A traditional Chinese medicine composition for improving heart-spirit imbalance and heart-spleen heat type long-term insomnia and a preparation method thereof

Abstract

The present application belongs to the technical field of traditional Chinese medicine composition, and particularly relates to a traditional Chinese medicine composition for improving long-term insomnia of heart-spleen heat type and a preparation method. The composition comprises poria, amber, calcined oyster shell, steamed schisandra, fried jujube seed, acorus gramineus soland, curcuma, fried coptis, fried malt and baked licorice. In the preparation, the calcined oyster shell is first decocted, and then the remaining medicines except the amber are added for decoction, filtration, re-decoction, combination of the decoction, and addition of the amber fine powder or the amber water extract. The present application can improve the symptoms of difficulty in falling asleep, easy wake-up, irritability, stomach burning, abdominal distension, and constipation, etc. by the combination of clearing heart-spleen heat, heavy tranquilization, yin-nourishing and spirit-concentrating, opening the orifices, relieving depression, and stomach digestion.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine composition technology, and particularly relates to a traditional Chinese medicine composition and preparation method for improving long-term insomnia caused by mental disorders and heart-spleen stagnation and heat. Background Technology

[0002] Insomnia is a common sleep disorder in clinical practice, typically manifesting as difficulty falling asleep, difficulty maintaining sleep, early awakening, poor sleep quality, and a lack of restorative feeling after falling asleep. It can also be accompanied by daytime fatigue, decreased attention, irritability, anxiety, and depression. Long-term insomnia not only affects patients' quality of life but can also exacerbate dysfunction in the nervous, cardiovascular, endocrine, and immune systems. Current Western medicine treatments for insomnia primarily utilize benzodiazepines, non-benzodiazepines, melatonin receptor agonists, orexin receptor antagonists, and cognitive behavioral therapy. While drug therapy can improve difficulty falling asleep and maintaining sleep in the short term, long-term use may lead to problems such as tolerance, dependence, daytime sleepiness, cognitive decline, and rebound effects upon discontinuation. Although cognitive behavioral therapy has better long-term effects, it requires significant resources, patient compliance, and sustained intervention, limiting its widespread clinical application.

[0003] In Traditional Chinese Medicine (TCM), insomnia is often categorized under "insomnia," and its pathogenesis is typically related to malnourishment of the heart and spirit, disturbance of the heart and spirit, imbalance of Yin and Yang, and failure of Yang to enter Yin, involving multiple organs such as the heart, liver, spleen, and kidneys. Common clinical patterns include liver fire disturbing the heart, phlegm-heat disturbing the heart, deficiency of both heart and spleen, disharmony between heart and kidneys, and deficiency of heart and gallbladder Qi. TCM treatment for insomnia emphasizes syndrome differentiation and treatment, often improving sleep through methods such as nourishing the heart and calming the spirit, clearing heat and resolving phlegm, soothing the liver and relieving depression, strengthening the spleen and stomach, and harmonizing the heart and kidneys. Due to the complex etiology of insomnia, simply using sedatives or heat-clearing drugs sometimes fails to address the combined symptoms of long-term insomnia patients, such as emotional distress, spleen and stomach disharmony, internal generation of phlegm and blood stasis, stomach discomfort, halitosis, thirst, and constipation.

[0004] There are already various traditional Chinese medicine compositions for treating insomnia in the existing technology. For example, Chinese patent CN103211892B discloses a traditional Chinese medicine composition for treating insomnia, which is composed of raw materials such as peony bark, bupleurum, gardenia, atractylodes macrocephala, dragon bone, oyster shell, poria cocos, jujube seed, polygala tenuifolia, arborvitae seed, salvia miltiorrhiza, licorice, polygonum multiflorum, albizia bark, codonopsis pilosula, angelica sinensis, white peony root, and processed astragalus membranaceus. It is used to treat insomnia by soothing the liver and relieving depression, clearing heat and calming the mind, and nourishing qi and blood. This prescription includes commonly used calming and spleen-strengthening herbs such as dragon bone, poria cocos, jujube seed, licorice, codonopsis, and atractylodes macrocephala, which are somewhat targeted at general insomnia. However, its prescription structure focuses on soothing the liver and clearing heat, nourishing blood and calming the mind, and tonifying qi and strengthening the body. It does not establish a clear drug combination relationship for the specific long-term insomnia syndrome of "disorder of the mind and stagnation of heat in the heart and spleen", nor does it fully highlight the synergistic relationship between clearing heat in the heart and spleen, opening up the orifices, calming the mind and harmonizing the stomach and promoting digestion.

[0005] For example, Chinese patent CN101327297B discloses a traditional Chinese medicine composition for treating insomnia, which consists of raw materials such as Codonopsis pilosula, Atractylodes macrocephala, Poria cocos, Lilium brownii, Nelumbo nucifera, Ophiopogon japonicus, Ziziphus jujuba var. spinosa, Astragalus membranaceus, Coptis chinensis, Paeonia lactiflora, donkey-hide gelatin, Scutellaria baicalensis, and Schisandra chinensis. It also points out that middle-aged and elderly patients with insomnia often experience reduced spleen and stomach function and decreased digestive and absorptive functions after prolonged illness, thus affecting the efficacy of the treatment. Therefore, it is necessary to combine this with stomach-strengthening and spleen-benefiting medications. This approach has already addressed the relationship between spleen and stomach function and the efficacy of insomnia treatment, and uses Coptis chinensis, Schisandra chinensis, and Ziziphus jujuba var. spinosa. However, its overall focus remains on strengthening the spleen, nourishing yin and calming the mind, and clearing heat. It does not provide a specific formulation for long-term insomnia patients who also experience symptoms of heart and spleen stagnation and heat, such as irritability, burning sensation in the stomach, abdominal distension, acid reflux, bad breath, thirst, constipation, or difficulty defecating.

[0006] Therefore, while existing traditional Chinese medicine compositions for treating insomnia involve commonly used herbs such as Poria cocos, Ziziphus jujuba var. spinosa, fossilized bone, Coptis chinensis, Schisandra chinensis, Codonopsis pilosula, Atractylodes macrocephala, and Glycyrrhiza uralensis, and propose treatment strategies such as calming the mind, clearing heat, strengthening the spleen, and harmonizing the stomach, most regimens still focus on calming the mind or strengthening the spleen and clearing heat under traditional syndrome patterns, failing to systematically combine herbs to address the complex pathogenesis of long-term insomnia characterized by "disorder of the mind and stagnation of heat in the heart and spleen." For patients clinically presenting with long-term difficulty falling asleep, insomnia, or frequent awakenings, accompanied by symptoms such as irritability, burning sensation in the stomach, abdominal distension, acid reflux, bad breath, thirst, constipation, or difficulty defecating, current techniques still suffer from insufficient targeted diagnosis, inadequate consideration of the concurrent symptoms of sleep disorders and stagnation of heat in the spleen and stomach, and insufficient evidence for relapse control.

[0007] Therefore, it is still necessary to provide a new Chinese medicine composition that can target the pathogenesis of chronic insomnia caused by mental disorder and heart-spleen heat stagnation. This composition can regulate the mind and calm the spirit while clearing heart-spleen heat stagnation, opening the orifices and relieving depression, calming the mind and soothing the stomach and promoting digestion. This can improve difficulty falling asleep, sleep maintenance disorders and related spleen and stomach symptoms, and provide a safer and clinically applicable Chinese medicine treatment plan for patients with chronic insomnia. Summary of the Invention

[0008] The technical objective of this invention is to provide a traditional Chinese medicine composition for improving long-term insomnia caused by mental imbalance and stagnation of heat in the heart and spleen, as well as its preparation method and application. By specifically combining drugs that clear heat in the heart and spleen, calm the mind, nourish yin and astringe the spirit, open the orifices and relieve depression, and harmonize the stomach and promote digestion, this invention addresses the problem that existing traditional Chinese medicine compositions for insomnia are insufficient in addressing the combined symptoms of long-term insomnia patients, such as irritability, burning sensation in the stomach, abdominal distension, acid reflux, bad breath, thirst, constipation, or difficulty in defecation. This improves the patient's sleep quality, related TCM symptoms, and emotional state.

[0009] Firstly, in order to achieve the above-mentioned objectives, the present invention adopts the following technical solution:

[0010] A traditional Chinese medicine composition for improving chronic insomnia caused by mental disorders and stagnation of heat in the heart and spleen, the traditional Chinese medicine composition comprising a basic drug group, which is composed of Poria cocos, amber, calcined dragon bone, steamed Schisandra chinensis, stir-fried Ziziphus jujuba var. spinosa, Acorus tatarinowii, Curcuma longa, stir-fried Coptis chinensis, stir-fried malt and prepared licorice.

[0011] The traditional Chinese medicine composition consists of a basic drug group, which is composed of Poria cocos, amber, calcined dragon bone, steamed Schisandra chinensis, stir-fried Ziziphus jujuba var. spinosa, Acorus tatarinowii, Curcuma longa, stir-fried Coptis chinensis, stir-fried malt, and prepared licorice root. By weight: Poria cocos 12-18 parts, amber 4-6 parts, calcined dragon bone 18-25 parts, steamed schisandra chinensis 5-8 parts, stir-fried jujube seed 10-15 parts, acorus tatarinowii 8-12 parts, turmeric 8-12 parts, stir-fried coptis chinensis 3-5 parts, stir-fried malt 18-25 parts, and prepared licorice root 4-8 parts; Among them, the weight ratio of stir-fried Coptis chinensis to Poria cocos is 1:3-5, the weight ratio of calcined dragon bone to amber is 3.5-5.5:1, the total weight ratio of steamed Schisandra chinensis to stir-fried Ziziphus jujuba var. spinosa and the total weight ratio of Acorus tatarinowii to Curcuma longa is 0.7-1.2:1, and the total weight ratio of stir-fried malt to roasted licorice root and the weight ratio of stir-fried Coptis chinensis is 5-8:1.

[0012] Preferably, the basic medicinal group consists of the following components by weight: 15 parts Poria cocos, 5 parts amber, 20 parts calcined dragon bone, 6 parts steamed Schisandra chinensis, 12 parts stir-fried Ziziphus jujuba var. spinosa, 10 parts Acorus tatarinowii, 10 parts Curcuma longa, 4 parts stir-fried Coptis chinensis, 20 parts stir-fried malt, and 6 parts prepared licorice root.

[0013] Preferably, the insomnia of the mental disorder and heart-spleen heat type is characterized by at least one primary symptom of reduced sleep time, sleeplessness, difficulty falling asleep, easy awakening and inability to fall back asleep after waking up, and accompanied by at least two secondary symptoms of irritability, burning sensation in the stomach, abdominal distension, nausea and vomiting, acid reflux, bad breath, mouth ulcers, thirst, constipation or difficulty in defecation.

[0014] Preferably, the traditional Chinese medicine composition consists of the basic herbal group and the modified herbal group for phlegm accumulation and chest tightness, wherein the modified herbal group for phlegm accumulation and chest tightness consists of ginger-processed Pinellia ternata, Trichosanthes kirilowii peel, and Fritillaria thunbergii; by weight, the modified herbal group for phlegm accumulation and chest tightness includes 6-12 parts of ginger-processed Pinellia ternata, 8-15 parts of Trichosanthes kirilowii peel, and 8-15 parts of Fritillaria thunbergii. Alternatively, the traditional Chinese medicine composition consists of the basic medicine group and the modified medicine group for abdominal distension, wherein the modified medicine group for abdominal distension consists of agarwood koji and stir-fried immature bitter orange peel; by weight, the modified medicine group for abdominal distension includes 4-8 parts of agarwood koji and 8-12 parts of stir-fried immature bitter orange peel. Alternatively, the traditional Chinese medicine composition consists of the basic medicine group and the modified medicine group for sticky and smelly stool, wherein the modified medicine group for sticky and smelly stool consists of stir-fried Coptis chinensis and Shenqu (medicated leaven); by weight, the modified medicine group for sticky and smelly stool includes 4-8 parts of stir-fried Coptis chinensis and 15-25 parts of Shenqu (medicated leaven). Alternatively, the traditional Chinese medicine composition may consist of the basic herbal group and the modified herbal group for dry mouth and throat, wherein the modified herbal group for dry mouth and throat consists of Codonopsis pilosula, stir-fried Ophiopogon japonicus and Asparagus cochinchinensis; by weight, the modified herbal group for dry mouth and throat includes 15-25 parts of Codonopsis pilosula, 12-18 parts of stir-fried Ophiopogon japonicus and 8-15 parts of Asparagus cochinchinensis.

[0015] Secondly, the present invention also provides a pharmaceutical preparation comprising the aforementioned traditional Chinese medicine composition, its aqueous extract, its clear extract or its dry extract powder, and optional pharmaceutically acceptable excipients; the pharmaceutical preparation is a decoction, granules, oral liquid, capsules, tablets, pills or powders.

[0016] Thirdly, the present invention also provides a method for preparing the aforementioned traditional Chinese medicine composition, comprising the following steps:

[0017] S1. Weigh out the following ingredients by weight: Poria cocos, amber, calcined dragon bone, steamed Schisandra chinensis, stir-fried Ziziphus jujuba var. spinosa, Acorus tatarinowii, Curcuma longa, stir-fried Coptis chinensis, stir-fried malt, and prepared licorice root.

[0018] S2. Add water to calcined dragon bone and decoct for 20-40 minutes to obtain a decoction containing calcined dragon bone.

[0019] S3. Add Poria cocos, steamed Schisandra chinensis, stir-fried Ziziphus jujuba var. spinosa, Acorus tatarinowii, Curcuma longa, stir-fried Coptis chinensis, stir-fried malt and prepared licorice to the first decoction, continue to decoct for 20-45 minutes, and filter to obtain the first decoction.

[0020] S4. Add water to the dregs filtered in step S3 and decoct again for 20-40 minutes, then filter to obtain the second decoction.

[0021] S5. Combine the first and second decoctions, concentrate to the volume required for administration, and add fine amber powder or amber water extract to obtain a traditional Chinese medicine decoction.

[0022] Preferably, in step S5, the amber powder is fine powder that has passed through an 80-200 mesh sieve;

[0023] And / or, the herbal decoction is taken once a day, divided into two doses, 150-250 mL each time;

[0024] And / or, the preparation method further includes the following steps:

[0025] S6. Concentrate the traditional Chinese medicine decoction into a clear paste with a relative density of 1.05-1.30;

[0026] S7. The ointment is mixed with pharmaceutically acceptable excipients, and then granulated, dried and sized to obtain granules.

[0027] Fourthly, the present invention also provides the use of the aforementioned traditional Chinese medicine composition or the aforementioned pharmaceutical preparation in the preparation of a medicine for improving long-term insomnia of the type of mental disorder and heart-spleen stagnation and heat.

[0028] Preferably, the drug is used to improve at least one of the following symptoms: difficulty falling asleep, difficulty maintaining sleep, reduced sleep duration, frequent awakenings, irritability, heartburn, abdominal distension, acid reflux, bad breath, thirst, constipation, or difficulty defecating.

[0029] Preferably, the drug is used to improve at least one of the following evaluation indicators: Pittsburgh Sleep Quality Index score, Traditional Chinese Medicine syndrome score, Self-Rating Anxiety Scale score, and Self-Rating Depression Scale score.

[0030] The traditional Chinese medicine composition of this invention uses Poria cocos and stir-fried Coptis chinensis to clear heat from the heart and spleen and calm the mind; calcined dragon bone and amber to calm the mind and astringe the floating spirit; steamed Schisandra chinensis and stir-fried Ziziphus jujuba var. spinosa to nourish yin, astringe the spirit, replenish qi, and generate fluids; Acorus tatarinowii and Curcuma longa to open the orifices, relieve depression, and regulate the heart and spleen qi; and stir-fried malt and roasted licorice root to strengthen the spleen and stomach, promote digestion, and harmonize the other herbs. This creates a complex formula that "regulates the spirit, calms the mind, and harmonizes the spleen and stomach." Compared to simple calming, heat-clearing, or spleen-strengthening medications for insomnia, this invention not only improves sleep disorders such as difficulty falling asleep, reduced sleep duration, frequent awakenings, and difficulty falling back asleep, but also simultaneously addresses symptoms of heart and spleen heat and spleen and stomach disharmony, such as irritability, burning sensation in the stomach, abdominal distension, acid reflux, bad breath, thirst, constipation, or difficulty defecating. This helps improve the targeted diagnosis and overall conditioning effect of insomnia treatment. Clinical observation results show that after intervention with this composition, patients' TCM syndrome scores, Pittsburgh Sleep Quality Index scores, Self-Rating Anxiety Scale scores, and Self-Rating Depression Scale scores can all be improved. The short-term relapse rate after treatment is low, and no obvious adverse reactions related to medication are observed during the treatment process. This indicates that the present invention has good application value in improving long-term insomnia, relieving accompanying emotional abnormalities and gastrointestinal discomfort, improving sleep quality, and maintaining treatment stability. Attached Figure Description

[0031] Figure 1 This is a schematic diagram of the preparation process of the traditional Chinese medicine composition of the present invention.

[0032] Figure 2 This is a schematic diagram of the clinical observation process of the present invention.

[0033] Figure 3 This is a graph comparing the total scores of TCM syndromes before and after treatment.

[0034] Figure 4 This is a comparison chart of the total PSQI score before and after treatment.

[0035] Figure 5 This is a comparison chart of the total scores of SAS and SDS before and after treatment.

[0036] Figure 6 The graph shows the recurrence rate at 4 and 8 weeks after the end of treatment.

[0037] Figure 7 This is a schematic diagram showing the correspondence between the basic drug group of this invention and the insomnia syndrome of mental disorder and heart-spleen heat stagnation. Detailed Implementation

[0038] The present invention will be further described below with reference to embodiments, comparative examples, and accompanying drawings. It should be understood that the following embodiments are for illustrative purposes only and should not be construed as limiting the scope of protection of the present invention. Any equivalent substitutions, conventional adjustments, or dosage form changes made within the scope of the drug composition, weight range, preparation process, and use defined by the present invention shall fall within the scope of protection of the present invention.

[0039] The traditional Chinese medicine composition provided by this invention is mainly used to improve chronic insomnia caused by mental imbalance and stagnation of heat in the heart and spleen. This chronic insomnia caused by mental imbalance and stagnation of heat in the heart and spleen clinically includes at least one primary symptom: reduced sleep duration, insomnia, difficulty falling asleep, and frequent awakenings with inability to fall back asleep, accompanied by at least two secondary symptoms: irritability, burning sensation in the stomach, abdominal distension, nausea and vomiting, acid reflux, bad breath, oral ulcers, thirst, and constipation or difficulty defecating. The tongue and pulse may be characterized by a red tongue with a thin yellow coating and a rapid or thready pulse. The technical approach of this invention is not simply to use sedative drugs, nor is it simply to use heat-clearing or spleen-strengthening drugs. Instead, it revolves around the complex pathogenesis of "disorder of the spirit and stagnation of heat in the heart and spleen," and uses a combination of Poria cocos, stir-fried Coptis chinensis, calcined dragon bone, amber, steamed Schisandra chinensis, stir-fried Ziziphus jujuba var. spinosa, Acorus tatarinowii, Curcuma longa, stir-fried malt, and prepared licorice root to create a formula that combines clearing heat in the heart and spleen, calming the mind, nourishing yin and astringing the spirit, opening the orifices and relieving depression, and harmonizing the stomach and promoting digestion. The correspondence between the above basic drug groups and the symptoms is as follows: Figure 7 As shown.

[0040] I. Raw Material Description

[0041] All raw materials used in this invention can be prepared medicinal herbs that meet the requirements of the Chinese Pharmacopoeia or the clinical specifications for prepared medicinal herbs. Poria cocos is preferably dried, mold-free, and has a normal odor. Amber is preferably finely ground amber powder or slices that can be taken orally after purification and pulverization. Calcined dragon bone is preferably calcined dragon bone slices. Steamed Schisandra chinensis is preferably steamed Schisandra chinensis slices. Fried jujube seed is preferably fried jujube seed slices. Acorus tatarinowii is preferably dried rhizome slices. Curcuma longa is preferably turmeric slices that meet the requirements of the Pharmacopoeia. Fried Coptis chinensis is preferably fried Coptis chinensis slices. Fried malt is preferably fried malt slices. Prepared licorice is preferably honey-prepared licorice slices.

[0042] In the composition of this invention, Poria cocos and stir-fried Coptis chinensis are used to clear heat from the heart and spleen, and calm the mind; calcined dragon bone and amber are used to sedate the mind and restrain the restless spirit; steamed Schisandra chinensis and stir-fried Ziziphus jujuba var. spinosa are used to nourish yin and calm the spirit, and replenish qi and generate fluids; Acorus tatarinowii and Curcuma longa are used to open the orifices, relieve depression, and regulate the qi and spleen; stir-fried malt and roasted licorice root are used to strengthen the spleen and stomach, promote digestion, and harmonize the other herbs. The above-mentioned herbs form a synergistic compound, making this invention suitable for patients with chronic insomnia who also exhibit symptoms of heat from the heart and spleen, and disharmony between the spleen and stomach.

[0043] II. General Steps in Preparation

[0044] The traditional Chinese medicine composition of this invention can be prepared into decoctions, granules, oral liquids, capsules, tablets, pills, or powders. The following description uses decoctions and granules as examples; other dosage forms can be prepared according to conventional processes for traditional Chinese medicine preparations.

[0045] like Figure 1 As shown, the method for preparing the decoction includes the following steps:

[0046] S1. Weigh out the following ingredients according to the prescription: Poria cocos, amber, calcined dragon bone, steamed Schisandra chinensis, stir-fried Ziziphus jujuba var. spinosa, Acorus tatarinowii, Curcuma longa, stir-fried Coptis chinensis, stir-fried malt, and prepared licorice root.

[0047] S2. Place the calcined dragon bone in a clay pot or stainless steel decoction container, add water to submerge it and make sure it is 2-4 cm above the surface of the medicine, and decoct for 20-40 minutes to obtain a decoction containing calcined dragon bone.

[0048] S3. Add Poria cocos, steamed Schisandra chinensis, stir-fried Ziziphus jujuba var. spinosa, Acorus tatarinowii, Curcuma longa, stir-fried Coptis chinensis, stir-fried malt and prepared licorice to the first decoction. Continue to add water to 2-4 cm above the surface of the herbs, soak for 20-30 minutes, then decoct for 20-45 minutes and filter to obtain the first decoction.

[0049] S4. Add water to the dregs filtered in step S3 and decoct again for 20-40 minutes, then filter to obtain the second decoction.

[0050] S5. Combine the first and second decoctions, and concentrate or adjust to a daily dosage of 300-500 mL;

[0051] S6. Amber is added by taking fine powder or adding water extract. The fine powder of amber is preferably passed through an 80-200 mesh sieve. If amber water extract is used, the amber can be decocted separately or ground into a fine powder and then mixed with the combined decoction.

[0052] S7. The resulting decoction is taken once a day, divided into two doses, 150-250mL each time, preferably 200mL each time, 30 minutes after breakfast and dinner.

[0053] The preparation method for granules includes the following steps: Obtain the combined decoction according to the decoction preparation method, and concentrate it to a clear extract with a relative density of 1.05-1.30; mix the clear extract with dextrin, maltodextrin, lactose, soluble starch, or other pharmaceutically acceptable excipients, and granulate using wet granulation or spray drying. After drying, granulate to obtain the granules. The granules can be taken twice daily, equivalent to one dose of the original medicinal materials.

[0054] Figure 1 In this process, calcined dragon bone is decocted first at the beginning of the main process, while fine amber powder or amber aqueous extract is added after the combined decoction. This reflects the processing characteristics of heavy and mineral drugs in the preparation sequence of this invention. By decocting calcined dragon bone first, heavy and difficult-to-decoct drugs can fully participate in the decoction; by adding amber later, the loss of amber during long-term decoction, filtration, and concentration can be reduced, ensuring its effective addition to the composition.

[0055] III. Examples

[0056] Example 1: Preparation and Application of Basic Formula Decoctions

[0057] This embodiment is a preferred embodiment of the present invention. By weight, 15g of Poria cocos, 5g of amber, 20g of calcined dragon bone, 6g of steamed Schisandra chinensis, 12g of stir-fried Ziziphus jujuba var. spinosa, 10g of Acorus tatarinowii, 10g of Curcuma longa, 4g of stir-fried Coptis chinensis, 20g of stir-fried malt, and 6g of prepared licorice root are weighed.

[0058] In preparation, first add calcined dragon bone to a decoction container, add about 500mL of water, and decoct for 30 minutes. Then add Poria cocos, steamed Schisandra chinensis, stir-fried Ziziphus jujuba var. spinosa, Acorus tatarinowii, Curcuma longa, stir-fried Coptis chinensis, stir-fried malt, and prepared licorice root. Add water to about 3cm above the herbs, soak for 30 minutes, and then decoct for 35 minutes. Filter to obtain the first decoction. Add about 600mL of water to the dregs, decoct for 30 minutes, and filter to obtain the second decoction. Combine the first and second decoctions and concentrate to about 400mL. Grind amber into a fine powder, pass through a 100-mesh sieve, and take in two doses with the decoction. The resulting decoction is taken once daily, divided into two doses, about 200mL each time, in the morning and evening, for 8 consecutive weeks.

[0059] This embodiment is suitable for patients with long-term insomnia symptoms of mental imbalance and heart-spleen heat stagnation, especially those with difficulty falling asleep, reduced sleep duration, frequent awakenings, accompanied by irritability, heartburn, abdominal distension, acid reflux, bad breath, thirst, constipation, or difficulty defecating. In this embodiment, Poria cocos and stir-fried Coptis chinensis are combined to clear heart-spleen heat stagnation and calm the mind; calcined dragon bone and amber are combined to heavily sedate and calm the mind; steamed Schisandra chinensis and stir-fried Ziziphus jujuba var. spinosa are combined to nourish yin and calm the mind; Acorus tatarinowii and Curcuma longa are combined to open the orifices and relieve depression; stir-fried malt and prepared licorice root are combined to harmonize the stomach and regulate the effects of the other herbs. The above combinations correspond to... Figure 7 The relationship between the drug groups and the syndromes is shown.

[0060] Example 2: Preparation of a low-dose decoction based on the basic formula

[0061] Weigh out the following ingredients by weight: 12g of Poria cocos, 4g of amber, 18g of calcined dragon bone, 5g of steamed Schisandra chinensis, 10g of stir-fried Ziziphus jujuba var. spinosa, 8g of Acorus tatarinowii, 8g of Curcuma longa, 3g of stir-fried Coptis chinensis, 18g of stir-fried malt, and 4g of prepared licorice root.

[0062] The preparation method is the same as in Example 1. Specifically, calcined dragon bone is decocted for 25 minutes, then the remaining herbs except amber are added and decocted for 30 minutes. The decoction is then filtered to obtain the first decoction. The dregs are decocted again for 25 minutes and filtered to obtain the second decoction. The decoctions are combined and the volume is adjusted to approximately 350 mL. The amber powder is taken in two divided doses. In this example, each herb is at the lower end of the scope defined by the claims, making it suitable for those with weak constitutions, older age, or those who require a gentler initial treatment. Since the complete herbal composition of Poria cocos, stir-fried Coptis chinensis, calcined dragon bone, amber, steamed Schisandra chinensis, stir-fried Ziziphus jujuba var. spinosa, Acorus tatarinowii, Curcuma longa, stir-fried malt, and prepared licorice root is still retained, and the proportions of the herbs are still within the scope defined by this invention, the compatibility purpose of regulating the spirit, calming the mind, and harmonizing the spleen and stomach, which is basically the same as in Example 1, can be achieved.

[0063] Example 3: Preparation of a high-dose range decoction based on a basic formula

[0064] Weigh out the following ingredients by weight: 18g of Poria cocos, 6g of amber, 25g of calcined dragon bone, 8g of steamed Schisandra chinensis, 15g of stir-fried Ziziphus jujuba var. spinosa, 12g of Acorus tatarinowii, 12g of Curcuma longa, 5g of stir-fried Coptis chinensis, 25g of stir-fried malt, and 8g of prepared licorice root.

[0065] The preparation method is the same as in Example 1. Specifically, calcined dragon bone is decocted for 40 minutes, then the remaining herbs except amber are added and decocted for another 45 minutes. The decoction is then filtered to obtain the first decoction. The dregs are decocted again for 35 minutes and filtered to obtain the second decoction. The decoctions are combined and adjusted to approximately 450 mL. The amber powder is taken in two divided doses. In this example, each herb is at the high end of the scope defined by the claims, making it suitable for patients with relatively obvious symptoms, irritability, heartburn, and difficulty falling asleep. This example maintains the basic compatibility relationships between stir-fried Coptis chinensis and Poria cocos, calcined dragon bone and amber, steamed Schisandra chinensis and stir-fried Ziziphus jujuba var. spinosa, Acorus tatarinowii and Curcuma longa, and stir-fried malt and prepared licorice root, thus achieving essentially the same synergistic effect as in Example 1.

[0066] Example 4: Modified decoction for phlegm accumulation and chest tightness

[0067] In the basic formula of Example 1, 9g of ginger-processed Pinellia ternata, 10g of Trichosanthes kirilowii peel, and 12g of Fritillaria thunbergii were added. During preparation, calcined dragon bone was decocted for 30 minutes first; then Poria cocos, steamed Schisandra chinensis, stir-fried Ziziphus jujuba var. spinosa, Acorus tatarinowii, Curcuma longa, stir-fried Coptis chinensis, stir-fried malt, prepared licorice root, ginger-processed Pinellia ternata, Trichosanthes kirilowii peel, and Fritillaria thunbergii were added and decocted together; amber powder was then taken in divided doses after combining the decoctions.

[0068] This embodiment is applicable to patients with chronic insomnia due to mental imbalance and stagnation of heat in the heart and spleen, accompanied by symptoms such as phlegm accumulation, chest tightness, chest discomfort, difficulty expectorating phlegm, or a predominance of phlegm and dampness. Ginger-processed Pinellia ternata dries dampness, resolves phlegm, harmonizes the stomach, and relieves nausea; Trichosanthes kirilowii peel relieves chest tightness and resolves phlegm; Fritillaria thunbergii clears heat and resolves phlegm. These three ingredients, combined with Acorus tatarinowii, Curcuma longa, and Coptis chinensis (fried) in the basic formula, enhance the effects of resolving phlegm, relieving chest tightness, and clearing stagnant heat. This embodiment illustrates that the invention can be implemented within the scope of the claims regarding the addition of ingredients for concurrent symptoms, and that adjustments can be made based on syndrome differentiation for phlegm accumulation and chest tightness.

[0069] Example 5: Modified decoction for abdominal distension and other symptoms

[0070] In the basic formula of Example 1, 6g of agarwood starter and 10g of stir-fried immature bitter orange peel were added. The preparation method was the same as in Example 1, and the agarwood starter and stir-fried immature bitter orange peel were decocted together with the other drugs except amber.

[0071] This embodiment is suitable for those suffering from chronic insomnia due to mental imbalance and stagnation of heat in the heart and spleen, accompanied by abdominal distension, poor appetite, and difficulty in the descending of stomach qi, or even severe bloating after meals. Agarwood extract can regulate qi and harmonize the stomach, and promote digestion; stir-fried immature bitter orange can regulate qi and relieve chest congestion. Combined with stir-fried malt and prepared licorice root, it helps improve the obstruction of qi in the spleen and stomach. For insomnia of spleen and stomach disharmony manifested as "restlessness in the stomach leads to sleeplessness," this embodiment strengthens the stomach-harmonizing and digestive aid group to ensure smooth qi flow in the spleen and stomach, reducing factors that cause turbid qi to disturb the mind.

[0072] Example 6: Modified decoction for the concurrent symptoms of sticky and foul-smelling stool

[0073] In the basic formula of Example 1, 6g of stir-fried Coptis chinensis and 20g of Shenqu (medicated leaven) were added. The total amount of stir-fried Coptis chinensis could be adjusted according to the patient's symptoms. The basic formula contained 4g of stir-fried Coptis chinensis, and the added 6g of stir-fried Coptis chinensis, totaling 10g, which was used for patients with sticky, foul-smelling stools, bad breath, and obvious signs of spleen and stomach heat. The preparation method was the same as in Example 1, with Shenqu decocted together with the other herbs except for amber.

[0074] This embodiment is applicable to those suffering from chronic insomnia due to mental imbalance and stagnation of heat in the heart and spleen, accompanied by sticky, foul-smelling stools, food stagnation leading to heat, and bad breath. Fried Coptis chinensis (Huanglian) strengthens the clearing of heat stagnation in the heart and spleen, while Shenqu (Shenqu) aids digestion and harmonizes the stomach. Combined with fried malt, these two ingredients can improve insomnia by addressing stagnation in the spleen and stomach and the upward disturbance of stagnant heat. This embodiment illustrates that the invention can be modified according to the severity of sticky, foul-smelling stools and the predominance of heat stagnation in the spleen and stomach.

[0075] Example 7: Modified decoction for dry mouth and throat

[0076] In the basic formula of Example 1, 20g of Codonopsis pilosula, 15g of stir-fried Ophiopogon japonicus, and 12g of Asparagus cochinchinensis were added. The preparation method was the same as in Example 1, with Codonopsis pilosula, stir-fried Ophiopogon japonicus, and Asparagus cochinchinensis decocted together with the other herbs except for amber.

[0077] This example is applicable to patients with long-term insomnia of spirit disorder, heart-spleen stagnant heat type, accompanied by dry mouth and throat, insufficient body fluid, and dual deficiency of qi and yin. Pseudostellariae radix replenishes qi and promotes fluid production; stir-fried ophiopogonis radix and asparagi radix nourish yin and moisten dryness. When combined with steamed schisandrae chinensis fructus and stir-fried ziziphi spinosae semen, it can enhance the effects of replenishing qi and nourishing yin, converging spirit and calming the mind. For patients with long-term insomnia accompanied by thirst, dry mouth and dry throat, this example can clear stagnant heat from the heart and spleen while addressing the deficiency of qi and yin, avoiding damage to the spleen and stomach caused by simply using bitter-cold herbs to clear heat.

[0078] Example 8: Preparation of Granules

[0079] Weigh the raw materials by scaling up the prescription amount of Example 1 by 10 times, that is 150g of poriae cum rubra, 50g of succinum, 200g of calcined ossis draconis, 60g of steamed schisandrae chinensis fructus, 120g of stir-fried ziziphi spinosae semen, 100g of acori tatarinowii rhizoma, 100g of curcumae radix, 40g of stir-fried coptidis rhizoma, 200g of stir-fried hordei fructus germinatus, and 60g of glycyrrhizae radix et rhizoma praeparata cum melle.

[0080] During preparation, decoct calcined ossis draconis with water for 40 minutes first; then add poriae cum rubra, steamed schisandrae chinensis fructus, stir-fried ziziphi spinosae semen, acori tatarinowii rhizoma, curcumae radix, stir-fried coptidis rhizoma, stir-fried hordei fructus germinatus and glycyrrhizae radix et rhizoma praeparata cum melle, soak for 30 minutes and then decoct for 45 minutes, then filter; decoct the medicinal residue again for 35 minutes and filter; combine the decoctions, concentrate under reduced pressure to a clear paste with a relative density of about 1.15; grind succinum into fine powder, pass through a 120-mesh sieve, add it to the clear paste and mix uniformly; then add an appropriate amount of maltodextrin and dextrin, carry out wet granulation, dry at a temperature below 60°C, size the granules, and obtain the granule preparation. The obtained granules are taken orally twice a day in an amount equivalent to 1 dose of the original medicinal materials per day.

[0081] This example illustrates that the traditional Chinese medicine composition of the present invention can not only be prepared into a decoction, but also can be prepared into granules through conventional traditional Chinese medicine preparation processes, so as to improve the convenience of administration and dose consistency. Controlling low-temperature drying during the preparation of granules can reduce the loss of volatile or heat-sensitive components; adding succinum as fine powder after other processing steps is conducive to reducing the loss of mineral components during decoction and concentration. The preparation process of the granules in Example 8 can also refer to Figure 1 the preparation process shown for implementation.

[0082] IV. Clinical Data and Methods

[0083] (1) Clinical Data

[0084] 1. Research Subjects

[0085] All subjects were insomnia patients who visited the Lu's Internal Medicine Clinic of Zhejiang Provincial Tongde Hospital from November 2023 to February 2026, with a total of 70 cases. The clinical observation procedure is as Figure 2 shown. In this study, outpatient insomnia patients are screened first, then valid cases are determined according to inclusion criteria, exclusion criteria, elimination criteria and dropout criteria, and efficacy and safety evaluations are performed before and after treatment.

[0086] 2. Diagnostic Criteria

[0087] 2.1 Western Medicine Diagnostic Criteria

[0088] According to the standards established in the International Classification of Sleep Disorders, 3rd Edition (ISCD-3) and the 2023 edition of the Chinese Guidelines for the Diagnosis and Treatment of Insomnia in Adults, the diagnosis of insomnia requires meeting both of the following conditions: (1) and (2):

[0089] (1) Having one of the following symptoms: 1) Difficulty falling asleep (sleep time ≥ 30 minutes); 2) Difficulty maintaining sleep (waking up ≥ 2 times throughout the night); 3) Early awakening (waking up earlier than expected); 4) Sleep resistance (unwilling to fall asleep at the appropriate time); 5) Dependent sleep difficulty (requiring intervention from caregivers to fall asleep).

[0090] (2) One of the following daytime functional impairments is present: 1) fatigue or lack of energy; 2) decreased attention, concentration or memory; 3) impaired social, family, occupational or academic functioning; 4) irritability or agitation; 5) daytime sleepiness; 6) hyperactivity, impulsivity or aggression; 7) decreased interest or energy; 8) prone to making mistakes or getting into trouble; 9) worry about sleep quality.

[0091] 2.2 Traditional Chinese Medicine Diagnostic Criteria

[0092] Based on the relevant content in the textbook "Internal Medicine of Traditional Chinese Medicine" for general higher education and "Eight Major Syndromes and Treatments of Difficult and Miscellaneous Diseases" edited by Wang Fu, and combined with Professor Lu Zheng's "Theory and Clinical Practice of Tian Gui Disease", researchers with the title of associate chief physician or above have formulated the diagnostic criteria for the syndrome of "disorder of the spirit and stagnation of heat in the heart and spleen".

[0093] If a patient with insomnia presents with two of these secondary symptoms, and the results of tongue and pulse diagnosis are taken into account, the diagnosis can be made as "disorder of the spirit and stagnation of heat in the heart and spleen".

[0094] (1) Main symptoms: Reduced sleep time, sleeplessness, difficulty falling asleep, easy to wake up and unable to fall back asleep after waking up;

[0095] (2) Secondary symptoms: irritability, burning sensation in the stomach, abdominal distension, nausea and vomiting, acid reflux and heartburn, foul breath, mouth ulcers, thirst, dry stools or difficulty in defecation;

[0096] (3) Tongue and pulse: red tongue, thin yellow coating, rapid or thready pulse.

[0097] A diagnosis can be made if one primary symptom and two secondary symptoms are present.

[0098] 3. Inclusion criteria

[0099] (1) The patient meets the diagnostic criteria for insomnia;

[0100] (2) Meets the diagnostic criteria for insomnia “due to mental disorder and heat stagnation in the heart and spleen”;

[0101] (3) PSQI score > 7;

[0102] (4) Age 18 ≤ age ≤ 80, gender not limited;

[0103] (5) Those with complete records of prescription drugs and dosages;

[0104] (6) Those who have not used other types of hypnotic drugs;

[0105] (7) Those who did not participate in other clinical studies;

[0106] (8) Those who agree to participate in this study and sign the informed consent form.

[0107] 4. Exclusion Criteria

[0108] (1) Patients who do not meet the study inclusion criteria;

[0109] (2) Incomplete records of prescription drug names and dosages;

[0110] (3) Those with unhealthy lifestyle habits that affect sleep, such as long-term smoking, drinking coffee or strong tea, etc.;

[0111] (4) Individuals with serious primary or secondary diseases of the heart, brain, hematopoietic system, etc.;

[0112] (5) Those with serious psychological or mental abnormalities;

[0113] (6) Those who fail to take medication as prescribed or whose treatment efficacy cannot be determined;

[0114] 5. Elimination Criteria

[0115] (1) Patients who were found to be ineligible for inclusion after enrollment;

[0116] (2) Subjects with poor compliance and who are uncooperative during the research process;

[0117] (3) Patients who received other treatments or medications after enrollment in the study that may affect the conclusions of the trial;

[0118] (4) Patients whose clinical data collection is incomplete and may affect the trial results or safety assessment.

[0119] 6. Shedding Criteria

[0120] (1) Patients who experience serious adverse events or special physiological changes during the study and are therefore unsuitable to continue participating;

[0121] (2) Patients who develop serious complications during the study;

[0122] (3) Patients who privately adjusted their medication regimen during the study, which affected the assessment of efficacy;

[0123] (4) Patients who voluntarily withdrew from the study.

[0124] 7. Ethical requirements

[0125] This study has been reviewed and approved by the Ethics Committee of Zhejiang Provincial Tongde Hospital. All patients included in this study voluntarily agreed to participate after fully understanding the purpose, process and possible adverse reactions of the study.

[0126] (II) Research Methods

[0127] 1. Sample size estimation

[0128] This study included patients who visited the Lu's Internal Medicine Outpatient Clinic at Zhejiang Provincial Tongde Hospital between November 2023 and February 2026. Given that this is a single-center clinical observation study, the required sample size was calculated using the following formula:

[0129] ;

[0130] According to the principle of statistical sample size, let... =0.05, =80%, =0.1, then =1.96, calculated as follows =62. According to the requirements of the "Guiding Principles for Clinical Research of New Traditional Chinese Medicines" and in combination with the patients' medical records, the dropout rate was expected to be 20%. After final calculation, n≈69, therefore at least 69 subjects needed to be included in the study.

[0131] 2. Treatment Plan

[0132] Subjects meeting the inclusion criteria received routine clinical medication, a treatment plan based on the principle of "regulating the spirit, calming the mind, and harmonizing the spleen and stomach." The basic prescription was as follows: Poria cocos 15g, amber 5g, calcined dragon bone 20g, steamed schisandra chinensis 6g, stir-fried jujube seed 12g, acorus tatarinowii 10g, turmeric 10g, stir-fried coptis chinensis 4g, stir-fried malt 20g, and prepared licorice root 6g. The medication is modified as follows: For those with phlegm accumulation and chest tightness, add 9g of ginger-processed Pinellia ternata, 10g of Trichosanthes kirilowii peel, and 12g of Fritillaria thunbergii; for those with abdominal distension, add 6g of agarwood fermented and 10g of stir-fried Citrus aurantium; for those with sticky and foul-smelling stools, add 6g of stir-fried Coptis chinensis and 20g of Shen Qu (medicated leaven); for those with dry mouth and throat, add 20g of Codonopsis pilosula, 15g of stir-fried Ophiopogon japonicus, and 12g of Asparagus cochinchinensis; for those with cough and excessive phlegm, add 10g of honey-processed Aster tataricus and 10g of honey-processed Tussilago farfara; for those with sore throat, add 30g of Houttuynia cordata and 30g of Fagopyrum dibotrys. One dose is taken daily, divided into two administrations of 200mL each time, 30 minutes after breakfast and dinner. During the medication period, avoid raw, cold, greasy, fishy, ​​and spicy foods. The treatment cycle is 8 weeks.

[0133] 3. Observation Indicators

[0134] 3.1 Basic Data Collection

[0135] In the initial phase of the study, the system will collect basic patient information, including demographic data such as name and age, and perform statistical processing on the obtained data. All baseline characteristics will be included in the statistical analysis to ensure the comparability of the study sample characteristics.

[0136] 3.2 Evaluation criteria for sleep quality and therapeutic effects

[0137] Sleep quality assessment using the Pittsburgh Sleep Quality Index (PSQI): This scale uses 19 self-report items to calculate seven sleep factors, including sleep efficiency, sleep quality, sleep latency, use of hypnotic medications, daytime dysfunction, sleep duration, and sleep disturbance. Each factor has a score range of 0-3. Because this study excluded patients who had taken sedative-hypnotic drugs during the study period, the "hypnotic medications" factor was removed from the scale. The scores for the remaining six factors were recorded, and the scores were summed to obtain the total PSQI score, ranging from 0-18. A higher score indicates a greater severity of insomnia.

[0138] Pittsburgh Sleep Quality Index (PSQI): This index assesses sleep quality by reducing the PSQI score before and after treatment, thus evaluating treatment effectiveness. The calculation formula is as follows:

[0139] ;

[0140] in, PSQI score deduction rate The PSQI score before treatment. The PSQI score is the score after treatment.

[0141] The formula for calculating the overall effectiveness is as follows:

[0142] ;

[0143] in, For overall efficiency. The number of cured cases, For the number of cases with significant effect, For the number of valid cases, This represents the total number of cases.

[0144] Cure: PSQI score reduction rate ≥75%, sleep quality significantly improved; Significant effect: 50%≤PSQI score reduction rate <75%, sleep quality improved; Effective: 25%≤PSQI score reduction rate <50%, sleep quality slightly improved; Ineffective: PSQI score reduction rate <25%, sleep quality basically not improved.

[0145] 3.3 Evaluation Criteria for the Therapeutic Effect of Traditional Chinese Medicine Syndromes

[0146] Traditional Chinese Medicine Syndrome Assessment Scale Scoring: Based on the severity of the patient's symptoms, each symptom is scored using a 4-level grading standard. The specific grades and corresponding scores are as follows: Grade 0 (none) = 0 points; Grade I (mild symptoms, not affecting daily life) = 1 point; Grade II (obvious symptoms, partially affecting daily life) = 2 points; Grade III (severe symptoms, significantly affecting work and life) = 3 points.

[0147] Traditional Chinese Medicine (TCM) Syndrome Efficacy Index: This index compares the TCM syndrome efficacy before and after treatment, calculating the percentage reduction in syndrome score using the nimodipine method. The formula is as follows:

[0148] ;

[0149] in, To reduce the percentage of syndrome scores, The TCM syndrome score before treatment. The TCM syndrome score is calculated after treatment.

[0150] The symptoms are graded based on the percentage reduction in symptom scores, as follows: if symptoms are basically relieved and the percentage reduction is ≥95%, it is considered clinically cured; if symptoms are significantly improved and the percentage reduction is 70% ≤ 95%, it is considered significantly effective; if symptoms are somewhat improved and the percentage reduction is 30% ≤ 70%, it is considered effective; if symptoms do not improve significantly or even worsen and the percentage reduction is <30%, it is considered ineffective.

[0151] 3.4 Anxiety Level Assessment Criteria

[0152] The Self-Rating Anxiety Scale (SAS) was used to evaluate the treatment efficacy. Raw scores were calculated based on the patients' subjective states before and after treatment to assess their anxiety levels. A decrease in post-treatment scores compared to pre-treatment scores indicated an improvement in the patients' anxiety levels.

[0153] 3.5 Criteria for Evaluating Depression

[0154] The Self-Rating Depression Scale (SDS) was used to evaluate the treatment efficacy. Raw scores were calculated based on the patients' subjective experiences before and after treatment to assess the severity of their depression. A decrease in post-treatment scores compared to pre-treatment scores indicated an improvement in the patients' depression levels.

[0155] 3.6 Safety Evaluation Standards

[0156] The study included baseline physiological monitoring (including blood pressure, heart rate, heart rhythm, respiratory rate, and weight monitoring) and laboratory diagnostic tests (including a comprehensive five-part blood test, urinalysis, routine stool examination, biochemical assessment of liver and kidney function, and a standard 12-lead electrocardiogram). These tests were performed at baseline before treatment and at the end of the treatment course. The safety profile of the drug was systematically evaluated by dynamically comparing changes in these indicators. Any abnormal physiological reactions or deviations in laboratory values ​​during treatment were fully recorded, including the time of occurrence, clinical manifestations, and intervention measures. Drug relevance was determined to clarify the strength of the association between adverse events and the investigational drug.

[0157] The safety evaluation criteria were formulated with reference to the "Guiding Principles for Clinical Research of New Traditional Chinese Medicine Drugs": Level I: No adverse reactions were observed during the study, which is considered to be highly safe; Level II: Adverse reactions observed during the study were not serious and did not require special intervention, which was considered to be relatively safe and did not affect the subsequent use of the investigational drug; Level III: Adverse reactions requiring symptomatic treatment occurred during the study, which posed a certain safety risk, but the clinical trial could continue after treatment and improvement; Level IV: Serious adverse reactions occurred during the study, which made it impossible to continue the clinical trial.

[0158] (III) Statistical Methods

[0159] This study used Excel software for data standardization and cleaning, and SPSS 26.0 software for statistical modeling. The data analysis process included the following key steps: First, the distribution characteristics of the differences in indicators before and after treatment were assessed using the Shapiro-Wilk test. For data groups that met the normality assumption, the paired-samples t-test in the parametric test method was used for within-group comparisons. Quantitative data were expressed as mean (…). Data are presented in the form of 0.5 ± standard deviation (s). If the data deviates from a normal distribution, the rank-sum test, a nonparametric test, is used. Continuous variables are expressed as the median combined with the interquartile range values ​​[M(Q1, Q3)]. Statistical significance is set at α = 0.05. A difference is considered statistically significant when the two-tailed test p < 0.05.

[0160] V. Test Results

[0161] (a) Case completion status

[0162] like Figure 2 As shown, this study enrolled 76 eligible patients between November 2023 and February 2026. After rigorous screening, 4 patients were lost to follow-up, and 2 were excluded due to insufficient scale compliance, resulting in 70 valid cases. The data completeness rate was 92.1%, and the dropout rate was 7.9%. All patients who completed the study followed the established follow-up procedures and assessment milestones as required, meeting the analytical criteria of the protocol set. See Table 1 for details.

[0163] Table 1 Case Completion Status

[0164]

[0165] (II) Patient Basic Information

[0166] According to the data of 70 patients who completed the study, their ages ranged from 25 to 67 years, with a mean age of 47.29 ± 9.89 years. Male patients accounted for 25.71% and female patients accounted for 74.29%. See Tables 2 and 3 for details.

[0167] Table 2. Age distribution and average age of the study subjects

[0168]

[0169] Table 3. Gender structure characteristics of the research subjects

[0170]

[0171] (III) Clinical efficacy observation results

[0172] 1. Overall efficacy evaluation of TCM syndromes

[0173] After 8 weeks of intervention with traditional Chinese medicine decoctions guided by the principle of "regulating the spirit, calming the mind, and harmonizing the spleen and stomach," the overall effective rate of TCM syndromes in the study subjects reached 97.14% (68 / 70), including a clinical cure rate of 2.86% (2 / 70), a significant efficacy rate of 17.14% (12 / 70), an effective rate of 77.14% (54 / 70), and an ineffective rate of 2.86% (2 / 70). See Table 4 for details.

[0174] Table 4. Therapeutic effects of TCM syndromes on the research subjects.

[0175]

[0176] 2. Evaluation of Traditional Chinese Medicine Syndrome Scores

[0177] Statistical analysis was performed on the TCM syndrome scores of the 70 patients who ultimately completed the study, and the data were tested for normality. The results showed that the data did not conform to a normal distribution; therefore, a nonparametric rank-sum test was used for analysis. After 8 weeks of TCM treatment based on the principle of "regulating the spirit, calming the mind, and harmonizing the spleen and stomach," the patients' symptoms, including poor sleep, irritability, heartburn, abdominal distension, nausea and vomiting, acid reflux, bad breath, oral ulcers, thirst, constipation or difficulty defecating, and the total TCM syndrome score, all showed significant improvement compared to before treatment (P<0.01). See Table 5 for details. Figure 3 .

[0178] Table 5 Comparison of TCM syndrome scores and total scores before and after treatment [M(Q1, Q3), points]

[0179]

[0180] like Figure 3 As shown, the total TCM syndrome score of the patients before treatment was 17.00 (16.00, 19.00), and after treatment it dropped to 7.00 (6.00, 9.00), indicating that the TCM composition of the present invention can significantly reduce the total TCM syndrome score of patients with long-term insomnia due to mental disorders and heart-spleen stagnation and heat.

[0181] 3. Sleep quality score evaluation

[0182] Statistical analysis was performed on the PSQI scores of the 70 patients who completed the study. Normality tests were conducted on the scores of each factor and the total score. The results showed that the data did not conform to a normal distribution; therefore, a nonparametric rank-sum test was used. After 8 weeks of traditional Chinese medicine treatment based on the principle of "regulating the spirit, calming the mind, and harmonizing the spleen and stomach," the patients' sleep quality, sleep onset time, sleep duration, sleep disturbances, sleep efficiency, daytime dysfunction, and total PSQI score all showed significant improvements compared to before treatment (P<0.01). See Table 6 for details. Figure 4 .

[0183] Table 6 Comparison of PSQI factor scores and total scores before and after treatment [M(Q1, Q3), points]

[0184]

[0185] like Figure 4 As shown, the patient's total PSQI score was 14.00 (12.00, 15.00) before treatment and decreased to 7.00 (6.00, 7.00) after treatment, indicating that the traditional Chinese medicine composition of the present invention can improve the patient's sleep quality and reduce sleep quality-related scores.

[0186] 4. SAS Points Evaluation

[0187] Statistical analysis was performed on the SAS scores of the 70 patients who ultimately completed the study. A normality test was conducted on the SAS scores, and the results showed that the data conformed to a normal distribution; therefore, a paired-samples t-test was used. After 8 weeks of traditional Chinese medicine treatment based on the principle of "regulating the spirit, calming the mind, and harmonizing the spleen and stomach," the patients' anxiety levels significantly improved compared to before treatment (P<0.01). See Table 7 for details. Figure 5 .

[0188] Table 7 Comparison of SAS total scores before and after treatment ( ± ,point)

[0189]

[0190] 5. SDS Points Evaluation

[0191] Statistical analysis was performed on the SDS scores of the 70 patients who completed the study. A normality test was conducted on the SDS scores, and the results showed that the data conformed to a normal distribution; therefore, a paired-samples t-test was used. After 8 weeks of traditional Chinese medicine treatment based on the principle of "regulating the spirit, calming the mind, and harmonizing the spleen and stomach," the patients' depression levels significantly improved compared to before treatment (P<0.01). See Table 8 for details. Figure 5 .

[0192] Table 8 Comparison of SDS total scores before and after treatment in patients ( ± ,point)

[0193]

[0194] like Figure 5 As shown, the total scores of SAS and SDS were significantly reduced before and after treatment, indicating that the patient's anxiety and depression-related scores were improved after intervention with the traditional Chinese medicine composition of this invention.

[0195] 6. Comparison of recurrence rates

[0196] At weeks 4 and 8 after treatment, patients with effective or better outcomes were followed up by telephone, with 56 patients successfully followed up. Among them, 4 patients relapsed 4 weeks after treatment, with a relapse rate of 7.14%; and 6 patients relapsed a total of 10.71% 8 weeks after treatment. See Table 9 for details. Figure 6 .

[0197] Table 9 Recurrence Rate

[0198]

[0199] like Figure 6 As shown, the recurrence rate of the traditional Chinese medicine composition of the present invention was 7.14% 4 weeks after the end of treatment, and the cumulative recurrence rate was 10.71% 8 weeks after the end of treatment, indicating that the traditional Chinese medicine composition of the present invention has good therapeutic stability during short-term follow-up.

[0200] 7. Safety and Adverse Reaction Evaluation

[0201] Safety monitoring during the study showed that all subjects' vital signs remained within the normal physiological range. Laboratory tests before and after treatment, including complete blood count, liver and kidney function tests, urinalysis, stool analysis, and electrocardiogram, revealed no significant abnormalities. No adverse drug reactions or serious adverse events related to the traditional Chinese medicine intervention were recorded, suggesting that the "regulating the spirit, calming the mind, and harmonizing the spleen and stomach" method has good safety in improving insomnia symptoms caused by imbalances in the spirit and stagnation of heat in the heart and spleen.

[0202] VI. Comparative Example

[0203] The clinical data of this invention are single-group, self-controlled pre- and post-treatment observation data, without fabricating parallel comparison data with other traditional Chinese medicine prescriptions or prescription breakdown schemes. To more clearly illustrate the technical effects of the composition of this invention, the baseline state before treatment is used as the self-comparison example, and the results after treatment are compared below.

[0204] Comparative Example 1: Baseline status of TCM syndromes before treatment

[0205] This comparative study included 70 patients whose TCM syndrome scores were as follows before treatment. Before treatment, the total TCM syndrome score of the patients was 17.00 (16.00, 19.00), among which symptoms such as poor sleep, irritability, heartburn, abdominal distension, nausea and vomiting, oral ulcers, excessive thirst, bad breath, constipation or difficulty in defecation, and acid reflux were all present to varying degrees.

[0206] Compared with the results after 8 weeks of treatment with the composition described in Example 1, the total TCM syndrome score decreased to 7.00 (6.00, 9.00) after treatment, and the scores of each individual syndrome decreased compared with before treatment. Figure 3 The changes in the total score of TCM syndrome before and after treatment are visually displayed, indicating that the TCM composition of the present invention has an improving effect on TCM syndrome of long-term insomnia due to mental disorder and heart-spleen heat stagnation.

[0207] Comparative Example 2: Baseline PSQI sleep quality status before treatment

[0208] This comparison group includes 70 patients with pre-treatment PSQI scores. The pre-treatment PSQI total score was 14.00 (12.00, 15.00), and the scores for sleep quality, sleep onset time, sleep duration, sleep efficiency, sleep disturbances, and daytime dysfunction were all at a high level.

[0209] Compared with the results after 8 weeks of treatment with the composition described in Example 1, the total PSQI score decreased to 7.00 (6.00, 7.00) after treatment, and the scores of each factor decreased. Figure 4 The changes in the total PSQI score before and after treatment are visually displayed, indicating that the traditional Chinese medicine composition of the present invention can improve sleep quality, shorten the time to fall asleep, prolong sleep time, improve sleep efficiency, and reduce daytime dysfunction.

[0210] Comparative Example 3: Baseline Anxiety and Depression Status Before Treatment

[0211] This comparative study included 70 patients with pre-treatment SAS and SDS scores. The pre-treatment SAS total score was 33.11±4.70, and the pre-treatment SDS total score was 29.90±4.22. Compared to the results after 8 weeks of treatment with the composition described in Example 1, the post-treatment SAS total score decreased to 22.09±1.90, and the post-treatment SDS total score decreased to 21.80±1.77.

[0212] Figure 5 The changes in the total scores of SAS and SDS before and after treatment were visually displayed, indicating that the traditional Chinese medicine composition of the present invention can improve long-term insomnia and also improve the accompanying anxiety and depression.

[0213] Comparison Example 4: Long-term insomnia before treatment and follow-up status after treatment

[0214] This comparative example reflects the patient's persistent insomnia prior to treatment and the need for intervention. After 8 weeks of treatment with the traditional Chinese medicine composition described in Example 1, the overall effective rate of TCM syndrome was 97.14%. Follow-up of patients with effective or better results after treatment showed a relapse rate of 7.14% at 4 weeks and a cumulative relapse rate of 10.71% at 8 weeks.

[0215] Figure 6 The relapse rates at 4 and 8 weeks after treatment were shown. Compared with the persistent insomnia before treatment, the relapse rate was lower during the short-term follow-up period after treatment, indicating that the herbal composition of the present invention can maintain the improved sleep state after treatment to a certain extent.

[0216] VII. Analysis and Discussion

[0217] (I) The theoretical basis for treating insomnia using the method of "regulating the spirit, calming the mind, and harmonizing the spleen and stomach".

[0218] 1. Treating insomnia by addressing the heart and spleen

[0219] The heart, which houses the spirit and governs the blood vessels, is a vital organ for human life activities. When external pathogens invade the body or the functions of the internal organs are imbalanced, it can lead to restlessness of the spirit and an inability of yang to enter yin. If the heart blood is deficient or yin is deficient and fire is excessive, the heart spirit will not be nourished, easily resulting in insomnia. Professor Lu Zhizheng, a master of traditional Chinese medicine, pointed out that there are three main causes of restlessness of the heart spirit: first, deficiency of the heart itself; second, pathogenic factors such as heat, phlegm, and blood stasis disturbing the heart spirit; and third, dysfunction of other organs affecting the heart. The core of insomnia lies in the "heart spirit," and its pathogenesis is mostly caused by disturbance of the heart spirit. The nature of the disease is mostly fire syndrome, either due to excess fire or deficiency fire rising upwards. Therefore, clinical diagnosis and treatment should be based on the theory of the sovereign fire, with the core approach of regulating the heart and calming the spirit, clearing heat and reducing fire. Other scholars believe that the occurrence of insomnia is closely related to the mutual generation and restraint of the five internal organs, but tracing back to the core organ, the focus is always on the "heart"—dysfunction of other organs, which in turn disturbs the heart spirit. The spleen governs transportation and transformation and controls blood. Dysfunction of the spleen and stomach can lead to insomnia. Spleen deficiency weakens transportation and transformation, resulting in insufficient production of qi and blood to nourish the heart and liver, leading to excessive fire in the heart and liver, and ultimately causing insomnia. The spleen also governs thought. Excessive thinking can disrupt the spleen's ascending and descending functions, causing qi stagnation or blockage, both of which can disturb the mind and lead to insomnia. As stated in *Classified Treatments*, "Excessive thinking injures the spleen, leading to spleen blood deficiency and chronic insomnia." Excessive thinking damaging the spleen and causing qi and blood deficiency is a significant contributing factor to long-term insomnia. Furthermore, the spleen stores intention; if intention is not properly guarded, the mind will become restless and agitated.

[0220] 2. Treating insomnia from the perspective of the Supreme Deity's Desire for Nourishing Life

[0221] Professor Lu Zheng, in his book *New Theory of Tian Gui*, has extensively studied Tian Gui, revealing that it is not merely reproductive essence, but rather comprises various substances within the body, possessing unique regulatory and stimulating effects. Based on its nature and function, Tian Gui can be categorized into four types: Supreme Spirit Tian Gui, Supreme Qi Tian Gui, Supreme Fluid Tian Gui, and Supreme Essence Tian Gui. Supreme Spirit Tian Gui is a highly sensitive substance unique to the brain system, possessing the function of regulating sleep. If the generation of Supreme Spirit Tian Gui is abnormal, leading to a loss of regulation of the physiological functions of various organs, it indirectly affects the mind and spirit, causing insomnia. When Tian Gui is harmonious, and sleep is properly regulated, the cycle becomes regular, and sleep naturally becomes peaceful. If the spirit is disturbed by wind and yang, the imbalance of Tian Gui (menstrual blood) will lead to yang excess, causing a disorder in the regulation of sleep and wakefulness, resulting in insomnia. If the spirit is not nourished, yin deficiency will lead to a relative excess of yang, which will also cause a disorder in the regulation of sleep and wakefulness, resulting in insomnia. If stagnant fire disturbs the spirit, causing an excess of yang heat, the regulation of sleep and wakefulness will be disordered, which will also cause insomnia. If the spirit is weak and unable to effectively regulate sleep and wakefulness, sleep and wakefulness will be disordered, resulting in insomnia. If the spirit is depressed and unable to regulate itself, the regulation of sleep and wakefulness will be impaired, which will eventually lead to insomnia.

[0222] At the same time, the spirit can also indirectly improve sleep by regulating the functions of the heart, liver, kidneys, and spleen. When the spirit is at peace, the functions of the five internal organs are in harmony, and sleep is restful. If the spirit is disordered, its regulatory function over the internal organs is lost, leading to organ dysfunction, restlessness, and ultimately insomnia. In short, disorder of the spirit is the root cause of insomnia.

[0223] 3. The mechanism of insomnia due to "disorder of the spirit and stagnation of heat in the heart and spleen"

[0224] If insomnia is characterized by long-term, gradual, or recurrent episodes, difficulty falling asleep or complete sleeplessness, restless sleep, or intermittent awakenings, it is often caused by damage to the "Shen" (spirit) and "Tian Gui" (menstrual blood). The location of insomnia is in the heart, and it is closely related to the liver, spleen, and kidneys. If a patient's "Shen" and "Tian Gui" are damaged, and there is also stagnation of heat in the heart and spleen, symptoms such as complete sleeplessness or difficulty falling asleep, irritability, burning sensation in the stomach, abdominal distension, acid reflux, halitosis, thirst, scanty and dark urine, dry stools, or difficulty defecating will occur. Its characteristic syndrome lies in the presence of both "disorder of the Shen" and "stagnation of heat in the heart and spleen." The pathogenesis is often attributed to the disorder of the "Shen" and "Tian Gui," with the heart being troubled by pathogenic heat. The heart fire descends and injures the spleen and stomach, or the spleen fails to function properly, leading to deficiency of both Qi and Yin in the spleen and stomach, internal generation of phlegm and blood stasis, which stagnates and transforms into heat, disturbing the mind and spirit, ultimately forming a syndrome of disorder of the Shen and stagnation of heat in the heart and spleen.

[0225] 4. Analysis of the basic formula composition of the "regulating the spirit, calming the mind, and harmonizing the spleen and stomach" method

[0226] Conventional methods of clearing heat from the heart and purging the spleen are not very effective in treating insomnia in clinical practice. Professor Lu Zheng, through long-term clinical practice, summarized a basic formula guided by the principle of "regulating the spirit, calming the mind, and harmonizing the spleen and stomach," which is an effective formula for treating insomnia caused by "disorders of the spirit and stagnation of heat in the heart and spleen." This formula consists of 15g of Poria cocos, 5g of amber, 20g of calcined dragon bone, 6g of steamed Schisandra chinensis, 12g of stir-fried Ziziphus jujuba var. spinosa, 10g of Acorus tatarinowii, 10g of Curcuma longa, 4g of stir-fried Coptis chinensis, 20g of stir-fried malt, and 6g of prepared licorice root. Coptis chinensis and Poria cocos are the principal herbs in this formula. Coptis chinensis is bitter and cold, clearing heat from the heart and spleen, while Poria cocos is sweet and neutral, calming the mind and soothing the nerves. Together, they achieve the effect of clearing heat and calming the nerves. Dragon bone, amber, schisandra, and jujube seed are all used as assistant herbs. Dragon bone has astringent and consolidating functions, calms the mind and relieves anxiety. Its heavy and sinking nature can calm the restless mind. Amber calms the mind and relieves anxiety, and also promotes blood circulation, removes blood stasis, and promotes urination. It helps to preserve the mind and prevent blood stasis, and also draws heat outward. Schisandra chinensis invigorates qi and generates fluids, calms the mind and relieves anxiety. Jujube seed nourishes the heart and liver, calms the mind and relieves anxiety. When combined with jujube seed, the sour and sweet flavors transform into yin, which can nourish the spleen and qi, and also generate fluids and quench thirst. The four herbs work together to nourish while promoting circulation, and promote circulation while astringing. Acorus tatarinowii can open the orifices and awaken the mind, resolve dampness and harmonize the stomach, clear the heart orifices and calm the mind, and resolve spleen dampness and promote qi circulation. Curcuma longa has the effects of invigorating blood and relieving pain, promoting qi circulation and relieving depression, and can also clear the heart and cool the blood. When combined with Acorus tatarinowii, they work together to regulate the spleen and qi, and relieve depression and heat. Malt promotes digestion, strengthens the spleen, and stimulates appetite; it protects the stomach and soothes the stomach, while also facilitating the flow of qi in the spleen and stomach. These three herbs work together as adjuvants to clear heat from the heart and spleen, and relieve internal heat. Licorice root acts as an adjuvant and guiding herb, benefiting the heart and spleen, clearing heat and toxins, and harmonizing the other herbs, guiding them to the heart and spleen meridians. Furthermore, jujube seed and schisandra fruit nourish the spirit; dragon bone and amber calm the spirit; coptis root soothes the spirit; and acorus tatarinowii opens the orifices. All these herbs work together to regulate the spirit, calm the mind, and harmonize the spleen and stomach, addressing the complex pathogenesis of "insufficient spleen and qi yin, with internal generation of phlegm, blood stasis, and internal heat."

[0227] (II) Analysis of Research Results

[0228] 1. Case demographic data

[0229] This study included 76 patients who met the diagnostic criteria, and ultimately completed the full observation of 70 patients. Among them, 52 were female and 18 were male, with the proportion of female patients significantly higher than that of male patients. Regarding age, the average age of patients who completed follow-up was (47.29±9.89) years, ranging from 25 to 67 years, with 77.14% of patients being between 40 and 67 years old, primarily middle-aged and elderly. This indicates that the high-risk group for insomnia is trending towards aging and becoming more prevalent among women.

[0230] 2. Analysis of the efficacy of traditional Chinese medicine

[0231] After 8 weeks of treatment using the "regulating the spirit, calming the mind, and harmonizing the spleen and stomach" method, the overall effective rate of TCM efficacy in this study reached 97.14%. Compared with before treatment, the patients' symptoms of poor sleep, irritability, heartburn, abdominal distension, nausea and vomiting, acid reflux, bad breath, oral ulcers, thirst, constipation or difficulty in defecation, as well as the total TCM syndrome score, all showed significant improvement (P<0.01). This indicates that the "regulating the spirit, calming the mind, and harmonizing the spleen and stomach" method can improve insomnia caused by "disorders of the spirit and stagnation of heat in the heart and spleen," with significant overall efficacy. This treatment method was used to treat insomnia caused by "disorders of the spirit and stagnation of heat in the heart and spleen," and the improvement of various symptoms is evidenced by the saying "when the spirit is regulated, the mind is at peace; when the heart and spleen are in harmony, sleep is restful."

[0232] 3. Analysis of PSQI factor scores and total score before and after treatment

[0233] The PSQI scale is a commonly used scale for assessing insomnia, reflecting various aspects of sleep status and daytime mental state in insomnia patients. This study compared the scores of the remaining six factors in the PSQI scale, excluding the hypnotic drug factor, specifically sleep quality, sleep onset time, sleep duration, sleep disturbances, sleep efficiency, and daytime functional impairment. After 8 weeks of traditional Chinese medicine treatment using the method of "regulating the spirit, calming the mind, and harmonizing the spleen and stomach," the scores of each PSQI factor after treatment were significantly lower than before treatment (P<0.01); the total PSQI score after treatment was also significantly lower than before treatment (P<0.01). This indicates that for patients with insomnia due to "disorders of the spirit and stagnation of heat in the heart and spleen," the traditional Chinese medicine treatment using the method of "regulating the spirit, calming the mind, and harmonizing the spleen and stomach" has achieved significant efficacy in improving sleep quality, shortening sleep onset time, prolonging sleep duration, improving sleep efficiency, and alleviating daytime functional impairment.

[0234] 4. Analysis of SAS and SDS total scores before and after treatment

[0235] The SAS and SDS scores can reflect a patient's anxiety and depression, respectively, and to some extent, the severity of accompanying mental symptoms. The results of this study showed that after 8 weeks of traditional Chinese medicine treatment using the method of "regulating the spirit, calming the mind, and harmonizing the spleen and stomach," the total scores of both the SAS and SDS scores were significantly lower than before treatment (P<0.01). This indicates that the method of "regulating the spirit, calming the mind, and harmonizing the spleen and stomach" can effectively improve the anxiety and depression status of insomnia patients.

[0236] 5. Recurrence rate analysis

[0237] At weeks 4 and 8 after treatment, patients with effective or better outcomes were followed up by telephone, with a total of 56 patients successfully followed up. Of these, 4 patients relapsed at week 4 after treatment, a relapse rate of 7.14%; and 6 patients relapsed at week 8, a relapse rate of 10.71%. This indicates that the traditional Chinese medicine treatment method of "regulating the spirit, calming the mind, and harmonizing the spleen and stomach" achieved ideal long-term efficacy in treating insomnia caused by "disorders of the spirit and stagnation of heat in the heart and spleen." It also demonstrates that this treatment method addresses the root cause of the disease and has proven to be effective, potentially improving patients' insomnia and thus enhancing their quality of life.

[0238] 6. Security Analysis

[0239] No adverse events occurred throughout the study. Patients' vital signs remained within the normal range, and no significant abnormalities were detected in blood routine tests, liver and kidney function tests, or electrocardiogram monitoring before and after treatment. These results suggest that the "regulating the spirit, calming the mind, and harmonizing the spleen and stomach" method demonstrated good safety characteristics in this study. However, due to the small sample size involved in this study and the fact that the traditional Chinese medicine prescription was modified according to individual symptoms, there were differences in medication details between different individuals. Therefore, it cannot be directly concluded that this therapy has absolute safety.

[0240] The foregoing description of embodiments of the present invention, through which those skilled in the art are able to implement or use the present invention, will be readily apparent to those skilled in the art. Various modifications to these embodiments will be readily apparent to those skilled in the art. The general principles defined herein may be implemented in other embodiments without departing from the spirit or scope of the invention. Therefore, the present invention is not to be limited to the embodiments shown herein, but is to be accorded the widest scope consistent with the principles and novelty disclosed herein.

Claims

1. A traditional Chinese medicine composition for improving chronic insomnia caused by mental disorders and stagnation of heat in the heart and spleen, characterized in that, The traditional Chinese medicine composition consists of a basic drug group, which is composed of Poria cocos, amber, calcined dragon bone, steamed Schisandra chinensis, stir-fried Ziziphus jujuba var. spinosa, Acorus tatarinowii, Curcuma longa, stir-fried Coptis chinensis, stir-fried malt, and prepared licorice root. By weight: Poria cocos 12-18 parts, amber 4-6 parts, calcined dragon bone 18-25 parts, steamed schisandra chinensis 5-8 parts, stir-fried jujube seed 10-15 parts, acorus tatarinowii 8-12 parts, turmeric 8-12 parts, stir-fried coptis chinensis 3-5 parts, stir-fried malt 18-25 parts, and prepared licorice root 4-8 parts; Among them, the weight ratio of stir-fried Coptis chinensis to Poria cocos is 1:3-5, the weight ratio of calcined dragon bone to amber is 3.5-5.5:1, the total weight ratio of steamed Schisandra chinensis to stir-fried Ziziphus jujuba var. spinosa and the total weight ratio of Acorus tatarinowii to Curcuma longa is 0.7-1.2:1, and the total weight ratio of stir-fried malt to roasted licorice root and the weight ratio of stir-fried Coptis chinensis is 5-8:

1. The aforementioned insomnia due to mental imbalance and heart-spleen heat is characterized by at least one primary symptom of reduced sleep time, insomnia, difficulty falling asleep, and frequent awakenings with inability to fall back asleep, accompanied by at least two secondary symptoms of irritability, burning sensation in the stomach, abdominal distension, nausea and vomiting, acid reflux, foul breath, mouth ulcers, thirst, constipation, or difficulty defecating.

2. The traditional Chinese medicine composition according to claim 1, characterized in that, The basic medicinal group, by weight, consists of the following components: 15 parts Poria cocos, 5 parts amber, 20 parts calcined dragon bone, 6 parts steamed Schisandra chinensis, 12 parts stir-fried Ziziphus jujuba var. spinosa, 10 parts Acorus tatarinowii, 10 parts Curcuma longa, 4 parts stir-fried Coptis chinensis, 20 parts stir-fried malt, and 6 parts prepared licorice root.

3. A traditional Chinese medicine composition for improving chronic insomnia caused by mental disorders and stagnation of heat in the heart and spleen, characterized in that, The traditional Chinese medicine composition comprises the basic drug group as described in any one of claims 1-2 and the modified drug group for phlegm accumulation and chest tightness, wherein the modified drug group for phlegm accumulation and chest tightness comprises ginger-processed Pinellia ternata, Trichosanthes kirilowii peel and Fritillaria thunbergii; by weight, the modified drug group for phlegm accumulation and chest tightness comprises 6-12 parts of ginger-processed Pinellia ternata, 8-15 parts of Trichosanthes kirilowii peel and 8-15 parts of Fritillaria thunbergii. Alternatively, the traditional Chinese medicine composition consists of the basic medicine group as described in any one of claims 1-2 and the modified medicine group for abdominal distension, wherein the modified medicine group for abdominal distension consists of agarwood koji and stir-fried immature bitter orange peel; by weight, the modified medicine group for abdominal distension includes 4-8 parts of agarwood koji and 8-12 parts of stir-fried immature bitter orange peel; Alternatively, the traditional Chinese medicine composition consists of the basic drug group as described in any one of claims 1-2 and the modified drug group for sticky and smelly stool, wherein the modified drug group for sticky and smelly stool consists of stir-fried Coptis chinensis and Shenqu (medicated leaven); by weight, the modified drug group for sticky and smelly stool includes 4-8 parts of stir-fried Coptis chinensis and 15-25 parts of Shenqu (medicated leaven). Alternatively, the traditional Chinese medicine composition comprises the basic drug group as described in any one of claims 1-2 and the modified drug group for dry mouth and throat, wherein the modified drug group for dry mouth and throat comprises Codonopsis pilosula, stir-fried Ophiopogon japonicus and Asparagus cochinchinensis; by weight, the modified drug group for dry mouth and throat comprises 15-25 parts of Codonopsis pilosula, 12-18 parts of stir-fried Ophiopogon japonicus and 8-15 parts of Asparagus cochinchinensis.

4. A pharmaceutical preparation, characterized in that, The pharmaceutical preparation includes the traditional Chinese medicine composition according to any one of claims 1 to 3, its aqueous extract, its clear extract or its dry extract powder, and optional pharmaceutically acceptable excipients; the pharmaceutical preparation is a decoction, granules, oral liquid, capsule, tablet, pill or powder.

5. A method for preparing a traditional Chinese medicine composition according to any one of claims 1 to 2, characterized in that, Includes the following steps: S1. Weigh out the following ingredients by weight: Poria cocos, amber, calcined dragon bone, steamed Schisandra chinensis, stir-fried Ziziphus jujuba var. spinosa, Acorus tatarinowii, Curcuma longa, stir-fried Coptis chinensis, stir-fried malt, and prepared licorice root. S2. Add water to calcined dragon bone and decoct for 20-40 minutes to obtain a decoction containing calcined dragon bone. S3. Add Poria cocos, steamed Schisandra chinensis, stir-fried Ziziphus jujuba var. spinosa, Acorus tatarinowii, Curcuma longa, stir-fried Coptis chinensis, stir-fried malt and prepared licorice to the first decoction, continue to decoct for 20-45 minutes, and filter to obtain the first decoction. S4. Add water to the dregs filtered in step S3 and decoct again for 20-40 minutes, then filter to obtain the second decoction. S5. Combine the first and second decoctions, concentrate to the volume required for administration, and add fine amber powder or amber water extract to obtain a traditional Chinese medicine decoction.

6. The preparation method according to claim 5, characterized in that, In step S5, the amber powder is fine powder that has passed through an 80-200 mesh sieve; And / or, the herbal decoction is taken once a day, divided into two doses, 150-250 mL each time; And / or, the preparation method further includes the following steps: S6. Concentrate the traditional Chinese medicine decoction into a clear paste with a relative density of 1.05-1.30; S7. The ointment is mixed with pharmaceutically acceptable excipients, and then granulated, dried and sized to obtain granules.

7. The use of the traditional Chinese medicine composition according to any one of claims 1 to 3 or the pharmaceutical preparation according to claim 4 in the preparation of a medicine for improving long-term insomnia caused by mental disorders and stagnation of heart and spleen.

8. The application according to claim 7, characterized in that, The medication is used to improve at least one of the following symptoms: difficulty falling asleep, difficulty maintaining sleep, reduced sleep duration, frequent awakenings, irritability, heartburn, abdominal distension, acid reflux, bad breath, thirst, constipation, or difficulty defecating.

9. The application according to claim 7 or 8, characterized in that, The drug is used to improve at least one of the following evaluation indicators: Pittsburgh Sleep Quality Index score, Traditional Chinese Medicine syndrome score, Self-Rating Anxiety Scale score, and Self-Rating Depression Scale score.

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