Traditional Chinese medicine composition for treating cerebral small vascular diseases as well as preparation method and application of traditional Chinese medicine composition

Abstract

The invention provides a traditional Chinese medicine composition for treating cerebral small vascular diseases as well as a preparation method and application of the traditional Chinese medicine composition. The traditional Chinese medicine composition is prepared from the following components in parts by weight: 300 parts of astragalus membranaceus, 50 parts of leech, 100 parts of safflower carthamus, 100 parts of ligusticum wallichii, 90 parts of acorus calamus, 100 parts of radix puerariae, 200 parts of caulis spatholobi, 100 parts of glossy privet fruit, 100 parts of leonurus japonicus, 200 parts of poria cocos and 100 parts of radix puerariae. The invention also relates to a preparation method and application of the composition. The traditional Chinese medicine composition disclosed by the invention has the effects of tonifying qi and activating blood, nourishing liver and kidney, relieving dizziness and restoring consciousness, and inducing diuresis and dredging collaterals, and can effectively improve the cognitive function, gait disorder and other symptoms of a patient with the cerebral small vascular disease; the traditional Chinese medicine composition is high in safety, small in side effect and suitable for being taken for a long time; the preparation method of the traditional Chinese medicine composition is simple, low in cost and easy for industrial production.

Description

Technical Field

[0001] The present invention belongs to the field of drug applications; in particular, it relates to a traditional Chinese medicine composition for treating cerebral small vessel disease, a preparation method thereof, and an application thereof. Background Art

[0002] Cerebral small vessel disease (CSVD) is a common cerebrovascular disease, mainly manifested as cognitive decline, gait instability, mood disorders, etc. At present, the main treatment methods in Western medicine are to improve cerebral circulation and control risk factors, but the effects are limited and there are certain side effects. Traditional Chinese medicine has unique advantages in the treatment of cerebral small vessel disease. Its characteristics of overall regulation and multi-target action make it have potential application value in improving symptoms and delaying the progression of the disease.

[0003] Currently, the treatment of cerebral small vessel disease (CSVD) mainly includes: (1) Western medicine treatment, (2) traditional Chinese medicine treatment, (3) integrated traditional Chinese and Western medicine treatment;

[0004] Among them, (1) Western medicine treatment mainly includes the following treatment methods:

[0005] Controlling risk factors: antihypertensive treatment (calcium antagonists, angiotensin-converting enzyme inhibitors, etc.), blood sugar lowering, lipid lowering (statins, etc.) to slow down the progression of the disease.

[0006] Symptomatic treatment: including antiplatelet aggregation, improving cerebral circulation, neuroprotection, etc.

[0007] Rehabilitation treatment: carrying out rehabilitation training for cognitive dysfunction, motor dysfunction, etc.

[0008] The deficiencies of this treatment include:

[0009] Lack of specific treatment: Currently, Western medicine mainly focuses on symptomatic treatment and lacks specific drugs for cerebral small vessel disease.

[0010] Drug side effects: Long-term use of antihypertensive drugs, lipid-lowering drugs, etc. may cause adverse reactions.

[0011] Limited treatment effect: Some patients have poor drug tolerance and are prone to relapse after stopping the drug.

[0012] (2) Traditional Chinese medicine treatment mainly includes the following treatment methods:

[0013] Traditional Chinese medicine compound: such as "Naotai Fang" for hypertensive cerebral small vessel lesions, which can improve clinical symptoms through multi-target action.

[0014] Traditional Chinese medicine monomers: such as silychristin, quercetin, etc., which have anti-inflammatory, antioxidant, and blood vessel regeneration-promoting effects.

[0015] Acupuncture and rehabilitation: By stimulating specific acupoints, regulating the flow of qi and blood, and improving blood supply to the brain.

[0016] The deficiencies of this treatment include:

[0017] Lack of unified efficacy evaluation criteria: The efficacy evaluation of traditional Chinese medicine mainly relies on indicators such as traditional Chinese medicine syndrome scores, lacking unified international standards.

[0018] Insufficient research on the mechanism of action: Most of the mechanism studies still remain at the animal experiment stage, lacking large-scale and multi-center clinical trial support.

[0019] Drug quality control issues: Traditional Chinese medicine has complex components, and the quality and efficacy of different batches may vary.

[0020] Limitations in clinical research: Some studies lack unified syndrome differentiation and treatment typing and observation indicators, and there is a lack of high-quality clinical data.

[0021] (3) The integrated traditional Chinese and Western medicine treatment mainly includes the following treatment methods:

[0022] The integrated traditional Chinese and Western medicine treatment plan is under exploration. For example, the clinical research on the prevention and treatment of hypertensive cerebral small vessel disease carried out by Hunan University of Traditional Chinese Medicine aims to form a standardized treatment plan.

[0023] The deficiencies of this treatment include:

[0024] Great difficulty in integration: The integrated traditional Chinese and Western medicine treatment plan is still in the exploration stage, lacking mature clinical application guidelines.

[0025] Limited clinical promotion: The integrated traditional Chinese and Western medicine treatment plan needs to be further optimized and promoted to improve the universality and standardization of clinical application.

[0026] In summary, the treatment technology for cerebral small vessel disease is constantly progressing, but still faces many challenges. In the future, it is necessary to strengthen multidisciplinary cooperation and conduct more high-quality clinical research to optimize the treatment plan and improve the prognosis and quality of life of patients. Summary of the Invention

[0027] The purpose of the present invention is to provide a traditional Chinese medicine composition for treating cerebral small vessel disease, a preparation method and an application.

[0028] The present invention is achieved through the following technical solutions:

[0029] The present invention relates to a traditional Chinese medicine composition for treating cerebral small vessel disease, which is composed of the following components in parts by weight: 300 parts of the monarch drug, 450 parts of the ministerial drug, 490 parts of the adjuvant drug, and 100 parts of the courier drug. The traditional Chinese medicine composition of the present invention has the effects of supplementing qi and activating blood circulation, removing stasis and dredging collaterals, and nourishing yin and softening tendons, and is mainly used for treating limb numbness, muscle spasms, etc. caused by cerebral small vessel disease.

[0030] Preferably, the sovereign drug consists of Astragalus membranaceus, where Astragalus membranaceus is 300 parts; the ministerial drugs consist of Ligusticum wallichii, Hirudo, Carthamus tinctorius, and Spatholobus suberectus, where Ligusticum wallichii is 100 parts, Hirudo is 50 parts, Carthamus tinctorius is 100 parts, and Spatholobus suberectus is 200 parts; the adjuvant drugs consist of Ligustrum lucidum, Acorus calamus, Leonurus japonicus, and Poria cocos, where Ligustrum lucidum is 100 parts, Acorus calamus is 90 parts, Leonurus japonicus is 100 parts, and Poria cocos is 200 parts; the guiding drug consists of 100 parts of Pueraria lobata.

[0031] The present invention also relates to a preparation method of the aforementioned traditional Chinese medicine composition for treating cerebral small vessel disease, comprising the following steps:

[0032] Step 1, take each component according to the following weight parts and set aside; Astragalus membranaceus 300 parts, Hirudo 50 parts, Carthamus tinctorius 100 parts, Ligusticum wallichii 100 parts, Acorus calamus 90 parts, Pueraria lobata 100 parts, Spatholobus suberectus 200 parts, Ligustrum lucidum 100 parts, Leonurus japonicus 100 parts, Poria cocos 200 parts, Pueraria lobata 100 parts;

[0033] Step 2, crush Hirudo and Ligusticum wallichii into 80-mesh powder and set aside;

[0034] Step 3, decoct the remaining nine herbs twice with water. For the first time, add 10 times the amount of water and decoct for 2 hours, and for the second time, add 8 times the amount of water and decoct for 2 hours. Filter, combine the filtrates, and concentrate under reduced pressure to a relative density of 1.20 - 1.25 (60 °C) to obtain a clear paste;

[0035] Step 4, mix the powder of Hirudo and Ligusticum wallichii with the clear paste, dry, crush, add an appropriate amount of starch and mix evenly, granulate, dry, and size the granules.

[0036] The present invention also relates to the application of the aforementioned traditional Chinese medicine composition for treating cerebral small vessel disease, in the application of preparing a drug for treating cerebral small vessel disease, and the dosage form of this drug is a capsule; the traditional Chinese medicine composition of the present invention is applicable to symptoms such as sequelae of stroke, limb numbness, muscle contracture, dizziness, chest tightness and heart pain, irregular menstruation, dysmenorrhea and amenorrhea caused by qi and blood deficiency, blood stasis obstruction, and liver and kidney deficiency; its syndrome manifestations are limb numbness, muscle contracture, limited movement, dizziness, chest tightness and heart pain, dull complexion, dark tongue or ecchymosis, thin white tongue coating, thready and unsmooth or stringy and thready pulse, etc.

[0037] The functions of each component of the present invention are as follows:

[0038] Astragalus membranaceus: sweet in taste, slightly warm in nature, and attributive to the lung and spleen meridians. It has the effects of invigorating qi and lifting yang, strengthening the exterior and consolidating the superficies, promoting diuresis and detumescence, and expelling toxins and promoting granulation. In this formula, Astragalus membranaceus is used as the sovereign drug in a large amount, taking its function of greatly tonifying the qi of the spleen and lung. When qi is abundant, blood circulation is promoted, making it a powerful assistant for promoting blood circulation and removing blood stasis. At the same time, it tonifies qi to consolidate the superficies and enhances the body's disease resistance.

[0039] Chuanxiong (Rhizoma Chuanxiong): Pungent in taste, warm in nature, it pertains to the Liver, Gallbladder, and Pericardium meridians. It has the effects of promoting blood circulation to activate qi and dispelling wind to relieve pain. Chuanxiong is pungent, warm, fragrant, and spreading, being a qi drug in blood. It can ascend to the head and descend to the blood sea, promoting blood circulation to remove stasis and activating qi to relieve pain. When combined with Astragalus membranaceus, it can make qi flourish and blood circulate smoothly, removing stasis and generating new blood, jointly exerting the effect of supplementing qi and promoting blood circulation.

[0040] Leech: Salty and bitter in taste, neutral in nature, it pertains to the Liver meridian. It has the effects of breaking blood to dredge the meridians and removing stasis to dissipate masses. The medicinal property of leech is drastic and it specifically enters the blood aspect. It is good at breaking blood stasis without damaging new blood, can attack and resolve accumulation, and eliminate stasis stagnation. It is an important agent for removing stasis. When combined with Chuanxiong, it enhances the power of promoting blood circulation to remove stasis.

[0041] Safflower: Pungent in taste, warm in nature, it pertains to the Heart and Liver meridians. It has the effects of promoting blood circulation to dredge the meridians and dispelling stasis to relieve pain. Safflower is pungent and warm, can promote blood circulation to remove stasis and dredge the blood vessels. When used together with leech, it complements each other, enabling the stasis to be resolved and the blood vessels to be unobstructed.

[0042] Caulis Spatholobi: Bitter and sweet in taste, warm in nature, it pertains to the Liver meridian. It has the effects of promoting blood circulation to nourish blood, regulating menstruation to relieve pain, and relaxing tendons and activating collaterals. Caulis Spatholobi can not only promote blood circulation to remove stasis but also nourish blood, enabling stasis to be removed and new blood to be generated. Moreover, it can relax tendons and activate collaterals, alleviating the symptoms of cramped tendons. When combined with drugs such as Astragalus membranaceus and Chuanxiong, it treats both the principal and secondary aspects, with supplementation in the process of dredging and dredging in the process of supplementation.

[0043] Fructus Ligustri Lucidi: Sweet and bitter in taste, cool in nature, it pertains to the Liver and Kidney meridians. It has the effects of tonifying the Liver and Kidney and clearing away deficiency heat. Fructus Ligustri Lucidi tonifies the Liver and Kidney, nourishes yin and reduces fire, can nourish the yin of the Liver and Kidney, enabling the Liver and Kidney to be nourished, the tendons and vessels to be moistened, and the yin fluid to be sufficient, thus assisting the qi and blood circulation and preventing the regeneration of blood stasis.

[0044] Rhizoma Acori Tatarinowii: Pungent in taste, warm in nature, it pertains to the Heart and Stomach meridians. It has the effects of opening the orifices to resolve phlegm, promoting digestion by removing dampness, and calming the mind to improve intelligence. Rhizoma Acori Tatarinowii is pungent, warm, fragrant, and spreading. It can open the orifices to wake up the mind, resolve phlegm by removing dampness, making the mind clear, phlegm-dampness resolved, and qi movement smooth, which is helpful for the normal circulation of qi and blood.

[0045] Leonurus japonicus: Pungent and bitter in taste, slightly cold in nature, it pertains to the Heart, Liver, and Bladder meridians. It has the effects of promoting blood circulation to regulate menstruation and inducing diuresis to alleviate edema. Leonurus japonicus promotes blood circulation to remove stasis and induces diuresis to alleviate edema. It can remove stasis and generate new blood, enabling the stasis to be removed and the water and dampness to be eliminated. When combined with drugs such as Chuanxiong and safflower, it enhances the power of promoting blood circulation to remove stasis. At the same time, it induces diuresis to alleviate edema and reduces symptoms such as limb edema.

[0046] Poria cocos: Sweet and bland in taste, neutral in nature, it pertains to the Heart, Lung, Spleen, and Kidney meridians. It has the effects of promoting diuresis to eliminate dampness, strengthening the spleen and calming the mind. Poria cocos promotes diuresis to eliminate dampness, strengthens the spleen and calms the mind. It can promote diuresis to eliminate dampness, preventing the accumulation of water and dampness and the endogenous generation of phlegm-dampness. At the same time, it strengthens the spleen and supplements qi, assisting the qi-supplementing power of Astragalus membranaceus, and calms the mind to nourish the heart spirit, thus assisting the qi and blood circulation.

[0047] Kudzu Root: Sweet, pungent in taste, cool in nature, acting on the spleen and stomach meridians. It has the effects of relieving muscle fever, promoting the production of body fluid to quench thirst, ascending yang to stop diarrhea, and dredging channels and activating collaterals. Kudzu root can relieve muscle and induce sweating, promote the production of body fluid to quench thirst, ascending yang to stop diarrhea, and dredge channels and activate collaterals, so as to relax the limb tendons and vessels, relieve symptoms such as limb numbness and muscle contracture. Combined with herbs such as Astragalus membranaceus and Spatholobus suberectus, it treats both the principal and secondary aspects of the disease, and together they achieve the effects of supplementing qi and activating blood circulation, removing stasis and dredging collaterals, and nourishing yin and softening tendons.

[0048] The present invention has the following advantages:

[0049] (1) The traditional Chinese medicine composition for treating cerebral small vessel disease involved in the present invention, under the interaction of each component, enables the traditional Chinese medicine composition to have the effects of supplementing qi and activating blood circulation, nourishing the liver and kidney, extinguishing wind and awakening the brain, and promoting diuresis and dredging collaterals, and can effectively improve the cognitive function, gait disorder and other symptoms of patients with cerebral small vessel disease.

[0050] (2) The traditional Chinese medicine composition for treating cerebral small vessel disease involved in the present invention has high safety and few side effects, and is suitable for long-term use.

[0051] (3) The preparation method of the traditional Chinese medicine composition for treating cerebral small vessel disease involved in the present invention is simple, with low cost, and is easy for industrial production. Detailed implementation mode

[0052] The present invention will be described in detail below in conjunction with specific embodiments. It should be noted that the following embodiments are only further descriptions of the present invention, but the protection scope of the present invention is not limited to the following embodiments.

[0053] Embodiment

[0054] This embodiment relates to a traditional Chinese medicine composition for treating cerebral small vessel disease, which is composed of the following components in parts by weight: Astragalus membranaceus 300g, Hirudo 50g, Carthamus tinctorius 100g, Ligusticum wallichii 100g, Acorus calamus 90g, Kudzu Root 100g, Spatholobus suberectus 200g, Glossy privet fruit 100g, Leonurus japonicus 100g, Poria cocos 200g, Kudzu Root 100g;

[0055] The preparation method of the traditional Chinese medicine composition for treating cerebral small vessel disease includes the following steps:

[0056] Step 1, take each component according to the following parts by weight and set aside; Astragalus membranaceus 300g, Hirudo 50g, Carthamus tinctorius 100g, Ligusticum wallichii 100g, Acorus calamus 90g, Kudzu Root 100g, Spatholobus suberectus 200g, Glossy privet fruit 100g, Leonurus japonicus 100g, Poria cocos 200g, Kudzu Root 100g;

[0057] Step 2, pulverize Hirudo and Ligusticum wallichii into 80-mesh powder and set aside;

[0058] Step 3: The remaining nine herbs are decocted twice with water. For the first time, 10 times the amount of water is added and decocted for 2 hours. For the second time, 8 times the amount of water is added and decocted for 2 hours. After filtration, the filtrates are combined and concentrated under reduced pressure to a relative density of 1.20 - 1.25 (60 °C) to obtain a clear extract.

[0059] Step 4: Hirudo and Chuanxiong powder are mixed with the clear extract, dried, pulverized, mixed with an appropriate amount of starch, granulated, dried, and sized.

[0060] Clinical trials:

[0061] After a large number of experiments, it can promote the improvement of neurological function in rats with focal cerebral ischemia, promote the proliferation and differentiation of endogenous NSCs, reduce the volume of cerebral infarction, increase serum SOD, and decrease serum MDA. It has an obvious protective effect on the ischemic brain tissue of experimental animals.

[0062] The traditional Chinese medicine composition for treating cerebral small vessel disease prepared in this example is used to treat cerebral small vessel disease, and multiple clinical studies have been carried out. The research shows that this drug can significantly improve the TCM symptom score and neurological deficit score of patients, and shows positive effects in improving the motor impairment of patients. It also shows extremely high safety for patients with more intracranial microbleeds and does not increase the bleeding events of patients. In elderly patients with cerebral small vessel disease, the therapeutic effect of this traditional Chinese medicine composition is significantly better than that of aspirin enteric-coated tablets, and it has high safety.

[0063] Mechanism of action:

[0064] The traditional Chinese medicine composition for treating cerebral small vessel disease prepared in this example has a positive impact on the pathological process of cerebral small vessel disease through mechanisms such as improving microvascular endothelial cell function, protecting the blood-brain barrier, and promoting nerve cell proliferation; its mechanism of action is consistent with the modern medical understanding of cerebral small vessel disease and can act on the core pathological mechanisms of cerebral small vessel disease (such as endothelial dysfunction, inflammatory response, oxidative stress, etc.).

[0065] This traditional Chinese medicine composition has a clear TCM theoretical basis and multi-faceted pharmacological effects in the treatment of cerebral small vessel disease. Clinical studies also show good efficacy and safety, and it is expected to become an important option for the treatment of cerebral small vessel disease in the future.

[0066] The traditional Chinese medicine composition for treating cerebral small vessel disease involved in the present invention combines the overall concept of TCM syndrome differentiation and treatment and modern pharmacological research, reflecting the unique advantages of traditional Chinese medicine in the treatment of cerebrovascular diseases:

[0067] Multi-target treatment: Through multi-target action mechanisms such as supplementing qi and activating blood circulation, nourishing the liver and kidney, and calming endogenous wind and awakening the mind, it comprehensively improves the symptoms of patients with cerebral small vessel disease.

[0068] High safety: No obvious adverse reactions were found in clinical studies, indicating its good safety in elderly patients.

[0069] Comprehensive curative effect: It can not only improve the neurological function of patients, but also regulate blood lipids and improve hemorheology, showing a comprehensive therapeutic effect.

[0070] Contraindications and precautions:

[0071] It is prohibited for pregnant women and those with excessive menstruation, because drugs such as leech and safflower in the formula have strong blood-activating and stasis-removing effects, which are likely to cause miscarriage or exacerbate bleeding.

[0072] The traditional Chinese medicine composition involved in the present invention has a strong stasis-removing effect, and patients with hemorrhagic diseases should use it with caution to avoid exacerbating bleeding.

[0073] During the period of taking the traditional Chinese medicine composition involved in the present invention, it is necessary to avoid eating spicy, greasy, raw and cold, and stimulating foods, so as not to affect the drug efficacy or exacerbate the condition.

[0074] If the patient's condition is complex, or discomfort symptoms occur after taking the traditional Chinese medicine composition involved in the present invention, medical treatment should be sought in time to adjust the treatment plan.

[0075] The specific embodiments of the present invention have been described above. It should be understood that the present invention is not limited to the above specific embodiments, and those skilled in the art can make various deformations or modifications within the scope of the claims, which do not affect the essence of the present invention.

Claims

1. A Chinese medicine composition for treating cerebral small vessel disease, characterized in that: The invention is composed of the following components in parts by weight: 300 parts of main medicine, 450 parts of auxiliary medicine, 490 parts of adjuvant medicine and 100 parts of guiding medicine.

2. The Chinese medicine composition for treating cerebral small vessel disease according to claim 1, characterized in that: The monarch drug is composed of Astragalus, including 300 parts of Astragalus; the ministerial drugs are composed of Chuanxiong, Hirudo, Safflower, Millettia reticulata, including 100 parts of Chuanxiong, 50 parts of Hirudo, 100 parts of Safflower, and 200 parts of Millettia reticulata; the adjuvant drugs are composed of Ligustrum lucidum, Acorus calamus, Leonurus japonicus, and Poria, including 100 parts of Ligustrum lucidum, 90 parts of Acorus calamus, 100 parts of Leonurus japonicus, and 200 parts of Poria; the guiding drug is composed of 100 parts of Pueraria root.

3. A method for preparing the Chinese medicine composition for treating cerebral small vessel disease as claimed in claim 1, characterized in that: The steps include: Step 1, take the following components by weight and set aside: 300 parts of astragalus, 50 parts of leech, 100 parts of safflower, 100 parts of chuanxiong, 90 parts of calamus, 100 parts of kudzu root, 200 parts of millettia reticulata, 100 parts of glossy privet, 100 parts of motherwort, 200 parts of tuckahoe, 100 parts of kudzu root; Step 2, crush the leech and Chuanxiong into 80 mesh powder for later use; Step 3, the remaining nine herbs are decocted twice with water, the first time with 10 times the amount of water and decocted for 2 hours, the second time with 8 times the amount of water and decocted for 2 hours, filtered, the filtrate is combined, and concentrated under reduced pressure to a relative density of 1.20 to 1.25 to obtain a clear paste; Step 4, mix the leech, Chuanxiong powder and clear paste, dry, crush, add appropriate amount of starch to mix, granulate, dry and granulate.

4. Use of the Chinese medicine composition for treating cerebral small vessel disease as claimed in claim 1, characterized in that: The invention is used in the preparation of a medicine for treating cerebral small vessel disease, and the dosage form of the medicine is a capsule.