Traditional Chinese medicine composition for treating early awakening type insomnia and preparation method thereof

Abstract

The invention discloses a traditional Chinese medicine composition for treating early awakening type insomnia. The traditional Chinese medicine composition is mainly prepared from the following medicinal materials: cassia twig, calcined oyster shell, poria cocos, codonopsis pilosula, Chinese date, honey-fried licorice root, radix ophiopogonis, radix rehmanniae recen, rhizoma zingiberis, radix scrophulariae and tortoise-plastron glue. Research shows that the traditional Chinese medicine composition has the effects of soothing the nerves and helping sleep, can remarkably improve insomnia symptoms, and is relatively light in toxic and side effects and better in combined medication effect of traditional Chinese medicine and western medicine. Therefore, the composition disclosed by the invention is reasonable in formula and remarkable in curative effect, has potential application value in the aspect of preparing medicines for treating early awakening type insomnia, and can be used for alternative treatment or adjuvant treatment of western medicines to enhance the curative effect of the western medicines, so that the symptoms such as insomnia and early awakening are reduced or even replaced by the western medicines, and the toxic and side effects of the western medicines on human bodies are reduced.

Description

Technical Field

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

[0002] With the increase of social, environmental and psychological pressures, the risk of mental illness in the population increases, and most patients suffer from insomnia. Common clinical manifestations of insomnia include difficulty falling asleep, shallow sleep, frequent dreams, easy awakening, early awakening, difficulty falling asleep after waking up, fatigue and tiredness after sleeping, daytime sleepiness, etc. In addition to the above symptoms, patients with anxiety insomnia may also feel anxious emotions such as irritability, persistent restlessness, nervousness, fear, night terrors and panic, or accompanied by autonomic nervous system symptoms and somatic anxiety symptoms such as dry mouth and flushed face, sweating, tension headaches, convulsions and tremors. Long-term anxiety can lead to depression. Depressive symptoms are often manifested as low mood, slow thinking, sleep disorders, physical symptoms, etc. In severe cases, people will feel guilty and eventually lead to suicidal tendencies.

[0003] At present, the clinical treatment of insomnia mainly relies on Western medicine, and the side effects are obvious, usually manifested as drowsiness, dizziness, and exhaustion. Large doses are prone to ataxia, tremor, urinary retention, jaundice, and a few have rash, photosensitivity, leukopenia, excitement, polyphasia, sleep disorders, hallucinations, dry mouth, lack of concentration, sweating, palpitations, constipation or diarrhea, blurred vision, hypotension, etc. Ultimately, it aggravates the patient's depression and anxiety. In addition, Western medicine is mostly symptomatic treatment, and patients are prone to dependence, and patients cannot recover fundamentally.

[0004] Traditional Chinese medicine believes that insomnia belongs to the category of "insomnia". The Yellow Emperor's Classic of Internal Medicine once recorded insomnia as "cannot sleep", "cannot sleep", and "cannot lie down". Traditional Chinese medicine believes that insomnia is essentially a syndrome of deficiency and excess, which is closely related to dysfunction of the heart, liver, kidney, spleen and other organs, and mental malnutrition or restlessness. Since insomnia patients have a long course of disease, are prone to recurrent attacks, and are difficult to recover quickly, their treatment has always been one of the thorny problems faced by clinicians. In recent years, a large number of clinical practices have confirmed that traditional Chinese medicine has good clinical efficacy in the treatment of insomnia, and has unique advantages that Western medicine does not have, which can enable patients to obtain "twice the result with half the effort" clinical benefits. Therefore, traditional Chinese medicine treatment of insomnia, dreaminess, early awakening, anxiety, and depression has attracted great attention from medical workers. Summary of the invention

[0005] The technical problem to be solved by the present invention is to provide a Chinese medicine composition for treating early awakening insomnia with reasonable formula and significant curative effect and a preparation method thereof.

[0006] In order to solve the above technical problems, the present invention adopts the following technical solutions:

[0007] A traditional Chinese medicine composition for treating early awakening insomnia is mainly prepared from the following medicinal materials: cinnamon twig, calcined oyster, tuckahoe, codonopsis pilosula, jujube, roasted liquorice, ophiopogon japonicus, raw rehmannia root, dried ginger, scrophularia ningpoensis, and tortoise shell glue.

[0008] The above-mentioned traditional Chinese medicine composition is mainly made of the following medicinal materials by weight: 10-15 parts of cinnamon twig, 15-30 parts of calcined oyster shell, 10-15 parts of Poria cocos, 10-20 parts of Codonopsis pilosula, 6-10 parts of jujube, 5-15 parts of roasted licorice, 10-20 parts of Ophiopogon japonicus, 15-30 parts of Rehmannia root, 10-15 parts of dried ginger, 10-20 parts of Scrophularia ningpoensis, and 6-12 parts of tortoise shell glue.

[0009] The above-mentioned Chinese medicine composition is mainly made of the following medicinal materials by weight: 12 parts of cinnamon twig, 25 parts of calcined oyster, 12 parts of Poria, 12 parts of Codonopsis pilosula, 8 parts of jujube, 10 parts of roasted licorice, 15 parts of Ophiopogon japonicus, 20 parts of Rehmannia glutinosa, 12 parts of dried ginger, 15 parts of Scrophularia ningpoensis, and 10 parts of tortoise shell glue.

[0010] Application of the above Chinese medicine composition in preparing medicine for treating early awakening insomnia.

[0011] A medicine for treating early awakening insomnia contains the above-mentioned Chinese medicine composition.

[0012] The above-mentioned medicine for treating early awakening insomnia is an oral preparation.

[0013] Oral preparations are granules, decoctions, powders, capsules, tablets or oral solutions.

[0014] The preparation method of the above-mentioned medicine for treating early awakening insomnia,

[0015] Weigh the raw materials according to the formula, crush them and mix them; soak the crushed mixture in water; decoct after soaking; filter after decoction, concentrate the filtrate, and spray dry to obtain granules;

[0016] Alternatively, the raw materials are weighed and mixed according to the formula, the mixture is soaked in water, and then boiled after soaking, and the decoction is filtered out to obtain a decoction.

[0017] In the preparation method of granules, the soaking time is 2 hours; the decoction is performed twice, the first time the amount of water added is 12 times the weight of the mixed powder, and the decoction is performed for 1.5 hours, and the second time the amount of water added is 8 times the weight of the mixed powder, and the decoction is performed for 1 hour;

[0018] In the decoction preparation method, the soaking time is 2 hours; the decoction is performed twice, the first time the amount of water added is 8 times the weight of the mixed powder, and the decoction is performed for 1.5 hours, and the second time the amount of water added is 6 times the weight of the mixed powder, and the decoction is performed for 1 hour, and the decoctions are combined.

[0019] In view of the problem of early awakening insomnia, the inventor has developed a Chinese medicine composition for treating early awakening insomnia based on Changzhong Anshen Pills in combination with clinical practice. The composition is mainly made of the following medicinal materials: cinnamon twig, calcined oyster, Poria, Codonopsis, jujube, roasted licorice, Ophiopogon japonicus, Rehmannia root, dried ginger, Scrophularia, and tortoise shell glue. Studies have shown that the present invention has the effect of calming the nerves and helping sleep, can significantly improve the symptoms of insomnia, and has relatively mild toxic and side effects, and the effect of combined Chinese and Western medicine is better. Therefore, the composition of the present invention has a reasonable formulation and significant efficacy, and has potential application value in the preparation of drugs for treating early awakening insomnia. It can be used as an alternative treatment for Western medicine, or as an auxiliary treatment to enhance the efficacy of Western medicine, thereby reducing or even replacing Western medicine to treat symptoms such as insomnia and early awakening, thereby reducing the toxic and side effects of Western medicine on the human body. DETAILED DESCRIPTION

[0020] 1. Formula Principle and Analysis

[0021] The principle of insomnia treatment is to tonify deficiency and eliminate excess, adjust the yin and yang of the internal organs, and unblock the qi. If the internal organs are not harmonious, the qi will not rise and fall smoothly, and the emotions will be out of balance, which will lead to anxiety and insomnia. The spleen and stomach are the source of qi and blood production and the pivot of qi rise and fall. The "Four Sacred Heart Sources" says: Man and heaven and earth are in harmony; yin and yang are the foundation, and there is ancestral qi, which is the Tai Chi of man; within the ancestral qi, yin and yang are contained, and between yin and yang is the middle qi; the middle is earth, and the earth is divided into Wu and Ji. If the middle qi rotates to the left, it is Ji earth, and if the middle qi rotates to the right, it is Wu earth; Wu earth is the stomach, and Ji earth is the spleen.

[0022] This drug combination uses Changzhong Anshen Pills as the base formula, which can unclog the three energizers, regulate emotions, and harmonize the yin and yang organs. Licorice and Poria nourish the earth and replenish deficiency, and dried ginger is pungent and hot to disperse. The three drugs are combined to strengthen the one yang in Kan and restore the meaning of the left rotation of the wheel axis. Cinnamon twig warms and unclogs the meridians, warms and disperses, and its nature is compatible with the liver. It can make the internal organs and blood flow smoothly, so it is good at relieving spleen depression. Dried ginger and jujube are added to harmonize the spleen and stomach, and licorice is used as a messenger to harmonize the drugs. Therefore, the ancestral qi unclogs the three energizers and the symptoms of insomnia are reduced.

[0023] In addition, the nature of early awakening insomnia is due to yin deficiency. "Suwen·Qi Sheng Tong Tian Lun" says: "Yin is to store essence and get up quickly." Yin is inside, it governs the night, and has the function of absorbing yang energy, so that yang energy can be brewed and generated without leaking out. When yin and yang are balanced, each performs its own duties, and all diseases will not arise; if the yin of the body is insufficient, the absorption of yang energy will be lost, and the yin will not embrace the yang energy, so the yang energy will leak out. At dawn, the yang energy in the human body will come out of the body surface and the eyes will open and wake up. If the yin is deficient and the absorption of yang energy is lost, the yang energy will not be able to be consolidated, and the yang energy will come out of the body surface before the sun rises, which is early awakening. Therefore, this drug combination is intended to nourish the yin of the body, so as to show the function of astringing yin and suppressing yang, and harmonizing the yin and defense. Shengdihuang, Ophiopogon japonicus, Scrophularia ningpoensis, and turtle shell glue nourish the lungs and stomach, nourish the heart and kidney yin, and are supplemented with calcined oysters to calm the mind, suppress yang and replenish yin. The combination of these drugs can improve early awakening.

[0024] in,

[0025] 1) Roasted Licorice: It has the effects of tonifying the spleen and stomach, replenishing qi and restoring pulse, relieving cough and asthma, and relieving pain. It is sweet in taste and flat in nature. It belongs to the heart meridian, lung meridian, stomach meridian and spleen meridian. It has the effects of strengthening the spleen and replenishing qi, relieving cough and asthma, clearing away heat and detoxifying. It can treat symptoms such as spleen and stomach weakness, sinking of middle qi, qi deficiency and fatigue, and limb fatigue, thereby relieving insomnia symptoms. Roasted Licorice can also reconcile the properties of the medicine, enhance the efficacy of the medicine, and relieve the toxicity and potency of the medicine. It can also have a therapeutic effect on patients with some drug poisoning. In addition, Roasted Licorice can also play a role in reconciling various medicines and play a soothing role in the prescription.

[0026] 2) Cinnamon twig: harmonizes the Ying and Wei, regulates the Ying and Wei patrols to reconcile Yin and Yang. It has the effects of sweating, relieving muscles, promoting Yang and transforming Qi, warming the meridians and dredges the vessels.

[0027] 3) Poria: neutral in nature, sweet and light in taste. It enters the heart meridian, lung meridian, spleen meridian, and kidney meridian. It can promote diuresis and reduce swelling, strengthen the spleen and stop diarrhea, and calm the mind and tranquilize the nerves.

[0028] 4) Jujube: sweet, warm. Enters the spleen, stomach, and heart meridians. Functions and indications: tonifies the middle qi, nourishes blood and calms the mind. Used for spleen deficiency, loss of appetite, and fatigue.

[0029] 5) Codonopsis: sweet, neutral in nature. It can nourish the middle qi, quench thirst, strengthen the spleen and lungs, nourish blood and produce body fluid. It is used for spleen and lung qi deficiency, poor appetite and fatigue, cough and asthma, qi and blood deficiency, sallow complexion, palpitations and shortness of breath, thirst due to loss of body fluid, and internal heat and thirst.

[0030] 6) Calcined oyster: It can calm the mind, suppress yang and replenish yin, soften and disperse lumps. It is used to treat palpitations, insomnia, vertigo, tinnitus, scrofula, phlegm nodules, and lumps in the abdomen.

[0031] 8) Shengdihuang: sweet, bitter, cold in nature. Enters the heart, liver, and kidney meridians. It has the effects of clearing away heat, promoting the production of body fluid, nourishing yin, and nourishing blood. It can nourish the kidney and guide fire back to the origin. It is mainly used to treat fever due to yin deficiency, thirst, vomiting blood, epistaxis, metrorrhagia, irregular menstruation, restless fetal movement, constipation caused by yin injury, palpitations, recurrent oral ulcers, etc.

[0032] 9) Ophiopogon japonicus: sweet, slightly bitter, slightly cold in nature, enters the stomach, lung, and heart meridians, has the effects of nourishing yin and moistening the lungs, benefiting the stomach and producing body fluid, clearing the heart and relieving restlessness, and is used for dry cough due to lung dryness, tuberculosis due to yin deficiency, sore throat, thirst due to loss of body fluid, internal heat and thirst, restlessness and insomnia, dry intestines and constipation. It mainly contains scutellaria baicalensis, steroidal saponins, alkaloids, sitosterol, glucose, amino acids, vitamins, etc., and has the effects of anti-fatigue, scavenging free radicals, improving cellular immune function and lowering blood sugar. In addition, Ophiopogon japonicus has sedative, hypnotic, anti-myocardial ischemia, anti-arrhythmia, anti-tumor and other effects, especially for promoting the health of the elderly has many effects.

[0033] 10) Scrophularia: Sweet, bitter, salty, slightly cold in nature, enters the heart, lung, and kidney meridians. Treats febrile diseases that damage the yin, tongue ulcers, thirst, rash, bone steaming and fatigue fever, restless sleep, spontaneous sweating, night sweats, fluid damage and constipation, hematemesis and epistaxis, sore throat, carbuncle, scrofula, fever caused by warm toxins, red eyes, diphtheria, and sores.

[0034] 11) Dried ginger: warms the middle and dispels cold, restores yang and unclogs the meridians, warms the lungs and eliminates phlegm. Modern research has found that dried ginger combined with jujube can accelerate sleep, while jujube alone has no obvious effect.

[0035] 12) Turtle Shell Glue: sweet, salty, neutral, enters the lung, liver, and kidney meridians. Nourishes yin, replenishes blood, and stops bleeding. Treats yin deficiency and blood deficiency, fatigue and heat, bone steaming, vomiting blood, epistaxis, restlessness and palpitations, kidney deficiency and low back pain, weak feet and knees, metrorrhagia, and leucorrhea.

[0036] 2. Clinical Research and Results

[0037] 1Study medication

[0038] Recipe: 12 grams of cinnamon twig, 25 grams of calcined oyster, 12 grams of Poria, 12 grams of Codonopsis, 8 grams of jujube, 10 grams of roasted licorice, 15 grams of Ophiopogon japonicus, 20 grams of Rehmannia glutinosa, 12 grams of dried ginger, 15 grams of Scrophularia ningpoensis, and 10 grams of tortoise shell glue.

[0039] Preparation method: Weigh the raw materials according to the formula and mix them, soak the mixture in water for 2 hours; decoct after soaking, decoct twice, the first time add water amount of 8 times the weight of the mixture powder and decoct for 1.5 hours, the second time add water amount of 6 times the weight of the mixture powder and decoct for 1 hour; filter and combine the decoction to obtain a decoction (take twice in the morning and evening).

[0040] 2 Study design

[0041] The clinical study followed up 60 cases of insomnia with early awakening, using a self-controlled before-and-after study. Among them, 15 cases were treated with pure Chinese medicine, 28 cases were treated with pure Western medicine, and 17 cases were treated with a combination of Chinese and Western medicine. The ages of the patients ranged from 14 to 90 years old.

[0042] Reference criteria for inclusion of cases of early awakening insomnia: 1. Patients report waking up earlier than before the onset of the disease and having difficulty falling asleep after waking up; 2. It takes more than 30 minutes to fall asleep; the total sleep time is less than 6 hours; 3. Feeling dizzy, listless, and weak the next day; 4. The course of the disease lasts for 4 weeks to 6 months; 5. Using the PSQI scoring scale as a reference, scores between 16 and 21 points indicate poor sleep.

[0043] Dosage: 1 dose of decoction per day, taken twice a day with warm water. Observation indicators: PSQI was used to evaluate the therapeutic effect.

[0044] Clinical cure: clinical symptoms and signs of insomnia disappear or almost disappear, and the symptom score decreases by >95%; marked effect: clinical symptoms and signs of insomnia are significantly improved, and the symptom score decreases by 70%; effective: clinical symptoms and signs of insomnia are improved, and the symptom score decreases by 30%; ineffective: clinical symptoms and signs of insomnia are not significantly improved, or even aggravated, and the symptom score decreases by less than 30%. Note: The calculation formula (nimodipine method) is: [(score before treatment + score after treatment) / score before treatment]*100%

[0045] Pure Western medicine treatment was set as the control group, pure Chinese medicine treatment was set as treatment group 1, and combined Chinese and Western medicine treatment was set as treatment group 2.

[0046] In the control group, 70% of the patients took western medicine, mainly trazodone hydrochloride, alprazolam, etc., and the remaining 30% took clonazepam, sertraline, olanzapine, etc. The dosage was given according to the instructions depending on the specific situation of the patient.

[0047] 3 Research results (see Table 1)

[0048] Table 1 Clinical study results of the drug of the present invention

[0049]

[0050] Note: Total effective rate = cure rate + marked effective rate + effective rate.

[0051] Follow-up showed that some patients in the control group developed side effects such as hand tremor, dry mouth, nausea, hiccups, and drowsiness to varying degrees after treatment, while no obvious side effects were observed in the combined Chinese and Western medicine group and the pure Chinese medicine group.

[0052] Studies have shown that the Chinese medicine composition provided by the present invention has the effect of calming the nerves and promoting sleep, can significantly improve insomnia symptoms, and has relatively mild toxic and side effects. The effect of combined Chinese and Western medicine is better.

Claims

1. A Chinese medicine composition for treating early awakening insomnia, characterized in that It is mainly made of the following medicinal materials: cinnamon twig, calcined oyster, poria, codonopsis, jujube, roasted licorice, ophiopogon, raw rehmannia, dried ginger, Scrophularia, and tortoise shell glue.

2. The Chinese medicine composition according to claim 1, characterized in that The invention is mainly prepared from the following medicinal materials by weight: 10-15 parts of cassia twig, 15-30 parts of calcined oyster shell, 10-15 parts of poria, 10-20 parts of codonopsis pilosula, 6-10 parts of jujube, 5-15 parts of roasted licorice root, 10-20 parts of ophiopogon japonicus, 15-30 parts of raw rehmannia root, 10-15 parts of dried ginger, 10-20 parts of scrophularia ningpoensis and 6-12 parts of tortoise shell glue.

3. The Chinese medicine composition according to claim 2, characterized in that The invention is mainly prepared from the following medicinal materials by weight: 12 parts of cinnamon twig, 25 parts of calcined oyster shell, 12 parts of poria, 12 parts of codonopsis pilosula, 8 parts of jujube, 10 parts of roasted licorice root, 15 parts of ophiopogon, 20 parts of raw rehmannia root, 12 parts of dried ginger, 15 parts of scrophulariae and 10 parts of tortoise shell glue.

4. Use of the Chinese medicine composition according to any one of claims 1 to 3 in the preparation of a medicament for treating early awakening insomnia.

5. A drug for treating early awakening insomnia, characterized in that A Chinese medicine composition comprising any one of claims 1 to 3.

6. The drug for treating early awakening insomnia according to claim 5, characterized in that It is an oral preparation.

7. The drug for treating early awakening insomnia according to claim 6, characterized in that: The oral preparation is granules, decoctions, powders, capsules, tablets or oral liquids.

8. The method for preparing the drug for treating early awakening insomnia according to claim 7, characterized in that: Weigh the raw materials according to the formula, crush them and mix them; soak the crushed mixture in water; decoct after soaking; filter after decoction, concentrate the filtrate, and spray dry to obtain granules; Alternatively, the raw materials are weighed and mixed according to the formula, the mixture is soaked in water, and then boiled after soaking, and the decoction is filtered out to obtain a decoction.

9. The preparation method according to claim 8, characterized in that: In the preparation method of granules, the soaking time is 2 hours; the decoction is performed twice, the first time the amount of water added is 12 times the weight of the mixture powder and the decoction is performed for 1.5 hours, and the second time the amount of water added is 8 times the weight of the mixture powder and the decoction is performed for 1 hour; in the preparation method of decoction, the soaking time is 2 hours; the decoction is performed twice, the first time the amount of water added is 8 times the weight of the mixture powder and the decoction is performed for 1.5 hours, and the second time the amount of water added is 6 times the weight of the mixture powder and the decoction is performed for 1 hour, and the decoctions are combined.

Images