Traditional Chinese medicine composition for treating cerebrovascular diseases and preparation method thereof

Abstract

The invention belongs to the technical field of traditional Chinese medicines, and particularly relates to a traditional Chinese medicine composition for treating cerebrovascular diseases and a preparation method thereof. The traditional Chinese medicine composition for treating cerebrovascular diseases comprises the following raw materials in parts by weight: 19-24 parts of ligusticum wallichii, 15-20 parts of gastrodia elata, 8-14 parts of ampelopsis grossedentata, 11-17 parts of tetrastigma hemsleyanum, 3-9 parts of hibiscus flower, 7-12 parts of polygala tenuifolia and 2-5 parts of liquorice. In the composition, ligusticum wallichii can promote blood circulation and regulate qi, gastrodia elata can calm endogenous wind and relieve convulsion, and ligusticum wallichii and gastrodia elata are used as monarch The ampelopsis grossedentata and the radix tetrastigme are used as ministerial drugs, and the ampelopsis grossedentata is The radix tetrastigme has the effects of dispelling wind and relieving pain; the flos hibisci is used for inducing diuresis and regulating menstruation, the radix polygalae is used for tranquilizing and helping sleep, both the flos hibisci and the radix polygalae are used as adjuvant drugs, and the radix glycyrrhizae is used as a conductant drug and can regulate all the drugs, warm the middle and promote drug absorption. The traditional Chinese medicine composition has the effects of promoting blood circulation to remove blood stasis, activating meridians to stop pain, soothing the nerves, helping sleep and the like. The medicine has a good treatment effect on stroke, cerebral apoplexy and the like.

Description

TECHNICAL FIELD

[0001] The application belongs to the technical field of traditional Chinese medicine, and particularly relates to a traditional Chinese medicine composition for treating cerebrovascular diseases and a preparation method thereof. BACKGROUND

[0002] Cerebrovascular diseases are mainly caused by occlusion of the middle cerebral artery, insufficient blood supply, hypoxia or hemorrhage, and belong to a common clinical disease, including ischemic stroke, hemorrhagic stroke and transient ischemic attack, etc. The disease has a high incidence, high disability rate and high mortality rate. In recent years, the incidence of stroke has been increasing year by year, and has surpassed cardiovascular diseases to become the first cause of death of residents, and shows a trend of youth. This kind of disease not only causes huge economic burden, but also seriously damages the quality of life of patients, leading to sequelae such as motor disorders, cognitive dysfunction, emotional disorders, etc. Among them, ischemic stroke accounts for a large proportion of cerebrovascular diseases, therefore, developing a method for treating cerebral ischemic stroke has important significance for treating cerebrovascular diseases.

[0003] Ischemic stroke is mainly caused by arterial stenosis due to thrombosis of the carotid artery system, or cerebral arterial embolism caused by unstable plaque rupture and shedding, and further causes insufficient blood perfusion in the brain, leading to ischemic and hypoxic injury of brain tissue. The disease is clinically often manifested as facial paralysis, hemiplegia and epilepsy and other symptoms of nerve function damage, and has become a common and frequently-occurring disease that seriously affects the quality of life of the elderly population. Its pathological process is closely related to neuroinflammation: microglial cells are activated, astrocytes are reactively proliferated, and a variety of pro-inflammatory cytokines including IL-8, TNF-α and TGF-β are released. These inflammatory responses exacerbate neuronal damage through different signaling pathways, promote cell death, and further worsen the progression of ischemic stroke. At present, the treatment of cerebrovascular diseases such as stroke / cerebral apoplexy in the clinic mainly tends to be western medicine treatment, and the commonly used drugs include antithrombotic drugs, neuroprotective agents, calcium antagonists, excitatory amino acid receptor antagonists, free radical scavengers, adenosine transport inhibitors, citicoline, gangliosides, nerve growth factors, leukocyte adhesion inhibitors, nitric oxide synthase inhibitors, anti-apoptotic drugs, and anti-inflammatory drugs. However, these drugs will have different degrees of side effects after long-term use, and due to the complex pathogenesis, the existing means have limited effect on the intervention of nerve function repair and inflammation control.

[0004] Traditional Chinese medicine has unique advantages of "overall regulation and multi-target intervention" in the prevention and treatment of cerebrovascular diseases. Traditional Chinese medicine theory believes that cerebrovascular diseases belong to the category of "stroke", and the core pathogenesis is "stagnation of blood and obstruction of collaterals, wind-phlegm disturbing the upper, and disorder of qi and blood". The acute stage is mainly "wind, fire, phlegm and blood stasis", and the recovery stage is mainly "qi deficiency and blood stasis, and deficiency of liver and kidney". The current treatment principle emphasizes "activating blood circulation, resolving phlegm, opening orifices, and supporting healthy qi and tonifying the root". However, the therapeutic effect of the treatment of ischemic stroke by using only blood-activating and phlegm-resolving drugs is still not ideal.

[0005] Therefore, it is of great significance to develop a safer and more effective traditional Chinese medicine composition for treating cerebral ischemia for the treatment of cerebrovascular diseases. SUMMARY

[0006] In order to overcome the shortcomings of the prior art, the primary purpose of the present application is to provide a traditional Chinese medicine composition for treating cerebrovascular diseases. The traditional Chinese medicine composition has the effects of activating blood circulation, dredging collaterals, relieving pain, calming the mind and promoting sleep, and can be used for improving and treating diseases such as cerebral apoplexy and stroke.

[0007] Another purpose of the present application is to provide a preparation method of the traditional Chinese medicine composition for treating cerebrovascular diseases.

[0008] The purpose of the present application is achieved by the following technical scheme: A traditional Chinese medicine composition for treating cerebrovascular diseases, comprising the following raw materials in parts by weight: 19-24 parts of chuanxiong, 15-20 parts of goutweed, 8-14 parts of kudzu vine, 11-17 parts of San Ye Qing, 3-9 parts of hibiscus flower, 7-12 parts of polygala, and 2-5 parts of licorice.

[0009] Further, the traditional Chinese medicine composition for treating cerebrovascular diseases comprises the following raw materials in parts by weight: 20 parts of chuanxiong, 18 parts of goutweed, 12 parts of kudzu vine, 15 parts of San Ye Qing, 7 parts of hibiscus flower, 10 parts of polygala, and 3 parts of licorice.

[0010] The preparation method of the traditional Chinese medicine composition for treating cerebrovascular diseases comprises the following steps: (1) The raw materials are weighed according to the weight parts, crushed and sieved, then mixed uniformly, and soaked in water to obtain a mixed solution; after the soaking treatment is completed, the mixed solution is boiled, filtered to obtain a first filtrate and a first residue; (2) The first residue is soaked, boiled and filtered in water to obtain a second filtrate and a second residue; (3) The first filtrate and the second filtrate are combined, concentrated under reduced pressure, and the concentrated solution is collected; a pharmaceutically acceptable adjuvant is added to the concentrated solution to prepare a preparation, and the preparation is obtained.

[0011] Further, in step (1), the particle size of the crushed raw material is 50-80 mesh.

[0012] Further, in step (1), the solid-liquid ratio of the raw material and water is 1g:(5-10)mL.

[0013] Furthermore, in step (2), the solid-liquid ratio of the first filter residue to water is 1g:(6-8)mL.

[0014] Furthermore, the soaking time in steps (1) and (2) is 1-2 hours.

[0015] Furthermore, the simmering time in steps (1) and (2) is 2-3 hours.

[0016] Furthermore, the volume of concentrated liquid corresponding to each gram of active pharmaceutical ingredient is 3-5 mL.

[0017] Furthermore, the dosage form of the preparation is any one of capsules, granules, oral liquids, and tablets.

[0018] To facilitate a better understanding of this invention, the effects of each ingredient are explained below: Chuanxiong (Ligusticum striatum): Bitter and pungent in taste, with a slight numbing sensation on the tongue and a slightly sweet aftertaste; warm in nature. It enters the liver, gallbladder, and pericardium meridians. It has the functions of promoting blood circulation and regulating qi, dispelling wind and relieving pain; used for chest and spleen pain, and stabbing pain in the chest and ribs.

[0019] Gastrodia elata: sweet in taste, neutral in nature; enters the liver meridian. It is now listed as a substance that is traditionally both a food and a Chinese medicinal herb. Functions and indications: relieves wind and stops spasms, calms liver yang, dispels wind and unblocks the meridians. The *Yongyao Faxiang* records that it "treats wind-heat headache in adults; wind-induced epilepsy and palpitations in children; numbness and paralysis due to various wind-related conditions; and speech impairment due to wind-heat." Vine tea: Bitter and slightly astringent in taste, cool in nature. Its sweet taste and cool nature possess the effects of clearing heat and detoxifying, antibacterial and anti-inflammatory, dispelling wind and dampness, strengthening muscles and bones, lowering blood pressure, lowering blood lipids, and protecting the liver. It is used for dysentery, diarrhea, painful urination, hypertension, dizziness and eye swelling, and traumatic injuries. The *Hubei Traditional Chinese Medicine Records* states that it "clears heat and cools the blood. Used for hypertension, dizziness, and eye swelling." Three-leaf ivy: It is pungent, slightly sweet, astringent, and warm in nature. It has the effects of clearing heat and detoxifying, dispelling wind and resolving phlegm, promoting blood circulation and relieving pain, and dispersing blood stasis and reducing swelling. Soaking it in alcohol and applying it externally to the affected area can treat rheumatoid arthritis, traumatic swelling and pain, sequelae of poliomyelitis, insect and snake bites, etc. A decoction of the root of three-leaf ivy, mixed with an appropriate amount of rice wine, can treat swelling and pain from fractures.

[0020] Hibiscus flower: Sweet, neutral, non-toxic. It enters the heart, lung, liver, and spleen meridians. It has the effects of clearing the lungs, resolving phlegm, cooling the blood, and detoxifying. It can treat coughs due to phlegm and heat, nosebleeds, dysentery, leukorrhea, carbuncles, and boils. The *Lu Chuan Materia Medica* records its cooling and detoxifying properties. It treats blood heat, nosebleeds, itching, and boils.

[0021] Polygala tenuifolia: Its flavor is neutral and sweet. It enters the Stomach, Spleen, and Lung meridians. It is hailed as the "King of Herbs." Pharmacologically, it has the effects of clearing heat and detoxifying, tonifying the spleen and replenishing qi, relieving spasms and pain, resolving phlegm and relieving cough, detoxifying, and harmonizing the properties of other herbs. It is used to treat spleen and stomach weakness, fatigue, palpitations, shortness of breath, stomach and abdominal pain, and to alleviate drug toxicity and food poisoning. The *Compendium of Materia Medica* records: It treats cold and heat pathogens in the five internal organs and six bowels, strengthens tendons and bones, promotes muscle growth, increases strength, treats wounds and swelling, and detoxifies.

[0022] Licorice: Neutral in flavor, sweet in taste. It enters the stomach, spleen, and lung meridians. Its functions include clearing heat and detoxifying, tonifying the spleen and replenishing qi, relieving spasms and pain, resolving phlegm and relieving cough, detoxifying, and harmonizing the properties of other herbs.

[0023] The present invention has the following advantages over the prior art: In this formula, Chuanxiong (Ligusticum striatum) invigorates blood and regulates Qi, while Tianma (Gastrodia elata) calms wind and stops spasms; both serve as the principal herbs. Tengcha (Tetrapanax papyriferus) and Sanye Qingteng (Tetrapanax trifoliata) serve as assistant herbs; Tengcha disperses stagnation and unblocks the meridians, while Sanye Qingteng dispels wind and relieves pain. Zhujinhua (Hibiscus rosa-sinensis) promotes diuresis and regulates menstruation, while Yuanzhi (Polygala tenuifolia) calms the mind and aids sleep; both are adjuvant herbs. Gancao (Glycyrrhiza uralensis) serves as the guiding herb; it not only harmonizes the other herbs but also warms the middle Jiao (spleen and stomach) and promotes drug absorption. The formula in this invention features a well-balanced combination of principal, assistant, and adjuvant herbs, resulting in a synergistic effect that integrates the functions of invigorating blood, removing blood stasis, unblocking meridians, relieving pain, calming the mind, and aiding sleep. Experiments have demonstrated that it also reduces inflammatory responses and improves nervous system function, showing good therapeutic effects for conditions such as stroke and cerebral infarction. Detailed Implementation

[0024] The present invention will be further described in detail below with reference to embodiments, but the implementation of the present invention is not limited thereto. Unless otherwise specified, the reagents, methods, and equipment used in the present invention are conventional reagents, methods, and equipment in this technical field. Test methods in the following embodiments that do not specify specific experimental conditions are generally performed according to conventional experimental conditions or experimental conditions recommended by the manufacturer. Unless otherwise specified, the reagents and raw materials used in the present invention are commercially available.

[0025] Example 1 A traditional Chinese medicine composition for treating cerebrovascular diseases, comprising the following ingredients by weight: 20 parts of Ligusticum chuanxiong, 18 parts of Gastrodia elata, 12 parts of vine tea, 15 parts of three-leaf vine, 7 parts of Hibiscus rosa-sinensis, 10 parts of Polygala tenuifolia, and 3 parts of licorice.

[0026] The preparation method of the above-mentioned traditional Chinese medicine composition for treating cerebrovascular diseases includes the following steps: (1) Weigh each raw material according to the weight parts, crush and sieve and mix evenly. The particle size of the crushed raw material is 70 mesh. Then add water to soak for 1.5h, wherein the solid-liquid ratio of raw material and water is 1g:8mL to obtain a mixed solution. After the soaking treatment, decoct the mixed solution for 2.5h and filter to obtain the first filtrate and the first filter residue. (2) Soak the first filter residue in water for 1.5 h, with a solid-liquid ratio of 1 g to 7 mL; boil for 2.5 h and filter to obtain the second filtrate and the second filter residue; (3) Combine the first filtrate and the second filtrate, concentrate under reduced pressure, collect the concentrate, the volume of concentrate corresponding to each gram of raw material is 4 mL, add pharmaceutically acceptable excipients to the concentrate, and make capsules.

[0027] Example 2 A traditional Chinese medicine composition for treating cerebrovascular diseases, comprising the following ingredients by weight: 19 parts of Ligusticum chuanxiong, 15 parts of Gastrodia elata, 8 parts of vine tea, 11 parts of three-leaf vine, 3 parts of Hibiscus rosa-sinensis, 7 parts of Polygala tenuifolia, and 2 parts of licorice.

[0028] The preparation method of the above-mentioned traditional Chinese medicine composition for treating cerebrovascular diseases includes the following steps: (1) Weigh each raw material according to the weight parts, crush and sieve and mix evenly. The particle size of the crushed raw material is 50 mesh. Then add water to soak for 1 hour, wherein the solid-liquid ratio of raw material and water is 1g:5mL to obtain a mixed solution. After the soaking treatment, decoct the mixed solution for 2 hours and filter to obtain the first filtrate and the first filter residue. (2) Soak the first filter residue in water for 1 hour. The solid-liquid ratio of the first filter residue to water is 1 g: 6 mL. Boil for 2 hours and filter to obtain the second filtrate and the second filter residue. (3) Combine the first filtrate and the second filtrate, concentrate under reduced pressure, collect the concentrate, the volume of concentrate corresponding to each gram of raw material is 3 mL, add pharmaceutically acceptable excipients to the concentrate, and make capsules.

[0029] Example 3 A traditional Chinese medicine composition for treating cerebrovascular diseases, comprising the following ingredients by weight: 24 parts of Ligusticum chuanxiong, 20 parts of Gastrodia elata, 14 parts of vine tea, 17 parts of three-leaf vine, 9 parts of Hibiscus rosa-sinensis, 12 parts of Polygala tenuifolia, and 5 parts of licorice.

[0030] The preparation method of the above-mentioned traditional Chinese medicine composition for treating cerebrovascular diseases includes the following steps: (1) Weigh each raw material according to the weight parts, crush and sieve and mix evenly. The particle size of the crushed raw material is 80 mesh. Then add water to soak for 2 hours. The solid-liquid ratio of the raw material and water is 1g:10mL to obtain a mixed solution. After the soaking treatment, boil the mixed solution for 3 hours and filter to obtain the first filtrate and the first filter residue. (2) Soak the first filter residue in water for 2 hours. The solid-liquid ratio of the first filter residue to water is 1 g: 8 mL. Boil for 3 hours and filter to obtain the second filtrate and the second filter residue. (3) Combine the first and second filtrates, concentrate under reduced pressure, collect the concentrate, and the volume of concentrate corresponding to each gram of raw material is 5 mL. Add pharmaceutically acceptable excipients to the concentrate to make capsules.

[0031] Comparative Example 1 The traditional Chinese medicine composition of this comparative example, by weight, includes the following ingredients: 20 parts of Ligusticum chuanxiong, 18 parts of Gastrodia elata, 15 parts of San Ye Qing Teng, 7 parts of Hibiscus rosa-sinensis, 10 parts of Polygala tenuifolia, and 3 parts of Glycyrrhiza uralensis. That is, the addition of vine tea is omitted from the formula; otherwise, it remains consistent with Example 1.

[0032] Comparative Example 2 The traditional Chinese medicine composition of this comparative example, by weight, includes the following ingredients: 20 parts of Ligusticum chuanxiong, 18 parts of Gastrodia elata, 12 parts of vine tea, 7 parts of Hibiscus rosa-sinensis, 10 parts of Polygala tenuifolia, and 3 parts of licorice. That is, the addition of Trifolium repens is omitted from the formula; otherwise, it is consistent with Example 1.

[0033] Comparative Example 3 The traditional Chinese medicine composition of this comparative example, by weight, includes the following ingredients: 20 parts of Ligusticum chuanxiong, 18 parts of Gastrodia elata, 12 parts of vine tea, 15 parts of chicken blood vine, 7 parts of Hibiscus rosa-sinensis, 10 parts of Polygala tenuifolia, and 3 parts of licorice. The only difference is that the three-leaf vine in the formula is replaced with chicken blood vine; otherwise, it remains the same as in Example 1.

[0034] Comparative Example 4 The traditional Chinese medicine composition of this comparative example, by weight, includes the following ingredients: 20 parts of Ligusticum chuanxiong, 18 parts of Gastrodia elata, 12 parts of vine tea, 15 parts of three-leaf vine, 10 parts of Polygala tenuifolia, and 3 parts of licorice. That is, the addition of Hibiscus rosa-sinensis is omitted from the formula; otherwise, it remains consistent with Example 1.

[0035] Comparative Example 5 A traditional Chinese medicine composition for treating cerebrovascular diseases, by weight, comprises the following ingredients: 20 parts of Ligusticum chuanxiong, 18 parts of Gastrodia elata, 12 parts of vine tea, 15 parts of three-leaf vine, 7 parts of Paeonia lactiflora, 10 parts of Polygala tenuifolia, and 3 parts of Glycyrrhiza uralensis. The Hibiscus rosa-sinensis flower in the formula is replaced with Paeonia lactiflora; otherwise, it remains consistent with Example 1.

[0036] Experimental Example 1 To verify the safety of the traditional Chinese medicine compositions in Examples 1-3, the following experiments were conducted: Male SD rats weighing 200±20g were selected as experimental animals and purchased from Huaxing Experimental Animal Farm, Huiji District, Zhengzhou City. SPF grade rats were kept in an alternating 12h light / 12h dark cycle at a temperature of 23±2℃ and a relative humidity of 50±5% for one week of acclimatization. The SD rats were randomly divided into four groups (Example 1, Example 2, Example 3, and a blank control group), with six rats in each group. Each group was administered 5g / kg (based on crude drug) of the traditional Chinese medicine composition from Examples 1-3 via gavage. One group was administered an equal volume of physiological saline via gavage as a blank control group. All rats were housed separately and observed for 28 consecutive days.

[0037] Compared with the blank control group, after rats were administered the traditional Chinese medicine compositions of Examples 1-3 of this invention by gavage, the rats exhibited good behavior, urination and defecation, drinking and eating, and mental state, with no deaths. This indicates that the traditional Chinese medicine compositions of this invention have high safety for use in SD rats.

[0038] Experimental Example 2 To investigate the effects of the traditional Chinese medicine compositions of Examples 1-3 and Comparative Examples 1-5 on rats with cerebral ischemia, the following experiments were conducted: 1. Laboratory animals Male SD rats weighing 200±20g were selected as experimental animals and purchased from Huaxing Experimental Animal Farm, Huiji District, Zhengzhou City; SPF grade, randomly divided into 13 groups, with 10 rats in each group. A 12h light / 12h dark cycle was maintained, with a housing temperature of 23±2℃ and a relative humidity of 50±5%, for one week of acclimatization. All groups were fasted for 12 hours before the experiment but allowed free access to water.

[0039] 2. Constructing an animal model Twelve groups of SD rats (120 rats in total) were used to establish a cerebral ischemia model induced by middle cerebral artery occlusion using the suture occlusion method. The SD rats were anesthetized by intraperitoneal injection of 50 mg / kg of sulfadiazine. After anesthesia, the rats were fixed supine on the operating table. The neck area was shaved and disinfected with povidone-iodine. A surgical incision was made slightly to the right of the midline of the neck. The skin and superficial fascia were incised, and the tissue located between the submandibular glands on both sides was separated. The common carotid artery (CCA), external carotid artery (ECA), and internal carotid artery (ICA) were isolated. The distal ends of the ECA and CCA were ligated; simultaneously, the ICA was clamped with arterial clips. Make a 0.2mm incision at the ECA stump, insert the sterilized nylon suture through the incision into the CCA bifurcation, and then gently push it into the ICA through the ECA. Release the arterial clamp on the ICA until you feel slight resistance. At this point, the insertion length is about 18-19mm. Release the arterial clamp on the CCA. After the operation is completed, suture the incision skin. Administer 10,000 units of penicillin intramuscularly to each rat once a day for 3 consecutive days.

[0040] 3. Animal grouping The 12 groups of SD rats were randomly divided into the model group, the positive drug group, the low-dose group of Example 1, the medium-dose group of Example 1, the high-dose group of Example 1, the low-dose group of Example 2, the low-dose group of Example 3, the low-dose group of Comparative Example 1, the low-dose group of Comparative Example 2, the low-dose group of Comparative Example 3, the low-dose group of Comparative Example 4, and the low-dose group of Comparative Example 5. An additional group of SD rats that did not receive any treatment served as the blank control group.

[0041] 4. Drug administration Example 1 Low-dose group: Based on crude drug, 0.5 g / kg of the traditional Chinese medicine composition of Example 1 was administered by gavage once a day for 21 consecutive days; In Example 1, the dosage group was administered 1.0 g / kg of the traditional Chinese medicine composition of Example 1 by gavage once a day for 21 consecutive days, based on the amount of raw drug. Example 1 High-dose group: Based on crude drug, 2.0 g / kg of the traditional Chinese medicine composition of Example 1 was administered by gavage once a day for 21 consecutive days; Example 2 Low-dose group: Based on crude drug, 0.5 g / kg of the traditional Chinese medicine composition of Example 2 was administered by gavage once a day for 21 consecutive days; Example 3 Low-dose group: Based on crude drug, 0.5 g / kg of the traditional Chinese medicine composition of Example 3 was administered by gavage once a day for 21 consecutive days; Comparative Example 1 Low-dose group: Based on crude drug, 0.5 g / kg of the traditional Chinese medicine composition of Comparative Example 1 was administered by gavage once a day for 21 consecutive days; Comparative Example 2 Low-dose group: Based on crude drug, 0.5 g / kg of the traditional Chinese medicine composition of Comparative Example 2 was administered by gavage once a day for 21 consecutive days; Comparative Example 3 Low-dose group: Based on crude drug, 0.5 g / kg of the traditional Chinese medicine composition of Comparative Example 3 was administered by gavage once a day for 21 consecutive days; Comparative Example 4 Low-dose group: Based on crude drug, 0.5 g / kg of the traditional Chinese medicine composition of Comparative Example 4 was administered by gavage once a day for 21 consecutive days; Comparative Example 5 Low-dose group: Based on crude drug, 0.5 g / kg of the traditional Chinese medicine composition of Comparative Example 5 was administered by gavage once a day for 21 consecutive days; Positive drug group: Nimodipine solution 10 mg / kg was administered by gavage once a day for 21 consecutive days; Blank control group and model group: The same volume of physiological saline was administered by gavage once a day for 21 consecutive days.

[0042] 5. Indicator Testing 5.1 Neurological Function Scoring Test in SD Rats: The changes in physical signs of SD rats were observed 24 hours after the last day of drug administration, and then a neurological function score was calculated: Grade 0: No neurological dysfunction, recorded as 0 points; inability to extend the paralyzed forelimb, recorded as 1 point; rotation towards the paralyzed side, recorded as 2 points; tilting towards the paralyzed side, recorded as 3 points; no voluntary movement and loss of consciousness, recorded as 4 points. The experimental results are shown in Table 1.

[0043] Table 1. Neurological function scores of different groups of traditional Chinese medicine compositions As shown in Table 1, compared with the blank control group, the neurological function scores of rats in the model group were significantly higher 24 hours after administration. Compared with the model group, the neurological function scores of rats in the example group were significantly lower. These experimental results demonstrate that the intervention of the traditional Chinese medicine composition of this invention significantly improves the behavioral performance of rats, providing a theoretical basis for the clinical treatment of ischemic stroke.

[0044] 5.2 After the last administration, SD rats were fasted for 12 hours, but water was allowed. Each SD rat was anesthetized by intraperitoneal injection of 50 mg / kg of salbutamol. Blood was collected from the abdominal aorta, centrifuged, and the supernatant plasma was collected. The levels of inflammatory factors tumor necrosis factor-α (TNF-α) and interleukin-8 (IL-8) in the serum of SD rats were detected according to the instructions of the ELISA kit. The experimental results are shown in Table 2.

[0045] Table 2. Levels of IL-8 and TNF-α in different groups of traditional Chinese medicine compositions. The stroke process is closely related to changes in neuroinflammatory factors. Detecting the levels of IL-8 and TNF-α in animals is to directly assess whether traditional Chinese medicine compositions for treating cerebrovascular diseases can effectively inhibit key and harmful neuroinflammatory responses after the onset of cerebrovascular diseases.

[0046] As shown in Table 2, compared with the blank control group, the levels of IL-8 and TNF-α in the model group were significantly increased, indicating that the inflammatory response in rats was exacerbated after the ischemic stroke model was established. Compared with the model group, the IL-8 and TNF-α levels in each embodiment group of the present invention were significantly reduced and higher than those in comparative groups 1-5. These results indicate that the traditional Chinese medicine combination of the present invention can significantly reduce the levels of inflammatory factors IL-8 and TNF-α and inhibit the reaction process of inflammatory factors. That is, the traditional Chinese medicine composition of the present invention is beneficial to controlling the inflammatory response in the stroke process and can be used to treat stroke and effectively alleviate the condition.

[0047] Compared to Example 1, Comparative Examples 1-5 omitted *Ipomoea batatas*; omitted *Ipomoea trifoliata*; replaced *Ipomoea trifoliata* with *Spatholobus suberectus*; omitted *Hibiscus rosa-sinensis*; and replaced *Hibiscus rosa-sinensis* with *Paeonia lactiflora*. Although all of them could reduce the inflammation level to varying degrees, the effect was poor.

[0048] The above embodiments are merely preferred embodiments of the present invention and should not be construed as limiting the scope of protection of the present invention. Any non-substantial changes and substitutions made by those skilled in the art based on the present invention shall fall within the scope of protection claimed by the present invention.

Claims

1. A traditional Chinese medicine composition for treating cerebrovascular diseases, characterized in that, By weight, it includes the following ingredients: 19-24 parts of Ligusticum chuanxiong, 15-20 parts of Gastrodia elata, 8-14 parts of vine tea, 11-17 parts of three-leaf vine, 3-9 parts of Hibiscus rosa-sinensis, 7-12 parts of Polygala tenuifolia, and 2-5 parts of licorice.

2. The traditional Chinese medicine composition for treating cerebrovascular diseases according to claim 1, characterized in that, By weight, it includes the following ingredients: 20 parts of Ligusticum chuanxiong, 18 parts of Gastrodia elata, 12 parts of vine tea, 15 parts of three-leaf vine, 7 parts of Hibiscus rosa-sinensis, 10 parts of Polygala tenuifolia, and 3 parts of licorice.

3. A method for preparing a traditional Chinese medicine composition for treating cerebrovascular diseases according to claim 1 or 2, characterized in that, Includes the following steps: (1) Weigh each raw material according to the weight parts, crush and sieve, mix evenly, add water for soaking treatment to obtain a mixture; after the soaking treatment is completed, decoct the mixture, filter to obtain the first filtrate and the first filter residue; (2) Soak, boil and filter the first filter residue with water to obtain the second filtrate and the second filter residue; (3) Combine the first filtrate and the second filtrate, concentrate under reduced pressure, collect the concentrate, add pharmaceutically acceptable excipients to the concentrate, and prepare a formulation.

4. The method for preparing a traditional Chinese medicine composition for treating cerebrovascular diseases according to claim 3, characterized in that, In step (1), the particle size of the raw material after pulverization is 50-80 mesh.

5. A method for preparing a traditional Chinese medicine composition for treating cerebrovascular diseases according to claim 3, characterized in that, In step (1), the solid-liquid ratio of the raw material and water is 1g:(5-10)mL.

6. The method for preparing a traditional Chinese medicine composition for treating cerebrovascular diseases according to claim 3, characterized in that, In step (2), the solid-liquid ratio of the first filter residue to water is 1g:(6-8)mL.

7. The method for preparing a traditional Chinese medicine composition for treating cerebrovascular diseases according to claim 3, characterized in that, The soaking time described in steps (1) and (2) is 1-2 hours.

8. The method for preparing a traditional Chinese medicine composition for treating cerebrovascular diseases according to claim 3, characterized in that, The simmering time described in steps (1) and (2) is 2-3 hours.

9. A method for preparing a traditional Chinese medicine composition for treating cerebrovascular diseases according to claim 3, characterized in that, The volume of concentrated liquid corresponding to each gram of raw material is 3-5 mL.

10. A method for preparing a traditional Chinese medicine composition for treating cerebrovascular diseases according to claim 3, characterized in that, The dosage form of the preparation is any one of capsules, granules, oral liquids, and tablets.

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