CN116350725B

CN116350725B - Traditional Chinese medicine composition for treating heart-spleen deficiency type insomnia and application thereof

Info

Publication number: CN116350725B
Application number: CN202310333557.6A
Authority: CN
Inventors: 范方田; 刘慧�
Original assignee: BENGBU MEDICAL COLLEGE
Current assignee: BENGBU MEDICAL COLLEGE
Priority date: 2023-03-31
Filing date: 2023-03-31
Publication date: 2024-02-09
Anticipated expiration: 2043-03-31
Also published as: CN116350725A

Abstract

The invention discloses a traditional Chinese medicine composition for treating heart-spleen deficiency type insomnia, which comprises the following raw materials in parts by weight: the invention has good effects of tonifying heart and spleen, harmonizing stomach and resolving stagnation, calming heart and soothing nerves, nourishing blood and soothing nerves, reducing phlegm and relieving turbid urine, soothing liver and relieving restlessness, and treating insomnia caused by heart and spleen deficiency.

Description

Traditional Chinese medicine composition for treating heart-spleen deficiency type insomnia and application thereof

Technical Field

The invention relates to the technical field of traditional Chinese medicines, in particular to a traditional Chinese medicine composition for treating heart-spleen deficiency type insomnia and application thereof.

Background

Insomnia is called insomnia, its core disease is in the heart and brain, and the basic pathogenesis is that the heart and mind are restless due to malnutrition or disturbance of the spirit hidden in the heart and brain. Insomnia refers to viscera including heart, spleen, liver, kidney, gallbladder, stomach and brain, and its pathogenesis is divided into deficiency and excess. Deficiency syndrome is mainly caused by deficiency of yin and blood, malnutrition of heart and brain, and is characterized by weak constitution, lusterless complexion, listlessness, palpitation, amnesia, and tinnitus due to spleen malformation, liver malnutrition, kidney malnutrition, heart-mind malnutrition, and deficiency of brain and sea; the excessive syndrome is marked by excessive fire disturbing the mind or stagnant blood, and is characterized clinically by restlessness, irritability, bitter taste in the mouth, dry throat, constipation, dark urine, chest distress and pain, which are caused by excessive heart fire, liver depression transforming into fire, phlegm fire disturbing the heart and stagnant blood obstructing the collaterals.

The main disease location of insomnia is in the heart and brain. Insomnia due to malnutrition of heart-mind or disturbance of heart-mind, mental confusion; also, insomnia is caused by kidney essence deficiency and brain loss. Other viscera, such as liver, spleen, kidney, gallbladder, stomach, and other qi and blood imbalance of yin and yang, can disturb the mind of heart and brain to cause insomnia. At this time, it should be distinguished from the combination: for example, the patients with irritability and insomnia are mostly the internal disturbance of liver fire; pale complexion, tiredness and listlessness, while insomnia are mostly caused by spleen deficiency and loss of transportation; the complexion is pale, the mood is vexation, thinking is not absolute, the sleeping is not easy, the sleeping is easy to wake, and the sleeping is not easy to fall back after waking, so that the people mostly have deficiency of heart and spleen; restlessness, palpitation, dizziness, amnesia, waist-purgation, insomnia, excessive fire due to yin deficiency, and incoordination between heart and kidney; the night mare is linked with the sleep, and the heart and gallbladder deficiency is usually treated; gastric distress and greasy coating, while insomnia is usually caused by food retention and stagnation, and stomach qi disharmony.

Chinese invention patent: CN202011242587 discloses a Chinese medicinal preparation for treating insomnia due to internal disturbance of phlegm-heat and a preparation method thereof, which comprises three medicaments of rhizoma pinellinae praeparata, coptis chinensis and rhizoma corydalis which together form monarch medicaments for clearing heat and resolving phlegm, harmonizing stomach and lowering adverse qi and regulating spleen and stomach functions so as to achieve the aim of treating insomnia; chinese invention patent: CN201910327551 discloses a compound traditional Chinese medicine essential oil for treating insomnia, which takes lavender as a monarch, and has the effects of tranquilizing and allaying excitement, promoting qi circulation and dredging collaterals; takes cedarwood and benzoin as ministerial drugs to clear heart and induce resuscitation; the sandalwood, the dried orange peel and the clove are used for regulating qi and warming yang; cinnamon is used as a guide, and fire is led back to the element. The formula is matched and supplemented without stagnation, so that the qi stagnation is relieved, the mind is relieved, and the effects of soothing the nerves, aiding sleep, regulating qi and resolving stagnation are jointly exerted. The traditional Chinese medicine composition for treating insomnia caused by deficiency of both heart and spleen and application thereof are not found in the treatment concept of yin-middle-yang and yang-middle-yin in traditional Chinese medicine.

Disclosure of Invention

Aiming at the problems existing in the prior art, the invention provides a traditional Chinese medicine composition for treating insomnia caused by deficiency of heart and spleen, which comprises the following raw materials in parts by weight: 20-30 parts of astragalus membranaceus, 15-25 parts of bighead atractylodes rhizome, 20-30 parts of angelica sinensis, 15-25 parts of dried orange peel, 30-40 parts of hawthorn, 20-30 parts of malt, 15-25 parts of radish seed, 10-20 parts of nutgrass galingale rhizome, 20-30 parts of tuber fleeceflower stem, 10-20 parts of wild jujube seed, 20-30 parts of poria cocos, 10-20 parts of liquorice, 10-20 parts of poria with hostwood, 15-25 parts of rehmannia glutinosa, 10-20 parts of ligusticum wallichii, 15-25 parts of polygala tenuifolia, 8-12 parts of fritillaria cirrhosa, 15-20 parts of arisaema cum bile, 10-20 parts of radix bupleuri and 10-20 parts of rhizoma anemarrhenae.

Preferably, the traditional Chinese medicine composition comprises the following raw materials in parts by weight: 25 parts of astragalus membranaceus, 20 parts of bighead atractylodes rhizome, 25 parts of Chinese angelica, 20 parts of dried orange peel, 35 parts of hawthorn, 25 parts of malt, 20 parts of radish seed, 15 parts of nutgrass galingale rhizome, 25 parts of tuber fleeceflower stem, 15 parts of spina date seed, 25 parts of poria cocos, 15 parts of liquorice, 15 parts of poria with hostwood, 20 parts of rehmannia glutinosa, 15 parts of ligusticum wallichii, 20 parts of polygala tenuifolia, 10 parts of fritillaria cirrhosa, 18 parts of arisaema cum bile, 15 parts of radix bupleuri and 15 parts of rhizoma anemarrhenae.

Still further, the traditional Chinese medicine composition is prepared into clinically acceptable pharmaceutical preparations according to a traditional Chinese medicine conventional preparation method.

The traditional Chinese medicine composition is prepared into decoction, granules, powder, capsules, tablets, mixture or oral liquid.

The application of the traditional Chinese medicine composition in preparing a medicine for treating heart-spleen deficiency type insomnia.

The application of the traditional Chinese medicine composition in preparing the medicine for improving the sleep time of the heart-spleen deficiency type insomnia patient.

A medicine for treating insomnia caused by deficiency of heart and spleen is prepared from the traditional Chinese medicine composition and pharmaceutically acceptable auxiliary materials.

The preparation method of the traditional Chinese medicine composition comprises the following steps:

(1) Taking the following raw materials according to the proportion of the traditional Chinese medicine composition: astragalus root, white atractylodes rhizome, angelica, dried orange peel, hawthorn, malt, radish seed, nutgrass galingale rhizome, tuber fleeceflower stem, wild jujube seed, indian buead, liquoric root, indian bread with hostwood, prepared rhizome of rehmannia, szechuan lovage rhizome, thinleaf milkwort root-bark, fritillary bulb, arisaema cum bile, chinese thorowax root and common anemarrhena rhizome are soaked in water for 1 hour;

(2) Adding 10 times of water into the raw materials for the first time, decocting for 1.5 hours, and pouring out the liquid medicine after the decoction is finished;

(3) Adding 10 times of water into the medicinal materials for the second time, decocting for 1 hour, and pouring out the medicinal liquid after the decoction is finished;

(4) Mixing the two medicinal liquids, bagging, and packaging to obtain one of decoction, mixture and oral liquid.

(4) Mixing the two medicinal liquids, concentrating, spray drying, adding adjuvants, and making into granule, powder, capsule, or tablet.

The auxiliary materials may include, for example, excipients, binders, disintegrants, lubricants, etc.

Excipients include starch, lactose, anhydrous lactose, microcrystalline cellulose, silicified microcrystalline cellulose, hypromellose, silicic anhydride, calcium phosphate, anhydrous calcium phosphate, dibasic calcium phosphate, anhydrous dibasic calcium phosphate, calcium silicate, dextrin, dextrose, dextran salt, mannitol, maltose, sorbitol, sucrose, polyethylene glycol, sodium chloride, and the like, and these may be used alone or in combination of two or more.

Disintegrants include crospovidone, croscarmellose sodium, sodium starch glycolate, pregelatinized starch, low-substituted hydroxypropylcellulose, cereal starch, etc., and these may be used alone or in combination of two or more.

Lubricants include magnesium stearate, stearic acid, talc, silica, colloidal silica, sodium stearyl fumarate, sodium lauryl sulfate, poloxamer and the like, and these may be used alone or in combination of two or more.

The binder includes povidone, copovidone, methylcellulose, hydroxymethyl cellulose, hydroxypropyl methylcellulose, hydroxypropyl cellulose, hydroxyethyl cellulose, gelatin, guar gum, xanthan gum, etc.

And (3) square solution:

insomnia syndrome, deficiency and excess are combined, and deficiency is more. For the deficiency, common pathogenesis is: 1. the seven emotions are extremely excessive, so that the five zang organs and the brain spirit can be influenced, and insomnia, especially overhappy, overanger, overstep and overstep are more common, because the change of the emotional stress often consumes the essence of the five zang organs, and the essence deficiency and the brain orifices lose nourishment, the brain spirit is not calm, and the insomnia is generated. The relationship among the heart, spleen and liver is the most closely. The heart stores spirit, overstrain heart, consume heart blood, and the heart fire is reddish with one's head, disturbing the mind; or the player is playing inordinately, the mind is excited, the mind is restless, and the player is easy to insomnia. Spleen stores, excessive thinking would damage spleen qi, cause biochemical fatigue, deficiency of qi and blood, and mental confusion. Liver stores blood, blood takes over spirit, anger hurts liver, qi stagnation turns into fire, spirit can not store, and insomnia is also caused. 2. Excessive labor, consumption of yin blood, or prolonged metrorrhagia, puerperal blood loss; the deficiency of qi and blood can be caused by the failure of the body after illness or major surgery or by the failure of the old to consume qi and blood, and insomnia can be caused by the lack of the nourishment of the heart spirit and the brain. There are also diseases such as vomiting, diarrhea, diet, fatigue, etc. which cause restlessness and insomnia due to spleen and stomach injury, spleen and stomach disharmony, anorexia, deficiency of qi and blood, and no nourishment of heart and brain. 3. If the essence is weak or the kidney yin of a patient suffering from a long-term illness is damaged, the heart cannot be acted on, and the water does not help with fire, the heart yang is solely excessive; or excessive five emotions, excessive heart fire, failure to descend to the kidneys, heart-kidney disharmony, excessive heart fire, disturbance of heat, mental confusion, restlessness and insomnia. "Jingyue holly............ Miscellaneous pattern, insomnia" says: the deficiency of true yin and essence and blood, disharmony between yin and yang, and uneasiness in the ear. The "ventricle" refers to the ventricle, and the true yin is not filled in the ventricle, so that the mind cannot be sustained, and insomnia occurs. 4. Impairment of the emotion, liver failure, depression of qi, fire transformation, and flaming up; or liver yin deficiency, liver yang hyperactivity disturbing brain spirit, unsteadiness of mind, and insomnia. 5. Heart deficiency timidity, no authority in resolution, easy convulsion, restlessness, insomnia. Insomnia is caused by frightening and hacking, emotional tension, and the vigilance of the whole day, gradually reaching the timidity of heart deficiency. Either due to deficiency or convulsion, they are often caused by each other, ultimately affecting brain orifices and failing to sleep. 6. The patients who feel too much, the liver qi is depressed, the spleen is not healthy and moves, and dampness is accumulated to generate phlegm; or, the long-term fei-gan-more-damp herbs can not transform into phlegm. If phlegm-fire is mixed and steamed, it will gather brain orifices and disturb the mind, and the mind is not in good care, resulting in insomnia and dreaminess. There are also those with excessive liver-gallbladder-stomach fire, which can activate phlegm-fire, which can disturb the clear orifices, restlessness, irritability, insomnia. The invention treats the heart and spleen deficiency, wherein the heart and spleen deficiency is the most common, and the heart and spleen is required to be tonified because the thought is too excessive and the liver qi is depressed and the spleen is not healthy, so that the heart and spleen deficiency is caused; secondly, due to the deficiency of both the heart and spleen, the spleen and stomach often have impaired transportation and transformation functions, abnormal spleen and stomach qi, abnormal stomach qi and yang floating outside, so that the patient is not safe to sleep, and clinically has the symptoms of abdominal distention, nausea, vomiting, eructation and acid regurgitation. Stomach harmonizing and stagnation resolving are needed; thirdly, due to deficiency of heart and spleen, heart deficiency and timidity are often accompanied, and the decision is not right, people are easy to fright and mind are not calm, so that insomnia is caused, and the heart is calm and tranquilized; the deficiency of both heart and spleen is often accompanied by chronic disease or metrorrhagia and metrostaxis of women, postpartum blood loss, deficiency of qi and blood, heart blood deficiency, heart failure, heart spirit malnutrition, blood nourishing and tranquillization; fifthly, phlegm-heat is often accompanied by deficiency of heart and spleen, and is obstructed to suppress upper disturbance of middle energizer, so that phlegm-heat is required to be resolved and turbid urine is required to be discharged; and six, because of heart-spleen deficiency, the emotion is often accompanied with the symptoms of depression, anger hurting the liver, liver qi stagnation, liver depression transforming into fire, the soul can not be stored, and liver soothing and restlessness relieving are needed. The whole formula is prepared from astragalus root, white atractylodes rhizome, chinese angelica, dried orange peel and tonifying heart and spleen; fructus crataegi, fructus Hordei Germinatus, raphani semen, rhizoma Cyperi, and stomach regulating and stagnation resolving, which are principal drugs, caulis Polygoni Multiflori, semen Ziziphi Spinosae, poria, glycyrrhrizae radix, and Poria, radix rehmanniae Preparata, rhizoma Ligustici Chuanxiong, and cortex et radix Polygalae with effects of nourishing blood and tranquilizing mind; fritillary bulb and arisaema cum bile are used as auxiliary drugs for resolving phlegm, discharging turbidity, bupleurum, rhizoma anemarrhenae, soothing liver and relieving restlessness, and the whole formula has remarkable effect of treating insomnia caused by deficiency of both heart and spleen.

Detailed Description

The invention is further described below in conjunction with the detailed description. It is to be understood that these examples are illustrative of the present invention and are not intended to limit the scope of the present invention. Further, it is understood that various changes and modifications of the present invention may be made by those skilled in the art after reading the description of the present invention, and that such equivalents are intended to fall within the scope of the claims appended hereto.

Example 1: 20g of astragalus, 25g of bighead atractylodes rhizome, 20g of Chinese angelica, 25g of dried orange peel, 30g of hawthorn, 30g of malt, 15g of radish seed, 20g of nutgrass galingale rhizome, 20g of tuber fleeceflower stem, 20g of wild jujube seed, 20g of poria cocos, 20g of liquorice, 10g of poria with hostwood, 25g of rehmannia glutinosa, 10g of ligusticum wallichii, 25g of polygala tenuifolia, 8g of fritillaria cirrhosa, 20g of arisaema cum bile, 10g of radix bupleuri and 20g of rhizoma anemarrhenae.

Example 2: 30g of astragalus, 15g of bighead atractylodes rhizome, 30g of Chinese angelica, 15g of dried orange peel, 40g of hawthorn, 20g of malt, 25g of radish seed, 10g of nutgrass galingale rhizome, 30g of tuber fleeceflower stem, 10g of wild jujube seed, 30g of poria cocos, 10g of liquorice, 20g of poria with hostwood, 15g of rehmannia glutinosa, 20g of ligusticum wallichii, 15g of polygala tenuifolia, 12g of fritillaria cirrhosa, 15g of arisaema cum bile, 20g of radix bupleuri and 10g of rhizoma anemarrhenae.

Example 3: 20g of astragalus, 15g of bighead atractylodes rhizome, 20g of Chinese angelica, 15g of dried orange peel, 30g of hawthorn, 20g of malt, 15g of radish seed, 10g of nutgrass galingale rhizome, 20g of tuber fleeceflower stem, 10g of wild jujube seed, 20g of poria cocos, 10g of liquorice, 10g of poria with hostwood, 15g of rehmannia glutinosa, 10g of ligusticum wallichii, 15g of polygala tenuifolia, 8g of fritillaria cirrhosa, 15g of arisaema cum bile, 10g of radix bupleuri and 10g of rhizoma anemarrhenae.

Example 4: 30g of astragalus, 25g of bighead atractylodes rhizome, 30g of Chinese angelica, 25g of dried orange peel, 40g of hawthorn, 30g of malt, 25g of radish seed, 20g of nutgrass galingale rhizome, 30g of tuber fleeceflower stem, 20g of wild jujube seed, 30g of poria cocos, 20g of liquorice, 20g of poria with hostwood, 25g of rehmannia glutinosa, 20g of ligusticum wallichii, 25g of polygala tenuifolia, 12g of fritillaria cirrhosa, 20g of arisaema cum bile, 20g of radix bupleuri and 20g of rhizoma anemarrhenae.

Example 5: 25g of astragalus, 20g of bighead atractylodes rhizome, 25g of Chinese angelica, 20g of dried orange peel, 35g of hawthorn, 25g of malt, 20g of radish seed, 15g of nutgrass galingale rhizome, 25g of tuber fleeceflower stem, 15g of wild jujube seed, 25g of poria cocos, 15g of liquorice, 15g of poria with hostwood, 20g of rehmannia glutinosa, 15g of ligusticum wallichii, 20g of polygala tenuifolia, 10g of fritillaria cirrhosa, 18g of arisaema cum bile, 15g of radix bupleuri and 15g of rhizoma anemarrhenae.

Example 6: decoction

The preparation method comprises the following steps:

the raw material medicines are respectively taken according to the weight parts of the following examples 1-5: astragalus root, white atractylodes rhizome, angelica, dried orange peel, hawthorn, malt, radish seed, nutgrass galingale rhizome, tuber fleeceflower stem, wild jujube seed, indian buead, liquoric root, indian bread with hostwood, prepared rhizome of rehmannia, szechuan lovage rhizome, thinleaf milkwort root-bark, fritillary bulb, arisaema cum bile, chinese thorowax root and common anemarrhena rhizome are soaked in water for 1 hour; adding 10 times of water into the raw materials for the first time, decocting for 1.5 hours, and pouring out the raw materials after the decoction is finished; adding 10 times of water into the medicinal materials for the second time, decocting for 1 hour, and pouring out; combining the two medicinal liquids, and packaging in bags.

Example 7: granule preparation

The preparation method comprises the following steps:

the raw material medicines are respectively taken according to the weight parts of the following examples 1-5: astragalus root, white atractylodes rhizome, angelica, dried orange peel, hawthorn, malt, radish seed, nutgrass galingale rhizome, tuber fleeceflower stem, wild jujube seed, indian buead, liquoric root, indian bread with hostwood, prepared rhizome of rehmannia, szechuan lovage rhizome, thinleaf milkwort root-bark, fritillary bulb, arisaema cum bile, chinese thorowax root and common anemarrhena rhizome are soaked in water for 1 hour; adding 10 times of water into the raw materials for the first time, decocting for 1.5 hours, and pouring out the raw materials after the raw materials are decocted; adding 10 times of water into the medicinal materials for the second time, decocting for 1 hour, and pouring out; mixing the two medicinal liquids, concentrating, spray drying, adding starch, and making into granule.

Example 8: tablet formulation

The preparation method comprises the following steps:

the raw material medicines are respectively taken according to the weight parts of the following examples 1-5: astragalus root, white atractylodes rhizome, angelica, dried orange peel, hawthorn, malt, radish seed, nutgrass galingale rhizome, tuber fleeceflower stem, wild jujube seed, indian buead, liquoric root, indian bread with hostwood, prepared rhizome of rehmannia, szechuan lovage rhizome, thinleaf milkwort root-bark, fritillary bulb, arisaema cum bile, chinese thorowax root and common anemarrhena rhizome are soaked in water for 1 hour; adding 10 times of water into the raw materials for the first time, decocting for 1.5 hours, and pouring out the raw materials after the raw materials are decocted; adding 10 times of water into the medicinal materials for the second time, decocting for 1 hour, and pouring out; mixing the two medicinal liquids, concentrating the medicinal liquid, spray drying, pulverizing, granulating, and making into tablet.

Example 9: capsule preparation

The preparation method comprises the following steps:

the raw material medicines are respectively taken according to the weight parts of the following examples 1-5: astragalus root, white atractylodes rhizome, angelica, dried orange peel, hawthorn, malt, radish seed, nutgrass galingale rhizome, tuber fleeceflower stem, wild jujube seed, indian buead, liquoric root, indian bread with hostwood, prepared rhizome of rehmannia, szechuan lovage rhizome, thinleaf milkwort root-bark, fritillary bulb, arisaema cum bile, chinese thorowax root and common anemarrhena rhizome are soaked in water for 1 hour; adding 10 times of water into the raw materials for the first time, decocting for 1.5 hours, and pouring out the raw materials after the raw materials are decocted; adding 10 times of water into the medicinal materials for the second time, decocting for 1 hour, and pouring out; mixing the two medicinal liquids, concentrating the medicinal liquid, spray drying, pulverizing, granulating, and making into capsule.

Example 10: pharmacodynamic test

Effect detection on mouse barbital sodium sleep time: the mice were randomly divided into 5 groups, i.e., physiological saline control group, granule group prepared by the prescription of example 1-3, stable positive control group, 12 each.

Group of examples: the fine powder of the medicine is infused with the stomach at the dosage of 10.0g/kg, the dosage of 5ml/kg and the dosage volume of 0.2ml/10g, and the stomach is infused;

stable positive control group: 1mg/kg of diazepam is administered and the stomach is irrigated;

saline control group: the same volume of physiological saline is administered and the stomach is irrigated.

60 minutes after gastric lavage, each group of mice was given 40mg/kg of pentobarbital sodium, respectively, for intraperitoneal injection. The sleep time of the mice (the disappearance of the flip-flop is regarded as the fall-to-sleep time, and the disappearance of the flip-flop to the recovery time is regarded as the sleep duration) was recorded.

The results are shown in Table 1.

TABLE 1 influence of sodium pentobarbital on sleep time in mice

	Dosage (g/kg)	Sleep time (minutes)
			Physiological saline group	10	52.7±3.7
Example 1 granule group	10	87.9±4.8*
			Example 2 granule group	10	90.2±5.1*
Example 3 granule group	10	85.3±6.1*
			Stabilizing set	0.001	118.8±6.4**

P <0.05, P <0.01 compared to normal saline group

The results in the table show: the medicine of the invention obviously prolongs the sleeping time of mice and has obvious difference compared with normal saline group.

Example 11: clinical trial

Criteria for selecting cases: the valve has the following characteristics: (1) sleep latency is prolonged: the sleeping time exceeds 30min; (2) sleep maintenance disorder: the number of times of awakening at night is more than or equal to 2 or early awakening in the early morning; (3) sleep quality is degraded: shallow sleep and dreaminess; (4) total sleep time; shortening: typically < 5h; (5) daytime residual effect: the morning feels dizziness, listlessness, somnolence, hypodynamia and the like; the sleep disorder is at least 3 times per week and maintained for more than 1 month. The ages are 15-60 years, and can be used as the standard (inclusion standard) for selecting cases, and the cases are all cases of the subsidiary hospitals of the medical college of the conchoidal space.

Diagnostic criteria: according to the Chinese mental disorder classification and diagnosis standard: has the following characteristics: (1) sleep latency is prolonged: the sleeping time exceeds 30min; (2) sleep maintenance disorder: the number of times of awakening at night is more than or equal to 2 or early awakening in the early morning; (3) sleep quality is degraded: shallow sleep and dreaminess; (4) total sleep time. Shortening: typically < 5h; (5) daytime residual effect: the morning feels dizziness, listlessness, somnolence, hypodynamia, etc. The sleep disorder is at least 3 times per week and maintained for more than 1 month. According to the traditional Chinese medicine medical industry standard of the people's republic of China, the diagnosis and treatment effect standard of traditional Chinese medicine symptoms: the traditional Chinese medicine has the symptoms of insomnia caused by deficiency of heart and spleen, patients are not easy to fall asleep, or dreaminess is easy to wake up during sleep, and then are difficult to fall asleep after waking up, or palpitation, listlessness, hypodynamia, oral weakness, or abdominal distension after eating, nausea, abdominal pain, abnormal stool, poor appetite, sallow complexion, pale tongue with thin white or yellow coating, slow and weak pulse, and the patients can be diagnosed with insomnia caused by deficiency of heart and spleen through detection, and the traditional Chinese medicine is used for treating.

Treatment protocol: the traditional Chinese medicine oral liquid of the embodiment 1 is used for treating the patient with the diagnosis, and is orally taken twice a day, once a day, 20-30ml each time, 14 days as a treatment course, and the curative effect is counted.

Efficacy assessment criteria: according to the clinical study guidelines of new traditional Chinese medicines, (1) recovery, namely disappearance of clinical symptoms, recovery of sleep time to be normal or more than 6 hours, deep sleep and full energy after waking; (2) has obvious effects that clinical symptoms basically disappear, sleep is obviously improved, sleep time is increased by more than 3 h, and sleep depth is increased; (3) effective in alleviating symptoms and increasing sleep time by less than 3 h; (4) the insomnia is not obviously improved or aggravated after treatment.

And (3) statistical treatment: 100 patients with definite diagnosis are treated for 14 days, 62 patients are cured by statistical treatment, and 62 percent of the patients account for the obvious effects: 26 persons account for 26%, 7 persons are effective (improved), 7% are effective (improved), 5 persons are ineffective, the total effective rate is 95%, and no toxic or side effect is found in the treatment period, so that the medicine has stable and reliable curative effect and safe administration.

Conclusion: the traditional Chinese medicine composition has the advantages of scientific and reasonable components, safe and effective dosage, has the effects of tonifying heart and spleen, harmonizing stomach, relieving stagnation, calming heart, tranquillizing, nourishing blood, tranquillizing, resolving phlegm, discharging turbidity, soothing liver and relieving restlessness, is effectively used for treating heart-spleen deficiency type insomnia, has good curative effect, safe administration, high curative effect and total effective rate of up to 95 percent, is a great innovation in medicaments for treating heart-spleen deficiency type insomnia, and has good economic and social benefits.

Although embodiments of the present invention have been shown and described, it will be understood by those skilled in the art that various changes, modifications, substitutions and alterations can be made therein without departing from the principles and spirit of the invention, the scope of which is defined in the appended claims and their equivalents.

Claims

1. The traditional Chinese medicine composition for treating heart-spleen deficiency type insomnia is characterized by being prepared by extracting the following raw materials in parts by weight: 20-30 parts of astragalus membranaceus, 15-25 parts of bighead atractylodes rhizome, 20-30 parts of angelica sinensis, 15-25 parts of dried orange peel, 30-40 parts of hawthorn, 20-30 parts of malt, 15-25 parts of radish seed, 10-20 parts of nutgrass galingale rhizome, 20-30 parts of tuber fleeceflower stem, 10-20 parts of wild jujube seed, 20-30 parts of poria cocos, 10-20 parts of liquorice, 10-20 parts of poria with hostwood, 15-25 parts of rehmannia glutinosa, 10-20 parts of ligusticum wallichii, 15-25 parts of polygala tenuifolia, 8-12 parts of fritillaria cirrhosa, 15-20 parts of arisaema cum bile, 10-20 parts of radix bupleuri and 10-20 parts of rhizoma anemarrhenae.

2. The traditional Chinese medicine composition according to claim 1, wherein the traditional Chinese medicine composition is prepared by extracting the following raw materials in parts by weight: 25 parts of astragalus membranaceus, 20 parts of bighead atractylodes rhizome, 25 parts of Chinese angelica, 20 parts of dried orange peel, 35 parts of hawthorn, 25 parts of malt, 20 parts of radish seed, 15 parts of nutgrass galingale rhizome, 25 parts of tuber fleeceflower stem, 15 parts of spina date seed, 25 parts of poria cocos, 15 parts of liquorice, 15 parts of poria with hostwood, 20 parts of rehmannia glutinosa, 15 parts of ligusticum wallichii, 20 parts of polygala tenuifolia, 10 parts of fritillaria cirrhosa, 18 parts of arisaema cum bile, 15 parts of radix bupleuri and 15 parts of rhizoma anemarrhenae.

3. The traditional Chinese medicine composition according to claim 1 or 2, wherein the traditional Chinese medicine composition is prepared into clinically acceptable pharmaceutical preparations according to a traditional Chinese medicine conventional preparation method.

4. The Chinese medicinal composition according to claim 3, wherein the pharmaceutical preparation is a decoction, a granule, a powder, a capsule, a tablet, a mixture or an oral liquid.

5. The use of a Chinese medicinal composition according to claim 1 or 2 in the preparation of a medicament for treating insomnia due to deficiency of both heart and spleen.

6. The use of a Chinese medicinal composition according to claim 1 or 2 for preparing a medicament for improving sleep time of a patient suffering from insomnia due to deficiency of both heart and spleen.

7. The traditional Chinese medicine composition according to claim 1, wherein the preparation method of the traditional Chinese medicine composition comprises the following steps:

(1) Taking the following raw materials in proportion: astragalus root, white atractylodes rhizome, angelica, dried orange peel, hawthorn, malt, radish seed, nutgrass galingale rhizome, tuber fleeceflower stem, wild jujube seed, indian buead, liquoric root, indian bread with hostwood, prepared rhizome of rehmannia, szechuan lovage rhizome, thinleaf milkwort root-bark, fritillary bulb, arisaema cum bile, chinese thorowax root and common anemarrhena rhizome are soaked in water for 1 hour;

8. The traditional Chinese medicine composition according to claim 1, wherein the preparation method of the traditional Chinese medicine composition comprises the following steps:

(1) The traditional Chinese medicine composition according to claim 1 is prepared from the following raw materials: astragalus root, white atractylodes rhizome, angelica, dried orange peel, hawthorn, malt, radish seed, nutgrass galingale rhizome, tuber fleeceflower stem, wild jujube seed, indian buead, liquoric root, indian bread with hostwood, prepared rhizome of rehmannia, szechuan lovage rhizome, thinleaf milkwort root-bark, fritillary bulb, arisaema cum bile, chinese thorowax root and common anemarrhena rhizome are soaked in water for 1 hour;