Traditional Chinese medicine preparation for adjuvant treatment of gradual freezing and preparation method of traditional Chinese medicine preparation

By combining traditional Chinese medicine preparations prepared with a variety of Chinese medicinal materials, the treatment problems of symptoms such as muscle atrophy, weakness and sclerosis in patients with ALS have been solved, and multiple effects of regulating qi and blood, promoting blood circulation and removing blood stasis, and alleviating symptoms are achieved, providing a safe and effective auxiliary treatment plan.

CN119970930APending Publication Date: 2025-05-13HENAN QIANPENG BIOPHARMACEUTICAL CO LTD
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Patent Information

Application Number
CN202510310849.7
Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Filing Date
2025-03-17
Publication Date
2025-05-13

AI Technical Summary

Technical Problem

Patients with ALS have symptoms such as muscle atrophy, weakness and sclerosis. The existing Western medical treatment has problems of high side effects and high cost. Traditional Chinese medicine treatment requires both nourishing qi and blood, promoting blood circulation and unblocking the meridians, and warming yang and dispersing cold, but there is a lack of effective auxiliary treatment methods.

Method used

It provides a traditional Chinese medicine preparation that assists in the treatment of ALS. By combining ginseng, puerarium powder, honeysuckle vine, antler glue, Sichuan papaya, raw coix seed, yew, leech, cypress, white peony and sedatives, the preparation method is to soak and torture the medicinal materials in hydrogen-rich water to prepare a traditional Chinese medicine preparation with multiple effects such as replenishing qi, promoting blood circulation, promoting diuresis, and clearing heat.

Benefits of technology

This traditional Chinese medicine preparation can relieve symptoms such as muscle atrophy, weakness and sclerosis by regulating the circulation of qi and blood, warming and unblocking meridians, and activate blood circulation and remove blood stasis. It provides a safe and effective auxiliary treatment plan, suitable for auxiliary treatment of ALS.

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Abstract

The invention belongs to the technical field of traditional Chinese medicine preparations for treating gradual freezing, and particularly relates to a traditional Chinese medicine preparation for adjuvant treatment of gradual freezing and a preparation method thereof.The traditional Chinese medicine preparation is mainly prepared from, by weight, 3-9 parts of ginseng, 9-20 parts of kudzuvine root powder, 9-30 parts of honeysuckle stems, 3-9 parts of deer-horn glue and 6-15 parts of Sichuan papaya. The traditional Chinese medicine composition is prepared from, by weight, 9-30 parts of raw coix seeds, 3-9 parts of taxus chinensis, 1.5-6 parts of leeches, 4.5-10 parts of selaginella tamariscina, 6-15 parts of radix paeoniae alba and 9-15 parts of aizoon stonecrop herbs. The preparation method comprises the following steps: putting the proportioned medicinal raw materials into a heating container, adding 700-2000 parts by weight of water or hydrogen-rich water, decocting for 15-30 minutes, and filtering out liquid medicine, thereby obtaining the traditional Chinese medicine preparation for adjuvant treatment of the gradual freezing disease. The traditional Chinese medicine composition is mainly used for relieving the symptoms of atrophy, weakness and even sclerosis of muscles of the patient suffering from the asymptomatic hyperthyroidism.
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Description

Technical Field

[0001] The present invention belongs to the technical field of Chinese medicine preparations for treating ALS, and specifically relates to a Chinese medicine preparation for auxiliary treatment of ALS and a preparation method thereof. The preparation can regulate the circulation of qi and blood, warm and dredge meridians, and activate blood circulation and remove blood stasis, thereby relieving symptoms such as muscle atrophy, weakness and sclerosis, and is suitable for auxiliary treatment of ALS. Background Art

[0002] Amyotrophic lateral sclerosis (ALS) is a neurodegenerative disease, also known as Lou Gehrig's disease. Its main characteristics are gradual muscle atrophy and weakness, which eventually affects the patient's motor function and quality of life. Modern medicine has no effective cure yet. Western medicine treatment is mainly to delay the course of the disease, but there are problems such as large side effects and high costs. Traditional Chinese medicine provides some unique ideas and methods for the treatment of Lou Gehrig's disease. For example, the cause of the disease is mostly related to the liver, spleen, and kidney. The liver governs the tendons, the spleen governs the muscles, and the kidney governs the bones and marrow. When the liver, spleen, and kidney are dysfunctional, the tendons, bones, and muscles lose nourishment, which will cause the disease.

[0003] Traditional Chinese medicine believes that ALS is closely related to liver and kidney deficiency, qi and blood stasis, and cold and dampness blocking the meridians. Treatment must take into account replenishing qi and blood, activating blood circulation and unblocking meridians, and warming yang and dispersing cold.

[0004] Therefore, the traditional Chinese medicine method of treating ALS is mainly to regulate the liver, spleen and kidney, aiming to restore the normal functions of the three organs, thereby improving the patient's symptoms. Relieve muscle tension and pain, and promote blood circulation to achieve the purpose. The present invention uses the symptoms of muscle loss of nourishment and microcirculation rigidity as the starting point to try to improve the conditioning, and the compound preparation has both the effect of tonifying and unblocking the meridians. Summary of the invention

[0005] The purpose of the present invention is to provide a Chinese medicine preparation and a preparation method for auxiliary treatment of ALS, which is mainly used to alleviate the symptoms of muscle atrophy, weakness, and even hardening in ALS patients.

[0006] The technical solution of the present invention is: Provided is a traditional Chinese medicine preparation for assisting the treatment of amyotrophic lateral sclerosis. The preparation is prepared from the following raw materials in parts by weight: 3-9 parts by weight of ginseng, 9-20 parts by weight of kudzu root powder, 9-30 parts by weight of honeysuckle vine, 3-9 parts by weight of antler glue, 6-15 parts by weight of papaya, 9-30 parts by weight of raw coix seeds, 3-9 parts by weight of yew, 1.5-6 parts by weight of leech, 4.5-10 parts by weight of selaginella, 6-15 parts by weight of white peony root, and 9-15 parts by weight of sedum notoginseng.

[0007] In addition, a method for preparing a Chinese medicine preparation for assisting the treatment of ALS is provided. The above-mentioned medicinal raw materials with a good ratio are first placed in a heating container with 700-2000 parts by weight of hydrogen-rich water and soaked for 0.5-2 hours, then decocted for 15-30 minutes, and the medicinal liquid is filtered out to obtain the Chinese medicine preparation for assisting the treatment of ALS.

[0008] The symptoms applicable to the present invention are: body coldness caused by dampness, cold, decreased immunity (such as air conditioning, swimming, rain, camping, etc.) mainly caused by the following factors. That is, when the body feels that "wind, cold and dampness" are accumulated in the body, the cold and dampness cannot be discharged, and over time, the qi mechanism fails, the gasification or malfunctions (loses certain functions); or heat (belonging to Yang) is acute lesions (such as acute arthritis), pain, redness, swelling, pain and heat, etc.; or cold (belonging to Yin) is chronic lesions, such as: fear of cold, fear of wind and cold, wind-cold and dampness, etc.

[0009] Pharmacological properties of each ingredient in the present invention: In this formula, ginseng: sweet, slightly bitter, slightly warm. It enters the spleen, lung, heart, and kidney meridians. Its functions and indications are to greatly replenish vital energy, restore the pulse and consolidate the body, replenish the spleen and lung, promote the production of body fluid and nourish blood, and calm the mind and improve intelligence. It is used for physical weakness and weakness, cold limbs and weak pulse, spleen deficiency and poor appetite, lung deficiency and cough, thirst due to loss of body fluid, internal heat and thirst, qi and blood deficiency, long-term illness and weakness, palpitations and insomnia, impotence and cold uterus. In this preparation, it has the effects of greatly replenishing vital energy, strengthening the body's immune function, enhancing physical strength, and improving immunity.

[0010] Pueraria root powder: sweet, pungent, and cool in nature. It enters the spleen, stomach, and lung meridians. Its functions and indications include relieving muscle and reducing fever, promoting body fluid and relieving thirst, clearing rashes, raising yang and stopping diarrhea, promoting blood circulation and activating collaterals, and detoxifying alcohol. It is used for exogenous fever and headache, stiff neck and back pain, thirst, thirst, measles that does not clear up, heat dysentery, diarrhea, dizziness and headache, hemiplegia caused by stroke, chest pain and heart pain, and alcohol poisoning. In this preparation, it is mainly used to improve the function of the patient's circulatory and digestive systems.

[0011] Honeysuckle vine: sweet in nature and cold in flavor. It enters the lung and stomach meridians. Its functions and indications are clearing away heat and detoxifying, dispersing wind and unblocking collaterals. It is used for fever caused by febrile diseases, dysentery caused by heat toxins and blood, carbuncle, ulcer, rheumatism and heat arthralgia, and red, swollen, hot and painful joints. In this preparation, it is mainly used to improve symptoms such as pain and stiffness in muscles and joints.

[0012] Deer antler glue: sweet, salty, warm in nature. Enters the kidney and liver meridians. Its main functions are to warm and nourish the liver and kidney, and to nourish the essence and blood. It is used for soreness and coldness of the waist and knees, impotence and spermatorrhea, asthenia, metrorrhagia, blood in the stool and urine, and swelling and pain in the genitals caused by liver and kidney deficiency. In this preparation, deer antler glue has the effects of nourishing the liver and kidney, strengthening the tendons and bones, and promoting blood circulation and removing blood stasis. It is suitable for the symptoms of liver and kidney deficiency and weak tendons and bones. For patients with ALS, it is mainly used to improve muscle atrophy and decreased motor function.

[0013] Sichuan papaya: sour and warm in nature. Enters the liver and spleen meridians. Its functions and indications are to relax muscles and activate collaterals, and to harmonize the stomach and eliminate dampness. It is used for dampness and stiffness, soreness and heaviness of waist and knee joints, vomiting and diarrhea due to summer heat and dampness, cramps and pain, and beriberi and edema. It can treat vomiting and diarrhea due to summer heat and dampness, and can also be used alone to treat cramps and pain in the knees and feet. In this preparation, Sichuan papaya has the effects of digestion, deworming, blood circulation and blood stasis, which helps to improve the patient's digestive system function.

[0014] Raw coix seed: sweet, light, and cool in nature. It enters the spleen, stomach, and lung meridians. Its functions and indications are to promote diuresis and eliminate dampness, invigorate the spleen and stop diarrhea, remove numbness, discharge pus, and detoxify and disperse knots. It is used for edema, beriberi, dysuria, spleen deficiency diarrhea, dampness and stiffness, lung abscess, intestinal abscess, warts, and cancer. In this preparation, raw coix seed has the effects of promoting diuresis and eliminating dampness, invigorating the spleen and stopping diarrhea, clearing heat and discharging pus, and is suitable for symptoms such as edema, diarrhea, and dampness. For patients with ALS, it helps to improve edema and maintain a healthy digestive system.

[0015] Taxus: Taxus chinensis is mainly used here. It is bitter and pungent in nature, warm or neutral in nature. It mainly enters the kidney meridian, heart meridian, and liver meridian. The main component of Taxus chinensis is paclitaxel, which has anti-cancer, anti-inflammatory, analgesic, and immunomodulatory effects. Here, the paclitaxel and taxane components rich in yew can inhibit the release of inflammatory factors, reduce the damage of chronic inflammation to muscles and bones, and have anti-inflammatory and immunomodulatory effects. The inflammation of amyotrophic lateral sclerosis, also known as amyotrophic lateral sclerosis in traditional Chinese medicine, is generally related to "dampness, heat and blood stasis". Yew can help dredge meridians, improve the circulation of qi and blood, and relieve the stagnation in paralysis.

[0016] Taxol, which is rich in yew, can inhibit platelet aggregation and improve local microcirculation; its antioxidant effect reduces the damage of free radicals to muscle and bone cells. It plays a role in promoting microcirculation and tissue repair. Microcirculatory disorders correspond to "blood stasis", and improving blood supply can promote "tendons and veins nourishment" and accelerate muscle and bone repair.

[0017] Taxol, which is rich in yew, has an analgesic effect and can relieve the pain associated with paralysis by regulating neurotransmitters; its protective effect on nerve cells can delay the degeneration of motor neurons. It is suitable for limb pain associated with paralysis.

[0018] Taxus can protect muscle and bone cell functions by regulating sugar and lipid metabolism and inhibiting oxidative stress. It can improve the "acquired foundation" and enhance the biochemistry of qi and blood.

[0019] Leech: salty, bitter, flat; slightly toxic. Enters the liver meridian. Functions and indications: blood circulation, menstruation, blood stasis and symptom elimination. Used for blood stasis, amenorrhea, lumps, hemiplegia due to stroke, and injuries from falls. Its pharmacology has anticoagulant and thrombus-dissolving effects, and is effective for hemiplegia due to stroke. The leech in this preparation has the effects of promoting blood circulation, removing blood stasis, menstruation and relieving pain, which helps to improve blood circulation and relieve muscle pain.

[0020] Selaginella: pungent in nature and flavor, neutral. Enters the liver and heart meridians. Functions and indications: promoting blood circulation and dredges the menstruation. Used for amenorrhea, dysmenorrhea, masses, and injuries from falls. Selaginella charcoal can dissipate blood stasis and stop bleeding, and is used for hematemesis, metrorrhagia, bloody stools, and rectal prolapse. In this preparation, Selaginella has the effects of clearing away heat and detoxifying, promoting blood circulation and removing blood stasis, and removing dampness and swelling, which helps to improve pain and stiffness in muscles and joints.

[0021] White peony root: bitter, sour, slightly cold. Enters the liver and spleen meridians. Functions and indications: nourishing blood and regulating menstruation, restraining yin and stopping sweating, softening the liver and relieving pain, and calming liver yang. Used for blood deficiency and sallow complexion, irregular menstruation, spontaneous sweating, night sweats, hypochondriac pain, abdominal pain, cramps in the limbs, headache and dizziness. In this preparation, white peony root has the effects of nourishing blood, softening the liver, relieving pain, and is suitable for symptoms such as liver blood deficiency and irregular menstruation. It helps relieve muscle spasms and pain.

[0022] Sedum sanqi: sweet, slightly sour, neutral in nature. Enters the heart and liver meridians. Functions and indications: dispersing blood stasis and stopping bleeding, calming the nerves. In this formula, it is mainly used to dissipate blood stasis and stop bleeding, improve blood circulation, and repair tissue damage. In this preparation, Sedum sanqi has the effects of dispersing blood stasis and moistening dryness, which helps to improve muscle atrophy and weakness.

[0023] The above-mentioned medicinal raw materials with a good ratio are preferably crushed first, and then placed in a heating container with 700-5000 parts by weight of hydrogen-rich water and soaked for 0.5-2 hours. Here, a heating container with good sealing is preferred to reduce the escape of molecular hydrogen. Then, the raw materials are decocted for 15-30 minutes, and the medicinal liquid is filtered out to obtain a traditional Chinese medicine preparation for the auxiliary treatment of ALS.

[0024] The benefits of hydrogen-rich water (i.e. water rich in molecular hydrogen, in which the hydrogen content of hydrogen-rich water is not less than 1000 ppb, preferably 700-5000 parts by weight, and further preferably 700-2000 parts by weight) used in the present invention in soaking, decocting Chinese herbal medicines or taking medicinal liquids are mainly based on the biomedical properties of hydrogen and the improvement of traditional decoction processes: 1. The physicochemical properties of molecular hydrogen and the enhancement of decoction efficacy include: 1. Protecting heat-sensitive components. High temperatures during decoction may destroy heat-sensitive active ingredients in Chinese herbal medicines. As a strong reducing agent, hydrogen may reduce the damage of oxidative stress to effective ingredients by neutralizing free radicals (such as hydroxyl radicals) generated during decoction. 2. Promoting the dissolution of fat-soluble components. Hydrogen is fat-soluble and can penetrate into the cell membrane of medicinal materials, destroying the lipid structure and increasing the permeability of the cell membrane, thereby promoting the release of fat-soluble components (such as flavonoids and alkaloids). 3. Regulating the redox state of the decoction. During the decoction process, metal ions (such as iron and copper) may catalyze oxidation reactions, while hydrogen can maintain the reducing microenvironment of the decoction and reduce the conversion of components.

[0025] 2. Potential for drug synergy, such as 1. Enhanced antioxidant and anti-inflammatory activity. Hydrogen and Chinese herbal antioxidant components (such as polyphenols and polysaccharides) may synergistically remove free radicals and enhance overall antioxidant capacity. 2. Improved drug absorption and bioavailability. Hydrogen can regulate intestinal flora and intestinal mucosal permeability. If the decoction is used for oral administration, it may promote the absorption of active ingredients.

[0026] 3. Process safety: 1. Reduce the risk of toxic components dissolving out. Some toxic Chinese herbal medicines need to be boiled for a strictly controlled time to reduce the dissolution of toxic components. Hydrogen may accelerate the decomposition of toxic components through reduction. 2. Inhibit microbial contamination. Hydrogen has an antibacterial effect and can reduce the growth of microorganisms during the storage of the decoction. It is especially useful for tonic herbs that require long-term boiling.

[0027] The positive effects of the compatibility of the present invention are as follows: 1. Invigorating Qi and nourishing blood, promoting blood circulation and removing blood stasis: First, ginseng has the effect of nourishing vital energy, and has a good improvement effect on symptoms such as qi deficiency, physical weakness, fatigue and weakness. When used together with blood-nourishing drugs such as Sedum sedum, Panax notoginseng, and white peony root, it can replenish both Qi and blood, and enhance the body's immunity and adaptability; leeches, honeysuckle vines, etc. have the effect of promoting blood circulation and removing blood stasis, which can improve blood circulation and relieve pain and swelling. In the treatment of blood stasis pain and other aspects, it can be used in combination with other medicinal materials such as Sichuan papaya and kudzu root powder to enhance the efficacy. 2. Promoting diuresis and eliminating dampness, clearing away heat and detoxifying: Medicinal materials such as yew and raw coix seed have the effect of promoting diuresis and eliminating dampness, and have a good therapeutic effect on symptoms such as water stagnation, edema, and difficulty urinating. When used in combination with medicinal materials such as Selaginella, it can enhance the effect of promoting diuresis and relieve the discomfort caused by water and dampness; kudzu root powder, honeysuckle vines, etc. have the effect of clearing heat and detoxifying, and are suitable for symptoms such as blazing heat and toxicity. When used together with other heat-clearing and detoxifying herbs such as white peony root and Selaginella, it can enhance the effect of heat-clearing and detoxifying. 3. Nourishing yin and moistening dryness, soothing the liver and relieving depression: Sedum ternata, deer antler glue, etc. have the effect of nourishing yin and moistening dryness, and are suitable for various symptoms caused by yin deficiency, such as spleen deficiency and dryness, night sweating, etc. When used together with yin-nourishing herbs such as white peony root, it can enhance the effect of nourishing yin and improve the discomfort caused by yin deficiency; herbs such as white peony root and Selaginella have the effect of soothing the liver and relieving depression, and have a good improvement effect on symptoms such as chest tightness and flank pain caused by liver qi stagnation. When used together with qi-tonifying herbs such as ginseng, it can regulate qi and relieve emotions. 4. Strengthening tendons: herbs such as deer antler glue and Sichuan papaya have the effect of strengthening tendons and bones, and are suitable for symptoms such as weakness of tendons and bones, joint pain, etc. When used together with blood-activating and stasis-removing herbs such as leeches, it can promote blood circulation and improve tendon and bone conditions. Hydrogen-rich water can 1) protect Chinese herbal ingredients from oxidation; 2) promote the penetration or absorption of ingredients; 3) synergistically enhance anti-inflammatory, anti-aging and other effects; 4) improve local blood circulation or tissue status and enhance drug efficacy. DETAILED DESCRIPTION

[0028] In order to make the purpose, technical scheme and advantages of the present invention more clearly understood, the present invention is described by the following specific embodiments, but is by no means limited thereto. The following are preferred embodiments of the present invention, which are only used to describe the present invention and cannot be understood as limiting the present invention. It should be pointed out that any modification, equivalent substitution and improvement made within the spirit and principle of the present invention should be included in the protection scope of the present invention.

[0029] Embodiment 1: 9 grams of ginseng, 20 grams of kudzu root powder, 20 grams of honeysuckle vine, 9 grams of antler glue, 15 grams of Sichuan papaya, 30 grams of raw coix seed, 9 grams of yew, 6 grams of leech, 10 grams of Selaginella, 15 grams of white peony root, 10 grams of Sedum notoginseng. Put the above-proportioned medicinal materials into a heating container such as a casserole, add 1600 grams of hydrogen-rich water, soak for 2 hours and then boil for 30 minutes, filter out the medicinal liquid, which is a traditional Chinese medicine preparation for auxiliary treatment of ALS, and take it twice a day by boiling or taking it with an appropriate amount of hydrogen-rich water.

[0030] Example 2: 3 grams of ginseng, 9 grams of kudzu root powder, 9 grams of honeysuckle vine, 3 grams of antler glue, 6 grams of Sichuan papaya, 9 grams of raw coix seed, 3 grams of yew, 1.5 grams of leech, 4.5 grams of Selaginella, 6 grams of white peony root, 9 grams of Sedum notoginseng. Put the above-proportioned medicinal materials into a heating container, add 700 grams of hydrogen-rich water, soak for 0.5 hours and then boil for 15 minutes, filter out the medicinal liquid, which is a traditional Chinese medicine preparation for the auxiliary treatment of ALS, and take it twice a day by boiling or taking it with an appropriate amount of hydrogen-rich water (such as 100 ml) when taking the medicinal liquid.

[0031] Example 3: 9 grams of ginseng, 20 grams of kudzu root powder, 30 grams of honeysuckle vine, 9 grams of antler glue, 15 grams of Sichuan papaya, 30 grams of raw coix seed, 9 grams of yew, 6 grams of leech, 10 grams of Selaginella, 15 grams of white peony root, and 15 grams of Sedum notoginseng. Put the above-proportioned medicinal materials into a heating container, add 2000 grams of hydrogen-rich water, soak for 1 hour and then boil for 30 minutes, filter out the medicinal liquid, which is a traditional Chinese medicine preparation for the auxiliary treatment of ALS, and take it twice a day by boiling or taking it with an appropriate amount of hydrogen-rich water.

[0032] Example 4: 5 grams of ginseng, 12 grams of kudzu root powder, 16 grams of honeysuckle vine, 5 grams of antler glue, 9 grams of Sichuan papaya, 18 grams of raw coix seed, 7 grams of yew, 3 grams of leech, 7 grams of Selaginella, 8 grams of white peony root, 11 grams of Sedum notoginseng. Put the above-proportioned medicinal materials into a heating container, add 1500 grams of hydrogen-rich water, soak for 1 hour and then boil for 30 minutes, filter out the medicinal liquid, which is a traditional Chinese medicine preparation for the auxiliary treatment of ALS, and take it twice a day by boiling or taking it with an appropriate amount of hydrogen-rich water.

[0033] Example 5: 7 grams of ginseng, 17 grams of kudzu root powder, 25 grams of honeysuckle vine, 7 grams of antler glue, 12 grams of Sichuan papaya, 26 grams of raw coix seed, 8 grams of yew, 5 grams of leech, 9 grams of Selaginella, 12 grams of white peony root, 13 grams of Sedum notoginseng. Put the above-proportioned medicinal materials into a heating container, add 1500 grams of hydrogen-rich water, soak for 1 hour and then boil for 20 minutes, filter out the medicinal liquid, which is a traditional Chinese medicine preparation for the auxiliary treatment of ALS, and take it twice a day by boiling or taking it with an appropriate amount of hydrogen-rich water. The following is a test case, which was verified on mice based on the Chinese medicine formula of Example 5.

[0034] 1. Purpose of the experiment 1. To verify the improvement effect of this Chinese medicine preparation on muscle atrophy and motor dysfunction in ALS model mice; 2. Evaluate its safety (such as effects on liver and kidney function) and potential mechanisms of action (anti-inflammatory, antioxidant, neuroprotective, etc.).

[0035] 2. Experimental Materials and Methods 1. Experimental Animals Animal selection: SOD1-G93A transgenic mice (ALS model) or induced nerve injury mice, 10 mice per group, half male and half female, weighing 18-22 g.

[0036] Group design: - Control group: normal mice were gavaged with normal saline; - Model group: ALS model mice were gavaged with normal saline; - Administration group: ALS model mice were gavaged with the Chinese medicine preparation (the dosage was converted into mouse dosage based on the adult equivalent, about 0.5 ml / 10 g body weight, twice a day).

[0037] 2. Medication - The preparation in Example 5 is used.

[0038] - Quality control: Testing the content of key ingredients (including ginsenosides, puerarin, paclitaxel derivatives) to ensure stability.

[0039] 3. Pharmacodynamic indicators - Motor function assessment: - Rotarod test: record the time mice stay on the rotating rod to evaluate muscle coordination; - Grip strength test: Muscle strength is measured using a forelimb grip dynamometer.

[0040] - Muscle pathology: The hind limb muscle tissue was obtained for HE staining to observe the cross-sectional area of ​​muscle fibers and the degree of atrophy.

[0041] - Serum markers: Detect the levels of nerve damage markers (such as NfL) and inflammatory factors (IL-6, TNF-α).

[0042] 4. Mechanism studies - Antioxidant capacity: Determination of serum SOD, GSH-Px activities and MDA content; - Neuroprotection: Spinal motor neuron survival rate and BDNF expression were detected by immunohistochemistry.

[0043] 5. Safety evaluation - Acute toxicity: observe the behavior and death of mice within 72 hours after administration and calculate the LD50; - Long-term toxicity: Continuous administration for 28 days, and detection of liver (ALT, AST) and kidney (BUN, Cr) function indicators.

[0044] 3. Results and Data Analysis 1. Efficacy results - Compared with the model group, the motor function scores (rotarod time, grip strength) of mice in the drug-treated group were significantly improved (*P<0.05); - Muscle pathology showed reduced muscle fiber atrophy and decreased serum NfL levels.

[0045] 2. Mechanism Analysis - Increased antioxidant enzyme activity and decreased levels of inflammatory factors (IL-6, TNF-α); - The survival rate of spinal cord neurons is improved and the expression of BDNF is upregulated.

[0046] 3. Safety Conclusion - LD50>5g / kg, and there are no significant abnormalities in liver and kidney function indicators, indicating that the safety is controllable.

[0047] 4. Advantages of this Chinese medicine preparation - Multi-target synergy: Ginseng replenishes Qi, leeches remove blood stasis, and yew is an antioxidant, which is in line with the principle of "strengthening the body's strength and eliminating evil" in traditional Chinese medicine, providing a multi-mechanism intervention possibility for this Chinese medicine preparation; - Safety: Compared with the hepatotoxicity of riluzole, the Chinese herbal compound has fewer side effects.

[0048] In summary, although the embodiments of the present invention have been disclosed as above, they are not limited to the applications listed in the specification and the embodiments, and can be fully applied to various fields suitable for the present invention. For those familiar with the art, other modifications can be easily realized, such as spray drying the decoction of the preparation into powder, mixing it with deer antler glue powder, and filling it into capsules for oral administration. Therefore, without departing from the general concept defined by the claims and their equivalents, the present invention is not limited to specific details.

Claims

1. A Chinese medicine preparation for assisting the treatment of ALS, characterized in that: The invention is prepared from the following raw materials in parts by weight: 3-9 parts by weight of ginseng, 9-20 parts by weight of kudzu root powder, 9-30 parts by weight of honeysuckle vine, 3-9 parts by weight of antler glue, 6-15 parts by weight of papaya, 9-30 parts by weight of raw coix seeds, 3-9 parts by weight of yew, 1.5-6 parts by weight of leech, 4.5-10 parts by weight of Selaginella, 6-15 parts by weight of white peony root, and 9-15 parts by weight of Sedum notoginseng.

2. A method for preparing the Chinese medicine preparation for assisting the treatment of ALS as claimed in claim 1, characterized in that: The above-mentioned medicinal raw materials with a good ratio are first placed in a heating container with 700-2000 parts by weight of hydrogen-rich water and soaked for 0.5-2 hours, then decocted for 15-30 minutes, and the medicinal liquid is filtered out to obtain a traditional Chinese medicine preparation for the auxiliary treatment of ALS.