Traditional Chinese medicine composition for treating cerebellar ataxia syndrome, preparation method, pharmaceutical preparation and application

Abstract

The invention belongs to the technical field of traditional Chinese medicine, and particularly relates to a traditional Chinese medicine composition for treating cerebellar ataxia syndrome, a preparation method, a pharmaceutical preparation and application. The composition comprises the following components: radix rehmanniae recen, prepared rehmannia root, cistanche, radix morindae officinalis, dogwood, dendrobe, rhizoma curculiginis, ginseng, radix ophiopogonis, polygala tenuifolia, rhizoma acori graminei, radix angelicae, poria cocos, schisandra chinensis, pericarpium citri reticulatae and fructus amomi. The preparation method comprises the following steps: soaking the radix rehmanniae recen and the prepared rehmannia root to obtain a mixture A; mixing other raw materials, and adding water for soaking to obtain a mixture B; and finally, combining the mixture A and the mixture B, and decocting to obtain the traditional Chinese medicine composition. The traditional Chinese medicine prescription can be used for treating the cerebellar ataxia syndrome and improving the main symptoms of ataxia, such as unstable walking, balance disorder and dysarthria; meanwhile, secondary symptoms such as urination and defecation disorder, sleep disorder and mental disorder can be improved, the compliance of a patient is improved, the progress of the disease course is delayed and stabilized, and the living quality of the patient is improved.

Description

Technical Field

[0001] The present invention belongs to the technical field of traditional Chinese medicine, and in particular relates to a traditional Chinese medicine composition for treating cerebellar ataxia syndrome, a preparation method, a pharmaceutical preparation and application. Background Art

[0002] Cerebellar ataxia syndromes are a group of chronic progressive neurodegenerative diseases characterized by cerebellar dysfunction or combined with other neurological abnormalities, with clinical manifestations such as abnormal gait, impaired balance, poor limb coordination and language disorders. The disease progresses progressively, and the patient may lose the ability to walk in the middle and late stages, and eventually die. Once the disease occurs, the course of the disease is irreversible, which not only seriously affects the patient's quality of life, but also puts great pressure on the social medical system. The mechanism of cerebellar ataxia is complex and the etiology is diverse. Most of them are autosomal dominant, a few are autosomal recessive, and some are sporadic. At present, there is no effective drug that can be used as a routine treatment to prevent or delay the progression of the disease. Only drugs can temporarily relieve the symptoms of ataxia.

[0003] Currently, most drugs for the treatment of cerebellar ataxia syndrome are still in clinical trials, but most of them can only improve the main symptoms of some types of ataxia, with limited effects, and have no effect on the secondary symptoms of the syndrome. Traditional Chinese medicine prescriptions have the limitations of poor efficacy on targeted symptoms, unstable efficacy, and difficulty in use, resulting in poor medication compliance in some patients, and failing to achieve the effect of delaying the progression of the stable disease. Summary of the invention

[0004] In view of the problems existing in the prior art, the present invention provides a traditional Chinese medicine composition for treating cerebellar ataxia syndrome, a preparation method and application thereof.

[0005] In order to achieve the purpose of the invention, the technical solution adopted is as follows:

[0006] A Chinese medicine composition for treating cerebellar ataxia syndrome comprises the following components: raw rehmannia root, cooked rehmannia root, cistanche deserticola, euphorbia officinalis, cornus officinalis, dendrobium, curculigo, ginseng, ophiopogon japonicus, polygala tenuifolia, calamus tatarinowii, angelica dahurica, tuckahoe, schisandra chinensis, tangerine peel and amomum villosum.

[0007] Preferably, the invention comprises the following components by weight: 20-50 parts of raw rehmannia root, 30-100 parts of cooked rehmannia root, 15-30 parts of cistanche deserticola, 15-30 parts of eucommia bark, 15-30 parts of cornus officinalis, 10-15 parts of dendrobium, 10-20 parts of curculigo, 5-10 parts of ginseng, 6-9 parts of ophiopogon, 5-10 parts of polygala, 6-12 parts of calamus, 6-15 parts of angelica dahurica, 15-30 parts of poria, 6-15 parts of schisandra chinensis, 10-15 parts of tangerine peel and 5-10 parts of amomum.

[0008] Preferably, the Polygala root is processed Polygala root, and the composition further comprises 30-100 parts by weight of rice wine.

[0009] Preferably, by weight, the composition comprises the following components: 50 parts of raw rehmannia root, 50 parts of cooked rehmannia root, 30 parts of cistanche deserticola, 30 parts of eucommia bark, 30 parts of cornus officinalis, 15 parts of dendrobium, 10 parts of curculigo, 10 parts of ginseng, 9 parts of ophiopogon, 10 parts of processed polygala, 12 parts of calamus, 12 parts of angelica dahurica, 15 parts of poria, 10 parts of schisandra chinensis, 10 parts of tangerine peel and 10 parts of amomum.

[0010] The second object of the present invention is to provide a method for preparing the above-mentioned Chinese medicine composition, comprising the following steps:

[0011] (1) soaking raw rehmannia root and cooked rehmannia root in a solvent to obtain a mixture A;

[0012] (2) mixing Cistanche deserticola, Morinda officinalis, Cornus officinalis, Dendrobium officinale, Curculigo orchioides, Ginseng, Ophiopogon japonicus, Polygala tenuifolia, Acorus calamus, Angelica dahurica, Poria cocos, Schisandra chinensis, Tangerine peel and Amomum villosum, and soaking the mixture in water to obtain a mixture B;

[0013] (3) After the mixture A and the mixture B are combined, they are decocted and the decoction is collected to obtain the product.

[0014] Preferably, the solvent in step (1) is rice wine, and the soaking time is 10-50 minutes.

[0015] Preferably, the amount of water used in step (2) is Cistanche deserticola, Morinda officinalis, Cornus officinalis, Dendrobium officinale, Curculigo orchioides, Ginseng,

[0016] The amount of the mixture is 2-8 times of the total weight of Radix Ophiopogonis, Radix Polygalae, Rhizoma Acorus Calamus, Radix Angelicae Dahuricae, Poria, Fructus Schisandrae Chinensis, Pericarpium Citri Reticulatae and Fructus Amomum, and the soaking time is 10-40 minutes.

[0017] Preferably, in step (3), the decoction is performed 1-3 times, and the decoctions are combined; and the decoction time is 30-50 minutes.

[0018] Preferably, in step (3), after the decoction is collected, it is also concentrated and dried.

[0019] Another object of the present invention is to provide a pharmaceutical preparation, comprising the above-mentioned Chinese medicine composition or the Chinese medicine composition prepared by the preparation method, and pharmaceutically acceptable excipients.

[0020] Another object of the present invention is to provide the use of the above-mentioned Chinese medicine composition or the Chinese medicine composition prepared by the preparation method in the preparation of drugs for treating or relieving cerebellar ataxia syndrome.

[0021] Compared with the prior art, the present invention has the following beneficial effects:

[0022] (1) The present invention provides a Chinese medicine prescription combination for treating cerebellar ataxia syndrome, which is based on tonifying the kidney, filling the marrow and benefiting the brain, and supplemented by strengthening the spleen and clearing turbidity. The main drug is effective in improving the main symptoms of ataxia, such as unsteady walking, balance disorders, and dysarthria; the auxiliary drug clears turbidity and can also improve secondary symptoms such as defecation and urination disorders, sleep disorders, and mental disorders, thereby promoting the improvement of patient compliance, thereby delaying the progression of stable diseases and improving the quality of life of patients.

[0023] (2) The above-mentioned composition provided by the present invention, based on the theory of state-target differentiation and treatment and the dose-effect relationship of traditional Chinese medicine, uses large doses of Rehmannia glutinosa and Rehmannia glutinosa as the main medicine to nourish the kidney and fill the marrow, which can not only replenish the functional state of kidney deficiency and marrow deficiency, but also can restore the clinical symptom target of cerebellar functional atrophy in a targeted manner; using larger doses of Cistanche deserticola, Morinda officinalis, Cornus officinalis, Curculigo orchioides, etc. as the assistant medicine to enhance the function of nourishing the kidney and filling the marrow; Dendrobium, Ophiopogon japonicus, and Schisandra chinensis nourish the lungs and kidneys, and the metal and water are mutually generated, and the water is strengthened to help the fire, which are all assistant medicines. It is assisted by Polygala tenuifolia, Acorus calamus, and Angelica dahurica to resolve phlegm, open the mind, and wake up the brain to restore cerebellar aphasia; Poria cocos, dried tangerine peel, and Amomum villosum to strengthen the spleen and help the digestion, and also assist in the spleen-inhibiting drugs of replenishing essence and nourishing greasiness. The above-mentioned medicinal materials are used together, with a combined effect, and can nourish the kidney and fill the marrow, and have a good therapeutic effect when applied to cerebellar ataxia syndrome with kidney deficiency as the main manifestation. DETAILED DESCRIPTION

[0024] The technical scheme in the present invention will be clearly and completely described below in conjunction with the embodiments. Obviously, the described embodiments are only a part of the embodiments of the present invention, rather than all the embodiments. Although the representative embodiments of the present invention have been described in detail, it will be understood by those skilled in the art that various modifications and changes can be made to the present invention without departing from the scope of the present invention. Therefore, the scope of the present invention should not be limited to the embodiments, but should be limited by the attached claims and their equivalents.

[0025] Example 1

[0026] A Chinese medicine composition for treating cerebellar ataxia syndrome comprises the following raw materials: 50 parts of raw rehmannia root, 50 parts of cooked rehmannia root, 30 parts of cistanche deserticola, 30 parts of euphorbia officinalis, 30 parts of cornus officinalis, 15 parts of dendrobium, 10 parts of curculigo, 10 parts of ginseng, 9 parts of ophiopogon, 10 parts of processed polygala, 12 parts of calamus, 12 parts of angelica dahurica, 15 parts of poria, 10 parts of schisandra chinensis, 10 parts of dried tangerine peel and 10 parts of amomum.

[0027] Preparation method:

[0028] (1) Soak raw Rehmannia root and cooked Rehmannia root in yellow wine for 30 minutes to obtain a mixture A.

[0029] (2) The remaining raw materials were mixed, and then 500 ml of purified water was added and soaked for 30 min to obtain a mixture B.

[0030] (3) After the mixture A and the mixture B are combined, they are decocted, and the decoction is collected to obtain the traditional Chinese medicine composition.

[0031] In the above-mentioned preparation method, in step (3), in the decoction step, the mixed raw materials are decocted twice and the decoctions are combined; wherein the first decoction is for 40 minutes, and the second decoction is performed by adding 600 ml of water and decocting for 40 minutes.

[0032] Example 2

[0033] A Chinese medicine composition for treating cerebellar ataxia syndrome comprises the following raw materials: 20 parts of raw rehmannia root, 30 parts of cooked rehmannia root, 15 parts of cistanche deserticola, 15 parts of euphorbia officinalis, 15 parts of cornus officinalis, 10 parts of dendrobium, 10 parts of curculigo, 5 parts of ginseng, 6 parts of ophiopogon, 5 parts of processed polygala, 6 parts of calamus, 6 parts of angelica dahurica, 15 parts of poria, 6 parts of schisandra chinensis, 10 parts of dried tangerine peel and 5 parts of amomum.

[0034] Preparation method:

[0035] (1) Soak raw Rehmannia root and cooked Rehmannia root in rice wine for 10 minutes to obtain a mixture A.

[0036] (2) The remaining raw materials were mixed, and then 500 ml of purified water was added and soaked for 10 min to obtain a mixture B.

[0037] (3) After the mixture A and the mixture B are combined, they are decocted, and the decoction is collected to obtain the traditional Chinese medicine composition.

[0038] In the above-mentioned preparation method, in step (3), in the decoction step, the mixed raw materials are decocted twice and the decoctions are combined; wherein the first decoction is for 30 minutes, and the second decoction is performed by adding 600 ml of water and decocting for 30 minutes.

[0039] Example 3

[0040] A Chinese medicine composition for treating cerebellar ataxia syndrome comprises the following raw materials: 40 parts of raw rehmannia root, 100 parts of cooked rehmannia root, 25 parts of cistanche deserticola, 25 parts of euphorbia officinalis, 25 parts of cornus officinalis, 12 parts of dendrobium, 15 parts of curculigo, 8 parts of ginseng, 8 parts of ophiopogon, 8 parts of processed polygala, 10 parts of calamus, 10 parts of angelica dahurica, 25 parts of poria, 15 parts of schisandra chinensis, 10 parts of tangerine peel and 10 parts of amomum.

[0041] Preparation method:

[0042] (1) Soak raw Rehmannia root and cooked Rehmannia root in yellow wine for 50 minutes to obtain a mixture A.

[0043] (2) The remaining raw materials were mixed, added with 800 ml of purified water and soaked for 40 min to obtain a mixture B.

[0044] (3) After the mixture A and the mixture B are combined, they are decocted, and the decoction is collected to obtain the traditional Chinese medicine composition.

[0045] In the above preparation method, in step (3), in the decoction step, the mixed raw materials are decocted twice and the decoctions are combined; wherein the first decoction is for 50 minutes, and the second decoction is performed by adding 800 ml of water and decocting for 50 minutes.

[0046] The following are some individual recipes screened in the early stages of the experiment.

[0047] Comparative Example 1

[0048] The difference between this comparative example and Example 1 is that Curculigo orchioides is replaced with Epimedium brevicornum, as follows.

[0049] A Chinese medicine composition comprises the following raw materials: 50 parts of raw rehmannia root, 50 parts of cooked rehmannia root, 30 parts of cistanche deserticola, 30 parts of eucommia bark, 30 parts of cornus officinalis, 15 parts of dendrobium, 10 parts of epimedium, 10 parts of ginseng, 9 parts of ophiopogon, 10 parts of processed polygala root, 12 parts of calamus, 12 parts of angelica dahurica, 15 parts of poria, 10 parts of schisandra chinensis, 10 parts of dried tangerine peel and 10 parts of amomum.

[0050] Preparation method:

[0051] (1) Soak raw Rehmannia root and cooked Rehmannia root in yellow wine for 30 minutes to obtain a mixture A.

[0052] (2) The remaining raw materials were mixed, and then 500 ml of purified water was added and soaked for 30 min to obtain a mixture B.

[0053] (3) After the mixture A and the mixture B are combined, they are decocted, and the decoction is collected to obtain the traditional Chinese medicine composition.

[0054] In the above-mentioned preparation method, in step (3), in the decoction step, the mixed raw materials are decocted twice and the decoctions are combined; wherein the first decoction is for 40 minutes, and the second decoction is performed by adding 600 ml of water and decocting for 40 minutes.

[0055] Comparative Example 2

[0056] The difference between this comparative example and Example 1 is that the raw material formula of the composition is different. The details are as follows.

[0057] A Chinese medicine composition comprises the following raw materials: 50 parts of raw rehmannia root, 50 parts of cooked rehmannia root, 30 parts of cistanche deserticola, 30 parts of euphorbia officinalis, 15 parts of dendrobium, 40 parts of curculigo, 10 parts of ginseng, 9 parts of ophiopogon, 10 parts of processed polygala root, 12 parts of calamus, 12 parts of angelica dahurica, 15 parts of poria, 10 parts of schisandra chinensis, 10 parts of dried tangerine peel and 10 parts of amomum.

[0058] Preparation method:

[0059] (1) Soak raw Rehmannia root and cooked Rehmannia root in yellow wine for 30 minutes to obtain a mixture A.

[0060] (2) The remaining raw materials were mixed, and then 500 ml of purified water was added and soaked for 30 min to obtain a mixture B.

[0061] (3) After the mixture A and the mixture B are combined, they are decocted, and the decoction is collected to obtain the traditional Chinese medicine composition.

[0062] In the above-mentioned preparation method, in step (3), in the decoction step, the mixed raw materials are decocted twice and the decoctions are combined; wherein the first decoction is for 40 minutes, and the second decoction is performed by adding 600 ml of water and decocting for 40 minutes.

[0063] Comparative Example 3

[0064] The difference between this comparative example and Example 1 is that the raw material formula of the composition is different, specifically:

[0065] A Chinese medicine composition comprises the following raw materials: 50 parts of raw rehmannia root, 50 parts of cooked rehmannia root, 30 parts of cistanche deserticola, 30 parts of eucommia barbata, 40 parts of cornus officinalis, 15 parts of dendrobium, 10 parts of ginseng, 9 parts of ophiopogon japonicus, 10 parts of processed polygala root, 12 parts of calamus gramineus, 12 parts of angelica dahurica, 15 parts of poria, 10 parts of schisandra chinensis, 10 parts of dried tangerine peel and 10 parts of amomum villosum.

[0066] Preparation method:

[0067] (1) Soak raw Rehmannia root and cooked Rehmannia root in yellow wine for 30 minutes to obtain a mixture A.

[0068] (2) The remaining raw materials were mixed, and then 500 ml of purified water was added and soaked for 30 min to obtain a mixture B.

[0069] (3) After the mixture A and the mixture B are combined, they are decocted, and the decoction is collected to obtain the traditional Chinese medicine composition.

[0070] In the above-mentioned preparation method, in step (3), in the decoction step, the mixed raw materials are decocted twice and the decoctions are combined; wherein the first decoction is for 40 minutes, and the second decoction is performed by adding 600 ml of water and decocting for 40 minutes.

[0071] Comparative Example 4

[0072] The difference from Example 1 is that the Amomum villosum is replaced by white cardamom.

[0073] A Chinese medicine composition comprises the following raw materials: 50 parts of raw rehmannia root, 50 parts of cooked rehmannia root, 30 parts of cistanche deserticola, 30 parts of eucommia barbata, 30 parts of cornus officinalis, 15 parts of dendrobium, 10 parts of curculigo, 10 parts of ginseng, 9 parts of ophiopogon, 10 parts of processed polygala, 12 parts of calamus, 12 parts of angelica dahurica, 15 parts of poria, 10 parts of schisandra chinensis, 10 parts of tangerine peel and 10 parts of white cardamom.

[0074] Preparation method:

[0075] (1) Soak raw Rehmannia root and cooked Rehmannia root in yellow wine for 30 minutes to obtain a mixture A.

[0076] (2) The remaining raw materials were mixed, and then 500 ml of purified water was added and soaked for 30 min to obtain a mixture B.

[0077] (3) After the mixture A and the mixture B are combined, they are decocted, and the decoction is collected to obtain the traditional Chinese medicine composition.

[0078] In the above-mentioned preparation method, in step (3), in the decoction step, the mixed raw materials are decocted twice and the decoctions are combined; wherein the first decoction is for 40 minutes, and the second decoction is performed by adding 600 ml of water and decocting for 40 minutes.

[0079] Experiment 1: Drug intervention experiment in ataxia rat model

[0080] SPF grade SD rats, male, weighing (220±10) g, were taken and subjected to adaptive feeding for 1 week and then divided into 9 groups, namely, normal group, model group, Example 1, 2, 3 groups, Comparative Example 1, 2, 3, 4 groups, 8 rats in each group.

[0081] (1) Rotarod test

[0082] The balance and motor coordination of rats were evaluated using a Rotamex-5Rota Rod tester (manufacturer: Columbus Instruments). Experimental tests were performed using a 7 cm diameter spindle rod. Rats were placed on the rod rotating at 20 rpm for 180 seconds, 3 times a day, and adapted for 3 days so that they would not fall off.

[0083] Determine baseline latency to fall: Baseline performance was then determined on days 4 and 7 by performing an acceleration paradigm in which the rats were placed on a rotating rod with an initial rotation speed of 4 rpm and an acceleration of 0.2 rpm / s, three times a day. The baseline latency to fall was calculated (the average of the three longest times the animal could stay on the rod during the two assessment days).

[0084] Modeling method: On the second day after the baseline latency measurement on the 7th day, rats other than the normal group were intraperitoneally injected with 3-AP at a dose of 60 mg / kg, and the normal group was intraperitoneally injected with the same dose of saline. The gait of the rats was observed on the second day. The limbs on the same side of the modeling rats were difficult and clumsy to move, swayed from side to side, the tail was not raised, and the body could not be coordinated and balanced. The modeling was successful.

[0085] Administration method: Chinese medicine was administered by gavage 3 hours after modeling. The normal group and the model group were gavaged with physiological saline, and the Example 1, 2, 3 groups and the Comparative Example 1, 2, 3, 4 groups were respectively given the Chinese medicine composition prepared by the corresponding group, with a dosage of 30 g of raw medicine / kg, and the gavage was continued for 21 days.

[0086] The fall latency was re-tested on the 2nd and 21st days after the start of medication. Each test was performed 3 times and the average value was taken.

[0087] The results of rat behavioral coordination and latency to fall are shown in Table 1.

[0088] Table 1

[0089]

[0090] Note: In the same column, compared with the normal group, * P<0.05, ** P<0.01, compared with the model group, & P<0.05, && P<0.01; compared with the Example 1 group, # P<0.05, ## P<0.01.

[0091] Experiment 2: Single-arm trial of clinical efficacy of the Chinese medicine composition of the present invention

[0092] 1. Case data

[0093] 1.1 The cases were from 17 patients with cerebellar ataxia syndrome who visited Chief Physician Zhu Wenzong's outpatient clinic from March 2023 to August 2024 and met the requirements of this study.

[0094] 1.2 Diagnostic criteria

[0095] 1.2.1 Western medicine diagnostic criteria

[0096] In modern medicine, cerebellar ataxia syndrome specifically includes the following diseases: hereditary ataxia, multiple system atrophy-cerebellar type, and adult sporadic ataxia.

[0097] Hereditary ataxia (HA): Referring to the 2024 Chinese Expert Consensus on the Diagnosis and Treatment of Hereditary Ataxia, HA is diagnosed based on molecular genetic testing and family history, with auxiliary clinical features including: (1) chronic onset; (2) progressively worsening symmetrical cerebellar ataxia; (3) relevant neuroimaging, electrophysiological examination, and biochemical evidence; and (4) exclusion of other degenerative diseases involving the cerebellum and brainstem.

[0098] Multiple system atrophy cerebellar type (MSA-C): Mainly refer to the "Chinese Expert Consensus on MSA Diagnostic Criteria (2022)". The diagnostic criteria divide MSA into four levels: neuropathologically confirmed, clinically confirmed, clinically probable, and prodromal MSA. This study included patients who met the diagnostic criteria of "clinically confirmed MSA", "clinically probable MSA", and "prodromal MSA" and had cerebellar ataxia as the first manifestation and / or the main clinical manifestation.

[0099] Sporadic Adult-Onset Ataxia (SAOA): Refer to the diagnostic criteria for SAOA in the 2018 Manual of Clinical Neurology: (1) progressively worsening symmetrical cerebellar ataxia; (2) onset in adulthood;

[0100] (3) Exclude acute or subacute onset; (4) Complete family history data, exclude familial ataxia history; (5) Exclude evidence of pathogenic gene mutation; (6) Exclude definite acquired causes; (7) No severe autonomic failure.

[0101] 1.2.2 TCM diagnostic criteria

[0102] Referring to the "Kidney Essence Deficiency Syndrome" in the "Diagnostic Criteria for Common Syndromes in Traditional Chinese Medicine", combined with the clinical manifestations of cerebellar ataxia syndrome of kidney deficiency and marrow deficiency and the definition of "aural rash", the TCM diagnostic criteria for cerebellar ataxia of kidney deficiency and marrow deficiency are comprehensively considered:

[0103] Main symptoms: slurred speech; unsteady standing; difficulty walking; tremor in movements; fatigue and weakness.

[0104] Secondary symptoms: dizziness; insomnia; forgetfulness; blurred vision; tinnitus, deafness; soreness of waist and knees or back pain; silent expression, few words and no joy; cold limbs; weak or dry stools; frequent urination, frequent urination at night, urinary incontinence; impotence or loss of libido; weak and thready pulse or a weak radial pulse.

[0105] Two of the above main symptoms and two of the secondary symptoms are required to form a diagnosis.

[0106] 1.3 Inclusion criteria

[0107] (1) Meet the diagnostic criteria of Western medicine;

[0108] (2) Meet the diagnostic criteria of traditional Chinese medicine;

[0109] (3) Willing to follow the physician's diagnosis and treatment arrangements, and cooperate with information collection and scale assessment. Concomitant medication: No Chinese or Western medicine treatment in the past; or no Chinese medicine for tonifying the kidney and replenishing essence in the 2 weeks before enrollment; or Western medicine has been taken and the efficacy has been stable for at least 30 days, and the Western medicine treatment plan remains unchanged or the dosage of Western medicine is reduced during the 3-month follow-up treatment.

[0110] 1.4 Exclusion criteria

[0111] Patients with severe impaired consciousness and inability to communicate smoothly; patients with cerebrovascular disease and white matter lesions; patients with serious primary diseases of the cardiovascular, renal, pulmonary, liver, hematopoietic system, etc. or mental illness.

[0112] 1.5 Falling off and rejection criteria

[0113] Patients with severe complications or disease progression during treatment, which are life-threatening; patients who drop out naturally or are lost during observation, including those who are effectively treated but cannot complete the entire course of treatment, resulting in incomplete clinical data and affecting the judgment of efficacy and safety; patients who stop taking Chinese medicine on their own, or take or use other drugs or treatments related to their condition at the same time; patients who suffer from trauma, fractures, or undergo major surgery during treatment, which affects the evaluation results; patients who request to withdraw from this clinical study midway.

[0114] 1.6 Ethical requirements

[0115] This study should strictly follow the Declaration of Helsinki and Chinese regulations on clinical laboratory research. Each subject should carefully read the informed consent form and sign it.

[0116] 2. Experimental plan

[0117] 2.1 Intervention plan

[0118] All patients were treated with the Chinese medicine composition prepared in Example 1, taking one dose per day, one dose being: 288g of the equivalent amount of crude drug ( / 400ml) taken in two doses. 90 days was one course of treatment, and observation and evaluation were performed before and after the course of treatment.

[0119] 2.2 Observation items

[0120] The scales were evaluated before and after treatment, and the scores of each scale were compared before and after treatment. The scales were evaluated by two postgraduate students in neurology who had received professional scale training. They included: Scale for the Assessment and Rating of Ataxia (SARA), International Cooperative Ataxia Rating Scale (ICARS) of the World Federation of Neurology, Activities of daily living (ADL), and TCM syndrome score scale.

[0121] 2.3 Safety evaluation

[0122] Safety evaluation of patients was performed before and after the experimental intervention, vital signs and general condition of follow-up patients were monitored regularly, and adverse reactions during the experiment were promptly handled and recorded.

[0123] 2.4 Statistical methods

[0124] SPSS 25.0 statistical software was used for data analysis. The measured data that conformed to the normal distribution were expressed as mean ± standard deviation, and the measured data that were not normally distributed were expressed as median and quartile. The data whose differences conformed to the normal distribution were compared using paired sample t test, and the data whose differences did not conform to the normal distribution were compared using non-parametric test. P < 0.05 was considered statistically significant.

[0125] 3 Results

[0126] 3.1 Comparison of total disorder scores before and after treatment is shown in Table 2.

[0127] Table 2 Comparison of SARA and ICARS scores before and after medication

[0128]

[0129] As can be seen from the above table, after taking the Chinese medicine composition for 90 days, the SARA score decreased, p<0.05, and the difference was statistically significant; the ICARS score decreased, p<0.05, and the difference was statistically significant.

[0130] 3.2 The scores of the daily living activities scale before and after treatment are shown in Table 3.

[0131] Table 3 Comparison of ADL scores before and after medication

[0132]

[0133] It can be seen from the above table that after taking the Chinese medicine composition for 90 days, the ADL score decreased, p<0.05, and the difference was statistically significant.

[0134] 3.3 The TCM syndrome scoring scale scores before and after treatment are shown in Table 4.

[0135] Table 4 Comparison of TCM syndrome score scale before and after medication

[0136]

[0137] As can be seen from the above table, after taking the Chinese medicine composition for 90 days, the score of the TCM syndrome integral scale decreased, p<0.05, and the difference was statistically significant.

[0138] 3.4 Adverse Reactions

[0139] During the period when patients took the Chinese medicine composition orally, 3 cases of diarrhea occurred. After the dosage was adjusted within the weight range of the Chinese medicine combination, the diarrhea symptoms improved, no other obvious adverse reactions occurred, and no patient stopped taking the drug due to adverse drug reactions.

[0140] 3.5 Conclusion

[0141] Combined with the above results, it can be seen that the Chinese medicine composition of the present invention can effectively improve the ataxia symptoms of patients with ataxia syndrome, improve the daily living ability of patients, and improve other related symptoms and improve the life treatment of patients. Referring to previous literature data and standards, it can be seen that the Chinese medicine composition has the effect of delaying or even reversing the progression of the disease to a certain extent.

[0142] Experiment 3: Case Examples

[0143] Patient, male, 56 years old, employee. Unsteady walking and slurred speech for more than 1 year. Unsteady walking, poor balance, and slurred speech occurred without obvious cause 1 year ago. The symptoms gradually worsened. He was treated at Wenfu Second Hospital. After examination, he was diagnosed with spinocerebellar ataxia type 2 (SCA2). Symptomatic treatment (specific plan unknown) was ineffective. The symptoms continued to worsen, balance function was abnormal, walking was unstable, and limbs trembled when moving. In February 2024, he came to the outpatient clinic for treatment. Unsteady walking, poor balance function, obvious when climbing stairs, unbalanced sitting, slurred speech, poetry-like language, normal sleep, good appetite, slightly hard stool, and no difference in urine. Physical examination: wide-spacing gait, finger-nose test (+), rapid alternation (±), difficult to stand with eyes closed (+), unable to complete a straight step, normal muscle strength and muscle tension, International Cooperative Ataxia Rating Scale (ICARS) score: 37 points. Diagnosis: SCA2. The TCM syndrome is kidney deficiency and marrow deficiency. Treatment is to tonify the kidney, replenish essence and benefit the marrow. The Chinese medicine composition of the present invention is used: the decoction is taken once a day, divided into 2 doses and taken warm. The patient took the medicine for 3 months, and the patient had multiple follow-up visits during the period. The dosage of the raw materials of the Chinese medicine combination was adjusted according to clinical dialectics. After the follow-up visit 3 months later, the unsteady walking and slurred speech were improved, the bowel movements were smooth, and the ICARS score was 33 points. The prescription was continued to consolidate the therapeutic effect.

[0144] The above detailed description is a specific description of one feasible embodiment of the present invention. The embodiment is not intended to limit the patent scope of the present invention. Any equivalent implementation or modification that does not deviate from the present invention should be included in the scope of the technical solution of the present invention.

Claims

1. A Chinese medicine composition for treating cerebellar ataxia syndrome, characterized in that: The invention comprises the following components: raw rehmannia root, cooked rehmannia root, cistanche deserticola, euphorbia officinalis, cornus officinalis, dendrobium, curculigo orchioides, ginseng, ophiopogon japonicus, polygala tenuifolia, calamus tatarinowii, angelica dahurica, poria, schisandra chinensis, tangerine peel and amomum villosum.

2. The Chinese medicine composition according to claim 1, characterized in that: The invention comprises the following components by weight: 20-50 parts of raw rehmannia root, 30-100 parts of cooked rehmannia root, 15-30 parts of cistanche deserticola, 15-30 parts of eucommia bark, 15-30 parts of cornus officinalis, 10-15 parts of dendrobium, 10-20 parts of curculigo, 5-10 parts of ginseng, 6-9 parts of ophiopogon, 5-10 parts of polygala, 6-12 parts of calamus, 6-15 parts of angelica dahurica, 15-30 parts of poria, 6-15 parts of schisandra chinensis, 10-15 parts of tangerine peel and 5-10 parts of amomum.

3. The Chinese medicine composition according to claim 1, characterized in that The polygala is processed polygala, and the composition further comprises 30-100 parts by weight of rice wine.

4. The Chinese medicine composition according to claim 1, characterized in that: The invention comprises the following components by weight: 50 parts of raw rehmannia root, 50 parts of cooked rehmannia root, 30 parts of cistanche deserticola, 30 parts of eucommia bark, 30 parts of cornus officinalis, 15 parts of dendrobium, 10 parts of curculigo, 10 parts of ginseng, 9 parts of ophiopogon, 10 parts of processed polygala root, 12 parts of calamus, 12 parts of angelica dahurica, 15 parts of poria, 10 parts of schisandra chinensis, 10 parts of tangerine peel and 10 parts of amomum.

5. A method for preparing the Chinese medicine composition according to any one of claims 1 to 4, characterized in that: The steps include: (1) soaking raw rehmannia root and cooked rehmannia root in a solvent to obtain a mixture A; (2) mixing Cistanche deserticola, Morinda officinalis, Cornus officinalis, Dendrobium officinale, Curculigo orchioides, Ginseng, Ophiopogon japonicus, Polygala tenuifolia, Acorus calamus, Angelica dahurica, Poria cocos, Schisandra chinensis, Tangerine peel and Amomum villosum, and soaking the mixture in water to obtain a mixture B; (3) After the mixture A and the mixture B are combined, they are decocted and the decoction is collected to obtain the product.

6. The preparation method according to claim 5, characterized in that: In step (1), the solvent is rice wine, and the soaking time is 10-50 minutes.

7. The preparation method according to claim 5, characterized in that: The amount of water used in step (2) is 2-8 times the total mass of Cistanche deserticola, Morinda officinalis, Cornus officinalis, Dendrobium officinale, Curculigo orchioides, Ginseng, Ophiopogon japonicus, Polygala tenuifolia, Acorus calamus, Angelica dahurica, Poria cocos, Schisandra chinensis, Tangerine peel and Amomum villosum, and the soaking time is 10-40 min.

8. The preparation method according to claim 5, characterized in that: In step (3), the decoction is performed 1-3 times, and the decoctions are combined; the decoction time is 30-50 minutes; And / or, in step (3), after the decoction is collected, it is also concentrated and dried.

9. A pharmaceutical preparation, characterized in that The invention comprises the Chinese medicine composition according to any one of claims 1 to 4 or the Chinese medicine composition prepared by the preparation method according to any one of claims 5 to 8, and pharmaceutically acceptable excipients.

10. Use of the Chinese medicine composition according to any one of claims 1 to 4 or the Chinese medicine composition prepared by the preparation method according to any one of claims 5 to 8 in preparing a drug for treating or alleviating or treating cerebellar ataxia syndrome.

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