A traditional Chinese medicine compound preparation for treating motor dysfunction of Parkinson's disease

Abstract

This invention relates to the field of pharmaceutical technology for treating motor dysfunction in Parkinson's disease, and particularly to a traditional Chinese medicine preparation for treating motor dysfunction in Parkinson's disease. The formula consists of Cimicifuga rhizome, processed turtle shell, Angelica sinensis, raw licorice root, ginger-processed Pinellia ternata, Gastrodia elata, and scorpion. This invention uses a traditional Chinese medicine formula to treat motor dysfunction in Parkinson's disease. The medicinal materials comply with national regulations for the management of traditional Chinese medicine materials and have undergone clinical testing. The formula is rationally formulated with high synergistic effects and long-lasting and stable efficacy. Based on the principles of traditional Chinese medicine syndrome differentiation and treatment, this formula addresses the deficiency of both liver and kidney, and the insufficiency of qi and blood, with tremor and paralysis attributed to internal liver wind. It significantly improves motor dysfunction and tremor symptoms in Parkinson's disease. This preparation is highly effective, safe, reliable, and has few side effects. It can also significantly reduce the expression levels of tyrosine hydroxylase in the substantia nigra and striatum. This preparation represents a new approach to treating motor dysfunction in Parkinson's disease and has broad prospects in the field of treating this condition.

Description

Technical Field

[0001] This invention relates to the field of pharmaceutical technology for treating Parkinson's disease, and more particularly to a traditional Chinese medicine compound preparation for treating motor dysfunction in Parkinson's disease. Background Technology

[0002] Parkinson's disease (PD) is a progressive neurodegenerative disease characterized by the progressive death of dopaminergic neurons in the pars compacta of the substantia nigra and the formation of Lewy bodies in the cytoplasm of the remaining neurons. Clinically, PD is characterized by motor symptoms such as bradykinesia, resting tremor, and rigidity, as well as non-motor symptoms such as cognitive impairment, mood changes, sleep disturbances, sensory disturbances, and gastrointestinal dysfunction. Currently, the main treatment for PD is medication (levodopa, dopaminergic valerate, pramipexole, etc.), supplemented by exercise therapy. However, these methods can only improve symptoms to a certain extent and cannot effectively stop the progression of the disease. Long-term use leads to diminishing efficacy and a series of complications, placing a heavy burden on society and families. With the increasing prominence of aging in my country, the incidence of PD continues to rise. Therefore, there is an urgent need to explore and develop effective and safe traditional Chinese medicine preparations for the treatment of PD, especially targeting motor dysfunction, to significantly improve patients' quality of life, which has significant practical implications. Summary of the Invention

[0003] To address at least one of the above problems, this invention provides a traditional Chinese medicine compound preparation for treating motor dysfunction in Parkinson's disease, characterized in that: the components include Cimicifuga rhizome, turtle shell, Angelica sinensis, licorice root, scorpion, Pinellia ternata, Gastrodia elata, and centipede.

[0004] Preferably, the turtle shell is processed turtle shell, the licorice is raw licorice, the scorpion is whole scorpion, and the pinellia is ginger-processed pinellia.

[0005] Preferably, the composition, by weight parts, consists of 5-20 parts of Cimicifuga rhizome, 20-45 parts of processed turtle shell, 3-10 parts of Angelica sinensis, 5-30 parts of raw licorice root, 8-20 parts of ginger-processed Pinellia ternata, 10-30 parts of Gastrodia elata, 5-20 parts of scorpion, and 10-20 parts of centipede.

[0006] Preferably, the raw material formula is as follows by weight: Cimicifuga rhizome: 10 parts, processed turtle shell: 35 parts, Angelica sinensis: 5 parts, raw licorice root: 10 parts, ginger-processed Pinellia ternata: 15 parts, Gastrodia elata: 15 parts, scorpion: 15 parts, centipede: 15 parts.

[0007] The present invention also provides a method for preparing a traditional Chinese medicine compound preparation for treating motor dysfunction in Parkinson's disease, comprising the following steps: firstly, soaking all components; secondly, decocting turtle shell first, then adding the remaining components and decocting; and finally concentrating the decoction to obtain the preparation.

[0008] Furthermore, the process prior to concentration also includes a filtration process prior to filtration.

[0009] Furthermore, the process before concentration also includes a re-boiling process before filtration.

[0010] Further, the steps include (1) soaking Cimicifuga, Angelica sinensis, raw licorice, ginger-processed Pinellia ternata, Gastrodia elata, scorpion, and centipede in deionized water at 10-30°C for several minutes;

[0011] (2) Use deionized water to decoct the roasted turtle shell first at 70-100℃ for several minutes;

[0012] (3) Add the remaining liquid containing other drugs and decoct at 70-100℃ for several minutes;

[0013] (4) Take the decoction, filter it, and then boil it for several hours;

[0014] (5) Concentrate the medicine solution.

[0015] Furthermore, the "several minutes" refers to 30 minutes, and the "several hours" refers to 1 hour.

[0016] The present invention has at least one of the following beneficial effects:

[0017] 1. This invention uses traditional Chinese medicine formulas to treat motor dysfunction in Parkinson's disease. The medicinal materials in the formula comply with national regulations for the management of Chinese medicinal materials. The formula has been tested over time and has undergone clinical trials in traditional Chinese medicine. The formula is rationally composed, has high synergistic effects, and its efficacy is long-lasting and stable.

[0018] 2. The traditional Chinese medicine compound preparation of this invention has the characteristics of significant efficacy, safety and reliability, and few toxic side effects in treating motor dysfunction of Parkinson's disease.

[0019] 3. Taking a holistic approach, this multi-component, multi-target intervention for Parkinson's disease significantly reduces the expression levels of tyrosine hydroxylase in the substantia nigra and striatum, showing promising clinical application prospects.

[0020] 4. This formula is based on traditional Chinese medicine theory and emphasizes syndrome differentiation and treatment. Starting with the pathogenesis, Parkinson's disease in traditional Chinese medicine is considered to be caused by deficiency of both liver and kidney, and insufficient qi and blood, with tremors and paralysis attributed to internal liver wind. This formula, based on clinical experience, has developed a new compound traditional Chinese medicine with significant efficacy and few side effects, showing remarkable improvement in motor impairment and tremor symptoms of Parkinson's disease.

[0021] 5. The method of using this invention is simple and easy to understand. This invention uses traditional Chinese medicine formulas, which is a new approach to treating motor dysfunction in Parkinson's disease. It will have wide applications in the field of treating motor dysfunction in Parkinson's disease. Attached Figure Description

[0022] Figure 1The effect of the traditional Chinese medicine compound concentrate of this invention on motor function in mice with Parkinson's disease;

[0023] Figure 2 The effect of the compound concentrate of this invention on the expression level of tyrosine hydroxylase in the substantia nigra of Parkinson's mice. Detailed Implementation

[0024] The technical solutions in the embodiments of the present invention will be clearly and completely described below. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments.

[0025] Advantages of the various medicinal materials selected in this invention

[0026] Cimicifuga rhizome is pungent, light, and ascending, clearing and purging. It disperses pathogenic factors from the skin surface and Yangming meridian to release the exterior, clears heat, detoxifies, and promotes rash eruption, making it most effective in treating Yangming headaches. Preclinical studies have shown that its component, cimicifuga glycoside, has been reported to have significant efficacy in treating Parkinson's disease. It primarily unblocks the Qi flow in Parkinson's patients, relieving mobility impairment.

[0027] Roasted turtle shell

[0028] It enters the liver and kidney meridians, nourishing kidney yin, reducing fever and eliminating steaming sensations, as well as calming liver yang, softening hardness and dissipating nodules. It is effective in treating yin deficiency with yang hyperactivity and internal wind stirring due to deficiency. Specifically for Parkinson's disease with internal liver wind stirring, it effectively relieves symptoms such as limb tremors, bradykinesia, difficulty moving, and limb stiffness.

[0029] Angelica sinensis

[0030] Its sweetness nourishes and moistens, while its pungent and warm properties promote circulation. It excels at replenishing and invigorating blood, and its blood-dispersing effect can improve symptoms such as liver and kidney deficiency, limb weakness, and lower limb weakness in Parkinson's disease patients.

[0031] Raw licorice

[0032] It is sweet and nourishing, moistening and soothing, replenishing qi and strengthening the middle jiao, relieving spasms and pain, harmonizing various medicines, and detoxifying.

[0033] Ginger Pinellia

[0034] It has the effects of warming the middle jiao (spleen and stomach), resolving phlegm, and relieving nausea and vomiting. Its main therapeutic purpose is to relieve symptoms such as limb immobility, joint inability to move, and excessive phlegm in Parkinson's patients.

[0035] Gastrodia elata

[0036] It is sweet, mild, and heavy, moistening and not drying. It effectively calms wind and stops spasms, and suppresses liver yang, treating various symptoms of liver yang and liver wind. It dispels wind and unblocks the meridians, treating numbness, limb pain, and hemiplegia. It is particularly effective for Parkinson's disease caused by internal liver wind.

[0037] Whole scorpion

[0038] Its effects include calming wind and relieving spasms, clearing the meridians and relieving pain, and attacking toxins and dispersing nodules. It is mainly used to treat internal wind in the liver, causing spasms and convulsions. It effectively improves motor function symptoms in Parkinson's disease.

[0039] centipede

[0040] It relieves wind and stops spasms, unblocks meridians and relieves pain, mainly alleviating muscle stiffness and tremor disorders in Parkinson's disease.

[0041] The following describes preferred embodiments of the present invention:

[0042] Example 1

[0043] A traditional Chinese medicine compound preparation for treating motor dysfunction in Parkinson's disease, the formula consists of Cimicifuga rhizome, turtle shell, Angelica sinensis, licorice root, scorpion, Pinellia ternata, Gastrodia elata, and centipede.

[0044] Preferably, the composition consists of 5 parts of Cimicifuga rhizome, 20 parts of processed turtle shell, 3 parts of Angelica sinensis, 5 parts of licorice root, 8 parts of Pinellia ternata, 10 parts of Gastrodia elata, 5 parts of scorpion, and 10 parts of centipede.

[0045] The formula components are concentrated to prepare concentrated formulations of different shapes and sizes.

[0046] Example 2

[0047] A traditional Chinese medicine compound preparation for treating motor dysfunction in Parkinson's disease, preferably composed of 20 parts of Cimicifuga rhizome, 45 parts of processed turtle shell, 10 parts of Angelica sinensis, 30 parts of raw licorice root, 20 parts of ginger-processed Pinellia ternata, 30 parts of Gastrodia elata, 20 parts of scorpion, and 20 parts of centipede.

[0048] Example 3

[0049] This invention provides a traditional Chinese medicine compound preparation for treating motor dysfunction in Parkinson's disease. The formula consists of traditional Chinese medicine ingredients, which include the following raw materials or raw material extracts in parts by weight: Cimicifuga rhizome: 10 parts, processed turtle shell: 35 parts, Angelica sinensis: 5 parts, raw licorice root: 10 parts, ginger-processed Pinellia ternata: 15 parts, Gastrodia elata: 15 parts, scorpion: 15 parts, and centipede: 15 parts.

[0050] Example 4

[0051] The present invention discloses a method for preparing a traditional Chinese medicine compound preparation for treating motor dysfunction in Parkinson's disease. The steps include: firstly, soaking all components; secondly, decocting turtle shell first, then adding the remaining components and decocting; and finally concentrating the decoction to obtain the preparation. The detailed preferred preparation process is as follows:

[0052] (1) Soak Cimicifuga rhizome, Angelica sinensis, raw licorice root, ginger-processed Pinellia ternata, Gastrodia elata, scorpion, and centipede in deionized water at 25°C for 30 minutes.

[0053] (2) Use deionized water to decoct the roasted turtle shell at 100°C for 30 minutes.

[0054] (3) Add the remaining liquid containing other drugs and decoct at 100°C for 30 minutes.

[0055] (4) Take the decoction, filter it, and then boil it for 1 hour.

[0056] (5) Concentrate the medicine solution to obtain the final product.

[0057] The effects of this invention are illustrated below through clinical trials and typical cases:

[0058] The detailed testing method is as follows: The experiment involved 200 subjects, including 100 female subjects and 100 male subjects, all aged between 45 and 60 years old; all subjects presented with bradykinesia and recurrent Parkinson's disease motor dysfunction symptoms.

[0059] Two hundred subjects with recurrent Parkinson's disease motor dysfunction symptoms were randomly divided into three groups: Group 1 (n=50), Group 2 (n=50), Group 3 (n=50), and Control Group (n=50). Each group included 25 female and 25 male subjects. Group 1 used the preparation described in Example 1 of this invention; Group 2 used the concentrated preparation described in Example 2 of this invention; Group 3 used the concentrated preparation described in Example 3 of this invention; and the control group used existing dopamine drugs. The administration method was as follows: the concentrated preparation prepared in this invention was taken once daily, twice daily (morning and evening), half an hour before meals, for one month as one course of treatment. The dopamine drugs were taken once daily. All subjects used the treatment continuously for 31 days. After 31 days of continuous treatment, the effects in the experimental groups were significantly better than those in the control group. The specific test results are shown in the table below.

[0060]

[0061] As shown in the table above, the Seven-Flavor Prepared Turtle Shell Powder of the present invention has a low recurrence rate, high safety, and no obvious side effects such as digestive and sleep disorders in the treatment of motor dysfunction in Parkinson's disease. Its performance is superior to that of current dopamine drugs.

[0062] Furthermore, the following typical tests illustrate the therapeutic effect of the concentrated agent of the present invention on a mouse model of Parkinson's disease, with the dosage and administration method as follows: A traditional Chinese medicine compound preparation for treating motor dysfunction in Parkinson's disease.

[0063] Materials: A traditional Chinese medicine compound extract for treating motor dysfunction in Parkinson's disease (12.3 g / kg and 24.6 g / kg); MPTP (30 mg / kg), a drug for modeling Parkinson's disease; SPF-grade C57BL / 6 mice.

[0064] Methods: Forty mice were randomly divided into four groups (n=10 per group): normal control group, model group, low-dose traditional Chinese medicine (TCM) compound group, and high-dose TCM compound group. Mice were acclimatized for 7 days. The TCM compound was administered intraperitoneally to establish the model. Near the experimental endpoint, behavioral training and experiments were conducted, including grip strength tests, open field tests, rotarod tests, suspension tests, and pole climbing tests to assess the mice's motor function. Immunohistochemistry was used to detect the expression level of tyrosine hydroxylase in the substantia nigra of mice. Western blotting was used to detect the protein expression level of tyrosine hydroxylase in the substantia nigra of mice. The results were statistically analyzed.

[0065] result:

[0066] 1. Effects of concentrated traditional Chinese medicine compound on motor function in mice with Parkinson's disease

[0067] Grasping strength test results showed that the model group had significantly lower gripping strength compared to the normal group (P<0.01), while both low-dose and high-dose traditional Chinese medicine compound treatments significantly improved the gripping strength of Parkinson's mice (P<0.01). Suspension test results showed that the model group had significantly lower suspension scores compared to the normal group (P<0.01), while both low-dose and high-dose traditional Chinese medicine compound treatments significantly improved the suspension scores of Parkinson's mice (P<0.01). Pole climbing test results showed that the model group took significantly longer to climb than the normal group (P<0.01), while low-dose and high-dose traditional Chinese medicine compound treatments significantly shortened the pole climbing time for Parkinson's mice (P<0.01). Open field test results showed that, compared with the normal group, the total movement distance of mice in the model group was significantly lower (P<0.01), and the average movement speed was significantly decreased (P<0.01). After treatment with traditional Chinese medicine compound, the total movement distance of mice in the model group increased, and the average movement speed increased significantly (P<0.01). (See...) Figure 1 )

[0068] 2. Effects of concentrated traditional Chinese medicine compound on the expression level of tyrosine hydroxylase in the substantia nigra of Parkinson's mice

[0069] Immunohistochemical results showed (see) Figure 2 Compared with the normal group, the number of neurons expressing tyrosine hydroxylase in the substantia nigra of mice in the model group was significantly reduced, while both low and high doses of the traditional Chinese medicine compound significantly increased the expression of tyrosine hydroxylase in the substantia nigra.

[0070] Western blot results showed that, compared with the normal group, the expression level of tyrosine hydroxylase in the striatum of the model group mice was significantly reduced (P<0.01). After treatment with traditional Chinese medicine compound, the high-dose group could significantly increase the protein expression level of tyrosine hydroxylase in Parkinson's mice (P<0.01).

[0071] The results showed that the traditional Chinese medicine compound significantly improved motor dysfunction in a mouse model of Parkinson's disease induced by MPTP, and also increased the number of black stratum neurons in the mice with Parkinson's disease, suggesting that this compound has good application prospects for the treatment of Parkinson's disease.

[0072] As can be seen from the above experiments and typical tests, the medicine of the present invention has undergone clinical testing in traditional Chinese medicine. The formulation is reasonable and synergistic, and the efficacy is long-lasting and stable. The medicine of the present invention can be made into various different preparations. The preparation method is simple and efficient. The combination of medicinal materials and the usage method are simple and easy to understand. The present invention uses traditional Chinese medicine formulas, which is a new approach to treating motor dysfunction in Parkinson's disease. It will have wide applications in the field of treating motor dysfunction in Parkinson's disease.

[0073] This invention presents a traditional Chinese medicine compound preparation for treating motor dysfunction in Parkinson's disease, characterized by significant efficacy, safety, and minimal side effects. Taking a holistic approach, it intervenes in Parkinson's disease through multiple components and targets, significantly reducing the expression levels of tyrosine hydroxylase in the substantia nigra and striatum, demonstrating promising clinical application prospects. This formula is based on traditional Chinese medicine theory, employing a dialectical approach. Starting with the pathogenesis, Parkinson's disease in traditional Chinese medicine is considered to be due to deficiency of both liver and kidney, and insufficient qi and blood, with tremor and paralysis attributed to internal liver wind. This formula, combining clinical experience with theoretical understanding of this pathogenesis, has developed a new traditional Chinese medicine compound with significant efficacy and minimal side effects, showing remarkable improvement in motor dysfunction and tremor symptoms in Parkinson's disease.

[0074] The above description is only a preferred embodiment of the present invention, but the scope of protection of the present invention is not limited thereto. Any equivalent substitutions or modifications made by those skilled in the art within the scope of the technology disclosed in the present invention, based on the technical solution and inventive concept of the present invention, should be covered within the scope of protection of the present invention.

Claims

1. A traditional Chinese medicine compound preparation for treating motor dysfunction of Parkinson's disease, characterized in that: The raw materials of the preparation, by weight, are: 5-20 parts of Cimicifuga rhizome, 20-45 parts of processed turtle shell, 3-10 parts of Angelica sinensis, 5-30 parts of raw licorice root, 8-20 parts of ginger-processed Pinellia ternata, 10-30 parts of Gastrodia elata, 5-20 parts of scorpion, and 10-20 parts of centipede. ​ 2. The traditional Chinese medicine compound preparation for treating motor dysfunction in Parkinson's disease as described in claim 1, characterized in that: The raw materials of the preparation, by weight, are: 10 parts of Cimicifuga rhizome, 35 parts of processed turtle shell, 5 parts of Angelica sinensis, 10 parts of raw licorice root, 15 parts of ginger-processed Pinellia ternata, 15 parts of Gastrodia elata, 15 parts of scorpion, and 15 parts of centipede.

3. A method for preparing a traditional Chinese medicine compound for treating motor dysfunction in Parkinson's disease, characterized in that: The steps include: first, soaking 5-20 parts of Cimicifuga rhizome, 20-45 parts of processed turtle shell, 3-10 parts of Angelica sinensis, 5-30 parts of raw licorice root, 8-20 parts of ginger-processed Pinellia ternata, 10-30 parts of Gastrodia elata, 5-20 parts of scorpion, and 10-20 parts of centipede; second, decocting the turtle shell first, then adding the remaining components and decocting; finally, concentrating the decoction to obtain the preparation.

4. The preparation method according to claim 3, characterized in that: The process before concentration also includes filtration.

5. The preparation method according to claim 3, characterized in that: After filtering, it also includes a process of simmering again.

6. The preparation method according to claim 3, characterized in that: The steps include (1) soaking Cimicifuga rhizome, Angelica sinensis, raw licorice root, ginger-processed Pinellia ternata, Gastrodia elata, scorpion, and centipede in deionized water at 10-30°C for several minutes; (2) Use deionized water to decoct the roasted turtle shell at 70-100℃ for several minutes; (3) Add the remaining liquid containing other drugs and decoct at 70-100℃ for several minutes; (4) Take the decoction, filter it, and then boil it for several hours; (5) Concentrate the medicine solution.

7. The preparation method according to claim 3, characterized in that: The number of minutes refers to 30 minutes, and the number of hours refers to 1 hour.

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