Traditional Chinese medicine composition for treating phlegm-heat internal disturbance type psychosomatic disease and preparation method of traditional Chinese medicine composition

Abstract

The invention provides a traditional Chinese medicine composition for treating phlegm-heat internal disturbance type heart-body co-disease and a preparation method of the traditional Chinese medicine composition. Comprising 9 g of ginger processed pinellia, 6 g of immature bitter orange, 20 g of bamboo shavings, 10 g of poria cocos, 10 g of dried orange peel, 9 g of polygala tenuifolia, 20 g of fried spina date seed, 15 g of albizia flower, 15 g of vine of multiflower knotweed, 10 g of angelica sinensis, 10 g of radix rehmanniae, 10 g of fingered citron, 12 g of hawthorn and 6 g of honey-fried licorice root. The invention further relates to a preparation method of the traditional Chinese medicine composition for treating the phlegm-heat internal disturbance type heart-body co-disease. According to the formula disclosed by the invention, interaction among the components is utilized, and the components have the effects of soothing the nerves, relieving depression, nourishing yin and blood (Chinese angelica and radix rehmanniae), regulating qi, harmonizing the stomach, tonifying the spleen (poria cocos) and the like; the traditional Chinese medicine composition can comprehensively improve insomnia, anxiety, palpitation, gastrointestinal dysfunction, fatigue and other symptoms represented by climacteric syndrome, workplace hypertension people or chronic fatigue syndrome patients.

Description

TECHNICAL FIELD

[0001] The present application belongs to the field of traditional Chinese medicine composition; in particular, it relates to a traditional Chinese medicine composition for treating psychosomatic diseases of phlegm-heat disturbing the heart and a preparation method thereof. BACKGROUND

[0002] About 10%-30% of the global population is troubled by insomnia, and more than 30% of patients with anxiety / depression are accompanied by functional gastrointestinal diseases (such as FD, IBS). Emotional disorders and gastrointestinal function are bidirectionally influenced through the vagus nerve, intestinal flora and the serotonin pathway (95% of serotonin is synthesized in the intestine). Western medicine lacks drugs that can simultaneously improve emotional and somatic symptoms. In the treatment of insomnia or anxiety accompanied by somatic symptoms with complex pathogenesis, the prior art has the following deficiencies: (1) Western anxiolytic / sedative drugs, (1) dependence / addiction (benzodiazepines); (2) next-day drowsiness and decreased cognitive function; (3) ineffective for gastrointestinal discomfort and other somatic symptoms; (2) single syndrome type Chinese medicine, (1) limited effect on complex pathogenesis (such as phlegm-heat + blood deficiency + liver stagnation); (2) slow onset and incomplete coverage of symptoms; (3) traditional Wendan decoction, (1) insufficient anxiolytic effect (lack of Suanzaoren and Hehuanhua); (2) no yin-nourishing and blood-nourishing effect (lack of Danggui and Shengdi); (4) drugs specifically for anxiolytic drugs, (1) often ignore the correlation between gastrointestinal function and emotion; (2) liver-soothing drugs mostly use Chaihu (which easily consumes qi) and rarely use Foshou and Shanzha in combination.

[0003] In view of the deficiencies of the prior art, the present application utilizes the interaction between the components: Wendan decoction (Banxia, Citrus aurantium, Zhuru, Chenpi and Fuling) to clear phlegm-heat; Suanzaoren, Renshen, Hehuanhua and Shouwuteng to nourish the heart, calm the mind and relieve depression; Danggui and Shengdi to nourish blood and yin; Foshou to soothe the liver and regulate qi; Shanzha to promote digestion and invigorate the stomach (stomach discomfort leads to sleeplessness); and Gancao to harmonize the drugs, thereby obtaining a traditional Chinese medicine composition that has a synergistic therapeutic effect on complex diseases (phlegm-heat + heart and mind deficiency + liver stagnation / blood deficiency), which is more comprehensive and has fewer side effects than single syndrome type drugs or western medicine. SUMMARY

[0004] The present application aims to provide a traditional Chinese medicine composition for treating psychosomatic diseases of phlegm-heat disturbing the heart and a preparation method thereof.

[0005] The present application is achieved by the following technical solutions:

[0006] The present application relates to a traditional Chinese medicine composition for treating psychosomatic diseases of phlegm-heat disturbing the heart, which comprises: a phlegm-heat clearing component 55g, a mind-calming and depression-relieving component 59g, a blood and yin nourishing component 20g, a liver-soothing and stomach-regulating component 22g, and a drug harmonizing component (Gancao) 6g.

[0007] Preferably, the phlegm-heat clearing component 55g comprises: Jiangbanxia 9g, Citrus aurantium 6g, Zhuru 20g (an amount exceeding the normal amount), Fuling 10g and Chenpi 10g.​

[0008] The shenjiejudu component 59g: 9g of radix polygalae + 20g of fried jujube kernel (high-dose synergism) + 15g of flos albizziae + 15g of radix polygoni multiflori; the blood nourishing and yin tonifying component 20g: 10g of angelica sinensis + 10g of radix rehmanniae; the liver and stomach soothing component 22g: 10g of bergamot (instead of bupleurum) + 12g of hawthorn (food digestion and sleep aid).

[0009] The components and interactions of the present application are as follows:

[0010] Bamboo 20g, breakthrough heat phlegm, inhibit nerve excitement;

[0011] Fried jujube kernel 20g, significantly improve the sedative and hypnotic effect;

[0012] Hawthorn 12g, synergistic calming + regulating gastrointestinal motility;

[0013] Bergamot 10g, soothing liver without damaging yin, long-term safety advantage.

[0014] Bamboo 20g (clearing heat phlegm) + 10g of angelica sinensis / 10g of radix rehmanniae (yin blood protection), significantly improve the phlegm heat clearance rate without increasing yin deficiency;

[0015] Hawthorn 12g activates Ghrelin (hunger hormone) to promote gastrointestinal peristalsis, while increasing the level of GABA in the brain → achieve "stomach and sleep security";

[0016] Bergamot 10g instead of bupleurum → soothing liver and relieving depression equivalent, but without dry mouth and fatigue and other side effects.

[0017] The present application also relates to the preparation method of the aforementioned traditional Chinese medicine composition for treating psychosomatic disease of phlegm-heat disturbing type, comprising the following steps:

[0018] Step 1, water extraction: all medicinal materials are soaked in 10 times the amount of water for 30 min, decocted twice, and the filtrates are combined;

[0019] Step 2, concentration: concentrated under reduced pressure to a relative density;

[0020] Step 3, drying: spray drying to obtain dry extract powder;

[0021] Step 4, preparation molding:

[0022] Granules: the extract powder and dextrin are proportioned, granulated, and dried;

[0023] Capsules: 0.4g / grain (equivalent to 5g of crude drug) is filled;

[0024] The medicinal materials include: 9g of ginger and pinellia, 6g of immature bitter orange, 20g of bamboo shavings, 10g of poria, 10g of dried tangerine peel, 9g of polygala, 20g of stir-fried spinach seeds, 15g of jujube flowers, 15g of Polygonum multiflorum, 10g of angelica, 10g of raw rehmannia, 10g of bergamot, 12g of hawthorn, and 6g of roasted liquorice. The effects of each component are shown in Table 1:

[0025] Table 1

[0026]

[0027]

[0028] In terms of insomnia: the present invention combines 20g of stir-fried Chinese jujube seeds, 15g of julibrissin flowers, and 15g of Polygonum multiflorum vine to calm the mind, and 20g of bamboo shavings to clear phlegm and heat and aid sleep, which has a significant effect in treating insomnia. Compared with traditional drugs for treating insomnia, the sleep latency period is shortened by ≥40% after using the present invention (the average of Western medicine is 30%), and there is no side effect of drowsiness the next day.

[0029] Anxiety / depression: The present invention combines 10g of bergamot to soothe the liver, 9g of polygala to relieve depression, and 12g of hawthorn to regulate brain-gut peptides. Compared with traditional drugs for treating anxiety / depression, the HAMA anxiety score is reduced by 50% after using the present invention (SSRIs take 4 weeks to take effect, while this prescription takes 2 weeks).

[0030] In terms of gastrointestinal dysfunction: the present invention combines Wen Dan Tang (ginger and pinellia + immature bitter orange + dried tangerine peel) to resolve phlegm stagnation, and bergamot + hawthorn to promote gastrointestinal motility. Compared with traditional drugs for treating gastrointestinal dysfunction, the abdominal distension relief rate after using the present invention is 91% (the Western medicine mosapride is only 68%).

[0031] In terms of Yin deficiency and blood deficiency: the present invention combines 10g of Angelica sinensis and 10g of Rehmannia glutinosa to nourish Yin and blood, offsetting the dryness of expectorant drugs. Compared with traditional drugs for treating Yin deficiency and blood deficiency, the frequency of menopausal hot flashes is reduced by 60% after using the present invention.

[0032] Menopausal women (symptoms: insomnia + hot flashes + abdominal distension) who used the present invention achieved a total effective rate of 91.3% (estrogen replacement therapy is only 76% and increases the risk of thrombosis).

[0033] After using the present invention, the symptom score of people with high pressure in the workplace (symptoms: anxiety insomnia + functional dyspepsia) decreased by ≥50% within 2 weeks, and there was no rebound after stopping the drug;

[0034] After using the present invention, the fatigue scale (FSS) score of chronic fatigue syndrome (symptoms: fatigue + mood disorder + gastrointestinal disorder) improved by 64% (38% in the Western medicine group).

[0035] The above components of the present invention are indispensable for the following reasons:

[0036] (1) After removing bergamot / crataegus pinnatifida, the improvement rate of gastrointestinal symptoms decreased by 42%; after removing angelica / radix rehmanniae, the recurrence rate of insomnia increased by 35%;

[0037] (2) When the dosage of bamboo shavings is less than 15 g, the elimination rate of phlegm-heat symptoms is less than 50%;

[0038] (3) When the amount of jujube seeds is less than 15g, the improvement of sleep efficiency is less than 30%.

[0039] Preferably, in step 1, the first decoction time is 1.5 hours, and the second decoction time is 1 hour.

[0040] Preferably, in step 2, the relative density is 1.10-1.15 and the temperature is 60°C.

[0041] Preferably, in step 3, the inlet air temperature of the spray drying is 180°C and the outlet air temperature is 85°C.

[0042] Preferably, in step 4, the extract powder and dextrin are used in a ratio of 1:1.5.

[0043] Preferably, in step 4, the drying temperature is 60°C.

[0044] The invention is applicable to various modern dosage forms such as granules and oral liquids, and the decoction rate of active ingredients (such as spinosin and bamboo shavings flavonoids) is ≥90%.

[0045] The present invention is an extended prescription of "Wendantang" (resolving phlegm and clearing heat), which integrates the medicine group for calming the mind and relieving depression (sonan jujube seeds, polygala tenuifolia, julibrissin flowers, and Polygonum multiflorum) and the medicine group for nourishing blood and soothing the liver (angelica sinensis, raw rehmannia, and bergamot), and adds hawthorn to promote digestion.

[0046] The invention avoids conventional liver-soothing drugs (such as bupleurum) and instead uses bergamot + hawthorn + warming gallbladder decoction to regulate qi, resolve phlegm and promote digestion, and is combined with blood-nourishing and moisturizing drugs (angelica and rehmannia), which is more suitable for patients with spleen deficiency, phlegm and dampness or liver-stomach disharmony.

[0047] The present invention includes four major modules: ① Wen Dan Tang (resolving phlegm and clearing heat) + ② Ziziphus jujuba seeds / Polygala tenuifolia / Albizia julibrissin flowers / Polygonum multiflorum (calming the mind and relieving depression) + ③ Angelica sinensis / Rehmannia glutinosa (nourishing yin and blood) + ④ Citron / Hawthorn (soothing the liver and promoting digestion); the key dosage difference: the dosage of Rhizoma Anemarrhenae (20g), stir-fried Ziziphus jujuba seeds (20g) and Hawthorn (12g) is significantly higher than that of the conventional combination.

[0048] The present invention has the following advantages:

[0049] (1) The formula of the present invention utilizes the interaction between the various components: Wen Dan Tang (Pinellia tuber, Citrus aurantium, Rhizoma Anemarrhenae, Citrus reticulatae, Poria) clears phlegm and heat; stir-fried Ziziphus jujuba seeds, Polygala tenuifolia, Flos albizziae, and Polygonum multiflorum nourish the heart, calm the mind, and relieve depression; Angelica sinensis and Rehmannia root nourish the blood and nourish yin; Buddha's hand soothes the liver and regulates qi; Hawthorn fruit helps digestion and strengthens the stomach (a disharmony in the stomach leads to restlessness); and Licorice harmonizes. The composition obtained by the present invention under the above-mentioned proportions of the various components has a synergistic therapeutic effect on complex diseases (phlegm and heat + malnutrition of the mind + liver depression / blood deficiency), and is more comprehensive and has fewer side effects than single-syndrome medication or Western medicine.

[0050] (2) The formula of the present invention utilizes the interaction between the various components: tranquilizing and anti-depressant drugs (Ziziphus jujuba seeds, Polygala tenuifolia, Albizia julibrissin flowers, Polygonum multiflorum vine) regulate mood; Qi-regulating, phlegm-resolving and stomach-regulating drugs (Wendan decoction + Buddha's hand + Crataegus pinnatifida) directly improve gastrointestinal motility and digestive function; Angelica sinensis and Rehmannia root nourish blood and soften the liver; thus, it becomes a combination with a synergistic mechanism of "regulating emotions" and "harmony of the spleen and stomach", which can more comprehensively improve the psychosomatic symptoms in the state of anxiety.

[0051] (3) The present invention is a treatment plan for functional dyspepsia with specific TCM syndromes such as "liver-stomach disharmony", "heart-spleen deficiency" or "phlegm-heat disturbing the heart", and utilizes the interaction between the various components: Wen Dan Tang + Buddha's hand + Hawthorn can regulate qi and resolve phlegm, harmonize the stomach and promote digestion; the tranquilizing and relieving depression medicine group can relieve emotional symptoms; Angelica sinensis and Rehmannia glutinosa have a nourishing effect on the gastrointestinal mucosa; its dual-target effect of regulating gastrointestinal function and emotional center is integrated to prepare a Chinese medicine composition that can improve dyspepsia symptoms (such as abdominal distension, belching, and poor appetite) while effectively alleviating accompanying emotional problems such as anxiety and insomnia.

[0052] (4) The formula of the present invention utilizes the interaction between the various components to calm the mind, relieve depression, nourish yin and blood (Danggui, Shengdi), regulate qi and harmonize the stomach, and strengthen the spleen (Poria), etc., to obtain a traditional Chinese medicine composition that can comprehensively improve the various symptoms of menopausal syndrome or chronic fatigue syndrome such as insomnia, anxiety, palpitations, gastrointestinal dysfunction, fatigue, etc. DETAILED DESCRIPTION

[0053] The present invention will be described in detail below with reference to specific embodiments. It should be noted that the following embodiments are only for further explanation of the present invention, but the protection scope of the present invention is not limited to the following embodiments.

[0054] Example 1

[0055] This embodiment relates to a traditional Chinese medicine composition for treating phlegm-heat internal disturbance type psychosomatic co-morbidity, comprising: 9g of ginger and pinellia, 6g of immature bitter orange, 20g of bamboo shavings, 10g of poria, 10g of dried tangerine peel, 9g of polygala, 20g of stir-fried spiny jujube seeds, 15g of julibrissin flower, 15g of Polygonum multiflorum vine, 10g of angelica, 10g of raw rehmannia, 10g of citron, 12g of hawthorn, and 6g of roasted liquorice.

[0056] This embodiment also relates to a method for preparing the aforementioned Chinese medicine composition for treating phlegm-heat internal disturbance type psychosomatic co-morbidity, comprising the following steps:

[0057] Step 1, water extraction: add 10 times the amount of water to all the medicinal materials, soak for 30 minutes, decoct twice, and combine the filtrates;

[0058] Step 2, concentration: concentrate under reduced pressure to a relative density;

[0059] Step 3, drying: spray drying to obtain dry extract powder;

[0060] Step 4: Forming the preparation.

[0061] In step 1, the first decoction time is 1.5 hours, and the second decoction time is 1 hour.

[0062] In step 2, the relative density is 1.10-1.15 and the temperature is 60°C.

[0063] In step 3, the inlet air temperature of the spray drying is 180°C and the outlet air temperature is 85°C.

[0064] The Chinese medicine composition for treating phlegm-heat internal disturbance type psychosomatic co-morbidity prepared in the above example was tested:

[0065] (1) Quality control standards, see Table 2:

[0066] Table 2

[0067] Ingredients Detection method Content standard Spinonin HPLC ≥1.8mg / g (from Zizyphus jujuba) Bamboocaulis flavone UV ≥3.5％ Hesperidin TLC Positive detection (marker of Pericarpium Citri Reticulatae)

[0068] (2) Technical effect verification

[0069] (1) Pharmacodynamics experiments

[0070] Insomnia model:

[0071] Mice were injected intraperitoneally with p-chlorophenylalanine (PCPA) to establish the model and were divided into groups and given the drug for 7 days;

[0072] Observation indicators: sleep onset latency and sleep duration in the prescription group.

[0073] Results: The Chinese medicine composition of the present invention shortened the sleep latency by 52% (vs. the model group) and increased the sleep duration by 120% (P < 0.01).

[0074] Gastrointestinal motility test:

[0075] Rats were gavaged with loperamide hydrochloride to establish the model and measure the gastric emptying rate;

[0076] Result indicators: Gastric emptying rate of this prescription group.

[0077] Results: The gastric emptying rate of the traditional Chinese medicine composition involved in the present application is 89% (the cisapride group is 76%, P<0.05).

[0078] (3) Clinical trials

[0079] Subjects: 218 cases of insomnia with gastrointestinal dysfunction of phlegm-heat disturbing the interior (diagnostic criteria: DSM-5+TCM syndrome score);

[0080] Grouping:

[0081] Test group (n=109): one dose of the granules of the present application per day;

[0082] Control group (n=109): 1mg of estazolam per night + 5mg of mosapride per time, 3 times per day;

[0083] Course of treatment: 4 weeks.

[0084] Evaluation index: the improvement rates of PSQI sleep quality score, abdominal distension symptom score, and HAMA anxiety score of the experimental group and the control group, as shown in Table 3.

[0085] Table 3

[0086]

[0087]

[0088] The traditional Chinese medicine composition for treating psychosomatic diseases of phlegm-heat disturbing the interior prepared in Example 1 is applied clinically:

[0089] Subjects: 62 cases of insomnia with functional dyspepsia of phlegm-heat disturbing the interior (TCM syndrome score≥15);

[0090] Method of use: one dose per day, taken in the morning and evening, with a course of treatment of 4 weeks;

[0091] Evaluation index: the improvement rates of PSQI sleep score, abdominal distension frequency (times per day), and serum GABA (μg / ml) before and after treatment, as shown in Table 4.

[0092] Table 4

[0093] Index Mean before treatment Mean after treatment Improvement rate PSQI sleep score 16.8±2.1 7.2±1.8★ 57.1％ Abdominal distension frequency (times / day) 5.3±1.2 1.1±0.6★ 79.2％ Serum GABA (μg / ml) 75.3±12.4 128.6±15.2★ 70.8％ (★P<0.01 vs before treatment)

[0094] Example 2

[0095] This example relates to the preparation and quality standards of granules

[0096] I. Preparation process:

[0097] Extraction: mix the medicinal materials, decoct with 12 times the amount of water for 2 times (1.5h for the first time and 1h for the second time), and filter;

[0098] Concentration: Combine the filtrates and concentrate under reduced pressure to an extract with a relative density of 1.25 (60°C);

[0099] Drying: add dextrin to the extract (1:1.5), spray dry (inlet air 180℃, outlet air 85℃), and granulate.

[0100] The medicinal materials include: 9g of ginger and pinellia, 6g of immature bitter orange, 20g of bamboo shavings, 10g of poria, 10g of dried tangerine peel, 9g of polygala, 20g of stir-fried jujube seeds, 15g of julibrissin flower, 15g of Polygonum multiflorum vine, 10g of angelica, 10g of raw rehmannia, 10g of bergamot, 12g of hawthorn, and 6g of roasted licorice.

[0101] 2. Quality Control:

[0102] Identification:

[0103] Hesperidin (from dried tangerine peel) and spinosin (from jujube seeds) were detected by TLC;

[0104] Content determination: Detect the content of spinosum and total flavonoids in bamboo shavings.

[0105] Example 3

[0106] This example involves capsule preparation and pharmacodynamics experiments

[0107] 1. Preparation process

[0108] Prepare dry extract powder according to the method of Example 2;

[0109] 0.5% magnesium stearate was added and the capsules were filled (0.4 g per capsule, equivalent to 5 g of crude drug).

[0110] 2. Efficacy Verification (Animal Experiment)

[0111] Insomnia model rats (n=40): The sleep latency and sleep duration of the blank control group, model group, low-dose of this prescription (1.8 g / kg), high-dose of this prescription (3.6 g / kg) and estazolam group (1 mg / kg) were compared. The results are shown in Table 5.

[0112] Table 5

[0113]

[0114] Example 4

[0115] This example involves oral liquid preparation and stability test

[0116] 1. Preparation process:

[0117] The mixture was decocted and concentrated to a ratio of 1:1 (g crude drug / ml) according to the method of Example 1; 0.1% potassium sorbate and 5% honey were added for flavor correction, the pH value was adjusted to 4.5-6.5, and the mixture was filled and sterilized (100°C, 30 minutes).

[0118] Quality control methods

[0119] Properties: Brown liquid, slightly fragrant, slightly bitter taste

[0120] pH value: 4.5~6.5

[0121] Relative density: not less than 1.05

[0122] Identification: TLC method to identify the main medicinal flavors (such as jujube seeds, angelica, etc.)

[0123] Content determination: HPLC method was used to determine the content of the main active ingredients (such as jujuboside A and B)

[0124] 2. Conduct accelerated stability test.

[0125] Stability test design

[0126] 1. Influencing factors test

[0127] High temperature test: Place at 60℃ for 10 days, and take samples for testing at 0, 5 and 10 days;

[0128] High humidity test: Place under 25℃, RH90%±5% for 10 days, and take samples for testing at 0, 5 and 10 days;

[0129] Strong light irradiation test: Place under 4500±500Lx conditions for 10 days, and take samples for testing at 0, 5, and 10 days;

[0130] 2. Accelerated testing

[0131] Place under the conditions of 40℃±2℃ and 75%±5% relative humidity for 6 months;

[0132] Sampling and testing were conducted at the end of 0, 1, 2, 3, and 6 months;

[0133] 3. Long-term trials

[0134] Place under the conditions of temperature 25℃±2℃ and relative humidity 60%±10% for 24 months;

[0135] Sampling and testing were conducted at the end of 0, 3, 6, 9, 12, 18, and 24 months;

[0136] 4. Detection indicators

[0137] Physical indicators: appearance, pH value, relative density, clarity;

[0138] Chemical indicators: content of main active ingredients and related substances;

[0139] Microbial indicators: limit inspection of bacteria, mold, E. coli, etc.

[0140] The formula of the present invention utilizes the interaction between the various components to achieve multiple effects, such as calming the mind, relieving depression, nourishing yin and blood (angelica, raw rehmannia), regulating qi and harmonizing the stomach, and strengthening the spleen (poria), thereby obtaining a traditional Chinese medicine composition that can comprehensively improve multiple symptoms such as insomnia, anxiety, palpitations, gastrointestinal dysfunction, fatigue, etc., exhibited by patients with menopausal syndrome, people under high pressure in the workplace, or chronic fatigue syndrome.

[0141] The above describes the specific embodiments of the present invention. It should be understood that the present invention is not limited to the above specific embodiments, and those skilled in the art may make various variations or modifications within the scope of the claims, which do not affect the essence of the present invention.

Claims

1. A Chinese medicine composition for treating phlegm-heat internal disturbance type psychosomatic comorbidity, characterized in that: include: 55g of phlegm-resolving and heat-clearing components, 59g of tranquilizing and relieving depression components, 20g of blood-nourishing and yin-invigorating components, 22g of liver-soothing and stomach-regulating components, and 6g of harmonizing drugs.

2. The Chinese medicine composition for treating phlegm-heat internal disturbance type psychosomatic comorbidity according to claim 1, characterized in that: The phlegm-resolving and heat-clearing component 55g: 9g of ginger and pinellia + 6g of immature bitter orange + 20g of bamboo shavings + 10g of poria + 10g of dried tangerine peel; the calming and depression-relieving component 59g: 9g of polygala + 20g of stir-fried spinach seeds + 15g of julibrissin flowers + 15g of Polygonum multiflorum; the blood-nourishing and yin-nourishing component 20g: 10g of angelica + 10g of raw rehmannia; the liver-soothing and stomach-regulating component 22g: 10g of bergamot + 12g of hawthorn.

3. The Chinese medicine composition for treating phlegm-heat internal disturbance type psychosomatic comorbidity according to claim 1, characterized in that: The harmonizing medicine is prepared by roasting liquorice.

4. A method for preparing the Chinese medicine composition for treating phlegm-heat internal disturbance type psychosomatic comorbidity according to claim 1, characterized in that: The following steps are involved: Step 1, water extraction: add 10 times the amount of water to all the medicinal materials, soak for 30 minutes, decoct twice, and combine the filtrates; Step 2, concentration: concentrate under reduced pressure to a relative density; Step 3, drying: spray drying to obtain dry extract powder; Step 4, preparation molding: Granules: mix extract powder and dextrin in proportion, granulate and dry; Capsules: filling 0.4g / capsule; Among them, the medicinal materials include: 9g of ginger and pinellia, 6g of immature bitter orange, 20g of bamboo shavings, 10g of poria, 10g of dried tangerine peel, 9g of polygala, 20g of stir-fried jujube seeds, 15g of julibrissin flower, 15g of Polygonum multiflorum vine, 10g of angelica, 10g of raw rehmannia, 10g of bergamot, 12g of hawthorn, and 6g of roasted licorice.

5. The method for preparing the Chinese medicine composition for treating phlegm-heat internal disturbance type psychosomatic co-morbidity according to claim 4, characterized in that: In step 1, the first decoction time is 1.5 hours, and the second decoction time is 1 hour.

6. The method for preparing the Chinese medicine composition for treating phlegm-heat internal disturbance type psychosomatic co-morbidity according to claim 4, characterized in that: In step 2, the relative density is 1.10-1.15 and the temperature is 60°C.

7. The method for preparing the Chinese medicine composition for treating phlegm-heat internal disturbance type psychosomatic co-morbidity according to claim 4, characterized in that: In step 3, the inlet air temperature of the spray drying is 180°C and the outlet air temperature is 85°C.

8. The method for preparing the Chinese medicine composition for treating phlegm-heat internal disturbance type psychosomatic co-morbidity according to claim 4, characterized in that: In step 4, the extract powder and dextrin are used in a ratio of 1:1.

5.

9. The method for preparing the Chinese medicine composition for treating phlegm-heat internal disturbance type psychosomatic comorbidity according to claim 4, characterized in that: In step 4, the drying temperature is 60°C.

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