A traditional Chinese medicine composition for removing vascular plaques and its preparation method

Abstract

The present invention discloses a traditional Chinese medicine composition for removing vascular plaques and a preparation method thereof. The traditional Chinese medicine composition for removing vascular plaques is made from the following raw materials in parts by weight: 8-12 parts of nattokinase, 8-12 parts of chrysanthemum, 6-10 parts of dandelion, 6-10 parts of honeysuckle, 6-10 parts of kudzu root, 4-8 parts of fingered citron, 6-10 parts of citron, 4-8 parts of peach kernel, 10-14 parts of angelica, 10-14 parts of hawthorn, 6-10 parts of allium macrostemon, 8-12 parts of wolfberry fruit, 4-8 parts of cornel, 4-8 parts of cinnamon, 10-14 parts of Chinese date, and also discloses the preparation method. After the medicinal materials are extracted, nattokinase is added and prepared into one of tablets, capsules and granules. The present invention can clear heat and detoxify, resolve phlegm, promote blood circulation to remove blood stasis, and nourish the liver and kidney, and has an eliminating effect on carotid artery plaques formed by senile carotid atherosclerosis of liver-kidney yin deficiency type, with good effects.

Description

Technical Field

[0001] The invention relates to the technical field of traditional Chinese medicine preparations, in particular to a traditional Chinese medicine composition for removing vascular plaques and a preparation method thereof. Background Art

[0002] The prevalence of CAD in the elderly has been gradually increasing, and people are paying more and more attention to this disease. TCM syndrome types divide CAD in the elderly into four types: phlegm turbidity obstruction, phlegm and blood stasis, spleen and kidney yang deficiency, and liver and kidney yin deficiency. Referring to the "Standards for Diagnosis and Efficacy of TCM Diseases and Syndromes" and "Guidelines for Clinical Research of New Chinese Medicines (Trial)" formulated by the State Administration of Traditional Chinese Medicine and the 5th edition of the textbook "Internal Medicine of Traditional Chinese Medicine" for medical colleges and universities, the characteristics of each syndrome are as follows: ① Phlegm turbidity obstruction type: obese body, heavy limbs, heavy head, poor appetite, abdominal distension, sputum and salivation, lethargy, chest tightness and nausea, enlarged tongue, pale tongue, white and greasy fur, slippery pulse, or red tongue, yellow and greasy fur, slippery and rapid pulse. ② Phlegm and blood stasis type: chest tightness and phlegm, white or yellow phlegm, thick texture, phlegm sound in the throat, local tingling, or numbness of limbs, cyanosis of lips and nails, dark or dark purple tongue, varicose veins under the tongue, greasy coating, and slippery pulse. ③ Spleen and kidney yang deficiency type: soreness of waist and knees, cold pain in the abdomen, cold body and cold limbs, diarrhea at dawn, diarrhea, edema of limbs, and even abdominal distension like a drum; or frequent urination, residual dripping, pale and fat tongue or teeth marks on the edges, white and smooth tongue coating, deep and weak pulse. ④ Liver and kidney yin deficiency type: dizziness and tinnitus, soreness of waist and knees, fever in the five hearts, forgetfulness and insomnia, dry mouth, red tongue, less coating, and thin and rapid pulse. The study shows that the elastic imaging score of hypoechoic plaques in liver and kidney yin deficiency type is significantly lower than that in phlegm and blood stasis type (P<0.01). The lower the elastic imaging score, the softer and more unstable the plaque is, and it is easy to fall off, causing stroke.

[0003] Nattokinase (NK) is an alkaline serine protease secreted by Bacillus subtilis (natto), with the advantages of long half-life, strong specificity, small side effects, and direct oral administration. Nattokinase is extracted from food natto or produced by natto bacteria. It is a protein with a molecular weight far smaller than UK, SK, and tPA, and can be absorbed by the intestine. The in vitro and in vivo thrombolytic properties of nattokinase have also been determined through experiments. At the same time, it is concluded that the in vivo thrombolytic activity of nattokinase is four times that of plasmin, and it acts rapidly and lasts for a long time in the body. It can also activate tPA in the body, so that it can gently and continuously increase the fibrinolytic activity of the blood.

[0004] CAD patients not only have the risk factors of advanced age, but also are prone to suffer from multiple diseases. The coexistence of multiple diseases is more likely to lead to disharmony of zang-fu organs, endogenous toxin, physical deterioration, and cause plaque injury and shedding. There is a certain correlation between the shedding of carotid plaques and stroke. Therefore, a traditional Chinese medicine composition for removing vascular plaques is proposed. It is unexpectedly found that the compatibility of traditional Chinese medicine and nattokinase has a significant effect in promoting the ablation of carotid plaques, and is particularly suitable for plaques formed by senile carotid atherosclerosis of the liver-kidney yin deficiency type. Summary of the Invention

[0005] The purpose of the present invention is to provide a traditional Chinese medicine composition for removing vascular plaques and its preparation method.

[0006] To achieve the above purpose, the present invention provides the following technical solution: A traditional Chinese medicine composition for removing vascular plaques, wherein the traditional Chinese medicine composition for removing vascular plaques is made from the following raw materials in parts by weight: 8-12 parts of nattokinase, 8-12 parts of chrysanthemum, 6-10 parts of dandelion, 6-10 parts of honeysuckle, 6-14 parts of kudzu root, 4-8 parts of fingered citron, 6-10 parts of citron, 4-8 parts of peach kernel, 10-14 parts of angelica, 10-14 parts of hawthorn, 6-10 parts of Chinese chive, 8-12 parts of wolfberry fruit, 4-8 parts of cornel, 3-8 parts of cinnamon, and 10-14 parts of Chinese date.

[0007] For the traditional Chinese medicine composition for removing vascular plaques, 8 parts of nattokinase, 12 parts of chrysanthemum, 6 parts of dandelion, 10 parts of honeysuckle, 6 parts of kudzu root, 4 parts of fingered citron, 10 parts of citron, 4 parts of peach kernel, 14 parts of angelica, 10 parts of hawthorn, 10 parts of Chinese chive, 8 parts of wolfberry fruit, 8 parts of cornel, 3 parts of cinnamon, and 14 parts of Chinese date.

[0008] For the traditional Chinese medicine composition for removing vascular plaques, 12 parts of nattokinase, 8 parts of chrysanthemum, 10 parts of dandelion, 6 parts of honeysuckle, 14 parts of kudzu root, 8 parts of fingered citron, 6 parts of citron, 8 parts of peach kernel, 10 parts of angelica, 14 parts of hawthorn, 6 parts of Chinese chive, 12 parts of wolfberry fruit, 4 parts of cornel, 8 parts of cinnamon, and 10 parts of Chinese date.

[0009] For the traditional Chinese medicine composition for removing vascular plaques, 10 parts of nattokinase, 10 parts of chrysanthemum, 8 parts of dandelion, 8 parts of honeysuckle, 12 parts of kudzu root, 6 parts of fingered citron, 8 parts of citron, 6 parts of peach kernel, 12 parts of angelica, 12 parts of hawthorn, 8 parts of Chinese chive, 10 parts of wolfberry fruit, 6 parts of cornel, 6 parts of cinnamon, and 12 parts of Chinese date.

[0010] For the traditional Chinese medicine composition for removing vascular plaques, 10 parts of nattokinase, 12 parts of kudzu root, 12 parts of hawthorn, 6 parts of Chinese chive, 3 parts of cinnamon, and 12 parts of Chinese date.

[0011] The traditional Chinese medicine composition for removing vascular plaques is prepared as follows: (1) Take honeysuckle, peach kernel, citron, cinnamon and angelica, and perform steam distillation extraction on them to extract the volatile oils of honeysuckle, peach kernel, citron, cinnamon and angelica for standby; (2) Filter the aqueous solution after steam distillation extraction of honeysuckle, peach kernel, citron, cinnamon and angelica to obtain the aqueous solution after distillation of honeysuckle, peach kernel, citron, cinnamon and angelica, heat and concentrate it, and perform alcohol precipitation to obtain the supernatant, which is the water extraction alcohol precipitation concentrated solution after steam distillation of honeysuckle, peach kernel, citron, cinnamon and angelica for standby; Keep the medicinal residues after steam distillation extraction of honeysuckle, peach kernel, citron, cinnamon and angelica for standby; (3) Mix the medicinal residues after steam distillation extraction of honeysuckle, peach kernel, citron, cinnamon and angelica obtained in step (2) with the medicinal materials of chrysanthemum, dandelion, kudzu root, bergamot, hawthorn, allium macrostemon, wolfberry fruit, cornel and Chinese date, add 10 times the weight of water of the medicinal materials and decoct twice, each time for 2 hours, filter to obtain the water extraction solution, concentrate it, and perform alcohol precipitation to obtain the supernatant, which is the water extraction alcohol precipitation concentrated solution; (4) Combine the water extraction alcohol precipitation concentrated solution obtained in step (3) and the water extraction alcohol precipitation concentrated solution after distillation of honeysuckle, peach kernel, citron, cinnamon and angelica obtained in step (2), perform spray drying, add the volatile oils of honeysuckle, peach kernel, citron, cinnamon and angelica obtained in step (1) and nattokinase, and prepare into a preparation to obtain the product.

[0012] The traditional Chinese medicine composition for removing vascular plaques is prepared as follows: (1) Take cinnamon and perform steam distillation extraction on it to extract the cinnamon volatile oil for standby; (2) Filter the aqueous solution after steam distillation extraction of cinnamon to obtain the aqueous solution after distillation of cinnamon, heat and concentrate it, and perform alcohol precipitation to obtain the supernatant, which is the water extraction alcohol precipitation concentrated solution after steam distillation of cinnamon for standby; Keep the medicinal residues after steam distillation extraction of cinnamon for standby; (3) Mix the medicinal residues after steam distillation extraction of cinnamon obtained in step (2) with the medicinal materials of kudzu root, hawthorn, allium macrostemon and Chinese date, add 10 times the weight of water of the medicinal materials and decoct twice, each time for 2 hours, filter to obtain the water extraction solution, concentrate it, and perform alcohol precipitation to obtain the supernatant, which is the water extraction alcohol precipitation concentrated solution; (4) Combine the water extraction alcohol precipitation concentrated solution obtained in step (3) and the water extraction alcohol precipitation concentrated solution after distillation of cinnamon obtained in step (2), perform spray drying, add the cinnamon volatile oil obtained in step (1) and nattokinase, and prepare into a preparation to obtain the product.

[0013] The preparation of the traditional Chinese medicine composition for removing vascular plaques is one of tablets, capsules and granules.

[0014] For the traditional Chinese medicine composition for removing vascular plaques, the conditions for both alcohol precipitations are: add 95% ethanol, stir well to make the alcohol content in the medicinal liquid reach 70%, close the lid of the alcohol precipitation tank, and let it stand for 24 hours.

[0015] The Chinese medicinal composition for removing vascular plaques is used in preparing a health product for eliminating carotid plaques formed by elderly carotid atherosclerosis, wherein the syndrome type of carotid atherosclerosis is liver-kidney yin deficiency type.

[0016] Nattokinase is prepared according to the method shown in Example 1 of Patent Application No. 201310547971.3, and the nattokinase activity is 3.75 million U / g.

[0017] Chrysanthemum is the flower head of the plant chrysanthemum of the genus Chrysanthemum of the Asteraceae family. The main types of chrysanthemum on the market are Boju, also known as white chrysanthemum, including Boju from Bo County, Anhui, Huaiju from Henan, Chuanju from Sichuan, and Qiju from Hebei. It tastes bitter and sweet, and is slightly cold in nature. It enters the lung and liver meridians. It dispels wind and clears heat, soothes the liver and improves eyesight, and clears heat and detoxifies. The present invention uses Boju.

[0018] Dandelion (Latin name: Taraxacum mongolicum Hand.-Mazz.), Asteraceae, Taraxacum genus perennial herb. The flower head has a pompom of white pappus on the seeds. After the flowers bloom, they are blown to new places by the wind to breed new life. It is the dried whole herb of Taraxacum mongolicum, Taraxacum alkali or several plants of the same genus in the Asteraceae family. It tastes bitter, sweet and cold. It is mainly used for carbuncle, breast carbuncle, scrofula, red eyes, sore throat, lung carbuncle, intestinal carbuncle, damp-heat jaundice, hot stranguria and sore throat.

[0019] Honeysuckle is the dried buds or flowers of Lonicera japonica Thunb. of the Caprifoliaceae family. It has the effect of clearing away heat and detoxifying. It is mainly used to treat exogenous wind-heat or fever caused by febrile diseases, heatstroke, heat-toxic bloody diarrhea, carbuncle, sore throat, and various infectious diseases.

[0020] Buddha's hand is the dried fruit of the Rutaceae plant Citrusmedica Lvar.sarcodac-tylis Swingle. The fruit is harvested in autumn before or when it turns yellow, cut into thin slices, and dried in the sun or at low temperature. It is pungent, bitter, sour, and warm in nature. It enters the liver, spleen, stomach, and lung meridians. It soothes the liver and regulates qi, harmonizes the stomach and relieves pain, and dries dampness and resolves phlegm. It is used for liver and stomach qi stagnation, chest and flank distension and pain, epigastric fullness, loss of appetite and vomiting, and cough with excessive phlegm.

[0021] Citron is the mature fruit of Citrus medica L. or Citrus wilsonii Tanaka, a plant of the Rutaceae family. The fruit is harvested in autumn when it is ripe, sliced ​​while fresh, and dried in the sun or at low temperature. Citron can also be dried in the sun or at low temperature after being cut in half or cut in half. It is pungent, bitter, sour, and warm in nature. It enters the liver, spleen, and lung meridians. It soothes the liver and regulates qi, relieves fullness, and resolves phlegm. It is used for liver and stomach qi stagnation, chest and flank distension and pain, abdominal distension, vomiting, belching, and cough with excessive phlegm.

[0022] Peach kernels are the dried mature seeds of Prunus persica (L.) Batsch or Prunus davidiana (Carr.) Franch. of the Rosaceae family. After the fruits are mature, they are harvested, the flesh and the shell of the pit are removed, the seeds are taken out and dried in the sun. They are widely cultivated throughout the country. It has the effects of promoting blood circulation to remove blood stasis, moistening the intestines and relieving constipation, and relieving cough and asthma. It is used for amenorrhea and dysmenorrhea, abdominal masses, lung abscess and intestinal abscess, traumatic injury, intestinal dryness and constipation, cough and asthma.

[0023] Angelica sinensis is the dried root of Angelica sinensis (Oliv.) Diels of the Umbelliferae family. It is mainly produced in the southeastern part of Gansu Province. Min County has a large output and good quality. Secondly, it is also produced in Yunnan, Sichuan, Shaanxi, Hubei and other provinces, all of which are cultivated. It has the effects of enriching blood and promoting blood circulation, regulating menstruation and relieving pain, and moistening the intestines and relieving constipation. It is commonly used for sallow complexion due to blood deficiency, dizziness and palpitation, irregular menstruation, amenorrhea and dysmenorrhea, deficiency-cold abdominal pain, rheumatic arthralgia, traumatic injury, carbuncles and ulcers, intestinal dryness and constipation. Angelica sinensis processed with wine promotes blood circulation and dredges the meridians. It is used for amenorrhea and dysmenorrhea, rheumatic arthralgia, and traumatic injury.

[0024] Wolfberries are the mature fruits of Lycium chinense Miller of the Solanaceae family. They are picked when the fruits are mature in summer and autumn. After removing the fruit stalks, they are placed in a cool place until the peel wrinkles, and then exposed to the sun until the outer skin is dry and hard and the pulp is soft. If there is rain, they can be dried with a low fire. Wolfberries have a variety of health care effects and are foods that can be used both as medicine and as food approved by the Ministry of Health. Appropriate consumption is beneficial to health, and it has the effect of clearing the liver and improving eyesight when combined with chrysanthemum and wolfberry tea.

[0025] Fructus Corni is the dried mature flesh of Cornus officinalis Sieb. et Zucc. of the Cornaceae family. It is distributed in Shanxi, Jiangsu, Zhejiang, Anhui, Jiangxi, Shandong, Henan, Hunan, Sichuan, Shaanxi, Gansu and other places. It has the effects of tonifying the liver and kidney, astringing and arresting discharge. It is commonly used for dizziness and tinnitus, soreness and weakness of the waist and knees, impotence and spermatorrhea, enuresis and frequent urination, metrorrhagia and leukorrhea, profuse sweating and collapse, and internal heat and polydipsia.

[0026] Kudzu root is the dried root of Pueraria lobata (Willd.) Ohwi of the Leguminosae family, commonly known as Pueraria lobata. It is dug in autumn and winter, and cut into thick slices or small pieces while it is fresh; then dried. It is sweet, pungent and cool. It has the functions of relieving muscle fever, promoting eruption, promoting the production of body fluid to quench thirst, and raising yang to stop diarrhea. It is commonly used for exterior syndrome fever, stiffness and pain of the nape and back, failure of measles to come out, thirst due to febrile disease, yin deficiency and polydipsia, febrile diarrhea and dysentery, and spleen deficiency diarrhea.

[0027] Hawthorn is the dried mature fruit of Crataegus pin,natiida Bge.var.majorN.E.Br. or Crataegus pin.nati fida Bge. of the Rosaceae family. The fruit is harvested in autumn when it is ripe, sliced ​​and dried. It is sour, sweet and slightly warm in nature. It enters the spleen, stomach and liver meridians. It helps digestion and invigorates the stomach, promotes qi and dissipates blood stasis, removes turbidity and reduces fat. It is used for meat stagnation, fullness in the stomach, abdominal pain due to diarrhea, amenorrhea due to blood stasis, postpartum blood stasis, stabbing pain in the heart and abdomen, chest pain, hernia pain and hyperlipidemia. The effect of charred hawthorn on digestion and stagnation is enhanced. It is used for meat stagnation and diarrhea.

[0028] Xiebai is the dried bulb of Allium macrostemon Bunge., a plant of the Liliaceae family. It is collected in summer and autumn, washed, the fibrous roots are removed, steamed or boiled thoroughly, and dried in the sun. It is pungent, bitter, and warm in nature. It enters the heart, lung, stomach, and large intestine meridians. It promotes yang and dissipates stagnation, promotes qi and removes stagnation. It is used for chest pain, abdominal distension and pain, and heaviness after diarrhea.

[0029] Cinnamon bark is the dried bark of Cinnamomum cassia Presl, a plant of the Lauraceae family. It is usually peeled in autumn and dried in the shade. It is pungent and sweet in nature and very hot in nature. It enters the kidney, spleen, heart and liver meridians. It has the effects of replenishing fire and yang, guiding fire back to the origin, dispersing cold and relieving pain, and warming and unblocking the meridians. It is used for impotence, cold uterus, cold pain in the waist and knees, asthma due to kidney deficiency, floating of false yang, dizziness and red eyes, cold pain in the heart and abdomen, vomiting and diarrhea due to deficiency and cold, abdominal pain due to cold hernia, dysmenorrhea and amenorrhea.

[0030] Jujube is the ripe fruit of the rhamnaceae plant Ziziphus jujuba Mill. It is harvested in autumn when the fruit is ripe. Remove impurities and dry in the sun. Or bake until the skin is soft and then dry in the sun. Or boil it in water to make the flesh soft but the skin is not wrinkled, then pick it up and dry it in the sun. Functions and indications: tonify the spleen and stomach, replenish qi and produce body fluid, regulate the body's defense system, and detoxify drugs. It can treat weak stomach and poor appetite, weak spleen and loose stools, insufficient qi, blood and body fluid, disharmony between the body's defense system, palpitations and restlessness. It can also cause women to be irritable and impatient. ① "Ben Jing": It can treat evil qi in the heart and abdomen, calm the middle and nourish the spleen, and help the twelve meridians. It can calm the stomach qi, open the nine orifices, replenish insufficient qi and body fluid, treat deficiency in the body, great shock, heaviness in the limbs, and harmonize all medicines. ② "Ben Cao Jing Ji Zhu": It can kill the poison of Aconitum. ③ "Bie Lu": nourishes the middle and replenishes qi, strengthens, eliminates depression, treats heart hanging, intestinal urticaria ④ "Yao Dui": kills the poison of aconite and Tianxiong. ⑤ Meng Shen: mainly replenishes body fluid, washes away evil qi in the heart and abdomen, harmonizes the poison of hundreds of medicines, opens the nine orifices, replenishes insufficient qi, cooks and replenishes the stomach and intestines, and is the best for nourishing the middle and replenishing qi. Children suffering from autumn dysentery can eat it with worm dates, which is good. ⑥ "Rihuazi Bencao": moisturizes the heart and lungs, stops cough. Nourish the five internal organs, treat asthenia, and eliminate gastrointestinal tinea. ⑦ "Zhenzhu Nang": warms the stomach. ⑧ Li Gao: warms to replenish the deficiency of spleen meridian, sweet to slow down yin blood, harmonizes yin and yang, regulates Ying and Wei, and produces body fluid. ⑨ "Yaoyao Huayi": nourishes blood and replenishes liver. ⑩ "Ben Cao Zai Xin": nourishes the middle and replenishes qi, nourishes the kidney and warms the stomach, and treats yin deficiency. ⑪ "Zhongguo Yaozhi Tujian": treats allergic purpura, anemia and hypertension.

[0031] Compared with the prior art, the beneficial effects of the present invention are as follows:

[0032] 1. Carotid atherosclerotic plaque belongs to the concept in Western medicine, and this disease name has never appeared in the classic works of traditional Chinese medicine throughout history. According to its clinical manifestations, it can be classified into the category of "vascular bi-syndrome". Vascular bi-syndrome was first seen in "Plain Questions - Treatise on Bi-syndromes", which states: "Those who encounter this in summer are suffering from vascular bi-syndrome", and "Bi-syndrome... in the vessels means blood stasis and non-flow". The heart is connected to the qi of summer and governs blood vessels. In summer, when affected by wind-cold-damp pathogens, it is easy to lodge internally in the vessels, resulting in vascular bi-syndrome and causing blood stasis and non-flow. Research shows that liver-kidney yin deficiency is the most common pattern differentiation in traditional Chinese medicine for carotid atherosclerosis. Those with liver-kidney yin deficiency have kidney deficiency as the root. Since the liver and kidney share the same origin, when kidney yin is insufficient, liver yin will also be deficient. Yin deficiency generates internal heat, and heat, as a yang pathogen, can consume the body's yin fluid, burn the liver meridian, and further damage the yin of the liver and kidney. In this way, a vicious cycle occurs, ultimately leading to disharmony of zang-fu functions, endogenous toxin formation, yin deficiency and toxic heat, damaging the physical form, and causing plaque damage and detachment. The present invention believes that phlegm and stasis are the pathological basis for plaque formation. Phlegm causes stasis, and phlegm and stasis are mutually intertwined. "The change starts from toxin" is the main cause of the pathological evolution of the plaque. At the same time, there are also inflammatory factors in carotid atherosclerotic plaques. The clinical manifestations of the liver-kidney yin deficiency type are: dizziness and tinnitus, soreness and weakness of the waist and knees, feverish sensation in the five centers (palms, soles, and chest), forgetfulness and insomnia, dry mouth, red tongue, little coating, and thready and rapid pulse. Therefore, it is proposed to use heat-clearing and detoxifying herbs to stabilize the plaque, use phlegm-resolving herbs to dissolve the plaque, then use blood-activating and stasis-removing herbs to carry away the dissolved small plaques, and use the method of nourishing yin and tonifying the liver and kidney to strengthen the constitution. Therefore, the treatment principles of the present invention are as follows: First, use heat-clearing and detoxifying herbs to anti-inflammatory and bactericidal, inhibit the inflammatory reaction of the plaque, and at the same time stabilize the plaque; Second, use phlegm-resolving herbs to dissolve the plaque; Third, Wang Qingren discussed that "prolonged illness enters the collaterals and turns into stasis", and Ye Tianshi also said: "Prolonged illness enters the collaterals", "Prolonged pain enters the collaterals", "Generally, the meridians govern qi, and the collaterals govern blood. Prolonged illness leads to blood stasis", "Most cases of prolonged illness are treated from blood". Therefore, traditional Chinese medicine classifies this disease into the categories of "blood stasis" and "accumulation". Use blood-activating and stasis-removing herbs to improve hemorheology; Fourth, nourish the liver and kidney to make the essence of the kidney be properly stored and the liver yin be nourished. In the whole formula, chrysanthemum, dandelion, honeysuckle, and kudzu root clear heat and detoxify, and fingered citron and citron fruit resolve phlegm and dissolve the plaque, serving as the monarch herbs; peach kernel, angelica, hawthorn, and allium macrostemon are the minister herbs, promoting digestion and strengthening the spleen, promoting qi movement and removing stasis, promoting yang and dispersing binds, regulating qi and promoting qi stagnation; wolfberry fruit, cornelian cherry fruit, cinnamon, and Chinese date nourish the liver and kidney, tonify primordial yang, and promote blood circulation as the assistant and guiding herbs. The whole formula can dissolve the plaque, improve carotid atherosclerosis, and especially has an eliminating effect on carotid plaques formed by elderly carotid atherosclerosis of the liver-kidney yin deficiency type, with good effects.

[0033] 2. Nattokinase originally has in vivo thrombolytic activity, which complements and interacts with the traditional Chinese medicine composition of the present invention, playing a synergistic role. Detailed implementation manners

[0034] Based on the embodiments in the present invention, all other embodiments obtained by those of ordinary skill in the art without creative efforts shall fall within the protection scope of the present invention.

[0035] Example 1: Take 8 g of nattokinase, 12 g of chrysanthemum, 6 g of dandelion, 10 g of honeysuckle, 6 g of kudzu root, 4 g of fingered citron, 10 g of citron, 4 g of peach kernel, 14 g of angelica, 12 g of hawthorn, 10 g of Chinese chive, 8 g of wolfberry, 8 g of cornel, 3 g of cinnamon, and 14 g of Chinese date. The preparation method is as follows: (1) Take honeysuckle, peach kernel, citron, cinnamon, and angelica, and perform steam distillation on them to extract the volatile oils of honeysuckle, peach kernel, citron, cinnamon, and angelica for standby; (2) Filter the aqueous solution after steam distillation extraction of honeysuckle, peach kernel, citron, cinnamon, and angelica to obtain the aqueous solution after distillation of honeysuckle, peach kernel, citron, cinnamon, and angelica, heat and concentrate it, and perform alcohol precipitation to obtain the supernatant, which is the water extraction alcohol precipitation concentrate after steam distillation of honeysuckle, peach kernel, citron, cinnamon, and angelica for standby; Keep the medicinal residues after steam distillation extraction of honeysuckle, peach kernel, citron, cinnamon, and angelica for standby; (3) Mix the medicinal residues after steam distillation extraction of honeysuckle, peach kernel, citron, cinnamon, and angelica obtained in step (2) with the medicinal materials of chrysanthemum, dandelion, kudzu root, fingered citron, hawthorn, Chinese chive, wolfberry, cornel, and Chinese date, add 10 times the weight of the medicinal materials of water and decoct twice, each time for 2 hours, combine the water extraction solutions, filter, obtain the water extraction solution, concentrate it, and perform alcohol precipitation to obtain the supernatant, which is the water extraction alcohol precipitation concentrate; (4) Combine the water extraction alcohol precipitation concentrate obtained in step (3) and the water extraction alcohol precipitation concentrate after distillation of honeysuckle, peach kernel, citron, cinnamon, and angelica obtained in step (2), perform spray drying, add the volatile oils of honeysuckle, peach kernel, citron, cinnamon, and angelica and nattokinase obtained in step (1), add starch, and prepare into tablets. The conditions for both alcohol precipitations are: add 95% ethanol, stir well to make the alcohol content in the medicinal liquid reach 70%, close the lid of the alcohol precipitation tank, and let it stand for 24 hours.

[0036] Example 2: Take 8 g of nattokinase, 12 g of chrysanthemum, 6 g of dandelion, 10 g of honeysuckle, 6 g of kudzu root, 4 g of fingered citron, 10 g of citron, 4 g of peach kernel, 14 g of angelica, 12 g of hawthorn, 10 g of allium macrostemon, 8 g of wolfberry fruit, 8 g of cornel, 3 g of cinnamon, and 14 g of Chinese date. The preparation method is as follows: (1) Take honeysuckle, peach kernel, citron, cinnamon, and angelica, perform steam distillation on them to extract the volatile oils of honeysuckle, peach kernel, citron, cinnamon, and angelica, and set aside; (2) Filter the aqueous solution after steam distillation extraction of honeysuckle, peach kernel, citron, cinnamon, and angelica to obtain the aqueous solution after distillation of honeysuckle, peach kernel, citron, cinnamon, and angelica, heat and concentrate it, and perform alcohol precipitation to obtain the supernatant, which is the water extraction alcohol precipitation concentrate after steam distillation of honeysuckle, peach kernel, citron, cinnamon, and angelica, and set aside; Reserve the medicinal residues after steam distillation extraction of honeysuckle, peach kernel, citron, cinnamon, and angelica, and set aside; (3) Mix the medicinal residues after steam distillation extraction of honeysuckle, peach kernel, citron, cinnamon, and angelica obtained in step (2) with the medicinal materials of chrysanthemum, dandelion, kudzu root, fingered citron, hawthorn, allium macrostemon, wolfberry fruit, cornel, and Chinese date, add 10 times the weight of the medicinal materials of water and decoct twice, each time for 2 hours, filter to obtain the water extraction solution, concentrate it, and perform alcohol precipitation to obtain the supernatant, which is the water extraction alcohol precipitation concentrate; (4) Combine the water extraction alcohol precipitation concentrate obtained in step (3) and the water extraction alcohol precipitation concentrate after distillation of honeysuckle, peach kernel, citron, cinnamon, and angelica obtained in step (2), perform spray drying, add the volatile oils of honeysuckle, peach kernel, citron, cinnamon, and angelica and nattokinase obtained in step (1), and add starch to prepare into capsules. The conditions for both alcohol precipitations are: add 95% ethanol, stir well to make the alcohol content in the medicinal liquid reach 70%, close the lid of the alcohol precipitation tank, and let it stand for 24 hours.

[0037] Example 3: Take 10 g of nattokinase, 10 g of chrysanthemum, 8 g of dandelion, 8 g of honeysuckle, 8 g of kudzu root, 6 g of bergamot, 8 g of citron, 6 g of peach kernel, 12 g of angelica, 12 g of hawthorn, 8 g of allium macrostemon, 10 g of wolfberry fruit, 6 g of cornel, 6 g of cinnamon, and 12 g of Chinese date. The preparation method is as follows: (1) Take honeysuckle, peach kernel, citron, cinnamon, and angelica, and perform steam distillation on them to extract the volatile oils of honeysuckle, peach kernel, citron, cinnamon, and angelica for standby; (2) Filter the aqueous solution obtained after the steam distillation of honeysuckle, peach kernel, citron, cinnamon, and angelica to obtain the aqueous solution after the distillation of honeysuckle, peach kernel, citron, cinnamon, and angelica, heat and concentrate it, and perform alcohol precipitation to obtain the supernatant, which is the water extraction alcohol precipitation concentrated solution after the steam distillation of honeysuckle, peach kernel, citron, cinnamon, and angelica for standby; Keep the medicinal residues obtained after the steam distillation of honeysuckle, peach kernel, citron, cinnamon, and angelica for standby; (3) Mix the medicinal residues obtained after the steam distillation of honeysuckle, peach kernel, citron, cinnamon, and angelica in step (2) with the medicinal materials of chrysanthemum, dandelion, kudzu root, bergamot, hawthorn, allium macrostemon, wolfberry fruit, cornel, and Chinese date, add 10 times the weight of the medicinal materials of water and decoct twice, each time for 2 hours, filter to obtain the water extraction solution, concentrate it, and perform alcohol precipitation to obtain the supernatant, which is the water extraction alcohol precipitation concentrated solution; (4) Combine the water extraction alcohol precipitation concentrated solution obtained in step (3) and the water extraction alcohol precipitation concentrated solution after the distillation of honeysuckle, peach kernel, citron, cinnamon, and angelica obtained in step (2), perform spray drying, add the volatile oils of honeysuckle, peach kernel, citron, cinnamon, and angelica and nattokinase obtained in step (1), and add starch to prepare granules. The conditions for both alcohol precipitations are: add 95% ethanol, stir well to make the alcohol content of the medicinal liquid reach 70%, close the lid of the alcohol precipitation tank, and let it stand for 24 hours.

[0038] Example 4: Take 10 g of nattokinase, 12 g of kudzu root, 12 g of hawthorn, 6 g of allium macrostemon, 3 g of cinnamon, and 12 g of Chinese date. The preparation method is as follows: (1) Take cinnamon and perform steam distillation on it to extract the volatile oil of cinnamon for standby; (2) Filter the aqueous solution obtained after the steam distillation of cinnamon to obtain the aqueous solution after the distillation of cinnamon, heat and concentrate it, and perform alcohol precipitation to obtain the supernatant, which is the water extraction alcohol precipitation concentrated solution after the steam distillation of cinnamon for standby; Keep the medicinal residues obtained after the steam distillation of cinnamon for standby; (3) Mix the medicinal residues obtained after the steam distillation of cinnamon in step (2) with the medicinal materials of kudzu root, hawthorn, allium macrostemon, and Chinese date, add 10 times the weight of the medicinal materials of water and decoct twice, each time for 2 hours, filter to obtain the water extraction solution, concentrate it, and perform alcohol precipitation to obtain the supernatant, which is the water extraction alcohol precipitation concentrated solution; (4) Combine the water extraction alcohol precipitation concentrated solution obtained in step (3) and the water extraction alcohol precipitation concentrated solution after the distillation of cinnamon obtained in step (2), perform spray drying, add the volatile oil of cinnamon obtained in step (1) and nattokinase, and add starch to prepare granules. The conditions for both alcohol precipitations are: add 95% ethanol, stir well to make the alcohol content of the medicinal liquid reach 70%, close the lid of the alcohol precipitation tank, and let it stand for 24 hours.

[0039] Comparative Example 1: Take 10 g of chrysanthemum, 8 g of dandelion, 8 g of honeysuckle, 8 g of kudzu root, 6 g of fingered citron, 8 g of citron, 6 g of peach kernel, 12 g of angelica, 12 g of hawthorn, 8 g of allium macrostemon, 10 g of wolfberry fruit, 6 g of cornel, 6 g of cinnamon, and 12 g of Chinese date. The preparation method is as follows: (1) Take honeysuckle, peach kernel, citron, cinnamon, and angelica, and perform steam distillation on them to extract the volatile oils of honeysuckle, peach kernel, citron, cinnamon, and angelica for standby; (2) Filter the aqueous solution after steam distillation extraction of honeysuckle, peach kernel, citron, cinnamon, and angelica to obtain the aqueous solution after distillation of honeysuckle, peach kernel, citron, cinnamon, and angelica, heat and concentrate it, and perform alcohol precipitation to obtain the supernatant, which is the water extraction and alcohol precipitation concentrated solution after steam distillation of honeysuckle, peach kernel, citron, cinnamon, and angelica for standby; Keep the medicinal residues after steam distillation extraction of honeysuckle, peach kernel, citron, cinnamon, and angelica for standby; (3) Mix the medicinal residues after steam distillation extraction of honeysuckle, peach kernel, citron, cinnamon, and angelica obtained in step (2) with the medicinal materials of chrysanthemum, dandelion, kudzu root, fingered citron, hawthorn, allium macrostemon, wolfberry fruit, cornel, and Chinese date, add 10 times the weight of the medicinal materials of water, decoct twice, each time for 2 hours, filter to obtain the water extraction solution, concentrate it, and perform alcohol precipitation to obtain the supernatant, which is the water extraction and alcohol precipitation concentrated solution; (4) Combine the water extraction and alcohol precipitation concentrated solution obtained in step (3) and the water extraction and alcohol precipitation concentrated solution after distillation of honeysuckle, peach kernel, citron, cinnamon, and angelica obtained in step (2), perform spray drying, add the volatile oils of honeysuckle, peach kernel, citron, cinnamon, and angelica obtained in step (1), and add starch to prepare granules. The conditions for both alcohol precipitations are: add 95% ethanol, stir well to make the alcohol content in the medicinal liquid reach 70%, close the lid of the alcohol precipitation tank, and let it stand for 24 hours.

[0040] Example 5: Functional experiment research

[0041] General information: Select inpatients with bilateral carotid artery plaques confirmed by ultrasound in the school outpatient department, and divide them into the Example 3 group, the Example 4 group, the Comparative Example 1 group, and the nattokinase group according to the random number table method, with 30 patients in each group, a total of 120 cases, including 66 males and 54 females; aged 68 - 75 years old; compare before and after administration.

[0042] Diagnostic criteria: The diagnostic criteria for carotid atherosclerosis are based on the "Vascular Ultrasound Examination Guidelines" formulated by the Ultrasound Physicians Branch of the Chinese Medical Doctor Association in 2009: For the definition of carotid intima-media thickness and plaque, IMT≥1.0 mm is defined as intimal thickening, and local IMT≥1.5 mm or more than 50% of the surrounding is defined as plaque. Those who meet the above diagnostic criteria and have no active plaques and the number of plaques does not exceed 3 are diagnosed as: liver-kidney yin deficiency type: dizziness and tinnitus, soreness and weakness of the waist and knees, five-palm heat, forgetfulness and insomnia, dry mouth, red tongue, less coating, and thready and rapid pulse.

[0043] Treatment process: Use the granules prepared in Example 3 group, Example 4 group, and Comparative Example 1 group of the present invention, 3 times a day, 2 bags each time, with 15 grams of traditional Chinese medicine in each bag. For the nattokinase group (nattokinase activity is 3.75 million U / g), take 3 g each time, 3 times a day, for 1 month.

[0044] Observation indicators: Carotid plaque ultrasound examination. Before and after treatment, instruct the patient to fully expose the neck, and use a color Doppler ultrasound instrument (Philips, model: IUelite) to explore the bilateral carotid arteries. Continuously scan through the longitudinal section and transverse section, and sequentially explore the plaque conditions of the common carotid artery and its bifurcation, external carotid artery, and internal carotid artery to obtain the plaque area; measure the intima-media thickness (IMT) of the carotid artery at 1 cm distal to the bifurcation on both sides of the common carotid artery, 1 cm from the origin of the internal carotid artery and carotid bulb. Refer to the Crouse scoring method for carotid atherosclerotic plaques for plaque scoring: Add up the maximum thickness (mm) of the isolated carotid plaques on the same side, and then obtain the plaque score of the carotid artery on that side. The sum of the plaque scores of the carotid arteries on both sides of each case is the total plaque score of the patient.

[0045] Table 1 Comparison of IMT, plaque area, and Crouse score in three groups of patients before and after treatment (x±s)

[0046]

[0047] Compared with before this treatment: *P<0.05, **P<0.01

[0048] Results: By comparing the oral administration of Example 3 group, Example 4 group, Comparative Example 1 group, and nattokinase group of the present invention, it was found through color Doppler ultrasound detection that it can reduce the IMT and plaque area, and reduce the plaque Crouse score. Compared with Example 3 group, although the prescription of Example 4 group was streamlined, the effect was still obvious. And after nattokinase was combined with the traditional Chinese medicine in the traditional Chinese medicine composition of the present invention, the effect was significantly better than that of using the traditional Chinese medicine composition alone (without nattokinase) or nattokinase alone, indicating that there is a synergistic effect between the traditional Chinese medicine and nattokinase in the traditional Chinese medicine composition of the present invention.

[0049] Although the description of the present invention is through specific embodiments, those skilled in the art should understand that the present invention can also cover other embodiments within the scope of the present invention as described in the text.

Claims

1. A traditional Chinese medicine composition for removing vascular plaques, characterized in that: The traditional Chinese medicine composition for removing vascular plaques is made from the following raw materials by weight: 8-12 parts of nattokinase, 8-12 parts of chrysanthemum, 6-10 parts of dandelion, 6-10 parts of honeysuckle, 6-14 parts of kudzu root, 4-8 parts of fingered citron, 6-10 parts of citron, 4-8 parts of peach kernel, 10-14 parts of angelica, 10-14 parts of hawthorn, 6-10 parts of Chinese chive bulb, 8-12 parts of wolfberry fruit, 4-8 parts of cornel, 3-8 parts of cinnamon, 10-14 parts of Chinese date. The preparation method is as follows: (1) Take honeysuckle, peach kernel, citron, cinnamon and angelica, and carry out steam distillation extraction on them to extract the volatile oils of honeysuckle, peach kernel, citron, cinnamon and angelica, and reserve them for later use; (2) Filter the aqueous solution after the steam distillation extraction of honeysuckle, peach kernel, citron, cinnamon and angelica to obtain the aqueous solution after the steam distillation of honeysuckle, peach kernel, citron, cinnamon and angelica, heat and concentrate it, and carry out alcohol precipitation. The alcohol precipitation conditions are: add 95% ethanol, stir well to make the alcohol content of the medicinal liquid reach 70%, close the lid of the alcohol precipitation tank, and let it stand for 24 hours to obtain the supernatant, which is the water extraction alcohol precipitation concentrated liquid after the steam distillation of honeysuckle, peach kernel, citron, cinnamon and angelica, and reserve it for later use; Keep the medicinal residues after the steam distillation extraction of honeysuckle, peach kernel, citron, cinnamon and angelica for later use; (3) Mix the medicinal residues after the steam distillation extraction of honeysuckle, peach kernel, citron, cinnamon and angelica obtained in step (2) with the medicinal materials of chrysanthemum, dandelion, kudzu root, fingered citron, hawthorn, Chinese chive bulb, wolfberry fruit, cornel and Chinese date, add 10 times the weight of water of the medicinal materials, decoct twice, each time for 2 hours, filter to obtain the water extraction solution, concentrate it, and carry out alcohol precipitation. The alcohol precipitation conditions are: add 95% ethanol, stir well to make the alcohol content of the medicinal liquid reach 70%, close the lid of the alcohol precipitation tank, and let it stand for 24 hours to obtain the supernatant, which is the water extraction alcohol precipitation concentrated liquid; (4) Combine the water extraction alcohol precipitation concentrated liquid obtained in step (3) and the water extraction alcohol precipitation concentrated liquid after the steam distillation of honeysuckle, peach kernel, citron, cinnamon and angelica obtained in step (2), carry out spray drying, add the volatile oils of honeysuckle, peach kernel, citron, cinnamon and angelica and nattokinase obtained in step (1), and prepare them into a preparation to obtain the product.

2. The traditional Chinese medicine composition for removing vascular plaques according to claim 1, characterized in that: 8 parts of nattokinase, 12 parts of chrysanthemum, 6 parts of dandelion, 10 parts of honeysuckle, 6 parts of kudzu root, 4 parts of fingered citron, 10 parts of citron, 4 parts of peach kernel, 14 parts of angelica, 10 parts of hawthorn, 10 parts of Chinese chive bulb, 8 parts of wolfberry fruit, 8 parts of cornel, 3 parts of cinnamon, 14 parts of Chinese date.

3. The traditional Chinese medicine composition for removing vascular plaques according to claim 1, characterized in that: 12 parts of nattokinase, 8 parts of chrysanthemum, 10 parts of dandelion, 6 parts of honeysuckle, 14 parts of kudzu root, 8 parts of fingered citron, 6 parts of citron, 8 parts of peach kernel, 10 parts of angelica, 14 parts of hawthorn, 6 parts of Chinese chive bulb, 12 parts of wolfberry fruit, 4 parts of cornel, 8 parts of cinnamon, 10 parts of Chinese date.

4. The traditional Chinese medicine composition for removing vascular plaques according to claim 1, characterized in that: 10 parts of nattokinase, 10 parts of chrysanthemum, 8 parts of dandelion, 8 parts of honeysuckle, 12 parts of kudzu root, 6 parts of fingered citron, 8 parts of citron, 6 parts of peach kernel, 12 parts of angelica, 12 parts of hawthorn, 8 parts of Chinese scallion, 10 parts of wolfberry fruit, 6 parts of dogwood, 6 parts of cinnamon, and 12 parts of Chinese date.

5. The traditional Chinese medicine composition for removing vascular plaques according to claim 1, characterized in that: the preparation is one of tablets, capsules, and granules.

6. Application of the traditional Chinese medicine composition for removing vascular plaques according to claim 1 in the preparation of drugs for eliminating carotid plaques formed by senile carotid atherosclerosis, and the syndrome type of carotid atherosclerosis is the type of deficiency of liver and kidney yin.

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