Traditional Chinese medicine composition for treating insomnia and application thereof

Abstract

The invention relates to the technical field of traditional Chinese medicines, in particular to a traditional Chinese medicine composition for treating insomnia and application thereof. The traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 20 to 80 parts of radix codonopsis, 25 to 100 parts of rhizoma atractylodis macrocephalae, 20 to 80 parts of poria cocos, 7.5 to 30 parts of pericarpium citri reticulatae, 7.5 to 30 parts of rhizoma pinelliae, 15 to 60 parts of longan pulp, 25 to 100 parts of jujube kernel, 12.5 to 50 parts of semen boitae, 25 to 100 parts of rhizoma gastrodiae, 25 to 100 parts of tuber fleeceflower stem, 25 to 100 parts of fructus corni and 5 to 20 parts of rhizoma nardostachyos. The traditional Chinese medicine composition is scientific and reasonable in component compatibility, has the effects of nourishing yin and blood and arresting convulsion and soothing the nerves, is safe to take and good in curative effect, can be effectively used for treating insomnia caused by heart and spleen blood deficiency, is a great innovation in medicines for treating insomnia caused by heart and spleen blood deficiency, and has remarkable economic and social benefits.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine technology, specifically to a traditional Chinese medicine composition for treating insomnia and its application. Background Technology

[0002] Insomnia is a common and frequently occurring clinical condition, and its incidence is increasing with rising societal pressures. Its clinical manifestations vary, including difficulty falling asleep, frequent awakenings after falling asleep, difficulty falling back asleep, early awakening, shallow sleep, and sometimes even complete sleeplessness. Insomnia treatment aims to restore a person's effective sleep time to the average sleep duration appropriate for their age group, thereby eliminating fatigue and restoring both mental and physical well-being.

[0003] Modern medicine primarily treats this condition with sedatives and hypnotics. These medications mainly include benzodiazepines and non-benzodiazepines. Benzodiazepines include diazepam, lorazepam, oxazepam, clonazepam, midazolam maleate, estazolam, and alprazolam; non-benzodiazepines include zolpidem tartrate, zaleplon, zopiclone, and eszopiclone. These medications can help patients fall asleep and improve sleep quality, but long-term use may lead to dependence and other adverse reactions.

[0004] Traditional Chinese medicine (TCM) treatment has unique advantages. When treating insomnia, TCM medications have relatively fewer side effects and cause less harm to the body, making them suitable for long-term use. Furthermore, TCM treatment for insomnia does not lead to drug dependence or withdrawal symptoms, and medication can be discontinued at any time depending on the condition, with good efficacy. Therefore, this invention provides a TCM composition for treating insomnia and its application. Summary of the Invention

[0005] The technical problem to be solved by this invention is to provide a traditional Chinese medicine composition for treating insomnia and its application. The aim is to provide a traditional Chinese medicine composition for insomnia caused by deficiency of heart and spleen blood.

[0006] The technical solution of the present invention to solve the above-mentioned technical problems is as follows: In a first aspect, a traditional Chinese medicine composition for treating insomnia, said composition being made from the following raw materials in parts by weight: Codonopsis pilosula 20-80 parts, Atractylodes macrocephala 25-100 parts, Poria cocos 20-80 parts, Citrus reticulata peel 7.5-30 parts, Pinellia ternata 7.5-30 parts, Longan pulp 15-60 parts, Ziziphus jujuba seed 25-100 parts, Platycladus orientalis seed 12.5-50 parts, Gastrodia elata 25-100 parts, Polygonum multiflorum 25-100 parts, Cornus officinalis 25-100 parts, Nardostachys chinensis 5-20 parts.

[0007] Based on the above technical solution, the present invention can be further improved as follows.

[0008] Furthermore, the traditional Chinese medicine composition is made from the following raw materials in parts by weight: Codonopsis pilosula 30-60 parts, Atractylodes macrocephala 35-75 parts, Poria cocos 30-60 parts, Citrus reticulata peel 10-20 parts, Pinellia ternata 10-20 parts, Longan pulp 25-45 parts, Ziziphus jujuba seed 35-75 parts, Platycladus orientalis seed 17.5-40 parts, Gastrodia elata 35-75 parts, Polygonum multiflorum stem 35-75 parts, Cornus officinalis fruit 35-75 parts, Nardostachys chinensis 7.5-16.5 parts.

[0009] Furthermore, the traditional Chinese medicine composition is made from the following raw materials in parts by weight: 40 parts of Codonopsis pilosula, 50 parts of Atractylodes macrocephala, 40 parts of Poria cocos, 15 parts of Citrus reticulata peel, 15 parts of Pinellia ternata, 30 parts of longan pulp, 50 parts of Ziziphus jujuba seed, 25 parts of Platycladus orientalis seed, 50 parts of Gastrodia elata, 50 parts of Polygonum multiflorum stem, 50 parts of Cornus officinalis fruit, and 10 parts of Nardostachys chinensis.

[0010] Furthermore, the dosage form of the traditional Chinese medicine composition is an oral preparation.

[0011] Furthermore, the oral preparations include pills, oral liquids, or granules.

[0012] Furthermore, if the dosage form of the traditional Chinese medicine composition is pills, it is mainly prepared by the following method: mixing the raw materials of the traditional Chinese medicine composition, grinding them into fine powder and passing them through a 600-1000 mesh sieve, then adding honey equivalent to 0.5-2 times the total weight of the raw materials to make pills. The pill-making process can be carried out using conventional techniques.

[0013] Furthermore, if the dosage form of the traditional Chinese medicine composition is an oral liquid, it is mainly prepared by the following method: mixing the raw materials of the traditional Chinese medicine composition, decocting with water equivalent to 3 to 20 times the total weight of the raw materials, and then filtering and concentrating sequentially to obtain the oral liquid. The decoction conditions are 95℃ to 100℃ for 0.5 to 2 hours; concentration is then achieved to the specified concentration.

[0014] Furthermore, if the dosage form of the traditional Chinese medicine composition is granules, it is mainly prepared by the following method: mixing the raw materials of the traditional Chinese medicine composition, grinding them into fine powder and passing them through an 800-1000 mesh sieve, adding starch equivalent to 0.5-2 times the total weight of the raw materials, and pressing them into granules. The pressing process into granules can be performed using conventional methods.

[0015] Secondly, the application of a traditional Chinese medicine composition for treating insomnia, wherein the traditional Chinese medicine composition for treating insomnia is used in the preparation of a drug for treating insomnia.

[0016] Furthermore, the insomnia described is insomnia due to deficiency of heart and spleen blood.

[0017] The components in the traditional Chinese medicine composition include: Codonopsis pilosula has the effects of tonifying the middle energizer and replenishing qi, strengthening the spleen and benefiting the lungs; it also has the effects of enhancing immunity, dilating blood vessels, lowering blood pressure, improving microcirculation, and enhancing hematopoietic function.

[0018] Atractylodes macrocephala has the functions of tonifying the spleen and stomach, drying dampness and promoting diuresis.

[0019] Poria cocos has diuretic and antibacterial effects and can enhance the body's immunity.

[0020] Dried tangerine peel has the functions of regulating qi and strengthening the spleen, harmonizing the middle jiao, drying dampness, and resolving phlegm.

[0021] Pinellia ternata has the effects of drying dampness and resolving phlegm, relieving nausea and vomiting, and eliminating masses and nodules.

[0022] Longan pulp has anti-stress, anti-anxiety, antioxidant, antibacterial, anti-aging, and immune-enhancing effects.

[0023] Jujube seeds have the effects of calming the mind and soothing the nerves, astringing sweat and consolidating the exterior, nourishing the liver and kidneys, improving anxiety, and benefiting the cardiovascular system.

[0024] Arborvitae seeds have the effects of nourishing the heart and calming the mind, moistening the intestines and relieving constipation, and stopping sweating.

[0025] Gastrodia elata has the effects of calming wind and stopping spasms, suppressing liver yang, and dispelling wind and unblocking collaterals.

[0026] Polygonum multiflorum has the effects of nourishing the heart and calming the mind, dispelling wind, and unblocking the meridians.

[0027] Cornus officinalis has the effects of nourishing the liver and kidneys, and astringing and consolidating.

[0028] Nardostachys jatamansi has the effects of regulating qi and relieving pain, relieving depression and promoting spleen function, warming the middle jiao and dispelling cold, invigorating the spleen and stomach, anti-ulcer, sedation, regulating gastrointestinal motility, anti-arrhythmia and myocardial protection.

[0029] The beneficial effects of this invention are as follows: Atractylodes macrocephala, Ziziphus jujuba var. spinosa, Gastrodia elata, Polygonum multiflorum, and Cornus officinalis are the principal herbs, Codonopsis pilosula and Poria cocos are the assistant herbs, Longan aril and Platycladus orientalis are the adjuvant herbs, and Citrus reticulata, Pinellia ternata, and Nardostachys chinensis are the guiding herbs. The combination of each component in this invention is scientific and reasonable, and it has the effects of nourishing yin and blood, calming the mind and relieving anxiety. It is safe to take and has good efficacy. It can be effectively used to treat insomnia due to deficiency of heart and spleen blood. It is a major innovation in the treatment of insomnia due to deficiency of heart and spleen blood, and has significant economic and social benefits. Detailed Implementation

[0030] The principles and features of this invention are described below. The examples given are for illustrative purposes only and are not intended to limit the scope of the invention. Where specific techniques or conditions are not specified in the embodiments, they should be performed according to the techniques or conditions described in the literature in this field, or according to the product instructions. Reagents or instruments whose manufacturers are not specified are all conventional products that can be purchased through legitimate channels.

[0031] Example 1 A traditional Chinese medicine composition for treating insomnia, the composition being made from the following raw materials in parts by weight: 20 parts Codonopsis pilosula, 25 parts Atractylodes macrocephala, 20 parts Poria cocos, 7.5 parts Citrus reticulata peel, 7.5 parts Pinellia ternata, 15 parts Longan pulp, 25 parts Ziziphus jujuba seed, 12.5 parts Platycladus orientalis seed, 25 parts Gastrodia elata, 25 parts Polygonum multiflorum stem, 25 parts Cornus officinalis fruit, and 5 parts Nardostachys chinensis.

[0032] The traditional Chinese medicine composition for treating insomnia is mainly prepared by the following method: the raw materials of the traditional Chinese medicine composition are mixed, ground into fine powder and passed through a 600-1000 mesh sieve, and then honey equivalent to 1.5 times the total weight of the raw materials is added to make pills.

[0033] Example 2 A traditional Chinese medicine composition for treating insomnia, the composition being made from the following raw materials in parts by weight: 30 parts Codonopsis pilosula, 35 parts Atractylodes macrocephala, 30 parts Poria cocos, 10 parts Citrus reticulata peel, 10 parts Pinellia ternata, 25 parts Longan pulp, 35 parts Ziziphus jujuba seed, 17.5 parts Platycladus orientalis seed, 35 parts Gastrodia elata, 35 parts Polygonum multiflorum stem, 35 parts Cornus officinalis fruit, and 7.5 parts Nardostachys chinensis.

[0034] The traditional Chinese medicine composition for treating insomnia is mainly prepared by the following method: the raw materials of the traditional Chinese medicine composition are mixed, then ground into fine powder and passed through an 800-1000 mesh sieve, and starch equivalent to 1 times the total weight of the raw materials is added and pressed into granules.

[0035] Example 3 A traditional Chinese medicine composition for treating insomnia, the composition being made from the following raw materials in parts by weight: 40 parts Codonopsis pilosula, 50 parts Atractylodes macrocephala, 40 parts Poria cocos, 15 parts Citrus reticulata peel, 15 parts Pinellia ternata, 30 parts Longan aril, 50 parts Ziziphus jujuba seed, 25 parts Platycladus orientalis seed, 50 parts Gastrodia elata, 50 parts Polygonum multiflorum stem, 50 parts Cornus officinalis fruit, and 10 parts Nardostachys chinensis.

[0036] The traditional Chinese medicine composition for treating insomnia is mainly prepared by the following method: the raw materials of the traditional Chinese medicine composition are mixed, decocted with water equivalent to 10 times the total weight of the raw materials, and then filtered and concentrated to obtain an oral liquid. The decoction conditions are 95℃~100℃ and the time is 0.5~2 hours; it is then concentrated to the specified concentration.

[0037] Example 4 A traditional Chinese medicine composition for treating insomnia, the composition being made from the following raw materials in parts by weight: Codonopsis pilosula 60 parts, Atractylodes macrocephala 75 parts, Poria cocos 60 parts, Citrus reticulata peel 20 parts, Pinellia ternata 20 parts, Longan pulp 45 parts, Ziziphus jujuba seed 75 parts, Platycladus orientalis seed 40 parts, Gastrodia elata 75 parts, Polygonum multiflorum stem 75 parts, Cornus officinalis fruit 75 parts, Nardostachys chinensis 16.5 parts.

[0038] The traditional Chinese medicine composition for treating insomnia is mainly prepared by the following method: the raw materials of the traditional Chinese medicine composition are mixed, decocted with water equivalent to 10 times the total weight of the raw materials, and then filtered and concentrated to obtain an oral liquid. The decoction conditions are 95℃~100℃ and the time is 0.5~2 hours; it is then concentrated to the specified concentration.

[0039] Example 5 A traditional Chinese medicine composition for treating insomnia, the composition being made from the following raw materials in parts by weight: 80 parts Codonopsis pilosula, 100 parts Atractylodes macrocephala, 80 parts Poria cocos, 30 parts Citrus reticulata peel, 30 parts Pinellia ternata, 60 parts Longan aril, 100 parts Ziziphus jujuba seed, 50 parts Platycladus orientalis seed, 100 parts Gastrodia elata, 100 parts Polygonum multiflorum stem, 100 parts Cornus officinalis fruit, and 20 parts Nardostachys chinensis.

[0040] The traditional Chinese medicine composition for treating insomnia is mainly prepared by the following method: the raw materials of the traditional Chinese medicine composition are mixed, decocted with water equivalent to 10 times the total weight of the raw materials, and then filtered and concentrated to obtain an oral liquid. The decoction conditions are 95℃~100℃ and the time is 0.5~2 hours; it is then concentrated to the specified concentration.

[0041] Test case 1. Diagnostic criteria and inclusion criteria.

[0042] Diagnostic criteria for insomnia due to deficiency of heart and spleen blood: Sleep disturbances are the main symptoms, including difficulty falling asleep, shallow sleep, frequent awakenings, vivid dreams, early awakening or difficulty falling back asleep after waking up, discomfort and fatigue after waking up; the above sleep disturbances occur at least 3 times a week and last for more than 1 month; insomnia causes significant mood changes or a decline in mental activity efficiency.

[0043] Inclusion criteria: meeting the above diagnostic and syndrome differentiation criteria; aged 20–70 years; and signing an informed consent form.

[0044] 2. Treatment plan.

[0045] In the experiment, a control group and a treatment group based on the present invention were set up.

[0046] Group 1 (control group): Diazepam tablets, 2 tablets / time, taken once before bedtime.

[0047] Five treatment groups: Examples 1 to 5 of the present invention; taken once in the morning and once in the evening.

[0048] One course of treatment lasts 14 days. The efficacy of each group will be observed after one course of treatment. During the treatment period, strong tea, coffee, and spicy and stimulating foods should be avoided.

[0049] 3. Efficacy evaluation criteria.

[0050] According to the "Guiding Principles for Clinical Research of New Traditional Chinese Medicines": ① Cured: Clinical symptoms disappear, sleep time returns to normal or more than 6 hours, sleep is deep, and one is full of energy after waking up; ② Significantly effective: Clinical symptoms basically disappear, sleep is significantly improved, sleep time increases by more than 3 hours, and sleep depth increases; ③ Effective: Symptoms are relieved, and sleep time increases by less than 3 hours; ④ Ineffective: Insomnia does not improve significantly or symptoms worsen after treatment.

[0051] 4. Statistical analysis.

[0052] Case data: 240 outpatients from the First Affiliated Hospital of Guilin Medical University were selected and randomly divided into a treatment group and a control group (40 patients in each group) using a random number table at a 1:1 ratio. Statistical analysis showed no significant differences in general characteristics such as gender, age, and disease duration between the two groups (P>0.05), making them comparable. The clinical efficacy comparison between the two groups is shown in Table 1.

[0053] Table 1 Comparison of therapeutic effects between the two groups of patients As shown in the table above, the total effective rate of each of the five treatment groups was over 95%, while the total effective rate of the control group was 80%. Analysis of the efficacy comparison between the two groups showed a statistically significant difference (P < 0.026).

[0054] In summary, the ingredients of this invention are Atractylodes macrocephala, Ziziphus jujuba var. spinosa, Gastrodia elata, Polygonum multiflorum, and Cornus officinalis as principal herbs, Codonopsis pilosula and Poria cocos as assistant herbs, Longan aril and Platycladus orientalis as adjuvant herbs, and Citrus reticulata peel, Pinellia ternata, and Nardostachys chinensis as guiding herbs. The combination of these ingredients is scientific and reasonable, and the invention has the effects of nourishing yin and blood, calming the mind and relieving anxiety. It is safe to take and has good efficacy. It can be effectively used to treat insomnia caused by deficiency of heart and spleen blood. It is a major innovation in the treatment of insomnia caused by deficiency of heart and spleen blood, and has significant economic and social benefits.

[0055] Although embodiments of the present invention have been shown and described above, it is understood that the above embodiments are exemplary and should not be construed as limiting the present invention. Those skilled in the art can make changes, modifications, substitutions and variations to the above embodiments within the scope of the present invention.

Claims

1. A traditional Chinese medicine composition for treating insomnia, characterized in that, The traditional Chinese medicine composition is made from the following raw materials in parts by weight: Codonopsis pilosula 20-80 parts, Atractylodes macrocephala 25-100 parts, Poria cocos 20-80 parts, Citrus reticulata peel 7.5-30 parts, Pinellia ternata 7.5-30 parts, Longan pulp 15-60 parts, Ziziphus jujuba seed 25-100 parts, Platycladus orientalis seed 12.5-50 parts, Gastrodia elata 25-100 parts, Polygonum multiflorum 25-100 parts, Cornus officinalis 25-100 parts, Nardostachys chinensis 5-20 parts.

2. The traditional Chinese medicine composition for treating insomnia according to claim 1, characterized in that, The traditional Chinese medicine composition is made from the following raw materials in parts by weight: Codonopsis pilosula 30-60 parts, Atractylodes macrocephala 35-75 parts, Poria cocos 30-60 parts, Citrus reticulata peel 10-20 parts, Pinellia ternata 10-20 parts, Longan pulp 25-45 parts, Ziziphus jujuba seed 35-75 parts, Platycladus orientalis seed 17.5-40 parts, Gastrodia elata 35-75 parts, Polygonum multiflorum 35-75 parts, Cornus officinalis 35-75 parts, Nardostachys chinensis 7.5-16.5 parts.

3. The traditional Chinese medicine composition for treating insomnia according to claim 1, characterized in that, The traditional Chinese medicine composition is made from the following raw materials in parts by weight: Codonopsis pilosula 40 parts, Atractylodes macrocephala 50 parts, Poria cocos 40 parts, Citrus reticulata peel 15 parts, Pinellia ternata 15 parts, Longan pulp 30 parts, Ziziphus jujuba seed 50 parts, Platycladus orientalis seed 25 parts, Gastrodia elata 50 parts, Polygonum multiflorum 50 parts, Cornus officinalis 50 parts, and Nardostachys chinensis 10 parts.

4. A traditional Chinese medicine composition for treating insomnia according to any one of claims 1 to 3, characterized in that, The dosage form of the traditional Chinese medicine composition is an oral preparation.

5. The traditional Chinese medicine composition for treating insomnia according to claim 4, characterized in that, The oral preparations include pills, oral liquids, or granules.

6. The traditional Chinese medicine composition for treating insomnia according to claim 5, characterized in that, If the dosage form of the traditional Chinese medicine composition is pills, it is mainly prepared by the following method: mix the raw materials of the traditional Chinese medicine composition, grind them into fine powder and pass them through a 600-1000 mesh sieve, add honey equivalent to 0.5-2 times the total weight of the raw materials, and make pills.

7. The traditional Chinese medicine composition for treating insomnia according to claim 5, characterized in that, If the dosage form of the traditional Chinese medicine composition is an oral liquid, it is mainly prepared by the following method: mixing the raw materials of the traditional Chinese medicine composition, decocting with water equivalent to 3 to 20 times the total weight of the raw materials, and then filtering and concentrating in sequence to obtain the oral liquid.

8. The traditional Chinese medicine composition for treating insomnia according to claim 5, characterized in that, If the dosage form of the traditional Chinese medicine composition is granules, it is mainly prepared by the following method: mixing the raw materials of the traditional Chinese medicine composition, grinding them into fine powder and passing them through an 800-1000 mesh sieve, adding starch equivalent to 0.5-2 times the total weight of the raw materials, and pressing them into granules.

9. The application of a traditional Chinese medicine composition for treating insomnia, characterized in that, The traditional Chinese medicine composition for treating insomnia according to any one of claims 1 to 3 is used in the preparation of a medicament for treating insomnia.

10. The application of the traditional Chinese medicine composition for treating insomnia according to claim 9, characterized in that, The insomnia mentioned is insomnia due to deficiency of heart and spleen blood.

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