A Traditional Chinese Medicine Composition for Calming the Nerves and Promoting Sleep, Its Preparation Method and Application

Abstract

This invention discloses a traditional Chinese medicine composition for calming the mind and aiding sleep. This composition is prepared from the following raw materials in the indicated weight ratios: 10-15 parts peach kernel, 6-10 parts cinnamon twig, 3-10 parts rhubarb, 10-15 parts angelica root, 10-15 parts codonopsis root, 10-15 parts jujube seed, 15-30 parts mother-of-pearl, 3-10 parts fossilized teeth, 3-6 parts licorice root, and 5-10 parts mirabilite. Through extensive clinical trials, this traditional Chinese medicine compound composition for calming the mind and aiding sleep has shown good efficacy in treating sleep disorders caused by blood deficiency, blood stasis, phlegm-fire, and liver stagnation.

Description

Technical Field

[0001] The present invention relates to the field of traditional Chinese medicine, and particularly to a traditional Chinese medicine compound composition for soothing the nerves and promoting sleep, its preparation method and application. Background Art

[0002] Insomnia refers to the most common sleep disorder in which, under sufficient time and suitable environment, there is persistent difficulty in falling asleep, sleep maintenance disorder or poor sleep quality, and it affects daytime work and life. Its clinical manifestations are difficulty in falling asleep, persistent difficulty in sleeping (night waking), and early waking. These three symptoms may be mainly manifested by one symptom, or may coexist, and are accompanied by daytime discomfort as the main complaint. According to statistics, 40% - 50% of the world's population suffers from insufficient sleep. Long-term insomnia can lead to memory loss and reduced immune function in insomniacs, and even trigger mental diseases such as anxiety disorder and depression. Some studies have shown that sleep disorders are also closely related to the occurrence and development of organic diseases such as cardiovascular diseases. Western medicine treatment often adopts cognitive behavioral (CBT-I) non-drug therapy, as well as prescription drug therapies such as hypnosis and anti-anxiety. Although CBT-I is safe and effective, patients' recognition of CBT-I is not high, resulting in poor compliance; while long-term use of prescription drugs is prone to many adverse reactions such as drug resistance and dependence, making patients have resistance and fear psychology, thus increasing the physical and mental burden. Insomnia is also called "wakefulness" in traditional Chinese medicine. Its basic pathogenesis is yang excess and yin deficiency, with the loss of the intersection of yin and yang. The specific manifestations are: one is that yin deficiency cannot contain yang, and the other is that yang excess cannot enter yin. The pathological nature has two aspects of deficiency and excess. Liver depression transforming into fire and phlegm-heat disturbing the interior, with restlessness of the mind being excess; deficiency of the heart and spleen, deficiency of the heart and gallbladder qi, and disharmony between the heart and kidney, with the mind losing nourishment being deficiency. However, in long-term illness, it can be manifested as a combination of deficiency and excess, or caused by blood stasis. That is, the syndrome of insomnia is caused by various factors leading to disorder of qi and blood circulation, loss of the intersection of yin and yang, and the soul not being stored. Traditional Chinese medicine has many advantages in treating insomnia, such as multiple targets, good curative effect, safety and reliability. Summary of the Invention

[0003] The purpose of the present invention is to provide a new traditional Chinese medicine compound, which can be used for soothing the nerves and promoting sleep, and broaden the scope of drugs for the syndrome of wakefulness.

[0004] To achieve the above purpose, the present invention provides a traditional Chinese medicine composition for soothing the nerves and promoting sleep, which is prepared from the following raw materials in parts by weight: 10 - 15 parts of peach kernels, 6 - 10 parts of cassia twigs, 3 - 10 parts of rhubarb, 10 - 15 parts of angelica sinensis, 10 - 15 parts of codonopsis pilosula, 10 - 15 parts of wild jujube seeds, 15 - 30 parts of nacre, 3 - 10 parts of dragon's teeth, 3 - 6 parts of licorice, and 5 - 10 parts of mirabilite.

[0005] Among the above raw materials, peach kernels are prepared from stir-fried peach kernels, rhubarb is raw rhubarb, angelica sinensis is raw angelica sinensis, licorice is raw licorice, nacre is calcined nacre, and dragon's teeth are calcined dragon's teeth.

[0006] In some embodiments, as a preferred embodiment, the traditional Chinese medicine composition of the present invention is prepared from the following raw materials in the indicated weight ratios: 12 parts peach kernel, 8 parts cinnamon twig, 6 parts rhubarb, 12 parts angelica, 12 parts codonopsis, 12 parts jujube seed, 20 parts mother-of-pearl, 6 parts dragon teeth, 3 parts licorice, and 6 parts mirabilite.

[0007] The above-mentioned traditional Chinese medicine composition is prepared by the following method: mother-of-pearl and dragon teeth are crushed, wrapped in gauze, and decocted in water for 25-45 minutes; peach kernel, cinnamon twig, rhubarb, angelica, codonopsis, jujube seed and licorice are soaked in water for 30-60 minutes, then added to the decoction of mother-of-pearl and dragon teeth, decocted for 30-45 minutes, filtered, and the decoction is reserved. The dregs are then decocted in water for 20-30 minutes, the dregs are filtered, the decoctions are combined, Glauber's salt is added, and stirred evenly.

[0008] For mass production in factories, the preferred method for preparing the traditional Chinese medicine compound composition of the present invention is as follows: mother-of-pearl and dragon teeth are crushed and mixed with peach kernel, cinnamon twig, rhubarb, angelica, codonopsis, jujube seed and licorice. After soaking in water for 30-60 minutes, the mixture is heated and extracted for 3-4 hours. After filtration, the aqueous extract is reserved. The residue is then heated and extracted again for 1.5-3 hours. The residue is filtered, the aqueous extracts are combined, Glauber's salt is added, and the mixture is stirred evenly.

[0009] After the above-mentioned mixture is added, the amount of water added for the first heating extraction is 5 to 10 times, and the amount of water added for the second heating extraction is 4 to 8 times.

[0010] The present invention also provides a traditional Chinese medicine preparation for calming the mind and aiding sleep, which is a decoction prepared using the above-mentioned traditional Chinese medicine composition.

[0011] The traditional Chinese medicine preparations of the present invention can also be prepared by adding pharmaceutical excipients to the above-mentioned traditional Chinese medicine composition, including oral liquids, granules, tablets, capsules, pills or ointments.

[0012] Specifically, after adding Glauber's salt, the above composition is heated over low heat for 10 minutes and stirred evenly to obtain a decoction.

[0013] The decoction is concentrated under reduced pressure at 40-80℃ to a density of 1.05-1.25, and then excipients acceptable to the drug are added to prepare an oral liquid.

[0014] The decoction is concentrated under reduced pressure at 40-80℃ to a density of 1.15-1.30, and then excipients acceptable to the drug are added to prepare an ointment.

[0015] The decoction is concentrated under reduced pressure at 40-80℃ to a clear paste with a density of 1.25-1.40. The concentrated paste is dried at 50-90℃. After the dried paste is pulverized, pharmaceutically acceptable excipients are added to prepare any one of granules, tablets, capsules, or pills.

[0016] This invention also provides the application of the above-mentioned traditional Chinese medicine composition in the preparation of sedative and sleep-aiding drugs.

[0017] Especially in the preparation of medicines for treating sleep disorders caused by blood deficiency, blood stasis, phlegm-fire, or liver stagnation.

[0018] This invention, based on Taohe Chengqi Decoction, adds Angelica sinensis, Codonopsis pilosula, Ziziphus jujuba var. spinosa, fossilized teeth, and mother-of-pearl to enhance its calming effect. In this formula, peach kernel is bitter, sweet, and neutral, possessing the function of invigorating blood and removing blood stasis; rhubarb is bitter and cold, used to purge heat and remove blood stasis. The combination of these two herbs promotes blood circulation and regulates qi and blood, serving as the principal herbs. Angelica sinensis is sweet, warm, and moistening, nourishing and invigorating blood; Codonopsis pilosula is sweet and neutral, tonifying the middle jiao and replenishing qi and blood. Angelica sinensis and Codonopsis pilosula work together to replenish qi and nourish blood. Glauber's salt is salty, bitter, and cold, purging heat and softening hardness, eliminating phlegm, heat, dampness, and blood stasis; cinnamon twig is pungent, sweet, and warm, promoting blood circulation. It assists peach kernel and Angelica sinensis in invigorating blood and removing blood stasis, while preventing the cold and blood-clotting effects of Glauber's salt and rhubarb. Cinnamon twig, when used with Glauber's salt and rhubarb, complements each other. Cinnamon twig, when combined with Glauber's salt and rhubarb, becomes warm and unblocking without promoting heat; Glauber's salt and rhubarb, when combined with cinnamon twig, become cold and purging without being too cooling. Angelica sinensis, Codonopsis pilosula, cinnamon twig, and Glauber's salt serve as the assistant herbs. Sour jujube seed, dragon's teeth, and mother-of-pearl are used as adjuvant herbs to calm the mind and soothe the nerves. Licorice root protects the stomach and soothes the nerves, and moderates the harshness of the other herbs, serving as the guiding herb. The entire formula works to nourish and invigorate the blood, and calm the mind and soothe the nerves.

[0019] The traditional Chinese medicine compound composition for calming the mind and aiding sleep provided by this invention has shown good efficacy in treating sleep disorders caused by blood deficiency, blood stasis, phlegm-fire, and liver stagnation through extensive clinical trials. Detailed Implementation

[0020] The present invention will be further illustrated below with reference to specific embodiments. It should be understood that these embodiments are for illustrative purposes only and are not intended to limit the scope of the invention. After reading the present invention, any modifications of the present invention in various equivalent forms by those skilled in the art will fall within the scope defined by the appended claims.

[0021] In the following examples, the raw materials used are: roasted peach kernels, raw rhubarb, raw angelica, raw licorice, calcined mother-of-pearl, and calcined dragon teeth. All of these are commercially available Chinese medicinal materials.

[0022] Example 1

[0023] Weigh out 12g of peach kernel, 8g of cinnamon twig, 6g of rhubarb, 12g of angelica root, 12g of codonopsis root, 12g of jujube seed, 20g of mother-of-pearl, 6g of dragon teeth, 3g of licorice root, and 6g of mirabilite. Crush the mother-of-pearl and dragon teeth, wrap them in gauze, add 8 times the amount of water, and decoct over high heat for 40 minutes. Add 8 times the amount of water to the peach kernel, cinnamon twig, rhubarb, angelica root, codonopsis root, jujube seed, and licorice root, soak them for 30 minutes, add them to the decoction of mother-of-pearl and dragon teeth, decoct over high heat for 40 minutes, filter, and set aside the decoction. Add 8 times the amount of water to the dregs, decoct over high heat for 30 minutes, filter the dregs, combine the decoctions, add mirabilite, heat over low heat for 10 minutes, stir well, and the decoction is ready.

[0024] Example 2

[0025] Weigh out 12 kg of peach kernels, 8 kg of cinnamon twigs, 6 kg of rhubarb, 12 kg of angelica root, 12 kg of codonopsis root, 12 kg of jujube seed, 20 kg of mother-of-pearl, 6 kg of fossilized teeth, 3 kg of licorice root, and 6 kg of mirabilite. Crush the mother-of-pearl and fossilized teeth, mix them with the peach kernels, cinnamon twigs, rhubarb, angelica root, codonopsis root, jujube seed, and licorice root, add 10 times the amount of water, soak for 60 minutes, heat to extract for 4 hours, filter, and reserve the aqueous extract. Add 8 times the amount of water to the residue, heat to extract for 3 hours, filter the residue, combine the aqueous extracts, add mirabilite, heat for 10 minutes, and stir well. Concentrate the aqueous extract under reduced pressure at 70-80℃ to a density of 1.10-1.15, add acceptable flavoring agents and other excipients, and prepare an oral liquid.

[0026] Example 3

[0027] Weigh out 10 kg of peach kernels, 6 kg of cinnamon twigs, 3 kg of rhubarb, 10 kg of angelica root, 10 kg of codonopsis root, 10 kg of jujube seed, 15 kg of mother-of-pearl, 3 kg of fossilized teeth, 3 kg of licorice root, and 5 kg of mirabilite. Crush the mother-of-pearl and fossilized teeth, mix them with the peach kernels, cinnamon twigs, rhubarb, angelica root, codonopsis root, jujube seed, and licorice root, add 8 times the amount of water, soak for 40 minutes, heat to extract for 3 hours, filter, and reserve the aqueous extract. Add 6 times the amount of water to the residue, heat to extract for 2 hours, filter the residue, combine the aqueous extracts, add mirabilite, heat for 10 minutes, and stir well. Concentrate the aqueous extract under reduced pressure at 70-80℃ to a density of 1.18-1.25, add acceptable flavoring agents and other excipients to prepare a decoction.

[0028] Example 4

[0029] Weigh out 15kg of peach kernels, 10kg of cinnamon twigs, 6kg of rhubarb, 15kg of angelica root, 15kg of codonopsis root, 15kg of jujube seed, 25kg of mother-of-pearl, 5kg of fossilized teeth, 5kg of licorice root, and 6kg of mirabilite. Crush the mother-of-pearl and fossilized teeth, mix them with the peach kernels, cinnamon twigs, rhubarb, angelica root, codonopsis root, jujube seed, and licorice root, add 10 times the amount of water, soak for 40 minutes, heat to extract for 3 hours, filter, and reserve the aqueous extract. Add 8 times the amount of water to the residue, heat to extract for 1.5 hours, filter the residue, combine the aqueous extracts, add mirabilite, heat for 10 minutes, and stir well. Concentrate the decoction under reduced pressure at 75-80℃ to a clear extract with a density of 1.33-1.36. Dry the concentrated extract at 60-80℃, pulverize the dried extract, and add acceptable excipients, flavoring agents, and other excipients to prepare granules or tablets.

[0030] Example 5: Clinical efficacy evaluation of patients with insomnia

[0031] From September 2021 to June 2022, Jiangsu Academy of Traditional Chinese Medicine conducted a clinical efficacy observation of the herbal composition of this invention on patients with insomnia. A total of 60 cases were included, of which 30 cases were in the herbal composition group of this invention and 30 cases were in the control group. The treatment course was 3 months.

[0032] (1) Diagnostic criteria

[0033] Western medical diagnostic criteria: Refer to the relevant diagnostic criteria for sleep disorders in the Diagnostic and Statistical Manual of Mental Disorders published by the American Psychiatric Association in 2016.

[0034] Traditional Chinese Medicine (TCM) diagnostic criteria: Based on the "Standards for Diagnosis and Efficacy of TCM Diseases and Syndromes" formulated by the Key Specialty Collaboration Group of the State Administration of Traditional Chinese Medicine, the syndromes are manifested as liver stagnation, blood deficiency, blood stasis, phlegm-heat, etc.

[0035] Inclusion criteria: meeting the diagnostic criteria of both Western and Traditional Chinese Medicine; gender not limited, age 20-65 years; no use of sedative or hypnotic drugs within 1 month; informed consent and good compliance of the subjects.

[0036] (2) Experimental methods and observation indicators

[0037] The traditional Chinese medicine treatment group received a decoction of the traditional Chinese medicine composition prepared in Example 1 of this invention, one dose per day; the control group received oryzanol, three times per day. The treatment course was three months.

[0038] Observation indicators:

[0039] The PSQI was used to assess patients' sleep quality, with assessments conducted before and after treatment. (Cure: PSQI total score reduction rate ≥75%; Significant effect: PSQI total score reduction rate ≥50% and <75%; Effective: PSQI total score reduction rate ≥25% and <50%; Ineffective: PSQI total score reduction rate <25%;)

[0040] (3) Results

[0041] Table 1 shows that the PSQI scores of the traditional Chinese medicine composition group and the control group decreased by 57.99% and 40.96% respectively after treatment, indicating that the sleep disorders were improved compared with those before treatment (P<0.05); the effect of the traditional Chinese medicine composition group on improving sleep disorders was significantly better than that of the control group (P<0.05).

[0042] Table 1. Comparison of PSQI scores before and after treatment (x±s, n=3)

[0043] Group Before treatment After treatment Deduction Difference Traditional Chinese medicine composition group 15.19±3.31 6.38±1.71# 8.81±2.10* control group 15.33±3.20 9.05±2.28# 6.28±1.82

[0044] Note: Compared with the group before treatment, #P<0.05; compared with the control group after treatment, *P<0.05.

[0045] The above description is only a preferred embodiment of the present invention. It should be noted that for those skilled in the art, several improvements and modifications can be made without departing from the principle of the present invention, and these improvements and modifications should also be considered within the scope of protection of the present invention.

Claims

1. A traditional Chinese medicine composition for calming the nerves and aiding sleep, characterized in that, The traditional Chinese medicine composition is prepared from the following raw materials in the indicated weight ratios: 10-15 parts peach kernel, 6-10 parts cinnamon twig, 3-10 parts rhubarb, 10-15 parts angelica, 10-15 parts codonopsis, 10-15 parts jujube seed, 15-30 parts mother-of-pearl, 3-10 parts dragon teeth, 3-6 parts licorice, and 5-10 parts mirabilite. The traditional Chinese medicine composition is prepared by the following method: The mother-of-pearl and dragon teeth are pulverized, wrapped in gauze, and decocted in water for 25-45 minutes. The peach kernel, cinnamon twig, rhubarb, angelica, codonopsis, jujube seed, and licorice are soaked in water for 30-60 minutes, then added to the decoction of mother-of-pearl and dragon teeth, decocted for 30-45 minutes, filtered, and the decoction is reserved. The dregs are then decocted again in water for 20-30 minutes, the dregs are filtered, the decoctions are combined, mirabilite is added, and the mixture is stirred evenly.

2. The traditional Chinese medicine composition according to claim 1, characterized in that, The traditional Chinese medicine composition is prepared from the following raw materials in the indicated weight ratios: 12 parts peach kernel, 8 parts cinnamon twig, 6 parts rhubarb, 12 parts angelica, 12 parts codonopsis, 12 parts jujube seed, 20 parts mother-of-pearl, 6 parts fossilized teeth, 3 parts licorice, and 6 parts mirabilite.

3. The method for preparing the traditional Chinese medicine composition according to claim 1 or 2, characterized in that, The traditional Chinese medicine composition is prepared by the following method: mother-of-pearl and dragon teeth are crushed, wrapped in gauze, and decocted in water for 25-45 minutes; peach kernel, cinnamon twig, rhubarb, angelica, codonopsis, jujube seed and licorice are soaked in water for 30-60 minutes, then added to the decoction of mother-of-pearl and dragon teeth, decocted for 30-45 minutes, filtered, and the decoction is reserved. The dregs are then decocted in water for 20-30 minutes, the dregs are filtered, the decoctions are combined, Glauber's salt is added, and stirred evenly.

4. The method for preparing the traditional Chinese medicine composition according to claim 1 or 2, characterized in that, The traditional Chinese medicine composition is prepared by the following method: mother-of-pearl and dragon teeth are crushed and mixed with peach kernel, cinnamon twig, rhubarb, angelica, codonopsis, jujube seed and licorice. After soaking in water for 30-60 minutes, the mixture is heated and extracted for 3-4 hours. After filtration, the aqueous extract is reserved. The residue is then heated and extracted again for 1.5-3 hours. The residue is filtered, the aqueous extracts are combined, Glauber's salt is added, and the mixture is stirred evenly.

5. A traditional Chinese medicine preparation for calming the mind and aiding sleep, wherein the traditional Chinese medicine preparation is a decoction prepared using the traditional Chinese medicine composition according to claim 1 or 2.

6. A traditional Chinese medicine preparation for calming the mind and aiding sleep, wherein the traditional Chinese medicine preparation is prepared by adding pharmaceutical excipients to the traditional Chinese medicine composition according to claim 1 or 2, and wherein the traditional Chinese medicine preparation is an oral liquid, granules, tablets, capsules, pills or ointment.

7. The use of the traditional Chinese medicine composition according to claim 1 or 2 in the preparation of a sedative and sleep-aiding drug.

8. The use of the traditional Chinese medicine composition according to claim 1 or 2 in the preparation of a medicine for treating sleep disorders caused by blood deficiency, blood stasis, phlegm-fire or liver stagnation.