Traditional Chinese medicine decoction for treating insomnia and preparation method thereof

Abstract

The invention discloses a traditional Chinese medicine decoction for treating insomnia and a preparation method of the traditional Chinese medicine decoction, and relates to the technical field of traditional Chinese medicine decoction, the traditional Chinese medicine decoction is prepared from a traditional Chinese medicine composition, and the traditional Chinese medicine composition is prepared from 3-8 g of cassia twig, 4-9 g of liquorice, 25-35 g of dragon bone, 25-35 g of oyster, 10-20 g of semen cuscutae, 10-20 g of morinda officinalis, 10-20 g of poria with hostwood and 5-15 g of polygala tenuifolia. The traditional Chinese medicine decoction has the effects of regulating the heart and kidney, regulating yin and yang, and calming the heart and tranquilizing the mind, can shorten the sleeping time, prolong the sleeping time and improve the sleeping quality of a heart-yang deficiency type insomnia patient, and provides a new idea and an effective prescription for treating the insomnia by the traditional Chinese medicine.

Description

Technical Field

[0001] The invention relates to the technical field of traditional Chinese medicine decoctions, and in particular to a traditional Chinese medicine decoction for treating insomnia and a preparation method thereof. Background Art

[0002] Insomnia is the most common sleep disorder clinically, which is often manifested as difficulty falling asleep, easy awakening, and frequent dreams, which seriously affects the patient's quality of life and work efficiency.

[0003] Western medicine often uses sedatives and hypnotic drugs to treat insomnia. Although they can significantly improve sleep in the short term, they also have the following problems: 1. Drug residual effect: Some drugs stay in the body for a long time, which may cause daytime sleepiness and inattention; 2. Cognitive function impairment: Long-term use may affect cognitive ability, leading to memory loss and slow reaction; 3. Potential addictiveness: Some drugs are addictive, and patients may rely on drugs to fall asleep and find it difficult to restore normal sleep.

[0004] From the perspective of traditional Chinese medicine treatment, studies have found that patients with heart yang deficiency type insomnia are becoming more common in clinical practice, but related research is relatively rare. Summary of the invention

[0005] The purpose of the present invention is to solve the above problems and provide a Chinese medicine decoction for treating insomnia and a preparation method thereof.

[0006] In order to achieve the above-mentioned purpose, the technical scheme of the present invention is as follows: a Chinese medicine decoction for treating insomnia, wherein the raw materials of the Chinese medicine decoction are processed from a Chinese medicine composition, wherein the Chinese medicine composition is composed of 3-8 grams of cinnamon twig, 4-9 grams of licorice, 25-35 grams of dragon bone, 25-35 grams of oyster, 10-20 grams of dodder seed, 10-20 grams of Morinda officinalis, 10-20 grams of Poria, and 5-15 grams of Polygala tenuifolia.

[0007] Preferably, the weight ratio of cinnamon twig, liquorice, dragon bone, oyster, dodder seed, Morinda officinalis, poria and polygala in the traditional Chinese medicine composition is 1:1.2:6:6:3:3:3:2.

[0008] Preferably, the ratio of the traditional Chinese medicine composition is 5 grams of cinnamon twig, 6 grams of licorice, 30 grams of dragon bone, 30 grams of oyster, 15 grams of dodder seed, 15 grams of Morinda officinalis, 15 grams of poria, and 10 grams of polygala.

[0009] The present invention also provides a method for preparing the above-mentioned Chinese herbal decoction for treating insomnia, comprising the following steps: preparing the required medicinal materials according to the raw material formula ratio of the Chinese herbal decoction, first carefully rinsing the dragon bones and oysters with clean water to remove impurities and salt on the surface, then putting all the dry medicinal materials into a clean container, adding clean water, and soaking for 30 minutes, then pouring the soaked medicinal materials together with the soaking water into a cooking pot, boiling over high heat, then simmering over low heat, keeping it in a slightly open state, and cooking for 30 minutes; after cooking, filtering the soup with gauze or a fine sieve, taking out the clear soup, and discarding the residue.

[0010] Compared with the prior art, this solution has the following beneficial effects:

[0011] The flavored Guizhi Gancao Longgu Muli Decoction provided by the present invention can significantly improve the sleep quality of patients with heart yang deficiency type insomnia by calming the mind, replenishing heart yang and harmonizing yin and yang. Its ingredients such as dragon bone and oyster can relieve anxiety and enhance deep sleep time, while Guizhi and Morinda officinalis can improve heart function. In addition, the recipe also promotes the regulation of serum 5-HT levels, improves mood and mental state, has high safety, is suitable for long-term use, and effectively relieves symptoms such as palpitations, shortness of breath and fatigue. DETAILED DESCRIPTION

[0012] In order to enable those skilled in the art to better understand the solution of the present invention, the technical solution of the present invention will be further described in detail below in conjunction with the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, rather than all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in the field without creative work should fall within the scope of protection of the present invention.

[0013] It should be noted that, in the absence of conflict, the embodiments and features in the embodiments of the present invention can be combined with each other. The present invention will be described in detail below in conjunction with the embodiments.

[0014] Example:

[0015] 1. Prepare raw materials

[0016] A Chinese medicinal decoction for treating insomnia: modified cinnamon twig, licorice, dragon bone and oyster soup, the raw materials of the Chinese medicinal decoction are processed from a Chinese medicinal composition, wherein the proportions of the ingredients in the Chinese medicinal composition are: 5 grams of cinnamon twig, 6 grams of licorice, 30 grams of dragon bone, 30 grams of oyster, 15 grams of dodder seed, 15 grams of Morinda officinalis, 15 grams of poria and 10 grams of polygala.

[0017] 2 Preparation method

[0018] Preparation method of modified cinnamon twig, licorice, dragon bone and oyster soup

[0019] Prepare raw materials: Prepare the required medicinal materials according to the recipe ratio, and ensure that the medicinal materials are fresh and free of mold.

[0020] Cleaning the ingredients: Rinse the keel and oysters carefully with clean water to remove impurities and salt on the surface. Use a small brush to gently scrub to ensure cleanliness.

[0021] Soaking: Put all the dry herbs in a clean container, add enough water (about 500 ml), and soak for about 30 minutes. During the soaking process, you can stir gently to help the herbs absorb water better and promote the release of medicinal effects.

[0022] Cooking: Pour the soaked herbs and the soaking water into a pot, add about 250 ml of water (about 750 ml of total water). After boiling over high heat, turn to low heat and simmer, keep it slightly boiling, and cook for about 30 minutes. This process helps to fully release the active ingredients in the herbs.

[0023] Filter: After cooking, filter the soup through gauze or a fine sieve, remove the clear soup, and discard the residue. You can use a spoon to gently squeeze the residue to extract more soup.

[0024] Repackaging: Repack the filtered decoction into clean, airtight containers, avoid direct sunlight, and store in a cool, dry place.

[0025] 3. Directions:

[0026] It is recommended to drink 200-300 ml each time, and it is best to drink it warm.

[0027] It can be consumed 1-2 times a day, and it is recommended to be consumed 1 hour before bedtime to help improve sleep quality.

[0028] The following experiments demonstrate that the Chinese medicine composition provided by the present invention can be used to treat patients with insomnia of heart yang deficiency type.

[0029] 3 Clinical trials

[0030] 1) Research subjects:

[0031] Fifty patients with insomnia of heart yang deficiency type who were hospitalized in the outpatient department of neurology at Shanghai Baoshan District Hospital of Integrated Traditional Chinese and Western Medicine were selected as the research subjects.

[0032] 2) Grouping:

[0033] The patients were divided into an observation group and a control group in a 1:1 ratio using the block randomization method.

[0034] 3) Treatment methods:

[0035] The observation group was treated with modified Guizhi Gancao Longgu Muli Decoction for 2 weeks; the control group was treated with Estazolam tablets for 2 weeks.

[0036] 4) Observation indicators:

[0037] Evaluation of clinical efficacy: The clinical efficacy of modified Guizhi Gancao Longgu Muli Decoction in the treatment of insomnia of heart yang deficiency type was evaluated by comparing the changes in patients' sleep monitoring data, PSQI scale scores, and TCM symptom scores before and after treatment.

[0038] Regulatory effect on the level of neurotransmitter 5-HT: The double-antibody sandwich ELISA method was used to detect the 5-HT level in the patients' serum before and after treatment, and the regulatory effect of modified Guizhi Gancao Longgu Muli Decoction on the 5-HT level was observed.

[0039] Drug safety evaluation: The adverse reaction scale was measured after the first and second weeks of treatment. Blood routine, liver and kidney function, and electrocardiogram were tested before and after treatment to evaluate the clinical safety of Jiawei Guizhi Gancao Longgu Muli Decoction.

[0040] 5) Diagnostic criteria

[0041] 5.1 Western medicine diagnostic criteria

[0042] Western medicine diagnoses it as "insomnia", and the diagnostic criteria refer to the "International Classification of Sleep Disorders".

[0043] (1) Insomnia is the main symptom, including difficulty falling asleep, frequent dreams during sleep, shallow sleep and easy awakening, early awakening, difficulty falling asleep again after awakening, total sleep time less than 6 hours per night, fatigue, dizziness and discomfort after waking up, etc., which affect normal daytime life;

[0044] (2) Being overly concerned about sleep status and the consequences of insomnia;

[0045] (3) Dissatisfaction with sleep time and quality has caused or has caused social impairment, such as memory loss, emotional instability, lack of energy, and decreased social functions such as work or study;

[0046] (4) At least 3 times a week and not less than 1 month;

[0047] (5) Exclude secondary insomnia caused by medication, symptoms of mental disorders, or physical illness.

[0048] 5.2 TCM syndrome diagnostic criteria:

[0049] The insomnia caused by heart yang deficiency syndrome should refer to the "Diagnosis and Efficacy Standards for Chinese Medicine Internal Medicine Diseases" and "Chinese Medicine Diagnosis".

[0050] Insomnia: Difficulty falling asleep, or light sleep and waking up easily, difficulty falling asleep again after waking up, and in severe cases, difficulty sleeping all night.

[0051] Heart Yang Deficiency Syndrome: The main symptoms are insomnia, chest tightness, shortness of breath, palpitations, and restlessness; the secondary symptoms are headache and dizziness, frequent dreams and amnesia, fear of cold and cold limbs, spontaneous sweating and fatigue, or pale complexion. White, or dark purple face and lips; pale, fat or bluish-purple tongue, white and smooth tongue coating, weak or knotted or intermittent pulse.

[0052] The main symptoms were scored as 0, 2, 4, or 6 points according to their severity; the secondary symptoms were scored as 0, 1, 2, or 3 points according to their severity; the absence of tongue coating and pulse was scored as 0 point; presence of tongue coating and pulse was scored as 1 point.

[0053] 5.3 Inclusion criteria

[0054] (1) The patient must meet both the Western medical diagnostic criteria for insomnia and the TCM diagnostic criteria for heart yang deficiency, with a disease duration of 1 month or longer;

[0055] (2) Age 18–80 years old;

[0056] (3) Not participating in other research projects at the same time;

[0057] (4) Patients who are able to accept the Chinese medicine treatment specified in this experiment and sign the informed consent.

[0058] 5.4 Exclusion criteria

[0059] (1) Those who do not meet the inclusion criteria;

[0060] (2) Those who have taken medications that may affect sleep in the past week;

[0061] (3) Patients with serious primary diseases of the heart, brain, kidney, lung, endocrine, blood, metabolism and gastrointestinal tract, or mental illness;

[0062] (4) Pregnant or lactating women;

[0063] (5) Alcoholics, drug abusers, and those with severe drug dependence;

[0064] (6) Patients who are allergic to benzodiazepines and Chinese herbal medicines;

[0065] 5.5 Rejection and shedding criteria

[0066] (1) Cases that did not meet the inclusion criteria and were mistakenly included;

[0067] (2) Using other similar drugs at the same time during the trial, or participating in other similar clinical observations;

[0068] (3) poor compliance, failure to take medication as required, making it difficult to assess the efficacy of the medication;

[0069] (4) Those who voluntarily terminated the trial or were unable to continue participating in the trial due to the effects of medication;

[0070] (5) Those who have experienced serious adverse events, complications and can no longer receive treatment, or whose condition worsens.

[0071] 6) Experimental design

[0072] Randomization method: Simple randomization method was used for case grouping. The specific randomization method was that clinical researchers used SAS (Statistical Analysis System) software to obtain random numbers, and made random allocation cards, which were sealed with envelopes. The envelope serial number coincided with the card serial number. When qualified cases entered the trial, they opened envelopes with the same number in the order of their entry, and were treated according to the grouping specified on the card in the envelope. The random number table was saved as required.

[0073] A randomized controlled trial method was used to allocate eligible subjects to two groups at a ratio of 1:1: 25 cases in the modified Guizhi Gancao Longgu Muli Decoction group (observation group) and 25 cases in the estazolam tablets group (control group).

[0074] 7) Observation indicators

[0075] (1) Main observation indicators

[0076] ①Sleep monitoring data

[0077] During the treatment, the Xiaomi wristband is used to monitor the patient's sleep. According to the monitored sleep conditions of the patient: deep sleep time and light sleep time, statistical software is used to analyze the data and analyze the patient's sleep condition;

[0078] Sleep monitoring efficacy evaluation criteria

[0079] The efficacy is judged according to the international standard of increasing the patient's deep sleep time:

[0080] Calculation formula: Deep sleep increase time (h) = deep sleep time after treatment - deep sleep time before treatment

[0081] Recovery: Deep sleep time increased by 2-3 hours;

[0082] Significant effect: Deep sleep time increased by 1-2 hours;

[0083] Effective: Deep sleep time increased by 0-1h;

[0084] Ineffective: Deep sleep time is reduced;

[0085] The total effective rate is equal to the sum of cure, marked effect and effectiveness. The statistical results are shown in Table 1.

[0086] Table 1 Sleep monitoring data (before and after treatment)

[0087]

[0088] ②Pittsburgh Sleep Quality Index (PSQI) score:

[0089] Two trained assessors will evaluate the patients with the PSQI scale, usually through conversation and observation. After the examination, the two assessors will score independently. There are 7 scoring items in the table, each of which is scored as 0, 1, 2, or 3 according to the actual situation of the patient, with a total of 21 points. The higher the score, the worse the sleep condition.

[0090] PSQI scale score reduction rate method assessment standard:

[0091] Calculation formula: score reduction rate = (baseline total score - total score after treatment) / baseline total score × 100% cure: score reduction rate is between 75% and 100%;

[0092] Significantly effective: score reduction rate is between 50%-74%;

[0093] Effective: The reduction rate is between 25% and 49%;

[0094] Ineffective: reduction rate <25%.

[0095] The total effective rate is equal to the sum of cure, marked effect and effectiveness; the statistical results are shown in Table 2.

[0096] Table 2 PSQI scale scores

[0097]

[0098] (2) Secondary observation index

[0099] ①TCM clinical syndrome scoring scale

[0100] Two trained assessors will evaluate the patients using the TCM syndrome scoring scale, generally through conversation and observation. After the examination, the two assessors will independently score the patients. The scale is divided into 10 scoring items, and each item is scored as 0, 1, 2, or 3 according to the patient's actual situation. The total score is 30 points. The tongue coating and pulse are only observed and recorded, and are not scored.

[0101] Evaluation standard of medical syndrome efficacy

[0102] Calculation formula: Reduction rate = (baseline total score - total score after treatment) / baseline total score × 100% Recovery: The patient's symptoms basically disappear, and the reduction rate is between 75% and 100%;

[0103] Markedly effective: The patient's symptoms are significantly improved, with a reduction rate of 50%-74%;

[0104] Effective: The patient's symptoms are improved, with a reduction rate of 25%-49%;

[0105] Ineffective: The patient's symptoms did not improve or even worsened, and the score reduction rate was <25%.

[0106] The total effective rate is equal to the sum of cure, marked effect and effectiveness; the results are shown in Table 3.

[0107] Table 3 TCM symptom scores

[0108]

[0109] ② Serum 5-HT level

[0110] Blood was collected from the elbow vein at 07:00-09:00 in the morning before and after treatment. Strenuous exercise and drinking should be avoided within 24 hours before blood collection, and eating and sleeping habits should not be changed. Fasting for 12 hours before blood collection was carried out in strict accordance with the blood volume required by the hospital's unified vacuum negative pressure test tube. Blood was sent to the laboratory for testing at 10:00 in the morning of the same day. The double antibody sandwich ELISA method was used to detect serum 5-HT levels. The statistical results are shown in Table 4.

[0111] Table 4 Neurotransmitter levels (5-HT)

[0112]

[0113] The above specific embodiments are merely explanations of the present invention and are not limitations of the present invention. After reading this specification, those skilled in the art may make modifications to the embodiments without any creative contribution as needed. However, such modifications are protected by the patent law as long as they are within the scope of the claims of the present invention.

Claims

1. A Chinese medicine decoction for treating insomnia, wherein the raw materials of the Chinese medicine decoction are processed from a Chinese medicine composition, characterized in that: The Chinese medicine composition consists of 3-8 grams of cassia twig, 4-9 grams of liquorice, 25-35 grams of dragon bone, 25-35 grams of oyster, 10-20 grams of dodder seed, 10-20 grams of Morinda officinalis, 10-20 grams of poria and 5-15 grams of polygala.

2. A Chinese medicinal decoction for treating insomnia as claimed in claim 1, characterized in that: The weight ratio of cinnamon twig, liquorice, dragon bone, oyster, dodder seed, Morinda officinalis, poria and polygala in the traditional Chinese medicine composition is 1:1.2:6:6:3:3:3:

2.

3. A Chinese medicinal decoction for treating insomnia as claimed in claim 1, characterized in that: The proportion of the Chinese medicine composition is 5 grams of cinnamon twig, 6 grams of liquorice, 30 grams of dragon bone, 30 grams of oyster, 15 grams of dodder seed, 15 grams of Morinda officinalis, 15 grams of poria, and 10 grams of polygala.

4. A method for preparing a Chinese medicinal decoction for treating insomnia according to any one of claims 1 to 3, characterized in that: The following steps are involved: Prepare the required medicinal materials according to the formula ratio of Chinese herbal decoction. First, rinse the dragon bones and oysters carefully with clean water to remove impurities and salt on the surface. Then put all the dry medicinal materials into a clean container, add clean water, and soak for 30 minutes. Then pour the soaked medicinal materials together with the soaking water into the cooking pot. After boiling over high heat, turn to low heat and simmer, keep it in a slightly open state, and cook for 30 minutes. After cooking, use gauze or a fine sieve to filter the soup, take out the clear soup, and discard the residue.

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