, 15-30 parts of cassia twig, 10-20 parts of calcined ruddle, 20-30 parts of crude dragon bone, 25-45 parts of raw oyster shell, 15-25 parts of acanthopanax, 15-25 parts of poria with hostwood, 5-10 parts of fried spina date seed, 10-20 parts of honey-fried licorice root, 5-15 parts of stiff silkworm, 6-10 parts of cicada slough, 1-2 parts of scorpion and 10-15 parts of endothelium corneum gigeriae galli. , 10-15 parts of fingered citron, 15-30 parts of dark plum, 20-30 parts of white peony root and 5-15 parts of Chinese magnoliavine fruit. The scorpion is provided in a powder grinding form; the calcined ruddle, the crude dragon bone and the raw oyster shell are decocted with water and then mixed with the other raw medicinal materials, water is added for immersion and decoction for 2-3 times, decoction solutions are combined and mixed uniformly, and the traditional Chinese medicine decoction is obtained. The traditional Chinese medicine composition is prepared from traditional Chinese medicine decoction and scorpion powder.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine technology, and more specifically, to traditional Chinese medicine compositions and decoctions for treating insomnia. Background Technology

[0002] Insomnia, known as "insomnia" in Traditional Chinese Medicine, refers to a group of conditions characterized by the inability to obtain normal sleep. It is mainly manifested as insufficient sleep duration and depth. Mild cases involve difficulty falling asleep, restless sleep, frequent awakenings, or inability to fall back asleep after waking. Severe cases involve complete sleeplessness. With the accelerated pace of modern life and increased work pressure, the incidence of insomnia is rising year by year.

[0003] Currently, the main clinical treatment for insomnia uses Western sedative-hypnotic drugs (such as benzodiazepines). Although they are fast-acting, long-term use can easily lead to drug tolerance and dependence, and often has side effects such as hangover-like symptoms and memory loss. Traditional Chinese medicine (TCM) treatment for insomnia emphasizes syndrome differentiation and treatment, starting with regulating the Yin, Yang, Qi, and Blood of the internal organs, and has the advantages of stable efficacy and fewer side effects.

[0004] However, intractable insomnia commonly seen in clinical practice often has complex pathogenesis. It's not simply a matter of deficiency of both heart and spleen or yin deficiency with excessive fire; many patients present with complex syndromes such as "liver stagnation transforming into fire, phlegm-heat disturbing the interior, and yang failing to enter yin." Traditional single-treatment methods (such as simply nourishing blood and calming the mind or simply clearing heat and purging fire) are often ineffective. This is especially true for patients with a long course of illness, accompanied by anxiety, palpitations, and excessive dreaming, who often exhibit pathological changes such as "prolonged illness entering the collaterals and blood stasis obstructing the flow." Prolonged illness inevitably leads to blood stasis, and prolonged illness enters the collaterals, resulting in poor circulation of qi and blood and obstruction of the meridians. This makes it difficult for simple qi-regulating and phlegm-resolving drugs to directly reach the affected area, and conventional Chinese medicine formulas cannot fundamentally solve the complex problems of "stubborn phlegm entering the collaterals, internal liver wind stirring, and blood stasis obstructing the flow." Summary of the Invention

[0005] The technical problem to be solved by this invention is to provide a traditional Chinese medicine composition and decoction for treating insomnia that is well-formulated, has significant efficacy and low toxicity, and is effective in treating symptoms such as insomnia, excessive dreaming, palpitations, anxiety, depression, and chest tightness. The specific technical solution is as follows:

[0006] A traditional Chinese medicine composition for treating insomnia, characterized in that it is prepared from the following raw medicinal materials in parts by weight: Bupleurum chinense 10-20 parts, Scutellaria baicalensis 5-10 parts, Codonopsis pilosula 15-20 parts, Pinellia ternata 9-15 parts, Poria cocos 20-30 parts, Cinnamomum cassia 15-30 parts, Calcined hematite 10-20 parts, Raw dragon bone 20-30 parts, Raw oyster shell 25-45 parts, Acanthopanax senticosus 15-25 parts, Poria cocos sclerotium 15-25 parts, Fried jujube seed 5-10 parts, Prepared licorice root 10-20 parts, Bombyx mori 5-15 parts, Cicadae periostracum 6-10 parts, Buthus martensii 1-2 parts, Chicken gizzard lining 10-15 parts, Citrus medica 10-15 parts, Prunus mume 15-30 parts, Paeonia lactiflora 20-30 parts, Schisandra chinensis 5-15 parts.

[0007] The whole scorpion is provided in powder form; calcined hematite, raw dragon bone, and raw oyster shell are decocted with water first, and then mixed with the remaining raw medicinal materials, soaked in water and decocted 2-3 times. The decoctions are combined and mixed to obtain the Chinese medicine decoction; the Chinese medicine composition is composed of the Chinese medicine decoction and the whole scorpion powder.

[0008] As a further improvement to the above-mentioned traditional Chinese medicine composition for treating insomnia, it is prepared from the following raw medicinal materials in parts by weight: 10 parts of Bupleurum chinense, 5 parts of Scutellaria baicalensis, 15 parts of Codonopsis pilosula, 12 parts of Pinellia ternata, 20 parts of Poria cocos, 15 parts of Cinnamomum cassia, 10 parts of calcined hematite, 30 parts of raw dragon bone, 30 parts of raw oyster shell, 15 parts of Acanthopanax senticosus, 15 parts of Poria cocos sclerotium, 10 parts of stir-fried Ziziphus jujuba var. spinosa, 15 parts of prepared Glycyrrhiza uralensis, 5 parts of Bombyx mori, 6 parts of Cicadae periostracum, 2 parts of Buthus martensii, 12 parts of chicken gizzard lining, 12 parts of Citrus medica, 20 parts of Prunus mume, 25 parts of Paeonia lactiflora, and 10 parts of Schisandra chinensis.

[0009] As a further improvement to the above-mentioned traditional Chinese medicine composition for treating insomnia, it is prepared from the following raw medicinal materials in parts by weight: 20 parts of Bupleurum chinense, 10 parts of Scutellaria baicalensis, 20 parts of Codonopsis pilosula, 15 parts of Pinellia ternata, 20 parts of Poria cocos, 15 parts of Cinnamomum cassia, 20 parts of calcined hematite, 20 parts of raw dragon bone, 30 parts of raw oyster shell, 20 parts of Acanthopanax senticosus, 20 parts of Poria cocos sclerotium, 10 parts of stir-fried Ziziphus jujuba var. spinosa, 15 parts of prepared Glycyrrhiza uralensis, 12 parts of Bombyx mori, 9 parts of Cicadae periostracum, 2 parts of Buthus martensii, 15 parts of chicken gizzard lining, 10 parts of Citrus medica, 15 parts of Prunus mume, 20 parts of Paeonia lactiflora, and 6 parts of Schisandra chinensis.

[0010] As a further improvement to the above-mentioned traditional Chinese medicine composition for treating insomnia, it also includes at least one of the following by weight: 10-20 parts of prepared Polygala tenuifolia, 15-25 parts of Albizia julibrissin, and 10-20 parts of Curcuma longa.

[0011] As a further improvement to the above-mentioned traditional Chinese medicine composition for treating insomnia, it is prepared from the following raw medicinal materials in parts by weight: 15 parts of Bupleurum chinense, 10 parts of Scutellaria baicalensis, 20 parts of Codonopsis pilosula, 15 parts of Pinellia ternata, 20 parts of Poria cocos, 15 parts of Cinnamomum cassia, 15 parts of calcined hematite, 30 parts of raw dragon bone, 30 parts of raw oyster shell, 20 parts of Acanthopanax senticosus, 20 parts of Poria cocos, 10 parts of stir-fried Ziziphus jujuba var. spinosa, 15 parts of prepared Glycyrrhiza uralensis, 10 parts of Bombyx mori, 6 parts of Cicadae periostracum, 1.5 parts of Buthus martensii, 10 parts of chicken gizzard lining, 15 parts of Citrus medica, 25 parts of Prunus mume, 30 parts of Paeonia lactiflora, 10 parts of Schisandra chinensis, 15 parts of Albizia julibrissin, and 10 parts of Curcuma longa.

[0012] As a further improvement to the above-mentioned traditional Chinese medicine composition for treating insomnia, it is prepared from the following raw medicinal materials in parts by weight: 15 parts of Bupleurum chinense, 10 parts of Scutellaria baicalensis, 15 parts of Codonopsis pilosula, 15 parts of Pinellia ternata, 30 parts of Poria cocos, 30 parts of Cinnamomum cassia, 15 parts of calcined hematite, 30 parts of raw dragon bone, 45 parts of raw oyster shell, 25 parts of Acanthopanax senticosus, 25 parts of Poria cocos, 10 parts of stir-fried Ziziphus jujuba var. spinosa, 20 parts of prepared Glycyrrhiza uralensis, 15 parts of Bombyx mori, 10 parts of Cicadae periostracum, 2 parts of Buthus martensii, 15 parts of chicken gizzard lining, 10 parts of Citrus medica, 30 parts of Prunus mume, 30 parts of Paeonia lactiflora, 15 parts of Schisandra chinensis, 25 parts of Albizia julibrissin, and 20 parts of prepared Polygala tenuifolia.

[0013] As a further improvement to the above-mentioned traditional Chinese medicine composition for treating insomnia, it is prepared from the following raw medicinal materials in parts by weight: 15 parts of Bupleurum chinense, 10 parts of Scutellaria baicalensis, 15 parts of Codonopsis pilosula, 9 parts of Pinellia ternata, 20 parts of Poria cocos, 15 parts of Cinnamomum cassia, 15 parts of calcined hematite, 30 parts of raw dragon bone, 25 parts of raw oyster shell, 20 parts of Acanthopanax senticosus, 20 parts of Poria cocos sclerotium, 5 parts of stir-fried Ziziphus jujuba var. spinosa, 10 parts of prepared Glycyrrhiza uralensis, 8 parts of Bombyx mori, 6 parts of Cicadae periostracum, 1 part of Buthus martensii, 10 parts of chicken gizzard lining, 12 parts of Citrus medica, 15 parts of Prunus mume, 20 parts of Paeonia lactiflora, 5 parts of Schisandra chinensis, and 10 parts of prepared Polygala tenuifolia.

[0014] A traditional Chinese medicine decoction for treating insomnia is prepared by weighing and mixing the raw medicinal materials (excluding scorpion) according to the formula, adding water to cover and decocting 2-3 times, and then combining the decoctions.

[0015] The properties, meridian tropism, efficacy, and indications of each herb in the above-mentioned traditional Chinese medicine composition for treating insomnia are briefly described below:

[0016] Bupleurum: [Properties and Channels Entered] Bitter, pungent, slightly cold. Enters the Liver, Gallbladder, and Lung channels. [Functions and Indications] Disperses and reduces fever, soothes the liver and relieves depression, raises Yang and lifts prolapse. Mainly used for colds with fever, alternating chills and fever, chest and rib pain, irregular menstruation, uterine prolapse, and rectal prolapse. The Bupleurum used in this invention is the Bupleurum listed in the Pharmacopoeia of the People's Republic of China (2020 edition), including the dried root of Bupleurum chinense DC. (commonly known as Northern Bupleurum) or Bupleurum scorzonerifolium Willd. (commonly known as Southern Bupleurum), with Northern Bupleurum being preferred.

[0017] Scutellaria baicalensis: [Properties and Channels Entered] Bitter, cold. Enters the Lung, Gallbladder, Spleen, Large Intestine, and Small Intestine channels. [Functions and Indications] Clears heat and dries dampness, drains fire and detoxifies, cools blood, and calms the fetus. Mainly used for chest tightness and nausea caused by damp-heat or summer-dampness, damp-heat fullness in the epigastrium, cough due to lung heat, hematemesis due to blood heat, and threatened abortion.

[0018] Codonopsis pilosula: [Properties and Channels Entered] Sweet, neutral. Enters the spleen and lung channels. [Functions and Indications] Strengthens the spleen and lungs, nourishes blood and generates fluids. Indications include poor appetite, fatigue, cough, and wheezing due to spleen and lung qi deficiency; sallow complexion, palpitations, and shortness of breath due to qi and blood deficiency; thirst due to fluid depletion and internal heat.

[0019] Pinellia ternata (processed): [Properties and Channels Entered] Pungent, warm; toxic. Enters the spleen, stomach, and lung channels. [Functions and Indications] Dries dampness and resolves phlegm, relieves nausea and vomiting, dissipates phlegm and nodules. Indications include cough and asthma with excessive phlegm due to phlegm-dampness stagnation; dizziness and palpitations due to phlegm retention; vertigo due to wind-phlegm; headache due to phlegm syncope; vomiting and nausea; chest and epigastric fullness; globus hystericus.

[0020] Poria cocos: [Properties and Channels Entered] Sweet, bland, neutral. Enters the Heart, Lung, Spleen, and Kidney channels. [Functions and Indications] Promotes diuresis and eliminates dampness, strengthens the spleen, and calms the mind. Indications include edema with scanty urine, phlegm retention with dizziness and palpitations; spleen deficiency with poor appetite, loose stools and diarrhea; restlessness, palpitations, and insomnia.

[0021] Cinnamon Twig: [Properties and Channels Entered] Pungent, sweet, warm. Enters the Heart, Lung, and Bladder channels. [Functions and Indications] Induces sweating and relieves muscle tension, warms and unblocks the channels, assists Yang and transforms Qi, calms and descends Qi. Used to treat common cold due to wind-cold, abdominal pain due to cold, amenorrhea due to blood stasis, joint pain, phlegm retention, edema, palpitations, and sudden abdominal pain.

[0022] Calcined hematite: [Properties and Channels Entered] Bitter, cold. Enters the Liver and Heart channels. [Functions and Indications] Calms the liver and subdues yang, suppresses adverse qi, cools the blood and stops bleeding. Used for headache, dizziness, epilepsy, mania; belching, vomiting, wheezing; hematemesis, epistaxis, metrorrhagia.

[0023] Raw dragon bone: [Properties and Channels Entered] Sweet, astringent, neutral. Enters the Heart, Liver, and Kidney channels. [Functions and Indications] Calms the mind and spirit, soothes the liver and subdues yang, astringes and consolidates. Used to treat epilepsy, mania, palpitations, forgetfulness, insomnia, dreaminess, spontaneous sweating, night sweats, seminal emission, urinary tract infections, metrorrhagia, and leukorrhea.

[0024] Raw oyster: [Properties and Channels Entered] Salty, slightly cold. Enters the Liver and Kidney channels. [Functions and Indications] Calms the mind and spirit, nourishes Yin and subdues Yang, softens hardness and dissipates nodules. Used to treat palpitations, insomnia, dizziness, tinnitus, scrofula, phlegm nodules, abdominal masses, irritability, and anger.

[0025] Acanthopanax senticosus: [Properties and Channels Entered] Pungent, slightly bitter, warm. Enters the spleen, kidney, and heart channels. [Functions and Indications] Tonifies qi and strengthens the spleen, nourishes the kidneys and calms the mind. Indications include spleen and lung qi deficiency, general weakness and fatigue, loss of appetite, lung and kidney deficiency, chronic cough and wheezing, kidney deficiency with lower back and knee pain, heart and spleen insufficiency, insomnia and excessive dreaming.

[0026] Poria cocos: [Properties and Channels Entered] Sweet, bland, neutral. Enters the Heart and Spleen channels. [Functions and Indications] Calms the mind, soothes the nerves, and promotes urination. Used to treat palpitations due to heart deficiency, forgetfulness, insomnia, epilepsy, and difficulty urinating.

[0027] Stir-fried jujube seeds:

Properties and Channels Entered

Functions and Indications

[0028] Prepared licorice root: [Properties and Channels Entered] Sweet, neutral. Enters the Heart, Lung, Spleen, and Stomach channels. [Functions and Indications] Tonifies the Spleen and Stomach, replenishes Qi and restores pulse. Indications: Weakness of the Spleen and Stomach, fatigue, palpitations, and irregular pulse.

[0029] Silkworm (Bombyx mori): [Properties and Channels Entered] Salty, pungent, neutral. Enters the Liver, Lung, and Stomach channels. [Functions and Indications] Relieves wind and stops spasms, dispels wind and relieves pain, resolves phlegm and dissipates nodules. Used to treat infantile convulsions, epilepsy, stroke with facial paralysis, wind-heat headache, sore throat, scrofula, and phlegm nodules.

[0030] Cicada molting: [Properties and Channels Entered] Sweet, cold. Enters the Lung and Liver channels. [Functions and Indications] Disperses wind-heat, soothes the throat and improves voice, promotes rash eruption and relieves itching, improves vision and clears away corneal opacity, calms wind and relieves spasms. Used to treat wind-heat common cold, sore throat and hoarseness, incomplete measles eruption, itchy rashes, red eyes with corneal opacity, infantile convulsions, and tetanus.

[0031] Whole scorpion: [Properties and Channels Entered] Pungent, neutral; toxic. Enters the Liver channel. [Functions and Indications] Calms wind and relieves convulsions, unblocks channels and relieves pain, attacks toxins and dissipates nodules. Used to treat infantile convulsions, spasms, stroke with facial paralysis, hemiplegia, tetanus, stubborn rheumatism, migraine, sores, and scrofula.

[0032] Chicken gizzard lining: [Properties and Channels Entered] Sweet, neutral. Enters the spleen, stomach, small intestine, and bladder channels. [Functions and Indications] Strengthens the stomach and promotes digestion, astringes essence and stops seminal emission, clears urinary tract stones and dissolves stones. Used to treat indigestion, vomiting and diarrhea, infantile malnutrition, enuresis, seminal emission, painful urination with stones, and gallbladder distension and hypochondriac pain.

[0033] Buddha's Hand: [Properties and Channels Entered] Pungent, bitter, sour, warm. Enters the Liver, Spleen, Stomach, and Lung channels. [Functions and Indications] Soothes the Liver and regulates Qi, harmonizes the Stomach and relieves pain, dries dampness and resolves phlegm. Indications include Liver and Stomach Qi stagnation, chest and rib distension and pain, epigastric fullness, poor appetite and vomiting, and cough with excessive phlegm.

[0034] Ume (dried plum): [Properties and Channels Entered] Sour, astringent, neutral. Enters the Liver, Spleen, Lung, and Large Intestine channels. [Functions and Indications] Astringes the lungs, astringes the intestines, promotes the production of body fluids, and expels roundworms. Used to treat chronic cough due to lung deficiency, chronic diarrhea and dysentery, thirst due to deficiency heat, and vomiting and abdominal pain due to roundworm infestation.

[0035] White peony root: [Properties and Channels Entered] Bitter, sour, slightly cold. Enters the Liver and Spleen channels. [Functions and Indications] Nourishes blood and regulates menstruation, astringes Yin and stops sweating, softens the liver and relieves pain, and calms liver Yang. Used for blood deficiency and chlorosis, irregular menstruation, spontaneous sweating, night sweats, hypochondriac pain, abdominal pain, limb spasms, headache, and dizziness.

[0036] Schisandra chinensis: [Properties and Channels Entered] Sour, sweet, warm. Enters the Lung, Heart, and Kidney channels. [Functions and Indications] Astringent and consolidating, replenishing Qi and generating fluids, tonifying the kidneys and calming the mind. Indications include chronic cough and wheezing, nocturnal emission, frequent urination, chronic diarrhea, spontaneous sweating and night sweats, thirst due to fluid depletion, shortness of breath and weak pulse, internal heat and thirst, palpitations and insomnia.

[0037] Prepared Polygala tenuifolia: [Properties and Channels Entered] Bitter, pungent, warm. Enters the Heart, Kidney, and Lung channels. [Functions and Indications] Calms the mind and improves intelligence, harmonizes the Heart and Kidneys, eliminates phlegm, and reduces swelling. Primarily used to treat insomnia, excessive dreaming, forgetfulness, palpitations, mental confusion, and persistent cough with phlegm caused by disharmony between the Heart and Kidneys.

[0038] Albizia flower: [Properties and Channels Entered] Sweet, neutral. Enters the Heart and Liver channels. [Functions and Indications] Relieves depression and calms the mind, soothes the liver and regulates Qi. Primarily used to treat restlessness, depression, and insomnia.

[0039] Turmeric: [Properties and Channels Entered] Pungent, bitter, cold. Enters the Liver, Heart, and Lung channels. [Functions and Indications] Activates blood circulation and relieves pain, regulates qi and relieves depression, clears heat from the heart and cools the blood, promotes bile secretion and reduces jaundice. Indications include stabbing pain in the chest and hypochondrium, chest pain, amenorrhea, dysmenorrhea, breast distension and pain, delirium due to fever, epilepsy, hematemesis due to blood heat, and jaundice with dark urine.

[0040] The traditional Chinese medicine composition for treating insomnia described in this invention is an optimized formula based on the classic prescription "Chaihu Jia Longgu Muli Tang" (Bupleurum and Dragon Bone and Oyster Shell Decoction), deeply integrating the theories of "sour and sweet nourishing yin" and "insect-based medicine for unblocking collaterals," as well as long-term clinical experience. Its core therapeutic mechanism lies in: soothing the liver and calming yang, sedating the mind and soothing the nerves, harmonizing the heart and kidneys, and simultaneously addressing the spleen and stomach.

[0041] Bupleurum: It has the effects of soothing the liver and relieving depression, and clearing away stagnant yang. As the core drug of the whole formula, it is mainly used to treat liver qi stagnation, which is the key to solving the root cause of insomnia (qi stagnation and yin-yang imbalance). Raw dragon bone and raw oyster shell: When used raw, they have the function of sedating and suppressing rebellious qi, and can significantly calm the floating yang, targeting the core symptoms of insomnia such as "yang floating upward and the soul not resting". Fried jujube seed: It has the effects of nourishing the heart and liver, calming the mind and soothing the nerves. It is known as the "Oriental sleeping fruit" and is a special medicine for treating insomnia in traditional Chinese medicine. It can directly target the symptoms of "restlessness and insomnia". The above-mentioned drugs are the principal drugs. Bupleurum focuses on addressing the root cause of the disease (stagnation of Qi and imbalance of Yin and Yang), while raw dragon bone and raw oyster shell focus on relieving symptoms (sedation and tranquility). Ziziphus jujuba seed focuses on nourishing the mind and spirit (nourishing the spirit and calming the mind). The three work together to form a key defense in the treatment of insomnia, exerting the main therapeutic efficacy against the main symptoms (intractable insomnia) and the main syndromes (liver stagnation and yang hyperactivity, restlessness of the mind).

[0042] Scutellaria baicalensis: Its properties are bitter and cold, possessing the effects of clearing heat and purging fire, relieving irritability. When combined with Bupleurum chinense, it can exert the effect of "harmonizing the lesser yang," clearing away symptoms of internal heat and irritability caused by liver stagnation transforming into fire. Pinellia ternata, Poria cocos, and Poria cocos sclerotium: These have the effects of strengthening the spleen, removing dampness, resolving phlegm, and calming the mind. Pinellia ternata is good at resolving phlegm, targeting the pathogenesis of "restless sleep due to stomach disharmony" and "phlegm obstructing the qi mechanism"; Poria cocos and Poria cocos sclerotium can both remove dampness and calm the mind, assisting Ziziphus jujuba var. spinosa in exerting a calming effect. Cinnamomum cassia and Paeonia lactiflora: These functions harmonize the ying and wei, and connect yin and yang; Cinnamomum cassia warms and invigorates yang qi, and when combined with raw dragon bone and raw oyster shell, it can warm and tonify heart yang, guiding yang into yin, resolving the pathogenesis of insomnia due to yang not entering yin; Paeonia lactiflora nourishes blood and softens the liver, and when combined with Bupleurum chinense, it soothes the liver without harming yin, and when combined with Cinnamomum cassia, it can harmonize the ying and wei. Scorpion, silkworm, and cicada molting: These have the effects of dispelling wind and unblocking the meridians, calming the nerves and stopping spasms. They can target the pathogenesis of "prolonged illness entering the meridians" in intractable insomnia, assisting the principal drug in overcoming stubborn diseases and calming liver wind. Acanthopanax senticosus: This can invigorate qi and strengthen the spleen, tonify the kidneys and calm the mind, assisting the principal drug in replenishing deficiency and enhancing the body's ability to resist fatigue and regulate the nervous system. The above-mentioned drugs are assistant drugs, which can assist the principal drug in enhancing the therapeutic effect, or be used to treat concurrent symptoms (such as phlegm-heat, blood deficiency, and blood stasis).

[0043] Ume plum and Schisandra chinensis: Both have the effect of nourishing Yin with their sour and sweet properties, and can astringe Yin and generate fluids. Together with white peony root and prepared licorice root (a combination of sour and sweet Yin-nourishing herbs), they nourish liver Yin to prevent the warm and drying properties of Bupleurum chinense and cinnamon twig from damaging Yin fluids, and restrain the floating Yang Qi. They also assist raw dragon bone and raw oyster shell in exerting their function of suppressing Yang. Calcined hematite: It has the ability to suppress adverse Qi, cool the blood and stop bleeding. It assists raw dragon bone and raw oyster shell in exerting a calming effect, and is specifically for symptoms of Qi rising and not descending (such as hiccups, acid reflux, and difficulty falling asleep). Chicken gizzard lining and Buddha's hand: They can strengthen the stomach and promote digestion, regulate Qi and relieve chest tightness. Given that this formula uses a large number of mineral drugs (raw dragon bone, raw oyster shell, calcined hematite) and nourishing drugs, which can easily hinder the spleen and stomach's digestive function, chicken gizzard lining and Buddha's hand aim to protect the spleen and stomach's digestive function, ensure the absorption of the medicine, and prevent indigestion. They are a very important set of adjuvant drugs. Prepared Polygala tenuifolia, Albizia julibrissin flower, and Curcuma longa: Polygala tenuifolia harmonizes the heart and kidneys; Albizia julibrissin flower relieves depression and calms the mind; Curcuma longa promotes qi circulation and cools the blood. Adding these herbs to the formula enhances their effects of relieving depression and calming the mind. Of these three herbs, prepared Polygala tenuifolia focuses on harmonizing the heart and kidneys, calming the mind, and improving intelligence; Albizia julibrissin flower focuses on relieving depression, calming the mind, and regulating liver qi; and Curcuma longa focuses on promoting qi circulation, relieving depression, clearing the heart, and cooling the blood. Each herb has its own emphasis and complements the others. Clinicians can choose one, two, or all three herbs in combination based on the patient's specific symptoms: for those with predominantly heart-kidney disharmony, prepared Polygala tenuifolia can be selected; for those with predominantly liver qi stagnation and emotional depression, Albizia julibrissin flower and / or Curcuma longa can be selected; for those with concurrent symptoms, multiple herbs can be used in combination without affecting the overall compatibility and therapeutic effect of the basic formula. These herbs are adjuvants, used in conjunction with the principal and assistant herbs to treat concurrent symptoms, inhibit the toxicity / potency of the principal and assistant herbs, or exert a counteracting effect.

[0044] Prepared licorice root: It harmonizes the effects of other herbs, invigorates qi, and strengthens the middle jiao (spleen and stomach), thus mitigating the harshness of insect-derived herbs such as scorpion. Combined with white peony root, dried plum, and schisandra fruit, it forms a "sour and sweet yin-nourishing" structure to nourish yin fluids. Codonopsis root: It strengthens the spleen and lungs, nourishes blood, and generates fluids. Although Codonopsis root also has tonifying effects, in this formula it primarily protects the qi of the spleen and stomach, acts as a guide herb, assists in the dispersion of other herbs, and prevents heavy, sedative herbs from damaging the body's vital energy. The above herbs are guiding herbs, used to direct the flow of qi through the meridians or harmonize the effects of other herbs.

[0045] Compared with the prior art, the present invention has the following beneficial effects: (1) The present invention uses a combination of Chinese medicines that combine cold and hot properties, and attack and tonify. The formula contains both sedative and calming herbs and blood-nourishing and liver-soothing herbs, while also addressing phlegm and unblocking the meridians. It is especially suitable for patients with intractable insomnia whose condition is complex and whose symptoms are a mixture of deficiency and excess. (2) The innovative addition of three insect-based medicines, namely scorpion, silkworm, and cicada molting, targets the key pathogenesis of "prolonged illness entering the meridians" and "phlegm and blood stasis" in patients with intractable insomnia with a long course of disease, and can play a unique therapeutic role. In particular, the method of taking powdered scorpion with water maximizes the preservation of the bioactive components of scorpion (such as scorpion venom polypeptides), and enhances the sedative and anticonvulsant effects. (3) Clinical application in hospitals has verified that the formula has significant efficacy in improving sleep quality, prolonging sleep time, and reducing the number of nighttime awakenings, and the condition is not prone to recurrence after discontinuation of the medication.

[0046] The present invention will be further described below through specific embodiments. Additional aspects and advantages of the invention will be set forth in part in the description which follows, and in part will be obvious from the description, or may be learned by practice of the invention. Detailed Implementation

[0047] The present invention will now be clearly and completely described. Those skilled in the art will be able to implement the present invention based on this description. Before describing the present invention, it should be particularly noted that:

[0048] The technical solutions and features provided in the various parts of this invention, including the following description, can be combined with each other without conflict.

[0049] Furthermore, the embodiments of the present invention described below are generally only some, not all, of the embodiments of the present invention. Therefore, all other embodiments obtained by those skilled in the art based on the embodiments of the present invention without inventive effort should fall within the scope of protection of the present invention.

[0050] Regarding the terminology and units used in this invention: The terms "comprising," "having," and any variations thereof in the specification, claims, and related parts of this invention are intended to cover non-exclusive inclusion.

[0051] Example 1

[0052] The traditional Chinese medicine composition for treating insomnia in this embodiment is prepared from the following raw medicinal materials in parts by weight: Bupleurum chinense 10g, Scutellaria baicalensis 5g, Codonopsis pilosula 15g, Pinellia ternata 12g, Poria cocos 20g, Cinnamomum cassia 15g, Calcined hematite 10g, Raw dragon bone 30g, Raw oyster shell 30g, Acanthopanax senticosus 15g, Poria cocos sclerotium 15g, Fried jujube seed 10g, Prepared licorice root 15g, Bombyx mori 5g, Cicadae periostracum 6g, Scorpion 2g, Chicken gizzard lining 12g, Citrus medica 12g, Prunus mume 20g, Paeonia lactiflora 25g, Schisandra chinensis 10g.

[0053] The preparation method of the traditional Chinese medicine decoction in this embodiment is as follows:

[0054] The whole scorpion is ground into an extremely fine powder and then prepared in portions for use.

[0055] Soak raw dragon bone, raw oyster shell, and calcined hematite in water for 40 minutes, bring to a boil over high heat, then simmer over low heat for 20 minutes. Add the remaining 17 herbs and decoct twice.

[0056] First decoction: Add water to cover the herbs by 4cm, bring to a boil over high heat, then simmer over low heat for 25 minutes, and filter out the liquid.

[0057] Second decoction: Add water to cover the herbs by 3cm, bring to a boil over high heat, then simmer over low heat for 20 minutes, and filter out the liquid.

[0058] Combining the two medicinal solutions, approximately 400 mL, yields the traditional Chinese medicine decoction.

[0059] Dosage: One dose daily, taken warm in the morning and evening as part of the decocted Chinese medicine. The scorpion powder should also be taken twice daily, dissolved in the decoction.

[0060] Indications: Suitable for patients with insomnia caused by liver qi stagnation, restlessness, and failure of yang to enter yin.

[0061] Example 2

[0062] The traditional Chinese medicine composition for treating insomnia in this embodiment is prepared from the following raw medicinal materials in parts by weight: 20g of Bupleurum chinense, 10g of Scutellaria baicalensis, 20g of Codonopsis pilosula, 15g of Pinellia ternata, 20g of Poria cocos, 15g of Cinnamomum cassia, 20g of calcined hematite, 20g of raw dragon bone, 30g of raw oyster shell, 20g of Acanthopanax senticosus, 20g of Poria cocos sclerotium, 10g of stir-fried Ziziphus jujuba var. spinosa, 15g of prepared Glycyrrhiza uralensis, 12g of Bombyx mori, 9g of Cicadae periostracum, 2g of Buthus martensii, 15g of chicken gizzard lining, 10g of Citrus medica, 15g of Prunus mume, 20g of Paeonia lactiflora, and 6g of Schisandra chinensis.

[0063] Preparation and administration: Same as in Example 1.

[0064] Indications: Suitable for patients with severe liver qi stagnation, accompanied by dizziness, heaviness of the body, nausea, vomiting, and phlegm.

[0065] Example 3

[0066] The traditional Chinese medicine composition for treating insomnia in this embodiment is prepared from the following raw medicinal materials in parts by weight: Based on Example 1, the dosage of each drug is adjusted, and Albizia julibrissin and Curcuma longa are added, namely: Bupleurum chinense 15g, Scutellaria baicalensis 10g, Codonopsis pilosula 20g, Pinellia ternata 15g, Poria cocos 20g, Cinnamomum cassia 15g, Calcined hematite 15g, Raw dragon bone 30g, Raw oyster shell 30g, Acanthopanax senticosus 20g, Poria cocos 20g, Fried Ziziphus jujuba var. spinosa 10g, Prepared licorice root 15g, Bombyx mori 10g, Cicadae periostracum 6g, Scorpion 1.5g, Chicken gizzard lining 10g, Citrus medica 15g, Prunus mume 25g, Paeonia lactiflora 30g, Schisandra chinensis 10g, Albizia julibrissin 15g, Curcuma longa 10g.

[0067] Preparation and administration: Add mimosa flowers, turmeric and the "other 17 medicinal materials" in Example 1 together for decoction. The rest of the preparation and administration methods are the same as in Example 1.

[0068] Indications: Suitable for patients with depressive insomnia who experience significant symptoms such as low mood, chest tightness, and sighing.

[0069] Example 4

[0070] The traditional Chinese medicine composition for treating insomnia in this embodiment is prepared from the following raw medicinal materials in parts by weight: Based on Example 1, the dosage of each drug is adjusted, and Albizia julibrissin flower and processed Polygala tenuifolia are added, namely: Bupleurum chinense 15g, Scutellaria baicalensis 10g, Codonopsis pilosula 15g, Pinellia ternata 15g, Poria cocos 30g, Cinnamomum cassia 30g, calcined hematite 15g, raw dragon bone 30g, raw oyster shell 45g, Acanthopanax senticosus 25g, Poria cocos 25g, stir-fried Ziziphus jujuba var. spinosa 10g, processed Glycyrrhiza uralensis 20g, Bombyx mori 15g, Cicadae periostracum 10g, Buthus martensii 2g, Gallus gallus domesticus gizzard lining 15g, Citrus medica 10g, Prunus mume 30g, Paeonia lactiflora 30g, Schisandra chinensis 15g, Albizia julibrissin flower 25g, processed Polygala tenuifolia 20g.

[0071] Preparation and administration: Add Albizia julibrissin flowers, processed Polygala tenuifolia, and the remaining 17 medicinal materials from Example 1 together for decoction. The rest of the preparation and administration methods are the same as in Example 1.

[0072] Indications: Suitable for patients with severe heart-kidney disharmony, palpitations, and forgetfulness.

[0073] Example 5

[0074] The traditional Chinese medicine composition for treating insomnia in this embodiment is prepared from the following raw medicinal materials in parts by weight: Based on Example 1, the dosage of each drug is adjusted and processed Polygala tenuifolia is added, namely: Bupleurum chinense 15g, Scutellaria baicalensis 10g, Codonopsis pilosula 15g, Pinellia ternata 9g, Poria cocos 20g, Cinnamomum cassia 15g, calcined hematite 15g, raw dragon bone 30g, raw oyster shell 25g, Acanthopanax senticosus 20g, Poria cocos 20g, stir-fried Ziziphus jujuba var. spinosa 5g, processed Glycyrrhiza uralensis 10g, Bombyx mori 8g, Cicadae periostracum 6g, Buthus martensii 1g, chicken gizzard lining 10g, Citrus medica 12g, Prunus mume 15g, Paeonia lactiflora 20g, Schisandra chinensis 5g, processed Polygala tenuifolia 10g.

[0075] Preparation and administration: Add the prepared Polygala tenuifolia and the "other 17 medicinal materials" in Example 1 together for decoction. The rest of the preparation and administration methods are the same as in Example 1.

[0076] Indications: Suitable for patients with phlegm obstructing the heart orifices, mental confusion, and restless sleep.

[0077] The following are clinical efficacy data.

[0078] 1. Objects and Grouping

[0079] A total of 324 patients who met the diagnostic criteria for chronic insomnia and were treated with the above-mentioned traditional Chinese medicine composition in the applicant's wards and outpatient clinics from June 2021 to June 2024 were selected. All patients were fully informed of the treatment plan, medication contents, and possible adverse reactions before treatment and voluntarily accepted the treatment.

[0080] Inclusion criteria: (1) Meets the diagnostic criteria for insomnia in the Chinese Classification and Diagnostic Criteria for Mental Disorders (CCMD-3) and the diagnostic criteria for "insomnia" in Traditional Chinese Medicine Internal Medicine; (2) Duration of illness ≥ 3 months; (3) Age 18-80 years; (4) Total score of Pittsburgh Sleep Quality Index (PSQI) > 7; (5) Has not taken other sedative-hypnotic drugs within 2 weeks before treatment, or has completed the standard washout period.

[0081] Exclusion criteria: (1) Secondary insomnia caused by severe organic diseases (such as severe cardiovascular and cerebrovascular diseases, malignant tumors, severe liver and kidney dysfunction, etc.); (2) Those with severe mental illnesses such as schizophrenia and bipolar disorder; (3) Pregnant or lactating women; (4) Those with a known history of allergy to the drug components in this formula; (5) Those who are participating in other clinical trials.

[0082] Based on the order of patients' visits and their TCM syndrome differentiation results, combined with the specific characteristics of each patient's condition, 324 patients were divided into 6 groups. Patient information for each treatment group is as follows:

[0083] Treatment group 1: 76 cases, 31 males and 45 females, with a mean age of (65.2±8.3) years and a mean course of disease of (2.1±0.9) years.

[0084] Treatment group 2: 47 cases, 16 males and 31 females, with a mean age of (61.8±9.1) years and a mean course of disease of (1.8±0.7) years.

[0085] Treatment group 3: 43 cases, 15 males and 28 females, with a mean age of (54.5±7.6) years and a mean course of disease of (1.5±0.8) years.

[0086] Treatment group 4: 55 cases, 20 males and 35 females, with a mean age of (71.1±6.8) years and a mean course of disease of (2.8±1.2) years.

[0087] The treatment group consisted of 35 patients, including 16 males and 19 females, with a mean age of (67.3±7.5) years and a mean duration of illness of (2.3±1.0) years.

[0088] Treatment group 6: 68 cases, 27 males and 41 females, with a mean age of (66.1±8.0) years and a mean course of disease of (2.0±0.9) years.

[0089] Data analysis was performed using SPSS 26.0 statistical software. Quantitative data were expressed as mean ± standard deviation, and one-way ANOVA was used for comparisons between groups. Categorical data were expressed as number of cases and percentages, and chi-square (χ²) was used for comparisons between groups. 2 The gender composition (x̄ ± s) was tested; a p-value < 0.05 was considered statistically significant. Statistical analysis showed that the gender composition of each group of patients was relatively consistent (x̄ ± s). 2 There were no statistically significant differences (P>0.05) in terms of mean age (F=1.524, P=0.182), mean disease duration (F=1.107, P=0.356), and pre-treatment PSQI score (F=0.896, P=0.484), indicating that the differences were comparable.

[0090] 2. Treatment methods

[0091] Treatment groups 1-5 took the traditional Chinese medicine decoction prepared in Examples 1-5 respectively.

[0092] The Bupleurum and Dragon Bone Oyster Shell Decoction used in treatment group 6 is a contemporary clinically commonly used version of a classic formula from the *Shanghan Lun* (Treatise on Cold Damage). Its core drug components (Bupleurum, raw dragon bone, raw oyster shell, cinnamon twig, scutellaria, pinellia, poria, etc.) are consistent with the original formula, and the dosage is based on contemporary clinical practice, essentially equivalent to the corresponding drug dosages in treatment groups 1-5, to ensure the scientific rigor and fairness of the comparison results. The specific formula is: Bupleurum 15g, raw dragon bone 30g, raw oyster shell 30g, ginger 9g, codonopsis 15g, cinnamon twig 15g, poria 15g, scutellaria 10g, pinellia 9g, and jujube 10g (split). Decoct in water and take one dose daily, divided into two warm doses, morning and evening.

[0093] Treatment course: All groups were followed up after 4 weeks of continuous treatment.

[0094] 3. Criteria for Evaluating Therapeutic Effect

[0095] Recovery: Sleep duration returns to normal (>6 hours), wakes up feeling energetic, and accompanying symptoms disappear.

[0096] Significant effects: Sleep is significantly improved, with sleep time increasing by more than 3 hours and sleep depth increasing.

[0097] Effective: Sleep time increases by 1-3 hours, and symptoms are relieved.

[0098] Ineffective: Insomnia does not improve or worsens.

[0099] Cure rate = (Number of cured cases / Total number of cases) × 100%.

[0100] Overall effective rate = (cured + significantly effective + effective) / total number of cases × 100%.

[0101] 4. Comparison of treatment results

[0102] Table 1: Comparison data of clinical efficacy among different groups

[0103]

[0104] As shown in Table 1, the cure rate of treatment groups 1-5 was above 18%, and the total effective rate was above 83%, significantly higher than the 8.82% cure rate and 69.12% total effective rate of treatment group 6 (the chi-square test showed that the total effective rates of treatment groups 1-5 were statistically significant compared with those of treatment group 6, P < 0.05). This demonstrates that the herbal composition of this invention has significantly better clinical efficacy than the classic control formula in treating insomnia. The cure rate of treatment groups 1-5 (18.42-22.86%) was more than twice that of treatment group 6 (8.82%), indicating that the herbal composition of this invention not only improves insomnia symptoms overall but also fundamentally restores the patient's normal sleep function, reflecting a qualitative breakthrough in efficacy rather than merely a gradual improvement in quantity. In addition, treatment groups 3-5 added Albizia julibrissin, Curcuma longa, and Polygala tenuifolia to the basic formula, respectively. Their cure rate (20.93-22.86%) and total effective rate (86.05-88.57%) showed a further upward trend, indicating that the addition of the above-mentioned drugs that relieve depression, calm the mind, and harmonize the heart and kidneys can better target patients with concurrent symptoms such as emotional depression and heart-kidney disharmony, and enhance the overall treatment effect.

[0105] Table 2: Comparison of PSQI scores before and after treatment in each group

[0106]

[0107] As shown in Table 2, there were no statistically significant differences in PSQI scores between the groups before treatment (F=0.896, P=0.484), indicating that the baseline levels of each group were consistent and comparable. After treatment, one-way ANOVA and pairwise comparisons using the LSD method showed that the PSQI scores of treatment groups 1-5 were significantly lower than those of treatment group 6, with statistically significant differences (P<0.05). After 4 weeks of treatment, the PSQI scores of treatment groups 1-5 all decreased to below 8 points, approaching or reaching normal sleep quality levels. While the PSQI score of treatment group 6 decreased, it remained above 8 points, indicating that its overall sleep quality improvement was less than that of treatment groups 1-5. The lowest PSQI scores after treatment in treatment groups 4 and 5 further corroborated the synergistic effect of adding Albizia julibrissin and Polygala tenuifolia on improving sleep quality.

[0108] The overall effective rate of treatment groups 3-5 was slightly higher than that of treatment groups 1-2, but the differences between the treatment groups did not reach a statistically significant level (P>0.05). This suggests that the efficacy of treatment is improving after adding drugs such as Albizia julibrissin, Polygala tenuifolia, and Curcuma longa, but further verification with a larger sample size is needed.

[0109] All 324 patients underwent complete blood count, liver function tests (ALT, AST), and kidney function tests (BUN, Cr) before and after treatment. Results showed no statistically significant differences in liver and kidney function indicators between the pre- and post-treatment levels in any group (P > 0.05), and no drug-induced liver or kidney damage occurred. During treatment, 12 patients (3.70%) experienced mild gastrointestinal discomfort, which resolved spontaneously after slowing the administration rate or taking the medication warm after meals, without requiring discontinuation of the medication. No serious adverse reactions were observed. These results indicate that within the dosage range used in this invention (1-2 g / day of whole scorpion), this traditional Chinese medicine composition has good safety.

[0110] While treatment group 6 was effective, it lacked potent drugs to clear the meridians, resulting in a low cure rate for intractable insomnia. In contrast, treatment groups 1-5, using the herbal decoction of this invention, showed a significantly improved overall effective rate. This advantage did not stem from simply adjusting the dosage of individual drugs, but rather from the overall innovative formulation: First, this invention creatively introduces three insect-based drugs—scorpion, silkworm pupae, and cicada molting—using the method of "insect drugs to dispel wind and clear the meridians" to target the core pathogenesis of intractable insomnia: "prolonged illness leading to meridian obstruction and phlegm stagnation." Second, this invention constructs a "sour and sweet to nourish yin" formula with dried plum, schisandra fruit, white peony root, and prepared licorice root, simultaneously soothing the liver and calming yang while nourishing yin fluids, preventing warming and drying drugs from depleting yin and blood, thus achieving a combined approach of attacking and tonifying, treating both the root cause and the symptoms. Third, this invention also incorporates chicken gizzard lining and Buddha's hand, which regulate qi and strengthen the spleen to protect the spleen and stomach, ensuring full absorption of the entire formula's medicinal power and further guaranteeing the stability of clinical efficacy. In summary, by adding insect-based medicines such as whole scorpion and silkworm, as well as qi-regulating and spleen-strengthening medicines such as Buddha's hand and chicken gizzard, this invention can more effectively solve the problem of intractable insomnia caused by "phlegm and blood stasis obstructing the collaterals and liver and stomach disharmony".

[0111] 5. Typical Cases

[0112] (1) Typical case of Example 1: Ms. Zhang, 55 years old.

[0113] Chief complaint: Difficulty falling asleep and frequent awakenings for 2 years.

[0114] Medical History: The patient suffers from chronic insomnia due to high work stress, sleeping less than 4 hours per night. Insomnia worsens with work-related setbacks, accompanied by irritability, bitter taste in the mouth, constipation, pale red tongue with thin coating, and wiry pulse. The patient previously took Western medicine to aid sleep, which was initially effective, but the effect gradually diminished, requiring increased dosages to fall asleep.

[0115] Western medicine diagnosis: Chronic insomnia. Traditional Chinese medicine diagnosis: Insomnia (liver qi stagnation syndrome).

[0116] Treatment: The traditional Chinese medicine decoction described in Example 1 was used for treatment.

[0117] Efficacy: After one week of medication, irritability decreased and sleep onset time shortened. After four weeks of medication, sleep reached 6-7 hours per night, bowel movements were regular, and mood was stable. Medication was continued for one month before discontinuation. No recurrence was observed during a three-month follow-up.

[0118] (2) Typical case of Example 2: Mr. Li, 61 years old.

[0119] Chief complaint: Insomnia accompanied by dizziness for 1 year.

[0120] Medical history: The patient usually enjoys fatty, sweet, and alcoholic foods, suffers from insomnia and dreaminess, feels a heaviness in his head, chest tightness and nausea, feels as if something is stuck in his throat, coughs frequently, has sticky phlegm that is difficult to cough up, has a yellow and greasy tongue coating, and a wiry and slippery pulse. The syndrome is diagnosed as phlegm-heat disturbing the heart and qi stagnation.

[0121] Western medicine diagnosis: Chronic insomnia. Traditional Chinese medicine diagnosis: Insomnia (phlegm-heat disturbing the heart, qi stagnation syndrome).

[0122] Treatment: The traditional Chinese medicine decoction described in Example 2 was used for treatment.

[0123] Therapeutic effects: After taking 3 doses, dizziness and nausea lessened. After 2 weeks of medication, sleep improved significantly, and sputum production decreased. By the end of the treatment course, sleep returned to normal, and the tongue coating turned thin and white.

[0124] (3) Typical case of Example 3: Ms. Ma, 57 years old.

[0125] Chief complaint: Insomnia due to depressed mood for six months.

[0126] Medical history: Sighing all day long, chest and rib pain, insomnia or vivid dreams at night.

[0127] Western medicine diagnosis: Chronic insomnia. Traditional Chinese medicine diagnosis: Insomnia (liver qi stagnation syndrome).

[0128] Treatment: The traditional Chinese medicine decoction described in Example 3 was used for treatment.

[0129] Therapeutic effects: After one week of medication, chest and rib pain was relieved, and mood improved. After four weeks of medication, sleep was sound at night, with no further sleepless nights, and depressive mood significantly improved.

[0130] (4) Typical case of Example 4: Mr. Chen, 67 years old.

[0131] Chief complaint: Insomnia accompanied by palpitations for 3 years.

[0132] Medical history: Hot flashes and sweating, palpitations and forgetfulness, night terrors and easy awakening, unable to fall back asleep, symptoms indicate heart-kidney disharmony.

[0133] Western medicine diagnosis: Chronic insomnia. Traditional Chinese medicine diagnosis: Insomnia (disharmony between the heart and kidneys, and deficiency of heart yang).

[0134] Treatment: The traditional Chinese medicine decoction described in Example 4 was used for treatment.

[0135] Efficacy: After 2 weeks of medication, sweating decreased, palpitations disappeared, and the number of times the patient woke up at night decreased. After 4 weeks of medication, sleep quality significantly improved, and mental state was better.

[0136] (5) Typical case of Example 5: Ms. Yang, 65 years old.

[0137] Chief complaint: Confusion and restless sleep for 1 year.

[0138] Medical history: The patient has a history of cerebral infarction, and currently has difficulty speaking, restlessness at night, and is in a state of semi-sleep, with intermittent sleep of 3-4 hours at night. There is rattling in the throat, the tongue is purplish-dark, the coating is thin and yellow, and the pulse is deep and hesitant.

[0139] Western medicine diagnosis: Chronic insomnia. Traditional Chinese medicine diagnosis: Insomnia (Qi stagnation and blood stasis syndrome), headache (blood stasis obstructing the collaterals syndrome).

[0140] Treatment: The traditional Chinese medicine decoction described in Example 5 was used for treatment.

[0141] Efficacy: After 10 days of medication, rattling in the throat decreased and nighttime restlessness lessened. Continued use for 4 weeks resulted in more than 5 hours of peaceful sleep at night, and improved mental clarity. Following the doctor's instructions, continued treatment for another 2 weeks further improved sleep duration to more than 6 hours.

[0142] In summary, the traditional Chinese medicine composition provided by this invention, through scientific formulation, utilizes the wind-dispelling and meridian-clearing effects of insect-derived medicines such as scorpion and silkworm, combined with the liver-soothing and calming effects of bupleurum, raw dragon bone, and raw oyster shell, significantly improving the clinical efficacy for intractable insomnia. Compared with the traditional Bupleurum and Dragon Bone Oyster Shell Decoction, this invention not only significantly reduces toxic side effects through scientific formulation and processing, but also demonstrates significant advantages in improving sleep quality, shortening sleep onset time, and alleviating accompanying symptoms.

[0143] The foregoing has described the relevant content of the present invention. Those skilled in the art will be able to implement the present invention based on these descriptions. All other embodiments obtained by those skilled in the art based on the above description of the present invention without inventive effort should fall within the scope of protection of the present invention.

Claims

1. A traditional Chinese medicine composition for treating insomnia, characterized in that: It is prepared from the following raw medicinal materials in parts by weight: Bupleurum chinense 10-20 parts, Scutellaria baicalensis 5-10 parts, Codonopsis pilosula 15-20 parts, Pinellia ternata 9-15 parts, Poria cocos 20-30 parts, Cinnamomum cassia 15-30 parts, Calcined hematite 10-20 parts, Raw dragon bone 20-30 parts, Raw oyster shell 25-45 parts, Acanthopanax senticosus 15-25 parts, Poria cocos sclerotium 15-25 parts, Fried jujube seed 5-10 parts, Prepared licorice root 10-20 parts, Bombyx mori 5-15 parts, Cicadae periostracum 6-10 parts, Buthus martensii 1-2 parts, Chicken gizzard lining 10-15 parts, Citrus medica 10-15 parts, Prunus mume 15-30 parts, Paeonia lactiflora 20-30 parts, Schisandra chinensis 5-15 parts. The whole scorpion is provided in powder form; calcined hematite, raw dragon bone, and raw oyster shell are decocted with water first, and then mixed with the remaining raw medicinal materials, soaked in water and decocted 2-3 times, and the decoctions are combined and mixed to obtain a traditional Chinese medicine decoction; the traditional Chinese medicine composition is composed of the traditional Chinese medicine decoction and the whole scorpion powder.

2. The traditional Chinese medicine composition for treating insomnia according to claim 1, characterized in that: It is prepared from the following raw medicinal materials in parts by weight: 10 parts Bupleurum chinense, 5 parts Scutellaria baicalensis, 15 parts Codonopsis pilosula, 12 parts Pinellia ternata, 20 parts Poria cocos, 15 parts Cinnamomum cassia, 10 parts Calcined hematite, 30 parts Raw dragon bone, 30 parts Raw oyster shell, 15 parts Acanthopanax senticosus, 15 parts Poria cocos, 10 parts Fried Ziziphus jujuba var. spinosa, 15 parts Prepared Glycyrrhiza uralensis, 5 parts Bombyx mori, 6 parts Cicadae periostracum, 2 parts Buthus martensii, 12 parts Chicken gizzard lining, 12 parts Citrus medica, 20 parts Prunus mume, 25 parts Paeonia lactiflora, and 10 parts Schisandra chinensis.

3. The traditional Chinese medicine composition for treating insomnia according to claim 1, characterized in that: It is prepared from the following raw medicinal materials in parts by weight: 20 parts Bupleurum chinense, 10 parts Scutellaria baicalensis, 20 parts Codonopsis pilosula, 15 parts Pinellia ternata, 20 parts Poria cocos, 15 parts Cinnamomum cassia, 20 parts Calcined hematite, 20 parts Raw dragon bone, 30 parts Raw oyster shell, 20 parts Acanthopanax senticosus, 20 parts Poria cocos, 10 parts Fried Ziziphus jujuba var. spinosa, 15 parts Prepared Glycyrrhiza uralensis, 12 parts Bombyx mori, 9 parts Cicadae periostracum, 2 parts Buthus martensii, 15 parts Chicken gizzard lining, 10 parts Citrus medica, 15 parts Prunus mume, 20 parts Paeonia lactiflora, and 6 parts Schisandra chinensis.

4. The traditional Chinese medicine composition for treating insomnia according to claim 1, characterized in that: It also includes at least one of the following by weight: 10-20 parts of Polygala tenuifolia, 15-25 parts of Albizia julibrissin, and 10-20 parts of Curcuma longa.

5. The traditional Chinese medicine composition for treating insomnia according to claim 4, characterized in that: It is prepared from the following raw medicinal materials in parts by weight: Bupleurum chinense 15 parts, Scutellaria baicalensis 10 parts, Codonopsis pilosula 20 parts, Pinellia ternata 15 parts, Poria cocos 20 parts, Cinnamomum cassia 15 parts, Calcined hematite 15 parts, Raw dragon bone 30 parts, Raw oyster shell 30 parts, Acanthopanax senticosus 20 parts, Poria cocos sclerotium 20 parts, Fried jujube seed 10 parts, Prepared licorice root 15 parts, Bombyx mori 10 parts, Cicadae periostracum 6 parts, Scorpion 1.5 parts, Chicken gizzard lining 10 parts, Citrus medica 15 parts, Prunus mume 25 parts, Paeonia lactiflora 30 parts, Schisandra chinensis 10 parts, Albizia julibrissin flower 15 parts, Curcuma longa 10 parts.

6. The traditional Chinese medicine composition for treating insomnia according to claim 4, characterized in that: It is prepared from the following raw medicinal materials in parts by weight: Bupleurum chinense 15 parts, Scutellaria baicalensis 10 parts, Codonopsis pilosula 15 parts, Pinellia ternata 15 parts, Poria cocos 30 parts, Cinnamomum cassia 30 parts, Calcined hematite 15 parts, Raw dragon bone 30 parts, Raw oyster shell 45 parts, Acanthopanax senticosus 25 parts, Poria cocos sclerotium 25 parts, Fried jujube seed 10 parts, Prepared licorice root 20 parts, Bombyx mori 15 parts, Cicadae periostracum 10 parts, Scorpion 2 parts, Chicken gizzard lining 15 parts, Citrus medica 10 parts, Prunus mume 30 parts, Paeonia lactiflora 30 parts, Schisandra chinensis 15 parts, Albizia julibrissin flower 25 parts, Prepared Polygala tenuifolia 20 parts.

7. The traditional Chinese medicine composition for treating insomnia according to claim 4, characterized in that: It is prepared from the following raw medicinal materials in parts by weight: Bupleurum chinense 15 parts, Scutellaria baicalensis 10 parts, Codonopsis pilosula 15 parts, Pinellia ternata 9 parts, Poria cocos 20 parts, Cinnamomum cassia 15 parts, Calcined hematite 15 parts, Raw dragon bone 30 parts, Raw oyster shell 25 parts, Acanthopanax senticosus 20 parts, Poria cocos sclerotium 20 parts, Fried jujube seed 5 parts, Prepared licorice root 10 parts, Bombyx mori 8 parts, Cicadae periostracum 6 parts, Scorpion 1 part, Chicken gizzard lining 10 parts, Citrus medica 12 parts, Prunus mume 15 parts, Paeonia lactiflora 20 parts, Schisandra chinensis 5 parts, Prepared Polygala tenuifolia 10 parts.

8. A traditional Chinese medicine decoction for treating insomnia, characterized in that: The raw medicinal materials, excluding scorpion, in the traditional Chinese medicine composition according to any one of claims 1-7 are weighed according to the formula and mixed together. Water is added to submerge the raw materials and they are decocted 2-3 times. The decoctions are combined and mixed evenly to obtain the traditional Chinese medicine decoction.

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