A traditional Chinese medicine composition for treating liver-stagnated qi-depressed insomnia and a preparation method thereof

Abstract

The application belongs to the technical field of traditional Chinese medicines, and relates to a traditional Chinese medicine composition for treating liver stagnation and qi stagnation type insomnia and a preparation method thereof. The traditional Chinese medicine composition comprises the following components in parts by weight: 11-20 parts of bupleurum, 11-18 parts of curcuma zedoary, 11-18 parts of radix curcumae, 10-15 parts of oyster shell, 10-20 parts of oyster, 10-15 parts of white peony root, 8-12 parts of saussurea, 8-12 parts of radix angelica sinensis. Bupleurum is the monarch drug, radix curcumae, radix angelica sinensis and white peony root are the ministerial drugs, oyster shell and oyster are the auxiliary drugs, and radix angelica sinensis, radix angelica sinensis and saussurea are the ministerial drugs. Under the guidance of traditional Chinese medicine theory, the traditional Chinese medicinal materials are scientifically matched, the raw materials are matched and synergistically act, from the perspective of qi movement, liver and spleen are adjusted, liver and spleen are regulated, tranquilization and sedation, and yang and heat are discharged, and the insomnia caused by qi stagnation has remarkable curative effect.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine technology, specifically relating to a traditional Chinese medicine composition for treating insomnia caused by liver qi stagnation and its preparation method. Background Technology

[0002] Insomnia is a sleep disorder characterized by frequent and persistent difficulty falling asleep and / or maintaining sleep, leading to subjective dissatisfaction with one's sleep. Mild cases involve difficulty falling asleep, short periods of sleep, and inability to fall back asleep after waking, or the ability to fall asleep but experiencing fatigue and lethargy upon waking. Severe cases involve difficulty falling asleep throughout the night, often resulting in decreased bodily function. It is frequently accompanied by dizziness, headaches, palpitations, forgetfulness, and anxiety. According to recent epidemiological surveys, insomnia, as the most widespread sleep disorder, has an increasing incidence rate and shows a chronic prevalence, widely appearing in modern society. Insomnia often triggers emotional disturbances, memory loss, and other related problems; therefore, insomnia has become a significant social and medical issue. Many factors contribute to insomnia. Psychological and subjective factors are the main causes of primary insomnia, while physical illnesses, drug abuse, and mental disorders are the leading factors causing secondary insomnia. With the continuous advancement of modern clinical research, chronic insomnia has been recognized as an important factor in the development of various chronic diseases, seriously affecting people's physical and mental health.

[0003] Insomnia falls under the category of "insomnia" in Traditional Chinese Medicine (TCM). TCM believes that emotional imbalances and dietary disturbances lead to dysfunction of the internal organs, resulting in malnourishment of the spirit or restlessness of the mind, thus causing insomnia. Its pathogenesis is primarily characterized by disharmony of Qi and blood, imbalance of Yin and Yang, restlessness of the mind, and difficulty falling asleep. Although the etiology and pathogenesis of insomnia are complex, most physicians believe its underlying cause is Qi imbalance, thus treatment often focuses on regulating Qi. As stated in *Taiping Shenghui Fang*: "If there is excess liver Qi and gallbladder Qi, the excess will generate heat, and the heat will cause palpitations, restlessness, and difficulty in sleeping." In modern society, people are prone to anxiety, depression, worry, and panic due to various pressures, often leading to insomnia due to insufficient emotional release. Therefore, excessive emotions and internal damage to the emotional state are major causes of insomnia. Modern physicians often explore the diagnosis and treatment of insomnia from the perspective of soothing the liver and regulating qi. Based on the physiological characteristics of the liver and spleen, they propose that stagnation of liver qi, spleen deficiency and impaired transport, abnormal circulation of qi and blood, and failure of blood to nourish the spirit are the main causes of insomnia. They advocate treating insomnia from the perspective of the liver and spleen, by soothing the qi mechanism, smoothing the flow of qi and blood, so that the functions of various organs are normal, qi and blood are harmonious, the mind and spirit are nourished, and one can fall asleep peacefully.

[0004] Traditional Chinese medicine (TCM) classifies insomnia into several syndromes, primarily including deficiency of heart and gallbladder qi, deficiency of both heart and spleen, liver fire disturbing the heart, phlegm-fire disturbing the heart, and disharmony between heart and kidney. However, in clinical practice, through collecting medical records and analyzing patients' TCM symptom characteristics, it is not difficult to find that besides congenital factors, long-term negative emotional stimuli are also a major contributing factor to the onset of insomnia. Symptoms often include depressed mood, anxiety, chest and rib distension, frequent sighing, abdominal distension, and other signs of liver qi stagnation and impaired liver qi circulation, indicating dysfunction of the Shaoyang meridian. We categorize this as liver qi stagnation syndrome, and numerous epidemiological surveys show that people with this syndrome are more prone to insomnia. Furthermore, patients with chronic insomnia often experience low mood, depression, irritability, and anxiety due to long-term sleep deprivation. These negative emotional stimuli further aggravate liver qi stagnation, and the impaired qi circulation further exacerbates insomnia symptoms, ultimately creating a vicious cycle of "insomnia-qi stagnation-worsened insomnia." Therefore, by addressing the liver's stagnation and regulating Qi, the patient's insomnia problem can be fundamentally resolved.

[0005] Currently, medications for treating insomnia mainly consist of antidepressants, antihistamines, antipsychotics, and benzodiazepines. These drugs only induce sleep and do not fundamentally resolve the insomnia. Furthermore, they often have numerous side effects and can lead to dependence. Although many traditional Chinese medicine formulas are available for the prevention and treatment of insomnia, these formulas are of varying quality, and many are determined by practitioners based solely on experience. Current TCM treatments for insomnia often fall into the trap of simply relieving depression and calming the mind, frequently resulting in poor efficacy. In addition, the large volume and consistency of traditional Chinese medicine decoctions can irritate the gastrointestinal tract, and their inconvenience in carrying leads to poor patient adherence, making long-term use difficult. Summary of the Invention

[0006] In view of the problems existing in the prior art, the present invention provides a traditional Chinese medicine composition for treating insomnia of liver qi stagnation and its preparation method. The present invention is an improvement on the Chaihu Jia Longgu Muli Tang (Bupleurum and Dragon Bone and Oyster Shell Decoction), which comes from the "Treatise on Cold Damage" and has the effects of tonifying the spleen and soothing the liver, nourishing yin and suppressing yang, and calming the mind. It is often used for insomnia and other diseases belonging to the category of yang excess and yin deficiency. However, clinical observation has found that most patients have more severe symptoms of liver qi stagnation, and long-term liver qi stagnation affects the ascending and descending functions of the spleen and stomach. Therefore, it is necessary to strengthen the function of promoting qi circulation, regulate the liver and spleen, and add a small amount of blood-activating and blood-moving agents for long-term illness, which also plays a role in guiding the medicine to the meridians.

[0007] To achieve the above objectives, the present invention provides the following technical solutions.

[0008] A traditional Chinese medicine composition for treating insomnia due to liver qi stagnation comprises the following drug components in parts by weight: Bupleurum chinense 11-20 parts, Curcuma longa 11-18 parts, Cyperus rotundus 11-18 parts, Os draconis 10-15 parts, Ostrea gigas 10-20 parts, Paeonia lactiflora 10-15 parts, Aucklandia lappa 8-12 parts, Scutellaria baicalensis 8-12 parts, and Angelica sinensis 10-12 parts.

[0009] A method for preparing a traditional Chinese medicine composition for treating insomnia includes the following steps:

[0010] Take the prescribed dosage of nine herbs: Bupleurum, Cyperus, Curcuma, White Peony Root, Dragon Bone, Oyster Shell, Angelica, Scutellaria, and Aucklandia. Add 6-10 times the amount of water and decoct three times, each time for 2 hours. Filter the decoction and concentrate the filtrate under reduced pressure at 60°C. When the relative density of the extract reaches 1.10 (60°C), add 95% ethanol to adjust the extract concentration to 70%. Stir well, refrigerate overnight, filter, and take the supernatant. Recover the ethanol under reduced pressure at 80°C and concentrate the extract to a relative density of 1.30 (60°C). Dry under reduced pressure to obtain an extract powder. Add appropriate excipients, mix well, granulate, dry, and package to obtain a traditional Chinese medicine composition for treating insomnia.

[0011] In this formula, Bupleurum is the principal herb, Cyperus, Curcuma, and Paeonia lactiflora are the assistant herbs, Dragon Bone and Oyster Shell are the adjuvant herbs, and Scutellaria baicalensis, Angelica sinensis, and Aucklandia lappa are the guiding herbs. Modern pharmacological studies have shown that Bupleurum saponins can antagonize p-chlorophenylalanine, increasing serotonin concentration and thus promoting sleep. Bupleurum saponins can also effectively alleviate lipopolysaccharide-induced inflammation-related depressive behavior by improving inflammatory signaling pathways. Bupleurum combined with Dragon Bone and Oyster Shell can improve insomnia by increasing melatonin levels and inhibiting hypothalamic-pituitary-adrenal axis hyperfunction induced by stress in rats. Cyperus contains Cyperus polysaccharides, which have the effects of inhibiting liver fibrosis and promoting bile secretion. Curcuma contains β-sitosterol, a phytosterol. Studies have found that β-sitosterol can significantly increase the levels of dopamine and neurotransmitters in the brains of depressed mice, alleviating depressive-like behavior and effectively improving depressive symptoms. When Bupleurum is used in combination with Paeonia lactiflora and Aucklandia lappa, it promotes the biosynthesis of arginine, pyrimidine metabolism, and the reversal of the pentose phosphate pathway, thereby intervening in the development of insomnia and depression by regulating lipid metabolism and nucleotide metabolism. Baicalin can increase the concentration of GABA by inhibiting GABA transferase, which helps to enhance the sedative-hypnotic effect.

[0012] The properties, flavors, meridian tropisms, efficacy, and indications of each ingredient in the above-mentioned traditional Chinese medicine composition for treating insomnia due to qi stagnation are briefly described below.

[0013] Bupleurum: [Properties and Channels Entered] Pungent, bitter, slightly cold. Enters the Liver, Gallbladder, and Lung channels. [Functions and Indications] Disperses and reduces fever, soothes the liver and relieves stagnation, and raises Yang Qi. Used for chest and rib pain, and irregular menstruation.

[0014] Cyperus rotundus: [Properties and Channels Entered] Pungent, slightly bitter, slightly sweet, neutral. Enters the Liver, Spleen, and Triple Energizer channels. [Functions and Indications] Soothes the Liver and relieves stagnation, regulates Qi and relieves chest tightness, regulates menstruation and relieves pain. Used for Liver Qi stagnation, chest and rib pain, breast pain, Spleen and stomach Qi stagnation, epigastric and abdominal fullness, distension and pain.

[0015] Turmeric: [Properties and Channels Entered] Pungent, bitter, cold. Enters the Liver, Heart, and Lung channels. [Functions and Indications] Activates blood circulation and relieves pain, regulates qi and relieves depression, clears heat from the heart and cools the blood, promotes bile secretion and reduces jaundice. Used for stabbing pain in the chest and hypochondrium, chest pain, amenorrhea, dysmenorrhea, and breast distension and pain.

[0016] White peony root: [Properties and Channels Entered] Bitter, sour, slightly cold. Enters the Liver and Spleen channels. [Functions and Indications] Nourishes blood and regulates menstruation, astringes Yin and stops sweating, softens the liver and relieves pain, calms liver Yang. Used for blood deficiency and chlorosis, irregular menstruation, spontaneous sweating, night sweats, hypochondriac pain, headache and dizziness.

[0017] Dragon bone: [Properties and Channels Entered] Astringent and sweet in taste, neutral in nature. Enters the Heart, Liver, and Kidney channels. [Functions and Indications] Calms the mind and soothes the nerves, calms the liver and subdues yang, astringes and consolidates. Used for palpitations, insomnia, forgetfulness, epilepsy, dizziness, spontaneous sweating, and night sweats.

[0018] Oyster: [Properties and Channels Entered] Salty, slightly cold. Enters the Liver, Gallbladder, and Kidney channels. [Functions and Indications] Calms the mind and spirit, nourishes Yin and subdues Yang, softens hardness and dissipates nodules. Used for palpitations, insomnia, dizziness, and tinnitus.

[0019] Angelica sinensis: [Properties and Channels Entered] Sweet, pungent, warm. Enters the Liver, Heart, and Spleen channels. [Functions and Indications] Nourishes and invigorates blood, regulates menstruation and relieves pain, moistens the intestines and promotes bowel movement. Used for blood deficiency and chlorosis, dizziness and palpitations, irregular menstruation, amenorrhea and dysmenorrhea.

[0020] Scutellaria baicalensis: [Properties and Channels Entered] Bitter, cold. Enters the Lung, Gallbladder, Spleen, Large Intestine, and Small Intestine channels. [Functions and Indications] Clears heat and dries dampness, drains fire and detoxifies, stops bleeding, and calms the fetus. Used for damp-heat syndrome, summer-heat syndrome, chest tightness and nausea, and damp-heat fullness.

[0021] Costus root: [Properties and Channels Entered] Pungent, bitter, warm. Enters the spleen, stomach, large intestine, triple burner, and gallbladder channels. [Functions and Indications] Regulates qi and relieves pain, strengthens the spleen and promotes digestion. Used for chest and rib pain, abdominal distension and pain due to food stagnation, and loss of appetite.

[0022] Bupleurum is the chief herb in this formula, which soothes the liver, regulates qi, and harmonizes the qi mechanism. When combined with Scutellaria baicalensis, it harmonizes the pivot mechanism and clears the stagnant heat in the liver and gallbladder. Cyperus rotundus, Curcuma longa, and Paeonia lactiflora are the assistant herbs. Cyperus rotundus is the general manager of qi-related diseases, while Curcuma longa disperses blood stasis when it enters the blood, soothes the liver when it enters the qi, and opens the orifices when it enters the heart. Therefore, when the two are combined, the liver and spleen are regulated. Curcuma longa benefits the qi in the blood, and Cyperus rotundus promotes the blood in the qi. Together, they invigorate blood, regulate qi, and relieve chest congestion. Paeonia lactiflora nourishes blood, astringes yin, softens the liver, drains liver urgency, harmonizes blood, and consolidates liver blood. When combined with Bupleurum, it can not only clear the liver and gallbladder but also regulate the qi mechanism of the liver and gallbladder. Dragon bone and oyster shell are combined. Dragon bone benefits yin and can subdue the floating yang, while oyster shell benefits yin and can subdue the sinking yang, so that yin fluid is replenished, yang qi is subdued, and the mind is calmed. Angelica sinensis enters the liver meridian, promoting qi and blood circulation, nourishing liver blood, and strengthening the liver. Combined with costus root, it enhances the qi-regulating effect. Angelica sinensis and costus root, while promoting blood circulation and qi circulation, also guide the medicine into the collaterals. The combined effects of these herbs are to soothe the liver and regulate the spleen, calm the mind and spirit, and promote yang and clear heat.

[0023] Compared with the prior art, the beneficial effects of the present invention are as follows.

[0024] 1. Guided by the theory of traditional Chinese medicine, this invention scientifically combines various Chinese medicinal materials to achieve synergistic effects. From the perspective of the rise and fall of Qi, it regulates the liver and spleen, soothes the liver and spleen, calms the mind and soothes the nerves, and promotes Yang and clears heat, which has a significant effect on insomnia caused by Qi stagnation.

[0025] 2. The preparation method of this invention has a unique process, which reduces the loss of medicinal materials and greatly improves the efficacy of the medicine. It is easy to carry, convenient to take, and has high compliance. Oral administration can greatly improve the efficiency of the absorption of the medicine. After the medicine is absorbed by the blood, it is transported to the internal organs and then to the whole body, effectively treating and preventing diseases.

[0026] 3. This invention has significant clinical efficacy for insomnia caused by qi stagnation, with no dependence or toxic side effects. Detailed Implementation

[0027] The above description is merely a preferred embodiment of this application and is not intended to limit this application. Various modifications and variations can be made to this application by those skilled in the art. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of this application should be included within the protection scope of this application.

[0028] A traditional Chinese medicine composition for treating insomnia due to liver qi stagnation comprises the following drug components in parts by weight: Bupleurum chinense 11-20 parts, Curcuma longa 11-18 parts, Cyperus rotundus 11-18 parts, Os draconis 10-15 parts, Ostrea gigas 10-20 parts, Paeonia lactiflora 10-15 parts, Aucklandia lappa 8-12 parts, Scutellaria baicalensis 8-12 parts, and Angelica sinensis 10-12 parts.

[0029] A method for preparing a traditional Chinese medicine composition for treating insomnia includes the following steps:

[0030] Take the prescribed dosage of nine herbs: Bupleurum, Cyperus, Curcuma, White Peony Root, Dragon Bone, Oyster Shell, Angelica, Scutellaria, and Aucklandia. Add 6-10 times the amount of water and decoct three times, each time for 2 hours. Filter the decoction and concentrate the filtrate under reduced pressure at 60°C. When the relative density of the extract reaches 1.10 (60°C), add 95% ethanol to adjust the extract concentration to 70%. Stir well, refrigerate overnight, filter, and take the supernatant. Recover the ethanol under reduced pressure at 80°C and concentrate the extract to a relative density of 1.30 (60°C). Dry under reduced pressure to obtain an extract powder. Add appropriate excipients, mix well, granulate, dry, and package to obtain a traditional Chinese medicine composition for treating insomnia.

[0031] Example 1.

[0032] A traditional Chinese medicine composition for treating insomnia due to liver qi stagnation: Bupleurum 15 parts, Curcuma longa 12 parts, Cyperus rotundus 15 parts, Paeonia lactiflora 12 parts, Dragon bone 10 parts, Oyster shell 15 parts, Scutellaria baicalensis 10 parts, Angelica sinensis 10 parts, and Aucklandia lappa 10 parts.

[0033] The preparation method includes the following steps:

[0034] Take the prescribed dosage of nine herbs: Bupleurum chinense, Cyperus rotundus, Curcuma longa, Paeonia lactiflora, Os draconis, Ostrea gigas, Angelica sinensis, Scutellaria baicalensis, and Aucklandia lappa. Add 10 times the amount of water and decoct three times, each time for 2 hours. Filter the decoction and concentrate the filtrate under reduced pressure at 60°C. When the relative density of the extract is concentrated to 1.10 (60°C), add 95% ethanol to adjust the mass fraction concentration of the extract to 70%. Stir well, refrigerate overnight, filter, and take the supernatant. Recover the ethanol under reduced pressure at 80°C and concentrate to a relative density of 1.30 (60°C). Dry under reduced pressure to obtain the extract powder. Add appropriate excipients, mix well, granulate, dry, and package to obtain the traditional Chinese medicine composition for treating insomnia.

[0035] Example 2.

[0036] A traditional Chinese medicine composition for treating insomnia due to liver qi stagnation: Bupleurum chinense 20 parts, Curcuma longa 12 parts, Cyperus rotundus 15 parts, Paeonia lactiflora 12 parts, Os draconis 10 parts, Ostrea gigas 15 parts, Scutellaria baicalensis 10 parts, Angelica sinensis 10 parts, Aucklandia lappa 10 parts. The preparation method is the same as in Example 1.

[0037] Example 3.

[0038] A traditional Chinese medicine composition for treating insomnia due to liver qi stagnation: Bupleurum chinense 20 parts, Curcuma longa 15 parts, Cyperus rotundus 12 parts, Paeonia lactiflora 15 parts, Os draconis 15 parts, Ostrea gigas 9 parts, Scutellaria baicalensis 10 parts, Angelica sinensis 10 parts, Aucklandia lappa 10 parts. The preparation method is the same as in Example 1.

[0039] Example 4.

[0040] A traditional Chinese medicine composition for treating insomnia due to liver qi stagnation: Bupleurum chinense 15 parts, Curcuma longa 12 parts, Cyperus rotundus 12 parts, Paeonia lactiflora 10 parts, Os draconis 15 parts, Ostrea gigas 15 parts, Scutellaria baicalensis 10 parts, Angelica sinensis 12 parts, and Aucklandia lappa 8 parts. The preparation method is the same as in Example 1.

[0041] Example 5.

[0042] 1. Clinical Data

[0043] General information: Sixty patients with Qi stagnation-type insomnia who visited the Rehabilitation Department of Liaoning Traditional Chinese Medicine Jiahe Hospital between May and November 2023 were selected as the study subjects. The subjects were numbered according to their order of visit, and random numbers were generated using SPSS 25.0 software. A researcher randomly divided the patients into an observation group and a control group at a 1:1 ratio, with 30 patients in each group. All data were collected and evaluated by a dedicated researcher under blinded conditions.

[0044] 2. Diagnostic criteria

[0045] Western medicine diagnostic criteria:

[0046] The diagnostic criteria for insomnia are based on the Chinese Classification and Diagnostic Criteria for Mental Disorders (CCMD-3) formulated by the Chinese Medical Association Psychiatry Branch in 2001:

[0047] (1) One or more of the following main symptoms appear: difficulty falling asleep, poor sleep quality and insufficient sleep depth, many dreams, easy to wake up early, or unable to fall back asleep after waking up, accompanied by dizziness, headache, palpitations and forgetfulness, etc., and in severe cases, sleeplessness all night.

[0048] (2) The patient is still unable to eliminate fatigue after waking up, and experiences difficulty concentrating and feeling lack of energy during the day. In severe cases, cognitive impairment occurs, which seriously affects social work and life.

[0049] (3) The above symptoms occur 3 or more times per week and last for at least 1 month;

[0050] (4) After a specialist examination, the insomnia was ruled out as a neurological disease or a secondary insomnia caused by mental or physical illness.

[0051] Traditional Chinese Medicine (TCM) diagnostic criteria for diseases and syndromes:

[0052] In terms of TCM disease differentiation and syndrome diagnosis, the diagnostic criteria for insomnia are based on the key points of diagnosis in the "Standards for Diagnosis and Efficacy of Diseases and Syndromes in Traditional Chinese Medicine" (2012 edition), as follows:

[0053] (1) Primary symptoms: In mild cases, it is difficult to fall asleep or to fall asleep easily and then be unable to fall back asleep; in severe cases, it is difficult to sleep all night. Secondary symptoms: headache, dizziness, palpitations, forgetfulness, dreaming, etc.

[0054] (2) Symptom diagnosis of liver qi stagnation syndrome: chest and hypochondriac distension, frequent sighing, irritability, abdominal distension and pain; tongue appearance: dark tongue body, thin yellow coating; pulse appearance: wiry pulse;

[0055] (3) Laboratory tests have ruled out organic lesions or secondary insomnia in other systems.

[0056] Key points for diagnosis and treatment: The clinical manifestations include the main symptom and two or more secondary symptoms. A diagnosis can be made by combining two or more of the key points for diagnosing liver qi stagnation syndrome and tongue and pulse signs.

[0057] 3. Inclusion criteria

[0058] (1) 18 ≤ age ≤ 60 years old;

[0059] (2) Meets the Western medical diagnostic criteria for insomnia and the TCM diagnostic criteria for disease differentiation and syndrome differentiation;

[0060] (3) Those who have not received any psychotropic drugs or other treatments;

[0061] (4) Pittsburgh Sleep Quality Index (PSQI) score > 7;

[0062] (5) The course of the disease occurs more than 3 times a week (including 3 times) and lasts for at least 1 month (including 1 month);

[0063] (6) Voluntarily participate and sign the informed consent form for the treatment plan.

[0064] 4. Exclusion criteria

[0065] (1) Age < 18 years old or age > 60 years old;

[0066] (2) Pregnant and lactating women;

[0067] (3) Individuals with intolerance to traditional Chinese medicine or allergic constitution;

[0068] (4) Hamilton Depression Rating Scale score >17, Hamilton Anxiety Rating Scale score >14;

[0069] (5) Patients with mental illness or those with liver and kidney dysfunction, infectious diseases, tumors, cardiovascular and cerebrovascular diseases, or hematopoietic system diseases;

[0070] (6) Insomnia caused by pain, fever or other systemic diseases or external environmental factors.

[0071] Example 6.

[0072] Observation group: Example 1

[0073] The herbal composition of Example 1 was dissolved in warm water and taken orally, one dose per day, twice a day, 100ml each time, for 4 consecutive weeks.

[0074] Control group: Bupleurum, Dragon Bone, and Oyster Shell Decoction

[0075] The patient was treated with Chaihu Longgu Muli Decoction, composed of: Bupleurum 15 parts, Dragon Bone 9 parts, Oyster Shell 9 parts, Ginger 9 parts, Ginseng 9 parts, Cinnamon Twig 9 parts, Poria 9 parts, Scutellaria 9 parts, Lead Oxide 6 parts, Rhubarb 6 parts, Pinellia 6 parts, and Jujube 3 parts. The decoction was taken with water, one dose twice daily, 100ml each time, for four consecutive weeks.

[0076] Example 7.

[0077] Clinical observation indicators:

[0078] (1) PSQI scores before and after treatment;

[0079] (2) Comparison of cured, significantly effective, effective and ineffective treatments.

[0080] Cured: Those whose symptoms have completely disappeared and whose bodies have returned to normal.

[0081] Significant effect: Symptoms are significantly reduced and the body is noticeably better.

[0082] Effective: Symptoms are relieved and the body feels better.

[0083] Ineffective: Symptoms do not improve or worsen after treatment.

[0084] Data Analysis:

[0085] The data from this study were processed using SPSS 26.0. Quantitative data were expressed as (…). () indicates that a t-test was used; count data were expressed using x. ２ The test is performed, with P < 0.05 indicating a statistically significant difference and P < 0.01 indicating a highly statistically significant difference.

[0086] Efficacy assessment: The comparison of the average age and course of disease between the two groups of patients is shown in Table 1.

[0087] Table 1. Comparison of mean age and disease duration scores between the two groups of patients.

[0088]

[0089] The average gender, age, duration of illness, and frequency of X-ray in the two groups were similar. 2 The tests showed no statistically significant differences (P > 0.05), indicating that the samples were comparable.

[0090] Table 2 shows the PSQI scores of the two groups of patients before and after treatment.

[0091] Table 2. PSQI scores of the two groups of patients before and after treatment.

[0092]

[0093] The results showed that: (1) there were significant differences in all aspects of PSQI improvement between the two groups before and after treatment (P < 0.05). * <0.05), indicating that both groups were effective in improving overall sleep. (2) After treatment, there were significant differences between the two groups in terms of sleep onset time, sleep duration, sleep efficiency, sleep disorders, daytime dysfunction, and total score (P <0.05). # <0.05) indicates that the observation group has a better improvement in sleep function than the control group.

[0094] Table 3 shows the comparison of the therapeutic effects between the two groups of patients.

[0095] Table 3 Comparison of treatment efficacy between the two groups of patients.

[0096]

[0097] The results showed that: (1) After treatment, both groups were effective in improving overall sleep quality. (2) After treatment, the observation group was superior to the control group in terms of cure, significant effect, and effectiveness.

[0098] Example 8: Application Case.

[0099] 1. Ms. Wang, 52 years old, date of consultation: July 11, 2023

[0100] Chief complaint: Insomnia for more than two years, which has worsened in the past three months.

[0101] Symptoms include: difficulty falling asleep, frequent awakenings after falling asleep, unexplained tension and anxiety, chest and rib distension, frequent sighing, palpitations and fatigue, dark tongue with thin yellow coating, and wiry pulse.

[0102] Diagnosis: Insomnia (Liver Qi stagnation syndrome).

[0103] Treatment principles and methods: Soothe the liver and relieve depression, and calm the mind.

[0104] Prescription: Bupleurum 15 parts, Curcuma 12 parts, Cyperus rotundus 12 parts, Paeonia lactiflora 10 parts, Dragon bone 15 parts, Oyster shell 15 parts, Scutellaria baicalensis 10 parts, Angelica sinensis 12 parts, Aucklandia lappa 8 parts.

[0105] Dissolve in warm water and drink. Take 100ml twice daily, one dose per day.

[0106] After 3 days of taking the medication, Shan Taixi's symptoms improved significantly, and his sleep cycle lengthened. After 2 weeks of taking the medication, the symptoms disappeared, and his body returned to normal.

[0107] 2. Mr. Liu, 56 years old, date of consultation: September 2, 2023

[0108] Chief complaint: Insomnia and excessive dreaming for more than half a year.

[0109] Symptoms include: insomnia with vivid dreams, frequent awakenings after falling asleep, recurring nightmares, difficulty falling back asleep after waking up, chest and rib distension, frequent sighing, fatigue, irritability, dark tongue with yellow coating, and wiry pulse.

[0110] Diagnosis: Insomnia (Liver Qi stagnation syndrome).

[0111] Treatment principles and methods: Soothe the liver and relieve depression, and calm the mind.

[0112] Prescription: Bupleurum 20 parts, Curcuma longa 15 parts, Cyperus rotundus 12 parts, Paeonia lactiflora 15 parts, Os draconis 15 parts, Ostrea gigas 9 parts, Scutellaria baicalensis 10 parts, Angelica sinensis 10 parts, Aucklandia lappa 10 parts.

[0113] Dissolve in warm water and drink. Take 100ml twice daily, one dose per day.

[0114] After taking the medication for 3 days, the nightmares basically disappeared, and the symptoms of fatigue and weakness improved significantly. After taking it for 7 days, the quality and duration of sleep improved significantly. After taking it for 2 weeks, the symptoms disappeared, and the body returned to normal.

Claims

1. A traditional Chinese medicine composition for treating insomnia due to liver qi stagnation, characterized in that, It is prepared from the following parts by weight of herbs: Bupleurum 11-20 parts, Curcuma longa 11-18 parts, Cyperus rotundus 11-18 parts, Dragon bone 10-15 parts, Oyster shell 10-20 parts, White peony root 10-15 parts, Costus root 8-12 parts, Scutellaria baicalensis 8-12 parts, and Angelica sinensis 10-12 parts.

2. A traditional Chinese medicine composition for treating insomnia due to liver qi stagnation, characterized in that, It is prepared from the following parts by weight of herbs: Bupleurum 15 parts, Curcuma longa 12 parts, Cyperus rotundus 15 parts, Paeonia lactiflora 12 parts, Dragon bone 10 parts, Oyster shell 15 parts, Scutellaria baicalensis 10 parts, Angelica sinensis 10 parts, and Aucklandia lappa 10 parts.

3. A traditional Chinese medicine composition for treating insomnia due to liver qi stagnation, characterized in that, It is prepared from the following parts by weight of herbs: Bupleurum 20 parts, Curcuma longa 12 parts, Cyperus rotundus 15 parts, Paeonia lactiflora 12 parts, Dragon bone 10 parts, Oyster shell 15 parts, Scutellaria baicalensis 10 parts, Angelica sinensis 10 parts, and Aucklandia lappa 10 parts.

4. A traditional Chinese medicine composition for treating insomnia due to liver qi stagnation, characterized in that, It is prepared from the following parts by weight of herbs: Bupleurum 20 parts, Curcuma longa 15 parts, Cyperus rotundus 12 parts, Paeonia lactiflora 15 parts, Dragon bone 15 parts, Oyster shell 9 parts, Scutellaria baicalensis 10 parts, Angelica sinensis 10 parts, and Aucklandia lappa 10 parts.

5. A traditional Chinese medicine composition for treating insomnia due to liver qi stagnation, characterized in that, It is prepared from the following parts by weight of herbs: Bupleurum 15 parts, Curcuma longa 12 parts, Cyperus rotundus 12 parts, Paeonia lactiflora 10 parts, Dragon bone 15 parts, Oyster shell 15 parts, Scutellaria baicalensis 10 parts, Angelica sinensis 12 parts, and Aucklandia lappa 8 parts.

6. The method for preparing the traditional Chinese medicine composition for treating insomnia of liver qi stagnation type according to any one of claims 1-5, characterized in that, Includes the following steps: Take the prescribed dosage of nine herbs: Bupleurum chinense, Cyperus rotundus, Curcuma longa, Paeonia lactiflora, Os draconis, Ostrea gigas, Angelica sinensis, Scutellaria baicalensis, and Aucklandia lappa. Add 6-10 times the amount of water and decoct three times, each time for 2 hours. Filter the decoction and concentrate the filtrate under reduced pressure at 60°C. When the relative density of the extract is concentrated to 1.10 at 60°C, add 95% ethanol to adjust the mass fraction concentration of the extract to 70%. Stir well, refrigerate overnight, filter, and take the supernatant to recover the ethanol under reduced pressure at 80°C. Concentrate the supernatant to 1.30 at 60°C and dry under reduced pressure to obtain the extract powder. Add appropriate excipients, mix well, granulate, dry, and package to obtain a traditional Chinese medicine composition for treating insomnia of liver qi stagnation type.

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