A traditional Chinese medicine composition, a preparation method and an oral preparation

Abstract

This invention relates to the field of traditional Chinese medicine (TCM) technology, and discloses a TCM composition, preparation method, and oral formulation for treating cardiovascular and cerebrovascular diseases of the Qi deficiency and blood stasis type. The TCM composition is made from kudzu root, astragalus root, notoginseng, safflower, chuanxiong rhizome, hawthorn, angelica root, polygonum cuspidatum, licorice root, and salvia miltiorrhiza in specific weight parts. A preferred ratio is 60 parts kudzu root, 60 parts astragalus root, 25 parts notoginseng, 30 parts safflower, 25 parts chuanxiong rhizome, 30 parts hawthorn, 25 parts angelica root, 25 parts polygonum cuspidatum, 10 parts licorice root, and 26 parts salvia miltiorrhiza. It can be used for coronary heart disease, cerebral arteriosclerosis, cerebral thrombosis, hyperlipidemia, or sequelae of cerebral infarction. In preparation, the medicinal materials are cleaned, dried, mixed, and pulverized into a fine powder, passed through a 120-180 mesh sieve, and then formed into water pills using water as a binder. After drying and packaging, the product is obtained. This invention has a scientific formulation and precise proportions, making it suitable for the long-term prevention and treatment of cardiovascular and cerebrovascular diseases of the Qi deficiency and blood stasis type.

Description

Technical Field

[0001] This application relates to the field of traditional Chinese medicine technology, and more specifically, to a traditional Chinese medicine composition, preparation method and oral formulation. Background Technology

[0002] Cardiovascular and cerebrovascular diseases, due to their high incidence, disability rate, and mortality rate, have become a major challenge affecting public health. Conventional Western medicine treatments mainly employ antiplatelet aggregation drugs such as aspirin and clopidogrel, lipid-lowering and plaque-stabilizing drugs such as statins, and thrombolytic therapy. While these methods have some effectiveness in acute management, long-term use can easily lead to adverse reactions such as bleeding tendency (especially in the elderly), gastrointestinal mucosal damage, and increased burden on liver and kidney function, limiting the safety of continued use. Traditional Chinese medicine theory emphasizes "qi deficiency and blood stasis" as the core pathogenesis of these diseases, and has systemic advantages in improving microcirculation, regulating blood lipids at multiple targets, and invigorating qi and blood circulation. However, existing Chinese medicine compositions, such as those with Astragalus membranaceus, Pueraria lobata, and Panax notoginseng as main ingredients, generally suffer from unreasonable formulation design and a lack of precise control over the weight ratio of medicinal materials. This makes it difficult to accurately target qi deficiency and blood stasis, especially severe qi deficiency, resulting in unstable clinical efficacy and difficulty in ensuring safety during long-term use. Therefore, there is an urgent need for a traditional Chinese medicine composition with a scientifically rigorous formulation, outstanding qi-tonifying and blood-activating effects, suitable for long-term use, and significantly reduced bleeding risk.

[0003] To address the aforementioned issues, existing technologies urgently need improvement. Summary of the Invention

[0004] The purpose of this application is to provide a traditional Chinese medicine composition, preparation method and oral formulation, which has the advantages of scientific and rigorous formulation, precise weight ratio, accurate targeting of cardiovascular and cerebrovascular diseases of qi deficiency and blood stasis type, improved stability of clinical efficacy, reduced bleeding risk of long-term use and suitable for long-term use.

[0005] This application provides a traditional Chinese medicine composition for treating cardiovascular and cerebrovascular diseases of the qi deficiency and blood stasis type, the technical solution of which is as follows: A traditional Chinese medicine composition for treating cardiovascular and cerebrovascular diseases of the Qi deficiency and blood stasis type is made from the following raw materials in parts by weight: 40-80 parts of kudzu root, 40-80 parts of astragalus root, 15-35 parts of Panax notoginseng, 20-40 parts of safflower, 15-35 parts of chuanxiong rhizome, 20-40 parts of hawthorn fruit, 15-35 parts of angelica root, 15-35 parts of polygonum cuspidatum, 5-15 parts of licorice root, and 16-36 parts of salvia miltiorrhiza root.

[0006] Furthermore, this application also proposes that the above-mentioned traditional Chinese medicine composition comprises the following parts by weight: 60 parts of kudzu root, 60 parts of astragalus root, 25 parts of notoginseng, 30 parts of safflower, 25 parts of chuanxiong rhizome, 30 parts of hawthorn, 25 parts of angelica root, 25 parts of polygonum cuspidatum, 10 parts of licorice root, and 26 parts of salvia miltiorrhiza root.

[0007] Furthermore, this application also proposes that the cardiovascular and cerebrovascular diseases covered by the above-mentioned traditional Chinese medicine composition are coronary heart disease, cerebral arteriosclerosis, cerebral thrombosis, hyperlipidemia, or sequelae of cerebral infarction.

[0008] Furthermore, this application also proposes a method for preparing the above-mentioned traditional Chinese medicine composition, comprising the following steps: (1) Accurately weigh each Chinese medicinal material according to the weight proportions, clean and dry them; (2) Mix the dried medicinal materials evenly, pulverize them into fine powder, and pass them through a 120-180 mesh sieve to obtain mixed medicinal powder; (3) Using water as a binder, the mixed powder is made into water pills, with the weight of each pill controlled at 0.3g / pill. After drying, the pills are packaged into 5g / bags.

[0009] Furthermore, this application also proposes an oral preparation for treating cardiovascular and cerebrovascular diseases, made from the above-mentioned traditional Chinese medicine composition; the oral preparation is a water pill, powder, or capsule.

[0010] As can be seen from the above, the traditional Chinese medicine composition, preparation method and oral preparation provided in this application are a traditional Chinese medicine composition for treating cardiovascular and cerebrovascular diseases of qi deficiency and blood stasis type. It is made from raw materials in a specific weight proportion. Through scientific formulation and precise weight ratio, it solves the problems of unreasonable formulation structure design and lack of precise control of weight ratio among medicinal materials in the prior art. It has the advantages of scientific and rigorous formulation, precise weight ratio, accurate targeting of cardiovascular and cerebrovascular diseases of qi deficiency and blood stasis type, improved stability of clinical efficacy, reduced bleeding risk of long-term use, and suitability for long-term use. Detailed Implementation

[0011] This embodiment provides a traditional Chinese medicine composition for treating cardiovascular and cerebrovascular diseases of the qi deficiency and blood stasis type.

[0012] Traditional treatments for cardiovascular and cerebrovascular diseases, especially Western medicine, while capable of controlling the condition, often involve adverse reactions such as increased bleeding risk, gastrointestinal damage, and liver and kidney dysfunction with long-term use. Existing Chinese herbal medicine compositions still have room for improvement in terms of the precision of their formulation, the strength of their qi-tonifying and blood-activating effects, and their targeting of severe qi deficiency. They have not yet fully addressed the treatment challenges of qi-deficiency and blood stasis-type cardiovascular and cerebrovascular diseases.

[0013] In this regard, this application proposes a traditional Chinese medicine composition for treating cardiovascular and cerebrovascular diseases of the Qi deficiency and blood stasis type. The composition is made from raw materials such as kudzu root, astragalus, notoginseng, safflower, chuanxiong rhizome, hawthorn, angelica, polygonum cuspidatum, licorice and salvia miltiorrhiza in specific weight proportions. The aim is to provide a treatment plan with optimized compatibility, significant Qi-invigorating and blood-activating effects, and suitable for long-term use.

[0014] Example 1: Take 60g of kudzu root, 60g of astragalus root, 25g of notoginseng, 30g of safflower, 25g of chuanxiong rhizome, 30g of hawthorn, 25g of angelica root, 25g of polygonum cuspidatum, 10g of licorice root, and 26g of salvia miltiorrhiza root. Mix them evenly, pulverize them into a fine powder, and pass them through a 120-mesh sieve. Take the above fine powder, add an appropriate amount of water, and make it into water pills, controlling the weight of each pill to 0.3g / pill. Dry them and package them into 5g / bags.

[0015] Example 2: Take 40g of kudzu root, 40g of astragalus root, 15g of notoginseng, 20g of safflower, 15g of chuanxiong rhizome, 20g of hawthorn, 15g of angelica root, 15g of polygonum cuspidatum, 5g of licorice root, and 16g of salvia miltiorrhiza root. The preparation method and dosage form are the same as in Example 1.

[0016] Example 3: Take 80g of kudzu root, 80g of astragalus root, 35g of notoginseng, 40g of safflower, 35g of chuanxiong rhizome, 40g of hawthorn, 35g of angelica root, 35g of polygonum cuspidatum, 15g of licorice root, and 36g of salvia miltiorrhiza root. The preparation method and dosage form are the same as in Example 1.

[0017] Efficacy Verification (Example 1: Usage and Theoretical Effect Inference of the Formula): This medicine can be made into 0.3g water pills, packaged in 5g packets. The recommended adult dose is one packet (5g) twice daily, taken with warm water after meals.

[0018] The expected therapeutic effect of this invention (further experimental data is needed to support this): Based on in-depth analysis of pharmacological literature and the mechanism of the drug, this invention can indeed produce the following pharmacological effects: (1) Lowering blood pressure and lipids and anti-oxidation: Puerarin in kudzu root can dilate coronary arteries, and flavonoids and triterpenoids in hawthorn can significantly reduce serum total cholesterol (TC) and low-density lipoprotein (LDL-C). The combination of astragalus and angelica (Dang Gui Bu Xue Tang) can enhance myocardial contractility and regulate blood pressure.

[0019] (2) Antiplatelet aggregation and anticoagulation: Tanshinone IIA in Danshen and ligustrazine in Chuanxiong can directly inhibit platelet adhesion and aggregation, and antagonize thrombus formation.

[0020] (3) Improve microcirculation: safflower, Panax notoginseng and other drugs can significantly improve cerebral ischemia and myocardial ischemia, promote the recovery of nerve function, and thus relieve hemiplegia and limb numbness.

[0021] For ease of understanding, the following explains some key terms in this embodiment: Traditional Chinese medicine compositions refer to preparations made by combining various Chinese medicinal materials according to specific compatibility principles and proportions based on traditional Chinese medicine theory, aiming to exert synergistic effects and achieve the purpose of treating diseases.

[0022] Cardiovascular and cerebrovascular diseases of the Qi deficiency and blood stasis type refer to cardiovascular and cerebrovascular diseases with Qi deficiency as the root cause and blood stasis as the manifestation, manifested as symptoms such as chest tightness, palpitations, fatigue, and numbness of limbs. Its pathological basis involves poor circulation of Qi and blood and obstruction of blood vessels.

[0023] In traditional Chinese medicine, kudzu root is believed to have the effects of relieving muscle tension and fever, promoting body fluid production and quenching thirst, and raising yang energy and stopping diarrhea. It is often used to improve blood supply to the heart and brain.

[0024] Astragalus has the effects of invigorating qi and strengthening the exterior, promoting diuresis and reducing swelling, and promoting tissue regeneration and detoxification. It is an important medicine for invigorating qi and is used to enhance the body's resistance.

[0025] Panax notoginseng has the effects of dispersing blood stasis, stopping bleeding, reducing swelling and relieving pain. While promoting blood circulation and removing blood stasis, it also stops bleeding to balance the medicinal properties.

[0026] Safflower has the effects of promoting blood circulation, regulating menstruation, dispersing blood stasis, and relieving pain. It is used to promote blood circulation and resolve stagnation.

[0027] Chuanxiong has the effects of promoting blood circulation, dispelling wind and relieving pain. It is good at promoting blood circulation and improving qi stagnation and blood stasis.

[0028] Hawthorn has the effects of aiding digestion, strengthening the stomach, promoting qi circulation, and removing blood stasis. It helps to eliminate food stagnation and promote blood circulation.

[0029] Angelica sinensis has the effects of nourishing blood, promoting blood circulation, regulating menstruation and relieving pain, and moistening the intestines and relieving constipation. It is an important medicinal material for nourishing blood and promoting blood circulation.

[0030] Polygonum cuspidatum has the effects of promoting blood circulation and removing blood stasis, clearing heat and detoxifying, and promoting diuresis and relieving jaundice. It is used to promote blood circulation and unblock the meridians.

[0031] Licorice has the effects of tonifying the spleen and replenishing qi, clearing heat and detoxifying, resolving phlegm and relieving cough, relieving spasms and pain, and harmonizing the properties of various medicines. It is used to harmonize the properties of medicines and reduce side effects.

[0032] Danshen has the effects of promoting blood circulation and removing blood stasis, regulating menstruation and relieving pain, and clearing the mind and relieving irritability. It is a commonly used medicine for promoting blood circulation and removing blood stasis and is used to improve the microcirculation of the cardiovascular and cerebrovascular systems.

[0033] The traditional Chinese medicine composition provided in this application is designed for the treatment of cardiovascular and cerebrovascular diseases caused by qi deficiency and blood stasis. Specifically, this composition can be used to improve various cardiovascular and cerebrovascular symptoms caused by qi deficiency and blood stasis. For example, in clinical applications, this composition can be used to relieve patients' symptoms such as chest tightness, palpitations, shortness of breath, fatigue, numbness or tingling in the limbs. Its therapeutic target focuses on invigorating qi and promoting blood circulation, removing blood stasis and unblocking the meridians, in order to restore the balance of qi and blood circulation.

[0034] This traditional Chinese medicine composition is prepared from multiple raw materials in specific weight proportions. During preparation, each herb can be processed using conventional traditional Chinese medicine processing methods, such as cleaning, drying, slicing, or pulverizing. Subsequently, the pre-treated herbs are weighed according to the predetermined weight proportions and mixed thoroughly. The mixed herbs can be used directly as a powder or further processed into other dosage forms. For example, the herbs can be ground into coarse powder or directly mixed in the form of medicinal slices.

[0035] The weight percentage of kudzu root in this composition ranges from 40 to 80 parts. In actual preparation, any weight percentage within this range can be selected according to specific needs. For example, 45 or 75 parts of kudzu root can be weighed. Kudzu root can be added in the form of dried root slices or coarse powder.

[0036] The weight range of Astragalus membranaceus in this composition is 40-80 parts. For example, 50 or 70 parts of Astragalus membranaceus can be weighed out. Astragalus membranaceus can be added in the form of dried root slices or coarse powder.

[0037] The weight range of Panax notoginseng in this composition is 15-35 parts. For example, 20 or 30 parts of Panax notoginseng can be weighed. Panax notoginseng can be added in the form of dried root powder or slices.

[0038] The weight range of safflower in this composition is 20-40 parts. For example, 25 or 35 parts of safflower can be weighed. Safflower can be added in the form of dried flowers or coarse powder.

[0039] The weight range of Ligusticum chuanxiong in this composition is 15-35 parts. For example, 18 or 32 parts of Ligusticum chuanxiong can be weighed. Ligusticum chuanxiong can be added in the form of dried rhizome slices or coarse powder.

[0040] The weight range of hawthorn in this composition is 20-40 parts. For example, 22 or 38 parts of hawthorn can be weighed. Hawthorn can be added in the form of dried fruit or coarse powder.

[0041] The weight range of Angelica sinensis in this composition is 15-35 parts. For example, 16 or 34 parts of Angelica sinensis can be weighed. Angelica sinensis can be added in the form of dried root slices or coarse powder.

[0042] The weight range of Polygonum cuspidatum in this composition is 15-35 parts. For example, 17 or 33 parts of Polygonum cuspidatum can be weighed. Polygonum cuspidatum can be added in the form of dried rhizome slices or coarse powder.

[0043] The weight range of licorice in this composition is 5-15 parts. For example, 6 or 14 parts of licorice can be weighed. Licorice can be added in the form of dried root slices or coarse powder.

[0044] The weight range of Salvia miltiorrhiza in this composition is 16-36 parts. For example, 18 or 35 parts of Salvia miltiorrhiza can be weighed. Salvia miltiorrhiza can be added in the form of dried root slices or coarse powder.

[0045] The traditional Chinese medicine composition provided in this application, through the careful selection of kudzu root, astragalus root, notoginseng, safflower, chuanxiong rhizome, hawthorn, angelica root, polygonum cuspidatum, licorice root, and salvia miltiorrhiza, and the optimization of their weight ratios, achieves a synergistic effect of invigorating qi and promoting blood circulation, removing blood stasis and unblocking collaterals. This composition effectively improves the symptoms of cardiovascular and cerebrovascular diseases of qi deficiency and blood stasis type, while balancing the effects of promoting blood circulation and stopping bleeding, reducing the risk of bleeding that may result from long-term use, and harmonizing the properties of the herbs, thus providing a treatment plan with optimized compatibility and good safety.

[0046] In some of the solutions mentioned above in this application, a range of weight proportions was proposed for treating cardiovascular and cerebrovascular diseases of qi deficiency and blood stasis type. However, in this process, an excessively wide range may lead to unstable efficacy or large individual differences, affecting the treatment effect. Specifically, the precision of the herbal ratio is insufficient, and it is impossible to accurately target and optimize for severe qi deficiency, thereby reducing the reliability and safety of the overall efficacy.

[0047] In this regard, this application further proposes a traditional Chinese medicine composition for treating cardiovascular and cerebrovascular diseases of the Qi deficiency and blood stasis type, the weight parts of which are: 60 parts of kudzu root, 60 parts of astragalus root, 25 parts of Panax notoginseng, 30 parts of safflower, 25 parts of chuanxiong rhizome, 30 parts of hawthorn, 25 parts of angelica root, 25 parts of polygonum cuspidatum, 10 parts of licorice root, and 26 parts of salvia miltiorrhiza.

[0048] Specifically, a weight ratio of 60 parts of kudzu root, compared to the broader range of 40-80 parts, ensures a moderate and stable efficacy in invigorating qi and promoting blood circulation. This avoids excessive potency due to too high a ratio or insufficient efficacy due to too low a ratio, thus precisely controlling its therapeutic effect on cardiovascular and cerebrovascular diseases. This ratio is an optimized selection based on in-depth research and clinical experience of kudzu root's pharmacological effects, aiming to achieve its qi-invigorating, yang-raising, muscle-relaxing, and fluid-generating effects, while synergistically working with other herbs to enhance the therapeutic effect on cardiovascular and cerebrovascular diseases caused by qi deficiency and blood stasis. A weight ratio of 60 parts of astragalus provides strong support in tonifying qi, working synergistically with kudzu root to enhance the overall qi-invigorating effect. This precise ratio helps optimize the synergistic effect between herbs, preventing imbalances in efficacy caused by improper proportions, ensuring that qi is tonified without causing blood stasis, and blood circulation is promoted without harming the body's vital energy. The precise dosage of 25 parts by weight for Panax notoginseng ensures a stable and effective blood-activating and stasis-removing effect. This allows it to effectively improve blood stasis symptoms while avoiding the risk of bleeding from excessive dosage or the ineffectiveness of insufficient dosage, thus precisely targeting the blood stasis pathogenesis in Qi deficiency and blood stasis type cardiovascular and cerebrovascular diseases. The 30 parts by weight for Safflower enhances microcirculation and synergizes with Panax notoginseng, Ligusticum chuanxiong, and other herbs, improving the overall precision of blood-activating and stasis-removing effects. This dosage ensures that it activates blood without causing bleeding, making it gentle yet effective. The 25 parts by weight for Ligusticum chuanxiong assist in promoting Qi and blood circulation, alleviating cardiovascular and cerebrovascular discomfort caused by Qi stagnation and blood stasis. This precise dosage helps avoid drug interactions, ensuring harmonious compatibility with other blood-activating herbs and enhancing the overall therapeutic effect. The 30 parts by weight for Hawthorn optimizes blood lipid regulation, promotes digestion, and simultaneously assists in blood activation and stasis removal. This dosage ensures a balance between its digestive and lipid-lowering effects, avoiding potential gastrointestinal discomfort from excessive dosage, while effectively reducing the burden on the cardiovascular system. The 25 parts by weight of Angelica sinensis enhance the synergistic effect of nourishing both Qi and blood, simultaneously promoting blood circulation and replenishing blood, avoiding depletion of vital energy due to mere blood-activating effects. This precise dosage helps maintain the overall balance of the medicinal properties, ensuring comprehensive treatment. The 25 parts by weight of Polygonum cuspidatum exert its heat-clearing, detoxifying, blood-activating, and stasis-removing effects, while reducing potential toxicity risks. This dosage helps ensure medication safety while maximizing efficacy, especially for long-term users. The 10 parts by weight of Glycyrrhiza uralensis effectively harmonizes the various herbs, making the overall medicinal composition milder, reducing adverse reactions, and enhancing patient compliance. This dosage maintains the overall balance and harmony of the medicinal properties, a crucial component in ensuring the safety and effectiveness of the composition. The 26 parts by weight of Salvia miltiorrhiza strengthen the protective effect on the cardiovascular system and enhance the efficacy of targeted therapy. This dosage ensures its effects in improving microcirculation, anticoagulation, and lowering lipids, and works synergistically with other medicinal materials in the composition to comprehensively improve cardiovascular and cerebrovascular function.

[0049] Through the above technical solution, this application solves the problems of unstable efficacy, large individual differences, and insufficient targeting caused by excessively wide ranges of medicinal material ratios by precisely limiting the weight proportions of each medicinal material. This precise ratio is based on in-depth research on the pharmacological effects of each medicinal material and optimization results from clinical practice experience, aiming to achieve the best synergistic balance in the effects of each medicinal material in invigorating qi and promoting blood circulation, removing blood stasis and unblocking collaterals, and lowering lipids and stabilizing pigmentation. The combination of 60 parts of kudzu root and 60 parts of astragalus provides stable and strong support in invigorating qi; the combination of 25 parts of notoginseng, 30 parts of safflower, 25 parts of chuanxiong rhizome, and 26 parts of salvia miltiorrhiza precisely invigorates blood circulation and removes blood stasis, improving microcirculation; 30 parts of hawthorn optimizes blood lipids, 25 parts of angelica sinensis nourishes blood, 25 parts of polygonum cuspidatum clears heat and detoxifies, and 10 parts of licorice harmonizes the other herbs, together constructing a well-matched and stable Chinese medicine composition. This precise quantification makes the efficacy of the Chinese medicine composition more stable and reliable, significantly reducing batch-to-batch differences, thereby improving the predictability and consistency of therapeutic effects. Meanwhile, for cardiovascular and cerebrovascular diseases of the Qi deficiency and blood stasis type, especially "severe Qi deficiency," this precise formulation can more accurately target the pathogenesis, avoiding excessive or insufficient medicinal potency and effectively improving the accuracy of treatment. Furthermore, by optimizing the proportions of each medicinal material, this composition effectively balances the medicinal properties while exerting a powerful therapeutic effect, reducing the risk of adverse reactions that may arise from long-term use, such as bleeding and gastrointestinal damage, significantly improving the safety of medication. Overall, this precise formulation allows the efficacy of each medicinal material to better synergize and enhance, achieving superior overall therapeutic effects and effectively reducing individual differences among patients, making the treatment plan more universally applicable.

[0050] In some of the solutions mentioned above in this application, cardiovascular and cerebrovascular diseases are proposed to treat qi deficiency and blood stasis type symptoms. However, in this process, the scope of cardiovascular and cerebrovascular diseases is too broad and lacks specific disease type limitations, which may lead to the inability to accurately target specific diseases in clinical application, affecting the treatment effect and promotion.

[0051] In this regard, this application further proposes that the cardiovascular and cerebrovascular diseases mentioned are coronary heart disease, cerebral arteriosclerosis, cerebral thrombosis, hyperlipidemia, or sequelae of cerebral infarction.

[0052] Specifically, in Traditional Chinese Medicine (TCM) theory, coronary heart disease is often categorized under "chest pain" or "heart pain," with its core pathogenesis being obstruction of the heart vessels, and qi deficiency and blood stasis being common syndrome patterns. This TCM composition, by invigorating qi and promoting blood circulation, can effectively improve myocardial blood supply and relieve symptoms such as angina pectoris. Furthermore, coronary heart disease patients often have atherosclerosis, the pathological basis of which is also closely related to blood stasis. The blood-activating and stasis-removing components in this composition help improve vascular endothelial function and slow disease progression.

[0053] Cerebral arteriosclerosis is a major cause of insufficient blood supply to the brain. In Traditional Chinese Medicine (TCM), it is often attributed to qi deficiency leading to weak propulsion, sluggish blood circulation, or the accumulation of phlegm and blood stasis. This composition can replenish qi and blood, invigorate blood circulation, and improve cerebral microcirculation, thereby alleviating symptoms such as dizziness and forgetfulness caused by cerebral arteriosclerosis. Furthermore, the development of cerebral arteriosclerosis is related to vascular endothelial damage and lipid deposition; the blood-activating and stasis-removing herbs in this composition help clear stagnation from the vascular walls and maintain vascular elasticity.

[0054] Cerebral thrombosis is the main pathological basis of cerebral infarction, falling under the category of "stroke" in Traditional Chinese Medicine (TCM). Both the acute and recovery phases of cerebral infarction exhibit symptoms of Qi deficiency and blood stasis. This composition, through its effects of promoting blood circulation, removing blood stasis, and invigorating Qi, helps dissolve thrombi, improve local blood circulation, and reduce the risk of recurrent thrombosis. Simultaneously, its Qi-invigorating effect enhances the body's anticoagulant and thrombolytic abilities, promoting blood reperfusion in the lesion area.

[0055] Hyperlipidemia is a significant risk factor for cardiovascular and cerebrovascular diseases, and in Traditional Chinese Medicine (TCM), it is often associated with pathogenesis factors such as phlegm-dampness, blood stasis, and qi deficiency. The hawthorn and other components in this composition have lipid-lowering effects, and combined with blood-activating and stasis-removing herbs, they can synergistically regulate lipid metabolism and reduce lipid deposition on the blood vessel walls. Furthermore, hyperlipidemia increases blood viscosity, making blood stasis more likely; this composition can fundamentally improve blood rheological parameters.

[0056] Patients with sequelae of cerebral infarction often present with hemiplegia, speech impairment, etc., and the pathogenesis is mostly due to qi deficiency and blood stasis, and obstruction of the meridians. This composition helps promote the recovery of nerve function and improve limb dysfunction by continuously invigorating qi and blood circulation, clearing the meridians and relieving pain. On the other hand, long-term use can reduce the recurrence of cerebral infarction and improve the quality of life of patients, demonstrating the advantages of traditional Chinese medicine in chronic disease management.

[0057] Through the above technical solutions, this application clarifies the specific types of cardiovascular and cerebrovascular diseases targeted by the traditional Chinese medicine composition, including coronary heart disease, cerebral arteriosclerosis, cerebral thrombosis, hyperlipidemia, or sequelae of cerebral infarction. This precise disease limitation makes the traditional Chinese medicine composition more targeted in clinical applications, avoiding the blind treatment caused by a broad range of diseases. Given that these diseases are all highly related to the pathological mechanisms of qi deficiency and blood stasis, the medicinal materials contained in the above-mentioned traditional Chinese medicine composition, such as kudzu root, astragalus, notoginseng, safflower, chuanxiong rhizome, hawthorn, angelica, polygonum cuspidatum, licorice, and salvia miltiorrhiza, can synergistically exert the effects of invigorating qi and promoting blood circulation, removing blood stasis and unblocking collaterals. For example, for coronary heart disease and cerebral arteriosclerosis, its qi-invigorating and blood-activating effects can improve blood supply to the heart and brain and relieve ischemic symptoms; for cerebral thrombosis and hyperlipidemia, its blood-activating, blood-stasis-removing, and lipid-lowering effects help prevent and treat thrombosis and arteriosclerosis; for sequelae of cerebral infarction, it can promote the recovery of nerve function and reduce the impact of sequelae. Therefore, by combining traditional Chinese medicine compositions with specific cardiovascular and cerebrovascular diseases of the Qi deficiency and blood stasis type, this application can significantly improve the precision and effectiveness of treatment, provide patients with more targeted treatment options, and thus solve the problem of lack of specific disease type limitations in clinical applications.

[0058] In some of the above-mentioned schemes of this application, a traditional Chinese medicine composition is proposed for treating cardiovascular and cerebrovascular diseases of qi deficiency and blood stasis type. However, in the preparation process, there are challenges in ensuring that the effective components of the medicinal materials are not destroyed, the preparation is uniform and suitable for long-term use, and there are challenges such as improper handling of medicinal materials leading to component loss, uneven mixing affecting efficacy, and the inconvenience of oral administration of the preparation.

[0059] In this regard, this application further proposes a method for preparing the above-mentioned traditional Chinese medicine composition, which includes the following steps: (1) Accurately weigh each Chinese medicinal material according to the stated weight proportions, clean and dry them; (2) Mix the dried medicinal materials evenly, pulverize them into fine powder, and pass them through a 120-180 mesh sieve to obtain mixed medicinal powder; (3) Using water as a binder, the mixed powder is prepared into water pills, with the weight of each pill controlled at 0.3g / pill. After drying, the pills are packaged into 5g / bags.

[0060] Specifically, in step (1), accurately weighing each herb is to ensure the precision of the formula ratio and avoid affecting the final therapeutic effect due to dosage deviation. This weighing process can be carried out using a high-precision electronic balance or by using pre-packaged standardized herb packets. The cleaning process aims to remove impurities, non-medicinal parts, or foreign objects from the herbs to prevent foreign components from interfering with the efficacy or causing adverse reactions. This operation can be carried out using physical methods such as manual sorting, wind separation, or washing. The purpose of drying is to reduce the moisture content of the herbs, thereby effectively preventing mold and insect infestation, and maintaining the stability and activity of the active ingredients in the herbs. The drying method can be selected according to the properties of the herbs, such as natural sun-drying, oven drying, vacuum drying, or freeze-drying.

[0061] In step (2), the dried medicinal materials are mixed evenly to ensure that each ingredient is evenly distributed in the composition, thereby ensuring the uniformity of efficacy in each preparation and enhancing the overall synergistic effect. Mixing methods can include mechanical stirring, drum mixing, or airflow mixing. Subsequently, the medicinal materials are pulverized into fine powder. This significantly increases the surface area of ​​the medicinal materials, facilitating the full dissolution, release, and absorption of the active ingredients in the subsequent preparation, thereby improving bioavailability. Pulverizing equipment can include an ultrafine pulverizer, ball mill, or airflow pulverizer. Next, the powder is passed through a 120-180 mesh sieve to precisely control the fineness range, ensuring the powder is uniform and fine, avoiding fluctuations in efficacy due to uneven particle size, and also facilitating the smooth progress of the subsequent pill-making process. Sieving equipment can include a vibrating screen or an airflow sieve.

[0062] In step (3), water is used as a binder. This is to use natural, non-toxic water as a binder, avoiding the side effects or allergic reactions that may be caused by introducing chemical additives, making the prepared formulation safer and suitable for long-term use. The mixed powder is then formulated into water pills. Water pills, as a traditional Chinese medicine dosage form, have the characteristics of small size, easy swallowing, slow disintegration, and long-lasting efficacy, making them convenient for oral administration and effectively improving patient compliance. The formulation process can be carried out by traditional manual pill-forming or mechanical pill-forming machines. The pill weight is controlled at 0.3g / pill to precisely control the weight of each water pill, ensuring a consistent dosage each time, thereby guaranteeing the stability and controllability of the therapeutic effect. This can be achieved by adjusting the pill-forming process parameters or using automated pill-separating equipment. Finally, after drying, the pills are packaged into 5g / bags. Drying aims to further reduce the water content of the water pills, improving their stability and shelf life. Repackaging into small bags (5g / bag) makes it convenient for patients to carry, store, and use, while reducing the contact between the pills and air, maintaining the stability of the preparation, and preventing moisture absorption and deterioration. Drying methods can include low-temperature drying or vacuum drying, while repackaging can be done using automated packaging machines.

[0063] Through the above technical solution, this application provides a systematic, efficient, and safe preparation method that effectively solves problems such as loss of medicinal components, poor uniformity of preparation, and insufficient convenience of oral administration that may occur during the preparation of traditional Chinese medicine compositions. Specifically, by accurately weighing, cleaning, and drying the medicinal materials, the quality of the medicinal materials and the stability of the effective components are ensured from the source, avoiding component loss due to improper processing. Subsequently, the dried medicinal materials are thoroughly mixed and finely pulverized and sieved to ensure the uniformity and fineness of the powder. This not only facilitates the full release and absorption of the effective components of the medicinal materials but also ensures the uniformity of the efficacy of the preparation, avoiding fluctuations in efficacy caused by uneven mixing or differences in particle size. Furthermore, water is used as a binder to form water pills, avoiding the introduction of chemical additives, reducing the risk of potential side effects, and making the traditional Chinese medicine composition more suitable for long-term use. At the same time, the water pill dosage form itself is easy to swallow, and by precisely controlling the pill weight and packaging specifications, the accuracy of each dose and the convenience of use are ensured, significantly improving patient compliance. The synergistic effect of these preparation steps enables the prepared traditional Chinese medicine composition to maintain its qi-tonifying and blood-activating effects while having higher safety, stability, and ease of use, thereby better exerting its therapeutic effect on cardiovascular and cerebrovascular diseases of qi deficiency and blood stasis type.

[0064] In some of the above-mentioned schemes of this application, traditional Chinese medicine compositions are proposed for treating cardiovascular and cerebrovascular diseases of qi deficiency and blood stasis type. However, in the process of realizing them, there is a lack of optimized oral formulations, which may lead to inconvenient administration, low absorption efficiency or potential side effects, affecting the efficacy and safety of the drug.

[0065] In this regard, this application proposes an oral preparation for treating cardiovascular and cerebrovascular diseases, which is made from the aforementioned traditional Chinese medicine composition, and the oral preparation is a water pill, powder or capsule.

[0066] The preparation of this oral formulation first clarifies that its active ingredient originates from the traditional Chinese medicine composition for treating cardiovascular and cerebrovascular diseases of qi deficiency and blood stasis type as described in any one of claims 1 to 3. This means that the formulation inherits the pharmacological activities of the traditional Chinese medicine composition in invigorating qi and promoting blood circulation, improving microcirculation, etc., providing a solid efficacy basis for its treatment of cardiovascular and cerebrovascular diseases. By preparing the traditional Chinese medicine composition into a specific dosage form, problems such as inconvenience in administration, poor taste, and poor stability of active ingredients that may exist when directly using raw medicinal materials or simple mixtures can be effectively overcome.

[0067] Specifically, the oral preparation can be a water pill. Water pills are a traditional Chinese medicine dosage form, typically prepared by mixing medicinal powder with water or medicinal juice, and then forming spherical or near-spherical pills through methods such as pan-coating and rolling. Water pills are characterized by their small size, ease of swallowing, and relatively slow disintegration and absorption, which facilitates sustained drug release and reduces gastrointestinal irritation. The preparation methods can include: mixing the medicinal powder with an appropriate amount of water or diluted medicinal solution, forming it manually or mechanically, and then drying and coating it; or using modern granulation technology to granulate the medicinal powder and then compress it into pills.

[0068] The oral preparations may also be powders. Powders refer to dry, powdered preparations made by pulverizing and mixing drugs evenly. The advantages of powders are their convenience of administration; they can be taken directly by dissolving in water or mixing with water, have a rapid onset of action, and the dosage is easily adjustable, making them particularly suitable for children, the elderly, or patients with difficulty swallowing. The methods of implementation may include: pulverizing each herb in the traditional Chinese medicine composition to a specified fineness, mixing evenly, and then directly dispensing; or making the powder into granular powders to improve flowability and solubility.

[0069] Furthermore, the oral preparation can also be a capsule. A capsule is a solid preparation made by filling a capsule shell with a drug. Capsules can effectively mask the unpleasant odor and irritation of the drug, protect the drug from damage by light, moisture, and stomach acid, and simultaneously achieve timed, targeted, or sustained release of the drug. This can be achieved by: filling a hard capsule shell with a powder or granules made from a traditional Chinese medicine composition; or by mixing medicinal extracts with suitable excipients to form soft capsules.

[0070] The above-mentioned technical solutions enable the preparation of traditional Chinese medicine (TCM) compositions into oral formulations such as pills, powders, or capsules, effectively solving problems that may arise when TCM compositions are used directly, such as inconvenience in administration, unpleasant taste, low absorption efficiency, and potential gastrointestinal irritation. Specifically, pills, due to their slow disintegration, facilitate the sustained release and absorption of drug components, reduce immediate gastrointestinal irritation, and improve patient compliance; powders, due to their convenient administration and rapid onset of action, can meet the needs of different patient groups, especially suitable for patients who require rapid onset of action or have difficulty swallowing; capsules can effectively mask the unique bitterness or odor of TCM, protect the active ingredients, and, by selecting different types of capsule shells, achieve targeted or sustained release of the drug, thereby improving bioavailability and reducing adverse reactions. The introduction of these oral formulations allows TCM compositions to exert their therapeutic effects on cardiovascular and cerebrovascular diseases in a safer, more effective, and more convenient manner, thereby improving the overall treatment effect and the patient's medication experience.

[0071] The following example will provide a more detailed explanation of the above technical solution: This example provides a traditional Chinese medicine composition for treating cardiovascular and cerebrovascular diseases of the Qi deficiency and blood stasis type. This composition is specifically designed to treat User A's coronary heart disease accompanied by symptoms of Qi deficiency and blood stasis. User A has concerns about experiencing gastrointestinal discomfort and an increased risk of bleeding due to long-term use of Western medicine.

[0072] First, accurately weigh the following Chinese medicinal herbs according to the specified proportions: 60 parts kudzu root, 60 parts astragalus root, 25 parts notoginseng, 30 parts safflower, 25 parts chuanxiong rhizome, 30 parts hawthorn, 25 parts angelica root, 25 parts polygonum cuspidatum, 10 parts licorice root, and 26 parts salvia miltiorrhiza. These herbs are then cleaned and dried. Next, the dried herbs are mixed evenly, pulverized into a fine powder, and passed through a 120-180 mesh sieve to obtain a mixed medicinal powder. Using water as a binder, the mixed medicinal powder is formed into water pills, with each pill weighing 0.3g. After drying, the water pills are packaged into 5g packets to form an oral water pill dosage form.

[0073] This traditional Chinese medicine composition played a synergistic role in User A's treatment. Astragalus and Pueraria lobata, in a 60-part ratio, primarily invigorate Qi and Yang, improve Qi deficiency symptoms, and promote blood circulation. Panax notoginseng, Salvia miltiorrhiza, Carthamus tinctorius, and Ligusticum chuanxiong, in ratios of 25, 26, 30, and 25 respectively, work together to promote blood circulation, dilate blood vessels, and improve microcirculation, addressing symptoms of blood stasis. Angelica sinensis, in a 25-part ratio, nourishes and invigorates blood, further improving circulation. Hawthorn, in a 30-part ratio, aids digestion, promotes blood circulation, and regulates blood lipids. Polygonum cuspidatum, in a 25-part ratio, invigorates blood circulation, clears heat, and detoxifies. Licorice, in a 10-part ratio, harmonizes the other herbs, invigorates the spleen and Qi, and enhances the overall stability of the efficacy.

[0074] Through the above-described combination, this composition can comprehensively improve User A's Qi deficiency and blood stasis condition. The combination of kudzu root and astragalus root provides support for Qi deficiency symptoms, enhances cardiac pumping function, and improves cerebral blood supply. The blood-activating and stasis-removing effects of Panax notoginseng, Salvia miltiorrhiza, safflower, and Ligusticum chuanxiong help clear plaques in blood vessels, reduce blood viscosity, and prevent thrombosis. The addition of hawthorn further assists in lowering lipids and stabilizing vascular endothelial function. Angelica sinensis and Polygonum cuspidatum, from the perspectives of nourishing blood and unblocking collaterals, perfect the overall therapeutic effect. The harmonizing effect of licorice ensures synergistic effects among the various medicinal materials while reducing potential adverse reactions.

[0075] Compared to existing combinations containing only herbs such as Astragalus membranaceus, Pueraria lobata, and Panax notoginseng, the composition in this example exhibits higher precision in its herbal ratios. For instance, the equal proportions of Astragalus membranaceus and Pueraria lobata, along with the precise ratios of Panax notoginseng, Salvia miltiorrhiza, Carthamus tinctorius, and Ligusticum chuanxiong, enhance its targeted effect in invigorating Qi and promoting blood circulation, making it particularly suitable for patients with severe Qi deficiency. This precise ratio allows the composition to improve microcirculation and regulate blood lipids at multiple targets while reducing the risk of bleeding associated with long-term use. It also avoids common problems in Western medicine treatments such as gastrointestinal damage and liver and kidney dysfunction, providing a treatment option suitable for long-term use. The formulation as water pills also facilitates daily consumption and portability for user A.

[0076] The above description is merely an embodiment of this application and is not intended to limit the scope of protection of this application. Various modifications and variations can be made to this application by those skilled in the art. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of this application should be included within the scope of protection of this application.

Claims

1. A traditional Chinese medicine composition for treating cardiovascular and cerebrovascular diseases of the Qi deficiency and blood stasis type, characterized in that, The traditional Chinese medicine composition is made from the following raw materials in parts by weight: 40-80 parts of kudzu root, 40-80 parts of astragalus root, 15-35 parts of notoginseng, 20-40 parts of safflower, 15-35 parts of chuanxiong rhizome, 20-40 parts of hawthorn fruit, 15-35 parts of angelica root, 15-35 parts of polygonum cuspidatum, 5-15 parts of licorice root, and 16-36 parts of salvia miltiorrhiza root.

2. The traditional Chinese medicine composition according to claim 1, characterized in that, The weight proportions are as follows: 60 parts kudzu root, 60 parts astragalus root, 25 parts notoginseng, 30 parts safflower, 25 parts chuanxiong rhizome, 30 parts hawthorn, 25 parts angelica root, 25 parts polygonum cuspidatum, 10 parts licorice root, and 26 parts salvia miltiorrhiza.

3. The traditional Chinese medicine composition according to claim 1 or 2, characterized in that, The cardiovascular and cerebrovascular diseases mentioned are coronary heart disease, cerebral arteriosclerosis, cerebral thrombosis, hyperlipidemia, or sequelae of cerebral infarction.

4. A method for preparing a traditional Chinese medicine composition according to any one of claims 1 to 3, characterized in that, Includes the following steps: (1) Accurately weigh each Chinese medicinal material according to the stated weight proportions, clean and dry them; (2) Mix the dried medicinal materials evenly, pulverize them into fine powder, and pass them through a 120-180 mesh sieve to obtain mixed medicinal powder; (3) Using water as a binder, the mixed powder is prepared into water pills, with the weight of each pill controlled at 0.3g / pill. After drying, the pills are packaged into 5g / bags.

5. An oral preparation for treating cardiovascular and cerebrovascular diseases, characterized in that, It is made from the traditional Chinese medicine composition according to any one of claims 1 to 3; the oral preparation is a water pill, powder or capsule.