Application of traditional Chinese medicine composition in preparation of medicine for Parkinson's disease

Abstract

The invention relates to an application of a traditional Chinese medicine composition in preparation of a medicine for Parkinson's disease, 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 provided by the invention can obviously improve mouse dyskinesia caused by a Parkinson's disease model, reduce level rise of IL-1beta, IL-18 and TNF-alpha caused by the mouse Parkinson's disease model, obviously increase the level of DA in nigra of brain tissues of rats with Parkinson's disease, and reduce the levels of IL-1beta and IL-6, and has a good treatment effect on Parkinson's disease.

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 preparing a drug for Parkinson's disease. Background Art

[0002] Parkinson's disease (PD) is a chronic progressive neurodegenerative disease that primarily affects the motor system. Its pathological feature is the progressive loss of dopaminergic neurons in the substantia nigra of the midbrain, resulting in a significant decrease in dopamine levels in the striatum. This dopamine deficiency can cause a range of motor symptoms, including resting tremor, bradykinesia, muscle rigidity, and postural balance disorders. In addition, Parkinson's patients are often accompanied by non-motor symptoms such as hyposmia, sleep disorders, autonomic dysfunction, cognitive decline, and psychiatric symptoms. The exact cause of Parkinson's disease is still unclear, but it is generally believed to be related to the interaction of multiple factors such as genetic factors, environmental factors, and aging.

[0003] At present, the diagnosis of Parkinson's disease mainly relies on clinical manifestations and lacks objective biomarkers. Levodopa (L-dopa) replacement therapy is still the most effective drug treatment for Parkinson's disease, but long-term use can lead to motor complications such as wearing-off phenomenon, switching phenomenon and dyskinesia. In addition, surgical treatments such as deep brain stimulation (DBS) can also be used to improve motor symptoms in some patients. However, existing treatments can only relieve symptoms and cannot prevent or reverse the progression of the disease. Therefore, the development of disease-modifying treatments that can delay or prevent the progression of Parkinson's disease is the focus of current research. In recent years, new treatments such as stem cell transplantation, gene therapy and neuroprotectants have made some progress, but further clinical studies are still needed to verify their safety and effectiveness. Summary of the invention

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

[0005] According to the first aspect of the present invention, a Chinese medicine composition for Parkinson's disease 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 tatarinowii, and 1-100 parts of curcuma. The composition of the present invention can be directly ground into powder, or 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, and 9 parts of curcuma.

[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 Parkinson's disease 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 Parkinson's disease in the preparation of a drug for treating Parkinson's disease, 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 improve the abnormal motor function of mice caused by the Parkinson's disease model, improve the number of spontaneous standing times, increase the movement distance and speed in the open field, and at the same time reduce the increased levels of IL-1β, IL-18, and TNF-α caused by the Parkinson's disease model in mice; at the same time, it significantly increases the DA level in the substantia nigra of the brain tissue of Parkinson's disease rats, and reduces the levels of IL-1β and IL-6, indicating that the traditional Chinese medicine composition has a good therapeutic effect on Parkinson's disease. 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 Parkinson's disease. 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 1-methyl-4-phenyl-1,2,3,6-tetrahydropyridine (MPTP)-induced Parkinson's disease model in mice

[0029] 1. Experimental Materials

[0030] 1.1 Animals

[0031] Male C57 / BL6 mice, SPF grade, 60 mice, 8 weeks old, weighing 18-22 g, were purchased from Spefoc (Suzhou) Biotechnology Co., Ltd., experimental animal license number: SCXK (Suzhou) 2022-0006.

[0032] Breeding environment: room temperature 20-23℃, relative humidity controlled at 40-60%.

[0033] 1.2 Drugs

[0034] The Chinese medicine composition prepared in Example 1, Jiangsu Kangyuan Pharmaceutical Co., Ltd.;

[0035] 1-Methyl-4-phenyl-1,2,3,6-tetrahydropyridine (MPTP, Dalian Meilun Biotechnology Co., Ltd., catalog number: MB3783-100MG);

[0036] Dimethyl fumarate (DMF, Taoshu Biological, product number: T0492);

[0037] Mouse IL-1β ELISA kit (Thermo Fisher, catalog number: BMS6002-2);

[0038] Mouse IL-18 ELISA kit (Thermo Fisher, catalog number: KMC0181);

[0039] Mouse TNF-α ELISA kit (Thermo Fisher, catalog number: BMS607-3);

[0040] Dopamine (DA) adsorption assay kit (novus, catalog number: NBP2-67270);

[0041] Mouse monoamine oxidase B (MAO-B) ELISA kit (novus, catalog number: NBP2-81161).

[0042] 1.3 Instruments

[0043] Electronic balance (Sartorius Scientific Instruments, model BS224S); Electronic balance (G&G, model TC3K). Behavioral analysis system: TopScanTM 3.0; MULITSKAN Sky microplate reader (Thermo Fisher), 5418R low-temperature high-speed centrifuge (Eppendorf), MINI-4K microcentrifuge (Hangzhou Miou Instrument Co., Ltd.).

[0044] 2. Dosage design

[0045] 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 8.72g of crude drug / kg. Oral administration, 10mL / kg, once a day.

[0046] Dimethyl fumarate (DMF), the dosage is 50 mg / kg / day.

[0047] 3. Experimental Methods

[0048] C57 / BL6 mice were adaptively raised in a quarantine room for 7 days with free access to feed and water, and were randomly divided into a normal control group, a model control group, a DMF control group, and a high-, medium-, and low-dose group of the Chinese medicine composition according to body weight, with 10 mice in each group.

[0049] Each group of mice was gavaged once a day according to the corresponding dose, and the normal control group and the model group were given the same volume of pure water (10mL / kg·d) for 15 consecutive days. From the 8th day of administration, all mice except the normal control group were intraperitoneally injected with MPTP 30mg / (kg·d) to establish a Parkinson's disease model, and the control group was injected with the same volume of saline for 7 consecutive days. Ten minutes after the injection of MPTP on the 15th day, the mice showed tremor, arched back, erect tail, and erect hair, indicating that the model was successfully established.

[0050] One hour after the injection of MPTP on the last day, the mice were subjected to behavioral assessment, namely the open field test: the mice were moved to the experimental environment in advance to adapt for at least 30 minutes, and then placed in the open field. The movement distance, speed, and number of spontaneous standing times of the mice were recorded and analyzed by a behavioral analysis system for 5 minutes.

[0051] After the behavioral experiment, blood was collected from the mice's eyes and brain tissue was taken. The blood of the mice was heated at 4°C and 3000 r / min. -1After centrifugation for 10 minutes, the serum was separated and the levels of serum inflammatory factors IL-1β, IL-18, and TNF-α were measured according to the instructions of the ELISA kit. The substantia nigra of the brain tissue was obtained and homogenized with normal saline at a ratio of 1:9. The mixture was centrifuged at 4°C and 12000 r / min for 15 minutes. The supernatant was taken and the levels of DA and MAO-B were determined by enzyme-linked immunosorbent assay.

[0052] 4. Statistical methods

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

[0054] 5. Experimental Results

[0055] The results showed that 7 days after the MPTP injection, the model group had a significantly lower number of spontaneous standing times, and the total distance and speed of movement in the open field were significantly reduced compared with the normal control group (P<0.001); compared with the model group, the number of spontaneous standing times of the DMF control group and the high and medium dose groups of the Chinese medicine combination increased significantly to varying degrees (P<0.001)(P<0.01)(P<0.05), and the total distance and speed of movement in the open field of the DMF control group and the high, medium and low dose groups of the Chinese medicine combination increased significantly to varying degrees (P<0.001)(P<0.01)(P<0.05). See Table 1.

[0056] The serum of mice was tested. Compared with the control group, the levels of serum inflammatory factors IL-1β, IL-18, and TNF-α in the model group were significantly increased (P<0.001). Compared with the model group, the levels of serum inflammatory factors IL-1β, IL-18, and TNF-α in the DMF control group and the high, medium, and low dose groups of the Chinese medicine composition were significantly decreased to varying degrees (P<0.001). See Table 2.

[0057] The brain homogenate of mice was tested. Compared with the control group, the DA level in the model group was significantly decreased (P<0.001), and the MAO-B level was significantly increased (P<0.001). Compared with the model group, the DA levels in the DMF control group and the high- and medium-dose groups of the Chinese medicine combination increased significantly to varying degrees (P<0.001)(P<0.01). The MAO-B levels in the DMF control group and the high-, medium- and low-dose groups of the Chinese medicine combination were significantly decreased, and the high-dose group was the best (P<0.001)(P<0.01)(P<0.05), as shown in Table 3.

[0058] Table 1: Improvement of behavioral indicators in Parkinson's disease mouse model (n=10)

[0059]

[0060]

[0061] Note: Compared with the normal control group, ### P<0.001; compared with the model control group, *P<0.05, **P<0.01, ***P<0.001.

[0062] Table 2: Improvement of serum indexes in Parkinson's disease mouse model (n=10)

[0063]

[0064] Note: Compared with the normal control group, ### P<0.001; compared with the model control group, **P<0.01, ***P<0.001.

[0065] Table 3: Improvement of indicators in substantia nigra of brain tissue in Parkinson's disease mouse model (n=10)

[0066]

[0067] Note: Compared with the normal control group, ### P<0.001; compared with the model control group, *P<0.05, **P<0.01, ***P<0.001.

[0068] 6. Experimental conclusion

[0069] The above results indicate that the model group was successfully established, and the Chinese medicine composition can improve the abnormal motor function of mice caused by the Parkinson's disease model, improve the number of spontaneous standing times, increase the distance and speed of movement in the open field, reduce the increase in serum IL-1β, IL-18, TNF-α and brain tissue substantia nigra MAO-B levels caused by the mouse Parkinson's disease model, and at the same time increase the decrease in brain DA levels caused by the Parkinson's disease model. According to the above experimental results, it is shown that the Chinese medicine composition has a certain therapeutic effect on the MPTP-induced mouse Parkinson's disease model.

[0070] Experimental Example 3 Therapeutic Effect of Chinese Medicine Composition on 6-Hydroxydopamine-Induced Parkinson's Disease in Rats 1. Experimental Materials

[0071] 1.1 Animals

[0072] 60 male SD rats, SPF grade, weighing 180-200 g, were purchased from Sibeifu (Suzhou) Biotechnology Co., Ltd., experimental animal license number: SCXK (Suzhou) 2022-0006.

[0073] Breeding environment: room temperature 20-23℃, relative humidity controlled at 40-60%.

[0074] 1.2 Drugs

[0075] The Chinese medicine composition was prepared according to the method of Example 1 and provided by Jiangsu Kangyuan Pharmaceutical Co., Ltd.;

[0076] 6-hydroxydopamine (6-OHDA, sigma, batch number: MKBX4996V);

[0077] Madopar (Shanghai Roche Pharmaceuticals Co., Ltd., National Medicine Approval No.: H10930198);

[0078] Chloral hydrate (Sinopharm Chemical Reagent Co., Ltd., batch number 20200320);

[0079] Rat IL-1β ELISA kit (Thermo Fisher, catalog number: ERA32RB);

[0080] Rat IL-6 ELISA kit (Thermo Fisher, catalog number: ERA32RB).

[0081] Dopamine (DA) adsorption assay kit (novus, cat. no. NBP2-67270).

[0082] 1.3 Instruments

[0083] Electronic balance (Sartorius Scientific Instruments, model BS224S); electronic balance (G&G, model TC3K); low-temperature centrifuge (eppendorf, Germany, model 5804R); microplate reader (MeiGu Molecular, USA, model Flexstation 3); brain stereotaxic instrument (Shenzhen Reward Life Science Co., Ltd.); electric skull drill (Shenzhen Reward Life Science Co., Ltd.).

[0084] 2. Dosage design

[0085] 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*6.2=8.78g of crude drug / kg. According to the 1 / 4:1 / 2:1 dosing method, the low dose is 2.20g of crude drug / kg and the medium dose is 4.39g of crude drug / kg. Oral administration, 10mL / kg, once a day. The dose of the Medopar group is 20mg / kg, once a day. The normal control group and the model group were given the same volume of pure water (10mL / kg·d).

[0086] 3. Experimental Methods

[0087] The PD rat model was established by 6-hydroxydopamine (6-OHDA) medial forebrain bundle injection. The specific operation was as follows: first, the rats were anesthetized by intraperitoneal injection of 10% chloral hydrate (300 mg / kg), and the rats were fixed on a brain stereotaxic instrument, and the top of the head was adjusted to a horizontal position to ensure that the anterior and posterior fontanelles were on the same level. The rats were shaved and disinfected on the top of the skull, and a longitudinal incision was made and the periosteum was peeled off. The two coordinates of the right substantia nigra were determined according to the rat brain localization map, namely 5.2mm behind the anterior fontanelle, 1.0mm to the right of the midline, 9.0mm below the dura mater and 5.2mm behind the anterior fontanelle, 2.5mm to the right of the midline, 8.5mm below the dura mater. A skull drill was used to drill vertically until a sense of emptiness appeared. Then, a microinjector with 3uL 6-hydroxydopamine solution was inserted at a speed of 1.0mm / min. After the injection, the needle was left for 5min, and then the needle was withdrawn at a speed of 1.0mm / min. The operation of the two holes was consistent. Then, the skull hole was filled with medical gelatin sponge, the wound was sutured, disinfected, and penicillin was continuously injected intramuscularly for 7 days to prevent infection. After waking up, the rats were kept in cages. Ten normal control groups were reserved without intervention.

[0088] After successful modeling, the rats were randomly divided into model control group, Madopar control group, high-dose, medium-dose and low-dose groups of the Chinese medicine combination according to their body weight, with 10 rats in each group. Each group was given medication according to the corresponding dose for 14 consecutive days. One hour after the last day of medication, the rats were anesthetized and killed, and the substantia nigra of the brain tissue was taken and homogenized with normal saline at a ratio of 1:9, centrifuged at 4℃12000r / min for 15min, and the supernatant was taken for enzyme-linked immunosorbent assay of DA, IL-1β, and IL-6 levels.

[0089] 4. Statistical methods

[0090] The results were statistically analyzed using t-test.

[0091] 5. Experimental Results

[0092] 5.1 Effects on inflammation in substantia nigra of brain tissue in Parkinson's rats

[0093] The results showed that compared with the control group, the DA level in the substantia nigra of the brain tissue of the rats in the model group was significantly reduced (P<0.001), and the IL-1β and IL-6 levels were significantly increased (P<0.001). Compared with the model group, the DA level in the substantia nigra of the brain tissue of the Madopar control group, the high-dose and medium-dose groups of the Chinese medicine combination had different degrees of significant recovery (P<0.01)(P<0.05), and there was no significant difference in the recovery effect of the low-dose group; at the same time, the IL-1β and IL-6 levels in the substantia nigra of the brain tissue of the Madopar control group, the high-dose, medium-dose and low-dose groups of the Chinese medicine combination had different degrees of significant decreases compared with the model group (P<0.001)(P<0.01)(P<0.05). See Table 4.

[0094] Table 4: Effects on inflammation in substantia nigra of brain tissue in Parkinson's rats (n=10)

[0095]

[0096] Note: Compared with the normal control group, ### P<0.001; compared with the model control group, *P<0.05, **P<0.01, ***P<0.001.

[0097] 6. Experimental conclusion

[0098] The above results indicate that the Parkinson's disease rat model was successfully established, and the Chinese medicine composition can significantly increase the DA level in the substantia nigra of the rat brain tissue and reduce the levels of IL-1β and IL-6, indicating that the Chinese medicine composition has a certain therapeutic effect on 6-hydroxydopamine-induced Parkinson's disease in rats.

[0099] The above embodiments of the present invention are merely examples for clearly illustrating the present invention, and are not intended to limit the embodiments of the present invention. For those skilled in the art, other different forms of changes or modifications can be made based on the above description. It is not necessary and impossible to list all the embodiments here. Any modifications, equivalent substitutions and improvements made within the spirit and principles of the present invention should be included in the protection scope of the claims of the present invention.

Claims

1. Use of a traditional Chinese medicine composition in preparing a drug for Parkinson's disease, 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 turmeric.

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 turmeric.

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 turmeric.

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 turmeric.

5. The use according to any one of claims 1 to 4, characterized in that The Parkinson's disease drug further comprises 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 Parkinson's disease drug 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 a proportion, and 8 times the amount of water is added to soak for 1 hour. The volatile oil is extracted once for 5 hours. The volatile oil is extracted with ethyl acetate to collect the volatile oil. 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, 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. 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 to 1.10 (70±5°C), ethanol is added until the alcohol content reaches 70%, refrigerated and allowed to stand for more than 12 hours, filtered, ethanol is recovered, and concentrated into a thick paste with a relative density of 1.25 to 1.30 (70±5°C).

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