Traditional Chinese medicine composition for treating post-stroke sarcopenia as well as preparation method and application of traditional Chinese medicine composition

Abstract

The invention discloses a traditional Chinese medicine composition for treating post-stroke sarcopenia as well as a preparation method and application of the traditional Chinese medicine composition. The traditional Chinese medicine composition is prepared from radix rehmanniae preparata, fructus corni, radix morindae officinalis, herba cistanche, herba dendrobii, radix ophiopogonis, fructus schizandrae, poria cocos, radix aconiti lateralis preparata, cortex cinnamomi, radix astragali seu hedysari, radix codonopsis, fructus jujubae and caulis spatholobi. The 14 medicinal materials are prepared according to a specific weight ratio. Based on a traditional Chinese medicine treatment method of tonifying liver and kidney, strengthening spleen and stomach and dredging meridians and collaterals, the composition is precise and appropriate, and the pertinence is strong. Clinical research proves that the composition can remarkably improve the muscle strength, muscle quality and movement function of a patient suffering from post-stroke sarcopenia, and the curative effect is remarkably superior to that of conventional rehabilitation treatment. The research on the mechanism of action shows that muscle synthesis can be promoted by up-regulating an IGF-1 / Akt / mTOR (Insulin-like Growth Factor 1 / Akt / mTOR) signal channel, and muscle decomposition can be inhibited by down-regulating the expression of MuRF-1 / Atrogin-1 at the same time. A detailed dose ratio optimization research proves that a specific ratio (an optimal embodiment) has a synergistic effect. The invention provides an innovative traditional Chinese medicine treatment scheme with definite curative effect and high safety for the post-stroke sarcopenia, and has important clinical value and development prospect.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of traditional Chinese medicine, in particular to a traditional Chinese medicine composition for treating post-stroke sarcopenia, and also relates to a preparation method of the traditional Chinese medicine composition and application thereof. BACKGROUND

[0002] Stroke is the second leading cause of death and the leading cause of disability in adults worldwide. Sarcopenia, as a common complication after stroke, is characterized by progressive loss of skeletal muscle mass, muscle strength and physical function, which significantly increases the risk of falls, life dependency and death. Studies have shown that the incidence of post-stroke sarcopenia is as high as 38.6%, and its pathogenesis is closely related to loss of neural drive, activation of inflammatory factors, protein synthesis disorders and limited activity. Since the etiology of the disease is not fully understood, there is a lack of effective intervention measures, and the current main treatment regimen is nutritional support and exercise rehabilitation, but these methods have limited effect, and it is difficult to implement for patients with post-stroke mobility difficulties, so it is urgent to explore new treatment strategies.

[0003] Traditional Chinese medicine has a long history and unique advantages in the treatment of flaccid syndrome (muscle weakness and atrophy) and post-stroke sequelae. Post-stroke sarcopenia belongs to the category of "flaccid syndrome" in traditional Chinese medicine, and the core pathogenesis is "liver and kidney deficiency, spleen deficiency, and phlegm and blood stasis blocking collaterals". It is mostly "deficiency in the root and excess in the branches", "deficiency in the root" is due to liver and kidney deficiency and deficiency of qi and blood, and "excess in the branches" is due to phlegm and blood stasis blocking collaterals and muscle and tendon malnutrition. Although some existing traditional Chinese medicine prescriptions or traditional Chinese medicine have certain effects on post-stroke limb function recovery, most of them have complex prescription, lack of precise prescription targeting the specific pathological link of "sarcopenia", and often lack sufficient support from modern pharmacological research.

[0004] Therefore, there is an urgent need in the art for a traditional Chinese medicine treatment regimen targeting the etiology and pathogenesis of post-stroke sarcopenia, refined prescription, clear targeting, and supported by modern scientific evidence. SUMMARY

[0005] To solve the above problems in the prior art, the primary purpose of the present application is to provide a traditional Chinese medicine composition for treating post-stroke sarcopenia with definite effect. The second purpose of the present application is to provide a preparation method of the traditional Chinese medicine composition. The third purpose of the present application is to provide the application of the traditional Chinese medicine composition in preparing a medicine or health food for preventing and / or treating post-stroke sarcopenia.

[0006] In the first aspect, the present application provides a traditional Chinese medicine composition for treating post-stroke sarcopenia, which is prepared from the following raw materials by weight: Radix Rehmanniae Preparata 2-6 parts, Cinnamomum Cassia 2-6 parts, Radix Paeoniae Alba 15-30 parts, Radix Paeoniae Rubra 9-15 parts, Radix Astragali 15-30 parts, Radix Codonopsis 9-15 parts, Fructus Jujubae 9-15 parts, Caulis Spatholobi 9-15 parts.

[0007] The traditional Chinese medicine composition in the present application is formulated based on the treatment principle of "tonifying liver and kidney, invigorating spleen and stomach, and dredging meridians" in traditional Chinese medicine. Among them: Monarch drug: Radix Rehmanniae Preparata, Radix Morindae Officinalis, and Herba Cistanche - Radix Rehmanniae Preparata nourishes kidney yin and fills essence and marrow; Radix Morindae Officinalis and Herba Cistanche warm and tonify kidney yang and strengthen bones and muscles. These three drugs together as the monarch drug embody the thought of "the one who is good at tonifying yang must seek yang in yin", so that yin and yang are balanced and endless.

[0008] Minister drug: Radix Aconiti, Cinnamomum Cassia, Fructus Corni, and Fructus Schisandrae - small dose of Radix Aconiti and Cinnamomum Cassia assist yang and benefit fire; Fructus Corni and Fructus Schisandrae tonify liver and kidney and consolidate essence, and also assist Radix Rehmanniae Preparata in nourishing kidney yin. These four drugs together as the minister drug embody the thought of "the one who is good at tonifying yin must seek yin in yang".

[0009] Assistant drug: Radix Astragali, Radix Codonopsis, Poria, Dendrobium, Radix Ophiopogonis, and Caulis Spatholobi - Radix Astragali and Radix Codonopsis tonify the spleen and benefit qi; Dendrobium and Radix Ophiopogonis nourish yin and moisten dryness, assist Radix Rehmanniae Preparata in nourishing yin, and also restrict the warm and dry nature of Radix Aconiti and Cinnamomum Cassia to prevent injury to yin; Caulis Spatholobi promotes blood and invigorates the meridians, and focuses on the nourishment of the limbs and meridians. These six drugs together as the assistant drug.

[0010] Messenger drug: Fructus Jujubae tonifies the spleen and benefits qi to harmonize all drugs.

[0011] The whole formula is compatible, and can tonify liver and kidney, invigorate the spleen, and dredge the meridians, which is the core pathogenesis of "liver and kidney deficiency, spleen dysfunction, and phlegm and blood stasis blocking the collaterals" after cerebral apoplexy. Compared with traditional prescriptions, the formula is more refined and has stronger targeting.

[0012] Preferably, it is made of raw medicinal materials in the following weight parts: Radix Rehmanniae Preparata 18-25 parts, Fructus Corni 8-12 parts, Radix Morindae Officinalis 8-12 parts, Herba Cistanche 8-12 parts, Dendrobium 8-12 parts, Radix Ophiopogonis 8-12 parts, Fructus Schisandrae 8-12 parts, Poria 8-12 parts, Radix Aconiti 2-5 parts, Cinnamomum Cassia 2-5 parts, Radix Astragali 18-25 parts, Radix Codonopsis 8-12 parts, Fructus Jujubae 8-12 parts, and Caulis Spatholobi 8-12 parts.

[0013] Further preferably, it is made of raw medicinal materials in the following weight parts: Rehmannia 20 parts, Cornus 10 parts, Cistanche 10 parts, Dendrobium 10 parts, Ophiopogon 10 parts, Schisandra 10 parts, Poria 10 parts, Prepared Aconite 3 parts, Cinnamon 3 parts, Astragalus 20 parts, Codonopsis 10 parts, Jujube 10 parts, Spatholobus 10 parts. Through systematic experimental research, it is confirmed that the optimal weight ratio is the most significant in improving muscle mass and regulating key signal pathways compared with other weight ratios.

[0014] In a second aspect, the present application also provides a preparation method of the above-mentioned traditional Chinese medicine composition, comprising the following steps: (1) The raw medicinal materials are weighed according to the weight parts; (2) The raw medicinal materials weighed in step (1) are first soaked in water for 0.5-1 hours, and then boiled for 2-3 times, each time for 1-2 hours, and the decoction is combined; (3) The combined decoction in step (2) is filtered, and the filtrate is concentrated to a relative density of 1.10-1.30 at 50-60℃ to obtain an extract; or the filtrate is further spray-dried or vacuum-dried to prepare a dry extract powder.

[0015] As a preferred, the water added in step (2) is 8-12 times the total weight of the medicinal materials.

[0016] The present application can also be prepared into any orally administrable dosage form according to the conventional method of traditional Chinese medicine preparation, such as tablets, capsules, granules, pills, oral liquids, etc.

[0017] In a third aspect, the present application also provides the use of the above-mentioned traditional Chinese medicine composition in the preparation of a medicament for treating post-stroke sarcopenia.

[0018] In a fourth aspect, the present application provides the use of the above-mentioned traditional Chinese medicine composition in the preparation of a medicament for improving muscle mass, muscle strength or body function of a stroke patient.

[0019] In a fifth aspect, the present application provides the use of the above-mentioned traditional Chinese medicine composition in the preparation of a functional food or health food for preventing and / or improving post-stroke sarcopenia.

[0020] The present application has the following beneficial effects: 1. Strong targeting: The present application first proposes a traditional Chinese medicine composition targeting the specific disease of "post-stroke sarcopenia", combining disease and syndrome, and the target is clear.

[0021] 2. Scientific composition: Based on the classical theory of traditional Chinese medicine, combined with modern pathological research, the prescription compatibility is rigorous, the monarch, minister, assistant and messenger are clear, and multiple pathological links such as tonifying liver and kidney, invigorating spleen and stomach, and dredging meridians are considered, which embodies the advantages of multi-target treatment.

[0022] 3. Curative effect is definite: through the clinical observation data and protein immune experiment provided in the following specific embodiments, it is proved that the traditional Chinese medicine composition provided by the application can significantly increase the muscle strength, muscle mass and muscle function of the sarcopenia patient after stroke, and can regulate the key factors related to muscle synthesis and decomposition at the molecular level of the model animal.

[0023] 4. High safety: the selected medicinal materials are collected in the pharmacopoeia, are mild in nature, have no toxic side effects, are suitable for long-term taking, and meet the needs of chronic disease management.

[0024] 5. Wide application prospect: the composition of the application is suitable for long-term rehabilitation management of patients in the recovery period of stroke, can be used not only for the development of therapeutic drugs, but also can be used in combination with other rehabilitation methods, and even extended to the field of health food, to meet the long-term health management needs of patients in the recovery period of stroke, and has a wide clinical conversion prospect. BRIEF DESCRIPTION OF DRAWINGS

[0025] Figure 1 is a relative quantitative analysis diagram of each group of proteins. DETAILED DESCRIPTION

[0026] The application will be further described below through specific examples, but the application is not limited thereto. Example 1 Take 15g of prepared rehmannia, 9g of dogwood, 9g of leydig, 9g of dendrobium, 9g of maimendong, 9g of schisandra, 9g of poria, 9g of prepared aconite, 2g of cassia, 2g of astragalus, 15g of radix astragali, 9g of radix ginseng, 9g of jujube, and 9g of spatholobus.

[0027] Soak with water for 0.5 hours (the amount of water added is 10 times the total weight of the medicinal materials), boil with strong fire, and then simmer with weak fire for 1.5 hours, filter, and obtain filtrate ①.

[0028] Add 8 times the amount of water to the residue, and simmer for 1 hour, filter, and obtain filtrate ②.

[0029] Combine the filtrate ① and the filtrate ②, filter through a 200-mesh sieve, concentrate the filtrate under reduced pressure to a relative density of 1.20 at 60℃, obtain an extract, add 20%-30% of dextrin and a flavoring agent based on the weight of the extract, mix well, granulate, dry, and pack, and obtain granules 100g.

[0030] Example 2: Take 25g of prepared rehmannia, 12g of dogwood, 12g of leydig, 12g of dendrobium, 12g of maimendong, 12g of schisandra, 12g of poria, 12g of prepared aconite, 5g of cassia, 5g of astragalus, 25g of radix astragali, 12g of radix ginseng, 12g of jujube, and 12g of spatholobus.

[0031] Prepare granules according to the method of Example 1.

[0032] Example 3: Take Rehmannia 20g, Dogwood 10g, Cistanche 10g, Herba Epimedii 10g, Dendrobium 10g, Ophiopogon 10g, Schisandra 10g, Poria 10g, Prepared Aconite 3g, Cinnamon 3g, Astragalus 20g, Codonopsis 10g, Jujube 10g, Spatholobus 10g.

[0033] Granules were prepared according to the method of Example 1.

[0034] The Rehmannia, Dogwood, Cistanche, Herba Epimedii, Dendrobium, Ophiopogon, Schisandra, Poria, Prepared Aconite, Cinnamon, Astragalus, Codonopsis, Jujube, and Spatholobus in the present application are conventional traditional Chinese medicine decoction pieces, which are purchased from Hunan Songlingtang Traditional Chinese Medicine Decoction Pieces Co., Ltd.

[0035] Experiment 1: Clinical test of the traditional Chinese medicine composition in the present application In order to prove the clinical curative effect of the traditional Chinese medicine composition in the present application, the present application provides clinical observation data of 70 patients with ischemic stroke combined with sarcopenia from Yueyang City Hospital of Traditional Chinese Medicine. The 70 cases are divided into two groups according to the principle of random allocation, 35 cases in the traditional Chinese medicine group and 35 cases in the control group. The patients in the two groups are comparable in terms of age, gender, disease duration and other aspects.

[0036] 1. Diagnostic criteria 1.1.1 Western medicine diagnostic criteria: The diagnostic criteria for ischemic stroke are based on the 2014 Chinese Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke. The diagnostic criteria are as follows: (1) acute onset; (2) focal neurological deficits (facial or unilateral limb weakness or numbness, speech disorders, etc.), and a few are general neurological deficits; (3) duration of symptoms and signs is not limited (when imaging shows a responsible lesion), or lasts for more than 24 hours (when there is no responsible lesion); (4) exclude non-vascular causes; (5) exclude cerebral hemorrhage by head CT / MRI. The diagnostic criteria for sarcopenia refer to the relevant diagnostic criteria in the Chinese Expert Consensus on Diagnosis and Treatment of Sarcopenia in the Elderly: (1) limb muscle mass: male <7.0 kg / m2, female <5.7 kg / m2; (2) muscle strength: grip strength (male <28 kg, female <18 kg); (3) physical function: 6m daily walking speed <1.0 m / s or 5 times sit-up time >12 s or simple physical function test table ≤9 points. When (1)+(2) or (3) are met, sarcopenia is diagnosed.

[0037] 1.1.2 Diagnostic criteria for traditional Chinese medicine: Refer to the diagnostic criteria for "Liver and Kidney Deficiency Syndrome" in the 2012 edition of "Diagnostic Criteria and Curative Effect Standards for Traditional Chinese Medicine" : The patient has been ill for a long time, the limbs are flaccid and cannot be used, the muscles are atrophied, the body is thin and the bones are standing, the waist and knees are sore and soft, the head is dizzy and the ears are ringing, or the two excretory systems are incontinent. The tongue is red and dry, with little moss and thin pulse.

[0038] 1.2 Inclusion criteria Patients who meet the diagnostic criteria of Chinese and Western medicine; age 60-85 years old; in the recovery stage or sequelae stage; clear consciousness, can independently complete upper limb grip strength test, 6-meter walking speed test, BIA body fat test, and can cooperate with general; fully informed and agreed to the patient and family.

[0039] 1.3 Exclusion criteria Patients with cognitive impairment, speech impairment or hearing impairment; patients with mental illness; patients with metabolic disease or important organ failure; patients with a cardiac pacemaker or artificial joint implanted in the body; patients who cannot cooperate with the test due to severe disability; incomplete data and refusal to participate in the survey.

[0040] 1.4 Dropout criteria The subject voluntarily withdraws informed consent; lost follow-up (defined as unable to contact by pre-reserved telephone and address for 3 consecutive times); discontinued the trial due to serious adverse events judged by the researcher; violated the main study plan (such as less than 80% medication compliance or received prohibited combined treatment). To minimize loss of follow-up, we took measures such as sending regular follow-up reminder messages, providing transportation subsidies, and setting flexible follow-up time windows.

[0041] 1.5 Exclusion criteria Poor compliance; death during the trial.

[0042] 2, Implementation scheme 2.1 Basic treatment: including anti-platelet aggregation, lipid regulation and plaque stabilization, blood pressure and blood sugar control, brain protection, and anticoagulant therapy for patients with anticoagulant indications.

[0043] 2.2 Control group: in addition to the basic treatment, routine exercise therapy is added, including: ① resistance training: upper limb movements include hand gripping, abduction, lateral elevation and forward pushing; lower limb movements include knee flexion and extension, hip flexion and lifting, hip abduction and extension, and heel and toe movements; ② balance training: including backward walking, walking with turning, lateral step movement, heel walking, toe walking, heel-toe alternating forward walking, heel-toe alternating backward walking, single foot balance, and exercises from sitting to standing. Single training is controlled within 20 to 30 minutes, 3 to 5 times a week, for a total of 12 weeks. 2.3 Traditional Chinese medicine group: in addition to the control group, the granules of the traditional Chinese medicine composition of example 1 of the present application are orally taken, twice a day, 200g / d. Continuous treatment for 12 weeks. The results are counted after treatment.

[0044] 3, Result statistics 3.1 Comparison of clinical efficacy between the two groups of patients The total effective rate of the TCM group was 94.3% (33 / 35), and that of the control group was 74.3% (26 / 35). The difference between the two groups was statistically significant (z=-2.324, P=0.020), as shown in Table 1.

[0045]

[0046] 3.2 Comparison of TCM syndrome scores between the two groups before and after treatment After treatment, the scores of hemiplegia, shortness of breath, fatigue, soreness of waist and knees, dizziness, and incontinence decreased in both groups, and the TCM group had lower TCM syndrome scores than the control group, with a statistically significant difference (P<0.05), as shown in Table 2.

[0047]

[0048] 3.3 Comparison of grip strength between the two groups before and after treatment: The grip strength of both groups improved after treatment (P<0.01), and the grip strength of the TCM group was higher than that of the control group, with a statistically significant difference (P<0.01), as shown in Table 3.

[0049]

[0050] 3.4 Comparison of muscle mass between the two groups before and after treatment: The muscle mass of both groups improved after treatment (P<0.01), and the muscle mass of the TCM group was higher than that of the control group, with a statistically significant difference (P<0.01), as shown in Table 4.

[0051]

[0052] 3.5 Comparison of muscle function between the two groups before and after treatment: The muscle function of both groups improved after treatment (P<0.01), and the muscle function of the TCM group was higher than that of the control group, with a statistically significant difference (P<0.01), as shown in Table 5.

[0053]

[0054] The results of the experiment showed that the total effective rate of the TCM group (94.3%) was higher than that of the control group (74.3%), and the TCM group was superior to the simple exercise therapy in improving TCM syndrome scores, grip strength, muscle mass (SMI), muscle function (SPPB score), and reducing inflammatory factors (P<0.01).

[0055] Experiment Two Experimental animals: 15 male SPF SD rats aged 18 months and weighing 180-220 g were selected and raised in the SPF barrier environment of the Animal Experiment Center of Hunan University of Chinese Medicine. This study followed the internationally recognized animal welfare and ethical guidelines. The experiment was approved by the Animal Ethics Committee of Hunan University of Chinese Medicine and was conducted in the Experimental Animal Center of Hunan University of Chinese Medicine. The animals were raised with equal day-night rhythm, and the temperature was (24.0 ± 1.0) ℃, the relative humidity was (50 ± 10) %, and the food and water were supplied without difference during the period. The bedding was changed twice a week to keep the living environment clean and hygienic. After 1 week of adaptive feeding, the experiment was performed.

[0056] 2. Model establishment: The middle cerebral artery occlusion (MCAO) model was established by the modified thread embolism method. The specific operation is as follows: (1) After fasting for 12 hours, the rats were anesthetized by intraperitoneal injection of 3% sodium pentobarbital (40 mg / kg); (2) A midline incision was made on the neck, and the right common carotid artery, external carotid artery, and internal carotid artery were separated; (3) The distal end of the external carotid artery was ligated, and an arterial clip was placed at the proximal end of the common carotid artery; (4) A small opening was cut on the external carotid artery, and a thread embolism (diameter 0.26 mm) was inserted through the internal carotid artery into the brain to the initial part of the middle cerebral artery to block blood flow; (5) After 2 hours of ischemia, the thread embolism was removed to achieve reperfusion.

[0057] After the operation, a low-protein diet (protein content 8%) was given, and the activity was limited (single-cage feeding, with a normal activity space limited to 1 / 3). The post-stroke sarcopenia model was constructed. Neurological deficit score was performed 72 hours after the operation, and rats with a score ≥1 were considered to be successfully modeled.

[0058] Grouping and administration: The successfully modeled rats were randomly divided into a model group and a drug administration group, and a normal group was set as a control, with 5 rats in each group.

[0059] Preparation method of drugs in each group: (1) Drug administration group: The granules prepared in Example 1 were taken, and distilled water was used to prepare the required concentration before use.

[0060] (2) The normal control group and the model group were given an equal volume of normal saline by gavage. The drug was administered once a day, and the continuous intervention lasted for 8 weeks.

[0061] 3. Detection index: Molecular biology indicators: Western Blot or ELISA method is used to detect gastrocnemius muscle. Western Blot technology is used to detect the protein expression levels of IGF-1 / Akt / mTOR signal pathway (promote synthesis) and MuRF-1, Atrogin-1 (promote decomposition) in skeletal muscle tissue. Total protein of skeletal muscle tissue is extracted, protein concentration is determined, then SDS-PAGE electrophoresis separation is carried out, after membrane transfer, corresponding primary antibody is incubated, then secondary antibody is incubated, finally chemiluminescence is developed, and the gray value of protein band is analyzed by ImageJ software.

[0062] 4. Experimental results: At the molecular level, the traditional Chinese medicine composition in the application can significantly up-regulate the protein expression of IGF-1, p-Akt and p-mTOR, and down-regulate the protein expression of MuRF-1 and Atrogin-1, as shown in Figure 1 Protein relative quantification analysis chart of each group.

[0063] Experiment three: dose ratio optimization and synergistic effect research of the application 1. Experimental animals and models: 50 male SPF SD rats aged 18 months were selected. The weight, feeding conditions and modeling method of the rats were the same as those of experiment two.

[0064] 2. Grouping and administration: the successfully modeled rats were randomly divided into 5 groups, except for the model group and the normal group, three different ratio administration groups were set, and the experimental animal grouping and administration scheme are shown in Table 6.

[0065]

[0066] Preparation method of drugs in each group: (1) Normal group: equal volume of normal saline.

[0067] (2) Model group: equal volume of normal saline.

[0068] (3) Administration group 1: take the granules prepared in Example 1, and prepare the required concentration with distilled water before use.

[0069] (4) Administration group 2: take the granules prepared in Example 2, and prepare the required concentration with distilled water before use.

[0070] (5) Administration group 3: take the granules prepared in Example 3, and prepare the required concentration with distilled water before use.

[0071] Administration period: continuous gavage administration for 8 weeks.

[0072] Observation indicators and detection methods: 3.1 General observation: The mental state, activity, fur color, food and water intake, and defecation of the rats were observed daily.

[0073] 3.2 Body weight and food intake: The body weight and food intake of the rats were measured once a week.

[0074] 3.3 Grip strength determination: The grip strength of the rats was determined using a rat grip strength meter before administration, at 4 weeks of administration, and at 8 weeks of administration. Each rat was measured 3 times, and the average value was taken.

[0075] 3.4 Muscle mass determination: After the experiment, the rats were fasted for 12 hours, anesthetized, and sacrificed. The bilateral gastrocnemius muscle, tibialis anterior muscle, and soleus muscle were quickly separated, weighed using an electronic balance, and the muscle wet weight / body weight ratio was calculated.

[0076] 3.5 Muscle histopathology examination: Part of the gastrocnemius muscle tissue was fixed with 4% paraformaldehyde, embedded in paraffin, sectioned, HE stained, and observed under a light microscope for morphological changes in muscle tissue.

[0077] 3.6 Molecular biology index detection: Western Blot technology was used to detect the protein expression levels of IGF-1 / Akt / mTOR signaling pathway (promoting synthesis) and MuRF-1, Atrogin-1 (promoting decomposition) in skeletal muscle tissue.

[0078] 4. Experimental results 4.1 General condition: The rats in the normal control group were in good mental state, with normal activity, lustrous fur, and normal food and water intake. The rats in the model control group were in poor mental state, with reduced activity, partial signs of hemiplegia, dull fur, and reduced food and water intake. The general condition of the rats in each administration group was improved compared with the model control group, with the most significant improvement in the administration group 3.

[0079] 4.2 Body weight and muscle mass changes: The experimental results are shown in Table 7.

[0080]

[0081] 4.3 Changes in grip strength: The experimental results are shown in Table 8.

[0082]

[0083] 4.4 Molecular biology indicators: Western Blot detection results show that, compared with the normal control group, the expression of IGF-1, p-Akt and p-mTOR proteins in the skeletal muscle tissue of the model control group of rats was significantly down-regulated (P<0.01), while the expression of MuRF-1 and Atrogin-1 proteins was significantly up-regulated (P<0.01). Each administration group can reverse this trend to varying degrees, among which the administration group 3 has the most significant effect, almost restoring to the normal level. The specific results are shown in Table 9.

[0084]

[0085] Group n IGF-1 p-Akt p-mTOR MuRF-1 Atrogin-1 Normal control group 10 1.00±0.08△△ 1.00±0.07△△ 1.00±0.08△△ 1.00±0.09△△ 1.00±0.08△△ Model control group 10 0.42±0.06** 0.38±0.05** 0.45±0.07** 2.85±0.25** 2.76±0.23** Dosing group 1 10 0.65±0.05*# 0.62±0.06*# 0.68±0.06*# 1.95±0.20*# 1.88±0.19*# Dosing group 2 10 0.84±0.06△△# 0.82±0.05△△# 0.87±0.05△△# 1.42±0.15△△# 1.38±0.14△△# Dosing group 3 10 0.95±0.07△△ 0.94±0.06△△ 0.96±0.06△△ 1.15±0.12△△ 1.12±0.11△△

[0086] Note: compared with the normal control group, **P<0.01; compared with the model control group, △△P<0.01; compared with the best embodiment group, #P<0.05.

[0087] Conclusion: The traditional Chinese medicine composition can promote muscle synthesis and effectively inhibit muscle decomposition through multi-target regulation, thereby improving the clinical manifestations of post-stroke sarcopenia and having a clear therapeutic effect.

[0088] However, the best embodiment group of the present application, i.e. the administration group 3, is significantly better than the comparative example group, i.e. the administration group 1 (broad ratio), in improving muscle mass, muscle strength and activating the muscle synthesis signal pathway (p-mTOR) (P<0.05).

[0089] The effect of the preferred ratio group, i.e. the administration group 2, is also significantly better than the comparative example group, but slightly lower than the best embodiment group.

[0090] This result fully proves that the preferred range and the best embodiment ratio selected through a large number of experiments of the present application are not the conventional selection in the field, and the synergistic effect of each component reaches the unexpected technical effect of "1+1>2", which provides solid experimental support for the creativity and novelty of the dosage range.

Claims

1. A traditional Chinese medicine composition for treating sarcopenia after stroke, characterized in that, It is made from the following raw materials in parts by weight: 15-30 parts Rehmannia glutinosa, 9-15 parts Cornus officinalis, 9-15 parts Morinda officinalis, 9-15 parts Cistanche deserticola, 9-15 parts Dendrobium nobile, 9-15 parts Ophiopogon japonicus, 9-15 parts Schisandra chinensis, 9-15 parts Poria cocos, 2-6 parts Aconitum carmichaelii (processed), 2-6 parts Cinnamomum cassia, 15-30 parts Astragalus membranaceus, 9-15 parts Codonopsis pilosula, 9-15 parts Ziziphus jujuba, and 9-15 parts Spatholobus suberectus.

2. The traditional Chinese medicine composition according to claim 1, characterized in that, It is made from the following raw materials in parts by weight: 18-25 parts Rehmannia glutinosa, 8-12 parts Cornus officinalis, 8-12 parts Morinda officinalis, 8-12 parts Cistanche deserticola, 8-12 parts Dendrobium nobile, 8-12 parts Ophiopogon japonicus, 8-12 parts Schisandra chinensis, 8-12 parts Poria cocos, 2-5 parts Aconitum carmichaelii (processed), 2-5 parts Cinnamomum cassia, 18-25 parts Astragalus membranaceus, 8-12 parts Codonopsis pilosula, 8-12 parts Ziziphus jujuba, and 8-12 parts Spatholobus suberectus.

3. The traditional Chinese medicine composition according to claim 1, characterized in that, It is made from the following raw materials in parts by weight: 20 parts Rehmannia glutinosa, 10 parts Cornus officinalis, 10 parts Morinda officinalis, 10 parts Cistanche deserticola, 10 parts Dendrobium nobile, 10 parts Ophiopogon japonicus, 10 parts Schisandra chinensis, 10 parts Poria cocos, 3 parts Aconitum carmichaelii (processed), 3 parts Cinnamomum cassia, 20 parts Astragalus membranaceus, 10 parts Codonopsis pilosula, 10 parts Ziziphus jujuba, and 10 parts Spatholobus suberectus.

4. The traditional Chinese medicine composition according to any one of claims 1 to 3, characterized in that, The traditional Chinese medicine composition is prepared into a pharmaceutically acceptable dosage form, including but not limited to tablets, capsules, granules, pills, or oral liquids.

5. A method for preparing the traditional Chinese medicine composition according to any one of claims 1-3, characterized in that, Includes the following steps: (1) Weigh each raw material according to the stated weight proportions; (2) First, soak the raw materials weighed in step (1) in water for 0.5-1 hour, then add water and decoct 2-3 times, 1-2 hours each time, and combine the decoctions; (3) Filter the decoction combined in step (2), concentrate the filtrate at 50-60℃ to a relative density of 1.10-1.30 to obtain an extract; add 20%-30% of dextrin and flavoring agent by weight of the extract, mix well, granulate, dry, and package to obtain granules.

6. The use of the traditional Chinese medicine composition according to any one of claims 1-3 in the preparation of a medicament for the prevention and / or treatment of sarcopenia after stroke.

7. The use of the traditional Chinese medicine composition according to any one of claims 1-3 in the preparation of a medicament for improving muscle mass, muscle strength and / or physical function in stroke patients.

8. The use of the traditional Chinese medicine composition according to any one of claims 1-3 in the preparation of functional foods or health foods for the prevention and / or improvement of sarcopenia after stroke.

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