Zhuang medicine compound medicine for treating insomnia and preparation method thereof

Abstract

The invention discloses a Zhuang medicine compound medicine for treating insomnia and a preparation method of the Zhuang medicine compound medicine, and the Zhuang medicine compound medicine comprises the following raw materials in parts by weight: 17-24 parts of wintercreeper, 12-16 parts of gastrodia elata, 13-18 parts of spina date seed, 11-17 parts of platycladi seed and 8-12 parts of poria with hostwood. The preparation method of the Zhuang medicine compound medicine comprises the following steps: a, weighing the euonymus fortunei, the gastrodia elata, the spina date seeds, the platycladi seeds and the poria with hostwood according to the weight ratio; and b, putting the raw materials weighed in the step a into water, and decocting the raw materials to prepare liquid medicine, so as to prepare the Zhuang medicine compound medicine for treating insomnia. The Zhuang medicine compound medicine provided by the invention has the characteristics of being economical and practical, convenient to use, remarkable in effect, capable of consolidating basis, smoothing the dragon road, nourishing the fire road, calming the heart and soothing the nerves, small in toxic and side effects and the like, and shows many advantages.

Description

Technical Field

[0001] The invention belongs to the field of traditional Chinese medicine for treating insomnia, and specifically relates to a Zhuang medicine compound medicine for treating insomnia and a preparation method thereof. Technical Background

[0002] Insomnia is a common symptom. Most people have experienced occasional insomnia, but this does not represent a disease state. Insomnia is one of the most common sleep disorders in clinical practice. It affects people's physical and mental health, brain thinking, memory, creative function and social activity function. Since traditional sedatives and hypnotics are still used to treat insomnia, sedatives and hypnotics (mainly benzodiazepines) Adverse reactions of insomniacs (such as sedatives, sedatives, and sedatives) such as addiction, dependence, withdrawal reactions, respiratory depression, affecting daytime wakefulness, behavior, and prone to operational accidents have also become serious medical and social problems. Insomniacs suffer from daytime inattention, fatigue, and excessive sleepiness, which can lead to decreased alertness and slow reactions, which are the main causes of accidents. Zhuang medicine has a long history of treating insomnia, with rich treatment methods and unique efficacy.

[0003] Zhuang medicine calls the brain "Qiaowu", which is the center of the fire path. The trunk lines and networks of the fire path are spread all over the body, and are regulated by the "Qiaowu" to quickly sense various external stimuli and respond. Insomnia is also called "insomnia". Insomnia belongs to the category of "Nian Naonuo" in Zhuang medicine. It is caused by thinking, fatigue, emotional disorders, etc., which disturb the mind or cause deficiency of qi and blood, hurting the heart and "Milong" (spleen), insufficient blood production source, and "Qiaowu" malnutrition; and because of fear, irregular diet and other reasons, the yin and yang are out of balance, and the three qi of heaven, earth and man cannot be synchronized and insomnia occurs. Based on this, the Zhuang medicine Fuzao prescription is used to treat insomnia, which nourishes the fire path through the dragon path and calms the mind. It is suitable for insomnia patients of different populations, such as difficulty falling asleep, shallow sleep, and easy awakening.

[0004] Chinese patent CN115779031A discloses a Chinese medicine composition for treating insomnia, which is composed of the following Chinese medicine raw materials: astragalus, ophiopogon, rhodiola, schisandra, millettia, Polygonum multiflorum, sedum notoginseng, oyster, turtle shell, earthworm, Uncaria rhynchophylla, Cynanchum chinense, Coptis chinensis, and cinnamon.

[0005] Chinese patent CN115350256A discloses a Chinese medicine composition for treating insomnia and its preparation method, which relates to the technical field of Chinese medicine composition. Its formula includes the following ingredients: Polygala tenuifolia, Semen Ziziphi Spinosae, Radix Pseudostellariae, Oyster, Cinnamomum cassia, Rhizoma Chuanxiong, Citron, Rhizoma Alismatis, Rhizoma Atractylodis Macrocephalae, Radix Angelicae Sinensis, Radix Curcumae, Radix Bupleuri and Ginseng.

[0006] Chinese patent CN115006492A discloses a Chinese medicine composition for treating insomnia and its application. The Chinese medicine composition is made of the following raw materials in parts by weight: 6-15 parts of Ziziphus jujuba seeds, 5-12 parts of Cymbidium orientalis, 3-9 parts of Gardenia jasminoides, 3-9 parts of Citrus reticulata, 1-5 parts of Oroxylum bungeanum, 3-9 parts of Dendrobium officinale, 1-5 parts of Menthus officinalis, 3-9 parts of Aucklandia lappa, 22-38 parts of Dragon Bone, 3-9 parts of Licorice, 12-27 parts of Polygonatum sibiricum, 2-8 parts of Chrysanthemum, and 2-8 parts of Rose.

[0007] The drug formulas in the above three patents all incorporate a variety of drug ingredients, including some expensive rare medicinal materials. These medicinal materials are very volatile during the decoction process, so there are extremely strict requirements for decoction conditions and the operation is relatively complicated. In addition, the new drug application process is cumbersome, resulting in high drug costs. What is even more difficult is that the stability of drug ingredients during the decoction process is difficult to accurately control, which undoubtedly increases the difficulty of pharmaceutical production. Summary of the invention

[0008] The present invention aims at the deficiencies of various existing western medicines for treating insomnia and provides a Zhuang medicine compound medicine with ethnic medicine characteristics for effectively treating insomnia and a preparation method thereof. The Zhuang medicine compound medicine has the characteristics of being cheap, easy to use, having significant efficacy, supporting the true essence, nourishing the fire path, calming the nerves and having little toxic and side effects, and the preparation process is simple.

[0009] To achieve the above purpose, the technical solution adopted by the present invention is as follows:

[0010] A Zhuang medicine compound medicine for treating insomnia comprises the following raw materials in parts by weight: 17-24 parts of Euonymus fortunei, 12-16 parts of Gastrodia elata, 13-18 parts of Semen Ziziphi Spinosae, 11-17 parts of Semen Platycladi, and 8-12 parts of Poria.

[0011] Preferably, the Zhuang medicine compound medicine for treating insomnia comprises the following raw materials in parts by weight: 18 parts of Euonymus fortunei, 12 parts of Gastrodia elata, 13 parts of Semen Ziziphi Spinosae, 12 parts of Semen Platycladi, and 8 parts of Poria.

[0012] Preferably, the Zhuang medicine compound medicine for treating insomnia comprises the following raw materials in parts by weight: 20 parts of Euonymus fortunei, 15 parts of Gastrodia elata, 16 parts of Semen Ziziphi Spinosae, 14 parts of Semen Platycladi, and 10 parts of Poria.

[0013] Preferably, the Zhuang medicine compound medicine for treating insomnia comprises the following raw materials in parts by weight: 23 parts of Euonymus fortunei, 16 parts of Gastrodia elata, 18 parts of Semen Ziziphi Spinosae, 17 parts of Semen Platycladi, and 11 parts of Poria.

[0014] Preferably, the Zhuang medicine compound medicine for treating insomnia is used orally.

[0015] Preferably, the Zhuang medicine compound medicine for treating insomnia is taken orally twice a day.

[0016] Preferably, the Zhuang medicine compound medicine for treating insomnia is used twice a day, in the morning and after dinner.

[0017] Preferably, the Zhuang medicine compound medicine for treating insomnia is taken in 100 mL each time, and a course of treatment is 4 weeks.

[0018] The present invention also provides a method for preparing a Zhuang medicine compound for treating insomnia, comprising the following steps:

[0019] a. Weigh 10 grams of Eucommia ulmoides, Gastrodia elata, Semen Ziziphi spinulosae, Semen Platycladi, and Poria cocos according to weight ratio;

[0020] b. Put the weighed raw materials in step a into water, and boil the raw materials to prepare a medicinal liquid to obtain a Zhuang medicine compound for treating insomnia.

[0021] Preferably, the amount of water added in step b is 500 mL.

[0022] Compared with the prior art, the Zhuang medicine compound medicine of the present invention exhibits significant technical advantages, which are not only reflected in its unique drug composition, but also cover the various characteristics and application effects of the drug, which are specifically manifested in the following aspects:

[0023] (1) Uniqueness of drug composition and synergy of efficacy

[0024] The Zhuang medicine compound of the present invention carefully selects five distinctive Chinese Zhuang medicinal materials, namely, Fufangcao, Gastrodia elata, Ziziphus jujuba seeds, Platycladus orientalis seeds, and Poria cocos for scientific compatibility. Among them, Fufangcao, with its characteristics of dispersing blood stasis and stopping bleeding, relaxing muscles and activating collaterals, can effectively promote blood circulation and relieve discomfort caused by blood stasis; Gastrodia elata is good at stopping wind and convulsions, calming liver yang, dispelling wind and unblocking collaterals, and has significant effects on regulating wind evil in the body and calming excessive liver yang; Ziziphus jujuba seeds are praised as top-grade products for nourishing the heart and liver, calming the mind and tranquilizing the nerves, which can not only improve sleep quality, but also astringe sweat and produce body fluid, and alleviate physical weakness and excessive sweating caused by insomnia; Platycladus orientalis seeds also have the effect of nourishing the heart and tranquilizing the nerves, can enhance heart function and stabilize emotions; Poria cocos further consolidates the tranquilizing effect of the whole prescription with its calming power. These five herbs complement each other and work together on the human body, supporting the true essence and nourishing the fire path (in TCM theory, the "dragon path" and "fire path" represent the channels for the circulation of qi and blood and the pathways for energy metabolism, respectively), thereby achieving the purpose of calming the mind, harmonizing yin and yang, and harmonizing qi and blood. This precise compatibility mechanism enables the compound medicine to show excellent efficacy in the treatment of insomnia, "balance of yin and yang, and cure of spirit", enabling insomnia patients to recover as soon as possible, and has therefore been widely recognized and applied in clinical practice.

[0025] (2) Economical, convenient and safe drug

[0026] In addition to the uniqueness of the drug composition and significant therapeutic effects, the Zhuang medicine compound medicine of the present invention also has multiple advantages such as low cost, easy use, and low toxic and side effects. In terms of cost, since the selected medicinal materials are all common and relatively reasonably priced Chinese medicinal materials, the production cost of the drug is effectively controlled, providing patients with an economical and affordable treatment option. In terms of ease of use, the preparation process of the drug is simple. More importantly, while the compound medicine exerts a powerful therapeutic effect, it also shows extremely low toxic and side effects, which is due to the mutual restraint and balance between the medicinal materials, avoiding the adverse reactions that may be caused by a single medicinal material, and ensuring the safety of the medication. DETAILED DESCRIPTION

[0027] The following will be combined with the embodiments of the present invention to clearly and completely describe the technical solutions in the embodiments of the preferred examples. Obviously, the described embodiments are only 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.

[0028] In an embodiment of the present invention, a Zhuang medicine compound medicine for treating insomnia comprises the following raw materials in parts by weight: 17-24 parts of Euonymus fortunei, 12-16 parts of Gastrodia elata, 13-18 parts of Semen Ziziphi Spinosae, 11-17 parts of Semen Platycladi, and 8-12 parts of Poria. After weighing the above raw materials, add 500 ml of clean water, and after the raw materials are made into a liquid medicine, take 200 ml and take it warm twice a day after meals, morning and evening.

[0029] Technical principle of the present invention:

[0030] 1. The characteristics of the raw medicinal materials used are as follows:

[0031] Euonymus fortunei: It is an evergreen vine shrub of the genus Euonymus in the family Celastraceae. The medicinal part is the stems and branches with leaves. It tastes bitter and is warm in nature. It can relax muscles and activate collaterals, stop bleeding and eliminate cancer. It is mainly used to treat insomnia, lumbar muscle strain, rheumatism, hemoptysis, metrorrhagia, irregular menstruation, fractures from falls, and bleeding from trauma.

[0032] Gastrodia elata Blume, a plant of the genus Gastrodia in the orchid family, is sweet, pungent and neutral in nature. It enters the liver meridian. It can be used to extinguish wind and phlegm, stop spasms, soothe liver yang, dispel wind and dredge meridians. It can be used to treat insomnia, acute and chronic convulsions, convulsions, tetanus, vertigo, headache, hemiplegia, limb numbness, and rheumatic pain.

[0033] Ziziphus jujuba seed: This product is the seed of Ziziphus jujuba of the Rhamnaceae family. Nature and flavor: sour and sweet, neutral, enters the heart, spleen, liver, and gallbladder meridians. Efficacy: nourishes the liver, calms the mind, soothes the nerves, and astringes sweat. Treats insomnia, palpitations, thirst, and sweating.

[0034] Platycladus orientalis seeds: dried mature seeds of Platycladus orientalis, a plant of the Cupressaceae family. Nature and flavor: sweet, neutral. Enters the heart, kidney, and large intestine meridians. Efficacy: nourishes the heart and calms the mind, moistens the intestines and promotes bowel movements, and stops sweating. Indications: Yin-blood deficiency, insomnia due to deficiency, palpitations, constipation due to dry intestines, and night sweats due to Yin deficiency.

[0035] Fu Shen: The part of the sclerotium of Poria cocos (Poria cocos Schw.) Wolf, a plant of the Polyporaceae family, with pine roots in it. The original species is a lower plant, a fungus parasitic on pine trees. The medicinal part is the white part of the dried sclerotium with pine roots in it. It is sweet, mild and flat in nature, and enters the heart and spleen meridians. It has the functions of dispelling dampness, strengthening the spleen, and calming the mind. It is used for phlegm, edema, dysuria, diarrhea, palpitations, and dizziness. It is distributed all over the world.

[0036] 2. Mechanism of the synergistic interaction of the five raw materials in treating insomnia

[0037] (I) From the perspective of traditional Chinese medicine theory

[0038] 1. Basic effects and synergy of Euonymus fortunei

[0039] Fufang tung is bitter and warm in nature. It can relax muscles and activate collaterals, stop bleeding and eliminate blood stasis. In prescriptions, it can improve the running state of human qi and blood. Insomnia patients often have poor blood circulation, such as blood stasis caused by long-term stress and other factors. Fufang tung can disperse blood stasis, stop bleeding, relax muscles and activate collaterals, and provide a good foundation for the running of qi and blood for other medicinal materials to play their role.

[0040] Synergistic with Chinese jujube seeds and Chinese cypress seeds: Chinese jujube seeds and Chinese cypress seeds mainly act on nourishing the heart and calming the mind. Fufang Teng can dredge the qi and blood, making the heart meridian unobstructed, which helps Chinese jujube seeds and Chinese cypress seeds to better play the role of nourishing the heart blood and calming the mind. After the qi and blood are unobstructed, the heart blood nourished by Chinese jujube seeds and Chinese cypress seeds can be transported to the whole body to nourish the mind, thereby improving the symptoms of insomnia.

[0041] Synergistic with Gastrodia elata: Gastrodia elata can extinguish wind and phlegm, stop spasms, soothe liver yang, dispel wind and dredge collaterals. The relaxing and activating effects of Fufangteng complement it. When the body may suffer from insomnia due to liver wind or blocked meridians, Gastrodia elata soothes the liver and calms the wind, while Fufangteng dredges the meridians. The two work together to regulate the body's qi and blood, and prevent insomnia caused by wind movement, meridian blockage and other factors.

[0042] Synergizes with Fushen: Fushen has the functions of dispelling dampness, strengthening the spleen, and calming the mind. Fushen improves the circulation of qi and blood, while Fushen calms the mind and soothes the nerves on the basis of strengthening the spleen and dispelling dampness. The normal circulation of qi and blood is conducive to Fushen's calming effect, while Fushen's calming effect also helps consolidate the mental state after Fushen regulates qi and blood.

[0043] 2. Key Roles and Synergies of Gastrodia elata

[0044] Gastrodia elata is sweet, pungent, neutral, and enters the liver meridian. In prescriptions, it is mainly used to treat insomnia caused by hyperactivity of liver yang and internal liver wind. For example, when patients suffer from insomnia due to emotional fluctuations, excessive stress, and other factors that lead to liver depression and fire, hyperactivity of liver yang, and disturbance of the mind, Gastrodia elata can calm liver yang, extinguish wind and phlegm, and stop spasms.

[0045] Synergistically with Chinese jujube seeds and cypress seeds: Chinese jujube seeds and cypress seeds nourish the heart and calm the mind, while Gastrodia elata calms liver yang. Hyperactivity of liver yang can cause the mind to be disturbed, and Gastrodia elata calms liver yang, so that the mind is no longer disturbed by liver fire. Combined with the nourishing and calming effects of Chinese jujube seeds and cypress seeds, it can better calm the mind and improve the effect of treating insomnia.

[0046] Synergistic effect with Fu Shen: Fu Shen calms the mind and regulates the spleen and stomach. Gastrodia regulates the liver, while Fu Shen regulates the spleen, stomach and heart. In TCM theory, the liver, spleen and heart are interrelated. The synergistic effect of Gastrodia and Fu Shen can make the body's qi rise and fall in an orderly manner and harmonize qi and blood, thus helping to treat insomnia.

[0047] 3. The core role and synergy of Chinese date seeds

[0048] The taste of sour jujube seeds is sweet and sour, and it is flat. It enters the heart, spleen, liver, and gallbladder meridians, and has the effects of nourishing the liver, calming the heart, calming the nerves, and astringing sweat. It is one of the core medicinal materials for treating insomnia, mainly for symptoms such as restlessness and insomnia.

[0049] Synergistic with cypress seeds: cypress seeds nourish the heart and calm the mind, moisten the intestines and relieve constipation, and stop sweating. Both spinach seeds and cypress seeds have the effect of nourishing the heart and calming the mind, and the combination of the two can enhance the calming effect. For insomnia caused by insufficient yin and blood, they nourish the heart blood together, make the heart blood sufficient, and nourish the mind, thereby improving insomnia.

[0050] Synergistic with Fuling: Fuling calms the mind and soothes the nerves, while Ziziphus jujuba seeds can nourish the liver while nourishing the mind and soothing the nerves. The liver stores blood, and the heart governs blood. Fuling and Ziziphus jujuba seeds work together to regulate the body's qi, blood, and consciousness from the heart and liver, enhancing the effect of calming the mind and soothing the nerves, and have a good effect on improving insomnia-related symptoms such as palpitations.

[0051] 4. The important role and synergy of pine nuts

[0052] Baiziren is sweet in taste and neutral in nature. It enters the heart, kidney and large intestine meridians. Its main functions are nourishing the heart and calming the mind, moistening the intestines and relieving constipation, and stopping sweating. In the treatment of insomnia, it focuses on nourishing the heart and blood.

[0053] Synergistic with Fushen: Fushen calms the mind and soothes the nerves, while cypress seeds nourish the heart and soothe the nerves. The two nourish the mind and the spirit from different angles. Fushen calms the mind by penetrating dampness and strengthening the spleen, while cypress seeds soothe the nerves by nourishing the heart blood. They work together to nourish the mind in all directions, and have a good synergistic therapeutic effect on insomnia caused by heart-kidney disharmony, insufficient heart blood, etc.

[0054] 5. Synergistic integration of Poria

[0055] Poria is sweet, mild and flat in nature, and enters the heart and spleen meridians. It has the functions of penetrating dampness, strengthening the spleen and calming the mind. Its main function in prescriptions is to regulate the spleen and stomach and calm the mind.

[0056] Synergy with other herbs: By dispelling dampness and strengthening the spleen, Fu Shen can regulate the body's water metabolism and spleen and stomach function. Good spleen and stomach function is the source of Qi and blood biochemical, and can provide a material basis for other herbs to play their role. At the same time, the calming effect of Fu Shen cooperates with the calming effect of Fu Fang Teng, Gastrodia elata, Ziziphus jujuba seeds, and Platycladus orientalis seeds to regulate the body's consciousness as a whole and achieve the purpose of treating insomnia.

[0057] (II) From the perspective of Zhuang medicine theory

[0058] Zhuang doctors believe that "poison deficiency leads to all kinds of diseases". When the body's positive energy is deficient, poisonous evil invades, the dragon path is blocked, and the three qi cannot be synchronized, causing the spirit to be uneasy and "nian nao nuo" (insomnia) to occur. Fuzao prescription acts on the network of the dragon path and fire path of the human body, dredges the stagnation of the two paths, and removes the toxins.

[0059] Fufangteng can dissipate blood stasis and stop bleeding, relax muscles and activate collaterals, Gastrodia elata can calm wind and stop spasms, calm liver yang, dispel wind and dredge collaterals, Ziziphus jujuba seed can nourish the heart and liver, calm the mind and soothe the nerves, astringe sweat, and promote body fluid, Platycladus seed can nourish the heart and soothe the nerves, and Poria can calm the mind and soothe the nerves. These herbs work synergistically to dredge the dragon path and nourish the fire path. The combined use of the herbs in the prescription can invigorate the body's positive energy, enhance the function of running qi and blood in the two paths, restore the body's qi and blood balance, and achieve the purpose of calming the nerves, thereby treating insomnia.

[0060] 2. Importance and necessity of controlling the weight ratio of the five medicinal materials

[0061] 1. Importance

[0062] Each herb has its own unique efficacy and strength of action. It is of great significance to control the weight ratio of the five herbs within the range of (17-24):(12-16):(13-18):(11-17):(8-12). For example, Fufang Caulis plays the role of dispersing blood stasis, stopping bleeding, relaxing muscles and activating collaterals in the prescription. If its weight ratio is too high, the prescription may focus too much on unblocking qi and blood, and relatively weaken the effects of other herbs such as Ziziphus jujuba seeds and Platycladus orientalis seeds on nourishing the heart and calming the mind, making the prescription less effective in calming the mind. On the contrary, if the weight ratio of Fufang Caulis is too low, it may not be able to effectively improve the state of qi and blood circulation, affecting the basic conditions for other herbs to play their role, and also reducing the effect of the entire prescription in treating insomnia.

[0063] The weight ratio of Gastrodia elata is also critical. If the ratio of Gastrodia elata is too high, the effect of calming the liver and calming wind will be too strong, which may break the overall balance of the prescription and ignore other therapeutic effects such as nourishing the heart and blood. If the ratio is too low, the treatment effect for insomnia caused by hyperactivity of liver yang will be poor.

[0064] The weight ratio of Chinese date seeds, cypress seeds and poria also needs to be reasonably controlled. They work together to nourish the heart and calm the mind. If the ratio of any one of the herbs is unbalanced, it will affect the calming effect of the entire prescription, resulting in the treatment of insomnia not being able to achieve the best state.

[0065] (II) Necessity

[0066] 1. Ensure security and stability

[0067] If the weight ratio of medicinal materials is out of control, it may lead to excessive dosage of some medicinal materials, resulting in adverse reactions. For example, excessive dosage of Gastrodia elata may cause discomfort symptoms such as dizziness and nausea. By controlling the weight ratio of medicinal materials within the prescribed range, the potential safety risks caused by excessive dosage of individual medicinal materials can be avoided, ensuring the safety of the prescription.

[0068] Stable weight ratios also help ensure the stability of the prescription's efficacy. Preparing a prescription according to the weight ratio of the five herbs in the range of (17-24):(12-16):(13-18):(11-17):(8-12) can coordinate the effects of the various herbs, and each use can produce a relatively stable therapeutic effect, which is conducive to continuous and effective treatment of insomnia patients.

[0069] 2. Follow the compatibility principles of traditional Chinese medicine and Zhuang medicine theory

[0070] Both Chinese medicine and Zhuang medicine emphasize the principle of monarch, minister, assistant and envoy in prescription compatibility. Controlling the weight ratio of medicinal materials is a concrete manifestation of following these principles. In this prescription, various medicinal materials are combined with each other to achieve the purpose of synergistic treatment of insomnia. A reasonable weight ratio can ensure that the prescription compatibility meets the theoretical requirements, so that Fufangteng, Gastrodia elata, Ziziphus jujuba seeds, Platycladus orientalis seeds and Poria cocos play a role in a certain primary and secondary relationship, thereby achieving the effects of unblocking the dragon path, nourishing the fire path, and calming the mind, and improving the effect of treating insomnia.

[0071] In order to make the disclosure of the present invention more comprehensive, the present invention is further explained below in conjunction with specific implementation methods.

[0072] 1. Implementation

[0073] Example 1

[0074] A Zhuang medicine compound medicine for treating insomnia comprises the following raw materials in parts by weight: 18 parts of Euonymus fortunei, 12 parts of Gastrodia elata, 13 parts of Semen Ziziphi spinulosae, 12 parts of Semen Platycladi, and 8 parts of Poria.

[0075] Preparation method: After adding 500ml of clean water, after the raw materials are made into liquid medicine, take 200ml and take it warm twice a day, morning and evening, after meals.

[0076] The method of use of the invention is: oral administration, twice a day, 100 ml each time, 4 weeks as a course of treatment.

[0077] Example 2

[0078] A Zhuang medicine compound medicine for treating insomnia comprises the following raw materials in parts by weight: 20 parts of Euonymus fortunei, 15 parts of Gastrodia elata, 16 parts of Semen Ziziphi spinulosae, 14 parts of Semen Platycladi, and 10 parts of Poria.

[0079] Preparation method: After adding 500ml of clean water, after the raw materials are made into liquid medicine, take 200ml and take it warm twice a day, morning and evening, after meals.

[0080] The method of use of the invention is: oral administration, twice a day, 100 ml each time, 4 weeks as a course of treatment.

[0081] Example 3

[0082] A Zhuang medicine compound medicine for treating insomnia comprises the following raw materials in parts by weight: 23 parts of Euonymus fortunei, 16 parts of Gastrodia elata, 18 parts of Semen Ziziphi spinulosae, 17 parts of Semen Platycladi, and 11 parts of Poria.

[0083] Preparation method: After adding 500ml of clean water, after the raw materials are made into liquid medicine, take 200ml and take it warm twice a day, morning and evening, after meals.

[0084] The method of use of the invention is: oral administration, twice a day, 100 ml each time, 4 weeks as a course of treatment.

[0085] Comparative Example 1

[0086] A Zhuang medicine compound medicine for treating insomnia comprises the following raw materials in parts by weight: 8 parts of Euonymus fortunei, 20 parts of Gastrodia elata, 6 parts of Semen Ziziphi spinulosae, 25 parts of Semen Platycladi, and 4 parts of Poria.

[0087] Preparation method: After adding 500ml of clean water, after the raw materials are made into liquid medicine, take 200ml and take it warm twice a day, morning and evening, after meals.

[0088] The method of use of the invention is: oral administration, twice a day, 100 ml each time, 4 weeks as a course of treatment.

[0089] Comparative Example 2

[0090] A Zhuang medicine compound medicine for treating insomnia comprises the following raw materials in parts by weight: 35 parts of Euonymus fortunei, 6 parts of Gastrodia elata, 25 parts of Semen Ziziphi spinulosae, 5 parts of Semen Platycladi, and 20 parts of Poria.

[0091] Preparation method: After adding 500ml of clean water, after the raw materials are made into liquid medicine, take 200ml and take it warm twice a day, morning and evening, after meals.

[0092] The method of use of the invention is: oral administration, twice a day, 100 ml each time, 4 weeks as a course of treatment.

[0093] 2. Application Examples

[0094] Patient Tang, female, 58 years old, first visit: June 9, 2023. Main complaint: "intermittent difficulty falling asleep for 10+ years, aggravated for more than 1 month". Patients have had difficulty falling asleep, easy to wake up, difficult to fall asleep after waking up, dreamy, and sleepless all night without obvious causes for 10 years. Long-term oral administration of estazolam tablets can barely fall asleep, but the sleep duration is short. Current symptoms: difficulty falling asleep, irritability, bitter mouth, dry mouth, occasional headache, poor mental diet, frequent urination at night, stool adjustment, red tongue, yellow and greasy fur, and stringy and slippery pulse. After one course of medication treatment according to Example 1 of the present invention, follow-up after taking the medicine showed that the patient's sleep was significantly improved and the sleep time was prolonged.

[0095] Patient Fan, female, 41 years old, first visit date: July 14, 2023. Main complaint: intermittent insomnia for 1+ years. Current symptoms: difficulty falling asleep at night, many dreams, occasional distension and pain in the flanks, fever, bitter mouth and dry throat, early menstruation, more or less amount, dry stool, yellow urine, red tongue, thin yellow fur, stringy pulse, according to Example 2 of the present invention, after one course of medication treatment, follow-up after taking the medicine, the patient complained that it was easy to fall asleep, happy mood, no bitter mouth, no dry throat, normal menstruation, and normal bowel movements.

[0096] Zhang, male, 78 years old, repeated insomnia for more than 7 years, aggravated for half a year, intermittently taking tartrate oxazolidinone tablets to help sleep in the past six months, with poor effect. Complaint: difficulty falling asleep, dreaming after sleeping, frequent nightmares, no fatigue after waking up, hot at night, tinnitus with a chirping sound, dizziness and chest tightness from time to time, no special discomfort, normal appetite, and urination and defecation. Red tongue, less moss, and stringy pulse. After giving medication treatment for 1 course of treatment according to the embodiment of the present invention 3, insomnia has been significantly improved.

[0097] 3. Clinical Research

[0098] 1. Medical records

[0099] 1.1 Number of people selected

[0100] A total of 72 patients with insomnia were selected.

[0101] 1.2 Diagnostic criteria

[0102] 1.2.1 Diagnostic criteria for insomnia

[0103] Refer to the diagnostic and treatment standards for "insomnia disorder" in the "International Classification of Sleep Disorders (3rd Edition)" and the "Guidelines for Diagnosis and Treatment of Mental Disorders (2020)".

[0104] (1) At least one of the following symptoms must be present: ① Difficulty falling asleep (sleep latency > 30 min); ② Difficulty maintaining sleep; ③ Early awakening symptoms (total sleep time is shortened);

[0105] (2) At least one of the following symptoms must be present: ① daytime fatigue, sleepiness, drowsiness, prone to accidents, and dissatisfaction with one's nighttime sleep performance; ② decreased attention, social skills, and ability to maintain family relationships; ③ emotional or behavioral problems (such as irritability, hyperactivity, excessive exercise, etc.);

[0106] (3) the above symptoms occur at least three times a week for at least three months;

[0107] (4) Exclude other common sleep disorders and mental disorders.

[0108] Diagnostic criteria for insomnia:

[0109] TCM diagnostic criteria: TCM diagnostic criteria for liver depression and blood deficiency type refer to "Practical TCM Internal Medicine (1st Edition)".

[0110] 1) Anyone who has difficulty falling asleep, waking up easily during sleep, or even having trouble sleeping all night as the main clinical manifestations can be diagnosed with insomnia.

[0111] 2) Insomnia often causes symptoms such as fatigue, listlessness, weakness, loss of appetite, and decreased work ability.

[0112] 3) Clinical examination showed no organic lesions, but polysomnography showed disturbed sleep structure. This can be confirmed by combining sleep scales and relevant biochemical tests.

[0113] 4) Eliminate sleep disorders caused by diseases such as depression.

[0114] 1.2.2 Syndrome differentiation criteria for liver depression and blood deficiency

[0115] Main symptoms: difficulty falling asleep, waking up easily or waking up early;

[0116] Secondary symptoms: depression, irritability, and sighing;

[0117] Concomitant symptoms: pale complexion, dizziness, chest and flank pain, tendon and vein spasm;

[0118] Tongue and pulse: The tongue is red or light red, the tongue coating is white or slightly yellow, and the pulse is stringy and thin or stringy, thin and rapid.

[0119] The patient must have one main symptom and one or more secondary symptoms, and the diagnosis can be made based on the corresponding tongue and pulse.

[0120] 1.3 Case inclusion criteria

[0121] (1) Meet the diagnostic criteria of traditional Chinese medicine and Western medicine;

[0122] (2) Aged between 18 and 55 years old;

[0123] (3) PSQI score greater than 7 at enrollment;

[0124] (4) ISI score ≥11 points;

[0125] (5) PSS score greater than 43 points at enrollment;

[0126] (6) the negative emotion score in PANAS was greater than the positive emotion score at the time of enrollment;

[0127] (7) Volunteer to participate and sign the informed consent form;

[0128] (8) Understand the content of the scale and actively cooperate with treatment.

[0129] 1.4 Case Exclusion Criteria

[0130] (1) Those who do not meet the inclusion criteria;

[0131] (2) The syndrome does not belong to the liver depression and blood deficiency type;

[0132] (3) Professional drivers and high-altitude operators;

[0133] (4) Use of other drugs that interfere with the treatment effect within one month;

[0134] (5) Pregnant and lactating women;

[0135] (6) Those suffering from serious heart, brain, kidney, liver and blood system diseases;

[0136] (7) Patients with drug abuse and alcoholism;

[0137] (8) Allergic constitution, with a history of dietary and drug allergies;

[0138] (9) Patients with moderate to severe anxiety and depression (Hamilton Anxiety Rating Scale ≥ 14 points, Hamilton Depression Rating Scale score ≥ 17 points)

[0139] 1.5 Elimination criteria

[0140] (1) Those who were found not to meet the inclusion criteria after inclusion and were mistakenly selected;

[0141] (2) Those who did not follow the treatment plan during treatment;

[0142] (3) Those who cannot receive regular follow-up during treatment.

[0143] 1.6 Shedding Standard

[0144] (1) Those who are unable to receive treatment according to the plan due to various reasons;

[0145] (2) Those who dropped out of treatment midway.

[0146] 2. Methods

[0147] 2.1 Treatment methods

[0148] The random number table method was used, and the statisticians used SPSS24.0 software to generate a random number table. The 72 patients were divided into two groups, the treatment group and the control group, at a ratio of 1:1, with 36 cases in each group. The establishment of the group, the first scoring sheet filling, the last scoring sheet filling, and the data analysis were completed by four different physicians, and the four physicians were not allowed to exchange patient information.

[0149] The treatment group was given the Zhuang medicine compound medicine of Example 1 orally, and the control group was given Shumian capsule orally. Both groups of patients were given psychological counseling and sleep hygiene education.

[0150] Treatment group: oral administration of the Zhuang medicine compound medicine of Example 1

[0151] 18 parts of Euonymus fortunei, 12 parts of Gastrodia elata, 13 parts of Semen Ziziphi spinulosae, 12 parts of Semen Platycladi, and 8 parts of Poria.

[0152] Preparation method: After adding 500ml of clean water, after the raw materials are made into liquid medicine, take 200ml and take it warm twice a day, morning and evening, after meals.

[0153] Directions for use: Oral administration, twice a day, 100 ml each time, 4 weeks as a course of treatment.

[0154] Control group: Oral administration of Shumian capsules

[0155] Shumian Capsules (Manufacturer: Guizhou Dalong Pharmaceutical Co., Ltd., Production batch number: National Medicine Standard Z20000105, Specification: 36 capsules / box, 0.4g / capsule)

[0156] Take 3 capsules each time, a total of 1.2g, with warm water half an hour after breakfast and dinner. Take for 4 weeks.

[0157] 2.2 Observation indicators

[0158] (1) TCM symptoms: Use a table to record the patient's symptoms of difficulty falling asleep, easy awakening or early awakening, depression and irritability, sighing, pale complexion, dizziness, flank pain, tongue coating and pulse condition before, two weeks after, and four weeks after medication.

[0159] (2) Sleep scale: PSQI was used to record the patient's sleep status before and four weeks after medication. ISI, PSS, and PANAS were used to record the patient's stress status before and four weeks after medication.

[0160] 2.3 Efficacy determination

[0161] 2.3.1 Determination of TCM efficacy

[0162] According to the 2002 edition of the Guiding Principles for Clinical Research of New Chinese Medicines (Trial), the TCM symptom score (see the attached table for details) is used to determine the symptom efficacy by the decrease in the score (using the nimodipine method). The efficacy index (n) = [(score before treatment - score after treatment) / score before treatment] × 100%;

[0163] Cured: Clinical symptoms of TCM disappear or almost disappear, and syndrome score decreases by 75%-100%;

[0164] Markedly effective: TCM clinical symptoms improved, and syndrome scores decreased by 50%-74%;

[0165] Effective: TCM clinical symptoms improved, and syndrome scores decreased by 25%-49%;

[0166] Ineffective: There is no significant improvement in TCM clinical symptoms, or they may even get worse, and the symptom score decreases by less than 25%.

[0167] 2.3.2 Determination of the efficacy of Western medicine

[0168] PSQI was used to evaluate sleep quality, sleep onset time, sleep duration, sleep efficiency, daytime function,

[0169] Comprehensive assessment of main symptoms such as sleep disorders.

[0170] Clinical recovery: Pittsburgh Sleep Quality Scale total score reduction rate ≥ 75%;

[0171] Significantly effective: 50%-74%≤Pittsburgh Sleep Quality Scale total score reduction rate<75%;

[0172] Effective: 25%-49%≤Pittsburgh Sleep Quality Scale total score reduction rate<24%;

[0173] Ineffective: The Pittsburgh Sleep Quality Scale total score reduction rate is less than 25%.

[0174] 2.5 Data processing

[0175] All data were analyzed statistically using SPSS24.0 and Prism statistical software.

[0176] 3. Results

[0177] 3.1 Comparison of TCM syndrome efficacy between the treatment group and the control group after treatment

[0178]

[0179] Note: The total effective rates of the treatment group and the control group were 91.67% and 83.33% respectively. The effective rate of the treatment group was higher than that of the control group. After testing, there was a significant difference in the effective rates between the two groups (P<0.05).

[0180] 3.2 Comparison of TCM syndrome scores between the treatment group and the control group after treatment

[0181]

[0182] Note: After testing, the treatment group was better than the control group in improving difficulty falling asleep, waking up early, flank pain, and fatigue, and the difference was statistically significant (P < 0.05). The control group was better than the treatment group in improving irritability, and the difference was statistically significant (P < 0.05). There was no statistical difference in improving sighing, pale complexion, and dizziness (P > 0.05). There was no statistical difference between the treatment group and the control group. In terms of the overall improvement score, the treatment group was better than the control group, and the difference was statistically significant (P < 0.05).

[0183] IV. Comparative Test of Treatment Effects of Examples 1-3 and Comparative Examples 1 and 2

[0184] The random number table method was adopted, and the statisticians used SPSS24.0 software to generate a random number table. 180 patients were divided into 5 groups, 36 cases in each group, corresponding to Examples 1-3 and Comparative Examples 1 and 2, respectively. The inclusion, first scoring sheet filling, last scoring sheet filling, and data analysis were completed by four different physicians, and the four physicians were not allowed to exchange patient information. The results of the efficacy evaluation after treatment are shown in the following table.

[0185] 3.3 Comparison of TCM Syndrome Scores of Examples 1-3 and Comparative Examples 1 and 2 after Treatment

[0186]

[0187] It can be seen from the above table:

[0188] (1) The Zhuang medicine compound medicine of the present invention has shown good cure rate and effective rate in clinical medical practice. The compound medicine carefully combines the wisdom of traditional Zhuang medicine with the essence of modern pharmaceutical technology, and its excellent therapeutic effect has been widely verified. Specifically, its effective rate is as high as 91.67%, which not only far exceeds the average level of similar drugs (Shumian Capsules), but also fully meets the actual application needs of patients and medical institutions.

[0189] (2) By comparing and analyzing the therapeutic effect data in Examples 1 to 3 and Comparative Examples 1 and 2, the present invention can clearly see that the raw material ratio has an important influence on the efficacy of the drug. When the weight ratio of the five key medicinal materials of Eucommia ulmoides, Gastrodia elata, Semen Ziziphi Spinosae, Semen Platycladi, and Poria deviates from the carefully designed range of (17-24): (12-16): (13-18): (11-17): (8-12), the cure rate and effective rate of the drug both show a significant downward trend. This change is not accidental, but deeply reveals the scientific and rationality of the raw material dosage ratio in the drug formula.

[0190] Specifically, the drugs in Comparative Examples 1 and 2, because they do not strictly follow the raw material ratio determined by the present invention, have a significant difference in cure rate and effectiveness compared with Examples 1 to 3. This difference is not only reflected in the numerical value, but also in the direct impact on the treatment effect of patients.

[0191] This discovery not only re-verifies the scientificity and rationality of the raw material dosage ratio in the present invention, but also highlights the importance of controlling the weight ratio of the five medicinal materials within the range of (17-24): (12-16): (13-18): (11-17): (8-12) from a practical level. It can be said that the dosage of raw materials is the key to the efficacy of the drug. Any slight deviation may lead to a significant decrease in the efficacy of the drug, thereby affecting the therapeutic effect of the patient.

[0192] Therefore, this discovery not only provides strong data support and theoretical basis for the present invention, but also points out the direction for other new drug research and development. In the future research and development process, new drugs need to be further explored and optimized in drug formula to ensure that the dosage of each medicinal material can be accurately controlled within the optimal range, so as to further improve the efficacy and safety of the drug and bring better quality and efficient medical services to patients.

[0193] The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. For those skilled in the art, the present invention may have various modifications and variations. Any modification, equivalent replacement, improvement, etc. made within the spirit and principle of the present invention shall be included in the protection scope of the present invention.

Claims

1. A Zhuang medicine compound medicine for treating insomnia, characterized in that: The invention comprises the following raw materials in parts by weight: 17-24 parts of Euonymus fortunei, 12-16 parts of Gastrodia elata, 13-18 parts of Semen Ziziphi Spinosae, 11-17 parts of Semen Platycladi, and 8-12 parts of Poria.

2. The Zhuang medicine compound for treating insomnia according to claim 1, characterized in that: The invention comprises the following raw materials in parts by weight: 18 parts of Euonymus fortunei, 12 parts of Gastrodia elata, 13 parts of Semen Ziziphi Spinosae, 12 parts of Semen Platycladi and 8 parts of Poria.

3. The Zhuang medicine compound medicine for treating insomnia according to claim 1, characterized in that: The invention comprises the following raw materials in parts by weight: 20 parts of Euonymus fortunei, 15 parts of Gastrodia elata, 16 parts of Semen Ziziphi Spinosae, 14 parts of Semen Platycladi and 10 parts of Poria.

4. The Zhuang medicine compound medicine for treating insomnia according to claim 1, characterized in that: The invention comprises the following raw materials in parts by weight: 23 parts of Euonymus fortunei, 16 parts of Gastrodia elata, 18 parts of Semen Ziziphi Spinosae, 17 parts of Semen Platycladi and 11 parts of Poria.

5. The Zhuang medicine compound medicine for treating insomnia according to any one of claims 1 to 4, characterized in that: Use Zhuang medicine compound medicine by oral administration.

6. The Zhuang medicine compound for treating insomnia according to claim 5, characterized in that: Take the Zhuang medicine compound medicine orally twice a day.

7. The Zhuang medicine compound for treating insomnia according to claim 6, characterized in that: The Zhuang medicine compound medicine should be used twice a day, in the morning and after dinner.

8. The Zhuang medicine compound for treating insomnia according to claim 7, characterized in that: The Zhuang medicine compound medicine is taken 100 mL each time, and 4 weeks is a course of treatment.

9. A method for preparing a Zhuang medicine compound for treating insomnia according to any one of claims 1 to 8, characterized in that: The following steps are involved: a. Weigh 10 grams of Eucommia ulmoides, Gastrodia elata, Semen Ziziphi spinulosae, Semen Platycladi, and Poria cocos according to weight ratio; b. Put the weighed raw materials in step a into water, and boil the raw materials to prepare a medicinal liquid to obtain a Zhuang medicine compound for treating insomnia.

10. The method for preparing the Zhuang medicine compound for treating insomnia according to claim 9, characterized in that: The amount of water added in step b is 500 mL.

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