A medicine for improving the treatment of insomnia and its preparation method
By using traditional Chinese medicine combinations such as Pueraria root, Ganoderma lucidum, ginseng, Rehmannia glutinosa, lily, Ophiopogon japonicus, Poria cocos and Schisandra chinensis, oral dosage forms were prepared, and the treatment of heart-and-renal insomnia was treated, which solved the problem of the complex and inability to treat traditional Chinese medicine combinations in the prior art, and achieved the effect of significantly improving insomnia symptoms and improving sleep quality.
Patent Information
- Application Number
- CN202510039782.8
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Filing Date
- 2025-01-10
- Publication Date
- 2025-04-04
- Estimated Expiration
- Not applicable · inactive patent
AI Technical Summary
The prior art is difficult to effectively treat insomnia with the heart and kidney syndrome, and the combination of Chinese medicine is complex and cannot be treated symptomatically.
The oral dosage form is prepared through reflux extraction and spray drying and other processes, and the treatment of heart and kidney insomnia is treated with a combination of traditional Chinese medicines such as Pueraria root, Ganoderma lucidum, ginseng, Rehmannia glutinosa, lily, Ophiopogon japonicus, Poria cocos and Schisandra chinensis.
Significantly improves insomnia symptoms and improves the quality of sleep in patients, with an effective efficiency of 88.57%, with small side effects and mild drug properties.
Abstract
Description
Technical Field
[0001] The present invention relates to the technical field of traditional Chinese medicines, and in particular to a medicine for improving and treating insomnia and a preparation method thereof. Background Art
[0002] Insomnia is a disease that troubles many people. It is mainly manifested by difficulty falling asleep and poor sleep quality. Long-term insomnia can affect the body's immunity and induce a variety of complications. Insomnia mainly refers to sleep disorders caused by various factors. Although patients have a good sleeping environment and sleep opportunities, they still cannot achieve ideal sleep quality and sleep time, and their daytime functions are affected to a certain extent.
[0003] Insomnia is often treated with Western medicine. Estazolam is a benzodiazepine sedative hypnotic that acts on benzodiazepine receptors, strengthens inhibitory neurotransmitters in the brain, relieves anxiety and tension, and has a sedative and hypnotic effect. Although it has the characteristics of rapid onset and high patient tolerance, long-term use is addictive, and adverse reactions such as recurrence of insomnia are likely to occur after discontinuation of the drug.
[0004] The combination of Chinese medicines under the guidance of TCM theory has its advantages in clinical practice, with overall conditioning, syndrome differentiation and treatment, promoting the human body to restore normal sleep, safe medication, few side effects, and no dependence. Insomnia, called "insomnia" in TCM, can be caused by yang not entering yin, disharmony of Ying and Wei, and viscera disorder according to the pathogenesis of insomnia. After generations of doctors continuously enriched the pathogenesis of insomnia, a variety of Chinese medicines for insomnia caused by different syndromes were developed. However, some of the current existing technologies for insomnia of the heart-kidney disharmony syndrome type cannot be symptomatically treated or the drug composition and its medicinal properties are complex. Therefore, it is meaningful to develop a Chinese medicine that can symptomatically treat insomnia of the heart-kidney disharmony syndrome type. Summary of the invention
[0005] Therefore, based on the above background, the present invention provides a medicine for improving the treatment of insomnia and a preparation method thereof. The Chinese medicine composition of the present invention can play a significant therapeutic role in insomnia, especially for heart-kidney disharmony type insomnia.
[0006] The technical solution provided by the present invention is:
[0007] A drug for improving the treatment of insomnia, comprising drug A and drug B;
[0008] The raw materials of drug A are as follows:
[0009] 15-35 parts of Pueraria root, 10-25 parts of Ganoderma lucidum, 10-25 parts of ginseng, 15-30 parts of Rehmannia root, 10-25 parts of lily, 10-25 parts of Ophiopogon japonicus, and 10-20 parts of Poria cocos.
[0010] Drug B consisted of Schisandra chinensis.
[0011] Preferably, it is made from the following raw materials in parts by weight:
[0012] Drug A is composed of the following raw materials in parts by weight: 15 parts of Pueraria root, 10 parts of Ganoderma lucidum, 10 parts of ginseng, 15 parts of Rehmannia root, 10 parts of lily, 10 parts of Ophiopogon japonicus, and 10 parts of Poria cocos.
[0013] Preferably, the drug A is composed of the following raw materials in parts by weight: 25 parts of Pueraria root, 15 parts of Ganoderma lucidum, 15 parts of ginseng, 20 parts of Rehmannia root, 15 parts of lily, 15 parts of Ophiopogon japonicus, and 18 parts of Poria cocos.
[0014] Preferably, it is made from the following raw materials in parts by weight:
[0015] Drug A consists of the following raw materials in parts by weight:
[0016] 30 parts of Puerariae Radix, 25 parts of Ganoderma Lucidum, 20 parts of Ginseng, 25 parts of Rehmannia glutinosa, 20 parts of Lilium, 25 parts of Ophiopogon japonicus, and 20 parts of Poria.
[0017] Furthermore, the insomnia syndrome is caused by disharmony between the heart and kidney.
[0018] Furthermore, the dosage form of the drug is an oral dosage form.
[0019] Furthermore, the preparation thereof comprises the following steps:
[0020] 1) Ganoderma lucidum, ginseng, Rehmannia root, lily, Ophiopogon japonicus and Poria cocos are taken according to the proportion of drug A, crushed separately, mixed, added with 8-10 times of water by weight, and refluxed for 1 hour at 100° C. After the extraction, the extract is concentrated and spray-dried to obtain extract particles;
[0021] 2) Take Pueraria root according to proportion, crush it, add ethanol of 8-10 times its own weight, reflux and extract at 80-90° C. for 1 hour. After the extraction, concentrate the extract and spray dry it to obtain extract particles.
[0022] 3) Take Schisandra chinensis, make it with vinegar, crush it, and pass it through a 80-100 mesh sieve;
[0023] 4) The particles obtained in steps 1) and 2) are uniformly mixed to prepare drug A; the particles obtained in step 3) are drug B.
[0024] The pharmacology of each raw material of the present invention is shown below:
[0025] Pueraria root is sweet and pungent, light and dispersing, mild and slightly cool, and can clear the body. It enters the spleen and stomach meridians, and can not only penetrate and relieve wind-heat on the surface of the muscles, relieve muscles and reduce fever, and release the exterior, and cause rashes, but also encourage the spleen and stomach to rise and produce fluid to quench thirst, and raise yang to stop diarrhea. It is most suitable for treating stiff neck and back pain and Yangming headache, regardless of cold or heat, deficiency or excess, with or without sweat. It soothes the liver and regulates qi, improves liver qi stagnation, and clears away heat and detoxifies, promoting the discharge of toxins in the body.
[0026] Ganoderma lucidum replenishes qi and calms the mind, replenishes blood and nourishes the liver, strengthens the body and strengthens the foundation, and can effectively promote the liver's function of storing blood.
[0027] Ginseng has the effects of replenishing vital energy, restoring the pulse and strengthening the body, nourishing the spleen and lungs, promoting body fluid and nourishing blood, and calming the mind and improving intelligence.
[0028] Rehmannia root nourishes yin and blood, produces body fluid, and moistens the intestines. It treats dizziness and vertigo caused by liver and kidney deficiency, as well as blood and essence deficiency; low back pain and tinnitus; premature graying of hair; insomnia and nightmares; thirst due to loss of body fluid; diabetes; and dry intestines and constipation.
[0029] Lily nourishes yin and moistens the lungs, clears the heart and soothes the mind; Ophiopogon japonicus is moist and sweet, slightly bitter and cold, and clears the lungs, heart, and stomach meridians. It not only nourishes yin and produces fluid, moistens the lungs and benefits the stomach, but also clears the heart and nourishes the mind, relieves restlessness and soothes the mind, and also moisturizes the intestines and promotes bowel movements. It treats lung and stomach yin deficiency, restlessness and insomnia, and dry intestines and constipation.
[0030] Ophiopogon japonicus is moist and sweet in nature, slightly bitter and cold in nature, and has a clearing effect. It enters the lung, heart, and stomach meridians. It nourishes yin and produces fluid, while moistening the lungs and benefiting the stomach, it also nourishes the mind, while relieving restlessness and calming the nerves, it also moisturizes the intestines and promotes bowel movements, and it treats lung and stomach yin deficiency, restlessness and insomnia, and constipation due to dry intestines.
[0031] Poria cocos is sweet, mild, and can both infiltrate and nourish. It is neutral and impartial. It enters the spleen and kidney meridians, is good at infiltrating dampness and promoting water retention, and eliminates water retention, strengthens the spleen and promotes the transportation of dampness. It also enters the heart meridian, is good at calming the mind and tranquilizing the nerves, and is suitable for those with dampness and stagnation of fluid, regardless of cold or heat, or deficiency or not, and is especially good for those with edema due to deficiency or excessive dampness.
[0032] Schisandra chinensis is sour, astringent, moist, warm and nourishing, and has both astringent and nourishing properties. It enters the lung, kidney and heart meridians. It can astringe the lungs, relieve cough and asthma, nourish the kidneys, astringe essence and stop diarrhea, promote the production of body fluids, calm the mind and soothe the nerves, and has both astringent and nourishing properties, saving blood and strengthening. The present invention uses honey-processed Schisandra chinensis.
[0033] Heart-kidney disharmony, that is, deficiency of body fluid and blood, disturbance of phase fire, specifically, deficiency of body fluid and blood leads to kidney qi failure, phase fire disturbs the mind, leading to restlessness, yang not entering yin, leading to insomnia symptoms such as difficulty falling asleep, frequent dreams and easy awakening, so the present invention uses Ganoderma lucidum and Rehmannia glutinosa as the main medicine, Ganoderma lucidum enters the heart to produce blood, helps the heart to produce pulse, and Rehmannia glutinosa nourishes blood and produces body fluid, nourishes the liver and kidney, and replenishes kidney yin. The two are interdependent, replenish the heart and kidney essence and blood, nourish yin and suppress yang, so that water and fire complement each other, and yin and yang are harmonized; Pueraria lobata soothes the liver and regulates qi, relieves liver depression; Ginseng and Pueraria lobata are the assistant medicines, Pueraria lobata soothes the liver and regulates qi, relieves liver For relieving depression, ginseng replenishes qi and raises yang, replenishes qi and generates blood, replenishes qi and promotes blood circulation, so as to help the main medicine regulate qi and blood, nourish liver blood, and relieve liver qi; Poria, lily, and Ophiopogon are used as adjuvants, among which Poria strengthens the spleen and promotes the transportation of water and moisture, so as to help the main medicine generate qi and blood, and nourish the mind; Lily and Ophiopogon are used to clear away heat and relieve restlessness, clear the heart and calm the mind, and Schisandra chinensis is used as the guide to replenish the kidney and absorb qi, balance yin and yang, and make nervous excitement tend to be balanced. All the medicines work together to nourish the kidney and nourish the heart, soothe the liver and relieve depression, nourish blood and produce body fluid, and balance yin and yang, so as to effectively treat insomnia of heart-kidney disharmony type.
[0034] The invention adopts medicine and food homologous drugs to formulate prescriptions, has mild medicinal properties and small side effects. DETAILED DESCRIPTION
[0035] In order to make the purpose, technical solution and advantages of the embodiments of the present invention clearer, the technical solution in the embodiments of the present invention will be clearly and completely described below in combination with the embodiments of the present invention. Obviously, the described embodiments are part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.
[0036] Example 1: A drug for improving the treatment of insomnia, comprising drug A and drug B;
[0037] Drug A is composed of the following raw materials in parts by weight: 15 parts of Pueraria root, 10 parts of Ganoderma lucidum, 10 parts of ginseng, 15 parts of Rehmannia root, 10 parts of lily, 10 parts of Ophiopogon japonicus, and 10 parts of Poria cocos.
[0038] Drug B consisted of Schisandra chinensis.
[0039] Example 2: A drug for improving the treatment of insomnia, comprising drug A and drug B;
[0040] Drug A is composed of the following raw materials in parts by weight: 25 parts of Pueraria root, 15 parts of Ganoderma lucidum, 15 parts of ginseng, 20 parts of Rehmannia root, 15 parts of lily, 15 parts of Ophiopogon japonicus, and 18 parts of Poria cocos.
[0041] Drug B consisted of Schisandra chinensis.
[0042] Example 3: A drug for improving the treatment of insomnia, comprising drug A and drug B;
[0043] Drug A consists of the following raw materials in parts by weight:
[0044] 30 parts of Puerariae Radix, 25 parts of Ganoderma Lucidum, 20 parts of Ginseng, 25 parts of Rehmannia glutinosa, 20 parts of Lilium, 25 parts of Ophiopogon japonicus, and 20 parts of Poria.
[0045] Drug B consisted of Schisandra chinensis.
[0046] The preparation methods of Examples 1 to 3 include the following steps:
[0047] 1) Ganoderma lucidum, ginseng, Rehmannia root, lily, Ophiopogon japonicus and Poria cocos are taken according to the proportion of drug A, crushed separately, mixed, added with 8-10 times of water by weight, and refluxed for 1 hour at 100° C. After the extraction, the extract is concentrated and spray-dried to obtain extract particles;
[0048] 2) Take Pueraria root according to proportion, crush it, add ethanol of 8-10 times its own weight, reflux and extract at 80-90° C. for 1 hour. After the extraction, concentrate the extract and spray dry it to obtain extract particles.
[0049] 3) Take Schisandra chinensis, make it with vinegar, crush it, and pass it through a 80-100 mesh sieve;
[0050] 4) The particles obtained in steps 1) and 2) are uniformly mixed to prepare drug A; the particles obtained in step 3) are drug B.
[0051] When the present invention is used specifically, 1-3 g of Schisandra granules are taken once a week (within the recommended dosage of the Chinese Pharmacopoeia (2020 edition)), and 5-15 g of drug A is taken one hour before going to bed every night.
[0052] In specific application, drug A and drug B can be filled into capsules for oral administration, for example, 2 g of Schisandra chinensis can be filled into each capsule, or 6 g of drug A can be filled into each capsule.
[0053] Example 4: Clinical application
[0054] From June 2023 to 2024, 35 patients were diagnosed with insomnia due to heart-kidney disharmony, aged between 37 and 65 years old, including 14 males and 21 females, with a disease course of 3 months to 1 year.
[0055] Diagnosis criteria: meet the diagnostic criteria of insomnia due to heart-kidney disharmony in the "Guidelines for the Diagnosis and Treatment of Insomnia in China" (main symptoms: difficulty falling asleep at night, even staying awake all night; secondary symptoms: restlessness, dizziness, tinnitus, hot flashes, night sweats, nocturnal emission and impotence in men, irregular menstruation in women, forgetfulness, mouth and tongue ulcers, dry and hard stools; tongue and pulse: red tongue, thin and rapid pulse. Main symptoms and ≥ 2 secondary symptoms.
[0056] The above patients were confirmed to have no allergy to the drug of the present invention, no insomnia caused by alcoholism, drug (or narcotics) dependence, and no patients with other serious primary diseases (such as myocardial infarction, chronic obstructive pulmonary disease, liver and kidney failure, etc.).
[0057] All the patients reported that they had not received any relevant treatment in the past 2 weeks.
[0058] The drug of Example 2 was used for treatment. Specifically, 2 g of drug B was taken once a week and 6 g of drug A was taken every night. After 4 consecutive weeks of treatment, the efficacy was statistically analyzed.
[0059] Efficacy evaluation criteria:
[0060] The clinical efficacy of patients was evaluated according to the Guidelines for the Diagnosis and Treatment of Insomnia in Chinese Adults (2017 Edition).
[0061] Recovery: total sleep time>6h, sleep latency<0.5h, wake-up time after falling asleep<0.5h;
[0062] Significant effect: total sleep time 5-6 hours, sleep latency 0.5-1 hour, wake-up time after falling asleep 0.5-1 hour;
[0063] Effective: total sleep time 4 to <5 hours, sleep latency >1 to 1.5 hours, wake-up time after falling asleep >1 to 1.5 hours;
[0064] Invalid: total sleep time <4h, sleep latency >1.5h, wake-up time after falling asleep >1.5h.
[0065] Efficacy results: 9 patients were cured, 12 patients showed marked effect, 10 patients were effective, 4 patients were ineffective, and the effective rate was 88.57%.
[0066] Typical cases:
[0067] Case 1: Zhu, female, 36 years old, complained of insomnia for 3 months, with less than 4 hours of sleep per day, always waking up in the middle of the night, and was distressed by her usual irritability and irritability, and felt that her memory had deteriorated from time to time. She was diagnosed with insomnia of the heart-kidney disharmony type. After continuous treatment with the drug of Example 2 for 2 weeks, she took drug B 2g once a week and drug A 6g every night. After follow-up, she reported that her insomnia had been greatly improved, and her daily sleep time could be guaranteed to be more than 5 hours.
[0068] Case 2: Mr. Li, male, 52 years old, complained of insomnia for half a year. He woke up 2-3 times in the middle of the night every day. After waking up, he could not fall asleep again. He felt tired all over during the day and could not control his negative emotions. He also had loss of appetite, dizziness, headache, memory loss and other symptoms. He was diagnosed with loss of appetite, dizziness and headache. After continuous treatment with the drug of Example 2 for 4 weeks, he took drug B 2g once a week and drug A 6g every night. After follow-up, he reported that insomnia was greatly improved, and the number of times he woke up in the middle of the night was significantly reduced. Sometimes he did not wake up in the middle of the night. During the follow-up, he obviously felt that his mental state had improved. After 3 weeks of continued intensive medication, he stopped taking it.
[0069] Case 3: Ye, male, 47 years old, reported insomnia for nearly half a year, difficulty falling asleep, effective sleep time of no more than 4h, frequent irritability, and even unable to restrain conflicts with others in severe cases, accompanied by dizziness, tinnitus, and memory loss. After continuous treatment with the substance of Example 2 for 4 weeks, taking drug B 2g once a week and drug A 6g every night, feedback from follow-up visits showed that insomnia was greatly improved, emotions were controllable, and dizziness and tinnitus symptoms were significantly improved.
[0070] The present invention and its implementation methods are described above, and such description is not restrictive, and the actual methods are not limited thereto. In short, if ordinary technicians in the field are inspired by it, without departing from the purpose of the invention, they can design implementation methods and embodiments similar to the technical solution without creativity, which should all fall within the protection scope of the present invention.
Claims
1. A drug for improving the treatment of insomnia, characterized in that: It includes drug A and drug B; The raw materials of drug A are as follows: 15-35 parts of Pueraria root, 10-25 parts of Ganoderma lucidum, 10-25 parts of ginseng, 15-30 parts of Rehmannia root, 10-25 parts of lily, 10-25 parts of Ophiopogon japonicus, and 10-20 parts of Poria cocos. Drug B consisted of Schisandra chinensis.
2. A drug for improving and treating insomnia according to claim 1, characterized in that: Drug A is composed of the following raw materials in parts by weight: 15 parts of Pueraria root, 10 parts of Ganoderma lucidum, 10 parts of ginseng, 15 parts of Rehmannia root, 10 parts of lily, 10 parts of Ophiopogon japonicus, and 10 parts of Poria cocos.
3. A drug for improving and treating insomnia according to claim 1, characterized in that: Drug A is composed of the following raw materials in parts by weight: 25 parts of Pueraria root, 15 parts of Ganoderma lucidum, 15 parts of ginseng, 20 parts of Rehmannia root, 15 parts of lily, 15 parts of Ophiopogon japonicus, and 18 parts of Poria cocos.
4. The drug for improving and treating insomnia according to claim 1, characterized in that: Drug A consists of the following raw materials in parts by weight: 30 parts of Puerariae Radix, 25 parts of Ganoderma Lucidum, 20 parts of Ginseng, 25 parts of Rehmannia glutinosa, 20 parts of Lilium, 25 parts of Ophiopogon japonicus, and 20 parts of Poria.
5. A drug for improving and treating insomnia according to any one of claims 1 to 4, characterized in that: The syndrome of insomnia is caused by disharmony between heart and kidney.
6. A drug for improving and treating insomnia according to any one of claims 1 to 4, characterized in that: Its preparation comprises the following steps: 1) Ganoderma lucidum, ginseng, Rehmannia root, lily, Ophiopogon japonicus and Poria cocos are taken according to the proportion of drug A, crushed separately, mixed, added with 8-10 times of water by weight, and refluxed for 1 hour at 100° C. After the extraction, the extract is concentrated and spray-dried to obtain extract particles; 2) Take Pueraria root according to proportion, crush it, add ethanol of 8-10 times its own weight, reflux and extract at 80-90° C. for 1 hour. After the extraction, concentrate the extract and spray dry it to obtain extract particles. 3) Take Schisandra chinensis, make it with vinegar, crush it, and pass it through a 80-100 mesh sieve; 4) The particles obtained in steps 1) and 2) are uniformly mixed to prepare drug A; the particles obtained in step 3) are drug B.