A traditional Chinese medicine compound composition for treating cardiovascular and cerebrovascular diseases, and its preparation method and application

Abstract

The present invention discloses a Chinese medicine compound composition for treating cardiovascular and cerebrovascular diseases, and its preparation method and application. The Chinese medicine compound composition is composed of American ginseng, Panax notoginseng, Astragalus, Pueraria root, Crataegus, Chuanxiong and Salvia miltiorrhiza. The Chinese medicine compound composition adopts modern preparation technology, extracts and separates according to the effective chemical components of different medicinal flavors, obtains saponins, polysaccharides, flavonoids, alkaloids, phenolic acids and other effective medicinal ingredients, and then is fermented and degraded by probiotics to prepare the composition. The Chinese medicine compound composition of the present invention has the effects of replenishing vital energy, promoting blood circulation and removing blood stasis, dredging meridians, and awakening the brain and opening the mind. It is used to treat and prevent coronary heart disease caused by qi and blood deficiency, arteriosclerosis, fatigue, limb numbness, ischemic stroke, sequelae of cerebral hemorrhage, and anti-coagulation and anti-thrombosis after heart stent treatment. It has a small dosage and is easier to be absorbed and utilized by the body through fermentation to exert its medicinal effect.

Description

Technical Field

[0001] The present invention belongs to the technical field of traditional Chinese medicine and health care product preparations, and specifically discloses a traditional Chinese medicine compound composition for preventing and / or treating cardiovascular and cerebrovascular diseases such as arteriosclerosis, coronary heart disease, ischemic stroke, and the like, as well as a preparation method and application thereof. Background Art

[0002] Cardiovascular and cerebrovascular disease (CVD) is a general term for cardiovascular and cerebrovascular diseases, encompassing ischemic or hemorrhagic disorders of the heart, brain, and systemic tissues caused by conditions such as hyperlipidemia, blood viscosity, atherosclerosis, and hypertension. CVD not only severely impacts patients' quality of life but can also lead to serious complications, such as heart failure and multiple organ failure, further threatening their lives.

[0003] The drugs currently used to treat cardiovascular and cerebrovascular diseases mainly use the principles of promoting blood circulation and removing blood stasis, and unblocking meridians and collaterals as treatment principles. Through further understanding of cardiovascular and cerebrovascular diseases, we realize that: blood carries qi and circulates in the meridians, and qi pushes blood to reach the limbs and bones. Therefore, the key to treating cardiovascular and cerebrovascular diseases is to replenish qi and nourish blood, and solve the problems of yin and yang deficiency and blood stasis by replenishing qi and promoting blood circulation, so as to truly solve cardiovascular and cerebrovascular diseases from the root. Patent CN101020028A discloses a traditional Chinese medicine for treating cardiovascular and cerebrovascular diseases. Although it has the effects of replenishing qi, nourishing blood, promoting blood circulation and removing blood stasis, and dilating blood vessels, it has many components, contains expensive and fine medicinal materials, is relatively expensive, and the therapeutic effect on cardiovascular and cerebrovascular diseases needs to be further improved. Summary of the Invention

[0004] The purpose of the present invention is to overcome the above-mentioned defects and deficiencies in the prior art and to provide a Chinese medicine compound composition that can not only replenish vital energy and circulate qi and blood, but also promote blood circulation and blood stasis, dredge meridians and activate collaterals, replenish qi and blood, and thus promote a strong heart. It not only has simple components and low cost, but also significantly improves the therapeutic effect on cardiovascular and cerebrovascular diseases.

[0005] The second object of the present invention is to provide a method for preparing the Chinese medicine compound composition.

[0006] The third object of the present invention is to provide an application of the Chinese medicine compound composition.

[0007] The above-mentioned object of the present invention is achieved through the following technical solutions:

[0008] A traditional Chinese medicine compound composition is prepared from the following traditional Chinese medicine components in the following weight ratio: American ginseng: Panax notoginseng: Astragalus: Pueraria root: Crataegus: Chuanxiong: Salvia miltiorrhiza = (0.5-2): (0.5-2): (1-3): (1-4): (1-3): (0.5-2): (1-3).

[0009] In the Chinese medicine compound composition of the present invention:

[0010] Panax quinquefolium Panax quinquefolium The dried root of L. is sweet, slightly bitter, and cooling, and has the properties of tonifying Qi and Yin, clearing away heat and promoting salivation. Its main effects include boosting immunity and combating fatigue. It contains ginsenosides and polysaccharides, among other active ingredients.

[0011] Astragalus mongolica Astragalus membranaceus (Fisch.) Bge. var. Mongolian (Bge.)Hsiao or Astragalus membranaceus Astragalus membranaceus The dried root of Astragalus Fisch. (Bge.) is sweet and warm in nature, and has the effects of tonifying Qi and raising Yang, strengthening the Wei and strengthening the exterior, promoting diuresis and reducing swelling, and promoting the removal of toxins and promoting tissue regeneration. It primarily acts on the Ying and Wei, particularly tonifying Wei Qi, specifically addressing deficiency on the exterior of the body. It primarily contains astragaloside and astragaloside polysaccharides.

[0012] Pueraria lobata Lobed Pueraria The dried root of the plant (Willd.) Ohwi is sweet, pungent, and cooling. It has the properties of relieving muscle tension, reducing fever, promoting fluid production, quenching thirst, clearing rashes, promoting yang and stopping diarrhea, promoting blood circulation, and detoxifying alcohol. Pueraria root can help prevent and treat peripheral vascular disease by dilating capillaries and improving microcirculation. Its flavonoids and polysaccharides are its active ingredients.

[0013] Hawthorn is a plant of the Rosaceae family Hawthorn pinnatifida Bge. var. major NE Br. or Hawthorn Hawthorn pinnatifida The dried, mature fruit of Bge. is sour, sweet, and slightly warm. It promotes digestion, strengthens the stomach, promotes qi circulation, dissipates blood stasis, and reduces turbidity and lipids. Hawthorn can act on vascular smooth muscle, dilate blood vessels, lower blood pressure, and alleviate the burden on the heart. It primarily contains flavonoids and phenolic acids.

[0014] Chuanxiong Rhizoma Chuanxiong Oak chuanxiong The dried rhizome of Hort. is pungent and warm, promoting blood circulation and qi, dispelling wind and relieving pain. It is primarily used for chest pain, heart pain, and stabbing pain in the chest and ribs. It plays a vital role in the prevention and treatment of cardiovascular and cerebrovascular diseases, guiding drugs upward into the brain. It primarily contains Chuanxiong alkaloids and flavonoids.

[0015] Salvia miltiorrhiza Salvia miltiorrhiza The dried roots and rhizomes of Bge. are bitter and slightly cold, and have the effects of promoting blood circulation, removing blood stasis, relieving pain, clearing the heart and relieving restlessness, and cooling blood and eliminating carbuncles. Salvia miltiorrhiza has a significant effect in inhibiting platelet aggregation and promoting vascular repair. Salvianolic acids and flavonoids are its active ingredients.

[0016] The Suwen (Suwen) Treatise on the Origin of Life (Qi Tong Tian Lun) clearly states: "When righteous qi exists within, evil cannot harm us." This fully demonstrates the crucial role of righteous qi in defending against evil qi and maintaining health. When righteous qi is deficient, evil qi can easily invade the body, leading to various illnesses. In the case of cardiovascular and cerebrovascular diseases, their pathogenesis is closely linked to insufficient righteous qi.

[0017] The Golden Chamber states that "blood stasis is internal, and numbness is external," and that "phlegm and blood stasis under the heart cause palpitations," profoundly revealing the crucial pathogenic role of blood stasis in cardiovascular and cerebrovascular diseases. However, current clinical treatments for cardiovascular and cerebrovascular diseases primarily focus on promoting blood circulation, removing blood stasis, and activating meridians.

[0018] Through a systematic review of Traditional Chinese Medicine (TCM) literature, the present invention recognizes that blood flows through the meridians, driven by qi, and qi, in turn, reaches the limbs and bones through the transport of blood—the so-called "qi flows, blood flows." Therefore, the key to treating cardiovascular and cerebrovascular diseases lies in tonifying qi and nourishing blood. Only by replenishing qi and activating blood circulation can the problems of yin and yang deficiency and internal blood stasis be effectively addressed, fundamentally preventing and treating cardiovascular and cerebrovascular diseases.

[0019] Therefore, the present invention relates to a Chinese medicine composition, comprising American ginseng, Panax notoginseng, Astragalus root, Pueraria root, Crataegus pinnatifida, Chuanxiong rhizome and Salvia miltiorrhiza. The Chinese medicine composition comprises two categories of Chinese medicines: Qi-tonifying Chinese medicines and blood-activating Chinese medicines. Among them, the Qi-tonifying Chinese medicines are American ginseng and Astragalus root, which indirectly support the health of the cardiovascular and cerebrovascular system by enhancing immunity and improving heart and lung function; while the blood-activating Chinese medicines are Panax notoginseng, Pueraria root, Crataegus pinnatifida, Chuanxiong rhizome and Salvia miltiorrhiza, which directly act on the cardiovascular and cerebrovascular system to promote blood circulation, inhibit platelet aggregation, dilate blood vessels, reduce inflammation and oxidative damage, thereby preventing and treating cardiovascular and cerebrovascular diseases. The two categories of Chinese medicines complement each other through synergistic effects. The Qi-tonifying Chinese medicines provide a stable physical foundation for the blood-activating Chinese medicines and enhance their efficacy; while the blood-activating Chinese medicines further enhance the effect of the Qi-tonifying Chinese medicines by improving blood circulation and vascular function. The synergistic effect of this combination can comprehensively prevent and treat cardiovascular and cerebrovascular diseases, improve the quality of life, and prolong life.

[0020] Furthermore, the Chinese medicine compound composition is prepared by comprising the following Chinese medicine components in the following weight ratio: American ginseng: Panax notoginseng: Astragalus: Pueraria root: Crataegus: Chuanxiong: Salvia miltiorrhiza = (1-2): (1-2): (1-2): (1-3): (1-3): (1-2): (1-3).

[0021] Preferably, the Chinese herbal compound composition comprises the following Chinese herbal components in the following weight ratio: American ginseng: Panax notoginseng: Astragalus membranaceus: Pueraria root: Crataegus pinnatifida: Chuanxiong rhizome: Salvia miltiorrhiza = 1:1:1.25:1.875:1.625:1:1.625. For example: 80 g of American ginseng, 80 g of Panax notoginseng, 100 g of Astragalus membranaceus, 150 g of Pueraria root, 130 g of Crataegus pinnatifida, 80 g of Chuanxiong rhizome, and 130 g of Salvia miltiorrhiza.

[0022] The present invention also provides a method for preparing any of the above-mentioned Chinese medicine compound compositions, which specifically comprises the following steps:

[0023] S1. American ginseng and Panax notoginseng were mixed and crushed into a fine powder or American ginseng and Panax notoginseng were soaked in 8 to 10 times the amount of water for 1 to 4 hours, and then heated for extraction for 1.5 to 3 hours each time, extracted 2 to 3 times, filtered, and concentrated to obtain an aqueous extract;

[0024] S2. Soak Astragalus, Pueraria, and Salvia miltiorrhiza in 8-10 times the amount of water for 1-4 hours, heat and extract for 1.5-3 hours each time, extract 2-3 times, filter, and concentrate to obtain an aqueous extract or concentrate the aqueous extract to a thick extract, dry under reduced pressure, and grind to obtain an aqueous extract powder;

[0025] S3. Add 6 to 9 times the amount of 60 to 80% ethanol to hawthorn and Chuanxiong, heat and reflux for extraction, each time for 2 to 3.5 hours, extract 2 to 3 times, filter, combine the extracts, recover ethanol, and obtain an alcohol extract or dry the alcohol extract under reduced pressure, crush, and obtain an alcohol extract powder;

[0026] S4. The mixed fine powder of American ginseng and Panax notoginseng obtained in steps S1 to S3, the water extract powder of Astragalus, Pueraria, and Salvia miltiorrhiza, and the alcohol extract powder of Crataegus and Chuanxiong are mixed evenly to obtain a mixed powder; or the water extract of American ginseng and Panax notoginseng, the water extract of Astragalus, Pueraria, and Salvia miltiorrhiza, and the alcohol extract of Crataegus and Chuanxiong are mixed evenly to obtain a mixed liquid.

[0027] The Chinese medicine compound composition of the present invention is prepared by scientifically combining qi-invigorating Chinese medicines with blood-activating Chinese medicines, and combining modern extraction and preparation technologies. By extracting and separating the effective chemical components of American ginseng, Panax notoginseng, astragalus, kudzu root, hawthorn, Chuanxiong and Salvia miltiorrhiza, a variety of medicinal active ingredients such as saponins, polysaccharides, flavonoids, alkaloids, phenolic acids, etc. are obtained. The refined extracts can be directly made into suitable preparations.

[0028] Furthermore, the fine powder in step S1 is 80-100 mesh.

[0029] Furthermore, the ethanol in step S3 is 70% ethanol.

[0030] Furthermore, the present invention also innovatively provides a preparation method for fermenting the composition to form a preparation that is easier to absorb and exert therapeutic effects. The principle is that patients with cardiovascular and cerebrovascular diseases, hypertension, coronary heart disease, heart failure, etc. will all be accompanied by the occurrence of Qi deficiency syndrome, and the intestinal flora of the patients are mostly disordered, digestive enzymes are insufficient, and the digestion and absorption capacity are weakened. At present, the traditional Chinese medicine composition for treating Qi and blood deficiency is mainly composed of ginseng, American ginseng, and astragalus, but most of the active ingredients of this type are macromolecular substances such as saponins and polysaccharides, which have low bioavailability and low intestinal absorption, which will lead to a longer treatment cycle and the treatment obstacle of "deficiency cannot be supplemented".

[0031] Probiotics are beneficial microorganisms found throughout the human intestinal tract and reproductive system, playing a crucial role in the digestion and absorption of food and medication. Probiotics can transform saponins, polysaccharides, flavonoid glycosides, alkaloids, phenolic acids, and other components of traditional Chinese medicine into smaller molecules that are more easily absorbed by the body. They can even generate new, more active substances, rapidly tonifying Qi and activating blood circulation.

[0032] Specifically, the method comprises adding probiotics to the mixed extracts of American ginseng and Panax notoginseng water extracts, astragalus, kudzu root, and salvia miltiorrhiza water extracts, and hawthorn and Chuanxiong alcohol extracts in step S4, fermenting for 1 to 3 days to obtain a fermented liquid, and concentrating the liquid to obtain the obtained product. The extracts of the compound composition of the present invention are then fermented and degraded by probiotics such as lactobacillus and bifidobacteria to convert macromolecular saponins into aglycones or smaller molecular secondary saponins, cleave polysaccharides into smaller molecular sugar chains, and degrade flavonoids, alkaloids, phenolic acids, and other glycosides into small molecules, thereby facilitating the absorption of the drug by the body and better exerting the effects of replenishing vital energy, promoting blood circulation and removing blood stasis, unblocking meridians, and awakening the mind and opening the mind.

[0033] Furthermore, the probiotics are common species including Lactobacillus and Bifidobacterium, preferably Lactobacillus plantarum.

[0034] Furthermore, the method comprises adding lactobacillus or bifidobacterium powder to sterile physiological saline to prepare a bacterial suspension of 1 to 2 mg / mL (preferably 1 mg / mL), adding the bacterial suspension to the mixed extract of step S4 at a rate of 1% of the volume of the mixed solution, and fermenting at a temperature of 36 to 37° C. (preferably 36° C.) for 36 to 48 hours (preferably 48 hours). After fermentation, the fermentation is concentrated to obtain a fermentation concentrate; the fermentation concentrate is vacuum dried or spray dried, and pharmaceutically suitable excipients are added to prepare a Chinese medicine preparation that can be directly used.

[0035] Experiments have shown that the Chinese herbal compound composition of the present invention has the effects of replenishing vital energy, promoting blood circulation and removing blood stasis, dredging meridians, and refreshing the brain and invigorating the mind. It is used to treat and prevent coronary heart disease caused by qi and blood deficiency, arteriosclerosis, fatigue, limb numbness, ischemic stroke, sequelae of cerebral hemorrhage, and anti-coagulation and anti-thrombosis after heart stent treatment. The dosage is small and the fermentation makes it easier for the body to absorb and utilize it to exert its medicinal effects.

[0036] Therefore, the present invention also provides the use of any of the above-mentioned Chinese medicine compound compositions in the preparation of a method for preventing and / or treating cardiovascular and cerebrovascular diseases.

[0037] Furthermore, the cardiovascular and cerebrovascular diseases include coronary heart disease caused by insufficient qi and blood, arteriosclerosis, fatigue, limb numbness, ischemic stroke, sequelae of cerebral hemorrhage, or anticoagulation and anti-thrombosis after heart stent treatment.

[0038] Furthermore, the pharmaceutical preparations include but are not limited to water pills, granules, tablets or capsules.

[0039] The present invention also provides a medicine for preventing and / or treating cardiovascular and cerebrovascular diseases, comprising any one of the above-mentioned Chinese medicine compound compositions.

[0040] Furthermore, the medicine also includes pharmaceutically acceptable excipients.

[0041] For example, the mixed fine powder of American ginseng and Panax notoginseng obtained from the above extraction, the water extract powders of Astragalus, Pueraria, and Salvia miltiorrhiza, and the alcohol extract powders of Crataegus and Chuanxiong are uniformly mixed and added with pharmaceutically suitable excipients to prepare a Chinese medicine preparation that can be used directly. The fermentation concentrate is vacuum-dried or spray-dried and then added with pharmaceutically suitable excipients to prepare a Chinese medicine preparation that can be used directly.

[0042] Compared with the prior art, the present invention has the following beneficial effects:

[0043] The present invention provides a Chinese herbal compound composition for treating cardiovascular and cerebrovascular diseases, wherein the Chinese herbal compound composition is composed of American ginseng, Panax notoginseng, Astragalus, Pueraria root, Crataegus, Chuanxiong and Salvia miltiorrhiza. The Chinese herbal compound composition is prepared by extracting and separating the effective chemical components of different medicinal flavors using modern preparation technology to obtain a variety of effective medicinal ingredients such as saponins, polysaccharides, flavonoids, alkaloids, phenolic acids, etc., or is further prepared by fermentation and degradation with probiotics. The Chinese herbal compound composition of the present invention has the effects of replenishing vital energy, promoting blood circulation and removing blood stasis, unblocking meridians, and awakening the brain and opening the mind. It is used to treat and prevent coronary heart disease caused by qi and blood deficiency, arteriosclerosis, fatigue, limb numbness, ischemic stroke, sequelae of cerebral hemorrhage, and anticoagulation and anti-thrombosis after heart stent treatment. The dosage is small and fermentation makes it easier for the body to absorb and utilize it to exert its medicinal effect. The Chinese herbal compound composition of the present invention not only has simple components and low cost, but also significantly improves the therapeutic effect on cardiovascular and cerebrovascular diseases. DETAILED DESCRIPTION

[0044] The present invention is further described below with reference to specific examples, which, however, are not intended to limit the present invention in any way. Unless otherwise specified, the reagents, methods, and equipment used in the present invention are conventional reagents, methods, and equipment in the art.

[0045] Unless otherwise specified, the reagents and materials used in the following examples were commercially available. Example 1

[0046] A traditional Chinese medicine compound composition for treating cardiovascular and cerebrovascular diseases and its preparation method

[0047] The Chinese medicine compound composition is composed of 40 kg of American ginseng, 40 kg of Panax notoginseng, 50 kg of Astragalus, 75 kg of Pueraria, 65 kg of Crataegus, 40 kg of Chuanxiong and 65 kg of Salvia miltiorrhiza in the following medicinal proportions.

[0048] The preparation method of the above-mentioned Chinese medicine compound composition comprises the following specific steps:

[0049] (1) Grind the American ginseng and Panax notoginseng into 80 kg of 80-100 mesh fine powder and set aside.

[0050] (2) Soak Astragalus, Puerariae, and Salvia miltiorrhiza in 8-10 times the amount of water for 1-4 hours, then heat and extract for 1.5-3 hours each time, 2-3 times, filter, and concentrate to obtain a water extract, which is concentrated to a thick extract, dried under reduced pressure, and crushed to obtain 47.2 kg of water extract powder with a yield of 24.8%, which is set aside.

[0051] (3) Add 6 to 9 times the amount of 70% ethanol to hawthorn and Chuanxiong, heat and reflux for extraction, each time for 2 to 3.5 hours, extract 2 to 3 times, filter, combine the extracts, recover the ethanol, obtain the alcohol extract, dry under reduced pressure, and grind to obtain 17.5 kg of alcohol extract powder with a yield of 16.7%, which is set aside.

[0052] (4) 80 kg of the extracted American ginseng and Panax notoginseng mixed powder, 47.2 kg of the water extract powder of Astragalus, Pueraria and Salvia miltiorrhiza, and 17.5 kg of the alcohol extract powder of Crataegus and Chuanxiong were mixed evenly to a total of 144.7 kg.

[0053] (5) Take 20 kg of the mixed powder, add microcrystalline cellulose and 75% ethanol to moisten the soft material, and shape it into water pills. Then cover it, dry it, wrap it with wick charcoal, and polish it to make water pills.

[0054] (6) Take 20 kg of the mixed powder, add microcrystalline cellulose and 75% ethanol to moisten the granules, dry them, press them into tablets or put them into capsules after drying to make tablets or capsules. Example 2

[0055] The Chinese medicine compound composition is composed of 20 kg of American ginseng, 20 kg of Panax notoginseng, 25 kg of Astragalus, 37.5 kg of Pueraria, 32.5 kg of Crataegus, 20 kg of Chuanxiong, and 32.5 kg of Salvia miltiorrhiza in the following medicinal proportions.

[0056] The preparation method of the above-mentioned Chinese medicine compound composition comprises the following specific steps:

[0057] (1) Crush American ginseng and Panax notoginseng into coarse particles, add 8 to 10 times the amount of water, soak for 1 to 4 hours, heat and extract for 1.5 to 3 hours each time, extract 2 to 3 times, filter, concentrate, dry under reduced pressure, and crush to obtain 10.6 kg of water extract powder with a yield of 26.4%, which is set aside.

[0058] (2) Astragalus, Puerariae, and Salvia miltiorrhiza were prepared in the same manner as in Example 1 to obtain 23.6 kg of water extract powder, which was set aside.

[0059] (3) Prepare 8.75 kg of alcohol extract powder from hawthorn and chuanxiong in the same manner as in Example 1 and set aside.

[0060] (4) 10.6 kg of the mixed water extract powder of American ginseng and Panax notoginseng, 23.6 kg of the water extract powder of Astragalus, Pueraria and Salvia miltiorrhiza, and 8.75 kg of the alcohol extract powder of Crataegus and Chuanxiong were evenly mixed to a total of 42.9 kg.

[0061] (5) Take 10 kg of the mixed powder, add microcrystalline cellulose and 75% ethanol to moisten the soft material, and shape it into water pills. Then cover it, dry it, wrap it with wick charcoal, and polish it to make water pills.

[0062] (6) Take 10 kg of the mixed powder, add microcrystalline cellulose and 75% ethanol to moisten the granules, dry them, press them into tablets or put them into capsules after drying to make tablets or capsules.

[0063] (7) Take 10 kg of the mixed powder, add dextrin and 75% ethanol to moisten the mixture and make granules. Dry the mixture and package it to make granules. Example 3

[0064] The Chinese medicine compound composition is composed of 20 kg of American ginseng, 20 kg of Panax notoginseng, 25 kg of Astragalus, 37.5 kg of Pueraria, 32.5 kg of Crataegus, 20 kg of Chuanxiong, and 32.5 kg of Salvia miltiorrhiza in the following medicinal proportions.

[0065] The preparation method of the above-mentioned Chinese medicine compound composition comprises the following specific steps:

[0066] (1) Mix American ginseng and Panax notoginseng and crush them into coarse particles. Add 8 to 10 times the amount of water and soak for 1 to 4 hours. Heat and extract for 1.5 to 3 hours each time. Extract 2 to 3 times. Filter and concentrate to obtain the water extract for later use.

[0067] (2) Soak Astragalus, Pueraria root and Salvia miltiorrhiza in 8 to 10 times the amount of water for 1 to 4 hours, then heat and extract for 1.5 to 3 hours each time, 2 to 3 times, filter and concentrate to obtain the water extract for later use.

[0068] (3) Add 6 to 9 times the amount of 70% ethanol to hawthorn and Chuanxiong, heat and reflux for extraction, each time for 2 to 3.5 hours, extract 2 to 3 times, filter, combine the extracts, recover the ethanol, and obtain the alcohol extract for later use.

[0069] (4) Mix the extracted American ginseng and Panax notoginseng mixed water extract, astragalus, kudzu root, and salvia miltiorrhiza water extract, and hawthorn and Chuanxiong alcohol extract according to the prescribed ratio, cool to 36°C, and set aside.

[0070] (5) Lactobacillus plantarum is added to sterile physiological saline to prepare a 1 mg / mL bacterial suspension, which is added to the mixed solution of step (4) with the volume of the bacterial suspension being 1 to 3% of the volume of the mixed solution. Fermentation is carried out at a temperature of 36°C for 36 to 48 hours, and the fermentation concentrate is concentrated to obtain a fermentation concentrate for later use.

[0071] (6) The fermentation concentrate in step (5) is vacuum dried or spray dried and pulverized to obtain 41.5 kg of dry powder.

[0072] (5) Take 10 kg of the mixed powder, add microcrystalline cellulose and 75% ethanol to moisten the soft material, and shape it into water pills. Then cover it, dry it, wrap it with wick charcoal, and polish it to make water pills.

[0073] (6) Take 10 kg of the mixed powder, add microcrystalline cellulose and 75% ethanol to moisten the granules, dry them, press them into tablets or put them into capsules after drying to make tablets or capsules.

[0074] (7) Take 10 kg of the mixed powder, add dextrin and 75% ethanol to moisten the mixture and make granules. Dry the mixture and package it to make granules.

[0075] The Chinese herbal compound composition and its preparation of the present invention have the effects of replenishing vital energy, promoting blood circulation and removing blood stasis, unblocking meridians, and awakening the mind and invigorating the mind, and are used to treat and prevent cardiovascular and cerebrovascular diseases. Such cardiovascular and cerebrovascular diseases include coronary heart disease caused by qi and blood deficiency, arteriosclerosis, fatigue, limb numbness, ischemic stroke, sequelae of cerebral hemorrhage, and anticoagulation and thrombosis prevention after cardiac stent treatment.

[0076] Experimental Example 1 Protective Effects of Different Medication Groups on Myocardial Injury in Coronary Heart Disease Rat Model

[0077] Animals: 90 male SD rats, weighing 220-250 g.

[0078] Drugs: Example 1 water pills, Example 2 granules, Example 3 granules, positive drug: Di'ao Xinxuekang, comparative example group: tablets were prepared with reference to the method in the specific embodiment of CN101020028A.

[0079] Methods: Rats were randomly divided into 10 groups: blank group, model group, low-dose drug group, high-dose drug group, and positive drug group. All rats except the blank group were fed a high-fat, high-methionine diet (87.3% basal diet, 0.5% sodium cholate, 0.2% propylthiouracil, 2% cholesterol, 3% methionine, and 10% lard) for 6 weeks. At the same time, 30 g / kg posterior pituitary hormone was intraperitoneally injected once daily at intervals of 2 weeks for 3 consecutive days. Successful modeling was defined as the presence of ST-segment elevation >0.1 mV and a tall T wave on the electrocardiogram 30 minutes after injection.

[0080] Administration: After successful model establishment, oral administration began for 14 consecutive days. The blank and model groups received corresponding volumes of normal saline. The daily oral administration doses were: 1.89 g / kg for the low-dose group, 3.78 g / kg for the high-dose group, 3.78 g / kg for the positive drug group, and 1.89 g / kg (low dose) and 3.78 g / kg (high dose) for the control group. After the final administration, 4 mL of tail vein blood was collected and centrifuged for 15 minutes (3 cm radius, 3000 rpm). The supernatant was extracted and the levels of cardiac troponin (cTn) I and creatine kinase isoenzyme (CK-MB) were measured in each group. The results are shown in Table 1.

[0081]

[0082] Results: The data from the experimental study on myocardial damage protection in rat models of coronary heart disease (CHD) from different drug groups in Table 1 above demonstrate that the traditional Chinese medicine compound compositions prepared in Examples of the present invention significantly reduced levels of cardiac troponin (cTn) I and creatine kinase isoenzyme (CK-MB) in rat models of CHD. This indicates that the traditional Chinese medicine compound compositions of the present invention can reduce the levels of cardiac troponin and creatine kinase isoenzyme, the main substances reflecting myocardial cell damage, thereby alleviating myocardial damage in rats of CHD. The efficacy of the traditional Chinese medicine compound compositions administered in different dosage forms, preparation methods, and with different herbal combinations was superior to that of the positive drug group and the control group (low-dose and high-dose groups). The high-dose formulation of Example 3 showed the most significant effect, demonstrating that different drug combinations and ratios have distinct effects. In particular, the traditional Chinese medicine compound compositions of the present invention can further enhance their therapeutic efficacy after fermentation with probiotics.

[0083] Experimental conclusion: The Chinese herbal compound composition of the present invention can improve the cardiac damage caused by coronary heart disease.

[0084] Experimental Example 2 Effects of Different Medication Groups on Hemorheology and Hemodynamics in Rats with Atherosclerosis

[0085] Animals: 140 male SD rats, weighing 180-220 g.

[0086] Drugs: Example 1 water pills, Example 2 granules, Example 3 granules, positive drug: Di'ao Xinxuekang, comparative example group (same as Test Example 1).

[0087] Methods: Ten rats were randomly divided into blank group, model group, low-dose drug group, high-dose drug group, and positive drug group. All groups, except the blank group, were fed a high-fat diet for 10 weeks. One week after feeding, 600,000 U / kg vitamin D3 solution was intraperitoneally injected (once). Optical microscopy revealed atherosclerotic plaque formation in the rat aorta, with significant thickening of the vascular wall and intima, indicating that the AS rat model was successfully established.

[0088] Administration: After successful model establishment, oral administration began for four consecutive weeks. The blank and model groups received corresponding volumes of normal saline. The daily oral administration doses were: 1.89 g / kg for the low-dose group, 3.78 g / kg for the high-dose group, 3.78 g / kg for the positive drug group, and 1.89 g / kg (low-dose) and 3.78 g / kg (high-dose) for the control group. After the final administration, the rats were anesthetized with 3% sodium pentobarbital, the right common carotid artery was isolated, and the left ventricle was cannulated. The maximum rate of rise of intraventricular pressure (LV+dP / dTmax) and the time to peak intraventricular pressure (t-dP / dTmax) were monitored in each group using an MS4000U-1C biosignal recording system. The experimental results are shown in Table 2. Blood was then collected from the abdominal aorta of the rats and placed in tubes containing sodium heparin. Whole blood viscosity (low, medium, and high shear), plasma viscosity, hematocrit, and platelet adhesion rate were measured. The experimental results are shown in Table 3.

[0089]

[0090]

[0091] Results: According to the experimental data in Tables 2 and 3 above, which show the effects of different medication groups on hemorheology and hemodynamics in rats with atherosclerosis, the traditional Chinese medicine compound compositions prepared in the examples of the present invention can shorten the time to peak intraventricular pressure (t-dp / dtmax / ms) and increase the maximum rate of rise of intraventricular pressure (lv+dp / dtmax (mmHg / s)). They can also reduce whole blood viscosity (low shear, medium shear, and high shear), plasma viscosity, and platelet adhesion rate in rats, and also show a significant trend toward lowering hematocrit. The high-dose group of Example 3, i.e., the fermented medication group, showed a significant reduction in hematocrit, indicating a significant effect on hematocrit after fermentation. The test results of each example group were significantly better than those of the comparative example groups (low-dose and high-dose groups), with the low-dose and high-dose groups of Example 3 being particularly significant.

[0092] This demonstrates that the Chinese herbal compound composition of the present invention can promote blood circulation and dissipate blood stasis, promote meridian circulation, and play a therapeutic and preventive role in atherosclerosis by reducing blood viscosity, hematocrit, and platelet adhesion rate. The effects of the Chinese herbal compound composition administered in different dosage forms, formulation methods, and with different herbal compatibility varied slightly, with Example 3 showing the most significant effect. This demonstrates that the Chinese herbal compound composition of the present invention can further enhance its therapeutic efficacy after probiotic fermentation.

[0093] Experimental conclusion: The Chinese herbal compound composition of the present invention has the functions of promoting blood circulation, removing blood stasis, promoting blood circulation and activating collaterals, and can significantly improve atherosclerosis.

[0094] Experimental Example 3 Protective effects of different medication groups on rats with ischemic stroke

[0095] Animals: 180 male SD rats, weighing 220-250 g.

[0096] Drugs: Example 1 water pills, Example 2 granules, Example 3 granules, positive drug: Di'ao Xinxuekang, comparative example group (same as Test Example 1).

[0097] Methods: Rats were randomly divided into 20 groups: sham-operated group, model group, low-dose drug group, high-dose drug group, and positive drug group. After anesthesia, the rats were immobilized on a 37°C hot plate. The neck muscles were bluntly dissected, and the left common carotid artery, external carotid artery, and internal carotid artery were exposed in sequence. The common carotid artery and the external carotid artery were ligated. The internal carotid artery was clamped, and a small incision was made at the distal end of the common carotid artery. A 0.26 mm diameter nylon filament was inserted along the common carotid artery into the internal carotid artery to block blood flow to the middle cerebral artery. After 2 hours of ischemia, blood flow was restored, the internal carotid artery was ligated, and the surgical field was closed. Penicillin was injected intramuscularly to prevent infection. In the sham-operated group, only vascular dissection was performed without ischemia-reperfusion.

[0098] Administration: After successful model establishment, oral administration began for four consecutive weeks. The model and sham-operated groups received corresponding volumes of normal saline. The daily oral administration doses were: 1.89 g / kg for the low-dose group, 3.78 g / kg for the high-dose group, 3.78 g / kg for the positive drug group, and 1.89 g / kg (low-dose) and 3.78 g / kg (high-dose) for the control group. After the final administration, the rats were anesthetized with 3% sodium pentobarbital. Blood was collected from the carotid artery and placed in tubes containing sodium heparin for hemorheological analysis. The experimental results are shown in Table 4.

[0099]

[0100] Results: According to the experimental data in Table 4 above, the Chinese herbal compound composition prepared in the examples of the present invention can reduce the blood viscosity of rats and has a significant inhibitory effect on platelet aggregation. Compared with the model group, the TT time of each example group was prolonged, and the PT time of each example group was prolonged, with significant differences ( P <0.01), which was significantly better than the control group (low-dose and high-dose groups).

[0101] The results indicate that the Chinese herbal compound composition of the present invention can treat ischemic stroke and prevent thrombosis by reducing blood viscosity and inhibiting platelet aggregation, thereby promoting blood circulation and removing blood stasis, promoting blood circulation and activating collaterals. The effects of the Chinese herbal compound composition administered in different dosage forms, preparation methods, and with different herbal compatibility groups were slightly different, with the high-dose effect of Example 3 being the most significant. This indicates that the Chinese herbal compound composition of the present invention can further enhance its therapeutic effect after probiotic fermentation.

[0102] Experimental conclusion: The Chinese herbal compound composition of the present invention has the functions of promoting blood circulation, removing blood stasis, promoting blood circulation and activating collaterals, and can be used to treat and prevent ischemic stroke, sequelae of cerebral hemorrhage, and anti-coagulation and anti-thrombosis after heart stent treatment.

[0103] Experimental Example 4: Observation of the effects of different medication groups on patients with post-stroke limb numbness

[0104] Inclusion criteria: (1) meeting the diagnostic criteria of traditional Chinese and Western medicine; (2) confirmed by MRI or CT diagnosis; (3) duration of illness for more than 1 month; (4) stable vital signs and able to communicate normally; (5) informed consent from the patient or family member, and signed the informed consent form.

[0105] Efficacy criteria: (1) Cured: symptoms and signs are basically gone, muscle strength reaches level 4, speech is clear, limb numbness is basically gone, social function is basically restored, and the patient can take care of himself or return to work. (2) Markedly effective: symptoms and signs are significantly improved, muscle strength is improved by 2 levels, limb numbness is reduced, limb mobility is increased, social function is significantly restored, but fine activities of life are slightly worse. (3) Effective: symptoms and signs are partially improved, muscle strength is improved by 1 level, limb numbness is slightly reduced, limb activity is somewhat improved, and social function is restored. (4) Ineffective: The patient can perform simple limb activities, but there is no significant improvement in symptoms and signs.

[0106] Administration: (1) Drugs: Water pills of the Chinese herbal compound composition prepared in Example 1, granules of the Chinese herbal compound composition prepared in Example 2, granules of the Chinese herbal compound composition prepared by fermentation in Example 3, and tablets made from the powder of the Chinese herbal compound composition in the comparative example (same as in Test Example 1). (2) Dosage: Groups 1, 2, and 3 of Examples were given 3 g each time; the comparative example took the same dose of tablets 3 g each time. (3) Dosage: Take orally once in the morning and evening for 21 to 28 consecutive days with warm water.

[0107] Observe and record the improvement of symptoms. The results are shown in Table 5.

[0108]

[0109] Among them, there were 2 ineffective patients after treatment in Example 1, and the total effective rate was 93.3%; Example 2 was all extracted and processed before being used as medicine, which is equivalent to a higher content of active ingredients in the composition. After treatment, there was 1 ineffective patient, and the total effective rate was 96.7%; Example 3 was all extracted and processed, and then prepared by probiotic fermentation, which is equivalent to a higher content of active ingredients in the composition and is easy to be absorbed by the intestine after fermentation to exert a pharmacological effect. After treatment, all patients had obvious effects and a higher cure rate; the composition of the comparative example, because it contains precious and fine medicinal materials, is not only expensive, but also has a large dosage, and patient compliance is not ideal. There were 4 ineffective patients, and the total effective rate was 83.3%, which is significantly lower than the pharmaceutical composition of the present invention.

[0110] The pharmaceutical composition of the present invention has a proven efficacy, a simple prescription, and a relatively low cost, making it suitable for a wide range of patients. Most patients who experience ineffectiveness are elderly individuals with chronic underlying conditions who are also taking other medications during treatment, making it difficult to eliminate interference from these medications. While the composition of the present invention improves limb movement, the effect is not significant. However, the efficacy is significant in patients in the recovery period and in young adults, with most patients showing marked efficacy and some experiencing effective efficacy.

[0111] In addition, the outstanding feature of the present invention is that the effect is better after fermentation, especially for elderly patients with cardiovascular and cerebrovascular diseases, most of whom have weakened gastrointestinal digestion and absorption functions, which are also affected by the absorption of drugs. It is found that patients are more likely to accept the fermented granules of the pharmaceutical composition of the present invention, which are not greasy, easy to absorb, and have a quick onset of effect.

[0112] Conclusion: The efficacy of the Chinese herbal compound composition for patients with post-stroke limb numbness is as high as 93.3%. The Chinese herbal compound composition of the present invention can significantly alleviate the clinical symptoms of stroke patients and improve their daily living ability and limb motor function.

[0113] It should be noted that the above content is only used to illustrate the technical solution of the present invention, rather than to limit the scope of protection of the present invention. Simple modifications or equivalent substitutions of the technical solution of the present invention made by ordinary technicians in this field do not deviate from the essence and scope of the technical solution of the present invention.

Claims

1. A Chinese medicinal compound composition for preventing and / or treating cardiovascular and cerebrovascular diseases, characterized in that: The Chinese medicine compound composition is prepared from the following Chinese medicine components in the following weight ratio: American ginseng: Panax notoginseng: Astragalus: Pueraria root: Crataegus: Chuanxiong: Salvia miltiorrhiza = (0.5-2): (0.5-2): (1-3): (1-4): (1-3): (0.5-2): (1-3); the preparation method of the Chinese medicine compound composition comprises the following steps: S1. Soak American ginseng and Panax notoginseng in 8 to 10 times the amount of water for 1 to 4 hours, then heat and extract for 1.5 to 3 hours each time, 2 to 3 times, filter, and concentrate to obtain a water extract; S2. Soak Astragalus, Pueraria, and Danshen in 8-10 times the amount of water for 1-4 hours, then heat and extract for 1.5-3 hours each time, 2-3 times, filter, and concentrate to obtain an aqueous extract; S3. Add 6 to 9 times the amount of 60 to 80% ethanol to hawthorn and Chuanxiong, heat and reflux for extraction, each time for 2 to 3.5 hours, extract 2 to 3 times, filter, combine the extracts, recover ethanol, and obtain an alcohol extract; S4. The American ginseng, Panax notoginseng water extract, Astragalus, Pueraria, Salvia miltiorrhiza water extract, Hawthorn, Chuanxiong alcohol extract obtained in steps S1 to S3 were mixed to obtain a mixed solution; probiotics were then added and fermented for 1 to 3 days to obtain a fermentation broth, which was concentrated to obtain; The cardiovascular and cerebrovascular diseases are coronary heart disease, atherosclerosis, ischemic stroke or post-stroke limb numbness.

2. The Chinese medicine compound composition according to claim 1, characterized in that It is prepared from the following Chinese medicinal components in the following weight ratio: American ginseng: Panax notoginseng: Astragalus: Pueraria root: Crataegus: Chuanxiong: Salvia miltiorrhiza = (1-2): (1-2): (1-2): (1-3): (1-3): (1-2): (1-3).

3. Use of the Chinese herbal compound composition according to claim 1 or 2 in the preparation of a pharmaceutical preparation for preventing and / or treating cardiovascular and cerebrovascular diseases, characterized in that: The cardiovascular and cerebrovascular diseases are coronary heart disease, atherosclerosis, ischemic stroke or post-stroke limb numbness.

4. The application according to claim 3, characterized in that The preparation of the medicine is water pill, granule, tablet or capsule.

5. A drug for preventing and / or treating cardiovascular and cerebrovascular diseases, characterized in that: The Chinese medicine compound composition according to claim 1 or 2 is used as an effective ingredient.

6. The drug according to claim 5, characterized in that Pharmaceutically acceptable excipients are also included.

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