A traditional Chinese medicine for treating hyperlipidemia and hypertension and application thereof

Abstract

The application discloses a traditional Chinese medicine for treating hyperlipidemia and hypertension, which comprises an active ingredient, wherein the active ingredient is composed of the following components in parts by weight: American ginseng 6-14 parts, rhizoma polygonati 5-15 parts, fructus aurantii immaturus 9-15 parts, rhizoma atractylodis 18-60 parts, radix rehmanniae preparata 6-20 parts, prepared rhizome 15-60 parts, semen plantaginis 12-30 parts, earthworm 12-30 parts, hawthorn 15-60 parts, white mulberry root-bark 12-30 parts, and prunella vulgaris 20-80 parts; compared with the prior art, the application takes natural plants, American ginseng and prunella vulgaris, as the core components, and is composed of various traditional Chinese medicines for benefiting qi and invigorating the spleen, dredging bowels and resolving turbidity, so that the traditional Chinese medicine has the effects of invigorating the spleen, benefiting qi, dredging bowels and resolving turbidity; through organic matching of the medicines, three metabolisms are regulated, hyperlipidemia is reduced, the vascular intima is protected, blood lipid deposition in the vascular intima is reduced, the myocardial blood supply is improved, diuresis is achieved, the tension degree of blood vessels is relieved, and the like, so that the utility of improving clinical syndromes is achieved; the safety and effectiveness of the traditional Chinese medicine have been verified through clinical research, and the traditional Chinese medicine has good practical clinical application value.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine technology, specifically to a traditional Chinese medicine for treating hyperlipidemia and hypertension and its application. Background Technology

[0002] Hypertension is a common and frequently occurring disease, and also a silent killer. Poor control can lead to cardiovascular and cerebrovascular dysfunction and other complications. Cardiovascular and cerebrovascular diseases are among the most troublesome and difficult-to-treat diseases in the world today, and they also have the highest mortality and disability rates globally, with an increasing trend, especially among young and middle-aged people. This is a major problem for all mankind, and the serious consequences of poor treatment are a social responsibility of the medical community.

[0003] Traditional Chinese medicine (TCM) seeks to treat the root cause of disease; only by understanding the cause can we better treat the root cause. This is the fundamental starting point for TCM treatment.

[0004] (1) Hypertension is one of the important causes of cardiovascular and cerebrovascular diseases. Hypertension, hyperlipidemia, and diabetes are not terrible, but their complications are terrible. Hypertension, hyperlipidemia, and diabetes can all lead to cardiovascular and cerebrovascular diseases on their own. Moreover, in clinical practice, the three diseases often coexist and mutually exacerbate each other, making the condition more serious, more difficult to treat, and more difficult to control. Therefore, it is the most troublesome and difficult to cure disease in the world's medical community today. For example, primary hypertension is a cardiovascular disease. There are no ideal drugs for treating it with Western medicine, and they all have different degrees of side effects. For example, there are five types of commonly used antihypertensive drugs: ①. Diuretics hydrochlorothiazide. This drug reduces peripheral vascular resistance by promoting sodium and water excretion through the kidneys. Side effects of hydrochlorothiazide include hypokalemia, elevated blood glucose, uric acid, and cholesterol, which can accelerate cardiovascular and cerebrovascular complications. ② Beta-blockers, by blocking beta-receptors, slow heart rate, reduce cardiac output, increase the sensitivity of vascular smooth muscle to intravascular mediators, and inhibit renin secretion, thus lowering blood pressure. Side effects include bradycardia and conduction block, bronchospasm, heart failure, nausea, and diarrhea; they can also increase blood glucose, triglycerides, and cholesterol, and decrease high-density lipoprotein cholesterol levels; sudden discontinuation of these drugs in patients with coronary heart disease can induce angina. ③ Calcium channel blockers, by blocking calcium ion influx and intracellular calcium ion movement, affect myocardial and smooth muscle contraction, causing smooth muscle relaxation and peripheral vasodilation, thereby lowering blood pressure and relieving angina. Side effects include facial flushing, headache, dizziness, palpitations, and gastrointestinal discomfort. ④ Angiotensin-converting enzyme inhibitors, by inhibiting angiotensin-converting enzyme, reduce the production of angiotensin II, thereby reducing circulatory resistance and lowering blood pressure. Side effects include headache, nausea, loss of appetite, dry cough, rash, and decreased nuclear cells. ⑤ Alpha-receptor blockers block both α1 and α2 receptors by inhibiting adrenaline, noradrenaline, and the sympathetic nervous system, thereby reducing peripheral vascular resistance and dilating peripheral arterioles, thus lowering blood pressure. Side effects include headache, dizziness, fatigue, and tachycardia.

[0005] Hypertension is one of the main causes of cardiovascular and cerebrovascular diseases, and all five of the above-mentioned antihypertensive drugs have varying degrees of side effects. In particular, some antihypertensive drugs accelerate the progression of cardiovascular and cerebrovascular diseases, and commonly used antihypertensive drugs can lead to drug resistance, reducing their effectiveness.

[0006] Hyperlipidemia is a pathological condition resulting from three major metabolic disorders and is one of the main causes of hypertension. The formation of hyperlipidemia may involve many mechanisms; strengthening the control of blood lipid levels can indeed delay arteriosclerosis and prevent the development of hypertension. In addition, the normality of carbohydrate and protein metabolism, the activity of vascular endothelial cells and intima cells, the generation of mitochondrial reactive oxygen species, free radical oxidation, activation of intracellular signaling molecules, renal excretion, and hemodynamics are also pathways leading to its pathogenesis. These factors work together to cause hyperlipidemia and hypertension. Previously, the level of blood lipids and the degree of arteriosclerosis were generally considered important indicators of hyperlipidemia and hypertension. Arteriosclerosis is an initial indicator for determining the disease, but some hypertensive patients do not have the corresponding degree of arteriosclerosis as shown on imaging, yet their blood lipids and blood pressure remain high.

[0007] Currently, the prevention and treatment of hyperlipidemia mainly focuses on controlling blood lipids and blood pressure, with ideal blood lipid and blood pressure levels being the foundation of treatment. However, it is worth noting that the choice of Western medicine drugs remains quite confusing. Although many types of drugs can improve patients' blood lipid and blood pressure levels, their specific advantages in prevention and treatment still need to be clarified. Some require long-term or lifelong medication, and some have significant side effects. Regarding blood pressure control, while angiotensin-converting enzyme inhibitors and dihydropyridines can reduce mean arterial pressure by relieving vascular tension, lowering heart rate, improving calcium channel blocker function, and enhancing renal excretion, they have limited effect on regulating the body's own metabolic functions to promote blood lipid and blood pressure control.

[0008] To treat hypertension and / or hyperlipidemia and avoid the significant side effects of Western medicine, traditional Chinese medicine has accumulated rich experience in treatment. For example, patent application CN200710301254.7 discloses a drug for treating hypertension and hyperlipidemia and their complications, thereby addressing arteriosclerosis, coronary heart disease, angina pectoris, arrhythmia, myocardial infarction, cerebral thrombosis, cerebral embolism, cerebral infarction, cerebral atrophy, headache, dizziness, vertigo, sequelae of stroke, kidney deficiency, renal arteriosclerosis, renal hypertension, insomnia, and frequent urination. This medicine treats deficiency of both Qi and Blood, and also has therapeutic effects on fatty liver and diabetes. It is made from Ginkgo biloba leaves, Gynostemma pentaphyllum, Salvia miltiorrhiza, hawthorn slices, Ilex pubescens, Paeonia suffruticosa, leeches, Ligusticum chuanxiong, Curcuma longa, Angelica sinensis, processed Polygonum multiflorum, Eucommia ulmoides, Taxillus chinensis, Ligustrum lucidum, Epimedium brevicornu, Polygonatum sibiricum, Lycium chinense root bark, Pueraria lobata, Alisma plantago-aquatica, Cassia tora, Apocynum venetum, Uncaria rhynchophylla, Prunella vulgaris, Chrysanthemum indicum, Siegesbeckia orientalis, Scutellaria baicalensis, Pheretima aspergillum, and Allium macrostemon, prepared into powders and granules according to the conventional preparation methods in the pharmacopoeia. However, this drug contains a complex array of ingredients and, in addition to treating hypertension and hyperlipidemia, also considers treating arteriosclerosis, coronary heart disease, angina pectoris, arrhythmia, myocardial infarction, cerebral thrombosis, cerebral embolism, cerebral infarction, cerebral atrophy, headache, dizziness, vertigo, sequelae of stroke, kidney deficiency, renal arteriosclerosis, renal hypertension, insomnia, frequent urination, qi and blood deficiency syndrome, and also treats fatty liver, diabetes, and other diseases, which leads to a reduced therapeutic effect on hypertension and hyperlipidemia.

[0009] For example, patent application CN202011308614.8 discloses a traditional Chinese medicine composition for treating hypertension, which is made from the following medicinal materials in the following mass ratio: 17-22 parts of Salvia miltiorrhiza, 17-22 parts of Gastrodia elata, 15-20 parts of Polygonum multiflorum, 10-18 parts of Crataegus pinnatifida, 10-18 parts of Chrysanthemum indicum, 20-25 parts of Atractylodes macrocephala, 20-30 parts of Pueraria lobata, 25-33 parts of Uncaria rhynchophylla, 25-33 parts of Ginkgo biloba, 25-33 parts of Stephania tetrandra, 20-25 parts of Prunella vulgaris, 20-25 parts of Leonurus japonicus, 17-23 parts of Polygonatum sibiricum, 15-20 parts of Gardenia jasminoides, 20-30 parts of Alisma plantago-aquatica, 20-30 parts of Plantago asiatica, and 20-25 parts of Ligusticum chuanxiong; decocted and taken orally or as a tea substitute. This herbal composition contains too many and too varied ingredients. For example, the amount of Atractylodes macrocephala is too small and it does not have a diuretic or antihypertensive effect; Pueraria lobata and Stephania tetrandra do not have an antihypertensive effect.

[0010] Therefore, existing traditional Chinese medicines for treating hypertension and / or hyperlipidemia suffer from problems such as excessive and mixed medications, and a lack of research and development specifically targeting hypertension and / or hyperlipidemia, resulting in poor efficacy. Summary of the Invention

[0011] In view of the shortcomings of the existing technology, the purpose of this invention is to provide a traditional Chinese medicine for treating hyperlipidemia and hypertension and its preparation method, so as to solve the problem that the existing traditional Chinese medicines for treating hypertension and / or hyperlipidemia have the problems of excessive and complicated drugs and are not fully developed for hypertension and / or hyperlipidemia, resulting in poor efficacy.

[0012] To achieve the above objectives, the first aspect of the present invention adopts the following technical solution: a traditional Chinese medicine for treating hyperlipidemia and hypertension, comprising active ingredients, wherein the active ingredients are calculated by weight as follows: American ginseng 6-14 parts, Polygonatum sibiricum 6-15 parts, Citrus aurantium 9-15 parts, Atractylodes macrocephala 18-60 parts, Rehmannia glutinosa 6-20 parts, Polygonum multiflorum 15-60 parts, Plantago asiatica 12-30 parts, Pheretima aspergillum 12-30 parts, Crataegus pinnatifida 15-60 parts, Morus alba root bark 12-30 parts, and Prunella vulgaris 20-80 parts.

[0013] The second aspect of this invention adopts the following technical solution: the application of traditional Chinese medicine for treating hyperlipidemia and hypertension in the preparation of products for treating hyperlipidemia and hypertension.

[0014] Compared with the prior art, the present invention has the following beneficial effects:

[0015] The traditional Chinese medicine in this invention is based on natural plants American ginseng and prunella vulgaris as the core components, combined with a variety of other traditional Chinese medicines that invigorate qi, strengthen the spleen, and clear turbidity. This combination achieves the effects of invigorating the spleen, invigorating qi, clearing the bowels, and clearing turbidity. Through the organic combination of these drugs, it regulates the three major metabolisms, reduces hyperlipidemia, protects the vascular endothelium, reduces lipid deposition on the vascular wall, improves myocardial blood supply, promotes diuresis, and relieves vascular tension. These effects improve the efficacy of clinical symptoms. Clinical studies have confirmed its safety and effectiveness, demonstrating its good practical clinical application value. Detailed Implementation

[0016] The present invention will be further described in detail below through specific embodiments:

[0017] The first aspect of the present invention adopts the following technical solution: A traditional Chinese medicine for treating hyperlipidemia and hypertension, comprising active ingredients, and the active ingredients are composed of the following components according to parts by weight: 6-14 parts of American ginseng, 6-15 parts of polygonatum sibiricum, 9-15 parts of fructus aurantii immaturus, 18-60 parts of atractylodes macrocephala, 6-20 parts of rehmannia glutinosa, 15-60 parts of processed fleece-flower root, 12-30 parts of plantain seed, 12-30 parts of pheretima aspergillum, 15-60 parts of hawthorn fruit, 12-30 parts of mulberry bark, 20-80 parts of prunella vulgaris. Among them, the American ginseng can be 6 parts, 8 parts, 10 parts, 11 parts, 13 parts or 14 parts, etc.; the polygonatum sibiricum can be 6 parts, 7 parts, 10 parts, 11 parts, 12 parts or 15 parts, etc.; the fructus aurantii immaturus can be 9 parts, 10 parts, 12 parts, 14 parts or 15 parts, etc.; the atractylodes macrocephala can be 18 parts, 26 parts, 32 parts, 44 parts, 48 parts, 52 parts or 60 parts, etc.; the rehmannia glutinosa can be 6 parts, 10 parts, 12 parts, 14 parts, 16 parts, 18 parts or 20 parts, etc.; the processed fleece-flower root can be 15 parts, 20 parts, 30 parts, 40 parts, 50 parts or 60 parts, etc.; the plantain seed can be 12 parts, 15 parts, 18 parts, 20 parts, 25 parts or 30 parts, etc.; the pheretima aspergillum can be 12 parts, 15 parts, 18 parts, 21 parts, 24 parts, 27 parts or 30 parts, etc.; the hawthorn fruit can be 15 parts, 25 parts, 30 parts, 40 parts, 48 parts, 52 parts or 60 parts, etc.; the mulberry bark can be 12 parts, 14 parts, 18 parts, 23 parts, 26 parts or 30 parts, etc.; the prunella vulgaris can be 20 parts, 30 parts, 40 parts, 50 parts, 60 parts, 70 parts or 80 parts, etc.

[0018] Each of the above raw medicinal materials can be traditional Chinese medicine cut pieces; at the same time, for the convenience of drug quality control, each of the above raw medicinal materials can also be traditional Chinese medicine formula granules made by extracting and concentrating the traditional Chinese medicine cut pieces after processing according to traditional standards, and no specific limitation is made here. The specific effects of each raw medicinal material of the active ingredients are as follows:

[0019] American ginseng, sweet, slightly bitter, cool. Non-toxic. Returning to the heart, lung and kidney meridians. Mainly replenishing qi and nourishing yin, clearing heat and promoting fluid production. The medicinal power is mild, tonifying qi and yin, and being good at clearing and tonifying. It has the effects of anti-myocardial ischemia, protecting the myocardium, and inhibiting vascular tension, lipase activity and fat absorption.

[0020] Polygonatum sibiricum, sweet, flat. Non-toxic. Returning to the lung, spleen and kidney meridians. Mainly replenishing qi and nourishing yin, strengthening the spleen, moistening the lung and tonifying the kidney. "Compendium of Materia Medica" states that it "mainly replenishes the middle qi, removes dampness and tranquilizes the five internal organs". It has the effects of increasing coronary blood flow, significantly inhibiting cholesterol biosynthesis and reducing endogenous cholesterol production.

[0021] Fructus aurantii immaturus, bitter, sweet, sour, slightly cold. Returning to the spleen, stomach and large intestine meridians. Mainly breaking qi and reducing accumulation, resolving phlegm and removing stuffiness. "Supplementary Records of Materia Medica" states that it "expels phlegm, can break through walls and overthrow walls, and is a drug that lubricates the organs and discharges qi". Research shows that fructus aurantii immaturus has a dual regulatory effect on the contraction and relaxation of gastrointestinal smooth muscle, inhibits Helicobacter pylori and has a diuretic effect.

[0022] Atractylodes macrocephala, bitter, sweet, and warm in nature. Non-toxic. It enters the spleen and stomach meridians. Its main functions are to strengthen the spleen and replenish qi, dry dampness and promote diuresis. The *Benfang Tongcao* states, "This herb tonifies the spleen and stomach...when the earth element is strong, clear qi rises, and the essence ascends; turbid qi descends, and waste is transported downwards." It has an excitatory effect on intestinal smooth muscle, promotes diuresis, accelerates carbohydrate metabolism, and inhibits glycogenolysis.

[0023] Processed He Shou Wu (Polygonum multiflorum) is bitter, sweet, and slightly warm in nature. It enters the heart, liver, and kidney meridians. Its main functions are to tonify the liver and kidneys, strengthen tendons and bones, and reduce turbidity and lipids. The *Ben Cao Zhen Jing* (True Classic of Materia Medica) states that "He Shou Wu is slightly warm, neither too stagnant in yin nor too dry in yang, making it a yang-within-yin medicine," and that it is "necessary for regulating and tonifying acquired blood." It enhances the scavenging of oxygen free radicals, protects vascular endothelial cells, prevents atherosclerosis, regulates the three major metabolic processes, and promotes the restoration of normal liver lipid metabolism.

[0024] Rehmannia glutinosa (Shu Di Huang) is sweet and warm in nature. It enters the liver and kidney meridians. Its main functions are to nourish blood and yin, replenish essence and marrow. According to *Pharmacopoeia of Chinese Herbal Medicines*, it is a "holy medicine" that "soothes the five internal organs, harmonizes blood vessels, nourishes the heart and spirit, and replenishes true yin." It also has myocardial protection, blood pressure lowering, and intestinal beneficial flora enhancement effects, optimizing intestinal absorption. Furthermore, it has hypoglycemic and lipid-lowering functions.

[0025] Plantain seed, sweet and slightly cold in nature. It enters the liver, kidney, and small intestine meridians. Its main functions are clearing heat and promoting urination, draining dampness and stopping diarrhea, and eliminating phlegm. The *Compendium of Materia Medica* states that it "guides away heat from the small intestine." It also enhances the activity of superoxide dismutase, regulates lipid metabolism, and protects vascular endothelial cells.

[0026] Earthworm, salty and cold in nature. It enters the liver, spleen, and bladder meridians, and primarily clears heat, calms the nerves, unblocks the meridians, and promotes diuresis. Studies have shown that it regulates aldosterone levels and has a central nervous system effect, thereby lowering blood pressure. Its mechanism of action in lowering serum cholesterol is similar to that of statins, but without the side effects of statins.

[0027] Hawthorn is slightly warm and sweet. It enters the spleen, stomach, and liver meridians. Its main functions are to aid digestion, strengthen the spleen, promote qi circulation, dispel blood stasis, and reduce lipids. Studies have shown that hawthorn can dilate peripheral blood vessels to lower blood pressure, enhance the resistance of vascular endothelial cells to damage, and regulate and promote lipid breakdown.

[0028] Mulberry bark is sweet and cold in nature. It enters the lung meridian and is mainly used to purge lung heat, relieve asthma, promote diuresis, and reduce swelling. The Compendium of Materia Medica states, "Mulberry bark excels at purging water; its fruit is used to purge the seeds." It also inhibits aortic annulus contraction, improves microcirculation, and reduces the absorption of carbohydrates and lipids in the intestines.

[0029] Prunella vulgaris is pungent, bitter, and cold in nature. It enters the liver and gallbladder meridians, and is mainly used to clear liver heat and improve eyesight, as well as disperse nodules and reduce swelling. Modern pharmacological studies have shown that it has an antagonistic effect against vascular tension and can lower both diastolic and systolic blood pressure.

[0030] Hyperlipidemia is not a disease in traditional Chinese medicine (TCM) theory. Hypertension, on the other hand, falls under the categories of headache and chest pain in TCM. TCM theory considers its basic pathogenesis to be qi stagnation, liver yang hyperactivity, damp-heat in the liver and gallbladder, phlegm-heat disturbance, blood stasis, and deficiency of both qi and yin. The inventor believes that the core pathogenesis of hyperlipidemia and hypertension is the obstruction of qi, blood, and body fluid circulation, and phlegm-blood stasis. Hyperlipidemia and hypertension are the clinical symptoms. The key disease locations are the spleen, kidneys, small intestine, and bladder, and it also involves the lungs, liver, and heart.

[0031] Therefore, if the form is insufficient, warm it with qi; if the essence is insufficient, supplement it with flavor and drain its excess. In the aforementioned traditional Chinese medicine preparations, the spleen, being the central earth element, governs transportation and transformation, and is the source of qi, blood, and body fluids; the lungs, being the canopy, govern distribution. American ginseng and atractylodes macrocephala are used together to tonify qi and strengthen the spleen, serving as the principal herbs. The spleen and stomach, lungs and large intestine, heart and small intestine, and kidneys and bladder are internally and externally related. These three fu organs are important sites for separating clear and turbid fluids. The six fu organs function by unblocking. Fructus Aurantii Immaturus, Semen Plantaginis, and Fructus Crataegi are used to drain excess fluids. Radix Polygoni Multiflori and Rhizoma Polygonati are used to tonify qi and blood with a slightly warming effect, to prevent the coldness of herb Prunella vulgaris from harming the stomach. Cortex Mori var. Lung promotes lung function to assist the effects of American ginseng and atractylodes macrocephala. Fructus Crataegi, with its digestive and turbidity-resolving properties, serves as the assistant herbs. Herb Prunella vulgaris clears heat and removes dampness, preventing the tonifying effects of American ginseng, atractylodes macrocephala, Radix Polygoni Multiflori, and Rhizoma Polygonati from causing greasiness, generating heat and dampness, serving as the adjuvant herbs. Since the disease location is in the blood, Radix Rehmanniae Preparata is used to tonify blood and guide the medicine to the meridians, while Herba Pheretimaecifoliae is used to invigorate blood and unblock the collaterals, guiding the medicine to its proper channels, serving as the guiding herbs. When used together, these herbs have the effect of strengthening the spleen and replenishing qi, clearing away turbidity and lowering lipids.

[0032] Modern pharmacological studies have shown that Fructus Aurantii Immaturus and Panax notoginseng have cardiotonic effects, increasing blood circulation and reducing lipid deposition in blood vessels. Panax notoginseng, Prunella vulgaris, Polygonatum sibiricum, Pheretima aspergillum, Plantago asiatica, and Polygonum multiflorum have protective effects on vascular endothelial cells. Mulberry bark assists in improving vascular tension and dilating capillaries, thereby reducing peripheral resistance and lowering blood pressure. Fructus Aurantii Immaturus and Atractylodes macrocephala enhance gastrointestinal smooth muscle contraction and intestinal excretion, while Rehmannia glutinosa improves intestinal flora. These three, combined with Mulberry bark, reduce intestinal absorption of cholesterol and sugars. Panax notoginseng, Crataegus pinnatifida, Plantago asiatica, and Polygonum multiflorum promote hepatocyte activity, regulate the three major metabolic processes, promote lipase activity, and promote lipid conversion and decomposition. Plantago asiatica and Atractylodes macrocephala have diuretic functions and promote metabolic excretion. Therefore, the combination of these traditional Chinese medicine preparations can effectively reduce fat absorption, promote fat decomposition and excretion to lower lipids, and lower blood pressure by protecting vascular endothelial cells, improving vascular elasticity, relieving vascular tension, improving microcirculation, and reducing peripheral resistance.

[0033] The optimized weight ratio of American ginseng, Polygonatum sibiricum, Citrus aurantium, Atractylodes macrocephala, Rehmannia glutinosa, Polygonum multiflorum (processed), Plantago asiatica, Pheretima aspergillum, Crataegus pinnatifida, Morus alba root bark, and Prunella vulgaris is 1:1:1.5:3:1:4:2:2:3:2:4. For example, American ginseng is 6 parts, Polygonatum sibiricum is 6 parts, Citrus aurantium is 9 parts, Atractylodes macrocephala is 18 parts, Rehmannia glutinosa is 6 parts, Polygonum multiflorum (processed) is 24 parts, Plantago asiatica is 12 parts, Pheretima aspergillum is 12 parts, Crataegus pinnatifida is 18 parts, Morus alba root bark is 12 parts, and Prunella vulgaris is 24 parts. This is the optimal ratio of the active ingredients to achieve the best therapeutic effect.

[0034] Optimization also includes pharmaceutically acceptable excipients.

[0035] Optimized, the pharmaceutically acceptable excipients constitute 1%-98% of the weight of the traditional Chinese medicine. Specifically, the excipients can constitute 1%, 5%, 8%, 10%, 14%, 17%, 20%, 23%, 26%, 30%, 35%, 39%, 42%, 47%, 51%, 55%, 58%, 62%, 65%, 68%, 72%, 76%, 80%, 83%, 87%, 90%, 94%, or 98% of the weight of the traditional Chinese medicine; typically, 80% of the excipients constitute the weight of the traditional Chinese medicine.

[0036] Optimally, the excipients can be ion exchangers, alumina, aluminum stearate, mucin, buffering agents, glycerol, sorbitol, potassium sorbate, water, salts, or electrolytes. The buffering agents are phosphates, and the electrolytes include protamine sulfate, potassium hydrogen phosphate, zinc salts, etc.

[0037] Optimized, the dosage form of the traditional Chinese medicine is either a liquid dosage form or a solid dosage form.

[0038] Optimized, the liquid dosage forms include true solutions (such as decoctions), colloids, microparticles, emulsions, and suspensions.

[0039] Optimized, the solid dosage forms include oral tablets, capsules, pills, powders, granules, lyophilized powder injections, inclusion complexes, and implants.

[0040] Optimized, the oral tablets and capsules contain excipients, lubricants, disintegrants, or acceptable humectants. The excipients are preferably dextrin or corn silk starch, but calcium phosphate, sorbitol, or glycine can also be used; the lubricant can be magnesium stearate, talc, polyethylene glycol, or silica; the disintegrant can be potato starch; and the humectant can be sodium lauryl sulfate.

[0041] Note that when choosing, sodium salts and lipids should be used with caution.

[0042] The specific preparation method of the above-mentioned traditional Chinese medicine for treating hyperlipidemia and hypertension is not specifically limited, and those skilled in the art can produce and prepare it according to the corresponding dosage form. Clinical effects vary depending on the manufacturing process. In one specific embodiment of the present invention, the active pharmaceutical ingredient of the traditional Chinese medicine for treating hyperlipidemia and hypertension can be prepared by any one of the following two methods.

[0043] First preparation method:

[0044] 1. The above-mentioned Chinese herbs, including immature bitter orange, atractylodes macrocephala, prepared he shou wu, plantain seed, and mulberry bark, are decocted, cooled, and precipitated to form a concentrated liquid to obtain a clear extract.

[0045] 2. Grind American ginseng, polygonatum, rehmannia glutinosa, earthworm, hawthorn, prunella vulgaris, and other medicinal herbs into powder to form raw medicinal materials;

[0046] 3. Mix the above-mentioned ointment with the raw medicinal powder, add an appropriate amount of Yuxu flour, mix and shape into water pills, and then dry them (dry the water pills at 90 degrees for 15 minutes, and then at 45 degrees for 30-45 minutes).

[0047] The second preparation method:

[0048] 1. Mix American ginseng, polygonatum, immature bitter orange, atractylodes macrocephala, prepared rehmannia root, prepared fleeceflower root, plantain seed, hawthorn, mulberry bark, and prunella vulgaris;

[0049] 2. Add 8 times the amount of water, soak for 15 minutes, then decoct for 15 minutes and pour out the liquid.

[0050] 3. Add 6 times the amount of water to the dregs and simmer for 10 minutes. Finally, mix the two decoctions together.

[0051] 4. The mixed liquid is separated into solid and liquid components and concentrated. Dextrin and earthworm powder are added after concentration. The mixture is then spray-dried, dry-granulated, and sieved to obtain granules.

[0052] In another specific embodiment of the present invention, the application of the above-mentioned traditional Chinese medicine for treating hyperlipidemia and hypertension in the preparation of products for treating hyperlipidemia and hypertension is provided.

[0053] To enable those skilled in the art to better understand the technical solution of the present invention, the technical solution of the present invention will be described in detail below with reference to specific embodiments.

[0054] Example 1

[0055] A traditional Chinese medicine formula for treating hyperlipidemia and hypertension includes 6g of American ginseng, 6g of Polygonatum sibiricum, 9g of Citrus aurantium, 18g of Atractylodes macrocephala, 6g of Rehmannia glutinosa, 24g of Polygonum multiflorum (processed), 12g of Plantago asiatica, 30g of Pheretima aspergillum, 18g of Crataegus pinnatifida, 12g of Morus alba root bark, 24g of Prunella vulgaris, and 60g of corn silk flour. First, Citrus aurantium, Atractylodes macrocephala, Polygonum multiflorum (processed), Plantago asiatica, and Morus alba root bark are decocted, cooled, and allowed to settle to form a concentrated extract. Then, the American ginseng, Polygonatum sibiricum, Rehmannia glutinosa (processed), Pheretima aspergillum, Crataegus pinnatifida, Prunella vulgaris, and other herbs are pulverized to form medicinal powder. The concentrated extract is then mixed with the medicinal powder, and corn silk flour is added to form pills, which are then dried. The drying process involves first drying at 90 degrees Celsius for 15 minutes, and then drying at 45 degrees Celsius for 30-45 minutes.

[0056] Example 2

[0057] A traditional Chinese medicine formula for treating hyperlipidemia and hypertension includes 9g of American ginseng, 9g of Polygonatum sibiricum, 15g of Citrus aurantium, 30g of Atractylodes macrocephala, 9g of Rehmannia glutinosa, 36g of Polygonum multiflorum (processed), 18g of Plantago asiatica, 15g of Pheretima aspergillum, 27g of Crataegus pinnatifida, 15g of Morus alba root bark, 35g of Prunella vulgaris, and 60g of corn silk flour. First, Citrus aurantium, Atractylodes macrocephala, Polygonum multiflorum (processed), Plantago asiatica, and Morus alba root bark are decocted, cooled, and allowed to settle to form a concentrated extract. Then, the American ginseng, Polygonatum sibiricum, Rehmannia glutinosa, Pheretima aspergillum, Crataegus pinnatifida, Prunella vulgaris, and other herbs are pulverized to form a medicinal powder. The concentrated extract and the medicinal powder are then mixed, and the corn silk flour is added to form pills, which are then dried. The drying process involves first drying at 90 degrees Celsius for 15 minutes, and then drying at 45 degrees Celsius for 30-45 minutes.

[0058] Example 3

[0059] A traditional Chinese medicine for treating hyperlipidemia and hypertension includes 6g of American ginseng, 6g of Polygonatum sibiricum, 9g of Citrus aurantium, 20g of Atractylodes macrocephala, 6g of Rehmannia glutinosa, 24g of Polygonum multiflorum, 12g of Plantago asiatica, 20g of Pheretima aspergillum, 20g of Crataegus pinnatifida, 20g of Morus alba root bark, 35g of Prunella vulgaris, and 20g of dextrin. First, mix the American ginseng, Polygonatum sibiricum, Citrus aurantium, Atractylodes macrocephala, Rehmannia glutinosa, Polygonum multiflorum, Plantago asiatica, Crataegus pinnatifida, Morus alba root bark, and Prunella vulgaris. Then add 8 times the amount of water, soak for 15 minutes, then decoct for 15 minutes and pour out the liquid. Next, add 6 times the amount of water to the dregs and decoct for 10 minutes. Finally, mix the two liquids thoroughly. The mixed liquid is then subjected to solid-liquid separation and concentration. After concentration, dextrin and Pheretima aspergillum powder are added, followed by spray drying, dry granulation, and sieving to obtain granules.

[0060] Example 4

[0061] A traditional Chinese medicine for treating hyperlipidemia and hypertension includes 14g of American ginseng, 14g of Polygonatum sibiricum, 15g of Citrus aurantium, 40g of Atractylodes macrocephala, 15g of Rehmannia glutinosa, 40g of Polygonum multiflorum, 20g of Plantago asiatica, 20g of Pheretima aspergillum, 40g of Crataegus pinnatifida, 20g of Morus alba root bark, 50g of Prunella vulgaris, and 12g of dextrin. First, mix the American ginseng, Polygonatum sibiricum, Citrus aurantium, Atractylodes macrocephala, Rehmannia glutinosa, Polygonum multiflorum, Plantago asiatica, Crataegus pinnatifida, Morus alba root bark, and Prunella vulgaris. Then add 8 times the amount of water, soak for 15 minutes, then decoct for 15 minutes and pour out the liquid. Next, add 6 times the amount of water to the dregs and decoct for 10 minutes. Finally, mix the two liquids thoroughly. The mixed liquid is then subjected to solid-liquid separation and concentration. After concentration, dextrin and Pheretima aspergillum powder are added, followed by spray drying, dry granulation, and sieving to obtain granules.

[0062] Example 5

[0063] A traditional Chinese medicine for treating hyperlipidemia and hypertension includes 9g of American ginseng, 9g of Polygonatum sibiricum, 13.5g of Citrus aurantium, 27g of Atractylodes macrocephala, 9g of Rehmannia glutinosa, 36g of Polygonum multiflorum, 18g of Plantago asiatica, 18g of Pheretima aspergillum, 27g of Crataegus pinnatifida, 18g of Morus alba root bark, 36g of Prunella vulgaris, and 60g of dextrin. First, the American ginseng, Polygonatum sibiricum, Citrus aurantium, Atractylodes macrocephala, Rehmannia glutinosa, Polygonum multiflorum, Plantago asiatica, Crataegus pinnatifida, Morus alba root bark, and Prunella vulgaris are mixed into powder. The powder is then mixed with dextrin, spray-dried, dry-granulated, and sieved to obtain granules.

[0064] Example 6

[0065] A traditional Chinese medicine for treating hyperlipidemia and hypertension includes 6g of American ginseng, 6g of Polygonatum sibiricum, 9g of Citrus aurantium, 18g of Atractylodes macrocephala, 6g of Rehmannia glutinosa, 24g of Polygonum multiflorum, 12g of Plantago asiatica, 12g of Pheretima aspergillum, 18g of Crataegus pinnatifida, 12g of Morus alba root bark, 24g of Prunella vulgaris, and 60g of dextrin. First, the American ginseng, Polygonatum sibiricum, Citrus aurantium, Atractylodes macrocephala, Rehmannia glutinosa, Polygonum multiflorum, Plantago asiatica, Crataegus pinnatifida, Morus alba root bark, and Prunella vulgaris are mixed into powder. The powder is then mixed with dextrin, spray-dried, dry-granulated, and sieved to obtain granules.

[0066] Comparative Example 1

[0067] The difference from Example 6 is that: no immature bitter orange and American ginseng were added, and the amount of prunella vulgaris added was changed to 39g.

[0068] Comparative Example 2

[0069] The difference from Example 6 is that no immature bitter orange was added, and the amount of prunella vulgaris added was changed to 30g.

[0070] Comparative Example 3

[0071] The difference from Example 6 is that American ginseng was not added, and the amount of Prunella vulgaris added was changed to 33g.

[0072] Comparative Example 4

[0073] The difference from Example 6 is that the amount of Citrus aurantium added is changed to 14g and the amount of American ginseng added is changed to 10g.

[0074] Comparative Example 5

[0075] The difference from Example 6 is that the added Citrus aurantium is replaced with Citrus aurantium peel.

[0076] I. Experimental Verification

[0077] Twelve male, spontaneously hypertensive rats (SHR120, 12 weeks old, weighing 200±20g, Beijing Vital River Co., Ltd.) were randomly divided into 12 groups of 10 rats each using a random number table. The 11 groups of animals were administered 5g·kg⁻¹ of medication daily. -1 The dosages were administered by gavage once in Examples 1-6 and Comparative Examples 1-5. The blank group was given the same volume of physiological saline. After two months of continuous drug administration, the tail artery pulsation method was used to measure the blood pressure of rats non-invasively. The blood pressure of all rats was measured once before drug administration and once at one and two months after drug administration. The average value of three measurements was taken for each blood pressure measurement.

[0078] Table 1 Comparison of test values ​​before and after the experiment.

[0079]

[0080] In Examples 1-6, blood pressure and total cholesterol levels were effectively reduced before and after the experiment. However, compared with Example 6, Comparative Examples 1-6 showed that the combination of Citrus aurantium, Panax quinquefolius, Prunella vulgaris, and the other components of this traditional Chinese medicine was necessary to effectively improve blood pressure and total cholesterol levels.

[0081] II. Clinical Validation

[0082] Clinical efficacy evaluation of the combination of experimental testing and blood pressure monitoring in the treatment of hypertension and hyperlipidemia

[0083] Forty patients meeting the criteria of stage I hypertension (blood pressure 145-160 / 95-110 mmHg) and hyperlipidemia (total cholesterol 5.6-7 mmol / L) with LDL cholesterol higher than 4.11 mmol / L were included in this clinical study. They were randomly divided into a control group (n=10) and a traditional Chinese medicine (TCM) group (n=20). The TCM group was further divided into two subgroups: one subgroup received the TCM prepared in Example 2, and the other subgroup received the TCM prepared in Example 5. Clinical efficacy was evaluated through blood sampling, weight monitoring, and blood pressure monitoring.

[0084] Treatment plan:

[0085] The control group received the same health management treatment, but took oral sartans (a type of Western medicine).

[0086] In the traditional Chinese medicine group, patients with stage I hypertension received only traditional Chinese medicine, while patients with stage II hypertension received both valsartan (at the same dosage as the control group) and traditional Chinese medicine. After their blood pressure stabilized, the dosage of Western medicine was adjusted. After 30 days, the valsartan dosage was halved, and traditional Chinese medicine was continued. After 60 days, valsartan was completely discontinued, and only traditional Chinese medicine was taken. Changes in blood pressure and blood lipids were continuously monitored for 30 to 60 days.

[0087] Special notes: First, for patients with stage II and III hypertension, the use of Western antihypertensive drugs is to prevent hypertensive crisis, cerebral hemorrhage, etc.; for stage I hypertension, Western antihypertensive drugs are not used. Second, the purpose of this clinical observation is to prove that, in addition to treating patients with hypertension and hyperlipidemia, this invention can solve the problem of patients with hypertension and hyperlipidemia not having to take medication for life through clinical treatment and observation under the condition of consistent health management.

[0088] Monitoring Plan:

[0089] 1. Blood monitoring, fasting blood pressure three times a day: 7:30, 12:00, and 7:00; automatic blood pressure monitoring via cuff.

[0090] 2. Blood lipid monitoring: Venous blood lipid concentration monitoring every half month or 1 month.

[0091] In the control group, within one month, 50% of patients had stable hypertension within 15 days, 60% within 20 days, and 85% within 30 days, with 15% requiring the use of dihydropyridine calcium channel blockers. Upon discontinuation of medication after one month, the relapse rate reached 90% within 7 days, necessitating long-term medication. Blood lipid levels did not decrease significantly, remaining in a hyperlipidemic state.

[0092] In the traditional Chinese medicine group, within one month, 75% of patients with hypertension remained stable within 15 days, 90% within 20 days, and 95% within 30 days, with 5% requiring dihydropyridine calcium channel blockers. Within two months, Western medicine was discontinued, and only the traditional Chinese medicine prepared in Example 2 or Example 5 was used; there was no rebound rate within 15 days. Blood lipids decreased significantly; within 30 days, 65% had normal blood lipids; within two months, 90% had normal blood lipids, with only two patients achieving normal blood lipids after 35 days.

[0093] III. Specific Case Studies

[0094] Implementation Case 1

[0095] Mr. Fu, male, 51 years old, 169cm tall, weighing 78kg. One year ago, during a health check-up, his blood pressure was found to be 178mmHg systolic and 112mmHg diastolic; his blood lipids were 6.19mmol total cholesterol, including 1.07mmol high-density lipoprotein and 4.84mmol low-density lipoprotein.

[0096] The diagnosis was: primary stage II hypertension and hyperlipidemia.

[0097] Treatment regimen: Oral administration of valsartan 25mg and bendipine tablets 25mg, once daily. Oral administration of the traditional Chinese medicine prepared in Example 6, three times daily.

[0098] Health prescription: Monitor blood pressure three times a day (morning, noon, and evening), change dietary habits, and exercise appropriately.

[0099] Efficacy: After 15 days, blood pressure was 135 mmHg systolic and 94 mmHg diastolic, and weight was 74 kg. The treatment plan was adjusted to oral valsartan 25 mg once daily and the traditional Chinese medicine prepared in Example 6 three times daily. After one week of monitoring, the blood pressure remained stable at approximately 135 mmHg systolic and 94 mmHg diastolic. After 30 days, blood pressure remained at 135 mmHg systolic and 90 mmHg diastolic, and weight remained at approximately 71 kg. Blood lipids: total cholesterol 5.79 mmol, including 1.17 mmol high-density lipoprotein and 4.54 mmol low-density lipoprotein. The treatment plan was adjusted to oral valsartan 25 mg once daily and the traditional Chinese medicine prepared in Example 6 twice daily. After 2 months, blood pressure remained at 135 mmHg systolic and 90 mmHg diastolic, and weight remained at approximately 71 kg. Blood lipids: total cholesterol 4.09 mmol, including 1.25 mmol high-density lipoprotein and 2.04 mmol low-density lipoprotein. After discontinuing valsartan and taking only the traditional Chinese medicine described in Example 6, monitoring showed that blood pressure and blood lipid levels were within the normal range.

[0100] Implementation Case 2

[0101] Mr. Shao, male, 38 years old, 165cm tall, 84kg, presented with dizziness and palpitations 3 years ago. His blood pressure was 125mmHg systolic and 85mmHg diastolic. His blood lipids were 6.64mmol total cholesterol, including 1.25mmol high-density lipoprotein and 5.15mmol low-density lipoprotein.

[0102] The diagnosis was hyperlipidemia.

[0103] Treatment plan: Oral administration of the traditional Chinese medicine prepared in Example 6, 10 grams each time, three times a day.

[0104] Health prescription: Monitor your weight three times a day (morning, noon, and evening), change your diet structure, and exercise appropriately.

[0105] Efficacy: After 30 days, blood lipid monitoring showed total cholesterol of 5.91 mmol, including high-density lipoprotein (HDL) of 1.17 mmol and low-density lipoprotein (LDL) of 4.64 mmol; weight was 79 kg, and maintenance treatment was continued. Two months later, blood lipids were rechecked. Blood lipids showed total cholesterol of 5.60 mmol, including HDL of 2.17 mmol and LDL of 4.24 mmol; weight was 75 kg. The treatment plan was adjusted to oral administration of the traditional Chinese medicine prepared in Example 6, 10 grams each time, twice a day, for maintenance. After 3 months, medication was discontinued and a one-month follow-up was conducted, with only health management; blood lipids showed no rebound.

[0106] Implementation Case 3

[0107] Ms. Li, 56 years old, 155cm tall, 61kg, presented to the outpatient clinic 5 years ago with headaches, dizziness, palpitations, and irritability. She was diagnosed with primary stage II hypertension and hyperlipidemia and has been taking oral dihydropyridine calcium channel blockers. Due to unsatisfactory blood pressure control, fluctuating between high and low levels, she sought further medical attention. Her blood pressure was 152 mmHg systolic and 101 mmHg diastolic. Her blood lipids were: total cholesterol 6.04 mmol / L, including 1.25 mmol / L high-density lipoprotein and 4.65 mmol / L low-density lipoprotein. The diagnosis was primary hypertension and hyperlipidemia.

[0108] Treatment plan: Maintain the original medication regimen, oral dihydropyridine antihypertensive drugs; add oral administration of the traditional Chinese medicine in Example 6, 10 grams each time, three times a day.

[0109] Health prescription: Monitor your weight three times a day (morning, noon, and evening), change your diet structure, and exercise appropriately.

[0110] Efficacy: After 30 days, blood lipid monitoring showed: total cholesterol 5.84 mmol, including: high-density lipoprotein 1.19 mmol and low-density lipoprotein 4.80 mmol; weight 57 kg; blood pressure: systolic 140 mmHg and diastolic 95 mmHg; Western medicine was changed to valsartan 25 mg three times a day, while the traditional Chinese medicine treatment plan remained unchanged; at the follow-up visit 2 months later, blood pressure was stable at: systolic 140 mmHg and diastolic 90 mmHg, blood lipids: total cholesterol 5.10 mmol, including: high-density lipoprotein 1.71 mmol and low-density lipoprotein 3.04 mmol, and weight 54 kg; valsartan was discontinued, and only the traditional Chinese medicine of Example 6 was used, 10 grams each time, twice a day, for one month. At the follow-up visit, the relevant indicators returned to normal.

[0111] Implementation Case 4

[0112] Mr. Guan, male, 48 years old, 175cm tall, weighing 81kg; two years ago, he sought medical attention at the outpatient clinic due to dizziness, blurred vision, poor sleep, and was diagnosed with primary stage I hypertension and hyperlipidemia. He has been taking oral dihydropyridine calcium channel blockers and lipoprotein iodine. He came for further consultation because his diastolic blood pressure was not well controlled, consistently hovering around 95 mmHg, fluctuating between high and low levels. Physical examination: Blood pressure: systolic 145 mmHg, diastolic 100 mmHg; Blood lipids: total cholesterol 6.54 mmol, including: high-density lipoprotein 1.45 mmol, low-density lipoprotein 4.15 mmol; The diagnosis was: primary hypertension and hyperlipidemia.

[0113] Treatment plan: Oral administration of the traditional Chinese medicine prepared in Example 6, 12 grams each time, three times a day.

[0114] Health prescription: Monitor your weight three times a day (morning, noon, and evening), change your diet structure, and exercise appropriately.

[0115] Efficacy: At the follow-up visit after 30 days, physical examination revealed: blood pressure: systolic 139 mmHg, diastolic 94 mmHg; blood lipid monitoring showed: total cholesterol 5.78 mmol, including: high-density lipoprotein 1.25 mmol, low-density lipoprotein 4.53 mmol; weight 75 kg; maintenance treatment continued. At 2 months, physical examination revealed: blood pressure: systolic 130 mmHg, diastolic 85 mmHg; blood lipid re-examination showed: total cholesterol 5.60 mmol, including: high-density lipoprotein 2.07 mmol, low-density lipoprotein 4.54 mmol; weight 73 kg. The treatment plan was adjusted to oral administration of the traditional Chinese medicine prepared in Example 6, 10 grams each time, twice a day, for maintenance. After 3 months, medication was discontinued and a 1-month follow-up was conducted, with only health management; blood lipids showed no rebound.

[0116] Special Note: This invention of traditional Chinese medicine is guided by TCM theory and oriented towards clinical value. The technical solution provides a clear and complete description of the invention, including information on the raw materials of the medicinal materials, experimental data and implementation cases that meet the technical effects, the compatibility theory of the prescription and the principles of formulation, and meets the full disclosure requirements of relevant laws and regulations.

[0117] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention and are not intended to limit it. Although the present invention has been described in detail with reference to preferred embodiments, those skilled in the art should understand that modifications or equivalent substitutions can be made to the technical solutions of the present invention without departing from the spirit and scope of the technical solutions of the present invention, and all such modifications or substitutions should be covered within the scope of the claims of the present invention.

Claims

1. A traditional Chinese medicine for treating hyperlipidemia and hypertension, characterized in that, It is composed of active ingredients and pharmaceutically acceptable excipients. The active ingredients are composed of the following components in parts by weight: American ginseng 6-14 parts, Polygonatum sibiricum 6-15 parts, Citrus aurantium 9-15 parts, Atractylodes macrocephala 18-60 parts, Rehmannia glutinosa 6-20 parts, Polygonum multiflorum 15-60 parts, Plantago asiatica 12-30 parts, Pheretima aspergillum 12-30 parts, Crataegus pinnatifida 15-60 parts, Morus alba root bark 12-30 parts, and Prunella vulgaris 20-80 parts.

2. The traditional Chinese medicine for treating hyperlipidemia and hypertension according to claim 1, characterized in that: The optimal weight ratio of American ginseng, polygonatum, immature bitter orange, atractylodes macrocephala, prepared rehmannia root, prepared fleeceflower root, plantain seed, earthworm, hawthorn, mulberry bark, and prunella vulgaris is 1:1:1.5:3:1:4:2:2:3:2:

4.

3. The traditional Chinese medicine for treating hyperlipidemia and hypertension according to claim 1, characterized in that: The pharmaceutically acceptable excipients constitute 1%-98% of the weight of the traditional Chinese medicine.

4. The traditional Chinese medicine for treating hyperlipidemia and hypertension according to claim 3, characterized in that: The dosage form of the traditional Chinese medicine is either liquid or solid.

5. The traditional Chinese medicine for treating hyperlipidemia and hypertension according to claim 4, characterized in that: The liquid dosage forms include emulsions and suspensions.

6. The traditional Chinese medicine for treating hyperlipidemia and hypertension according to claim 4, characterized in that: The solid dosage forms include oral tablets, capsules, pills, powders, granules, and lyophilized powder injections.

7. The traditional Chinese medicine for treating hyperlipidemia and hypertension according to claim 6, characterized in that: The oral tablets and capsules contain excipients, lubricants, disintegrants, or acceptable humectants.

8. The use of any one of the traditional Chinese medicines for treating hyperlipidemia and hypertension according to claims 1-7 in the preparation of medicines for treating hyperlipidemia and hypertension.

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