Traditional Chinese medicine composition for treating Parkinson's disease and preparation method thereof

Abstract

The invention discloses a traditional Chinese medicine composition for treating Parkinson's disease, which belongs to the technical field of traditional Chinese medicines and comprises the following raw medicinal materials: prepared rhizome of rehmannia, pulp of dogwood fruit, Chinese yam, poria cocos, moutan bark, rhizoma alismatis, cassia twig, radix aconiti lateralis preparata, semen plantaginis, achyranthes root, liquorice, peach kernel, prepared rhubarb and mirabilite. The invention further discloses a preparation method and application of the traditional Chinese medicine composition. The traditional Chinese medicine has the beneficial effects that the radix rehmanniae preparata and the radix aconiti carmichaeli are used as monarch drugs to tonify kidney qi; the fructus corni and the rhizoma dioscoreae help the monarch drug to enhance the kidney tonifying effect, the cassia twig warms yang to help the kidney to gasify, and the radix achyranthis bidentatae and the semen persicae promote blood circulation to remove blood stasis; poria cocos, rhizoma alismatis and semen plantaginis are used for clearing damp and promoting diuresis, moutan bark is used for activating blood, and prepared rhubarb and mirabilite are used for activating blood and relaxing bowels; the liquorice is used as a guide to harmonize the medicines, so that the movement symptoms of PD, RBD and constipation are comprehensively improved.

Description

Technical Field

[0001] The present invention relates to the technical field of traditional Chinese medicine, and in particular to a traditional Chinese medicine composition for treating Parkinson's disease. Background Art

[0002] Parkinson's disease is a chronic progressive neurodegenerative disease. In addition to motor symptoms such as bradykinesia, limb tremor, muscle rigidity, abnormal posture and gait, it is also associated with non-motor symptoms such as rapid eye movement sleep behavior disorder (RBD), constipation, and depression. Among PD patients, the prevalence of constipation and RBD is as high as 70-80% and 42.3%, respectively, which are the main non-motor symptoms affecting the quality of life of PD patients. Madopar is a commonly used drug for the treatment of Parkinson's disease, but it has side effects on the gastrointestinal tract and nervous system damage.

[0003] In terms of Western medicine, according to the "Guidelines for the Treatment of Parkinson's Disease in China (Fourth Edition)", for PD patients with RBD, routine protective measures are adopted, and clonazepam or melatonin can be given before bedtime for frequent attacks. For constipation in PD patients, it is recommended to take in enough fluids, fruits, vegetables, cellulose or other mild laxatives, such as lactulose (LactuLose), Longhui pills, and rhubarb tablets; gastric motility drugs, such as domperidone and mosapride, can also be added; and increase exercise.

[0004] Parkinson's disease combined with RBD and constipation requires different treatment plans in Western medicine. The Western medicine treatment of Parkinson's disease combined with RBD is mainly based on clonazepam or melatonin. Among them, clonazepam increases the risk of falling. The Western medicine treatment of Parkinson's disease combined with constipation is mainly based on laxatives, gastrointestinal motility drugs, etc. This will put a burden on the patient's gastrointestinal system. Summary of the invention

[0005] In order to overcome the problem that the prior art has poor therapeutic effect on Parkinson's disease and its complications, the present invention provides a traditional Chinese medicine composition for treating Parkinson's disease, comprising the following raw medicinal materials: cooked rehmannia, cornus fruit, yam, tuckahoe, peony bark, oriental water chestnut, cassia twig, processed aconite, plantago seed, cyperus chinensis, licorice, peach kernel, cooked rhubarb, and mirabilite.

[0006] Preferably, the following raw medicinal materials are included, by mass: 25-35 parts of cooked rehmannia, 10-20 parts of cornus, 10-20 parts of yam, 10-20 parts of poria, 5-15 parts of peony bark, 10-20 parts of oriental alisma, 5-15 parts of cinnamon twig, 5-15 parts of processed aconite, 25-35 parts of plantago seed, 25-35 parts of cyathula, 5-15 parts of licorice, 5-15 parts of peach kernel, 5-15 parts of cooked rhubarb, and 1-10 parts of sodium sulfate.

[0007] Preferably, the following raw medicinal materials are included, by mass: 27-33 parts of cooked rehmannia, 12-18 parts of cornus, 12-18 parts of yam, 12-18 parts of poria, 7-13 parts of peony bark, 12-18 parts of oriental rhizome, 7-13 parts of cassia twig, 7-13 parts of processed aconite, 27-33 parts of plantago seed, 27-33 parts of cyathula, 7-13 parts of licorice, 7-13 parts of peach kernel, 7-13 parts of cooked rhubarb, and 3-7 parts of sodium sulfate.

[0008] Preferably, the following raw medicinal materials are included, by mass: 29-31 parts of cooked rehmannia, 14-16 parts of cornus fruit, 14-16 parts of yam, 14-16 parts of poria, 9-11 parts of peony bark, 14-16 parts of oriental rhizome, 9-11 parts of cinnamon twig, 9-11 parts of processed aconite, 29-31 parts of plantago seed, 29-31 parts of cyathula, 9-11 parts of licorice, 9-11 parts of peach kernel, 9-11 parts of cooked rhubarb, and 5-6 parts of sodium sulfate.

[0009] Preferably, it is a preparation prepared from the powder of the raw material drug, the water or organic solvent extract of the raw material drug as the active ingredient, and pharmaceutically acceptable excipients.

[0010] Preferably, the preparation is an oral preparation.

[0011] Preferably, the oral preparation is a decoction, an oral liquid, a granule, a capsule, a tablet, or a powder.

[0012] In addition, the present invention also provides a method for preparing a traditional Chinese medicine composition for treating Parkinson's disease, comprising: putting other raw medicinal materials except Glauber's salt into an initial solvent for decoction, filtering to obtain a first filtrate; subsequently adding a solvent and continuing to decoct, filtering to obtain a second filtrate, mixing the first filtrate and the second filtrate and adding Glauber's salt to obtain the traditional Chinese medicine composition for treating Parkinson's disease.

[0013] Preferably, the prepared aconite root is placed in the initial solvent and simmered over low heat for 15-25 minutes, then other raw medicinal materials except Glauber's salt are added and the first solvent addition is performed, the mixture is first boiled over high heat and then simmered over low heat for 30-50 minutes, and then filtered to obtain the first filtrate, and then the second solvent addition is performed, the mixture is first boiled over high heat and then simmered over low heat for 20-40 minutes, and then filtered to obtain the second filtrate.

[0014] Preferably, the initial solvent is water, and the amount of solvent added in the first solvent addition and the second solvent addition is 2-4 times of the initial solvent.

[0015] Beneficial effects:

[0016] The beneficial effects produced by the technical solution of the present invention are as follows:

[0017] The Chinese medicine composition provided by the present invention uses Rehmannia glutinosa and Radix Aconiti Lateralis Preparata as the main medicine, which can replenish kidney qi and replenish both yin and yang; Rehmannia glutinosa contains a variety of active pharmacological ingredients such as catalpol, rehmannia glycosides, Rehmannia glutinosa polysaccharides, and verbascoside, which has the effects of anti-oxidative stress response, inhibiting monoamine oxidase expression, reducing excitotoxicity, inhibiting cell apoptosis, regulating neurotrophic factor expression, inhibiting the release of pro-inflammatory factors, and regulating a variety of chemical components and related signal pathways and receptor molecules, thereby improving Parkinson's disease. Aconitum contains a variety of alkaloids, such as L-norhizomeline, palmarine, aconitine, and aconitine, which can promote dopamine secretion. The two are one yin and one yang, and they are mutually rooted and interdependent, and regulate the yin and yang balance of Parkinson's patients. Cornus officinalis and Chinese yam help Rehmannia glutinosa to enhance its kidney-tonifying effect, cinnamon twig helps Aconitum carmichaelii to enhance its warming yang effect and assist the kidney's qi transformation, Achyranthes bidentata and peach kernel promote blood circulation and remove blood stasis, and are all ministerial medicines; Poria cocos, Alisma orientalis, and Plantago seed cooperate with each other to promote diuresis and eliminate dampness, Paeonia suffruticosa promotes blood circulation, Rhubarb, Glauber's salt and peach kernel promote blood circulation and relieve constipation, and are all adjuvant medicines; Licorice harmonizes all the medicines as a messenger.

[0018] In addition, the Chinese medicine composition provided by the present invention adopts natural Chinese medicine for treatment, has multiple therapeutic effects, and has significant effects, and has the effect of improving diseases in multiple ways and targets. Through animal experiments, the low, medium, and high dose groups of the prescription can shorten the climbing time and balance beam test time of PD mice, improve the grip strength of mice, and the medium and high dose groups can increase the step length of PD mice and increase the expression level of TH protein in the striatum tissue of the mouse brain, and its effect is equivalent to the current positive drug levodopa. Moreover, based on the formula, a variety of convenient preparation forms such as granule formula or soup can be provided for clinical application, which is easy to popularize and promote, has high patient acceptance, and can improve the compliance of patients with drug use. BRIEF DESCRIPTION OF THE DRAWINGS

[0019] In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the drawings required for use in the embodiments will be briefly introduced below. It should be understood that the following drawings only show certain embodiments of the present invention and therefore should not be regarded as limiting the scope. For ordinary technicians in this field, other related drawings can be obtained based on these drawings without paying creative work.

[0020] Figure 1 Test results for mouse grip strength assessment;

[0021] Figure 2 Results of the mouse balance beam test;

[0022] Figure 3 Assessment of test results for mouse step distance;

[0023] Figure 4 This is the test result of the time it takes for mice to climb a pole;

[0024] Figure 5These are the test results of changes in TH protein expression in the striatum of the mouse brain. DETAILED DESCRIPTION

[0025] In order to make the purpose, technical solutions and advantages of the embodiments of the present invention clearer, the technical solutions in the embodiments of the present invention will be clearly and completely described below in conjunction with the drawings in the embodiments of the present invention. Obviously, the described embodiments are part of the embodiments of the present invention, not all of the embodiments. Therefore, the following detailed description of the embodiments of the present invention provided in the drawings is not intended to limit the scope of the claimed invention, but merely represents the selected embodiments of the present invention. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0026] This embodiment provides a traditional Chinese medicine composition for treating Parkinson's disease, comprising the following raw medicinal materials: cooked rehmannia, cornus fruit, yam, tuckahoe, peony bark, oriental water chestnut, cinnamon twig, processed aconite, plantago seed, cyathula officinalis, liquorice, peach kernel, cooked rhubarb, and mirabilite.

[0027] Rehmannia glutinosa: Rehmannia glutinosa is the rhizome of Rehmannia glutinosa or Rehmannia glutinosa of the Scrophulariaceae family, which is processed, steamed and dried. Rehmannia glutinosa is sweet and slightly warm in nature, and enters the liver and kidney meridians. Its chemical composition is similar to that of raw Rehmannia glutinosa, mainly containing styryl glycosides such as verbascoside; it also contains monosaccharides, amino acids, and vitamin A substances, and has the effects of nourishing blood, nourishing yin, and replenishing essence and filling marrow.

[0028] Cornus officinalis: Cornus officinalis is the dried mature pulp of Cornus officinalis, a plant of the genus Cornus in the family Cornaceae. It is sour, sweet, and slightly warm, and enters the liver and kidney meridians. It mainly contains iridoid glycosides, as well as ursolic acid, 7-dehydrolognyxin, cornus officinalis tannins 1, 2, 3, and volatile oils, and has the effects of nourishing the liver and kidneys and astringing and consolidating.

[0029] Chinese Yam: Chinese Yam is a Qi-tonifying medicine, which is the dried rhizome of the Dioscorea plant. Chinese Yam tastes sweet and flat, and enters the spleen, lung, and kidney meridians. This product mainly contains saponins, mucilage, glycoprotein, mannan, allantoin, yam, choline, dopamine, crude fiber, pectin, amylase, and trace elements, etc. It has the effects of nourishing Qi and Yin, nourishing the spleen, lungs, and kidneys, and stopping semen and leukorrhea.

[0030] Poria: Poria is a diuretic and dampness-inducing medicine. It is the dried sclerotium of the fungus Poria of the Polyporaceae family. Poria is sweet, light and flat in nature, and enters the heart, lung, spleen and kidney meridians. It mainly contains polysaccharides, triterpenoids, sterols, proteins, fats, lecithin, adenine and other ingredients, and has the functions of diuretic and dampness-inducing, spleen-strengthening, and tranquilizing the mind.

[0031] Peony bark: The Chinese medicinal material peony bark is a heat-clearing medicine. It is the dried root bark of the peony plant of the Ranunculaceae family. Peony bark is bitter, pungent, and slightly cold in nature, and it enters the heart, liver, and kidney meridians. Its main components are peony phenol, peony glycosides, peony phenol protoglycosides, peony phenol neoglycosides, paeoniflorin, oxidized paeoniflorin, benzoyl paeoniflorin, benzoyl oxidized paeoniflorin, etc. It also contains gallic acid, volatile oil, etc., and has the effects of clearing heat and cooling blood, promoting blood circulation and removing blood stasis.

[0032] Alisma: Alisma is a diuretic and dehumidifying medicine. It is the dried tuber of the plant Alisma Orientalis or Alisma of the Alismataceae family. Alisma is sweet, light and cold in nature, and enters the kidney and bladder meridians. Its main components are triterpenoids and sesquiterpenoids, such as alismatol F, as well as alismatol A, B, C and volatile oils, asparagine, resin and other ingredients, which have the effects of diuretic and dehumidifying, purging heat, clearing turbidity and reducing lipids.

[0033] Cinnamon twig: Cinnamon twig is a kind of antipyretic agent, which is the dried young branches of cinnamon bark, a plant of Lauraceae. Cinnamon twig is pungent, sweet and warm in nature, and enters the heart, lung and bladder meridians. Its main components are volatile oils, phenols, organic acids, polysaccharides, glycosides, coumarins and tannins, which have the effects of sweating, relieving muscles, warming and unblocking meridians, promoting yang and transforming qi, and balancing and descending qi.

[0034] Processed Aconite: Processed Aconite is a processed product of the rootlets of the Ranunculaceae plant Aconitum. Processed Aconite is pungent, sweet, and hot in nature; it is toxic and enters the heart, kidney, and spleen meridians. Its main ingredients are aconite alkaloids, berberine hydrochloride, berberine, ephedrine, atropine, etc. It has the effects of warming yang and replenishing fire, dispelling cold and relieving pain, restoring yang and rescuing adverse conditions, tonifying the kidney and strengthening yang, strengthening the heart and promoting diuresis, etc.

[0035] Plantago: Plantago is a diuretic and dampness-inducing medicine. It is the dried mature seeds of the plant Plantago or Plantago asiatica of the Plantaginaceae family. Plantago is sweet and cold in nature and enters the liver, kidney, lung and small intestine meridians. Its main components are iridoid components, verbascoside, racemic-plantagin, plantaginic acid, plantago mucopolysaccharide A and sterols, etc. It has the effects of clearing heat, promoting diuresis, relieving stranguria, inducing dampness and stopping diarrhea, improving eyesight and removing phlegm.

[0036] Rhizoma Achyranthis Bidentatae: Rhizoma Achyranthis Bidentatae is a blood-activating and blood-stasis-removing herb. It is the dried root of Rhizoma Achyranthis Bidentatae, a plant of the Amaranthaceae family. Rhizoma Achyranthis Bidentatae is bitter, sweet, sour and flat in nature, and is regulated by the liver and kidney meridians. It mainly contains sterone components, triterpenoid saponins, flavonoid components, polysaccharides and amino acids, and has the effects of removing blood stasis, tonifying the liver and kidneys, strengthening tendons and bones, promoting diuresis and relieving stranguria, and guiding blood downward.

[0037] Licorice: Licorice is a Qi-tonifying medicine, which is the dried root and rhizome of the leguminous plants Glycyrrhiza uralensis, Glycyrrhiza uralensis or Glycyrrhiza glabra. Licorice is sweet and flat in nature, and enters the heart, lung, spleen and stomach meridians. It mainly contains triterpenoid saponins and flavonoids, and has the functions of replenishing Qi, tonifying the middle, removing phlegm and relieving cough, detoxifying, relieving pain, and alleviating the properties of the medicine.

[0038] Peach kernel: Peach kernel is the dried mature seed of peach, a plant of the Rosaceae family. Peach kernel is bitter, dry and flat in nature, and is associated with the heart, liver and large intestine meridians. Its main components include volatile oils, cyanogenic glycosides, amino acids and proteins, flavonoids and their glycosides, sterols and their glycosides, aromatic glycosides, fatty acids, phenylpropanoids, nucleosides, trace elements, etc. It has the effects of promoting blood circulation and removing blood stasis, moistening the intestines and relieving constipation, and relieving cough and asthma.

[0039] Cooked rhubarb: Cooked rhubarb is a laxative, which is the dried root and rhizome of Rheum palmatum, Rheum tangutum or Rheum officinale. Cooked rhubarb is bitter and cold in nature, and enters the spleen, stomach and large intestine meridians. Its main components are anthraquinone derivatives, tannins, organic acids and estrogen-like substances, etc. It has the functions of purging, clearing away heat and purging fire, cooling blood and detoxifying, removing blood stasis and promoting menstruation, and removing dampness and jaundice.

[0040] Glauber's Salt: Glauber's Salt is a laxative, which is a crystal made by processing and refining. Glauber's Salt is salty, bitter and cold in nature, and it enters the stomach and large intestine meridians. Its main component is sodium sulfate, and it also contains a small amount of inorganic salts such as sodium chloride, magnesium sulfate, and calcium sulfate. It has the effects of laxative, moisturizing, softening, clearing heat and reducing swelling.

[0041] Specifically, the following raw medicinal materials are included by mass: 25-35 parts of cooked rehmannia, 10-20 parts of cornus, 10-20 parts of yam, 10-20 parts of poria, 5-15 parts of peony bark, 10-20 parts of oriental water chestnuts, 5-15 parts of cinnamon twigs, 5-15 parts of processed aconite, 25-35 parts of plantago seeds, 25-35 parts of cyathula, 5-15 parts of licorice, 5-15 parts of peach kernels, 5-15 parts of cooked rhubarb, and 1-10 parts of Glauber's salt.

[0042] Specifically, by weight, the following raw medicinal materials are included: 27-33 parts of cooked rehmannia, 12-18 parts of cornus fruit, 12-18 parts of yam, 12-18 parts of poria, 7-13 parts of peony bark, 12-18 parts of oriental water chestnuts, 7-13 parts of cinnamon twigs, 7-13 parts of processed aconite, 27-33 parts of plantago seed, 27-33 parts of cyathula, 7-13 parts of licorice, 7-13 parts of peach kernel, 7-13 parts of cooked rhubarb, and 3-7 parts of sodium sulfate.

[0043] Specifically, by mass, the following raw medicinal materials are included: 29-31 parts of cooked rehmannia, 14-16 parts of cornus fruit, 14-16 parts of yam, 14-16 parts of poria, 9-11 parts of peony bark, 14-16 parts of oriental water chestnuts, 9-11 parts of cinnamon twigs, 9-11 parts of processed aconite, 29-31 parts of plantago seed, 29-31 parts of cyathula, 9-11 parts of licorice, 9-11 parts of peach kernel, 9-11 parts of cooked rhubarb, and 5-6 parts of sodium sulfate.

[0044] Specifically, it is a preparation prepared from the powder of the raw material drug, the water or organic solvent extract of the raw material drug as the active ingredient, and pharmaceutically acceptable excipients.

[0045] Specifically, the preparation is an oral preparation.

[0046] Specifically, the oral preparation is a decoction, an oral liquid, a granule, a capsule, a tablet, or a powder.

[0047] In addition, the present invention also provides a method for preparing a traditional Chinese medicine composition for treating Parkinson's disease, comprising: putting other raw medicinal materials except Glauber's salt into an initial solvent for decoction, filtering to obtain a first filtrate; subsequently adding a solvent and continuing to decoct, filtering to obtain a second filtrate, mixing the first filtrate and the second filtrate and adding Glauber's salt to obtain the traditional Chinese medicine composition for treating Parkinson's disease.

[0048] Specifically, the processed aconite root is placed in an initial solvent and simmered over low heat for 15-25 minutes, then other raw medicinal materials except Glauber's salt are added and the first solvent addition is performed, the mixture is first boiled over high heat and then simmered over low heat for 30-50 minutes, and then filtered to obtain the first filtrate, and then the second solvent addition is performed, the mixture is first boiled over high heat and then simmered over low heat for 20-40 minutes, and then filtered to obtain the second filtrate.

[0049] Specifically, the initial solvent is water, and the amount of solvent added in the first solvent addition and the second solvent addition is 2-4 times of the initial solvent.

[0050] The present invention will be further explained below in conjunction with specific embodiments and comparative examples.

[0051] Embodiment 1:

[0052] A Chinese medicine composition for treating Parkinson's disease, wherein the Chinese medicine formula raw materials are grabbed according to the following mass parts: 25 parts of prepared rehmannia, 10 parts of cornus, 10 parts of yam, 10 parts of poria, 5 parts of peony bark, 10 parts of oriental rhizome, 5 parts of cinnamon twig, 5 parts of processed aconite, 25 parts of plantain seeds, 25 parts of radix achyranthis Bidentatae, 5 parts of liquorice, 5 parts of peach kernel, 5 parts of cooked rhubarb, and 1 part of mirabilite. The Chinese medicine composition for treating Parkinson's disease in the present embodiment is a Chinese medicine decoction, and its preparation method is as follows: after the processed aconite is put into 150mL of water and decocted on a slow fire for 15min, other raw medicinal materials and 300mL of water except mirabilite are added, first boiled with high heat and then decocted with a slow fire for 30min, then filtered to obtain the first filtrate, then 300mL of water is added for the second time, first boiled with high heat and then decocted with a slow fire for 20min, filtered to obtain the second filtrate, the first filtrate and the second filtrate are mixed and mirabilite is added to obtain the Chinese medicine composition for treating Parkinson's disease.

[0053] Embodiment 2:

[0054] A traditional Chinese medicine composition for treating Parkinson's disease comprises the following raw materials in parts by weight: 30 parts of cooked rehmannia, 15 parts of cornus fruit, 15 parts of yam, 15 parts of tuckahoe, 10 parts of peony bark, 15 parts of oriental water chestnuts, 10 parts of cassia twig, 10 parts of processed aconite, 30 parts of plantain seeds, 30 parts of radix polygoni multiflori, 10 parts of liquorice, 10 parts of peach kernel, 10 parts of cooked rhubarb and 5 parts of mirabilite. The Chinese medicine composition for treating Parkinson's disease in this embodiment is a Chinese medicine decoction, and its preparation method is as follows: put processed aconite root into 150 mL of water and simmer for 20 minutes, then add other raw medicinal materials except Glauber's salt and 450 mL of water, first boil with high heat and then simmer for 40 minutes, then filter to obtain a first filtrate, then add 450 mL of water for a second time, first boil with high heat and then simmer for 30 minutes, filter to obtain a second filtrate, mix the first filtrate and the second filtrate, and add Glauber's salt to obtain the Chinese medicine composition for treating Parkinson's disease.

[0055] Embodiment 3:

[0056] A traditional Chinese medicine composition for treating Parkinson's disease comprises the following raw materials in parts by weight: 35 parts of cooked rehmannia, 20 parts of cornus fruit, 20 parts of yam, 20 parts of poria, 15 parts of peony bark, 20 parts of oriental water chestnuts, 15 parts of cassia twig, 15 parts of processed aconite, 35 parts of plantain seeds, 35 parts of radix polygoni multiflori, 15 parts of liquorice, 15 parts of peach kernel, 15 parts of cooked rhubarb and 10 parts of sodium sulfate. The Chinese medicine composition for treating Parkinson's disease in this embodiment is a Chinese medicine decoction, and its preparation method is as follows: put processed aconite root into 150 mL of water and simmer for 25 minutes, then add other raw medicinal materials except Glauber's salt and 600 mL of water, first boil with high heat and then simmer for 50 minutes, then filter to obtain a first filtrate, then add 600 mL of water for a second time, first boil with high heat and then simmer for 40 minutes, filter to obtain a second filtrate, mix the first filtrate and the second filtrate, and add Glauber's salt to obtain the Chinese medicine composition for treating Parkinson's disease.

[0057] Embodiment 4:

[0058] A Chinese medicine composition for treating Parkinson's disease, wherein the Chinese medicine formula raw materials are grabbed according to the following mass parts: 27 parts of Rehmannia glutinosa, 12 parts of Cornus officinalis, 12 parts of Dioscorea opposita, 12 parts of Poria cocos, 7 parts of Paeonia suffruticosa, 12 parts of Rhizoma Alismatis, 7 parts of Cinnamomum cassia, 7 parts of Radix Aconiti Lateralis Preparata, 27 parts of Semen Plantaginis, 27 parts of Rhizoma Cyathulae, 7 parts of Licorice, 7 parts of Semen Persicae, 7 parts of Rheum officinale, and 3 parts of Sodium Sulfate. The Chinese medicine composition for treating Parkinson's disease in this embodiment is a Chinese medicine decoction, and its preparation method is the same as that in Example 2.

[0059] Embodiment 5:

[0060] A Chinese medicine composition for treating Parkinson's disease, wherein the Chinese medicine formula raw materials are grabbed according to the following mass parts: 33 parts of cooked rehmannia, 18 parts of cornus, 18 parts of yam, 18 parts of tuckahoe, 13 parts of peony bark, 18 parts of oriental rhizome, 13 parts of cassia twig, 13 parts of processed aconite, 33 parts of plantain seeds, 33 parts of radix achyranthis Bidentatae, 13 parts of liquorice, 13 parts of peach kernel, 13 parts of cooked rhubarb, and 7 parts of mirabilite. The Chinese medicine composition for treating Parkinson's disease in this embodiment is a Chinese medicine decoction, and its preparation method is the same as that in Example 2.

[0061] Embodiment 6:

[0062] A Chinese medicine composition for treating Parkinson's disease, wherein the Chinese medicine formula raw materials are grabbed according to the following mass parts: 29 parts of Rehmannia glutinosa, 14 parts of Cornus officinalis, 14 parts of Dioscorea opposita, 14 parts of Poria cocos, 9 parts of Paeonia suffruticosa, 14 parts of Rhizoma Alismatis, 9 parts of Cinnamomum cassia, 9 parts of Radix Aconiti Lateralis Preparata, 29 parts of Semen Plantaginis, 29 parts of Rhizoma Cyathulae, 9 parts of Licorice, 9 parts of Semen Persicae, 9 parts of Rhubarb Radix, and 5 parts of Sodium Sulfate. The Chinese medicine composition for treating Parkinson's disease in this embodiment is a Chinese medicine decoction, and its preparation method is the same as that in Example 2.

[0063] Embodiment 7:

[0064] A Chinese medicine composition for treating Parkinson's disease, wherein the Chinese medicine formula raw materials are grabbed according to the following mass parts: 31 parts of cooked rehmannia, 16 parts of cornus fruit, 16 parts of yam, 16 parts of tuckahoe, 11 parts of peony bark, 16 parts of oriental rhizome, 11 parts of cassia twig, 11 parts of processed aconite, 31 parts of plantain seed, 31 parts of radix achyranthis Bidentatae, 11 parts of liquorice, 11 parts of peach kernel, 11 parts of cooked rhubarb, and 6 parts of mirabilite. The Chinese medicine composition for treating Parkinson's disease in this embodiment is a Chinese medicine decoction, and its preparation method is the same as that in Example 2.

[0065] In order to verify the effect of the Chinese medicine composition provided by the present invention on Parkinson's disease, the following experiments were conducted:

[0066] 1. Establishment and drug administration of PD mouse model:

[0067] After 3 days of adaptive feeding, C57BL / 6J male mice were completely randomized according to body weight and divided into blank control group, model control group (PD), low-dose combination group, medium-dose combination group, high-dose combination group and positive drug group (madopar), with 6 mice in each group. Except for the blank control group, the other groups were intragastrically administered with 30 mg / kg rotenone (rotenone was dissolved in 0.5% CMC-Na solution) once a day for 28 consecutive days. From the 29th day to the 35th day, 30 mg / kg MPTP was intraperitoneally injected once a day. The blank control group was intragastrically administered with the same volume of 0.5% CMC-Na or intraperitoneally injected with the same volume of normal saline every day.

[0068] Weigh 30g of Rehmannia glutinosa, 15g of Cornus officinalis, 15g of Dioscorea opposita, 15g of Poria cocos, 10g of Paeonia suffruticosa, 15g of Alisma orientalis, 10g of Cinnamomum cassia, 10g of Aconite radix prepared, 30g of Plantago seed, 30g of Cyathula capitata, 10g of Licorice root, 10g of Semen Persicae, 10g of Rhubarb prepared, and 5g of Sodium Sulfate. Put the Aconite radix prepared into 150mL of water and simmer for 20min over low heat, then add other raw medicinal materials except Sodium Sulfate and 450mL of water, first boil with high heat and then simmer for 40min over low heat, then filter to obtain a first filtrate, then add 600mL of water for a second time, first boil with high heat and then simmer for 30min over low heat, filter to obtain a second filtrate, mix the first filtrate and the second filtrate, add Sodium Sulfate to obtain a Chinese medicine composition for treating Parkinson's disease. Add 95% ethanol to the decocted liquid, let it stand for 24 hours at 4°C, then filter it, use a rotary evaporator to remove the solvent, and finally reconstitute it with ultrapure water to an appropriate concentration. After the mouse modeling was completed, low-dose (27.95g / kg), medium-dose (111.8g / kg), and high-dose (223.6g / kg) liquids were gavaged once in the morning and evening for 14 consecutive days. Madopar was selected as the positive drug, the tablets were crushed, 0.5% CMC-Na was added and ground together, the dosage was 26.03mg / kg, and it was gavaged once in the morning and evening for 14 consecutive days. The normal control group was gavaged with the same volume of saline. The behavioral manifestations of tremors and slow movements in mice and the performance of climbing pole tests, balance beam tests, grip strength tests, and stride tests were indicators of successful modeling.

[0069] 2. Efficacy evaluation indexes of combined prescriptions in treating PD mice

[0070] 2.1. Pole climbing test

[0071] A metal rod about 60 cm long and 9 mm in diameter was wrapped with gauze bandage as a pole. Before the actual test, the mice were trained to climb the pole for two days. The mice were placed on the top of the pole, and the time it took for the mice to climb from the top of the pole to the base was recorded without external interference. The end of the test was defined as the mouse's limbs having touched the base. Each mouse was tested 3 times, and the results were taken as the average of the 3 tests.

[0072] 2.2 Balance beam test

[0073] A balance beam about 125 cm long and 1 cm wide was fixed at about 50 cm from the ground. The starting point was a lamp, which provided stimulation and forced the mice to crawl forward. The distance between the starting point and the end point was 100 cm. The mice were trained for two days before the formal test. Each mouse was placed at the starting point, a lamp was turned on, and the time required to pass the balance beam to the end point was recorded. Each mouse was tested 3 times, and the results were taken as the average of the 3 tests.

[0074] 2.3 Grip strength test

[0075] Place the mouse in the center of a 50×50cm wire mesh. When the mouse's limbs are fully grasped, flip the device 180° and start timing. Stop timing when the mouse falls (i.e., all four paws are completely out of the mesh). Each mouse is tested 3 times, and the results are averaged over the 3 tests.

[0076] 2.4 Stride Test

[0077] Prepare a 50cm long channel with a width comparable to that of mice. Train the mice for two days before the formal test so that they can pass through the channel smoothly. During the formal test, put paper under the channel, dip the soles of the forelimbs of the mice in red ink and the soles of the hindlimbs in blue ink, and record the stride of the mice when they walk. Take the three longest strides of all the strides, and take the average of the three strides.

[0078] 2.5. Western blotting to detect TH protein expression in substantia nigra

[0079] Lysis buffer (RIPA:PMSF=100:1) was prepared according to the recipe. 100 μL of lysis buffer was added to every 10 mg of tissue, and the samples were frozen and ground and placed on ice for 30 min. The samples were centrifuged at 13000 rpm / min at 4°C for 15 min, and the supernatant was collected. The protein concentration was determined using a BCA protein detection kit and diluted to a uniform concentration. After denaturation at 100°C for 10 min, 30 μg of protein in each sample was electrophoresed by SDS-PAGE and transferred to a PVDF membrane. The membranes were blocked with 5% skim milk in TBST containing 1% Tween20 for 3 h at room temperature, washed 5 times with 1×TBST for 6 min each, and then incubated with tyrosine hydroxylase primary antibody (1:1000) at 4°C overnight and washed 5 times with 1×TBST for 6 min each. Next, horseradish peroxidase-conjugated goat anti-rabbit IgG (1:5000) was incubated at room temperature for 1 h and washed 5 times with 1×TBST for 6 min each. Finally, proteins were detected by a chemiluminescent gel imaging system (Tanon, Shanghai, China) using an enhanced chemiluminescence substrate (PerkinElmer, Massachusetts, USA).

[0080] 3. Results Analysis

[0081] The above test results are as follows Figure 1-5 As shown:

[0082] (1) From Figure 1(Compared with the model group, ***P<0.001) We can see that compared with the blank group, the pole climbing time of PD mice was significantly prolonged. After treatment, the pole climbing time of mice in the positive drug group and the medium and high dose groups of the drug in Example 2 was significantly shortened.

[0083] (2) From Figure 2 (Compared with the model group, ***P<0.001) We can see that compared with the blank group, the time for PD mice to pass the balance beam was significantly prolonged. After treatment, the time for mice in the positive drug group and the medium and high dose groups of the drug in Example 2 to pass the balance beam was significantly shortened.

[0084] (3) From Figure 3 (Compared with the model group, **P<0.01, ***P<0.001) We can see that compared with the blank group, the grip strength test persistence time of PD mice was significantly shortened. After treatment, the grip strength test persistence time of mice in the positive drug group and the medium and high dose groups of the drug in Example 2 was significantly prolonged.

[0085] (4) From Figure 4 (Compared with the model group, ***P<0.001) We can see that compared with the blank group, the stride of PD mice was significantly reduced. After treatment, the stride of mice in the positive drug group and the medium and high dose groups of the drug in Example 2 was significantly increased.

[0086] (5) From Figure 5 From the test results (compared with the model group, *P<0.05, **P<0.01), we can see that compared with the blank group, the expression of TH protein in the striatum of the PD mice brain was significantly reduced. After treatment, the expression of TH protein in the striatum of the mice brain in the positive drug group and the medium and high dose groups of the drug in Example 2 was significantly increased.

[0087] In summary, we found that the treatment with the Chinese medicine composition can effectively improve the motor symptoms such as tremor, bradykinesia, and postural balance disorders in PD mice. Further detection of the expression of TH protein, a marker of dopamine neurons in the striatum of the mice brain, showed that the Chinese medicine composition treatment can protect dopamine neurons and improve dopamine neuron damage.

[0088] Typical cases:

[0089] Case 1: Liang Moumou, male, 60 years old, first diagnosed on June 12, 2024. Main complaint: right limb tremor for more than 3 years. The patient began to have right limb tremor and slow movement in 2021. The outpatient diagnosis was Parkinson's disease. He was given 0.25mg qd of Madopar orally, which was effective. He still had right limb tremor, low voice, poor appetite, poor sleep, difficulty falling asleep, RBD (shouting loudly during sleep at night), decreased sense of smell, frequent urination, weak urine, incomplete urine, soreness and backache in both lower limbs. The tongue is dark red with thin white greasy fur, and the pulse is slightly stringy and weak. Western medicine diagnosis: Parkinson's disease. Chinese medicine diagnosis: Tremor disease, the syndrome belongs to kidney deficiency and blood stasis. Treat with kidney tonification and blood circulation, take orally the decoction prepared by the implementation case 2 provided by the present invention, 1 dose per day, divided into 2 times. After taking the medicine for 2 weeks, sleep improved, limb tremor improved, bowel movements were smoother than before, and frequent urination, weak urine and incomplete feeling were relieved.

[0090] Case 2: He Moumou, male, 72 years old, first diagnosed on December 11, 2024. Main complaint: progressive worsening of slow movement for more than one month. After herpes zoster in October 2024, the patient developed slow movement of the left lower limb, reduced arm swing when walking, slow turning, reduced facial expression, and decreased sense of smell. Taking Madopar (0.125gbid) was effective, but still felt pain in the left knee and the outer side of the left thigh, RBD, difficult bowel movements, and urination. The tongue is dark red, the fur is thin and white, and the pulse is stringy. Western medicine diagnosis: Parkinson's disease. Chinese medicine diagnosis: constipation, the syndrome belongs to kidney deficiency and blood stasis. Treat with kidney tonification and blood circulation, orally take the decoction prepared by the implementation case 2 provided by the present invention, 1 dose per day, taken in 2 times. After taking the medicine for 1 month, RBD did not occur, the bowel movements were smooth, the pain in the left knee and the outer side of the left thigh was reduced by 90%, and the weakness of both lower limbs was reduced.

[0091] The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. For those skilled in the art, the present invention may have various modifications and variations. Any modification, equivalent replacement, improvement, etc. made within the spirit and principle of the present invention shall be included in the protection scope of the present invention.

Claims

1. A Chinese medicine composition for treating Parkinson's disease, characterized in that: Including the following raw medicinal materials: cooked rehmannia, cornus fruit, yam, poria, peony bark, oriental water plantain, cinnamon twig, processed aconite, plantago seed, Chinese rhubarb, licorice, peach kernel, cooked rhubarb, and Glauber's salt.

2. A Chinese medicine composition for treating Parkinson's disease according to claim 1, characterized in that: By weight, the raw medicinal materials include: 25-35 parts of cooked rehmannia, 10-20 parts of cornus, 10-20 parts of yam, 10-20 parts of poria, 5-15 parts of peony bark, 10-20 parts of oriental water chestnuts, 5-15 parts of cinnamon twigs, 5-15 parts of processed aconite, 25-35 parts of plantain seeds, 25-35 parts of Chinese rhubarb, 5-15 parts of licorice, 5-15 parts of peach kernels, 5-15 parts of cooked rhubarb, and 1-10 parts of sodium sulfate.

3. A Chinese medicine composition for treating Parkinson's disease according to claim 1, characterized in that: By weight, the raw medicinal materials include: 27-33 parts of cooked rehmannia, 12-18 parts of cornus, 12-18 parts of yam, 12-18 parts of poria, 7-13 parts of peony bark, 12-18 parts of oriental water chestnuts, 7-13 parts of cinnamon twigs, 7-13 parts of processed aconite, 27-33 parts of plantago seeds, 27-33 parts of cyathula, 7-13 parts of licorice, 7-13 parts of peach kernels, 7-13 parts of cooked rhubarb, and 3-7 parts of sodium sulfate.

4. A Chinese medicine composition for treating Parkinson's disease according to claim 1, characterized in that: By weight, the raw medicinal materials include: 29-31 parts of cooked rehmannia, 14-16 parts of cornus fruit, 14-16 parts of yam, 14-16 parts of poria, 9-11 parts of peony bark, 14-16 parts of oriental water plantain, 9-11 parts of cinnamon twig, 9-11 parts of processed aconite, 29-31 parts of plantain seed, 29-31 parts of cyathula, 9-11 parts of licorice, 9-11 parts of peach kernel, 9-11 parts of cooked rhubarb, and 5-6 parts of sodium sulfate.

5. The Chinese medicine composition for treating Parkinson's disease according to any one of claims 1 to 4, characterized in that: It is a preparation made from the powder of raw materials, water or organic solvent extracts of raw materials as active ingredients and pharmaceutically acceptable excipients.

6. The pharmaceutical composition according to claim 5, characterized in that The preparation is an oral preparation.

7. The pharmaceutical composition according to claim 6, characterized in that The oral preparations are decoctions, oral liquids, granules, capsules, tablets, and powders.

8. The method for preparing the Chinese medicine composition for treating Parkinson's disease according to any one of claims 1 to 7, characterized in that: include: Putting other raw medicinal materials except mirabilite into the initial solvent for decoction and filtering to obtain the first filtrate; Then, a solvent is added, the decoction is continued, and a second filtrate is obtained after filtering. The first filtrate and the second filtrate are mixed and then sodium sulfate is added to obtain a traditional Chinese medicine composition for treating Parkinson's disease.

9. The method for preparing a traditional Chinese medicine composition for treating Parkinson's disease according to claim 8, characterized in that: Put the processed aconite into the initial solvent and simmer over low heat for 15-25 minutes, then add other raw medicinal materials except Glauber's salt and add the first solvent. Boil it with high heat first, then simmer it with low heat for 30-50 minutes, and filter to obtain the first filtrate. Then add the second solvent and boil it with high heat first, then simmer it with low heat for 20-40 minutes, and filter to obtain the second filtrate.

10. The method for preparing a traditional Chinese medicine composition for treating Parkinson's disease according to claim 9, characterized in that: The solvent is water, and the amount of solvent added in the first solvent addition and the second solvent addition is 2-4 times of the initial solvent.

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