A traditional Chinese medicine composition for treating insomnia, and a preparation method and application thereof

Abstract

The application discloses a traditional Chinese medicine composition for treating insomnia and a preparation method and application thereof. The traditional Chinese medicine composition is mainly prepared from the following raw medicinal materials in proportion by weight: 20-60 parts of green malachite, 3-10 parts of radix curculiginis, 3-6 parts of amber powder and 3-6 parts of linaloe. The application further discloses a preparation method of the traditional Chinese medicine composition. The traditional Chinese medicine composition can be used for relieving insomnia, and has remarkable curative effect on insomnia of the phlegm-heat disturbing type.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine technology. More specifically, it relates to a traditional Chinese medicine composition for treating insomnia, its preparation method, and its application, particularly for treating insomnia caused by phlegm-heat disturbance. Background Technology

[0002] With increasing social pressure and changing lifestyles, insomnia has become a common disease, occurring independently or alongside other illnesses and serving as a risk factor for their development. According to the "2025 China Sleep Health Survey Report" released by the Chinese Sleep Research Society, the sleep disturbance rate among people aged 18 and above in China is as high as 48.5%, with main symptoms including difficulty falling asleep, frequent awakenings at night, and early awakenings. In terms of population distribution characteristics, insomnia shows a significant gender difference, with a much higher prevalence in women than men, at 51.1%. The sleep disturbance rate among the elderly aged 65 and above is as high as 73.7%, far exceeding the average level of the adult population. A clinical study on the prevalence of insomnia among urban and rural residents aged 60 and above in Henan Province showed that rural residence, female gender, and chronic diseases were highly associated with insomnia, and the consultation rate for urban patients was higher than that for rural patients. In conclusion, the prevalence of insomnia disorder in adults is not low, exhibiting significant gender and age differences, and is influenced by multiple biological, social, and psychological factors.

[0003] Insomnia-related psychological and physical symptoms are frequently observed, with complex and diverse etiologies and mechanisms, making treatment outcomes difficult to meet expectations. Currently, insomnia treatments mainly include psychotherapy, physical therapy, traditional Chinese medicine (TCM) therapy, and oral medication. However, due to the high cost and scarcity of psychotherapy resources in China, and the long treatment cycles of physical therapy, these treatments are difficult to widely implement. TCM therapies for insomnia, such as acupuncture, are often unacceptable to most people due to the sensation of needles, and there are individual differences in treatment outcomes. While Western medicine treatments for insomnia are numerous, they carry a certain degree of addictiveness and unavoidable side effects. TCM treatments have advantages such as significant efficacy, low addictiveness, and fewer side effects. Therefore, developing a TCM combination for treating insomnia that has no adverse reactions, is non-addictive, non-dependent, and has few side effects is of great importance. Summary of the Invention

[0004] To address the aforementioned technical problems, the first objective of this invention is to provide a novel traditional Chinese medicine composition for calming the mind, which is remarkably effective in relieving and treating insomnia caused by phlegm-heat disturbance.

[0005] The second objective of this invention is to provide a method for preparing the above-mentioned traditional Chinese medicine composition.

[0006] A third objective of this invention is to provide a traditional Chinese medicine preparation using the above-mentioned traditional Chinese medicine composition as an effective active ingredient.

[0007] The fourth object of the present invention is to provide the use of the above traditional Chinese medicine composition and traditional Chinese medicine preparation in the preparation of a drug for treating insomnia.

[0008] To achieve the above object, the present invention adopts the following technical solutions: In the first aspect, the present invention provides a traditional Chinese medicine composition for treating insomnia. Calculated by weight parts, the traditional Chinese medicine composition is mainly made from the following raw medicinal materials: 20-60 parts of lapis chloriti, 3-10 parts of concha armandii, 3-6 parts of amber powder, and 3-6 parts of lignum aquilariae resina.

[0009] In the prescription of the present invention, the functions and effects of each component are as follows: First, the monarch drug lapis chloriti, sweet, salty, flat, attributing to the lung, heart, and liver meridians, can reduce phlegm and lower qi, and calm the liver and suppress fright. It is used for stubborn phlegm binding, cough and dyspnea, epilepsy and mania, restlessness and chest distress, infantile convulsion and twitch. Modern research shows that its main component is a silicate mineral, rich in trace elements such as magnesium and iron, and has significant sedative and anti-convulsive effects. The mechanism may be related to regulating neurotransmitters in the brain (such as reducing the level of excitatory amino acid glutamate and increasing the content of inhibitory neurotransmitter GABA) and stabilizing the nerve cell membrane potential. Concha armandii contains various amino acids and trace elements, and pharmacological experiments have confirmed that it has definite antipyretic, anti-inflammatory and central inhibitory effects, and can effectively prolong the sleeping time of mice induced by pentobarbital sodium, verifying the scientific connotation of its "clearing the heart and calming fright".

[0010] The ministerial drug concha armandii, sweet, cold, attributing to the heart and liver meridians, has the effects of clearing heat and resolving phlegm, cooling the heart and calming fright. It is used for coma due to febrile disease, stroke with phlegm confining the mind, infantile phlegm-heat convulsion, twitch, and nocturnal crying. Modern pharmacological research shows that it contains various active components such as phenolic acids, polysaccharides, and trace elements. Animal experiments show that the extract of concha armandii can prolong the convulsion latency of mice induced by pentylenetetrazol, and may reduce the excitability of the central nervous system by regulating the levels of neurotransmitters such as γ-aminobutyric acid (GABA).

[0011] The adjuvant drug amber powder, sweet, flat and non-toxic, attributing to the small intestine, bladder, lung, and spleen meridians, has the effects of sedation, diuresis, and promoting blood circulation. It is used for infantile convulsion, epilepsy, palpitation, insomnia, dysuria, painful urination, hematuria, and amenorrhea. Modern pharmacological research shows that succinic acid contained in it is an important intermediate product of the tricarboxylic acid cycle in the brain tissue, can improve brain energy metabolism, increase cerebral blood flow, and has significant sedative, anti-convulsive and diuretic effects, and helps to eliminate cerebral edema and metabolic waste.

[0012] The adjuvant Chinese medicine Aquilariae Lignum Resinatum is pungent, bitter, and slightly warm, and belongs to the spleen, stomach, and kidney meridians. It has the effects of promoting qi circulation to relieve pain, warming the middle to stop vomiting, and accepting qi to relieve asthma. It is used for chest and abdominal distending pain, vomiting and hiccups due to stomach cold, and dyspnea due to kidney deficiency qi reversal. The sesquiterpenoids in Aquilariae Lignum Resinatum show good central inhibitory and gastrointestinal motility regulating effects. They can not only synergistically enhance the sedative effect, but also reduce the irritation of mineral medicines and cold medicines to the digestive tract by promoting gastrointestinal peristalsis and protecting the gastric mucosa, explaining its compatibility significance of "promoting qi circulation and benefiting the mechanism, preventing cold from damaging the stomach" from the perspective of modern medicine.

[0013] Insomnia is called "sleeplessness" in traditional Chinese medicine (TCM). TCM has a profound accumulation of understanding of sleeplessness. As early as in "Plain Questions: Treatise on Pathological Changes of Diseases", there is a statement that "if one's emotions are preoccupied, then lying down will be uneasy". TCM believes that the pathogenesis of sleeplessness is the imbalance of yin and yang, with yin unable to restrain yang. The diseased locations mainly involve the heart, liver, spleen, and kidney. If the liver fails to disperse and dredge, and the function of regulating qi movement is derelict, it is easy to lead to the abnormal rise and fall of qi movement. Qi is the commander of blood, and qi diseases are likely to involve the blood aspect. Poor blood circulation will conversely hinder qi movement and also affect the generation of new blood. Blood cannot contain the soul, and the vessels cannot house the spirit, so the soul and spirit have nowhere to return, resulting in sleeplessness. The heart is located above and the kidney is located below. The monarch and minister are in their proper positions and each performs its duties. When the heart and kidney are not in harmony, water and fire are not coordinated, and yin and yang are out of balance. Among the various TCM syndromes of insomnia, the syndrome of sleeplessness due to internal disturbance of phlegm-heat has attracted much attention due to its typical symptoms. The common clinical manifestations of this syndrome are insomnia with dreaminess, restlessness, chest distress with excessive phlegm, restlessness, red tongue with yellow and greasy coating, and string-taut and slippery pulse, etc. With the change of modern people's diet structure and the increase of life pressure, the incidence of sleeplessness due to internal disturbance of phlegm-heat has increased significantly. Epidemiological investigation and research show that the proportion of sleeplessness due to internal disturbance of phlegm-heat in insomnia patients is as high as 21.3%. Based on the etiology and pathogenesis of internal disturbance of phlegm-heat, this specific formula is designed. In the formula, Chloriti Lapis is the monarch drug, with a salty and neutral flavor, belonging to the liver and lung meridians. It can reduce phlegm and lower qi, and calm the liver and suppress fright. It is used to treat stubborn phlegm congestion, mania and epilepsy, etc. Chloriti Lapis belongs to mineral medicine and is good at reducing phlegm by heavy sedation and calming the liver and suppressing fright. It is mostly used for the syndrome of phlegm-heat blocking the interior and mental confusion. The minister drug is Concretio Silicea Bambusae, which is a good medicine for clearing the heart and suppressing fright, assisting Chloriti Lapis to clear and transform heat-phlegm and cool the heart and suppress fright. The adjuvant drugs are Succinum powder and Aquilariae Lignum Resinatum. Among them, Succinum powder is sweet and neutral, belonging to the heart, liver, and bladder meridians, and has the functions of calming the mind and relieving uneasiness and promoting blood circulation to remove stasis. For palpitations and insomnia due to the combination of phlegm-heat and poor blood circulation, it can play a unique role in sedation and improving microcirculation. Aquilariae Lignum Resinatum is pungent, warm, and dispersing, with a fragrant smell, mainly entering the spleen, stomach, and kidney meridians. Its function of promoting qi circulation to relieve pain and warming the middle and harmonizing the stomach can not only regulate the qi movement of the whole body and assist in the transportation and transformation of phlegm-dampness, but more importantly, use its warm nature to restrict the possible harm to the stomach caused by cold drugs such as Chloriti Lapis and Concretio Silicea Bambusae. It can not only "treat phlegm by treating qi first" but also "protect the stomach qi". The combination of various drugs plays the role of nourishing the heart and calming the mind, clearing heat and resolving phlegm. This formula closely focuses on the four core pathological links of "phlegm, heat, fright, and palpitation", aiming to clear heat and resolve phlegm to treat the root cause and calm the mind and suppress fright to treat the symptoms. The whole formula combines cold and warm drugs, combines attacking and tonifying, and coordinates ascending and descending, playing a grand effect of clearing heat and resolving phlegm, calming the liver and suppressing fright, and calming the heart and tranquilizing the mind.

[0014] For example, by weight, the traditional Chinese medicine composition of the present invention is mainly made of the following raw materials: 60 parts of chlorite, 10 parts of bamboo shavings, 6 parts of amber powder, and 6 parts of agarwood.

[0015] For example, by weight, the traditional Chinese medicine composition is mainly made of the following raw materials: 40 parts of chlorite, 6 parts of bamboo shavings, 5 parts of amber powder, and 5 parts of agarwood.

[0016] For example, by weight, the traditional Chinese medicine composition is mainly made of the following raw materials: 20 parts of chlorite, 3 parts of bamboo shavings, 3 parts of amber powder, and 3 parts of agarwood.

[0017] The basic formula of the above-mentioned traditional Chinese medicine composition of the present invention can be adjusted based on clinical symptoms in specific embodiments to enhance efficacy, achieve the purpose of calming the mind and promoting sleep while improving certain specific clinical symptoms, further enhance the adaptability of the composition of the present invention, and improve the therapeutic effect. These adjustments based on the basic formula of the present invention are also within the scope of protection of this application. Examples include adding Acorus tatarinowii, Poria cocos, Ziziphus jujuba var. spinosa, and Polygala tenuifolia.

[0018] Secondly, the present invention provides a method for preparing the above-mentioned traditional Chinese medicine composition for treating insomnia, the preparation method comprising: (1) Take the following ingredients according to the formula: chlorite, bamboo yellow, amber powder, and agarwood, and soak them in water for 20-30 minutes; (2) Simmer over low heat until boiling, then continue simmering for 15-20 minutes; (3) Filter, add water to the filter residue and continue to boil for 15-20 minutes; (4) Repeat step (3) 1-2 times and combine the filtrates; or, (5) Take the following ingredients according to the formula: chlorite, bamboo yellow, amber powder, and agarwood powder; (6) Mix the pulverized raw materials and extract with 70%-95% ethanol for 0.5-2 hours; (7) Filter, add 70%-95% ethanol to the residue and continue extraction for 0.5-2 hours; (8) Repeat step (7) 1-2 times, combine the filtrates, recover ethanol under reduced pressure, concentrate and dry to obtain the final product.

[0019] Furthermore, for ease of storage, the above preparation method may also include the step of concentrating the filtrate obtained in step (4) into an extract; optionally, the extract may be further dried into powder.

[0020] Thirdly, the present invention provides a traditional Chinese medicine preparation for treating insomnia, wherein the traditional Chinese medicine preparation uses the above-mentioned traditional Chinese medicine composition as the active ingredient.

[0021] Depending on actual needs, the traditional Chinese medicine preparations may also include pharmaceutically acceptable excipients. Various dosage forms, such as decoctions, granules, pills, capsules, tablets, powders, ointments, or oral liquids, are prepared according to conventional pharmaceutical processes.

[0022] Fourthly, the present invention also claims protection for the use of the above-mentioned traditional Chinese medicine composition or preparation in the preparation of a medicine for treating insomnia; especially for treating insomnia caused by phlegm-heat disturbance.

[0023] In addition, unless otherwise specified, all raw materials of the traditional Chinese medicine composition of the present invention can be obtained commercially available. Any traditional Chinese medicine composition of any range described in the present invention, including the end value and any value between the end values ​​and any sub-range formed by the end value or any value between the end values, can achieve the purpose of treating insomnia.

[0024] The beneficial effects of this invention are as follows: The combination of these herbs in this invention nourishes the heart and calms the mind, clears heat and resolves phlegm. It can effectively improve clinical symptoms of insomnia patients such as difficulty falling asleep, excessive dreaming, easy startling and waking, dizziness, abdominal distension, bitter taste in the mouth, irritability, and sticky phlegm. It is particularly effective in treating insomnia with phlegm-heat disturbance as the main pathogenesis. Detailed Implementation

[0025] To more clearly illustrate the present invention, the following description, in conjunction with preferred embodiments, further clarifies the invention. Those skilled in the art should understand that the specific descriptions below are illustrative rather than restrictive, and should not be construed as limiting the scope of protection of the present invention.

[0026] Example 1 Raw material formula: 40g of chlorite, 6g of bamboo shavings, 5g of amber powder, and 5g of agarwood.

[0027] Mix the above-mentioned raw materials together, place them in a clay pot, add water to cover the herbs, soak for 20-30 minutes, then simmer over low heat. After boiling, continue simmering for 15-20 minutes. Filter, add water to the dregs and simmer for another 15-20 minutes. Repeat this process three times, combining the three filtrates to obtain the decoction. Usage instructions: One dose daily, decocted in water, taken twice daily, morning and evening. A course of treatment is 7 days.

[0028] Example 2 Raw material formula: 60g of chlorite, 10g of bamboo shavings, 6g of amber powder, and 6g of agarwood.

[0029] The above-mentioned raw materials were pulverized and mixed, and three times their weight of 95% ethanol were added. The mixture was ultrasonically extracted for 1 hour. After filtration, the residue was ultrasonically extracted twice more with three times its weight of 80% ethanol, each time for 1 hour. The three filtrates were combined, the ethanol was recovered under reduced pressure, concentrated, and dried to obtain the ethanol extract.

[0030] The above-mentioned alcohol extract is made into tablets according to the conventional preparation methods in the art.

[0031] Example 3 Raw material drug formula: 20 g of lapis chloriti, 3 g of concretio silicea bambusae, 3 g of succinum powder, 3 g of lignum aquilariae resina.

[0032] Mix the above raw material drugs together, place them in a casserole, add water to cover the drug surface, soak for 20 - 30 minutes and then decoct with slow fire. After boiling, continue to decoct for 15 - 20 minutes, filter. Add water to the drug residues and decoct for 15 - 20 minutes. Decoct three times in total, and combine the filtrates of the three times to obtain a decoction.

[0033] Example 4 A non-inferiority randomized controlled trial was completed at Guang'anmen Hospital, China Academy of Chinese Medical Sciences from June 2025 to March 2026. The sample size was estimated to be 78 cases. A total of 78 patients were included, 5 cases dropped out, and 73 cases completed all observations. Among them, there were 37 cases in the Mengshi Anshen Fang group (the traditional Chinese medicine composition group of the present invention) and 3 group.

[0034] Treatment group: Treated with Mengshi Anshen Fang. The drug composition: 40 g of lapis chloriti, 6 g of concretio silicea bambusae, 5 g of succinum, 5 g of lignum aquilariae resina. All the medicinal materials used in this research were taken from the outpatient dispensing pharmacy of Guang'anmen Hospital, China Academy of Chinese Medical Sciences. The administration method was 1 dose per day, decocted in water to obtain juice, 200 ml was taken each time, 2 times a day, and the course of treatment was 4 weeks in total. After the treatment ended, follow-up was conducted for 2 weeks. Control group: Oral estazolam tablets (Shandong Xinyi Pharmaceutical Co., Ltd., 1 mg per tablet), 1 mg each time, 1 time a day, taken before going to bed. Treated for 4 weeks, and follow-up was conducted for 2 weeks after the treatment ended.

[0035] Inclusion criteria: (1) Meeting the diagnostic criteria of insomnia in traditional Chinese and Western medicine; (2) Meeting the syndrome criteria of phlegm-heat disturbing the interior syndrome; (3) Pittsburgh Sleep Quality Index (PSQI) ≥ 7 points; (4) Age greater than 18 years old; (5) Willing to abandon other treatments for insomnia during the intervention, including drug treatment and adjuvant sleep treatment; (6) The patient voluntarily signed the informed consent form and could cooperate with filling out the scale truthfully.

[0036] Exclusion criteria: (1) Patients with severe heart, brain, kidney, or liver diseases; (2) Patients taking medications that affect sleep (such as olanzapine, clozapine, etc.); (3) Patients who have used other traditional Chinese medicines or proprietary Chinese medicines for treating insomnia, or non-short-acting sedative-hypnotics, or antidepressants and anti-anxiety drugs within the past week; (4) Patients who have been using central nervous system depressants or stimulants for a long time; (5) Patients with sleep apnea or bipolar disorder; (6) Patients with severe anxiety, depression, or other mental illnesses (Hamilton Anxiety Scale score ≥14, Hamilton Depression Scale score ≥17). (7) Patients with suicidal tendencies; (8) Patients whose circadian rhythm is reversed due to work reasons; (9) Patients with known allergies to the drugs used in this study; (10) Patients whose liver function ALT and AST exceed the upper limit of the normal reference value by 1.5 times, or whose Scr exceeds the upper limit of the normal reference value; (11) Patients with other causes of insomnia in the past month, such as pain, fever, cough, surgery, external environmental interference or stressful life events; (12) Patients with habitual abortion, pregnant or pregnant women, or breastfeeding women; (33) Patients who have participated in other clinical trials in the past 3 months.

[0037] Primary efficacy endpoint: The Pittsburgh Sleep Quality Index (PSQI) was used. Developed by the University of Pittsburgh, this scale assesses patients' sleep quality over the past month. The PSQI is the most commonly used subjective scale for assessing sleep in clinical practice, possessing high reliability and validity. It is also currently the internationally recognized subjective sleep quality assessment scale; therefore, this study selected the PSQI as the primary efficacy endpoint. The scale consists of 19 self-report items and 5 peer-report items. Only the scores of the 18 self-report items were calculated, including 7 factors: subjective sleep quality, sleep onset time, sleep duration, sleep efficiency, sleep disturbances, hypnotic drug use, and daytime functioning. The total score for each factor was calculated, ranging from 0 to 21. A total score >7 was considered a sleep disturbance. In this study, the control group used sedative-hypnotic drugs; therefore, the hypnotic drug use score was not included in the calculation.

[0038] Clinical study results showed that the number of effective cases in the Mengshi Anshen Fang group was 32, with a total effective rate of 86.49% (32 / 37), and a 95% confidence interval of 71.23%–95.46%. The number of effective cases in the estazolam group was 32, with a total effective rate of 88.89% (32 / 36), and a 95% confidence interval of 73.94%–96.89%. The difference in total effective rate between the Mengshi Anshen Fang group and the estazolam group was -2.40% (95% CI: -18.34%–13.71%). There was no statistically significant difference in the effective rates between the two groups. This indicates that the clinical efficacy of Mengshi Anshen Fang is comparable to that of estazolam tablets.

[0039] Traditional Chinese medicine symptom statistics show that the improvement in clinical symptoms such as difficulty falling asleep, excessive dreaming, easy startling and waking, dizziness, abdominal distension, bitter taste in the mouth, irritability, and sticky phlegm in the Mengshi Anshen Formula group was significantly better than that in the estazolam group.P＜0.05 ).

[0040] Table 1 Effective Distribution

[0041] Classical Cases Case 1 Wang, male, 35 years old, visited the doctor due to "insomnia for more than 1 month". The patient had insomnia without obvious cause 1 month ago. Present condition: Difficulty falling asleep, only able to fall asleep for 1 - 2 hours every night, easily awakened, difficult to fall asleep again after waking up, accompanied by chest tightness and abdominal distension, excessive phlegm, thick and sticky, yellow and difficult to expectorate, bitter taste in the mouth, irritability, listlessness during the day, dizziness and heaviness in the head, poor appetite, red tongue, yellow and greasy coating, slippery and rapid pulse. Syndrome differentiation was insomnia of the type of internal disturbance of phlegm - heat. The prescription was given: Chlorite 40g, Bamboo Shavings 6g, Amber Powder 5g, Aquilaria 5g. 5 doses, decocted in water for oral administration, 1 dose per day, divided into 2 times, taken warm in the morning and evening. After taking the medicine for 7 doses, it was easier to fall asleep at night, and could fall asleep for 3 - 4 hours, and the symptom of excessive phlegm was relieved; after taking the medicine for 14 doses, fell asleep smoothly, could fall asleep for 5 - 6 hours every night, chest tightness and bitter taste in the mouth were relieved, and the amount of phlegm was significantly reduced; after taking the medicine for 21 doses, all symptoms disappeared, sleep returned to normal, and the mental state improved.

[0042] Case 2 Zhao, female, 42 years old, visited the doctor due to "intractable insomnia for more than 1 year". The patient had insomnia after eating spicy and greasy food 1 year ago, and had taken Anshen Bunaoye orally by herself with ineffective results, so she came to our hospital for treatment. Present condition: Tossing and turning at night, unable to fall asleep, even staying awake all night, accompanied by restlessness, chest tightness and excessive phlegm, thick and sticky, yellow, nausea and vomiting, bitter and sticky taste in the mouth, sticky and unsmooth stools, red tongue, thick and yellow greasy coating, slippery and rapid pulse. Syndrome differentiation was insomnia of the type of internal disturbance of phlegm - heat. The prescription was given: Chlorite 60g, Bamboo Shavings 10g, Amber Powder 6g, Aquilaria 6g. 7 doses, decocted in water for oral administration, 1 dose per day, divided into 2 times, and an additional dose was taken 1 hour before going to bed. After taking the medicine for 7 doses , could fall asleep for about 4 hours, and restlessness and nausea were relieved; after taking the medicine for 14 doses, fell asleep smoothly at night, and the symptoms of excessive phlegm and bitter taste in the mouth were significantly improved, and the stools were unobstructed; after taking the medicine for 28 doses, insomnia was cured.

[0043] Case 3 Chen, male, 48 years old, visited the doctor due to "insomnia for more than half a year". Half a year ago, the patient had insomnia at night after fatigue and took diazepam tablets intermittently, and could fall asleep briefly, but felt dizzier after waking up. To seek further diagnosis and treatment, he visited our hospital. Present symptoms: difficulty falling asleep, irritability easily after waking up, accompanied by headache and dizziness, excessive phlegm, thick and sticky, yellow in color, chest tightness, bitter taste in the mouth, general body heaviness and discomfort. The tongue is red, the tongue coating is yellow and greasy, and the pulse is slippery and rapid. The syndrome was differentiated as insomnia due to internal disturbance of phlegm-heat. The prescription was as follows: chlorite schist 30g, bamboo sap 5g, succinum powder 4g, and aquilaria 4g. Take 5 doses, decoct with water, 1 dose per day, warm and take in 2 times, and stop taking diazepam tablets. After taking 5 doses of the medicine, the headache was relieved and he could fall asleep for 3 hours; after taking 10 doses of the medicine, he could fall asleep smoothly, the excessive phlegm and chest tightness were relieved, and the bitter taste in the mouth disappeared; after taking ́15 doses of the medicine, the insomnia was cured, and the headache, general body heaviness and other symptoms disappeared completely, and there was no obvious discomfort.

[0044] Case 4 Li, female, 14 years old, junior high school student, visited the doctor due to "insomnia and restlessness for more than 1 month". One month ago, the patient had insomnia and restlessness after excessive learning pressure. Present symptoms: difficulty falling asleep, easy to wake up at night, and the pictures related to exercises and exams repeatedly appeared in the mind after waking up, restlessness and uneasiness, accompanied by chest tightness and excessive phlegm, thick and sticky, yellow in color, bitter taste in the mouth, dry mouth but not willing to drink water, poor appetite, inattention and listlessness in class. The tongue is red, the tongue coating is yellow and greasy, and the pulse is slippery and rapid. The syndrome was differentiated as insomnia due to internal disturbance of phlegm-heat. The prescription was as follows: chlorite schist 20g, bamboo sap 3g, succinum powder 3g, and aquilaria 3g. Take 7 doses, decoct with water, 1 dose per day, warm and take in 2 times, and instruct her to arrange her study time reasonably and avoid staying up late. After taking 7 doses of the medicine, the restlessness was relieved and she could fall asleep for 3-4 hours; after taking 14 doses of the medicine, the excessive phlegm decreased, the bitter taste in the mouth was relieved, the sleep time was prolonged, and the attention in class was more concentrated than before; after taking 21 doses of the medicine, the insomnia was cured, all symptoms disappeared, the diet and sleep returned to normal, the mood was stable, and she could study normally.

[0045] Obviously, the above embodiments of the present invention are merely examples for clearly illustrating the present invention, rather than limitations on the implementation manners of the present invention. For those of ordinary skill in the art, based on the above description, other different forms of changes or modifications can be made. It is impossible to list all the implementation manners here. Any obvious changes or modifications derived from the technical solutions of the present invention still fall within the protection scope of the present invention.

Claims

1. A traditional Chinese medicine composition for treating insomnia, characterized in that, The traditional Chinese medicine composition is mainly made of the following raw materials in parts by weight: 20-60 parts of chlorite, 3-10 parts of bamboo shavings, 3-6 parts of amber powder, and 3-6 parts of agarwood.

2. The traditional Chinese medicine composition according to claim 1, characterized in that, The traditional Chinese medicine composition is mainly made from the following raw materials in parts by weight: 60 parts of chlorite, 10 parts of bamboo shavings, 6 parts of amber powder, and 6 parts of agarwood.

3. The traditional Chinese medicine composition according to claim 1, characterized in that, The traditional Chinese medicine composition is mainly made from the following raw materials in parts by weight: 40 parts of chlorite, 6 parts of bamboo shavings, 5 parts of amber powder, and 5 parts of agarwood.

4. The traditional Chinese medicine composition according to claim 1, characterized in that, The traditional Chinese medicine composition is mainly made from the following raw materials in parts by weight: 20 parts of chlorite, 3 parts of bamboo shavings, 3 parts of amber powder, and 3 parts of agarwood.

5. A method for preparing the traditional Chinese medicine composition for treating insomnia according to any one of claims 1-4, characterized in that, The preparation method includes: (1) Take the following ingredients according to the formula: chlorite, agarwood, amber powder, and bamboo yellow, and soak them in water for 20-30 minutes; (2) Simmer over low heat until boiling, then continue simmering for 15-20 minutes; (3) Filter, add water to the dregs and continue to decoct for 15-20 minutes; (4) Repeat step (3) 1-2 times and combine the filtrates; or, (5) Take the following ingredients according to the formula: chlorite, agarwood, amber powder, and cinnamon powder; (6) Mix the pulverized raw materials and extract with 70%-95% ethanol for 0.5-2 hours; (7) Filter, add 70%-95% ethanol to the residue and continue extraction for 0.5-2 hours; (8) Repeat step (7) 1-2 times, combine the filtrates, recover ethanol under reduced pressure, concentrate and dry to obtain the final product.

6. The preparation method according to claim 5, characterized in that, The preparation method further includes the step of concentrating the filtrate obtained in step (4) into an extract; optionally, the extract is further dried into powder.

7. A traditional Chinese medicine preparation for treating insomnia, characterized in that, The traditional Chinese medicine preparation uses the traditional Chinese medicine composition according to any one of claims 1-4, or the traditional Chinese medicine composition prepared by the preparation method according to claim 5 or 6, as the active ingredient.

8. The traditional Chinese medicine preparation according to claim 7, characterized in that, The traditional Chinese medicine preparation also includes pharmaceutically acceptable excipients.

9. The traditional Chinese medicine preparation according to claim 7, characterized in that, The dosage forms of the traditional Chinese medicine preparations are decoctions, granules, pills, capsules, tablets, powders, ointments, or oral liquids.

10. The use of the traditional Chinese medicine composition according to any one of claims 1-4, or the traditional Chinese medicine composition prepared by the preparation method according to claim 5 or 6, or the traditional Chinese medicine preparation according to any one of claims 7-8 in the preparation of a drug for treating insomnia; Preferably, the insomnia is caused by phlegm-heat disturbance.

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