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

Abstract

The invention provides a traditional Chinese medicine composition for treating cerebrovascular diseases and a preparation method and application thereof, and belongs to the technical field of biological medicine. The traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 8 to 12 parts of rhizoma chuanxiong, 12 to 17 parts of radix paeoniae rubra, 13 to 18 parts of radix salviae miltiorrhizae, 8 to 12 parts of radix polygalae, 10 to 15 parts of rhizoma acori graminei, 27 to 32 parts of radix astragali seu hedysari, 0.3 to 0.7 part of borneol, 0.1 to 0.2 part of musk, 12 to 18 parts of radix angelicae sinensis, 6 to 12 parts of flos carthami, 7 to 12 parts of semen persicae and 5 to 7 parts of radix glycyrrhizae preparata. The traditional Chinese medicine composition disclosed by the invention has the curative effects of tonifying qi and activating blood, dispersing blood stasis and dredging collaterals, and restoring consciousness and inducing resuscitation. The traditional Chinese medicine composition can be combined with a leg electrical stimulation system to efficiently treat cerebral apoplexy hemiplegia and effectively treat vascular dementia, and has an obvious treatment effect on cerebrovascular diseases. The preparation method of the traditional Chinese medicine composition is simple, convenient and rapid, and is suitable for industrial production.

Description

Technical Field

[0001] This invention belongs to the field of biomedical technology, and in particular relates to a traditional Chinese medicine composition for treating cerebrovascular diseases, its preparation method and application. Background Technology

[0002] Stroke is a common cerebrovascular disease and a global health problem primarily affecting the elderly. Clinically, damage to brain and nerve function leads to varying degrees of limb dysfunction, resulting in hemiplegia. Stroke hemiplegia, also known as paralysis of one side of the body, initially manifests as immobility and lack of control over one side of the body. Some patients experience complete paralysis, while others retain some movement but exhibit significant clumsiness. Treatment for stroke hemiplegia sequelae currently relies on comprehensive therapies, including acupuncture, massage, and other methods. These therapies require hospital visits, causing inconvenience and often resulting in less than ideal rehabilitation outcomes. Current medications for stroke hemiplegia are not highly effective, the treatment process is lengthy, many patients require lifelong medication, and the condition is prone to relapse and even cerebral hemorrhage. Existing oral medications often have toxic side effects and are expensive, with limited therapeutic effects, placing a significant financial burden on patients' families.

[0003] Vascular dementia (VD) is a dementia caused by brain injury due to multiple factors. Patients' cognition, memory, and behavior gradually progress from functional impairment to the dementia stage. The area, size, and number of infarcts in stroke are closely related to the onset of vascular dementia. It mainly manifests as cognitive impairment, including intellectual, emotional, memory, and language impairments. The disease progresses, has a high disability rate, and in severe cases can be fatal, greatly threatening and affecting patients' lives and quality of life. In traditional Chinese medicine, vascular dementia falls under the category of "dementia," often occurring after stroke due to phlegm and blood stasis obstructing the brain's blood vessels and leading to malnourishment. Clinically, the main strategies are to improve cerebral blood flow perfusion and strengthen the treatment of underlying diseases, but satisfactory treatment results are often not achieved. Summary of the Invention

[0004] Therefore, the purpose of this invention is to provide a traditional Chinese medicine composition for treating cerebrovascular diseases, its preparation method, and its application.

[0005] To achieve the above-mentioned objectives, the present invention provides the following technical solution: This invention provides a traditional Chinese medicine composition for treating cerebrovascular diseases, the composition comprising the following raw materials in parts by weight: The ingredients are: 8-12 parts of Ligusticum chuanxiong, 12-17 parts of Paeonia lactiflora, 13-18 parts of Salvia miltiorrhiza, 8-12 parts of Polygala tenuifolia, 10-15 parts of Acorus tatarinowii, 27-32 parts of Astragalus membranaceus, 0.3-0.7 parts of Borneol, 0.1-0.2 parts of Musk, 12-18 parts of Angelica sinensis, 6-12 parts of Carthamus tinctorius, 7-12 parts of Prunus persica, and 5-7 parts of Glycyrrhiza uralensis (processed).

[0006] Preferably, the traditional Chinese medicine composition comprises the following raw materials in parts by weight: The ingredients are: 9-11 parts of Ligusticum chuanxiong, 13-16 parts of Paeonia lactiflora, 14-17 parts of Salvia miltiorrhiza, 9-11 parts of Polygala tenuifolia, 11-14 parts of Acorus tatarinowii, 29-31 parts of Astragalus membranaceus, 0.4-0.6 parts of Borneol, 0.11-0.17 parts of Musk, 14-16 parts of Angelica sinensis, 8-10 parts of Carthamus tinctorius, 9-11 parts of Prunus persica, and 5.5-6.5 parts of Glycyrrhiza uralensis (processed).

[0007] This invention provides a method for preparing the above-mentioned traditional Chinese medicine composition, comprising the following steps: The ingredients of Ligusticum chuanxiong, Paeonia lactiflora, Salvia miltiorrhiza, Polygala tenuifolia, Acorus tatarinowii, Astragalus membranaceus, Borneol, Musk, Angelica sinensis, Carthamus tinctorius, Prunus persica, and Glycyrrhiza uralensis were mixed, ground, and sieved to obtain a mixed powder. The mixed powder is mixed with rice vinegar to obtain the traditional Chinese medicine composition.

[0008] Preferably, the mesh size of the sieve is 80 to 120 mesh.

[0009] Preferably, the mass-to-volume ratio of the mixed powder to rice vinegar is 90-110g:35-45mL.

[0010] This invention provides a product combination for treating cerebrovascular diseases, the product combination being a traditional Chinese medicine composition and a leg electrical stimulation system; The traditional Chinese medicine composition is the traditional Chinese medicine composition described above or the traditional Chinese medicine composition prepared by the preparation method; The parameters of the leg electrical stimulation system include: current 20~60mA, pulse width 280~320μs, frequency 25~150Hz, stimulation time 3~7s, and interval time 3~7s after stimulation; the stimulation time for a single leg is 15~25min.

[0011] This invention provides an application of the above-mentioned traditional Chinese medicine composition and preparation method in the preparation of products for treating cerebrovascular diseases.

[0012] Preferably, the cerebrovascular disease is stroke and / or dementia.

[0013] Preferably, the dementia is vascular dementia.

[0014] Preferably, the stroke is hemiplegia due to stroke.

[0015] Compared with the prior art, the present invention has the following beneficial effects: This invention provides a traditional Chinese medicine composition for treating cerebrovascular diseases, its preparation method, and its application. The composition uses Astragalus membranaceus as the principal herb, aiming to promote blood circulation and remove blood stasis. Angelica sinensis is the assistant herb, having the effect of activating blood circulation and clearing the meridians without harming the blood. Red peony root, Ligusticum chuanxiong, peach kernel, safflower, Salvia miltiorrhiza, Polygala tenuifolia, and Acorus tatarinowii are the adjuvant herbs. Red peony root, Ligusticum chuanxiong, peach kernel, safflower, and Salvia miltiorrhiza work synergistically with Angelica sinensis to activate blood circulation and remove blood stasis. Polygala tenuifolia has the effect of calming the mind and improving intelligence. Acorus tatarinowii has the effect of aromatically resolving phlegm and awakening the mind. Borneol, musk, and prepared licorice root are the guiding herbs. Borneol has the effect of pungent and penetrating, guiding the herbs to the brain orifices. Musk has the effect of opening the orifices and awakening the mind, and circulating through the twelve meridians. Prepared licorice root has the effect of harmonizing the herbs and mitigating their harshness. The combined effects of these herbs achieve the therapeutic effects of tonifying qi and activating blood circulation, removing blood stasis and clearing the meridians, and awakening the mind. This traditional Chinese medicine composition, combined with a leg electrical stimulation system, can reduce brain inflammation, improve daily living abilities, lower NIHSS scores, and has excellent clinical therapeutic effects on stroke-induced hemiplegia, demonstrating highly effective treatment for stroke-induced hemiplegia. Furthermore, this traditional Chinese medicine composition, combined with the leg electrical stimulation system, can also improve cognitive function, daily living abilities, and cerebral hemodynamics in the treatment of vascular dementia, thereby achieving highly effective treatment for vascular dementia. The product combination of this invention can effectively treat both stroke-induced hemiplegia and vascular dementia, exhibiting significant therapeutic effects on cerebrovascular diseases. Moreover, the preparation method of this traditional Chinese medicine composition is simple and rapid, suitable for industrial production. Detailed Implementation

[0016] This invention provides a traditional Chinese medicine composition for treating cerebrovascular diseases, the composition comprising the following raw materials in parts by weight: The ingredients are: 8-12 parts of Ligusticum chuanxiong, 12-17 parts of Paeonia lactiflora, 13-18 parts of Salvia miltiorrhiza, 8-12 parts of Polygala tenuifolia, 10-15 parts of Acorus tatarinowii, 27-32 parts of Astragalus membranaceus, 0.3-0.7 parts of Borneol, 0.1-0.2 parts of Musk, 12-18 parts of Angelica sinensis, 6-12 parts of Carthamus tinctorius, 7-12 parts of Prunus persica, and 5-7 parts of Glycyrrhiza uralensis (processed).

[0017] In this invention, as a preferred embodiment, the traditional Chinese medicine composition comprises the following raw materials in parts by weight: 9-11 parts of Ligusticum chuanxiong, 13-16 parts of Paeonia lactiflora, 14-17 parts of Salvia miltiorrhiza, 9-11 parts of Polygala tenuifolia, 11-14 parts of Acorus tatarinowii, 29-31 parts of Astragalus membranaceus, 0.4-0.6 parts of Borneol, 0.11-0.17 parts of Musk, 14-16 parts of Angelica sinensis, 8-10 parts of Carthamus tinctorius, 9-11 parts of Prunus persica, and 5.5-6.5 parts of Glycyrrhiza uralensis (processed). More preferably, the traditional Chinese medicine composition is made from the following raw materials in parts by weight: 8-12 parts of Ligusticum chuanxiong, 12-17 parts of Paeonia lactiflora, 13-18 parts of Salvia miltiorrhiza, 8-12 parts of Polygala tenuifolia, 10-15 parts of Acorus tatarinowii, 27-32 parts of Astragalus membranaceus, 0.3-0.7 parts of Borneol, 0.1-0.2 parts of Musk, 12-18 parts of Angelica sinensis, 6-12 parts of Carthamus tinctorius, 7-12 parts of Prunus persica, and 5-7 parts of Glycyrrhiza uralensis (processed). More preferably, the traditional Chinese medicine composition is made from the following raw materials in parts by weight: 10 parts of Ligusticum chuanxiong, 15 parts of Paeonia lactiflora, 15 parts of Salvia miltiorrhiza, 10 parts of Polygala tenuifolia, 12 parts of Acorus tatarinowii, 30 parts of Astragalus membranaceus, 0.5 parts of Borneol, 0.15 parts of Musk, 15 parts of Angelica sinensis, 9 parts of Carthamus tinctorius, 9 parts of Prunus persica, and 6 parts of Glycyrrhiza uralensis (processed).

[0018] In this invention, the properties and meridians of Ligusticum chuanxiong are as follows: it is warm in nature and pungent in taste; it enters the liver, gallbladder and pericardium meridians, and has the functions of promoting qi and blood circulation and guiding the medicine upward. This invention does not have any special limitation on the source of Ligusticum chuanxiong, and commercially available products in this field can be used.

[0019] In this invention, the red peony root is described as having a bitter taste and slightly cold nature; it enters the liver meridian and has the functions of clearing heat and cooling blood, dispersing blood stasis and relieving pain. This invention does not have a specific limitation on the source of the red peony root; commercially available products in this field are acceptable.

[0020] In this invention, the described Salvia miltiorrhiza is bitter in taste and slightly cold in nature, and enters the heart and liver meridians, possessing the functions of promoting blood circulation, removing blood stasis, clearing the heart, and relieving irritability. This invention does not have specific limitations on the source of Salvia miltiorrhiza; commercially available products in this field are acceptable.

[0021] In this invention, the Polygala tenuifolia is bitter and pungent in taste and warm in nature; it enters the heart, kidney and lung meridians and has the effects of treating neurasthenia, palpitations, forgetfulness, insomnia, nocturnal emission, cough with phlegm, bronchitis, diarrhea, cystitis and carbuncles. This invention does not have a special limitation on the source of Polygala tenuifolia and commercially available products in this field can be used.

[0022] In this invention, the Acorus tatarinowii has a pungent and bitter taste, is warm in nature, and enters the heart and stomach meridians. It has the effect of amplifying the ability to resolve phlegm and open the orifices. This invention does not have a special limitation on the source of Acorus tatarinowii; commercially available products in this field can be used.

[0023] In this invention, the Astragalus membranaceus is sweet in taste and slightly warm in nature; it enters the spleen and lung meridians and has the functions of invigorating qi and strengthening the body, promoting blood circulation and unblocking collaterals. This invention does not have any special limitation on the source of Astragalus membranaceus and commercially available products in this field can be used.

[0024] In this invention, the borneol is pungent and bitter in taste, slightly cold in nature, and enters the heart, spleen, and lung meridians. It has the function of being pungent and aromatic, and guiding other medicines into the brain orifices. This invention does not have any special limitation on the source of borneol, and commercially available products in this field can be used.

[0025] In this invention, the musk is pungent and warm in nature; it enters the heart, liver and spleen meridians, and has the functions of opening the orifices and refreshing the mind, and circulating through the twelve meridians. This invention does not have a special limitation on the source of musk, and commercially available products in this field can be used.

[0026] In this invention, the Angelica sinensis is sweet and pungent in taste and warm in nature; it enters the liver, heart and spleen meridians and has the effect of promoting blood circulation and unblocking collaterals without harming blood. This invention does not have any special limitation on the source of Angelica sinensis and commercially available products in this field can be used.

[0027] In this invention, the safflower is pungent and warm in nature, and enters the heart and liver meridians. It has the functions of promoting blood circulation, regulating menstruation, removing blood stasis and relieving pain. This invention does not have a special limitation on the source of safflower, and commercially available products in this field can be used.

[0028] In this invention, the peach kernel is bitter and sweet in taste, neutral in nature, and enters the heart, liver, and large intestine meridians. It has the effect of breaking up blood stasis and moisturizing dryness. This invention does not have a special limitation on the source of peach kernel, and commercially available products in this field can be used.

[0029] In this invention, the prepared licorice root is sweet in taste, neutral in nature, and warm in nature. It enters the heart, lung, stomach, and spleen meridians and has the function of harmonizing various medicines and mitigating their harshness. This invention does not have any special limitation on the source of the prepared licorice root; commercially available products in this field are acceptable.

[0030] The traditional Chinese medicine composition of this invention uses Astragalus membranaceus as the principal herb, aiming to promote blood circulation when Qi is abundant, thereby clearing blood stasis and unblocking collaterals. Angelica sinensis is the assistant herb, which has the effect of activating blood circulation and unblocking collaterals without harming the blood. Paeonia lactiflora, Ligusticum chuanxiong, Prunus persica, Carthamus tinctorius, Salvia miltiorrhiza, Polygala tenuifolia, and Acorus tatarinowii are the adjuvant herbs. Among them, Paeonia lactiflora, Ligusticum chuanxiong, Prunus persica, Carthamus tinctorius, and Salvia miltiorrhiza work together with Angelica sinensis to activate blood circulation and remove blood stasis. Polygala tenuifolia has the effect of calming the mind and opening the orifices to improve intelligence. Acorus tatarinowii has the effect of aromatically resolving phlegm and awakening the mind and opening the orifices. Borneol, musk, and prepared licorice are the guiding herbs. Borneol has the effect of being pungent and aromatic, guiding the herbs to the brain orifices. Musk has the effect of opening the orifices and awakening the mind, and unblocking the twelve meridians. Prepared licorice has the effect of harmonizing the herbs and moderating their harshness. The combined use of these herbs achieves the therapeutic effects of invigorating Qi and activating blood circulation, removing blood stasis and unblocking collaterals, and awakening the mind and opening the orifices.

[0031] This invention provides a method for preparing the above-mentioned traditional Chinese medicine composition, comprising the following steps: The ingredients of Ligusticum chuanxiong, Paeonia lactiflora, Salvia miltiorrhiza, Polygala tenuifolia, Acorus tatarinowii, Astragalus membranaceus, Borneol, Musk, Angelica sinensis, Carthamus tinctorius, Prunus persica, and Glycyrrhiza uralensis were mixed, ground, and sieved to obtain a mixed powder. The mixed powder is mixed with rice vinegar to obtain the traditional Chinese medicine composition.

[0032] In this invention, the following herbs are mixed: Ligusticum chuanxiong, Paeonia lactiflora, Salvia miltiorrhiza, Polygala tenuifolia, Acorus tatarinowii, Astragalus membranaceus, Borneol, Musk, Angelica sinensis, Carthamus tinctorius, Prunus persica, and Glycyrrhiza uralensis (processed), then ground and sieved to obtain a mixed powder. The sieve mesh size is 80-120 mesh, more preferably 90-110 mesh, and even more preferably 100 mesh. This invention does not impose any special limitations on the mixing method; conventional methods in the art can be used.

[0033] In this invention, after obtaining the mixed powder, the mixed powder is mixed with rice vinegar to obtain the traditional Chinese medicine composition. The preferred mass-to-volume ratio of the mixed powder to rice vinegar is 90-110g:35-45mL, more preferably 95-105g:37-42mL, and even more preferably 100g:40mL. This invention utilizes the ability of rice vinegar to effectively extract the active ingredients from the traditional Chinese medicine composition, thereby enhancing its effects of promoting blood circulation, relieving pain, clearing blockages, and refreshing the mind.

[0034] This invention provides a product combination for treating cerebrovascular diseases, the product combination being a traditional Chinese medicine composition and a leg electrical stimulation system; The traditional Chinese medicine composition is the traditional Chinese medicine composition described above or the traditional Chinese medicine composition prepared by the preparation method; The parameters of the leg electrical stimulation system include: current 20~60mA, pulse width 280~320μs, frequency 25~150Hz, stimulation time 3~7s, and interval time 3~7s after stimulation; the stimulation time for a single leg is 15~25min.

[0035] In this invention, the preferred parameters of the leg electrical stimulation system are: current 30-40mA, pulse width 290-310μs, frequency 60-90Hz, stimulation time 4-6s, and interval 4-6s after stimulation; the stimulation time for a single leg is 17-23min; more preferably: current 35mA, pulse width 300μs, frequency 80Hz, stimulation time 5s, and interval 5s after stimulation; the stimulation time for a single leg is 20min. This invention utilizes electrical stimulation to replace or correct damaged nerves through an "immediate effect," achieving better rehabilitation results. It can effectively improve the muscle strength of the patient's limbs and reduce muscle tone. At the same time, electrical stimulation can also promote the recovery of peripheral nerves and input motor and sensory stimulation signals into the spinal cord center, thereby accelerating the recovery of the pyramidal tract conduction pathway, activating neurons in ischemic areas, and further repairing neuronal regeneration. It can also effectively activate brain cells, enhance the activity of brain electrical signals and the excitability of the cerebral cortex, help transmit motor nerve electrical signals in the patient's limbs, and thus improve the patient's limb function.

[0036] In this invention, the product portfolio addresses the patient's overall physical condition rather than merely treating symptoms. This approach maximizes the restoration and improvement of the patient's physical, psychological, and social functions. The product portfolio not only effectively treats stroke-induced hemiplegia but also provides effective treatment for vascular dementia.

[0037] This invention provides an application of the above-mentioned traditional Chinese medicine composition and preparation method in the preparation of products for treating cerebrovascular diseases.

[0038] In this invention, the cerebrovascular disease is stroke and / or dementia, and more preferably, the dementia is vascular dementia; the stroke is stroke-induced hemiplegia. That is, this invention provides an application of the above-mentioned traditional Chinese medicine composition, the traditional Chinese medicine composition or product combination prepared by the above-mentioned preparation method in the preparation of products for treating stroke-induced hemiplegia and / or vascular dementia.

[0039] The product is a medicine and / or instrument. In this invention, the dosage form of the traditional Chinese medicine composition is an ointment. The method of using the traditional Chinese medicine composition is to apply it to acupoints, including bilateral temples, bilateral Yifeng acupoints, and bilateral Shenmen acupoints; the application is once daily for 4 hours each time, for 4 weeks. The electrical stimulation is performed on the legs, including the thighs, calves, and ankles.

[0040] In this invention, unless otherwise specified, all raw material components are commercially available products well known to those skilled in the art.

[0041] The technical solutions provided by the present invention will be described in detail below with reference to the embodiments, but they should not be construed as limiting the scope of protection of the present invention.

[0042] Example 1 A traditional Chinese medicine composition for the prevention and / or treatment of cerebrovascular diseases, comprising the following raw materials by weight: Chuanxiong 10g, Chishao 15g, Danshen 15g, Yuanzhi 10g, Shichangpu 12g, Huangqi 30g, Borneol 0.5g, Musk 0.15g, Danggui 15g, Honghua 9g, Taoren 9g, and Zhigancao 6g.

[0043] The preparation method of the traditional Chinese medicine composition includes the following steps: Mix 10g of Ligusticum chuanxiong, 15g of Paeonia lactiflora, 15g of Salvia miltiorrhiza, 10g of Polygala tenuifolia, 12g of Acorus tatarinowii, 30g of Astragalus membranaceus, 0.5g of Borneol, 0.15g of Musk, 15g of Angelica sinensis, 9g of Carthamus tinctorius, 9g of Prunus persica, and 6g of Glycyrrhiza uralensis (processed with honey). Grind the mixture into powder and pass it through a 100-mesh sieve to obtain a mixed powder. Add 40mL of rice vinegar to 100g of the mixed powder and mix well to obtain a traditional Chinese medicine ointment.

[0044] Example 2 A traditional Chinese medicine composition for the prevention and / or treatment of cerebrovascular diseases, comprising the following raw materials by weight: Chuanxiong 8g, Chishao 12g, Danshen 13g, Yuanzhi 8g, Shichangpu 10g, Huangqi 27g, Borneol 0.3g, Musk 0.1g, Danggui 12g, Honghua 6g, Taoren 7g, and Zhigancao 5g.

[0045] The preparation method of the traditional Chinese medicine composition includes the following steps: Mix 8g of Ligusticum chuanxiong, 12g of Paeonia lactiflora, 13g of Salvia miltiorrhiza, 8g of Polygala tenuifolia, 10g of Acorus tatarinowii, 27g of Astragalus membranaceus, 0.3g of Borneol, 0.1g of Musk, 12g of Angelica sinensis, 6g of Carthamus tinctorius, 7g of Prunus persica, and 5g of Glycyrrhiza uralensis (processed with honey). Grind the mixture into powder and pass it through an 80-mesh sieve to obtain a mixed powder. Add 35mL of rice vinegar to 90g of the mixed powder and mix well to obtain a traditional Chinese medicine ointment.

[0046] Example 3 A traditional Chinese medicine composition for the prevention and / or treatment of cerebrovascular diseases, comprising the following raw materials by weight: Chuanxiong 12g, Chishao 17g, Danshen 18g, Yuanzhi 12g, Shichangpu 15g, Huangqi 32g, Borneol 0.7g, Musk 0.2g, Danggui 18g, Honghua 12g, Taoren 12g, and Zhigancao 7g.

[0047] The preparation method of the traditional Chinese medicine composition includes the following steps: Mix 12g of Ligusticum chuanxiong, 17g of Paeonia lactiflora, 18g of Salvia miltiorrhiza, 12g of Polygala tenuifolia, 15g of Acorus tatarinowii, 32g of Astragalus membranaceus, 0.7g of Borneol, 0.2g of Musk, 18g of Angelica sinensis, 12g of Carthamus tinctorius, 12g of Prunus persica, and 7g of Glycyrrhiza uralensis (processed with honey). Grind the mixture into powder and pass it through a 120-mesh sieve to obtain a mixed powder. Add 45mL of rice vinegar to 110g of the mixed powder and mix well to obtain a traditional Chinese medicine ointment.

[0048] Experimental Example 1 Clinical efficacy study of the traditional Chinese medicine ointment prepared in Example 1 in treating hemiplegia after stroke 1. Materials and Methods 1.1 General Information The study included 100 stroke patients with hemiplegia admitted to our hospital between January and December 2023. Patients were randomly assigned to either group (n=50 each) or control group (n=26 males and n=24 females, aged 58–76 years, mean age 66.5 ± 3.3 years). There were no statistically significant differences in data between the two groups (P>0.05).

[0049] 1.2 Inclusion and Exclusion Criteria Inclusion criteria included: Based on the Traditional Chinese Medicine (TCM) diagnosis according to the "2017 Chinese Guidelines for the Diagnosis and Treatment of Cerebral Infarction with Integrated Traditional Chinese and Western Medicine," patients exhibited symptoms such as confusion, hemiplegia, speech impairment, and facial asymmetry, possibly accompanied by warning signs such as transient syncope or speech difficulties, with symptoms recurring multiple times within 24 hours or persisting for several days. The Western medicine diagnosis must meet the definition of ischemic stroke in the "2018 Chinese Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke." Furthermore, patients had not received any TCM external therapies such as acupuncture or acupoint application before starting treatment, had no allergic reactions to Chinese medicine, and had stable physiological indicators.

[0050] Exclusion criteria include: patients with hemorrhagic stroke, those with abnormal liver or kidney function, individuals with allergic reactions to the treatment drugs, and patients with other diseases such as intracranial tumors or traumatic brain injury.

[0051] Exclusion criteria cover: cases that do not meet the legality criteria, i.e., those that are incorrectly included in randomization but do not meet the inclusion / exclusion criteria; participants who do not comply with randomization, or who do not use any investigational drug after allocation, or whose use is minimal (less than 10%); those who use other treatments or drugs that may affect efficacy and safety assessments; and cases that do not provide any data after randomization. These cases must be discussed and decided upon by the principal investigator, data manager, statistician, and sponsor during the blinded review period.

[0052] 1.3 Methods 1.3.1 Control Group Conventional Western medicine treatment was given, including oral aspirin tablets 0.1g once a day. For patients with hypertension, hyperglycemia, or other hypertension-related conditions, active cooperation with Western medicine treatment, hypoglycemic drugs, and lipid-lowering drugs was provided.

[0053] 1.3.2, Observation Group The herbal ointment prepared in Example 1 was made into a patch with a size of 1cm×1cm and a thickness of about 2mm, and fixed with 3cm×3cm adhesive tape, which is called an acupoint patch.

[0054] The observation group received acupoint application therapy combined with functional electrical stimulation (fEP) based on the traditional Chinese medicine ointment prepared in Example 1, in addition to the treatment given to the control group. Specific method: Acupoints were selected at the bilateral Taiyang (temple), Yifeng (TE17), and Shenmen (HT7) acupoints. The acupoint patches were applied to these points once daily for 4 hours each time, for 4 weeks. Simultaneously, daily electrical stimulation was performed: electrodes were placed on the patient's thighs, calves, and ankles; stimulation was conducted at 35 mA, with an excitation frequency of 80 Hz and a pulse width of 300 μs, with a 5-second interval between each 5-second stimulation. This was repeated on each leg simultaneously, for 20 minutes each time, for 4 weeks.

[0055] Both the control group and the observation group underwent a 4-week treatment course.

[0056] 1.4 Observation Indicators 1.4.1. Post-stroke stroke scale (NIHSS) (see Li Zhanghan, Li Huamao, Ai Niannian. Clinical study on the treatment of post-stroke dysphagia by acupuncture combined with breathing training [J]. Acupuncture Research, 2021, 46(10):875-879): Patients were assessed by NIHSS before and after treatment.

[0057] 1.4.2 Treatment efficacy rate: Excellent (the patient's neurological deficit score decreased by more than 90% after treatment), Good (the patient's neurological deficit score decreased by more than 60% after treatment), and Poor (none of the above were achieved). The neurological deficit score was calculated using the NIHSS score reduction rate: NIHSS score reduction rate (%) = (NIHSS score before treatment - NIHSS score after treatment) ÷ NIHSS score before treatment × 100%.

[0058] 1.4.3 Daily living function: The Basel score was used for evaluation (see Huang Longying, Yuan Weizhong. Clinical effect of acupuncture combined with swallowing function therapy in the treatment of patients with pseudobulbar palsy and dysphagia after stroke [J]. Medical Equipment, 2019, 32(23):93-95).

[0059] 1.4.4 Inflammation and Platelet Activity Assay: Changes in inflammatory factors such as TNF-α, IL-6, high-sensitivity C-reactive protein, VEGF, and platelet activation rate in the plasma of both groups were observed. Fasting blood (5 mL) was drawn from both the control and observation groups in the morning. The plasma was separated after centrifugation at 3000 rpm for 15 min. The levels of inflammatory cells and vascular endothelial growth factor were detected using a double-sided antibody sandwich enzyme-linked immunosorbent assay (ELISA). Platelet activity was detected using immunoturbidimetry. Platelet adhesion was assessed using glass transfection technology.

[0060] 1.5 Statistical Analysis The data in this experiment were statistically analyzed using SPSS 29.0. Count data were expressed as rates (%) and analyzed using the χ² test; continuous data (following a normal distribution) were expressed as variance (%). "±s)" indicates a "t" test; P < 0.05 indicates that the within-group indicator test is statistically significant, P < 0.01 indicates that the within-group statistical difference is significant, and P > 0.05 indicates that there is no statistical significance.

[0061] 2. Results 2.1 Stroke Scale (NIHSS) score The results in Table 1 show that there was no significant difference between the two groups before the intervention (P>0.05); the values ​​after the intervention were lower than those before the intervention, and the difference was statistically significant (P<0.05); the values ​​after the intervention in the observation group were lower than those in the control group (P<0.05).

[0062] Table 1. Stroke Scale (NIHSS) Scores [( ±s) points]

[0063] Note: Compared with before intervention in this group. a P<0.05.

[0064] 2.2 Clinical efficacy evaluation The results in Table 2 show that, in terms of the rate of excellent and good results, the observation group had a higher value than the control group, and the difference was statistically significant (P<0.05). See Table 2.

[0065] Table 2 Comparison of Treatment Effects (n)

[0066] 2.3 Daily Activities of Daily Living The results in Table 3 show that there was no significant difference between the two groups before the intervention (P>0.05); the values ​​after the intervention were higher than those before the intervention, and the difference was statistically significant (P<0.05); the values ​​after the intervention in the observation group were higher than those in the control group (P<0.05).

[0067] Table 3 Daily Activities of Daily Living [( ±s) points]

[0068] Note: Compared with before intervention in this group. a P<0.05.

[0069] 2.4 Inflammatory and Platelet Activity Indicators The results in Table 4 show that there was no significant difference between the two groups before the intervention (P>0.05); after the intervention, the values ​​in both groups were higher than before the intervention, and the difference was statistically significant (P<0.05); after the intervention, the hs-CRP and VEGF values ​​in the observation group were higher than those in the control group, while the IL-6 and TNF-α values ​​were lower than those in the control group (P<0.05).

[0070] Table 4 Comparison of inflammatory factor values ​​before and after treatment [( ±s) points]

[0071] Note: Compared with before intervention in this group. a P<0.05.

[0072] Experimental Example 2 Clinical efficacy study of the traditional Chinese medicine ointment prepared in Example 1 in the treatment of vascular dementia 1. Materials and Methods 1.1 General Information The study included 120 patients with vascular dementia admitted to our hospital from January 2024 to December 2024. Patients were randomly assigned to either group (n=60 per group). The observation group consisted of 29 males and 31 females, aged 65–83 years (mean age 75.5 ± 2.4 years). The control group consisted of 27 males and 33 females, aged 66–84 years (mean age 76.3 ± 3.5 years). There were no statistically significant differences between the two groups (P>0.05).

[0073] 1.2 Inclusion and Exclusion Criteria Inclusion criteria: (1) meeting the diagnostic criteria of the Chinese Dementia Diagnosis and Treatment Guidelines; (2) being ≥65 years old and having complete clinical data; (3) having dementia after stroke; and (4) being aware of this study and signing an informed consent form.

[0074] Exclusion criteria: individuals with primary dementia, depressive pseudodementia, or other secondary dementia; individuals with impaired language expression or severe aphasia; individuals with allergic reactions to the treatment drugs; and individuals who have received vascular dementia-related treatment within 2 weeks prior to admission.

[0075] Exclusion criteria cover: cases that do not meet the legality criteria, i.e., those that are incorrectly included in randomization but do not meet the inclusion / exclusion criteria; participants who do not comply with randomization, or who do not use any investigational drug after allocation, or whose use is minimal (less than 10%); those who use other treatments or drugs that may affect efficacy and safety assessments; and cases that do not provide any data after randomization. These cases must be discussed and decided upon by the principal investigator, data manager, statistician, and sponsor during the blinded review period.

[0076] 1.3 Methods 1.3.1 Control Group The patient was given conventional Western medicine treatment, including oral administration of butylphthalide soft capsules (CSPC Enbipu Pharmaceutical Co., Ltd., National Drug Approval Number H20050299, specification: 0.1g×24 capsules) 2 capsules each time, 3 times a day, before meals on an empty stomach, including medication to lower high blood pressure, high blood sugar or hypertension.

[0077] 1.3.2, Observation Group The herbal ointment prepared in Example 1 was made into a patch with a size of 1cm×1cm and a thickness of about 2mm, and fixed with 3cm×3cm adhesive tape, which is called an acupoint patch.

[0078] The observation group received acupoint application therapy combined with functional electrical stimulation (fEP) based on the traditional Chinese medicine ointment prepared in Example 1, in addition to the treatment given to the control group. Specific method: Acupoints were selected at the bilateral Taiyang (temple), Yifeng (TE17), and Shenmen (HT7) acupoints. The acupoint patches were applied to these points once daily for 4 hours each time, for 4 weeks. Simultaneously, daily electrical stimulation was performed: electrodes were placed on the patient's thighs, calves, and ankles; stimulation was conducted at 35 mA, with an excitation frequency of 80 Hz and a pulse width of 300 μs, with a 5-second interval between each 5-second stimulation. This was repeated on each leg, 20 minutes per session, for 4 weeks.

[0079] 1.4 Observation Indicators 1.4.1 Clinical efficacy Significant effect: Mini-Mental State Examination (MMSE) score increases by >40%, memory loss disappears, and the patient's self-care ability and social interaction ability are restored to a good level; Effective: MMSE score increases by 20%~40%, and the patient can handle daily life affairs and social activities; Ineffective: MMSE score increases by <20%, and memory problems are not significantly improved.

[0080] Overall effectiveness rate = (number of cases with significant effect + number of cases with effective effect) ÷ total number of cases × 100%.

[0081] 1.4.2 Observation Indicators The Mini-Mental State Examination (MMSE) was used to assess patients' mental status and cognitive function. The maximum score is 30 points, with a scoring standard of 27-30 points for normal, 21-26 points for mild, 10-20 points for moderate, and <10 points for severe. The Barthel Index (BI) was used to assess activities of daily living, with a total score of 0-100 points. Higher scores indicate greater independence and less dependence. Cerebral artery blood flow velocity: Doppler ultrasound was used to monitor and record the mean blood flow velocity of the middle cerebral artery and the vertebral artery. Adverse reactions: Palpitations, rash, nausea, vomiting, and itching were recorded during treatment.

[0082] 1.5 Statistical Analysis The data in this experiment were statistically analyzed using SPSS 29.0. Count data were expressed as rates (%) and analyzed using the χ² test; continuous data (following a normal distribution) were expressed as variance (%). "±s)" indicates a "t" test; P < 0.05 indicates that the within-group indicator test is statistically significant, P < 0.01 indicates that the within-group statistical difference is significant, and P > 0.05 indicates that there is no statistical significance.

[0083] 2. Results 2.1 Clinical efficacy The results in Table 5 show that, compared with the control group, the observation group had a higher effective rate in treating vascular dementia after applying the herbal ointment of the present invention, and the differences were statistically significant (P<0.05).

[0084] Table 5. Comparison of clinical efficacy between the observation group and the control group, cases (%)

[0085] Note: Compared with the control group, a P<0.05.

[0086] 2.2 MMSE Scoring The results in Table 6 show that before the cognitive function comparison treatment, there was no difference in MMSE scores between the two groups (P>0.05); after the cognitive function comparison treatment, the MMSE scores of the observation group after applying the herbal ointment of the present invention were higher than those of the control group, and the differences were statistically significant (P<0.05). The patients in the observation group after applying the herbal ointment of the present invention had normal cognitive function, while the patients in the control group still had mild cognitive impairment.

[0087] Table 6. Comparison of MMSE scores between the observation group and the control group (points)

[0088] Note: Compared with the control group, a P<0.05.

[0089] 2.3 BI Score The results in Table 7 show that before the treatment, there was no difference in the BI scores between the two groups of patients in terms of activities of daily living (P>0.05); after the treatment, the observation group had a higher BI score than the control group after applying the herbal ointment of the present invention, and the differences were statistically significant (P<0.05).

[0090] Table 7 Comparison of BI scores between the observation group and the control group (points)

[0091] Note: Compared with the control group, a P<0.05.

[0092] 2.4 Cerebral hemodynamic function The results in Table 8 show that before the treatment, there was no difference in the mean blood flow velocity of the middle cerebral artery and the mean blood flow velocity of the vertebral artery between the two groups (P>0.05); after the treatment, the mean blood flow velocity of the arteries and the mean blood flow velocity of the vertebral artery in the observation group were higher than those in the control group after the application of the herbal ointment of this invention, and the differences were statistically significant (P<0.05).

[0093] Table 8. Comparison of cerebral hemodynamic function between the observation group and the control group.

[0094] Note: Compared with the control group, a P<0.05.

[0095] No adverse reactions such as palpitations, rash, nausea, vomiting, or skin itching occurred in either the observation group or the control group during the treatment period.

[0096] The results in Tables 5-8 show that the application of the herbal ointment of the present invention has a significant positive effect on improving the daily living activities, cognitive function, and cerebral hemodynamic function of patients with vascular dementia.

[0097] The above description is only a preferred embodiment of the present invention. It should be noted that for those skilled in the art, several improvements and modifications can be made without departing from the principle of the present invention, and these improvements and modifications should also be considered within the scope of protection of the present invention.

Claims

1. A traditional Chinese medicine composition for treating cerebrovascular diseases, characterized in that, The traditional Chinese medicine composition comprises the following raw materials in parts by weight: The ingredients are: 8-12 parts of Ligusticum chuanxiong, 12-17 parts of Paeonia lactiflora, 13-18 parts of Salvia miltiorrhiza, 8-12 parts of Polygala tenuifolia, 10-15 parts of Acorus tatarinowii, 27-32 parts of Astragalus membranaceus, 0.3-0.7 parts of Borneol, 0.1-0.2 parts of Musk, 12-18 parts of Angelica sinensis, 6-12 parts of Carthamus tinctorius, 7-12 parts of Prunus persica, and 5-7 parts of Glycyrrhiza uralensis (processed).

2. The traditional Chinese medicine composition according to claim 1, characterized in that, The traditional Chinese medicine composition comprises the following raw materials in parts by weight: The ingredients are: 9-11 parts of Ligusticum chuanxiong, 13-16 parts of Paeonia lactiflora, 14-17 parts of Salvia miltiorrhiza, 9-11 parts of Polygala tenuifolia, 11-14 parts of Acorus tatarinowii, 29-31 parts of Astragalus membranaceus, 0.4-0.6 parts of Borneol, 0.11-0.17 parts of Musk, 14-16 parts of Angelica sinensis, 8-10 parts of Carthamus tinctorius, 9-11 parts of Prunus persica, and 5.5-6.5 parts of Glycyrrhiza uralensis (processed).

3. The method for preparing the traditional Chinese medicine composition according to claim 1 or 2, characterized in that, Includes the following steps: The ingredients of Ligusticum chuanxiong, Paeonia lactiflora, Salvia miltiorrhiza, Polygala tenuifolia, Acorus tatarinowii, Astragalus membranaceus, Borneol, Musk, Angelica sinensis, Carthamus tinctorius, Prunus persica, and Glycyrrhiza uralensis were mixed, ground, and sieved to obtain a mixed powder. The mixed powder is mixed with rice vinegar to obtain the traditional Chinese medicine composition.

4. The preparation method according to claim 3, characterized in that, The sieve mesh size is 80-120 mesh.

5. The preparation method according to claim 3, characterized in that, The mass-to-volume ratio of the mixed powder to rice vinegar is 90-110g:35-45mL.

6. A product portfolio for treating cerebrovascular diseases, characterized in that, The product combination consists of a traditional Chinese medicine composition and a leg electrical stimulation system; The traditional Chinese medicine composition is the traditional Chinese medicine composition according to claim 1 or 2 or the traditional Chinese medicine composition prepared by the preparation method according to any one of claims 3 to 5; The parameters of the leg electrical stimulation system include: current 20~60mA, pulse width 280~320μs, frequency 25~150Hz, stimulation time 3~7s, and interval time 3~7s after stimulation; the stimulation time for a single leg is 15~25min.

7. The use of the traditional Chinese medicine composition according to claim 1 or 2, the traditional Chinese medicine composition prepared by the preparation method according to any one of claims 3 to 5, or the product combination according to claim 6 in the preparation of products for treating cerebrovascular diseases.

8. The application according to claim 7, characterized in that, The cerebrovascular disease mentioned is stroke and / or dementia.

9. The application according to claim 8, characterized in that, The dementia mentioned is vascular dementia.

10. The application according to claim 8, characterized in that, The stroke mentioned refers to stroke-induced hemiplegia.

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