A traditional Chinese medicine composition for treating cerebral infarction

Abstract

This application belongs to the field of traditional Chinese medicine technology and relates to a traditional Chinese medicine composition for treating cerebral infarction. The traditional Chinese medicine composition of this application comprises the following raw materials in parts by weight: Ligusticum chuanxiong, Astragalus membranaceus, Pueraria lobata, Uncaria rhynchophylla, and a compound fungus; the traditional Chinese medicine composition is prepared by the following method: S1, Ligusticum chuanxiong, Astragalus membranaceus, Pueraria lobata, and Uncaria rhynchophylla are pulverized and the active ingredients are extracted by water extraction and alcohol precipitation to obtain an extract; S2, the compound fungus is pulverized, extracted by boiling with deionized water at normal pressure, and then fermented with fermenting bacteria in a sealed container to obtain a fermentation liquid; S3, the extract and fermentation liquid are combined, concentrated under reduced pressure, and spray-dried to obtain the traditional Chinese medicine composition. This application has a simple formula and safe ingredients. Through multiple effects such as promoting blood circulation and removing blood stasis, tonifying qi and strengthening the exterior, clearing heat and detoxifying, dilating blood vessels, and calming the liver and extinguishing wind, it jointly promotes cerebral blood circulation, reduces brain tissue damage, and promotes nerve cell repair and regeneration, showing broad clinical application prospects.

Description

Technical Field

[0001] This application relates to the field of traditional Chinese medicine technology, and more specifically, to a traditional Chinese medicine composition for treating cerebral infarction. Background Technology

[0002] Cerebral infarction, also known as ischemic stroke, is a disease caused by insufficient blood supply to the brain due to blockage of blood vessels, leading to brain tissue damage. Causes include atherosclerosis of the intracranial and carotid arteries, cardioembolism, and high-risk factors such as hypertension, heart disease, diabetes, and dyslipidemia. Middle-aged and elderly people are particularly susceptible. Cerebral infarction is one of the leading causes of death and disability worldwide. Severe cerebral infarction can lead to serious consequences such as paralysis, aphasia, and blindness, placing immense pressure on patients, families, and society. The incidence of cerebral infarction increases with age and with the increase of risk factors such as hypertension, diabetes, hyperlipidemia, and heart disease.

[0003] Modern medicine treats cerebral infarction primarily through thrombolytic therapy, anticoagulation therapy, fibrinogen reduction therapy, and cerebral vasodilation. Thrombolytic therapy restores blood supply to the brain by dissolving blood clots. Commonly used drugs include alteplase and reteplase. Thrombolytic therapy has a strict time window and is only applicable to patients with acute cerebral infarction within the time window (usually 4-6 hours) of middle cerebral artery occlusion. Anticoagulation therapy aims to prevent new thrombus formation. Commonly used anticoagulants include heparin and low molecular weight heparin. Anticoagulation therapy increases the risk of bleeding, including subcutaneous hemorrhage, urinary tract bleeding, gastrointestinal bleeding, and even intracranial hemorrhage. Fibrinogen reduction therapy reduces the thrombus burden by lowering fibrinogen levels in the blood. Commonly used drugs include injectable recombinant human prourokinase. Fibrinogen reduction therapy also increases the risk of bleeding. Cerebral vasodilation is an interventional procedure that uses a balloon catheter to dilate narrowed or blocked cerebral blood vessels, increasing cerebral blood flow. During the procedure, damage to the vessel wall may occur, leading to thrombus formation, and postoperative restenosis may occur. Therefore, although the above treatment methods can alleviate patients' symptoms to a certain extent, they still have corresponding limitations and cannot achieve the ideal treatment effect.

[0004] Traditional Chinese medicine (TCM) classifies cerebral infarction as a type of stroke, believing its pathogenesis primarily involves qi stagnation, blood stasis, and phlegm obstruction of the meridians. Therefore, TCM treatment strategies often focus on unblocking the meridians and promoting blood circulation. Existing TCM compositions for treating cerebral infarction typically contain multiple drug components, primarily those promoting blood circulation, removing blood stasis, and clearing the meridians. This approach suffers from problems such as numerous drug components, complex mechanisms of action, difficulty in achieving rapid and precise treatment, and room for improvement in therapeutic efficacy. Furthermore, the use of the primary blood-activating and stasis-removing drugs increases the risk of bleeding. Based on the above, this application proposes a TCM composition for treating cerebral infarction. Summary of the Invention

[0005] To address the problems of existing traditional Chinese medicine compositions for treating cerebral infarction, which typically contain multiple drug components, primarily those with effects such as promoting blood circulation, removing blood stasis, clearing phlegm, and unblocking collaterals, resulting in numerous drug components, complex mechanisms of action, inability to provide rapid and precise treatment, and insufficient improvement in treatment efficacy, and furthermore, the use of the main blood-activating and stasis-removing drugs is accompanied by an increased risk of bleeding, this application provides a traditional Chinese medicine composition for treating cerebral infarction.

[0006] This application provides a traditional Chinese medicine composition for treating cerebral infarction, employing the following technical solution:

[0007] A traditional Chinese medicine composition for treating cerebral infarction comprises the following raw materials in parts by weight: 10-15 parts of Ligusticum chuanxiong, 15-30 parts of Astragalus membranaceus, 10-15 parts of Pueraria lobata, 6-12 parts of Uncaria rhynchophylla, and 8-15 parts of compound fungi.

[0008] Preferably, the traditional Chinese medicine composition comprises the following raw materials in parts by weight: 12-14 parts of Ligusticum chuanxiong, 18-26 parts of Astragalus membranaceus, 12-14 parts of Pueraria lobata, 8-10 parts of Uncaria rhynchophylla, and 10-14 parts of compound fungi.

[0009] Preferably, the traditional Chinese medicine composition comprises the following raw materials in parts by weight: 13 parts of Ligusticum chuanxiong, 24 parts of Astragalus membranaceus, 12 parts of Pueraria lobata, 9 parts of Uncaria rhynchophylla, and 12 parts of compound fungi.

[0010] Preferably, the compound fungus comprises morel mushrooms and black fungus in a mass ratio of 1:2.8-3.2.

[0011] Preferably, the preparation method includes the following preparation steps:

[0012] S1. After crushing the chuanxiong, astragalus, kudzu root, and uncaria, extract the active ingredients by water extraction and alcohol precipitation to obtain the extract.

[0013] S2. After crushing the compound mushrooms, add deionized water and boil at normal pressure to extract them. Then add fermentation bacteria and seal for fermentation to obtain fermentation liquid.

[0014] S3. After combining the extract and fermentation broth, concentrate under reduced pressure and spray dry to obtain the traditional Chinese medicine composition.

[0015] Preferably, step S1 is performed as follows:

[0016] S11. Select high-quality medicinal materials such as Ligusticum chuanxiong, Astragalus membranaceus, Pueraria lobata and Uncaria rhynchophylla, wash them and dry them in hot air at 55-65℃. After drying, pulverize the medicinal materials and pass them through a 60-100 mesh sieve.

[0017] S12. Mix the medicinal powder with deionized water at a mass ratio of 1:8-12, heat to boiling, and extract for 1-2 hours while maintaining boiling. Filter, add ethanol to the filtrate to achieve a total alcohol concentration of 65-75%, let stand overnight, filter to remove precipitate, centrifuge the supernatant, control the centrifugation speed at 8000-10000 r / min, and centrifuge for 5-10 min to obtain the extract.

[0018] Preferably, step S2 is performed as follows:

[0019] S21. Select high-quality compound mushrooms, wash them, and dry them in hot air at 55-65℃. After drying, crush the compound mushrooms and pass them through a 60-100 mesh sieve.

[0020] S22. Add mushroom powder to deionized water at a material-to-liquid ratio of 1:15-20, boil for 20-40 minutes, and then cool to room temperature to obtain the fermentation liquid.

[0021] S23. Control the viable count of fermentation bacteria in the fermentation broth to be 1×10⁻⁶. 8 -3×10 8 Add fermentation bacteria (cfu / ml) to the broth to be fermented, seal and ferment at room temperature for 7-11 hours. Remove the precipitate by centrifugation, controlling the centrifugation speed at 8000-10000 r / min and the centrifugation time at 5-10 min to obtain the fermentation broth.

[0022] Preferably, the fermentation bacteria in step S23 are obtained by combining yeast and lactic acid bacteria; the ratio of live yeast to lactic acid bacteria is 1:3.5-4.

[0023] Preferably, in step S3, after spray drying, pharmaceutical excipients can be added to prepare a traditional Chinese medicine composition of the desired dosage form.

[0024] Preferably, the pharmaceutical excipients include, but are not limited to, disintegrants, binders, lubricants, fillers, and flavoring agents.

[0025] This application has positive and beneficial effects:

[0026] This application presents a simple formula with safe ingredients. Through multiple mechanisms, including promoting blood circulation, removing blood stasis, tonifying qi and strengthening the exterior, clearing heat and detoxifying, dilating blood vessels, and calming the liver and extinguishing wind, it collectively promotes cerebral blood circulation, reduces brain tissue damage, and promotes nerve cell repair and regeneration. The traditional Chinese medicine composition prepared in this application is convenient to take orally, rapidly absorbed, and has a quick onset of action. With dosage adjustments, it can be used for emergency treatment of acute cerebral infarction and functional repair in the recovery period. It boasts a high cure rate, few side effects, and is suitable for long-term use in the prevention, treatment, and recovery of cerebral infarction. It is highly safe and has broad clinical application prospects.

[0027] In this application's formula, Ligusticum chuanxiong has the effects of promoting blood circulation, removing blood stasis, regulating qi, and relieving pain. In the treatment of cerebral infarction, Ligusticum chuanxiong serves as the principal herb, mainly used to promote blood circulation, improve cerebral blood flow, and reduce thrombus formation, thereby alleviating the symptoms and consequences of cerebral infarction. Astragalus membranaceus has the effects of tonifying qi and strengthening the exterior, promoting diuresis and detoxification, draining pus, and promoting tissue regeneration. As an assistant herb, Astragalus membranaceus assists Ligusticum chuanxiong in enhancing the body's immunity and disease resistance, while also helping to restore physical strength and promote recovery. Pueraria lobata has anti-inflammatory, antioxidant, lipid-lowering, blood pressure-lowering, lung-clearing and heat-relieving, and meridian-activating effects, which help increase the oxygen content of cerebral blood and improve cerebral microcirculation. Uncaria rhynchophylla has the effects of calming the nerves, soothing the liver and extinguishing wind, and clearing heat and detoxifying, which help dilate blood vessels, clear cholesterol and triglycerides from the blood, and reduce nervous tension and anxiety after cerebral infarction. Pueraria lobata and Uncaria rhynchophylla together serve as adjuvant herbs to assist the principal and assistant herbs, and can work together to reduce cerebral inflammation and improve blood flow. Morel mushrooms in the compound mushroom blend have the effects of benefiting the stomach and intestines, aiding digestion, resolving phlegm and regulating qi, tonifying the kidneys and strengthening yang, and nourishing the brain and refreshing the mind. They help to enhance the patient's physical condition and inhibit platelet aggregation. Black fungus has the effects of clearing the lungs and moistening the intestines, nourishing yin and replenishing blood, and promoting blood circulation and removing blood stasis. It helps to improve blood circulation and reduce blood lipids and thrombus formation. As a coordinating agent, the compound mushroom blend helps to enhance the overall therapeutic effect of the entire formula, achieve precise and rapid treatment, and effectively avoid the bleeding risk associated with traditional blood-activating and stasis-removing formulas, thereby improving the patient's overall health. Detailed Implementation

[0028] The present application will be further described in detail below with reference to the embodiments.

[0029] Examples 1-5 provide a traditional Chinese medicine composition for treating cerebral infarction.

[0030] Example 1

[0031] A traditional Chinese medicine composition for treating cerebral infarction is made from the following raw materials: 11 parts of Ligusticum chuanxiong, 15 parts of Astragalus membranaceus, 10 parts of Pueraria lobata, 6 parts of Uncaria rhynchophylla, and 8 parts of compound fungi; the compound fungi include morel mushrooms and black fungus in a mass ratio of 1:2.8.

[0032] The traditional Chinese medicine composition used to treat cerebral infarction is prepared by the following method:

[0033] S1. After crushing the chuanxiong, astragalus, kudzu root, and uncaria, extract the active ingredients by water extraction and alcohol precipitation to obtain the extract.

[0034] S11. Select high-quality medicinal materials such as Ligusticum chuanxiong, Astragalus membranaceus, Pueraria lobata and Uncaria rhynchophylla, wash them and dry them in hot air at 55℃, then pulverize the dried medicinal materials and pass them through a 60-mesh sieve.

[0035] S12. Mix the medicinal powder with deionized water at a mass ratio of 1:8, heat to boiling, maintain boiling state for 1 hour, filter, add ethanol to the filtrate to make the total alcohol concentration reach 65%, let stand overnight, filter to remove precipitate, centrifuge the supernatant, control the centrifugation speed at 8000 r / min, centrifugation time at 10 min, and obtain the extract.

[0036] S2. After crushing the compound mushrooms, add deionized water and boil at normal pressure to extract them. Then add fermentation bacteria and seal for fermentation to obtain fermentation liquid.

[0037] S21. Select high-quality compound mushrooms, wash them and dry them in hot air at 55℃. Crush the dried compound mushrooms and pass them through a 60-mesh sieve.

[0038] S22. Add mushroom powder to deionized water at a material-to-liquid ratio of 1:15, boil for 20 minutes, and then cool to room temperature to obtain the fermentation liquid.

[0039] S23. The fermentation bacteria were obtained by mixing Pichia pastoris and Lactobacillus plantarum at a live cell ratio of 1:3.5, and the live cell count of the fermentation bacteria in the fermentation broth was controlled to be 1×10⁻⁶. 8 Add fermentation bacteria to the broth at cfu / ml, seal and ferment at room temperature for 11 hours, remove the precipitate by centrifugation, control the centrifugation speed at 8000 r / min and the centrifugation time at 10 min to obtain the fermentation broth;

[0040] S3. Combine the extract and fermentation broth, concentrate under reduced pressure to a relative density of 1.27, and spray dry to obtain the traditional Chinese medicine composition.

[0041] Example 2

[0042] A traditional Chinese medicine composition for treating cerebral infarction is made from the following raw materials: 12 parts of Ligusticum chuanxiong, 20 parts of Astragalus membranaceus, 12 parts of Pueraria lobata, 7 parts of Uncaria rhynchophylla, and 10 parts of compound fungi; the compound fungi include morel mushrooms and black fungus in a mass ratio of 1:2.9.

[0043] The traditional Chinese medicine composition used to treat cerebral infarction is prepared by the following method:

[0044] S1. After crushing the chuanxiong, astragalus, kudzu root, and uncaria, extract the active ingredients by water extraction and alcohol precipitation to obtain the extract.

[0045] S11. Select high-quality medicinal materials such as Ligusticum chuanxiong, Astragalus membranaceus, Pueraria lobata and Uncaria rhynchophylla, wash them and dry them in hot air at 55℃, then pulverize the dried medicinal materials and pass them through a 60-mesh sieve.

[0046] S12. Mix the medicinal powder with deionized water at a mass ratio of 1:8, heat to boiling, maintain boiling state for 1 hour, filter, add ethanol to the filtrate to make the total alcohol concentration reach 65%, let stand overnight, filter to remove precipitate, centrifuge the supernatant, control the centrifugation speed at 8000 r / min, centrifugation time at 10 min, and obtain the extract.

[0047] S2. After crushing the compound mushrooms, add deionized water and boil at normal pressure to extract them. Then add fermentation bacteria and seal for fermentation to obtain fermentation liquid.

[0048] S21. Select high-quality compound mushrooms, wash them and dry them in hot air at 55℃. Crush the dried compound mushrooms and pass them through a 60-mesh sieve.

[0049] S22. Add mushroom powder to deionized water at a material-to-liquid ratio of 1:15, boil for 20 minutes, and then cool to room temperature to obtain the fermentation liquid.

[0050] S23. The fermentation bacteria were obtained by mixing Pichia pastoris and Lactobacillus plantarum at a live cell ratio of 1:3.5, and the live cell count of the fermentation bacteria in the fermentation broth was controlled to be 1×10⁻⁶. 8 Add fermentation bacteria to the broth at cfu / ml, seal and ferment at room temperature for 11 hours, remove the precipitate by centrifugation, control the centrifugation speed at 8000 r / min and the centrifugation time at 10 min to obtain the fermentation broth;

[0051] S3. Combine the extract and fermentation broth, concentrate under reduced pressure to a relative density of 1.27, and spray dry to obtain the traditional Chinese medicine composition.

[0052] Example 3

[0053] A traditional Chinese medicine composition for treating cerebral infarction is made from the following raw materials: 13 parts of Ligusticum chuanxiong, 24 parts of Astragalus membranaceus, 12 parts of Pueraria lobata, 9 parts of Uncaria rhynchophylla, and 12 parts of compound fungi; the compound fungi include morel mushrooms and black fungus in a mass ratio of 1:3.

[0054] The traditional Chinese medicine composition used to treat cerebral infarction is prepared by the following method:

[0055] S1. After crushing the chuanxiong, astragalus, kudzu root, and uncaria, extract the active ingredients by water extraction and alcohol precipitation to obtain the extract.

[0056] S11. Select high-quality medicinal materials such as Ligusticum chuanxiong, Astragalus membranaceus, Pueraria lobata and Uncaria rhynchophylla, wash them and dry them in hot air at 60℃, then pulverize the dried medicinal materials and pass them through an 80-mesh sieve.

[0057] S12. Mix the medicinal powder with deionized water at a mass ratio of 1:10, heat to boiling, maintain boiling state for 1.5 hours, filter, add ethanol to the filtrate to make the total alcohol concentration reach 70%, let stand overnight, filter to remove precipitate, centrifuge the supernatant, control the centrifugation speed at 9000 r / min, centrifugation time at 8 min, and obtain the extract.

[0058] S2. After crushing the compound mushrooms, add deionized water and boil at normal pressure to extract them. Then add fermentation bacteria and seal for fermentation to obtain fermentation liquid.

[0059] S21. Select high-quality compound mushrooms, wash them and dry them in hot air at 60℃. Crush the dried compound mushrooms and pass them through an 80-mesh sieve.

[0060] S22. Add mushroom powder to deionized water at a material-to-liquid ratio of 1:18, boil for 30 minutes, and then cool to room temperature to obtain the fermentation liquid.

[0061] S23. The fermentation bacteria were prepared by mixing Pichia pastoris and Lactobacillus plantarum at a live cell ratio of 1:3.8, and the live cell count of the fermentation bacteria in the fermentation broth was controlled to be 2 × 10⁻⁶. 8 Add fermentation bacteria to the broth at cfu / ml, seal and ferment at room temperature for 9 hours, remove the precipitate by centrifugation, control the centrifugation speed at 9000 r / min and the centrifugation time at 8 min to obtain the fermentation broth;

[0062] S3. Combine the extract and fermentation broth, concentrate under reduced pressure to a relative density of 1.29, and spray dry to obtain the traditional Chinese medicine composition.

[0063] Example 4

[0064] A traditional Chinese medicine composition for treating cerebral infarction is made from the following raw materials: 14 parts of Ligusticum chuanxiong, 28 parts of Astragalus membranaceus, 14 parts of Pueraria lobata, 11 parts of Uncaria rhynchophylla, and 14 parts of compound fungi; the compound fungi include morel mushrooms and black fungus in a mass ratio of 1:3.1.

[0065] The traditional Chinese medicine composition used to treat cerebral infarction is prepared by the following method:

[0066] S1. After crushing the chuanxiong, astragalus, kudzu root, and uncaria, extract the active ingredients by water extraction and alcohol precipitation to obtain the extract.

[0067] S11. Select high-quality medicinal materials such as Ligusticum chuanxiong, Astragalus membranaceus, Pueraria lobata and Uncaria rhynchophylla, wash them and dry them in hot air at 65℃. Then, pulverize the dried medicinal materials and pass them through a 100-mesh sieve.

[0068] S12. Mix the medicinal powder with deionized water at a mass ratio of 1:12, heat to boiling, maintain boiling state for 2 hours, filter, add ethanol to the filtrate to make the total alcohol concentration reach 75%, let stand overnight, filter to remove precipitate, centrifuge the supernatant, control the centrifugation speed at 10000 r / min, centrifugation time at 10 min, and obtain the extract.

[0069] S2. After crushing the compound mushrooms, add deionized water and boil at normal pressure to extract them. Then add fermentation bacteria and seal for fermentation to obtain fermentation liquid.

[0070] S21. Select high-quality compound mushrooms, wash them and dry them in hot air at 65℃. After drying, crush the compound mushrooms and pass them through a 100-mesh sieve.

[0071] S22. Add mushroom powder to deionized water at a material-to-liquid ratio of 1:20, boil for 40 minutes, and then cool to room temperature to obtain the fermentation liquid.

[0072] S23. The fermentation bacteria were obtained by mixing Pichia pastoris and Lactobacillus plantarum at a live cell ratio of 1:4, and the live cell count of the fermentation bacteria in the fermentation broth was controlled to be 3 × 10⁻⁶. 8 Add fermentation bacteria to the broth at cfu / ml, seal and ferment at room temperature for 7 hours, remove the precipitate by centrifugation, control the centrifugation speed at 10000 r / min and the centrifugation time at 5 min to obtain the fermentation broth;

[0073] S3. Combine the extract and fermentation broth, concentrate under reduced pressure to a relative density of 1.31, and spray dry to obtain the traditional Chinese medicine composition.

[0074] Example 5

[0075] A traditional Chinese medicine composition for treating cerebral infarction is made from the following raw materials: 15 parts of Ligusticum chuanxiong, 30 parts of Astragalus membranaceus, 15 parts of Pueraria lobata, 12 parts of Uncaria rhynchophylla, and 15 parts of compound fungi; the compound fungi include morel mushrooms and black fungus in a mass ratio of 1:3.2.

[0076] The traditional Chinese medicine composition used to treat cerebral infarction is prepared by the following method:

[0077] S1. After crushing the chuanxiong, astragalus, kudzu root, and uncaria, extract the active ingredients by water extraction and alcohol precipitation to obtain the extract.

[0078] S11. Select high-quality medicinal materials such as Ligusticum chuanxiong, Astragalus membranaceus, Pueraria lobata and Uncaria rhynchophylla, wash them and dry them in hot air at 65℃. Then, pulverize the dried medicinal materials and pass them through a 100-mesh sieve.

[0079] S12. Mix the medicinal powder with deionized water at a mass ratio of 1:12, heat to boiling, maintain boiling state for 2 hours, filter, add ethanol to the filtrate to make the total alcohol concentration reach 75%, let stand overnight, filter to remove precipitate, centrifuge the supernatant, control the centrifugation speed at 10000 r / min, centrifugation time at 10 min, and obtain the extract.

[0080] S2. After crushing the compound mushrooms, add deionized water and boil at normal pressure to extract them. Then add fermentation bacteria and seal for fermentation to obtain fermentation liquid.

[0081] S21. Select high-quality compound mushrooms, wash them and dry them in hot air at 65℃. After drying, crush the compound mushrooms and pass them through a 100-mesh sieve.

[0082] S22. Add mushroom powder to deionized water at a material-to-liquid ratio of 1:20, boil for 40 minutes, and then cool to room temperature to obtain the fermentation liquid.

[0083] S23. The fermentation bacteria were obtained by mixing Pichia pastoris and Lactobacillus plantarum at a live cell ratio of 1:4, and the live cell count of the fermentation bacteria in the fermentation broth was controlled to be 3 × 10⁻⁶. 8 Add fermentation bacteria to the broth at cfu / ml, seal and ferment at room temperature for 7 hours, remove the precipitate by centrifugation, control the centrifugation speed at 10000 r / min and the centrifugation time at 5 min to obtain the fermentation broth;

[0084] S3. Combine the extract and fermentation broth, concentrate under reduced pressure to a relative density of 1.31, and spray dry to obtain the traditional Chinese medicine composition.

[0085] To verify the efficacy of the traditional Chinese medicine composition for treating cerebral infarction provided in this application, the applicant has set up comparative examples 1-5, wherein:

[0086] Comparative Example 1

[0087] A traditional Chinese medicine composition for treating cerebral infarction is made from the following raw materials: 11 parts of Ligusticum chuanxiong, 15 parts of Astragalus membranaceus, 10 parts of Pueraria lobata, 6 parts of Uncaria rhynchophylla, and 8 parts of morel mushroom.

[0088] The traditional Chinese medicine composition used to treat cerebral infarction is prepared by the following method:

[0089] S1. After crushing the chuanxiong, astragalus, kudzu root, and uncaria, extract the active ingredients by water extraction and alcohol precipitation to obtain the extract.

[0090] S11. Select high-quality medicinal materials such as Ligusticum chuanxiong, Astragalus membranaceus, Pueraria lobata and Uncaria rhynchophylla, wash them and dry them in hot air at 55℃, then pulverize the dried medicinal materials and pass them through a 60-mesh sieve.

[0091] S12. Mix the medicinal powder with deionized water at a mass ratio of 1:8, heat to boiling, maintain boiling state for 1 hour, filter, add ethanol to the filtrate to make the total alcohol concentration reach 65%, let stand overnight, filter to remove precipitate, centrifuge the supernatant, control the centrifugation speed at 8000 r / min, centrifugation time at 10 min, and obtain the extract.

[0092] S2. After crushing the morel mushrooms, add deionized water and boil at normal pressure to extract them. Then add fermentation bacteria and seal for fermentation to obtain fermentation liquid.

[0093] S21. Select high-quality morel mushrooms, wash them and dry them in hot air at 55℃. Crush the dried morel mushrooms and pass them through a 60-mesh sieve.

[0094] S22. Add morel powder to deionized water at a material-to-liquid ratio of 1:15, boil for 20 minutes, and then cool to room temperature to obtain the fermentation liquid.

[0095] S23. The fermentation bacteria were obtained by mixing Pichia pastoris and Lactobacillus plantarum at a live cell ratio of 1:3.5, and the live cell count of the fermentation bacteria in the fermentation broth was controlled to be 1×10⁻⁶. 8 Add fermentation bacteria to the broth at cfu / ml, seal and ferment at room temperature for 11 hours, remove the precipitate by centrifugation, control the centrifugation speed at 8000 r / min and the centrifugation time at 10 min to obtain the fermentation broth;

[0096] S3. Combine the extract and fermentation broth, concentrate under reduced pressure to a relative density of 1.27, and spray dry to obtain the traditional Chinese medicine composition.

[0097] Comparative Example 2

[0098] A traditional Chinese medicine composition for treating cerebral infarction is made from the following raw materials: 11 parts of Ligusticum chuanxiong, 15 parts of Astragalus membranaceus, 10 parts of Pueraria lobata, 6 parts of Uncaria rhynchophylla, and 8 parts of Auricularia auricula-judae.

[0099] The traditional Chinese medicine composition used to treat cerebral infarction is prepared by the following method:

[0100] S1. After crushing the chuanxiong, astragalus, kudzu root, and uncaria, extract the active ingredients by water extraction and alcohol precipitation to obtain the extract.

[0101] S11. Select high-quality medicinal materials such as Ligusticum chuanxiong, Astragalus membranaceus, Pueraria lobata and Uncaria rhynchophylla, wash them and dry them in hot air at 55℃, then pulverize the dried medicinal materials and pass them through a 60-mesh sieve.

[0102] S12. Mix the medicinal powder with deionized water at a mass ratio of 1:8, heat to boiling, maintain boiling state for 1 hour, filter, add ethanol to the filtrate to make the total alcohol concentration reach 65%, let stand overnight, filter to remove precipitate, centrifuge the supernatant, control the centrifugation speed at 8000 r / min, centrifugation time at 10 min, and obtain the extract.

[0103] S2. After crushing the black fungus, add deionized water and boil at normal pressure to extract it. Then add fermentation bacteria and seal for fermentation to obtain fermentation liquid.

[0104] S21. Select high-quality black fungus, wash it and dry it under hot air at 55℃. After drying, crush the black fungus and pass it through a 60-mesh sieve.

[0105] S22. Add deionized water to black fungus at a material-to-liquid ratio of 1:15, boil for 20 minutes, and then cool to room temperature to obtain the fermentation liquid.

[0106] S23. The fermentation bacteria were obtained by mixing Pichia pastoris and Lactobacillus plantarum at a live cell ratio of 1:3.5, and the live cell count of the fermentation bacteria in the fermentation broth was controlled to be 1×10⁻⁶. 8 Add fermentation bacteria to the broth at cfu / ml, seal and ferment at room temperature for 11 hours, remove the precipitate by centrifugation, control the centrifugation speed at 8000 r / min and the centrifugation time at 10 min to obtain the fermentation broth;

[0107] S3. Combine the extract and fermentation broth, concentrate under reduced pressure to a relative density of 1.27, and spray dry to obtain the traditional Chinese medicine composition.

[0108] Comparative Example 3

[0109] A traditional Chinese medicine composition for treating cerebral infarction is made from the following raw materials: 11 parts of Ligusticum chuanxiong, 15 parts of Astragalus membranaceus, 10 parts of Pueraria lobata, 6 parts of Uncaria rhynchophylla, and 8 parts of compound fungi; the compound fungi include morel mushrooms and black fungus in a mass ratio of 1:2.8.

[0110] The traditional Chinese medicine composition used to treat cerebral infarction is prepared by the following method:

[0111] S1. After crushing the chuanxiong, astragalus, kudzu root, and uncaria, extract the active ingredients by water extraction and alcohol precipitation to obtain the extract.

[0112] S11. Select high-quality medicinal materials such as Ligusticum chuanxiong, Astragalus membranaceus, Pueraria lobata and Uncaria rhynchophylla, wash them and dry them in hot air at 55℃, then pulverize the dried medicinal materials and pass them through a 60-mesh sieve.

[0113] S12. Mix the medicinal powder with deionized water at a mass ratio of 1:8, heat to boiling, maintain boiling state for 1 hour, filter, add ethanol to the filtrate to make the total alcohol concentration reach 65%, let stand overnight, filter to remove precipitate, centrifuge the supernatant, control the centrifugation speed at 8000 r / min, centrifugation time at 10 min, and obtain the extract.

[0114] S2. After crushing the compound mushrooms, add deionized water and boil at normal pressure to extract them. Then add fermentation bacteria and seal for fermentation to obtain fermentation liquid.

[0115] S21. Select high-quality compound mushrooms, wash them and dry them in hot air at 55℃. Crush the dried compound mushrooms and pass them through a 60-mesh sieve.

[0116] S22. Add mushroom powder to deionized water at a material-to-liquid ratio of 1:15, boil for 20 minutes, and then cool to room temperature to obtain the fermentation liquid.

[0117] S23. Control the viable count of fermentation bacteria in the fermentation broth to be 1×10⁻⁶. 8 Add the fermentation bacteria Pichia pastoris to the broth at cfu / ml, seal and ferment at room temperature for 11 hours, remove the precipitate by centrifugation, control the centrifugation speed at 8000 r / min and the centrifugation time at 10 min to obtain the fermentation broth;

[0118] S3. Combine the extract and fermentation broth, concentrate under reduced pressure to a relative density of 1.27, and spray dry to obtain the traditional Chinese medicine composition.

[0119] Comparative Example 4

[0120] A traditional Chinese medicine composition for treating cerebral infarction is made from the following raw materials: 11 parts of Ligusticum chuanxiong, 15 parts of Astragalus membranaceus, 10 parts of Pueraria lobata, 6 parts of Uncaria rhynchophylla, and 8 parts of compound fungi; the compound fungi include morel mushrooms and black fungus in a mass ratio of 1:2.8.

[0121] The traditional Chinese medicine composition used to treat cerebral infarction is prepared by the following method:

[0122] S1. After crushing the chuanxiong, astragalus, kudzu root, and uncaria, extract the active ingredients by water extraction and alcohol precipitation to obtain the extract.

[0123] S11. Select high-quality medicinal materials such as Ligusticum chuanxiong, Astragalus membranaceus, Pueraria lobata and Uncaria rhynchophylla, wash them and dry them in hot air at 55℃, then pulverize the dried medicinal materials and pass them through a 60-mesh sieve.

[0124] S12. Mix the medicinal powder with deionized water at a mass ratio of 1:8, heat to boiling, maintain boiling state for 1 hour, filter, add ethanol to the filtrate to make the total alcohol concentration reach 65%, let stand overnight, filter to remove precipitate, centrifuge the supernatant, control the centrifugation speed at 8000 r / min, centrifugation time at 10 min, and obtain the extract.

[0125] S2. After crushing the compound mushrooms, add deionized water and boil at normal pressure to extract them. Then add fermentation bacteria and seal for fermentation to obtain fermentation liquid.

[0126] S21. Select high-quality compound mushrooms, wash them and dry them in hot air at 55℃. Crush the dried compound mushrooms and pass them through a 60-mesh sieve.

[0127] S22. Add mushroom powder to deionized water at a material-to-liquid ratio of 1:15, boil for 20 minutes, and then cool to room temperature to obtain the fermentation liquid.

[0128] S23. Control the viable count of fermentation bacteria in the fermentation broth to be 1×10⁻⁶. 8 Add *Lactobacillus plantarum* (cfu / ml) to the broth to be fermented, seal and ferment at room temperature for 11 hours, remove the precipitate by centrifugation, control the centrifugation speed at 8000 r / min and the centrifugation time at 10 min to obtain the fermentation broth;

[0129] S3. Combine the extract and fermentation broth, concentrate under reduced pressure to a relative density of 1.27, and spray dry to obtain the traditional Chinese medicine composition.

[0130] Comparative Example 5

[0131] A traditional Chinese medicine composition for treating cerebral infarction is made from the following raw materials: 11 parts of Ligusticum chuanxiong, 15 parts of Astragalus membranaceus, 10 parts of Pueraria lobata, 6 parts of Uncaria rhynchophylla, and 8 parts of compound fungi; the compound fungi include morel mushrooms and black fungus in a mass ratio of 1:2.8.

[0132] The traditional Chinese medicine composition used to treat cerebral infarction is prepared by the following method:

[0133] S1. After crushing the chuanxiong, astragalus, kudzu root, uncaria and compound fungi, the active ingredients are extracted by water extraction and alcohol precipitation to obtain the extract.

[0134] S11. Select high-quality medicinal materials such as Ligusticum chuanxiong, Astragalus membranaceus, Pueraria lobata, Uncaria rhynchophylla and compound fungi, wash them and dry them in hot air at 55℃, then pulverize the dried medicinal materials and pass them through a 60-mesh sieve.

[0135] S12. Mix the medicinal powder with deionized water at a mass ratio of 1:8, heat to boiling, maintain boiling state for 1 hour, filter, add ethanol to the filtrate to make the total alcohol concentration reach 65%, let stand overnight, filter to remove precipitate, centrifuge the supernatant, control the centrifugation speed at 8000 r / min, centrifugation time at 10 min, and obtain the extract.

[0136] S2. Concentrate the extract under reduced pressure to a relative density of 1.27, and spray dry to obtain the traditional Chinese medicine composition.

[0137] The efficacy of the traditional Chinese medicine compositions used to treat cerebral infarction in Examples 1-5 and Comparative Examples 1-5 of this application was tested respectively.

[0138] 1. Experiment Content

[0139] Sixty male SD rats weighing 280-300g and aged 6-8 weeks (purchased from Liaoning Changsheng Biotechnology Co., Ltd.) were allowed free access to food and water and were acclimatized for one week. The 60 rats were randomly divided into 12 groups of 5 rats each, named Examples 1-5, Comparative Examples 1-5, Model Group, and Blank Control Group, respectively.

[0140] Before modeling, rats were fasted for 24 hours. Except for the blank control group, all rats were used to establish a cerebral infarction model. The specific method is as follows: After fixing the rats, they were anesthetized by intraperitoneal injection of 3% sodium pentobarbital. A midline incision was made in the neck to expose the left common carotid artery and vagus nerve. The internal and external carotid arteries were dissected and arterial embolization was performed. The proximal ends of the common and external carotid arteries were ligated. Blood flow perfusion was restored after 90 minutes of ischemia. When the rats showed signs such as pain, sluggishness, or disappearance of left limb retraction, flexion of the left upper limb towards the chest when hanging upside down, and tilting or turning to the left when walking, the nerve damage score was ≥2 (the specific criteria for the nerve damage score are as follows: 0 points for no nerve damage symptoms, 1 point for the inability to fully extend the forelimb on the opposite side of the lesion when the tail is lifted, 2 points for flexion of the forelimb on the opposite side of the lesion when the tail is lifted, 3 points for slight turning towards the paralyzed side when walking, 4 points for severe turning towards the paralyzed side when walking, and 5 points for being unable to walk spontaneously and falling to the opposite side). This indicated that the rat model of cerebral infarction was successfully established. The blank control group rats only had their common carotid artery, internal and external, exposed, without embolism.

[0141] After modeling was completed, the model rats were treated. Specifically, the rats in Examples 1-5 and Comparative Examples 1-5 were treated by oral administration of the traditional Chinese medicine composition prepared in Examples 1-5 and Comparative Examples 1-5 of this application at a concentration of 150 mg / kg / d (prepared with ultrapure water to a mass concentration of 10%). The blank control group and the model group were treated by oral administration of the same amount of ultrapure water for 14 days.

[0142] 2. Measurement of cerebral vascular permeability

[0143] One hour after the last administration, the model was established. Rats in the normal control group were injected via the femoral vein with Evans blue (purchased from Shanghai Ruiyong Biotechnology Co., Ltd.) without ligating the bilateral common carotid arteries. Rats in the other groups were injected via the femoral vein 5 minutes before carotid artery ligation. After ligation, the rats in each group were euthanized by cervical dislocation. The brain tissue was harvested through craniotomy, rinsed with physiological saline, blotted dry with filter paper, and weighed. The brain tissue was then incubated in 5 ml of dimethylformamide (purchased from Beijing Dingguo Changsheng Biotechnology Co., Ltd.) at 45°C for 72 hours. The supernatant was then measured at 620 nm using a spectrophotometer.

[0144] 3. Brain index and brain water content measurement

[0145] One hour after the last administration, the brain tissue was removed from the decapitated body and weighed (wet weight). It was then placed in a 120°C oven to dry and weighed again (dry weight). The water content of the brain tissue was calculated as (wet weight of brain tissue - dry weight of brain tissue) / wet weight of brain tissue × 100%.

[0146] 4. Measurement of nitric oxide synthase (NOS) and malondialdehyde (MDA) in brain tissue

[0147] After weighing the right brain, it was placed in a glass homogenizer, and 5 ml of physiological saline was added to prepare a brain homogenate. The homogenate was centrifuged at 3000 rpm for 10 min, and the supernatant was placed in an ice bath. The levels of NOS (NOS kit, purchased from Nanjing Jiancheng Biotechnology Institute) and MDA (MDA kit, purchased from Nanjing Jiancheng Biotechnology Institute) were determined according to the kit instructions.

[0148] 5. Experimental Data

[0149] Data are expressed as mean ± standard deviation. ANOVA one-way ANOVA was used for comparisons among multiple groups, and LSD was used for post-hoc comparisons. P < 0.05 was considered statistically significant. The specific results are shown in Table 1.

[0150] Table 1:

[0151]

[0152] Note: Different letters represent P < 0.05.

[0153] As shown in Table 1 above, the traditional Chinese medicine compositions prepared in Examples 1-5 of this application can effectively reduce cerebral vascular permeability, alleviate cerebral edema, and effectively reduce NOS and MDA levels in the brains of ischemic rats, thus protecting against brain damage caused by ischemia. The comprehensive therapeutic effect is far superior to that of Comparative Examples 1-5, and has broad clinical application prospects.

[0154] This specific embodiment is merely an explanation of this application and is not intended to limit it. After reading this specification, those skilled in the art can make modifications to this embodiment without contributing any inventive step, but such modifications are protected by patent law as long as they fall within the scope of the claims of this application.

Claims

1. A traditional Chinese medicine composition for treating cerebral infarction, characterized in that, It is made from the following ingredients in parts by weight: 10-15 parts of Ligusticum chuanxiong, 15-30 parts of Astragalus membranaceus, 10-15 parts of Pueraria lobata, 6-12 parts of Uncaria rhynchophylla, and 8-15 parts of compound fungi. The compound fungus is composed of morel mushrooms and black fungus in a mass ratio of 1:2.8-3.2; The preparation method of the traditional Chinese medicine composition for treating cerebral infarction includes the following preparation steps: S1. After crushing the chuanxiong, astragalus, kudzu root, and uncaria, extract the active ingredients by water extraction and alcohol precipitation to obtain the extract. S2. After crushing the compound mushrooms, add deionized water and boil at normal pressure to extract them. Then add fermentation bacteria and seal for fermentation to obtain fermentation liquid. S3. After combining the extract and fermentation broth, concentrate under reduced pressure and spray dry to obtain the traditional Chinese medicine composition; In step S2, the fermentation bacteria are obtained by combining Pichia pastoris and Lactobacillus plantarum; the live count ratio of Pichia pastoris and Lactobacillus plantarum is 1:3.5-4.

2. The traditional Chinese medicine composition for treating cerebral infarction according to claim 1, characterized in that, It is made from the following ingredients in parts by weight: 12-14 parts of Ligusticum chuanxiong, 18-26 parts of Astragalus membranaceus, 12-14 parts of Pueraria lobata, 8-10 parts of Uncaria rhynchophylla, and 10-14 parts of compound fungi.

3. The traditional Chinese medicine composition for treating cerebral infarction according to claim 1 or 2, characterized in that, It is made from the following ingredients in parts by weight: 13 parts of Ligusticum chuanxiong, 24 parts of Astragalus membranaceus, 12 parts of Pueraria lobata, 9 parts of Uncaria rhynchophylla, and 12 parts of compound fungi.

4. The traditional Chinese medicine composition for treating cerebral infarction according to claim 1, characterized in that, The specific operation of step S1 is as follows: S11. Select high-quality medicinal materials such as Ligusticum chuanxiong, Astragalus membranaceus, Pueraria lobata and Uncaria rhynchophylla, wash them and dry them in hot air at 55-65℃. After drying, pulverize the medicinal materials and pass them through a 60-100 mesh sieve. S12. Mix the medicinal powder with deionized water at a mass ratio of 1:8-12, heat to boiling, and extract for 1-2 hours while maintaining boiling. Filter, add ethanol to the filtrate to achieve a total alcohol concentration of 65-75%, let stand overnight, filter to remove precipitate, centrifuge the supernatant, control the centrifugation speed at 8000-10000 r / min, and centrifuge for 5-10 min to obtain the extract.

5. The traditional Chinese medicine composition for treating cerebral infarction according to claim 1, characterized in that, The specific operation of step S2 is as follows: S21. Select high-quality compound mushrooms, wash them, and dry them in hot air at 55-65℃. After drying, crush the compound mushrooms and pass them through a 60-100 mesh sieve. S22. Add mushroom powder to deionized water at a material-to-liquid ratio of 1:15-20, boil for 20-40 minutes, and then cool to room temperature to obtain the fermentation liquid. S23. Control the viable count of fermentation bacteria in the fermentation broth to be 1×10⁻⁶. 8 -3×10 8 Add fermentation bacteria (cfu / ml) to the broth to be fermented, seal and ferment at room temperature for 7-11 hours. Remove the precipitate by centrifugation, controlling the centrifugation speed at 8000-10000 r / min and the centrifugation time at 5-10 min to obtain the fermentation broth.

6. The traditional Chinese medicine composition for treating cerebral infarction according to claim 1, characterized in that, In step S3, after spray drying, pharmaceutical excipients can be added to prepare a traditional Chinese medicine composition of the desired dosage form.

7. The traditional Chinese medicine composition for treating cerebral infarction according to claim 6, characterized in that, The pharmaceutical excipients include, but are not limited to, disintegrants, binders, lubricants, fillers, and flavoring agents.

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