Traditional Chinese medicine composition capable of dredging collaterals and removing thrombus for preventing and treating stroke, vascular thrombus, arteriosclerosis, coronary heart disease or waist and leg pain

Abstract

The invention relates to a collateral-dredging thrombus-removing traditional Chinese medicine composition for preventing and treating stroke, vascular thrombus, arteriosclerosis, coronary heart disease or waist and leg pain. The traditional Chinese medicine composition is prepared from the following raw material medicines in parts by weight: 12-65 parts of cooked rhubarb, 10-72 parts of salvia miltiorrhiza, 12-65 parts of cortex moutan, 6-57 parts of rhizoma zingiberis, 8-50 parts of pseudo-ginseng, 15-45 parts of obscured homalomena rhizome, 10-68 parts of leech, 7-76 parts of earthworm, 15-70 parts of ligusticum wallichii, 6-52 parts of Tibetan capillary artemisia, 7-49 parts of cape jasmine, 3-25 parts of borneol, 6-75 parts of angelica sinensis, 12-65 parts of ginseng, 7-53 parts of pogostemon cablin and 10-77 parts of radix curcumae. The medicine has the effects of promoting blood circulation, removing blood stasis, dredging collaterals and removing thrombus. The traditional Chinese medicine composition can be used for preparing medicines for treating cerebral apoplexy, coronary heart disease, arteriosclerosis and static artery thrombosis diseases, or medicines for soothing channels, activating collaterals and promoting blood circulation to remove blood stasis, which are related to waist and leg pain diseases. The invention provides a prevention and treatment effective solution for people with stroke, vascular thrombosis, arteriosclerosis, coronary heart disease or waist and leg pain.

Description

Technical Field

[0001] The present invention belongs to the field of research and application of pure traditional Chinese medicine technology, and particularly relates to a traditional Chinese medicine composition for dredging collaterals and resolving thrombi, promoting blood circulation and removing stasis, which can prevent and treat stroke, vascular thrombosis, arteriosclerosis, coronary heart disease or lumbocrural pain. Background Art

[0002] Stroke (cerebral apoplexy), vascular thrombosis, arteriosclerosis and coronary heart disease are collectively referred to as cardiovascular and cerebrovascular diseases in modern medicine. In traditional Chinese medicine theory, the syndromes of these diseases are classified as blood stasis syndrome.

[0003] Blood stasis syndrome: With the changes in people's lifestyles and eating habits, such as coronary heart disease, myocardial infarction, carotid artery thrombosis, arteriosclerosis, stroke (cerebral apoplexy), etc., the incidence of these diseases shows an increasing trend, seriously threatening human health and remaining high. The pathological basis of these diseases is often closely related to atherosclerosis, gradual narrowing of blood vessels, calcification, fibrosis, vascular thrombosis, etc.

[0004] Arteriosclerosis refers to an arteriosclerotic disease characterized by thickening, hardening and decreased elasticity of the arterial wall, starting from atherosclerosis. Atherosclerosis is caused by lipid deposition, oxidation, calcification or fibrosis in the blood vessel wall; or by the combined action of multiple factors such as platelets and free radicals. Arteriosclerosis is the most common and harmful disease.

[0005] Vascular thrombosis is formed due to the inflammatory reaction caused by vascular endothelial injury affected by hypertension; or by the toxins remaining in the blood after being infected by bacteria or viruses; or by platelet aggregation caused by vascular trauma; or by the oxidation of thick and non-fluid blood.

[0006] The formation of coronary heart disease, except for a very small number of genetic factors, is mostly caused by coronary atherosclerosis, lipid precipitation, oxidation, calcification, fibrosis, resulting in stenosis and blockage of the coronary artery, causing insufficient blood supply to the coronary artery.

[0007] At present, most domestic and foreign Western medicine researchers adopt the methods of long-term anti-thrombosis and anticoagulation treatment, or use high-dose lipid-lowering drugs to stabilize ruptured or eroded plaques. However, the drugs used in the above methods will cause side effects such as liver and kidney function damage when taken for a long time; or Western medicine surgery is used, and the disability rate and fatality rate of surgery are relatively high, and at the same time, the treatment cost is expensive, and the costs of postoperative recovery and maintenance are also high.

[0008] In traditional Chinese medicine theory, the syndromes of diseases such as stroke (cerebral apoplexy), vascular thrombosis, arteriosclerosis and coronary heart disease are collectively classified as blood stasis syndrome. Traditional Chinese medicine takes dredging meridians, activating collaterals, promoting blood circulation and removing stasis, clearing the liver and gallbladder and strengthening healthy qi as the treatment guidance.

[0009] Lumbar and leg pain is classified as arthralgia syndrome in traditional Chinese medicine theory.

[0010] Arthralgia syndrome: The development of the disease of arthralgia syndrome is from numbness → stasis → blockage → paralysis. Although arthralgia syndrome and blood stasis syndrome have different disease inducing factors, their causes are both diseases caused by poor qi and blood circulation and blocked meridians.

[0011] The traditional Chinese medicine treatment method for lumbar and leg pain is also to dredge the meridians, activate the collaterals, promote blood circulation to remove blood stasis, clear the liver and gallbladder, and strengthen the healthy qi.

[0012] Therefore, in traditional Chinese medicine theory, these diseases can be treated with the same method for different diseases. Summary of the Invention

[0013] In view of the deficiencies of the prior art, a traditional Chinese medicine composition for dredging collaterals and dissolving thrombus, which can prevent and treat stroke, vascular thrombosis, arteriosclerosis, coronary heart disease, or lumbar and leg pain: Shuxin Tongluo Huashuan Pills (the temporary name of the traditional Chinese medicine composition of the present invention).

[0014] The traditional Chinese medicine composition of the present invention is formulated from the following pure traditional Chinese medicine by weight. Its raw materials include: 12 - 65 parts of prepared rhubarb, 10 - 72 parts of salvia miltiorrhiza, 12 - 65 parts of cortex moutan, 6 - 57 parts of dried ginger, 8 - 50 parts of notoginseng, 15 - 45 parts of homalomena occulta, 10 - 68 parts of leech, 7 - 76 parts of pheretima, 15 - 70 parts of chuanxiong rhizome, 6 - 52 parts of swertia mileensis, 7 - 49 parts of gardenia jasminoides, 3 - 25 parts of borneol, 6 - 75 parts of angelica sinensis, 12 - 65 parts of ginseng, 7 - 53 parts of pogostemon cablin, 10 - 77 parts of curcuma aromatica.

[0015] Further, it is prepared from raw materials containing the following weight ratio: 12 parts of prepared rhubarb, 10 parts of salvia miltiorrhiza, 12 parts of cortex moutan, 6 parts of dried ginger, 8 parts of notoginseng, 15 parts of homalomena occulta, 10 parts of leech, 7 parts of pheretima, 15 parts of chuanxiong rhizome, 6 parts of swertia mileensis, 7 parts of gardenia jasminoides, 3 parts of borneol, 6 parts of angelica sinensis, 12 parts of ginseng, 7 parts of pogostemon cablin, 10 parts of curcuma aromatica.

[0016] Further, it is a preparation prepared by adding pharmaceutically acceptable excipients or auxiliary components to the cut pieces of raw materials, the powder of raw materials, or the concentrated extract, or the medicinal solution, or the organic solvent extract of raw materials.

[0017] Further, the preparation is an oral preparation, and the oral preparation is pills, tablets, capsules, powders, granules, solutions, or ointments.

[0018] In order to achieve the purpose of the present invention, the preparation method of the traditional Chinese medicine composition includes the following steps:

[0019] (1) Weigh the raw materials of Chinese medicinal materials according to the aforementioned ratio;

[0020] (2) The crude drug is cut into slices, or ground into powder, and mixed with pharmaceutically acceptable excipients or auxiliary components and then made into pills, thus obtaining the product.

[0021] (3) The crude drug is ground into powder and then filled into capsules to form capsule preparations, thus obtaining the product.

[0022] (4) The crude drug is cut into slices, or ground into powder, and decocted with an appropriate amount of water, thus obtaining the product.

[0023] (5) The crude drug is ground into powder, mixed with pharmaceutically acceptable excipients or auxiliary components and then pressed into tablets, thus obtaining the product.

[0024] (6) The crude drug is ground into powder, or the liquid or organic solvent extract of the crude drug, and mixed with pharmaceutically acceptable excipients or auxiliary components, thus obtaining the product.

[0025] The present invention also provides the use of the aforementioned traditional Chinese medicine composition in the preparation of a drug for preventing and treating stroke, vascular thrombosis, arteriosclerosis, coronary heart disease or lumbocrural pain.

[0026] The present invention also equivalently provides the use of the aforementioned traditional Chinese medicine composition in the preparation of a drug for cardiovascular and cerebrovascular diseases.

[0027] In our traditional Chinese medicine theory, stroke, vascular thrombosis, arteriosclerosis and coronary heart disease are all attributed to the syndrome of blood stasis, which is caused by the failure of the liver and gallbladder to disperse and the stagnation of qi and blood. The pharmacological prescription of dredging meridians, activating collaterals, promoting blood circulation to remove blood stasis, clearing the liver and gallbladder and strengthening healthy qi is taken as the medication principle.

[0028] In traditional Chinese medicine theory, lumbocrural pain is attributed to arthralgia syndrome. The development of arthralgia syndrome is from numbness → blood stasis → blockage → arthralgia. Although the inducing factors of the syndrome of blood stasis and arthralgia syndrome are different, their etiologies are both due to qi and blood stasis and unsmooth meridians and collaterals. They can be treated with the same method in traditional Chinese medicine pharmacology. The pharmacological prescription of dredging meridians, activating collaterals, promoting blood circulation to remove blood stasis, clearing the liver and gallbladder and strengthening healthy qi is also taken as the medication principle.

[0029] The compatibility pharmacology of the traditional Chinese medicine composition of the present invention: Rheum palmatum L. var. tanguticum Maxim. ex Regel, Salvia miltiorrhiza Bunge, Paeonia suffruticosa Andr., Hirudo, Pheretima aspergillum (E. Perrier) are used as monarch drugs; Artemisia capillaris Thunb., Gardenia jasminoides Ellis, Curcuma aromatica Salisb. are used as ministerial drugs; Zingiber officinale Rosc., Angelica sinensis (Oliv.) Diels, Panax ginseng C. A. Mey., Panax notoginseng (Burkill) F. H. Chen ex Tsai & Tseng are used as adjuvant drugs; Ligusticum wallichii Franch., Homalomena occulta (Lour.) Schott, Borneolum syntheticum, Pogostemon cablin (Blanco) Benth. are used as guiding drugs.

[0030] Rheum palmatum L. var. tanguticum Maxim. ex Regel: Also known as Rheum palmatum L. var. tanguticum Maxim. ex Regel processed with wine, after being processed with wine, the original property of clearing heat and purging intestines is changed, and its effect of removing blood stasis and dredging meridians is enhanced. It belongs to the spleen, stomach, large intestine, liver and pericardium meridians, with bitter and cold properties. It is good at clearing heat toxin in the blood of the upper jiao, and is used for bleeding syndrome with blood stasis due to blood heat, cooling blood and removing stasis to stop bleeding;

[0031] Salvia miltiorrhiza: It pertains to the heart and liver meridians, with a bitter and slightly cold nature and flavor. Its functions include promoting blood circulation to remove stasis, calming the mind and relieving uneasiness. It is used to treat angina pectoris, abdominal pain due to blood stasis, thromboangiitis obliterans, coronary heart disease, and chronic hepatitis.

[0032] Moutan cortex: Also known as Cortex Moutan, it pertains to the heart, liver, and kidney meridians. Its effects include clearing heat and cooling blood, promoting blood circulation to remove stasis, and having antibacterial and anti-inflammatory properties. Moutan cortex is good at clearing blood and promoting blood circulation, enabling the blood to flow smoothly without leaving stasis. Clinically, it is used for anticoagulant effects, anti-inflammatory effects, antibacterial effects, treating hypertension, preventing thrombosis formation, and reducing the permeability of blood vessels. At the same time, in its pharmacological effects, it can also promote the formation of fat from glucose in the blood, thereby reducing blood sugar.

[0033] Leech: It pertains to the liver meridian, with a salty and bitter nature and flavor. Its effects include breaking blood stasis, removing stasis, and dredging meridians. Clinically, it is used to break blood stasis, dissolve thrombus and dredge meridians, resist the proliferation of fibroblasts induced by antithrombin and reduce the risk of vascular wall fibrosis formation. It can treat static and dynamic thrombi and dredge blood vessel blockages. Moreover, it can also resist the formation of bacterial endotoxin thrombi and has the effect of reducing blood lipid at the same time.

[0034] Pheretima: It pertains to the liver, spleen, and bladder meridians, with a salty and cold nature and flavor. Its effects include calming endogenous wind, treating hemiplegia due to stroke, rheumatic arthralgia, limb numbness, and hemiplegia. Its pharmacological effects include thrombolytic and anticoagulant effects, reducing blood viscosity, lowering blood pressure, and its effects on the central nervous system. It can be used to treat ischemic stroke (stroke), hypertension, and arteriovenous thrombosis.

[0035] In the traditional Chinese medicine composition of the present invention, the prepared rhubarb, Salvia miltiorrhiza, Moutan cortex, leech, and Pheretima, as the monarch drugs, mainly deal with the aggregation, precipitation, inflammatory reaction of thrombus and blood lipid, and lowering blood pressure, and prevent the formation of thrombus and dissolve thrombus, and are used to treat stroke, arteriosclerosis, vascular thrombus, and coronary heart disease.

[0036] Swertia chirayita: A key drug for protecting the liver, it can regenerate the liver. It has a bitter and cool nature and flavor, and its effects include clearing the liver and gallbladder to remove jaundice, promoting diuresis and reducing swelling.

[0037] Curcuma aromatica Salisb.: It pertains to the liver, heart, and lung meridians, with a pungent, bitter, and cold nature and flavor. Its effects include promoting qi circulation and removing stasis, clearing the heart and relieving depression, and promoting bile secretion and removing jaundice. Its pharmacological effects include enhancing lipid metabolism and reducing the precipitation of fat in blood vessels.

[0038] Gardenia jasminoides Ellis: It pertains to the heart, lung, and triple energizer meridians, with a bitter and cold nature and flavor. Its effects include purging fire and relieving restlessness, clearing away heat and promoting diuresis, cooling blood and detoxifying. It is mainly used to treat damp-heat jaundice. In terms of its drug components, Gardenia jasminoides Ellis contains rich crocin and also has a strong effect of promoting blood circulation to remove stasis.

[0039] In the traditional Chinese medicine composition of the present invention, Swertia chirayita, Curcuma aromatica Salisb., and Gardenia jasminoides Ellis, as the ministerial drugs, mainly clear the liver and gallbladder, dredge the "ducts" from the liver, gallbladder, pancreas to the duodenum, make the ducts unobstructed, and thus fundamentally assist the liver in the metabolism of blood sugar and blood lipid and the smooth excretion of toxin waste after liver detoxification, achieving the combined effect with the monarch drugs.

[0040] Dry Ginger: It enters the heart, spleen, stomach, and lung meridians. Its nature and flavor are pungent and hot. Its functions are to warm the middle-jiao to dispel cold, restore yang and promote blood circulation, and warm the lungs to resolve fluid-retention. In the present invention, its function of restoring yang and promoting blood circulation is mainly utilized.

[0041] Angelica Sinensis: It enters the liver, heart, and spleen meridians. Its nature and flavor are sweet, pungent, and warm. Its functions are to enrich blood and promote blood circulation, regulate menstruation and relieve pain, and moisten the intestines and relieve constipation. It is used for rheumatic arthralgia and traumatic injuries. Its pharmacological effects include protecting the liver, anti-arrhythmia, expanding the coronary artery to increase coronary blood flow, inhibiting platelet aggregation, reducing blood lipid and anti-atherosclerosis, anti-thrombosis, anti-inflammatory, antioxidant and free radical scavenging. It has a significant inhibitory effect on cerebral hypoxia, ischemia, and inhibition of increased lipid peroxidation in brain tissue. Clinically, it is mostly used in combination for treating hypertension, muscle and joint pain, neuralgia, menstrual diseases, etc.

[0042] Ginseng: It enters the heart, spleen, and lung meridians. Its nature and flavor are sweet, flat, and slightly bitter. Its functions are to greatly tonify primordial qi, restore pulse and arrest collapse, invigorate the spleen and benefit the lung, and are used for treating heart failure and cardiogenic shock. Its pharmacological effects include exciting the central nervous system, having a certain improvement effect on cardiac myocardial weakness, and having a hypoglycemic effect on hyperglycemia caused by adrenaline. Clinically, it is used for treating cardiovascular and cerebrovascular diseases, diabetes, first aid for collapse due to yang deficiency, neurasthenia, etc.

[0043] Notoginseng: It enters the liver and stomach meridians. Its nature and flavor are sweet, warm, and slightly bitter. Its functions are to disperse stasis and stop bleeding, reduce swelling and relieve pain. Its pharmacological effect is to inhibit platelet aggregation, reduce blood viscosity, and prevent thrombosis formation. Clinically, it is also used in combination for treating angina pectoris.

[0044] In the traditional Chinese medicine composition of the present invention, dry ginger, angelica sinensis, ginseng, and notoginseng are used as adjuvant drugs to deal with the occurrence of cardiovascular and cerebrovascular diseases, relieve symptoms, and nourish and treat the central nervous system before and after stroke.

[0045] Chuanxiong: It enters the liver, gallbladder, and pericardium meridians. Its nature and flavor are pungent and warm. Its functions are to promote blood circulation and qi movement, dispel wind and relieve pain. Its pharmacological effects include increasing coronary artery blood supply, increasing cerebral and femoral artery blood flow, reducing blood pressure, anti-platelet aggregation, and anti-thrombosis formation. Clinically, it can be used in combination for treating angina pectoris.

[0046] Homalomena Occulta: It enters the liver and kidney meridians. Its nature and flavor are pungent, bitter, and warm. Its functions are to treat rheumatic arthralgia, relax muscles and activate collaterals, promote qi movement and relieve pain, and reduce swelling. Its pharmacological effect can also inhibit bacteria.

[0047] Borneol: It enters the heart, spleen, and lung meridians. Its nature and flavor are pungent, bitter, and cold. Its functions are to induce resuscitation and awaken the mind, clear heat and reduce swelling and relieve pain, open all orifices, and disperse stagnated fire. It is used for stroke with phlegm syncope and sudden syncope with coma.

[0048] Patchouli Herb: It enters the spleen, stomach, and lung meridians. Its nature and flavor are pungent and slightly warm. Its functions are to aromatically eliminate dampness turbidity, induce sweating and relieve summer heat, and are used for dampness obstruction in the middle-jiao. In the present invention, it is mainly used for inducing sweating to assist the promoting blood circulation effect.

[0049] In the traditional Chinese medicine composition of the present invention, Chuanxiong Rhizome, Homalomena Root, Borneol, and Pogostemon Herb act as the envoy drugs, mainly to cooperate with the monarch drug, ministerial drug, and adjuvant drug, so that the total medicinal power of the monarch, ministerial, adjuvant, and envoy drugs can reach the terminal ends of each meridian, blood vessel, and nerve, to conduct complete dredging of collaterals and dissolving thrombi, promoting blood circulation to remove blood stasis, anti-inflammatory, antioxidant, scavenging free radicals, antibacterial, and promoting myelin formation and peripheral nerve regeneration during the degeneration process, so as to achieve the effect of treating or improving the patient's condition.

[0050] Compared with the prior art, the beneficial effects and advantages of the present invention are as follows:

[0051] The technical advantages of the present invention are that it is a pure traditional Chinese medicine formula, convenient for preparation and application. Relatively speaking, the medicinal properties are safe, and it has a comprehensive balanced conditioning effect on patients. The treatment effect is obvious, the medication course and recovery time are relatively short, and it can prevent and treat diseases such as stroke, blood vessel thrombosis, arteriosclerosis, coronary heart disease, or low back and leg pain. It has extremely high medical value and social and economic value. Specific Embodiments

[0052] The present invention is a traditional Chinese medicine composition for dredging meridians and dissolving thrombi that can prevent and treat stroke, blood vessel thrombosis, arteriosclerosis, coronary heart disease, or low back and leg pain. It is prepared from raw medicinal materials with the following weight ratio: 12 - 65 parts of Rheum palmatum L. var. tanguticum Maxim. ex Balf., 10 - 72 parts of Salvia miltiorrhiza Bunge, 12 - 65 parts of Cortex Moutan, 6 - 57 parts of Dry Ginger, 8 - 50 parts of Panax notoginseng (Burk.) F. H. Chen, 15 - 45 parts of Homalomena occulta (Lour.) Schott, 10 - 68 parts of Whitmania pigra Whitman, 7 - 76 parts of Pheretima aspergillum (E. Perrier), 15 - 70 parts of Chuanxiong Rhizome, 6 - 52 parts of Swertia chirayita (Roxb.) H. Karst., 7 - 49 parts of Gardenia jasminoides Ellis, 3 - 25 parts of Borneol, 6 - 75 parts of Angelica sinensis (Oliv.) Diels, 12 - 65 parts of Panax ginseng C. A. Mey., 7 - 53 parts of Pogostemon cablin (Blanco) Benth., 10 - 77 parts of Curcuma aromatica Salisb.

[0053] Among them, the Rheum palmatum L. var. tanguticum Maxim. ex Balf. by weight includes but is not limited to any point value within the range of 12 parts to 65 parts or the range value between any two of them.

[0054] Among them, the Salvia miltiorrhiza Bunge by weight includes but is not limited to any point value within the range of 10 parts to 72 parts or the range value between any two of them.

[0055] Among them, the Cortex Moutan by weight includes but is not limited to any point value within the range of 12 parts to 65 parts or the range value between any two of them.

[0056] Among them, the Dry Ginger by weight includes but is not limited to any point value within the range of 6 parts to 57 parts or the range value between any two of them.

[0057] Among them, the Panax notoginseng (Burk.) F. H. Chen by weight includes but is not limited to any point value within the range of 8 parts to 50 parts or the range value between any two of them.

[0058] Among them, Rhizoma Homalomenae includes, but is not limited to, any point value within the range of 15 parts to 45 parts by weight or any range value between any two of them.

[0059] Among them, Hirudo includes, but is not limited to, any point value within the range of 10 parts to 68 parts by weight or any range value between any two of them.

[0060] Among them, Pheretima includes, but is not limited to, any point value within the range of 7 parts to 76 parts by weight or any range value between any two of them.

[0061] Among them, Rhizoma Chuanxiong includes, but is not limited to, any point value within the range of 15 parts to 70 parts by weight or any range value between any two of them.

[0062] Among them, Herba Swertiae Punicae includes, but is not limited to, any point value within the range of 6 parts to 52 parts by weight or any range value between any two of them.

[0063] Among them, Fructus Gardeniae includes, but is not limited to, any point value within the range of 7 parts to 49 parts by weight or any range value between any two of them.

[0064] Among them, Borneolum Syntheticum includes, but is not limited to, any point value within the range of 3 parts to 25 parts by weight or any range value between any two of them.

[0065] Among them, Radix Angelicae Sinensis includes, but is not limited to, any point value within the range of 6 parts to 75 parts by weight or any range value between any two of them.

[0066] Among them, Radix Ginseng includes, but is not limited to, any point value within the range of 12 parts to 65 parts by weight or any range value between any two of them.

[0067] Among them, Herba Pogostemonis includes, but is not limited to, any point value within the range of 7 parts to 53 parts by weight or any range value between any two of them.

[0068] Among them, Radix Curcumae includes, but is not limited to, any point value within the range of 10 parts to 77 parts by weight or any range value between any two of them.

[0069] The following description of the embodiments is only used to help understand the method and its core idea of the present invention. It should be noted that for those of ordinary skill in the art of this technology, without departing from the traditional Chinese medicine theory and pharmacology of traditional Chinese medicine of the present invention, several improvements and modifications can still be made to the present invention, and these improvements and modifications also fall within the protection scope of the claims of the present invention. Therefore, the present invention will not be limited to the embodiments shown herein, but can be applied to a wider range that is consistent with the pharmacology and novel features of the traditional Chinese medicine prescriptions disclosed herein. Unless otherwise defined, all technical and traditional Chinese medicine terms used herein have the same meaning as commonly understood by those of ordinary skill in the technical field to which the present invention belongs.

[0070] Example, Preparation of Medicaments of the Traditional Chinese Medicine Composition of the Present Invention

[0071] Formula: 12 parts of processed rhubarb, 15 parts of salvia miltiorrhiza, 16 parts of cortex moutan, 7 parts of dried ginger, 17 parts of notoginseng, 15 parts of homalomena occulta, 18 parts of leech, 16 parts of pheretima, 13 parts of ligusticum wallichii, 9 parts of swertia chirayita, 12 parts of gardenia jasminoides, 7 parts of borneol, 11 parts of angelica sinensis, 18 parts of angelica ginseng, 10 parts of pogostemon cablin, 12 parts of curcuma aromatica.

[0072] Preparation method:

[0073] ① Weigh the above-mentioned traditional Chinese medicine pieces according to the weight ratio;

[0074] ② Powder them. Mix and grind the traditional Chinese medicine pieces described in step ① into powder;

[0075] ③ Sieve the mixed powder collected in step ② through a 50-mesh to 80-mesh sieve. Weigh 3000 grams and add auxiliary material honey to reconcile and knead into a medicine dough, and then make pills of 5 grams each. After drying, it becomes the pill form of Shuxin Tongluo Huashuan Pills.

[0076] Clinical Effect Observation of the Traditional Chinese Medicine Composition of the Present Invention in the Example:

[0077] The clinical effect observation of the traditional Chinese medicine composition of the present invention in the example is divided into 4 groups in total: Research Group 1, Research Group 2, Research Group 3, and Research Group 4.

[0078] From June 2023 to December 2024, in cooperation with the top three hospitals in the province, 120 patients were recruited as volunteer patients in the case research group. It is required that the volunteer patients can adhere to taking medicine for 60 days and meet the conditions for clinical follow-up. The disease diagnosis of all volunteer patients is based on the diagnosis of the top three hospitals. The 120 volunteer patients are divided into 4 groups in total: Research Group 1, Research Group 2, Research Group 3, and Research Group 4. The 120 volunteer patients were provided with free treatment of Shuxin Tongluo Huashuan Pills by our company for 2 months.

[0079] Research Group 1, select 30 non-hemorrhagic stroke (cerebral apoplexy) paralyzed patients:

[0080] Inclusion criteria for the cases in Research Group 1: Stroke paralysis patients who have not received surgical treatment, are willing to adopt conservative Chinese medicine treatment, and have stable conditions, including 17 males and 13 females, aged 47 - 69 years, with an average age of (56.4 ± 5.6) years; onset time ≥ 30 days; blood pressure < 170 / 100 mmHg at the time of case inclusion assessment; neurological signs consistent with cerebral infarction in the internal carotid artery blood supply area, able to swallow food; whole body CT scan and head CT scan confirmed no image of cerebral hemorrhage or low-density lesions; no atrial fibrillation or no severe t2 dysfunction; no other diseases with obvious embolic sources; no hemangioma image in whole body CT scan. Exclusion criteria for case inclusion: History of intracranial hemorrhage and tumor in the past six months; History of other hemorrhagic diseases; Pregnancy; Blood pressure that cannot be effectively controlled in a timely manner and has obvious fluctuations; Coma and severe mental disorders; Severe hepatic and renal insufficiency or severe diabetes history; Abnormal prothrombin time and activated partial thromboplastin time; Platelet count lower than 100 × 10 9 / L.

[0081] Medication for Research Group 1: Take Shuxin Tongluo Huashuan Pills prepared from the raw materials of the examples on an empty stomach three times a day in the early, middle, and late periods, 15 grams (3 pills) each time, and the course of treatment is two months. Avoid high-fat foods and mainly have a light diet.

[0082] Clinical efficacy evaluation criteria: Based on the examination of the neurological deficit score before and after medication and combined with the actual observation of the patient's self-care ability in clinical practice, a basic cure is evaluated as the patient can get out of bed and walk, can basically take care of themselves in life, and have clear language function. An effective evaluation is that the patient can get out of bed and sit in a wheelchair, can have the action of eating by themselves or can eat by themselves, and have language expression or the action of having language expression awareness, etc. An ineffective evaluation is that there is no obvious difference in the patient's various imaging data and symptoms compared with before treatment.

[0083] After the patients in Research Group 1 took Shuxin Tongluo Huashuan Pills, through observation and imaging data such as CT, it was gradually shown that the neurological deficit scores of 29 patients began to decline gradually from the 3rd to the 10th day and were gradually recovering.

[0084] The Shuxin Tongluo Huashuan Pills of the example of the traditional Chinese medicine composition of the present invention can penetrate the power to the ends of each meridian, nerve, and blood vessel, thereby promoting myelin formation and peripheral nerve regeneration during the degeneration process, so as to achieve the effect of treating and improving the patient's condition.

[0085] During the treatment process of taking Shuxin Tongluo Huashuan Pills, there were no records of bleeding manifestations such as gum, skin bleeding, oozing blood, and ecchymosis, nor were there any other adverse reaction records.

[0086] After two months of treatment, observation, and CT imaging and other examinations for the evaluation of the efficacy of Shuxin Tongluo Huashuan Pills, as shown in Table 1.

[0087] Table 1. Efficacy data of patients with stroke taking Shuxin Tongluo Huashuan Pills after 60 days of administration

[0088]

[0089] In the research group 1 of the example, after two months of treatment with Shuxin Tongluo Huashuan Pills, the basic cure rate of 30 non-hemorrhagic stroke (cerebral apoplexy) paralysis patients reached 83.33%, and the total effective rate was 96.66%.

[0090] Research group 2: 30 patients with carotid artery stenosis were selected:

[0091] Diagnostic criteria for carotid artery plaque: Examination by color Doppler ultrasound diagnostic instrument, CT angiography (CTA), and digital subtraction angiography (DSA). The carotid intima-media thickness (IMT) was examined to determine whether atherosclerotic plaques were formed. Currently, it is considered that the normal IMT value should be less than 1.0 mm. An IMT between 1.0 and 1.2 mm indicates intimal thickening, an IMT between 1.2 and 1.4 mm indicates plaque formation, and an IMT greater than 1.4 mm indicates carotid artery stenosis.

[0092] There are two commonly used measurement methods for carotid artery stenosis internationally, namely the North American Symptomatic Carotid Endarterectomy Trial Collaborators (NASCET) standard and the European Carotid Surgery Trialcollaborators Group (ECST) standard.

[0093] NASCET stenosis degree = (1 - blood flow width at the narrowest part of the internal carotid artery / internal diameter of the normal internal carotid artery distal to the stenosis lesion) × 100%

[0094] ECST stenosis degree = (1 - blood flow width at the narrowest part of the internal carotid artery / simulated internal diameter at the bulb of the internal carotid artery) × 100%

[0095] The above two methods both classify the degree of internal carotid artery stenosis into 4 grades:

[0096] ① Mild stenosis, with the arterial internal diameter reduced by < 30%;

[0097] ② Moderate stenosis, with the arterial internal diameter reduced by 30% - 69%;

[0098] ③ Severe stenosis, with the arterial internal diameter reduced by 70% - 99%;

[0099] ④ Complete occlusion.

[0100] Inclusion criteria for the cases in Research Group 2: The IMT value of carotid artery thrombus plaque is 2 - 12 mm, carotid artery stenosis < 60%. Among them, there are 19 males and 11 females, aged 45 - 75 years old, with an average age of (58.3 ± 3.6) years; Whole body CT scan and head CT scan confirm no intracerebral hemorrhage or low-density lesion images; Blood pressure < 170 / 100 mmHg during case inclusion assessment; No atrial fibrillation or severe t2 insufficiency, no other diseases with obvious embolic sources, and no hemangioma images in whole body CT scan. Exclusion criteria for case inclusion: History of intracranial hemorrhage and tumor in the past six months; History of other hemorrhagic diseases; Pregnancy; Blood pressure cannot be effectively controlled in time and has obvious fluctuations; Coma and severe mental disorders; Severe hepatic and renal insufficiency or severe diabetes history; Abnormal bleeding and clotting time; Platelet count is lower than 100×10 9 / L.

[0101] Efficacy evaluation criteria: Recovery is evaluated as IMT value < 1.4 mm and carotid artery stenosis degree < 5%. Effective is evaluated as the IMT value and carotid artery stenosis degree becoming smaller compared with the previous values. Ineffective is evaluated as no obvious difference in the patient's various imaging data and symptoms before and after treatment.

[0102] Medication for Research Group 2: Take Shuxin Tongluo Huashuan Pills prepared from the raw materials of the examples three times a day on an empty stomach in the morning, noon, and evening, 15 grams (3 pills) each time, and the course of treatment is two months. Avoid high-fat foods and mainly have a light diet.

[0103] During the treatment with Shuxin Tongluo Huashuan Pills, there are no records of bleeding manifestations such as gum bleeding, skin bleeding, oozing, and ecchymosis, nor any other adverse reaction records.

[0104] After two months of treatment, observation, and CT image and other examinations for the effect evaluation of Shuxin Tongluo Huashuan Pills, as shown in Table 2.

[0105] Table 2. Efficacy data of observing carotid artery stenosis patients after taking Shuxin Tongluo Huashuan Pills for 60 days

[0106]

[0107] After two months of treatment with Shuxin Tongluo Huashuan Pills in Research Group 2 of the example, the cure rate of 30 carotid artery stenosis patients is as high as 86.66%, and the total effective rate is 96.66%.

[0108] Research Group 3 of the example: Select 30 coronary heart disease patients:

[0109] Inclusion criteria for the patients in Research Group 3: The ends of each blood vessel with a coronary artery diameter < 2 mm showed good conditions, and for patients with a stenosis degree (≥ 25% stenosis degree ≤ 55%) who were unwilling to undergo surgical treatment and chose traditional Chinese medicine conservative treatment, there were 21 males and 9 females, aged 45 - 65 years old, with an average age of (52.6 ± 4.1) years; Whole-body CT scan and head CT scan confirmed no cerebral hemorrhage or low-density lesion images; When the cases were included for evaluation, blood pressure < 170 / 100 mmHg; No atrial fibrillation or no severe t2 dysfunction, no other diseases with obvious embolic sources, and no hemangioma images in the whole-body CT scan. Exclusion criteria for the cases included: Having a history of intracranial hemorrhage and tumors in the past six months; Having a history of other hemorrhagic diseases; Pregnancy; Blood pressure that could not be effectively controlled in a timely manner and had obvious fluctuations; Coma and severe mental disorders; Severe liver and kidney insufficiency or a history of severe diabetes; Abnormal bleeding and clotting time; Platelet count less than 100×10 9 / L.

[0110] The efficacy judgment referred to the "Efficacy Evaluation Criteria for Coronary Heart Disease Angina Pectoris" formulated at the Symposium on the Integrated Traditional Chinese and Western Medicine Treatment of Coronary Heart Disease, Angina Pectoris and Arrhythmia in 1997 and combined with imaging examination data such as CT.

[0111] Efficacy evaluation criteria: A complete recovery was evaluated as the complete disappearance of angina pectoris after the end of the treatment course and a coronary artery stenosis degree < 5%. An effective case was evaluated as the coronary artery stenosis degree shown by the imaging data being lower than the previous value. An ineffective case was evaluated as no obvious difference in the patient's various imaging data and symptoms compared with before the treatment.

[0112] Medication for Research Group 3: Take Shuxin Tongluo Huashuan Pills prepared from the raw materials of the examples three times a day on an empty stomach in the early, middle, and late periods, 15 grams (3 pills) each time, and the treatment course is two months. Avoid high-fat foods and mainly have a light diet.

[0113] During the treatment with Shuxin Tongluo Huashuan Pills, there were no records of bleeding manifestations such as gum bleeding, skin bleeding, oozing blood, and ecchymosis, nor were there any other adverse reaction records.

[0114] After two months of treatment, observation, and effect evaluation by CT imaging and other examinations for Research Group 3 of the examples, as shown in Table 3.

[0115] Table 3. Statistical data on the efficacy of observing coronary heart disease patients after taking Shuxin Tongluo Huashuan Pills for 60 days

[0116]

[0117] After two months of treatment with Shuxin Tongluo Huashuan Pills for Research Group 3 of the examples, the complete recovery rate of 30 coronary heart disease patients reached 80%, and the total effective rate was 96.66%.

[0118] Study Group 4 of the embodiment: 30 patients with low back and leg pain were selected:

[0119] The inclusion criteria of the 4 cases in the study group were as follows: patients with moderate lumbar disc herniation without bone spurs, including 23 males and 7 females, aged 45 to 65 years, with an average age of (52.2±4.1) years; the course of disease was 2 to 10 years, with an average course of disease of (4.6±0.5) years; whole body CT scan and head CT scan confirmed no cerebral hemorrhage or low-density lesions; blood pressure <170 / 100 mmHg at the time of case selection assessment; no atrial fibrillation or severe T2 dysfunction, no other obvious embolic embolic source diseases, and no hemangioma images on whole body CT scan. The exclusion criteria of the case inclusion and exclusion criteria were as follows: history of intracranial hemorrhage and tumor in the past six months; history of other bleeding diseases; pregnancy; blood pressure cannot be effectively controlled in time and has obvious fluctuations; coma and severe mental disorders; severe liver and kidney dysfunction or severe diabetes history; abnormal bleeding and coagulation time; platelet count less than 100×10 9 / L.

[0120] Nowadays, the clinical treatment methods for lumbar disc herniation are not the same. The Chinese medicine composition Shuxin Tongluo Huashuan Pills of the present invention can penetrate into various meridians and nerve and blood vessel terminals, thereby promoting myelin formation and regeneration of peripheral nerves in the degeneration process, so as to achieve the effect of treating and improving the patient's condition.

[0121] Evaluation of treatment effect: Cured: The patient's waist and leg pain disappears and they can resume normal work and life; Effective: The patient's waist and leg pain and other symptoms have improved significantly, but there is still discomfort. The patient's waist and leg pain and other symptoms have improved, and they can resume part of their work and life; Ineffective: The patient's waist and leg pain and other symptoms are no different from before treatment.

[0122] Study Group 4: Take Shuxin Tongluo Huashuan Pills prepared from the raw material medicine of Example three times a day on an empty stomach in the morning, noon and evening, 15g (3 pills) each time for a course of two months. Avoid high-fat foods and eat a light diet.

[0123] There were no adverse reactions recorded during the treatment with Shuxin Tongluo Huashuan Pills, including bleeding of the gums, skin, oozing of blood, ecchymosis, and other bleeding manifestations, and no other adverse reactions were recorded.

[0124] The results of two months of treatment with Shuxin Tongluo Huashuan Pills, observation, and CT imaging examinations are evaluated as shown in Table 4.

[0125] Table 4. Statistical data on the efficacy of Shuxin Tongluo Huashuan Pills for 60 days in patients with low back and leg pain

[0126]

[0127] In the research group 4 of the embodiment, after two months of treatment with Shuxin Tongluo Huashuan Pills, the cure rate of 30 patients with lumbocrural pain reached 93.33%, and the total effective rate was 96.66%.

[0128] Comprehensive evaluation of the efficacy of the traditional Chinese medicine composition of the present invention in the embodiment is shown in Table 5.

[0129] Table 5. Statistical results of the efficacy of 120 patients in Example 1 of the present invention after taking Shuxin Tongluo Huashuan Pills for 60 days

[0130]

[0131] Comprehensive efficacy evaluation of the traditional Chinese medicine composition of the present invention: The traditional Chinese medicine composition of the present invention has significant efficacy.

[0132] The above has described the embodiments of the present invention in detail, but the present invention is not limited to the described embodiments. According to the above content of the present invention, by the common general knowledge and conventional means in the art, it is obvious that for those skilled in the art, without departing from the traditional Chinese medicine theory and traditional Chinese medicine pharmacology of the present invention, various other forms of changes and modifications can be made to these embodiments, and this still falls within the protection scope of the present invention. Therefore, the present invention will not be limited to the embodiments shown herein, but can be applied to a wider range that is consistent with the traditional Chinese medicine prescription pharmacology and novel features disclosed herein, and this also still falls within the protection scope of the present invention.

Claims

1. A traditional Chinese medicine composition for dredging collaterals and resolving thrombus, which can prevent and treat stroke, vascular thrombosis, arteriosclerosis, coronary heart disease or lumbocrural pain, is characterized in that The traditional Chinese medicine composition is prepared from the following raw materials: processed rhubarb, salvia miltiorrhiza, cortex moutan, dried ginger, notoginseng, homalomena occulta, leech, pheretima, ligusticum wallichii, swertia chirayita, gardenia jasminoides, borneol, angelica sinensis, ginseng, pogostemon cablin, curcuma aromatica.

2. The traditional Chinese medicine composition according to claim 1, characterized in that, The traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 12-65 parts of processed rhubarb, 10-72 parts of salvia miltiorrhiza, 12-65 parts of cortex moutan, 6-57 parts of dried ginger, 8-50 parts of notoginseng, 15-45 parts of homalomena occulta, 10-68 parts of leech, 7-76 parts of pheretima, 15-70 parts of ligusticum wallichii, 6-52 parts of swertia chirayita, 7-49 parts of gardenia jasminoides, 3-25 parts of borneol, 6-75 parts of angelica sinensis, 12-65 parts of ginseng, 7-53 parts of pogostemon cablin, 10-77 parts of curcuma aromatica.

3. The application according to claim 1, characterized in that, The stroke mentioned above is cerebral apoplexy, including the prevention and treatment of stroke precursors and the treatment of stroke sequelae.

4. The application according to claim 1, wherein The vascular thrombosis mentioned above includes thrombosis of small arteries and veins.

5. The application according to claim 1, characterized in that, The arteriosclerosis mentioned above includes arteriolosclerosis, medial sclerosis of arteries, and atherosclerosis.

6. The application according to claim 1, characterized in that, The stroke, vascular thrombosis, arteriosclerosis, and coronary heart disease mentioned above are collectively referred to as cardiovascular and cerebrovascular diseases in modern medicine.

7. The application according to claim 1, characterized in that, The lumbocrural pain mentioned above is pain caused by non-traumatic or post-operative reasons.

8. The traditional Chinese medicine composition according to claims 1 to 7 and its application is characterized in that, It is prepared from the cut crude drugs, the medicinal powder of the crude drugs, or the concentrated extract extracted from the crude drugs, or the liquid of the crude drugs, or the organic solvent extract of the crude drugs, and a preparation prepared by adding pharmaceutically acceptable excipients or auxiliary components.

9. The traditional Chinese medicine composition according to claims 1 to 8 and the preparation using the same are characterized in that The preparation is an oral preparation, and the oral preparation is tablets, powders, granules, solutions, pills, ointments, capsules, and tea bags.

10. The use of the traditional Chinese medicine composition as claimed in claims 1-2 and the preparation in the application as claimed in any one of claims 3-9 in the preparation of drugs for preventing and / or treating stroke, vascular thrombosis, arteriosclerosis, coronary heart disease, or lumbocrural pain, dredging collaterals and resolving thrombosis, promoting blood circulation and removing stasis.

11. The use of the traditional Chinese medicine composition as claimed in claims 1-2 and the preparation in the application as claimed in any one of claims 2-9 in the preparation of drugs for preventing and / or treating cardiovascular and cerebrovascular diseases.

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