Traditional Chinese medicine composition for treating motor symptoms of Parkinson's disease as well as preparation method and application of traditional Chinese medicine composition

Abstract

The invention relates to the technical field of traditional Chinese medicines, in particular to application of a traditional Chinese medicine composition in preparation of a medicine for preventing and treating motor symptoms of Parkinson's disease. The traditional Chinese medicine composition is prepared from the following raw material medicines: 15-20 parts of rehmannia, 10-15 parts of eucommia ulmoides, 6-12 parts of gastrodia elata, 12-18 parts of concha haliotidis, 10-15 parts of parasitic loranthus, 12-18 parts of astragalus membranaceus, 6-12 parts of angelica sinensis, 5-8 parts of cassia twig and 10-15 parts of radix paeoniae alba. The composition is scientific and reasonable in component compatibility, has the effects of tonifying the kidney, calming the liver, benefiting qi, nourishing blood, regulating and tonifying the spleen and the stomach, relieving dizziness, activating blood, clearing damp and dredging collaterals, is safe to take and good in curative effect, can be effectively used for preventing and treating motor symptoms of the Parkinson's disease, and has a more remarkable treatment effect compared with other prescriptions.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine technology, specifically relating to a traditional Chinese medicine composition for treating motor symptoms of Parkinson's disease, its preparation method, and its application. Background Technology

[0002] In Traditional Chinese Medicine (TCM), Parkinson's disease falls under the categories of "tremor syndrome," "tremor disease," or "spasm disease." It is a common neurodegenerative disease affecting middle-aged and elderly people, characterized by the degeneration and loss of dopaminergic neurons in the substantia nigra pars compacta and the formation of Lewy bodies. Motor symptoms of Parkinson's disease include bradykinesia, rigidity, resting tremor, and postural and gait abnormalities.

[0003] The team's preliminary research found that: (1) Bradykinesia and rigidity in Parkinson's disease are caused by insufficient Qi and blood, deficiency of essence and marrow, and lack of nourishment of tendons and vessels, manifested as stiffness, rigidity and inflexibility of limbs, slow and unskilled movement; (2) "All dizziness and vertigo belong to the liver", so tremor is most related to "internal movement of liver wind"; (3) "All tendons belong to joints", so the postural and gait disorders of Parkinson's disease patients are a manifestation of insufficient liver blood, lack of nourishment of tendons and weak tendon strength; at the same time, "the spleen cannot transport the fluids of the stomach, the four limbs cannot receive the Qi of water and grain, the Qi declines day by day, the pulse is obstructed, and the tendons, bones and muscles have no Qi to generate, so they are not used", indicating that the postural and gait abnormalities of Parkinson's disease patients are also related to the spleen's lack of strength.

[0004] Motor symptoms in Parkinson's disease significantly reduce patients' quality of life. However, there is currently no disease-paclitaxel to slow or halt the progression of Parkinson's disease motor symptoms. The most prevalent treatment methods both domestically and internationally remain dopaminergic replacement therapy, represented by combination levodopa, dopamine receptor agonists, monoamine oxidase B inhibitors, and catechol-O-methyltransferase inhibitors. While existing Western medicines can improve motor symptoms in the short term, long-term use can easily lead to complications such as end-of-dose symptoms and dyskinesia. Traditional Chinese medicine preparations, such as Yanggan Xifeng Wan and Guilu Erxian Jiao, while nourishing the liver and kidneys, cannot simultaneously address the comprehensive needs of tremor control, rigidity improvement, and motor coordination regulation. Therefore, developing innovative traditional Chinese medicine preparations that comprehensively regulate the motor symptoms of Parkinson's disease has urgent clinical value. Summary of the Invention

[0005] In view of this, the technical problem to be solved by the present invention is to provide the application of traditional Chinese medicine composition in the preparation of a drug for preventing and treating motor symptoms of Parkinson's disease.

[0006] This invention provides the application of a traditional Chinese medicine composition in the preparation of a drug for preventing and treating motor symptoms of Parkinson's disease.

[0007] In this invention, the traditional Chinese medicine composition comprises the following raw materials in parts by weight:

[0008] Rehmannia glutinosa 15-20 parts, Eucommia ulmoides 10-15 parts, Gastrodia elata 6-12 parts, Abalone shell 12-18 parts, Taxillus chinensis 10-15 parts, Astragalus membranaceus 12-18 parts, Angelica sinensis 6-12 parts, Cinnamomum cassia 5-8 parts, and Paeonia lactiflora 10-15 parts.

[0009] The traditional Chinese medicine composition provided by this invention is based on long-term clinical practice. The components are scientifically and rationally combined according to the principles of traditional Chinese medicine (TCM) formulation, where each component supports the other. Specifically:

[0010] Rehmannia glutinosa nourishes Yin and tonifies the kidneys, replenishes essence and marrow, while Eucommia ulmoides tonifies the liver and kidneys and strengthens tendons and bones. Together, they serve as the principal herbs to nourish Yin and tonify Yang, thus building a solid foundation for strengthening the body's vital energy.

[0011] Gastrodia elata and abalone shell calm the liver and extinguish wind, directly targeting the tremors caused by internal wind; Taxillus chinensis dispels wind and dampness, tonifies the liver and kidneys, and strengthens tendons and bones; Astragalus membranaceus and Angelica sinensis replenish qi and blood, nourish tendons and vessels, and improve stiffness and qi deficiency and blood stasis. Together they are the assistant herbs.

[0012] Raw white peony nourishes blood, softens tendons, soothes the liver, and relieves spasms. When combined with cinnamon twig, which is pungent and sweet to transform yang and sour and sweet to transform yin, it adopts the same proportion as Jianzhong Decoction. Together, they work to regulate blood vessels and harmonize the spleen and stomach, serving as adjuvant herbs.

[0013] Cinnamon twig also serves as an adjuvant, warming and unblocking the meridians, promoting qi and blood circulation, coordinating the effects of other herbs, enhancing the overall invigorating effect of the prescription, while also warming the medicinal properties and guiding them directly to the affected area, and preventing the tonic herbs from being too rich and cloying.

[0014] In a specific embodiment, the traditional Chinese medicine composition is made from the following raw materials in parts by weight:

[0015] 18 parts Rehmannia glutinosa, 12 parts Eucommia ulmoides, 9 parts Gastrodia elata, 15 parts Abalone shell, 12 parts Taxillus chinensis, 15 parts Astragalus membranaceus, 9 parts Angelica sinensis, 6 parts Cinnamomum cassia, and 12 parts Paeonia lactiflora.

[0016] In some embodiments, the Rehmannia glutinosa is prepared Rehmannia glutinosa, and the Paeonia lactiflora is raw Paeonia lactiflora.

[0017] This invention provides a traditional Chinese medicine extract, which is obtained by extraction from a traditional Chinese medicine composition.

[0018] As a feasible example, the preparation of the extract can be carried out by water decoction extraction, percolation extraction, solution immersion extraction, or ultrasonic-assisted extraction, microwave-assisted extraction, or enzymatic extraction.

[0019] Furthermore, the present invention also provides a method for preparing the Chinese herbal extract as described above, which includes: extracting Rehmannia glutinosa, Eucommia ulmoides, Gastrodia elata, Haliotis diversicolor, Taxillus chinensis, Astragalus membranaceus, Angelica sinensis, Cinnamomum cassia and Paeonia lactiflora by decoction with water.

[0020] In some embodiments, the water mass in the decoction extraction is 5 to 8 times the total mass of the medicinal materials. For example, the water mass is 5, 6, 7, or 8 times the total mass of the medicinal materials. In a specific embodiment, the water mass in the decoction extraction is 6 times the total mass of the medicinal materials.

[0021] In some embodiments, the water decoction extraction is performed 1 to 5 times, and the extracts are combined after extraction. For example, the water decoction extraction is performed 1, 2, 3, 4, or 5 times. In a specific embodiment, the water decoction extraction is performed 2 times.

[0022] In some embodiments, the conditions for water decoction extraction include: each extraction lasting 30-90 minutes. For example, the extraction time may be 30, 40, 50, 60, 70, 80, or 90 minutes. In a specific embodiment, the extraction time is 60 minutes. In the embodiments of the present invention, the extraction time may be the same or different each time, and the present invention does not limit this.

[0023] In some embodiments, the conditions for water decoction extraction further include controlling the water decoction extraction temperature to a state of slight boiling to boiling. For example, a gentle simmer is maintained, or a vigorous boil is maintained. In specific implementation, the heat can be adjusted in stages, either by slow simmering or rapid simmering, depending on the properties of the medicinal materials. In a specific embodiment, the water decoction extraction temperature is 100°C. This invention does not limit the method of heat control.

[0024] The preparation method of this invention further includes a step of filtering the traditional Chinese medicine extract. The method of filtration is not limited in this invention. For example, filtration methods may include double-layer gauze filtration, microporous membrane filtration, plate and frame filtration, or centrifugal filtration. In a specific embodiment, the filtration method is double-layer gauze filtration. All of the above methods can be used in the preparation method of this invention.

[0025] The preparation method of the present invention further includes a step of concentrating the traditional Chinese medicine extract, wherein the concentration is such that the relative density of the extract at 60-80°C is 1.14-1.15. For example, the relative density of the extract is 1.14, 1.142, 1.144, 1.146, 1.148, or 1.15. In a specific embodiment, the relative density of the extract is 1.145.

[0026] The method of drug concentration is not limited in this invention. For example, concentration methods may include vacuum concentration, atmospheric pressure concentration, multi-effect concentration, or thin-film concentration. All of the above methods can be used in the preparation method described in this invention. In a specific embodiment, the concentration method is vacuum concentration, with the conditions being a concentration pressure of -0.07 MPa and a concentration temperature of 70°C.

[0027] The preparation method of this invention further includes a step of drying the herbal extract. The method of drying the extract is not limited in this invention. For example, drying methods may include oven drying, vacuum drying, freeze drying, spray drying, microwave drying, or far-infrared drying. All of the above methods can be used in the preparation method of this invention. In a specific embodiment, the drying method is spray drying.

[0028] Furthermore, the present invention also provides the application of the aforementioned traditional Chinese medicine composition, the aforementioned traditional Chinese medicine extract, and the traditional Chinese medicine extract prepared by the aforementioned preparation method in the preparation of a drug for preventing and treating motor symptoms of Parkinson's disease.

[0029] In this invention, the prevention and treatment include prevention and / or treatment. Prevention of Parkinson's disease motor symptoms prevents or reduces disease-related symptoms (including improving postural and gait disturbances and overall motor function, and slowing disease progression), while treatment of Parkinson's disease motor symptoms reduces or cures clinical symptoms (specifically manifested as significantly improving the overall motor function of patients with Parkinson's disease motor symptoms, and effectively improving the patient's quality of life and TCM syndromes through multi-target regulation).

[0030] In this invention, the motor symptoms of patients with Parkinson's disease include the MDS-UPDRS motor component score, functional gait assessment, standing-walking time, frozen gait questionnaire, quality of life of Parkinson's patients, and the Parkinson's disease TCM syndrome scale.

[0031] In this invention, the targets of prevention and control include humans or mammals. These mammals include, but are not limited to, orangutans, gibbons, baboons, macaques, rhesus monkeys, cynomolgus monkeys, marmosets, mice, rats, guinea pigs, hamsters, rabbits, dogs, cats, pigs, sheep, horses, cattle, and camels.

[0032] Furthermore, the present invention also provides a medicament for treating motor symptoms of Parkinson's disease, comprising: pharmaceutically acceptable excipients and the traditional Chinese medicine composition as described above, the traditional Chinese medicine extract as described above, or the traditional Chinese medicine extract prepared by the preparation method as described above.

[0033] In this invention, the dosage form of the drug is decoction, granules, pills, powder, capsules, tablets, oral liquid, syrup, ointment, pill, or drop pill.

[0034] The method for preparing the Chinese herbal extract as described above in this invention further includes mixing the Chinese herbal extract with excipients, drying, and granulating to obtain the extract.

[0035] Preferably, the pharmaceutically acceptable excipients include, but are not limited to, at least one of the following: fillers (e.g., starch, dextrin, sucrose, lactose, microcrystalline cellulose), binders (e.g., sodium carboxymethyl cellulose, hydroxypropyl methyl cellulose, ethyl cellulose, povidone, hydroxypropyl cellulose), disintegrants (e.g., crospovidone, crospovidone), lubricants (e.g., magnesium stearate, talc, micronized silica gel, sodium lauryl sulfate), surfactants (e.g., polyethylene glycol), or oils (e.g., petrolatum, lanolin, beeswax).

[0036] In some embodiments, the excipient includes dextrin, and the mass ratio of dextrin to the concentrated material is 1:(10~15). For example, the mass ratio of dextrin to the concentrated material is 1:10, 1:11, 1:12, 1:13, 1:14, or 1:15. In a specific embodiment, the mass ratio of dextrin to the concentrated material is 1:12.

[0037] Furthermore, the present invention also provides a method for preventing and treating motor symptoms of Parkinson's disease, comprising administering the traditional Chinese medicine composition as described above, the traditional Chinese medicine extract as described above, or the traditional Chinese medicine extract prepared by the preparation method as described above.

[0038] In this invention, the methods of administration include, but are not limited to, oral administration.

[0039] The traditional Chinese medicine composition provided by this invention is made from 15-20 parts of Rehmannia glutinosa, 10-15 parts of Eucommia ulmoides, 6-12 parts of Gastrodia elata, 12-18 parts of Haliotis diversicolor, 10-15 parts of Taxillus chinensis, 12-18 parts of Astragalus membranaceus, 6-12 parts of Angelica sinensis, 5-8 parts of Cinnamomum cassia, and 10-15 parts of Paeonia lactiflora. This composition has a scientifically and rationally formulated composition, possessing the effects of nourishing the liver and kidneys, invigorating qi and strengthening the spleen, softening tendons and nourishing blood vessels, extinguishing wind and stopping tremors, and promoting blood circulation and removing dampness. It is safe to take, has good efficacy, and can be effectively used to treat the motor symptoms of Parkinson's disease, exhibiting a more significant therapeutic effect compared to other prescriptions. Detailed Implementation

[0040] This invention provides a traditional Chinese medicine composition for preventing and treating motor symptoms of Parkinson's disease. Those skilled in the art can refer to the content of this document and appropriately modify the process parameters to achieve the desired result. It should be particularly noted that all similar substitutions and modifications are obvious to those skilled in the art and are considered to be included in this invention. The methods and applications of this invention have been described through preferred embodiments. Those skilled in the art can obviously make modifications or appropriate alterations and combinations to the methods and applications described herein without departing from the content, spirit, and scope of this invention to realize and apply the technology of this invention.

[0041] Unless otherwise defined in this invention, the scientific and technical terms associated with this invention shall have the meanings understood by one of ordinary skill in the art.

[0042] The terms “comprising,” “including,” and “having” are used interchangeably to indicate the inclusiveness of a scheme, meaning that the scheme may contain elements other than those listed. It should also be understood that the use of “comprising,” “including,” and “having” herein also provides for schemes “consisting of…”.

[0043] When used herein, the term “and / or” includes the meaning of “and,” “or,” and “all or any other combination of elements linked by the term.”

[0044] The term "at least one" means one or more, and "more than one" means two or more. "At least one of the following" or similar expressions refer to any combination of these items, including any combination of single or multiple items.

[0045] It should be understood that in the various embodiments of this application, the order of the above processes does not imply the order of execution. Some or all steps may be executed in parallel or sequentially. The execution order of each process should be determined by its function and internal logic, and should not constitute any limitation on the implementation process of the embodiments of this application.

[0046] The test materials used in this invention are all common commercially available products, and can be purchased on the market. Among them:

[0047] Rehmannia root is the dried tuberous root of Rehmannia glutinosa Libosch., a plant in the Scrophulariaceae family. Prepared Rehmannia root is a processed product made by repeatedly steaming and drying (with or without rice wine) until it is black inside and out and oily. It is sweet and slightly warm in nature, entering the liver and kidney meridians, nourishing blood and yin, and replenishing essence and marrow.

[0048] Eucommia ulmoides Oliv., a plant in the Eucommaceae family, is the dried bark of the tree. It is sweet and warm in nature, entering the liver and kidney meridians. It tonifies the liver and kidneys, strengthens tendons and bones, and calms the fetus, preventing miscarriage.

[0049] Gastrodia elata is the dried tuber of the orchid Gastrodia elata Bl. It is sweet and neutral in nature, enters the liver meridian, and has the functions of calming wind and stopping spasms, suppressing liver yang, and dispelling wind and unblocking the meridians.

[0050] Abalone shell is the dried shell of Haliotis diversicolor Reeve and other abalone species belonging to the family Haliotisidae. It is salty and cold in nature, enters the liver meridian, and has the functions of calming the liver and suppressing yang, clearing the liver and improving eyesight, and calming the nerves and relieving anxiety.

[0051] Taxillus chinensis (DC.) Danser is the dried leafy stem and branches of the plant Taxillus chinensis (DC.) Danser, belonging to the Loranthaceae family. It is bitter, sweet, and neutral in nature, entering the liver and kidney meridians. Its functions include dispelling wind-dampness, tonifying the liver and kidneys, strengthening tendons and bones, and calming the fetus and stopping bleeding.

[0052] Astragalus is the dried root of *Astragalus membranaceus* (Fisch.) Bge. var. *mongholicus* (Bge.) Hsiao or *Astragalus membranaceus* (Fisch.) Bge., belonging to the Fabaceae family. It is sweet and slightly warm in nature, entering the spleen and lung meridians. It tonifies qi and raises yang, strengthens the exterior and stops sweating, and promotes diuresis and reduces swelling.

[0053] Angelica sinensis is the dried root of Angelica sinensis (Oliv.) Diels, a plant belonging to the Apiaceae family. It is sweet, pungent, and warm in nature, and enters the liver, heart, and spleen meridians. It nourishes and invigorates blood, regulates menstruation and relieves pain, and moistens the intestines to promote bowel movements.

[0054] Cinnamon twigs are the dried young branches of the cinnamon tree (Cinnamomum cassia Presl). They are pungent, sweet, and warm in nature, entering the heart, lung, and bladder meridians. They promote sweating and relieve muscle tension, warm and unblock the meridians, and assist yang in the transformation of qi.

[0055] Raw white peony root is the dried root of Paeonia lactiflora Pall., a plant in the Ranunculaceae family. It is bitter, sour, and slightly cold in nature. It enters the liver and spleen meridians, nourishes blood and regulates menstruation, astringes yin and stops sweating, and soothes the liver and relieves pain.

[0056] The above-mentioned components are scientifically and rationally combined according to the principles of traditional Chinese medicine (TCM) for the compatibility of principal, assistant, adjuvant, and guide herbs. They support each other. Rehmannia glutinosa nourishes Yin and tonifies the kidneys, replenishes essence and marrow; Eucommia ulmoides tonifies the liver and kidneys, strengthens tendons and bones. Together they serve as the principal herbs, nourishing Yin and Yang, consolidating the foundation and cultivating the source. Gastrodia elata and Haliotis diversicolor calm the liver and extinguish wind, directly targeting the tremors caused by internal wind. Taxillus chinensis dispels wind and dampness, tonifies the liver and kidneys, and strengthens tendons and bones. Astragalus membranaceus and Angelica sinensis tonify Qi and generate blood, nourish tendons and vessels, and improve stiffness and Qi deficiency and blood stasis. Together they serve as the assistant herbs. Paeonia lactiflora nourishes blood, softens tendons, soothes the liver and relieves spasms. Combined with Cinnamomum cassia, which is pungent and sweet, transforms into Yang and sour and sweet, transforms into Yin, using the ratio of Jianzhong Decoction, together they work to regulate blood vessels and harmonize the spleen and stomach. Together they serve as the adjuvant herbs. Cinnamomum cassia also serves as the guide herb, warming and unblocking the meridians, promoting Qi and blood circulation, coordinating the effects of the other herbs, enhancing the overall invigorating effect of the formula, warming the medicinal properties, guiding the medicinal properties directly to the disease site, and preventing the tonifying herbs from being too greasy. The combined use of these herbs achieves a comprehensive and systematic intervention on motor symptoms such as bradykinesia, rigidity, tremor, and postural and gait disturbances through multi-target synergistic effects, including tonifying the kidneys, calming the liver, strengthening the spleen, replenishing qi, nourishing blood, extinguishing wind, unblocking meridians, and dispelling dampness. This addresses the shortcomings of existing treatments that are often singular and incomplete. Clinical studies have confirmed that this combination (in conjunction with conventional Western medicine) can significantly improve patients' overall motor function, quality of life, and TCM syndromes, with a particularly strong advantage in improving postural and gait disturbances that are difficult to address with traditional therapies. Its readily available raw materials, simple preparation, and high safety profile provide an effective and safe new option for the treatment of motor symptoms in Parkinson's disease, demonstrating significant clinical value and promising application prospects.

[0057] The numerical ranges and parameters involved in this invention have been presented as precisely as possible in the specific embodiments. However, any numerical value inevitably contains standard deviations due to individual test methods. Therefore, unless otherwise expressly stated, it should be understood that all numerical ranges or specific data used in this disclosure may have a reasonable deviation within a certain range, such as ±10%, ±5%, ±1%, or ±0.5%.

[0058] The present invention will be further illustrated below with reference to the embodiments:

[0059] Example 1

[0060] A compound traditional Chinese medicine for preventing and treating motor symptoms of Parkinson's disease is prepared from raw materials including 18 parts of Rehmannia glutinosa, 12 parts of Eucommia ulmoides, 9 parts of Gastrodia elata, 15 parts of Haliotis diversicolor, 12 parts of Taxillus chinensis, 15 parts of Astragalus membranaceus, 9 parts of Angelica sinensis, 6 parts of Cinnamomum cassia, and 12 parts of Paeonia lactiflora. The water content is 5 to 8 times the total weight of the medicinal materials. The decoction is performed twice, each time for 60 minutes. The two filtrates are combined and filtered through double-layer gauze to obtain the final product.

[0061] Example 2

[0062] A compound traditional Chinese medicine for preventing and treating motor symptoms of Parkinson's disease is prepared from raw materials including 18 parts Rehmannia glutinosa, 12 parts Eucommia ulmoides, 9 parts Gastrodia elata, 15 parts Haliotis diversicolor, 12 parts Taxillus chinensis, 15 parts Astragalus membranaceus, 9 parts Angelica sinensis, 6 parts Cinnamomum cassia, and 12 parts Paeonia lactiflora. The water content is 6 times the total mass of the medicinal materials. The decoction is performed twice, each time for 60 minutes. The two decoctions are combined, filtered through double-layer gauze, and concentrated until the extract has a relative density of 1.14–1.15 at 60–80°C. Dextrin is diluted with pure water, filtered, and mixed evenly with the extract. The mass of the extract is 12 times the total mass of the dextrin. The mixture is then spray-dried and granulated to obtain the final product.

[0063] Efficacy Verification 1

[0064] The relevant experimental data are as follows:

[0065] I. Criteria for Case Selection

[0066] The clinical manifestations of motor symptoms in Parkinson's disease include resting tremor, bradykinesia, rigidity, and postural and gait disturbances. Symptoms often begin unilaterally and progressively worsen, and may include a "mask-like face," micrographia, and a weak voice. Tongue examination often reveals tremors, a pale tongue, or petechiae. The pulse is often thready or weak and thready. Non-motor symptoms such as constipation and sleep disturbances are common. In advanced stages, it can lead to difficulty in movement, swallowing, and speech. Patients exhibiting any of the above symptoms can be used as selection criteria for cases.

[0067] The 72 Parkinson's disease cases that met the inclusion criteria were all patients who visited Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, affiliated with Shanghai University of Traditional Chinese Medicine, between June 2024 and May 2025. After fully understanding the trial content, risks, benefits, and participant rights, the subjects voluntarily signed written informed consent forms. The 72 eligible patients were randomly assigned to two groups: one group received the present invention and conventional Western medicine treatment, and the other group received a placebo and conventional Western medicine treatment. During the trial, neither the subjects nor the researchers conducting the assessments knew their respective groups. During follow-up, 4 patients dropped out or were lost to follow-up in the present invention treatment group, and 3 patients dropped out or were lost to follow-up in the placebo control group. Ultimately, 32 patients were included in the present invention treatment group and 33 patients in the placebo control group for the analysis.

[0068] Inclusion criteria: ① Meets the diagnostic criteria for primary Parkinson's disease as revised by the International Movement Disorders Association in 2015; ② Hoehn & Yahr classification is 1-4; ③ Age is 40-80 years, gender is not limited; ④ Signed informed consent form; ⑤ Anti-Parkinson's drugs and dosage have been relatively stable for at least 12 weeks prior to this clinical trial, and there are no plans to change the existing treatment regimen in the next 3 months.

[0069] Exclusion criteria: ① Age under 40 years or over 80 years; ② Other diseases that cause gait abnormalities; ③ Parkinson's syndrome caused by cerebrovascular disease, encephalitis, poisoning, drugs, etc., and Parkinson's disease plus syndrome; ④ Severe diseases of the heart, liver, kidneys, etc.; ⑤ History of dementia or mental illness; ⑥ Pregnant or lactating women; ⑦ Participation in other clinical studies within the past 12 weeks.

[0070] II. Diagnostic Criteria

[0071] (1) Western medical diagnostic criteria for Parkinson's disease: Refer to the latest revised diagnostic criteria for "clinically diagnosed Parkinson's disease" by the International Movement Disorders Association in 2015.

[0072] (2) Diagnostic criteria for Parkinson's disease in traditional Chinese medicine: Refer to the diagnostic criteria in the "Standards for Diagnosis and Efficacy Evaluation of Tremor Syndrome in Traditional Chinese Medicine in the Elderly (Trial)" formulated by the Geriatrics Society of the Chinese Association of Traditional Chinese Medicine in 1992.

[0073] III. Treatment Plan

[0074] During the trial, the present invention was used to treat the patients and to placebo control the patients.

[0075] The treatment group of this invention, namely Example 2, is made from 18 parts of Rehmannia glutinosa (processed), 12 parts of Eucommia ulmoides, 9 parts of Gastrodia elata, 15 parts of Haliotis diversicolor, 12 parts of Taxillus chinensis, 15 parts of Astragalus membranaceus, 9 parts of Angelica sinensis, 6 parts of Cinnamomum cassia, and 12 parts of Paeonia lactiflora. One packet is taken twice daily, dissolved in warm water after breakfast and dinner, for 12 weeks.

[0076] Placebo control group: The placebo used is a mimic of the drug used in the treatment group of this invention, and its appearance (color, shape, size, odor, etc.) is indistinguishable to the naked eye. Take one packet twice daily, dissolved in warm water after breakfast and dinner, for 12 weeks.

[0077] During treatment, avoid rich, fatty, cold, and spicy foods.

[0078] IV. Efficacy Evaluation Criteria

[0079] (1) Main therapeutic indicators:

[0080] The motor component of the World Society of Movement Disorders' New Version of the Comprehensive Evaluation Scale for Parkinson's Disease (MDS-UPDRSⅢ) was used. Secondary efficacy endpoints included Functional Gait Assessment (FGA), Time to Stand and Walk (TUG), Freeze-of-Gait Questionnaire (FOG-Q), Parkinson's Disease Patient Quality of Life Questionnaire-39 (PDQ-39), and the Traditional Chinese Medicine Syndrome Scale for Parkinson's Disease (PD-TCMSS). Evaluations were performed at baseline, 4 weeks after treatment, 8 weeks after treatment, and 12 weeks after treatment.

[0081] (2) Safety indicators:

[0082] Adverse reactions are monitored dynamically through blood routine tests, liver and kidney function tests, urine and stool routine tests, and electrocardiograms.

[0083] V. Statistical Analysis of Test Results

[0084] (1) Baseline characteristics of patients in the treatment group and placebo control group of the present invention

[0085] Table 1. Comparison of baseline characteristics between the two groups of patients

[0086]

[0087] Note: MDS-UPDRS Ⅲ: Motor score of the new version of the Parkinson's Disease Comprehensive Assessment Scale of the World Society for Movement Disorders; FGA: Functional Gait Assessment; TUG: Standing-Walking Time; FOG-Q: Freeze-of-Gait Questionnaire; PDQ-39: Parkinson's Disease Patient Quality of Life Questionnaire; PD-TCMSS: Traditional Chinese Medicine Syndrome Scale for Parkinson's Disease; P > 0.05.

[0088] (2) Analysis of the efficacy of the two groups of patients after 12 weeks of treatment

[0089] Table 2. Evaluation of efficacy in the two groups of patients after 12 weeks of treatment.

[0090]

[0091] Note: MDS-UPDRS Ⅲ: Motor score of the new version of the World Society for Movement Disorders Parkinson's Disease Comprehensive Assessment Scale; FGA: Functional Gait Assessment; TUG: Standing-to-Walk Timing; FOG-Q: Freeze-of-Gait Questionnaire; PDQ-39: Parkinson's Disease Patient Quality of Life Questionnaire; PD-TCMSS: Parkinson's Disease Traditional Chinese Medicine Syndrome Scale; A linear mixed-effects model was used for analysis, and all P values ​​were <0.01.

[0092] (3) Safety analysis of the two groups of patients during the 12-week treatment period

[0093] Table 3. Adverse reactions in the two groups during the 12-week treatment period.

[0094]

[0095] Note: Fisher's exact test p > 0.05.

[0096] Compared with the prior art, the present invention has the following beneficial effects: (1) It has a definite curative effect and can significantly improve the motor function of patients with motor symptoms of Parkinson's disease. Clinical research results show that after 12 weeks of treatment with the traditional Chinese medicine composition of the present invention on the basis of conventional treatment, the patients' MDS-UPDRS motor scores showed significant improvement. Compared with the placebo control group, the average score of the combined treatment group decreased by about -3.70, and the difference between the groups was statistically significant (P < 0.001). (2) It comprehensively improves clinical symptoms: The present invention can effectively improve the patients' motor function, gait function and quality of life. (3) It has high safety and compliance: During the study, the incidence of gastrointestinal adverse reactions was not statistically different from that of the placebo control group (P>0.05); no obvious toxic side effects or any serious adverse events were observed, indicating that the traditional Chinese medicine composition of the present invention is safe and reliable. The total dropout rate of the two groups was less than 10% (9.72%), indicating good compliance and tolerability, and good statistical accuracy and representativeness.

[0097] VI. Analysis

[0098] Pathological Analysis: In Traditional Chinese Medicine (TCM), Parkinson's disease is mainly classified under the categories of "tremor syndrome" or "spasm syndrome." Broadly speaking, tremor syndrome refers to diseases characterized by shaking and trembling of the limbs due to various causes. Narrowly defined, tremor syndrome specifically refers to chronic, progressive diseases characterized by resting tremor, muscle rigidity, bradykinesia, and postural and gait abnormalities, often caused by internal injuries and accumulated damage. Modern medical Parkinson's disease falls under this narrower definition. Parkinson's disease is a common neurodegenerative disease, most typical in middle-aged and elderly people, slightly more common in men than women. Its incidence increases significantly with age, making it a major chronic neurodegenerative disease that seriously affects the quality of life of the elderly. The disease has a long course, progressively worsens, and is currently difficult to cure. In its late stages, it often leads to significant functional impairment and even inability to care for oneself. The motor symptoms include bradykinesia, muscle rigidity, resting tremor, and postural and gait abnormalities.

[0099] Based on traditional Chinese medicine theory and clinical practice, the core pathogenesis of late-stage Parkinson's disease is considered to be "deficiency of the root and excess of the branch." Deficiency of the root is the fundamental cause of the disease, manifested as a deficiency of Yin, Yang, Qi, and Blood, primarily kidney deficiency. The deficiency of the root precedes the excess of the branch, which arises from the deficiency and is mainly caused by wind, blood stasis, and dampness. The disease location is in the brain, and it is most closely related to the kidneys, liver, and spleen. Based on a comprehensive analysis of the pathogenesis of motor symptoms in Parkinson's disease, our invention team has summarized "nourishing the liver and kidneys, invigorating Qi and strengthening the spleen, nourishing blood and softening tendons, and extinguishing wind and stopping tremors" as the basic treatment principle for motor symptoms of Parkinson's disease, aiming to slow disease progression and improve quality of life and TCM syndromes.

[0100] Fang Yi's analysis: (1) Rehmannia glutinosa nourishes Yin and tonifies the kidneys, replenishes essence and marrow, while Eucommia ulmoides tonifies the liver and kidneys and strengthens tendons and bones. The two are the principal herbs, which nourish Yin and tonify Yang, and together build a foundation for strengthening the body and cultivating the source. (2) Gastrodia elata and Abalone shell calm the liver and extinguish wind, mainly targeting the symptoms of internal wind due to deficiency, namely tremor. Taxillus chinensis can dispel wind and dampness, tonify the liver and kidneys, and strengthen bones. Astragalus membranaceus and Angelica sinensis tonify Qi and generate blood, and invigorate Qi and blood. They can nourish tendons and vessels, relieve patients' stiffness and abnormal posture and gait, and improve the symptoms of Qi deficiency and blood stasis. The above five herbs are all assistant herbs; (3) Raw white peony can nourish blood and soften tendons, and also help soften the liver and relieve urgency; Cinnamon twig and raw white peony are pungent and sweet to transform yang and sour and sweet to transform yin. They are combined with the "Jianzhong Decoction" to achieve the effect of regulating blood vessels and harmonizing the spleen and stomach. Therefore, the two are both adjuvant herbs; (4) Cinnamon twig is also an adjuvant herb. It warms and unblocks the meridians, promotes qi and blood circulation, coordinates the herbs, and enhances the overall effect of the prescription. At the same time, it warms the medicinal properties and guides the medicinal properties to the disease site. It can also prevent the tonifying herbs from being too greasy. Therefore, this prescription has the effects of nourishing the liver and kidneys, invigorating qi and strengthening the spleen, nourishing blood and softening tendons, and extinguishing wind and stopping tremors.

[0101] VII. Conclusion

[0102] The TCM syndrome characteristics of Parkinson's disease generally fall under the category of "deficiency of the root and excess of the branch." The root deficiency in its motor symptoms is liver and kidney yin deficiency and insufficient qi and blood, while the branch excess is obstruction of the brain orifices by phlegm, blood stasis, wind, and toxins. Therefore, prevention and treatment should fundamentally follow the principles of nourishing the liver and kidneys to strengthen the root, invigorating qi and strengthening the spleen to replenish the source of qi and blood, calming the liver and extinguishing wind to stop tremors, nourishing blood and softening tendons to relieve spasms, and promoting blood circulation and removing dampness to clear stagnation. This formula has remarkable efficacy in preventing and treating the motor symptoms of Parkinson's disease. Experimental and clinical studies have shown that the combination of principal, assistant, and adjuvant Chinese herbs in this invention is scientifically sound and combines the effects of nourishing the liver and kidneys, invigorating qi and strengthening the spleen, softening tendons and nourishing blood vessels, extinguishing wind and stopping tremors, and promoting blood circulation and removing dampness. It can significantly improve symptoms such as tremor, rigidity, bradykinesia, and postural instability in patients with Parkinson's disease, with definite efficacy, rapid onset of action, safe and reliable administration, no toxic side effects, and a total effective rate as high as 81.3%. This product is currently a relatively ideal traditional Chinese medicine preparation for the prevention and treatment of motor symptoms of Parkinson's disease. It is a major innovation in the treatment of motor symptoms of Parkinson's disease and has significant economic and social benefits.

[0103] The above are merely preferred embodiments of the present invention. It should be noted that those skilled in the art can make various improvements and modifications without departing from the principle of the present invention, and these improvements and modifications should also be considered within the scope of protection of the present invention.

Claims

1. A traditional Chinese medicine composition, characterized in that, Made from the following parts by weight of raw materials: Rehmannia glutinosa 15-20 parts, Eucommia ulmoides 10-15 parts, Gastrodia elata 6-12 parts, Abalone shell 12-18 parts, Taxillus chinensis 10-15 parts, Astragalus membranaceus 12-18 parts, Angelica sinensis 6-12 parts, Cinnamomum cassia 5-8 parts, and Paeonia lactiflora 10-15 parts.

2. The traditional Chinese medicine composition according to claim 1, characterized in that, Made from the following parts by weight of raw materials: The ingredients are: Rehmannia glutinosa (18 parts), Eucommia ulmoides (12 parts), Gastrodia elata (9 parts), Haliotis diversicolor (15 parts), Taxillus chinensis (12 parts), Astragalus membranaceus (15 parts), Angelica sinensis (9 parts), Cinnamomum cassia (6 parts), and Paeonia lactiflora (12 parts).

3. The traditional Chinese medicine composition according to claim 1 or 2, characterized in that, The Rehmannia glutinosa mentioned is prepared Rehmannia glutinosa, and the Paeonia lactiflora mentioned is raw Paeonia lactiflora.

4. A traditional Chinese medicine extract, characterized in that, It is prepared by extraction from the traditional Chinese medicine composition according to any one of claims 1 to 3.

5. The method for preparing the traditional Chinese medicine extract according to claim 4, characterized in that, include: The product is prepared by decocting Rehmannia glutinosa, Eucommia ulmoides, Gastrodia elata, Haliotis diversicolor, Taxillus chinensis, Astragalus membranaceus, Angelica sinensis, Cinnamomum cassia, and Paeonia lactiflora in water.

6. The preparation method according to claim 5, characterized in that, In the water decoction extraction, the mass of water is 5 to 8 times the total mass of the medicinal materials, and the water decoction extraction is performed twice, each time for 60 minutes.

7. The preparation method according to claim 5, characterized in that, After the water decoction extraction, the process further includes concentration and drying steps, wherein the concentration is such that the relative density of the extract is 1.14 to 1.15 at 60 to 80°C.

8. The traditional Chinese medicine composition according to claim 1 or 2, or the traditional Chinese medicine composition prepared by the preparation method according to claim 5, is used in the preparation of a drug for preventing and treating motor symptoms of Parkinson's disease.

9. The application according to claim 8, characterized in that, The prevention and treatment include improving motor symptoms in patients with Parkinson's disease.

10. Medications for preventing and treating motor symptoms of Parkinson's disease, including: Pharmaceutically acceptable excipients and the traditional Chinese medicine composition according to any one of claims 1 to 3, the traditional Chinese medicine extract according to claim 4, or the traditional Chinese medicine extract prepared by the preparation method according to any one of claims 5 to 7.

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