Application of traditional Chinese medicine composition in preparation of medicine for treating depression

Abstract

The invention relates to an application of a traditional Chinese medicine composition in preparation of a medicament for treating depression, which is characterized in that the traditional Chinese medicine composition is prepared from ginseng, rehmannia, cistanche, salvia miltiorrhiza, polygala tenuifolia, rhizoma acori graminei and curcuma aromatica. The composition can obviously improve the depression-like behavior of a depression model mouse, improve the level of nutritional factors in the brain of the depression model mouse and reduce the level of pro-inflammatory cytokines of the depression model mouse, and has a good treatment effect on depression.

Description

Technical Field

[0001] The invention belongs to the technical field of traditional Chinese medicines, relates to a new use of a traditional Chinese medicine composition, and specifically relates to an application of the traditional Chinese medicine composition in the preparation of a drug for depression. Background Art

[0002] Depression is a common and serious mental illness characterized by persistent low mood, loss of interest or pleasure, and accompanied by significant changes in cognitive, behavioral, and physiological symptoms. Its etiology is complex, involving the interaction of multiple factors such as genetics, biology, psychology, and social environment. Studies have shown that dysfunction of neurotransmitters (such as serotonin, norepinephrine, and dopamine) in the brains of patients with depression, as well as overactivation of the hypothalamic-pituitary-adrenal axis (HPA axis), play an important role in the occurrence and development of the disease. In addition, psychosocial factors such as chronic stress, traumatic events, and lack of social support are also considered to be important causes of depression.

[0003] The diagnosis of depression is mainly based on the assessment of clinical symptoms. The diagnostic criteria for mental illnesses currently widely used internationally include the Diagnostic and Statistical Manual of Mental Disorders (DSM) and the International Classification of Diseases (ICD). Treatments for depression mainly include medication, psychotherapy, and physical therapy. Antidepressants improve symptoms by regulating the levels of neurotransmitters in the brain, while psychotherapy focuses on helping patients identify and change negative thinking patterns and behaviors. In recent years, physical therapy methods such as transcranial magnetic stimulation (TMS) and vagus nerve stimulation (VNS) have also been gradually applied in clinical practice, providing new treatment options for patients with depression. However, due to the heterogeneity and complexity of depression, the formulation and long-term management of individualized treatment plans remain clinical challenges. Summary of the invention

[0004] The first object of the present invention is to provide a traditional Chinese medicine composition for depression. The second object of the present invention is to provide a method for preparing the traditional Chinese medicine composition. The third object of the present invention is to provide an application of the traditional Chinese medicine composition.

[0005] According to the first aspect of the present invention, a Chinese medicine composition for depression is provided, wherein the main active ingredients thereof include, by weight: 1-100 parts of ginseng, 1-100 parts of rehmannia root, 1-100 parts of cistanche deserticola, 1-100 parts of salvia miltiorrhiza, 1-100 parts of polygala tenuifolia, 1-100 parts of calamus, and 1-100 parts of curcuma. The composition of the present invention can be directly ground into powder, or it can be an extract prepared by conventional means in the art. The Chinese medicine used in the composition of the present invention can also be used in the form of direct grinding into powder, extract, or other processed forms.

[0006] The preferred weight ratio is: 9-36 parts of ginseng, 20-80 parts of rehmannia root, 20-80 parts of cistanche deserticola, 9-36 parts of salvia miltiorrhiza, 9-36 parts of polygala tenuifolia, 9-36 parts of calamus tatarinowii, and 9-36 parts of curcuma.

[0007] Optionally, the Chinese medicine composition consists of the following components: 9-10 parts of ginseng, 18-20 parts of rehmannia root, 18-20 parts of cistanche deserticola, 9-10 parts of salvia miltiorrhiza, 9-10 parts of polygala tenuifolia, 9-10 parts of calamus tatarinowii, and 9-10 parts of curcuma.

[0008] In some embodiments, the main active ingredients include, by weight: 9 parts of ginseng, 20 parts of rehmannia root, 20 parts of cistanche deserticola, 9 parts of salvia miltiorrhiza, 9 parts of polygala tenuifolia, 9 parts of calamus tatarinowii, 9 parts of curcuma aromatica

[0009] In some embodiments, pharmaceutically acceptable adjuvants are also included. Specifically, the adjuvants used are carriers or excipients commonly used in the art, including but not limited to starch, lactose, glucose, sodium carboxymethyl cellulose, ethyl cellulose, methyl cellulose, malt, gelatin, polyols (such as propylene glycol, glycerol, mannitol), compressed tablets, etc., to help improve the stability or activity of the drug, or produce an acceptable taste or smell in the case of oral administration.

[0010] In some embodiments, the Chinese medicine composition can be prepared as granules, decoctions, tablets, capsules, oral liquids or dripping pills, etc., so as to facilitate clinical administration.

[0011] According to a second aspect of the present invention, a method for preparing the above-mentioned Chinese medicine composition for depression is provided, and the preparation method comprises the following steps:

[0012] The raw medicinal materials are mixed according to the proportion, and 8 times the amount of water is added to soak for 1 hour, and the volatile oil is extracted once for 5 hours. The volatile oil is extracted and collected by ethyl acetate, and the ethyl acetate solution of the volatile oil and the extract are stored in separate containers for standby use; the ethyl acetate solution of the volatile oil is recovered at low temperature to obtain the volatile oil, which is stored in separate containers for standby use; the obtained volatile oil is ground and included with 10 times the amount of β-cyclodextrin and 20 times the amount of water, and is dried and crushed to obtain a volatile oil inclusion compound for standby use; the remaining five flavors are decocted with water twice, each time for 1 hour, filtered, and the filtrate is combined, and the filtrate is combined with the medicinal solution after the volatile oil is extracted, and concentrated into a clear paste with a relative density of 1.08-1.10 (70±5°C), ethanol is added until the alcohol content reaches 70%, and the mixture is refrigerated and allowed to stand for more than 12 hours, filtered, and the ethanol is recovered, and the mixture is concentrated into a thick paste with a relative density of 1.25-1.30 (70±5°C).

[0013] Furthermore, when the Chinese medicine composition is a granule, dextrin, stevioside and inclusion compound fine powder can be added to the above composition for fluidized bed granulation, coating and drying to obtain the granule.

[0014] According to the third aspect of the present invention, there is provided the use of the above-mentioned Chinese medicine composition for depression in the preparation of a drug for treating depression, wherein the use may be any method that is beneficial to improving the corresponding symptoms of the patient, including treatment or prevention.

[0015] Specifically, the Chinese medicine composition consists of the following components in parts by mass: 1-100 parts of ginseng, 1-100 parts of rehmannia root, 1-100 parts of cistanche deserticola, 1-100 parts of salvia miltiorrhiza, 1-100 parts of polygala tenuifolia, 1-100 parts of calamus tatarinowii, and 1-100 parts of curcuma.

[0016] The preferred weight ratio is: 9-36 parts of ginseng, 20-80 parts of rehmannia root, 20-80 parts of cistanche deserticola, 9-36 parts of salvia miltiorrhiza, 9-36 parts of polygala tenuifolia, 9-36 parts of calamus tatarinowii, and 9-36 parts of curcuma.

[0017] Optionally, the Chinese medicine composition consists of the following components: 9-10 parts of ginseng, 18-20 parts of rehmannia root, 18-20 parts of cistanche deserticola, 9-10 parts of salvia miltiorrhiza, 9-10 parts of polygala tenuifolia, 9-10 parts of calamus tatarinowii, and 9-10 parts of curcuma.

[0018] In some embodiments, the composition comprises: 9 parts of ginseng, 20 parts of rehmannia root, 20 parts of cistanche deserticola, 9 parts of salvia miltiorrhiza, 9 parts of polygala tenuifolia, 9 parts of calamus tatarinowii, and 9 parts of curcuma aromatica.

[0019] Furthermore, when the drug is selected from granules, the preparation method thereof comprises the following steps:

[0020] Mix the raw medicinal materials according to the proportion, add 8 times the amount of water to soak for 1 hour, extract the volatile oil once, the extraction time is 5 hours, and collect the volatile oil by ethyl acetate extraction. The ethyl acetate solution of the volatile oil and the extract are stored in separate containers for standby use; the ethyl acetate solution of the volatile oil is recovered at low temperature to obtain the volatile oil, which is stored in another container for standby use; the obtained volatile oil is ground and included with 10 times the amount of β-cyclodextrin and 20 times the amount of water, dried and crushed to obtain the volatile oil inclusion compound for standby use; the remaining five flavors are added with water Decoction twice, each time for 1 hour, filter, combine the filtrate, combine the filtrate with the medicinal solution after extracting volatile oil, concentrate into a clear paste with a relative density of 1.08-1.10 (70±5°C), add ethanol until the alcohol content reaches 70%, refrigerate and stand for more than 12 hours, filter, recover ethanol, concentrate into a thick paste with a relative density of 1.25-1.30 (70±5°C), add dextrin, stevioside, and inclusion compound fine powder to carry out fluidized bed granulation, coating, drying, and the product is obtained.

[0021] The composition of the present invention can significantly increase the amount of central area movement of depression model mice in an open field, shorten the immobility time of tail suspension of depression model mice, improve the novel exploration behavior of the cross elevated maze of depression mice, increase the BDNF content in the brain, and reduce the content of IL-1β and IL-6, two proinflammatory cytokines, in depression mice. It is suggested that the Chinese medicine composition can significantly improve depressive-like mood, increase brain tissue nutritional factors, inhibit the release of proinflammatory factors, and has a good therapeutic effect on depression. DETAILED DESCRIPTION

[0022] As mentioned above, the present invention aims to provide a use of a Chinese medicine composition in the preparation of a drug for depression. The following will be described in detail in conjunction with the content of a specific experiment.

[0023] The following experiments, if no specific conditions are specified, are conducted under conventional conditions or conditions recommended by the manufacturer. The raw materials or excipients used, as well as the reagents or instruments used, if the manufacturer is not specified, are all conventional products that can be purchased commercially. Unless otherwise specified, all percentages, ratios, proportions or parts are by weight. Unless otherwise specified, the medicinal materials of the present invention can be raw products or processed products thereof without significantly affecting the overall effect of the prescription.

[0024] Unless otherwise defined, all professional and scientific terms used herein have the same meanings as those familiar to those skilled in the art. In addition, any methods and materials similar or equivalent to those described herein can be applied to the present invention.

[0025] Example 1 Preparation of Chinese medicine composition

[0026] The Chinese medicine composition granule is prepared from the following raw materials in parts by weight: 300g of ginseng, 666g of rehmannia root, 666g of cistanche deserticola, 300g of salvia miltiorrhiza, 300g of polygala tenuifolia, 300g of calamus tatarinowii and 300g of curcuma aromatica.

[0027] The above raw medicinal materials are mixed according to the proportion, 8 times the amount of water is added to soak for 1 hour, the volatile oil is extracted once, the extraction time is 5 hours, the volatile oil is extracted and collected by ethyl acetate, the volatile oil ethyl acetate solution and the extract are stored in separate containers for standby use; the volatile oil ethyl acetate solution is recovered at low temperature to obtain the volatile oil, which is stored in another container for standby use; the obtained volatile oil is ground and included with 10 times the amount of β-cyclodextrin and 20 times the amount of water, dried and crushed to obtain the volatile oil inclusion compound for standby use; the remaining five flavors are decocted in water for two times, each time for 1 hour, filter, combine the filtrate, combine the filtrate with the medicinal solution after extracting volatile oil, concentrate it into a clear paste with a relative density of 1.08-1.10 (70±5°C), add ethanol until the alcohol content reaches 70%, refrigerate and stand for more than 12 hours, filter, recover ethanol, and concentrate it into a thick paste with a relative density of 1.25-1.30 (70±5°C) to obtain a traditional Chinese medicine composition, add dextrin, stevioside, and inclusion compound fine powder to carry out fluidized bed granulation, coating, and drying to obtain the traditional Chinese medicine composition.

[0028] Experimental Example 2 Therapeutic Effect of Chinese Medicine Composition on Depression-like Behavior of Mice Induced by CUMS 1. Experimental Materials

[0029] 1.1 Animals

[0030] BALB / C mice, SPF grade, 60 mice, weighing 19-21 g, half male and half female.

[0031] Rearing environment: room temperature 20-26℃, relative humidity controlled at 40-70%. Males and females were reared in separate cages, 5 per cage / sex / group.

[0032] 1.2 Drugs

[0033] The Chinese medicine composition prepared in Example 1, Jiangsu Kangyuan Pharmaceutical Co., Ltd.; Fluoxetine hydrochloride capsules (20 mg / capsule, Eli Lilly Suzhou Pharmaceutical Co., Ltd.).

[0034] 1.3 Instruments

[0035] Electronic balance (Sartorius Scientific Instruments, model BS224S). SuperMzaze analysis system, open field box, elevated plus maze, and forced swimming apparatus were all from Shanghai Xinruan Information Technology Co., Ltd.

[0036] 2. Dosage design

[0037] The daily dosage of the Chinese medicine composition is 85g of crude drug / day. According to the body surface area conversion method, the equivalent dose for mice is 85g / 60kg*12.3=17.43g of crude drug / kg. According to the 1 / 4:1 / 2:1 dosing method, the low dose is 4.36g of crude drug / kg and the medium dose is 8.71g of crude drug. Oral administration, 0.2mL / 10g, once a day.

[0038] The daily dosage of fluoxetine hydrochloride is 20 mg / day. According to the body surface area conversion method, the equivalent dose for mice is 20 mg / 60 kg*12.3=4.1 mg / kg. Oral administration, 0.2 mL / 10 g, once a day.

[0039] 3. Experimental Methods

[0040] 3.1 Model construction

[0041] Chronic unpredictable stress (CUMS) is currently the most common way to make depression model mice. Mice can induce obvious depressive-like behaviors in a series of chronic unpredictable mild stress. In this study, a total of 14 stress conditions were randomly combined, and 2 stress methods were selected every day for 28 days. The 14 stress conditions were fasting for 24 hours, water deprivation for 24 hours, 45-degree tilted cage for 24 hours, day and night reversal, all-night light for 12 hours, wet bedding for 24 hours, bedding removal for 24 hours, noise for 1 hour (100 decibels), foot shock for 1 hour (0.8mA, 5s / min), tail clamping for 1 minute, suspension for 30 minutes, vibration cage for 1 hour (220r / min), body restraint for 2 hours, cold water swimming for 6 minutes. The specific experimental arrangements are shown in Table 1.

[0042] Table 1 Chronic unpredictable stress experimental process

[0043]

[0044]

[0045] 3.2 Behavioral testing

[0046] (1) Open field test:

[0047] The open field test is a classic unconditioned reflex model, which is currently widely used to study the neuropsychiatric conditions of rodents, mainly to test anxiety behavior and autonomous exploratory behavior in a new environment. The mouse to be tested is gently placed in the center area of ​​the open field. The specifications of the open field are 50cm×50cm×50cm, and the bottom is divided into 16 small grids (12.5cm×12.5cm), with 4 small grid areas in the center of the central area. The autonomous activity of the mouse is automatically recorded for 10 minutes by the video capture and analysis system. The SuperMzaze software is used to automatically obtain the activity time of each mouse in the central area of ​​the open field as analysis data.

[0048] (2) Elevated plus maze test:

[0049] The elevated plus maze (about 40 cm from the ground) usually has an open arm (30 cm long, 6 cm wide) and a closed arm (30 cm long, 6 cm wide, 15 cm high). The frequency and duration of animals entering the open arms are negatively correlated with anxiety. The lower the frequency of animals entering the open arms and the shorter the duration, the stronger the depression of the animals. The method steps are as follows: (A) Place the mouse in the middle area formed by the intersection of two open arms and two closed arms, and let the mouse head face the open arm directly. (B) Record the time and number of times the mouse stays in the open arm within five minutes. (C) After each mouse is tested, wipe the elevated plus maze clean with an alcohol cotton ball to avoid interference of mouse odor and excrement on the behavior of the next mouse.

[0050] (3) Tail suspension test:

[0051] The mouse was attached to an "S"-shaped hook 1 cm away from the tail and hung upside down in the test box. The test was recorded for 6 minutes. The SuperMzaze high-throughput tail suspension test analysis system was used to record and analyze the immobility time of the mouse. The data analysis used the immobility time in the 2nd to 6th minute period.

[0052] 4. Statistical methods

[0053] The results were statistically analyzed using t-test.

[0054] 5. Experimental Results

[0055] The results of the open field test showed that compared with the normal control group, the total movement distance and the time to enter the central area of ​​the model mice were significantly reduced, with statistical differences (P<0.01); after treatment with the Chinese medicine composition, compared with the model group, the total movement distance and the time to enter the central area of ​​the three Chinese medicine dosage groups were significantly increased, with statistical differences (P<0.01). See Table 2.

[0056] Table 2: Effects of the Chinese herbal medicine combination on the total distance traveled and the number of times the model mice entered the central area in the open field test

[0057]

[0058]

[0059] Note: Compared with the normal control group, **P<0.01; compared with the model group ### P<0.0001.

[0060] The results of the elevated experiment showed that compared with the normal control group, the time and frequency of the model mice entering the open arms were significantly reduced, with statistical differences (P<0.01); after treatment with the Chinese medicine composition, compared with the model control group, the time and frequency of the three Chinese medicine dosage groups entering the open arms were significantly increased, with statistical differences (P<0.01). See Table 3.

[0061] Table 3: Effects of the Chinese medicine composition on the time and number of times model mice entered the open arms in the elevated test

[0062]

[0063] Note: Compared with the normal control group, ***P<0.001; compared with the model group ### P<0.0001.

[0064] The results of the tail suspension test showed that compared with the normal control group, the immobility time of the model mice was significantly increased, with a statistical difference (P<0.01); after treatment with the Chinese medicine composition, compared with the model group, the immobility time of the three Chinese medicine dosage groups was significantly reduced, with a statistical difference (P<0.01). See Table 4.

[0065] Table 4: Effect of the Chinese medicine composition on the immobility time of model mice in the tail suspension test

[0066]

[0067]

[0068] Note: Compared with the normal control group, ***P<0.001; compared with the model group ### P<0.0001.

[0069] 6. Experimental conclusion

[0070] The Chinese herbal composition can significantly improve the anxiety-like depressive behavior of model mice, suggesting that the Chinese herbal composition has a certain therapeutic effect on the depressive-like behavior of mice caused by CUMS.

[0071] Experimental Example 3 Protective Effect of Chinese Medicine Composition on Depression Induced by Chronic Unpredictable Stress 1. Experimental Materials

[0072] 1.1 Test samples

[0073] After all behavioral tests, the mice were killed, the hippocampus was removed, 0.2 mL of phosphate buffered saline was added to 20 mg of hippocampal tissue, and the supernatant was collected after homogenization and centrifugation at 3000 rpm for 10 minutes. The blood of the mice was centrifuged at 3000 rpm for 10 minutes. The relevant experimental operations were carried out strictly in accordance with the instructions provided by the manufacturer of the ELISA kit. The above supernatant was frozen in an ultra-low temperature refrigerator at -80°C and taken out when needed.

[0074] 1.2 Reagents

[0075] Mouse corticosterone (CORT) ELISA kit (Wuhan Huamei Bioengineering Co., Ltd., CSB-E07969m), mouse interleukin 6 (IL-6) ELISA kit (Elabscience, E-EL-M0044), mouse interleukin 1β (IL-1β) ELISA kit (Elabscience, E-EL-M0037).

[0076] 1.3 Instruments

[0077] Low-temperature centrifuge (Eppendorf, Germany, 5804R); ELISA reader (Flexstation3, USA).

[0078] 3. Experimental Methods

[0079] Serum CORT, hippocampal homogenate IL-1β, and IL-6 were detected by ELISA. The experimental operation was as follows: standard wells, sample wells, and blank wells were set up respectively. There were 7 standard wells, and 100 μL of different concentrations of standard and sample wells were added in turn. The ELISA plate was coated, and the liquid was discarded after incubation at 37°C for 1 hour, and then dried. 100 μL of detection solution A working solution (prepared before use) was added to each well, and the ELISA plate was coated and incubated at 37°C for 1 hour. The liquid in the well was discarded, and each well was washed with 350 μL of washing solution, soaked for 2 minutes, and the ELISA plate was tapped on absorbent paper to remove all the liquid in the well. Repeat the washing three times. After the last wash, absorb or pour out the remaining washing buffer, turn the ELISA plate upside down on absorbent paper, and absorb all the liquid remaining in the well. 100 μL of detection solution B working solution (prepared before use) was added to each well, and the ELISA plate was coated and incubated at 37°C for 30 minutes. Discard the liquid in the wells, spin dry, and wash the plate 5 times. Add 90μL of TMB substrate solution to each well, cover the plate with film, and color at 37℃ in the dark. Add 50μL of stop solution to each well to stop the reaction, and the blue color will turn yellow immediately. The order of adding the stop solution should be as consistent as possible with the order of adding the substrate solution. After ensuring that there are no water droplets on the bottom of the plate and no bubbles in the wells, immediately use an ELISA reader to measure the optical density of each well at a wavelength of 450nm.

[0080] 4. Statistical methods

[0081] The results were statistically analyzed using t-test.

[0082] 5. Experimental Results

[0083] 5.1 Effect of Chinese herbal medicine combination on serum CORT in chronic unpredictable stress-induced depression model mice

[0084] Compared with the control group, the CORT level in the serum of the model group was significantly increased. Compared with the model group, the CORT level in the fluoxetine hydrochloride group and each example group was significantly decreased, and there was a statistical difference (P<0.01). See Table 5.

[0085] Table 5: Effects of Chinese herbal medicine combination on serum CORT in chronic unpredictable stress-induced depression model mice

[0086]

[0087] Note: Compared with the normal control group, ***P<0.001; compared with the model group ### P<0.0001.

[0088] 5.2 Effects of Chinese herbal medicine combination on IL-1β and IL-6 in the hippocampus of mice with chronic unpredictable stress-induced depression model

[0089] Compared with the control group, the levels of IL-1β and IL-6 in the hippocampus of the model group were significantly increased, with statistical differences (P<0.01). Compared with the model group, the levels of IL-1β and IL-6 in the fluoxetine hydrochloride group and each embodiment group were significantly reduced, with statistical differences (P<0.01). See Table 6.

[0090] Table 6: Effects of Chinese herbal medicine combination on IL-1β and IL-6 in the hippocampus of mice with chronic unpredictable stress-induced depression model

[0091]

[0092]

[0093] Note: Compared with the normal control group, ***P<0.001; compared with the model group ### P<0.0001.

[0094] 6. Experimental conclusion

[0095] All three doses of the Chinese medicine composition can significantly inhibit the elevated glucocorticoid levels in the model mice and reduce the levels of IL-1β and IL-6 in the hippocampal tissue, suggesting that the Chinese medicine composition may exert a therapeutic effect on CUMS-induced depressed mice by reducing HPA axis hyperfunction and anti-inflammatory pathways.

Claims

1. Use of a Chinese medicine composition in the preparation of a drug for depression, characterized in that: The traditional Chinese medicine composition consists of the following components: 1-100 parts of ginseng, 1-100 parts of rehmannia root, 1-100 parts of cistanche deserticola, 1-100 parts of salvia miltiorrhiza, 1-100 parts of polygala tenuifolia, 1-100 parts of calamus tatarinowii and 1-100 parts of curcuma.

2. The use according to claim 1, characterized in that: The traditional Chinese medicine composition consists of the following components: 9-36 parts of ginseng, 20-80 parts of rehmannia root, 20-80 parts of cistanche deserticola, 9-36 parts of salvia miltiorrhiza, 9-36 parts of polygala tenuifolia, 9-36 parts of calamus tatarinowii and 9-36 parts of curcuma.

3. The use according to claim 1, characterized in that: The traditional Chinese medicine composition consists of the following components: 9-10 parts of ginseng, 18-20 parts of rehmannia root, 18-20 parts of cistanche deserticola, 9-10 parts of salvia miltiorrhiza, 9-10 parts of polygala tenuifolia, 9-10 parts of calamus tatarinowii and 9-10 parts of curcuma.

4. The use according to claim 1, characterized in that: The traditional Chinese medicine composition consists of the following components: 9 parts of ginseng, 20 parts of rehmannia root, 20 parts of cistanche deserticola, 9 parts of salvia miltiorrhiza, 9 parts of polygala tenuifolia, 9 parts of calamus tatarinowii and 9 parts of curcuma.

5. The use according to any one of claims 1 to 4, characterized in that: The drug for depression also includes pharmaceutically acceptable excipients.

6. The use according to claim 5, characterized in that The pharmaceutically acceptable excipients include fillers, disintegrants, lubricants, suspending agents, binders, sweeteners, flavoring agents, preservatives, and bases.

7. The use according to claim 5, characterized in that: The dosage form of the drug for depression is granules, decoction, tablets, capsules, oral liquid or pills.

8. The use according to any one of claims 1 to 4, characterized in that: The preparation method of the Chinese medicine composition comprises the following steps: The raw medicinal materials are mixed according to the proportion, and 8 times the amount of water is added to soak for 1 hour, and the volatile oil is extracted once for 5 hours. The volatile oil is extracted and collected by ethyl acetate, and the ethyl acetate solution of the volatile oil and the extract are stored in separate containers for standby use; the ethyl acetate solution of the volatile oil is recovered at low temperature to obtain the volatile oil, which is stored in separate containers for standby use; the obtained volatile oil is ground and included with 10 times the amount of β-cyclodextrin and 20 times the amount of water, and is dried and crushed to obtain a volatile oil inclusion compound for standby use; the remaining five flavors are decocted with water twice, each time for 1 hour, filtered, and the filtrate is combined, and the filtrate is combined with the medicinal solution after the volatile oil is extracted, and concentrated into a clear paste with a relative density of 1.08-1.10 (70±5°C), ethanol is added until the alcohol content reaches 70%, and the mixture is refrigerated and allowed to stand for more than 12 hours, filtered, and the ethanol is recovered, and the mixture is concentrated into a thick paste with a relative density of 1.25-1.30 (70±5°C).

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