CN115137811A - Traditional Chinese medicine composition for removing vascular plaque and preparation method thereof - Google Patents

Abstract

The invention discloses a traditional Chinese medicine composition for removing vascular plaque and a preparation method thereof, wherein the traditional Chinese medicine composition for removing the vascular plaque is prepared from the following raw material medicines 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 medlar, 4-8 parts of dogwood, 4-8 parts of cinnamon and 10-14 parts of Chinese date.

Description

Traditional Chinese medicine composition for removing vascular plaque and preparation method thereof

Technical Field

The invention relates to the technical field of traditional Chinese medicine preparations, in particular to a traditional Chinese medicine composition for removing vascular plaque and a preparation method thereof.

Background

The prevalence rate of senile carotid atherosclerosis CAD has a tendency to gradually rise, and the attention of people to the disease are higher and higher. The traditional Chinese medicine syndrome type divides the senile carotid atherosclerosis CAD into four types, namely phlegm stagnation, phlegm-stasis mutual accumulation, spleen-kidney yang deficiency and liver-kidney yin deficiency. Referring to the diagnostic and therapeutic criteria of traditional Chinese medicine syndrome (trial) formulated by the State administration of traditional Chinese medicine, the clinical research guidelines of new traditional Chinese medicines and the syndrome differentiation and typing of headache, dizziness, dementia, consumptive disease, stroke and other diseases in the 5 th edition of the teaching materials of the internal medicine of the higher medical institutions, the symptoms and signs are (1) phlegm turbidity retardation type, namely, obesity, tired limbs, heavy head, anorexia and epigastric distention, excessive phlegm and spitting, sleepiness, chest distress and nausea, swollen and big tongue, pale tongue, white and greasy fur, slippery pulse, or red tongue, yellow and greasy fur and slippery pulse. (2) Phlegm-blood stasis type, oppression in the chest with profuse phlegm, white or yellow phlegm, thick texture, wheezy phlegm in the throat, local stabbing pain, or numbness of limbs, cyanosis of lips and nails, dark or purple tongue, varicose veins under the tongue, greasy coating, and slippery pulse. (3) Spleen-kidney yang deficiency type with soreness of waist and knees, cold pain in abdomen, cold body, cold limbs, diarrhea before dawn, edema of limbs, and even abdominal distention; or frequent urination, dribbling urine, pale and swollen tongue with teeth marks, white and slippery tongue coating, deep, thready and weak pulse. (4) Vertigo, tinnitus, soreness and weakness of waist and knees, dysphoria with smothery sensation in chest, amnesia, insomnia, dry mouth, red tongue with little coating, and thready and rapid pulse due to liver and kidney yin deficiency. Research shows that the elastography score of the liver-kidney yin deficiency type low-echo plaque is obviously lower than that of the phlegm-blood stasis type (P is less than 0.01), and the lower the elastography score is, the softer and more unstable plaque is, and the plaque is easy to fall off to cause cerebral apoplexy.

NattoKinase (NK) is an alkaline serine protease secreted by Bacillus subtilis (natto), and has the advantages of long half-life, strong specificity, small side effect, direct oral administration and the like. The nattokinase is extracted from food natto or produced by bacillus natto, is a protein with molecular weight far less than that of UK, SK and tPA, can be absorbed by intestinal tract, and the in vitro and in vivo thrombolysis properties of the nattokinase are also determined by experiments.

CAD patients not only occupy the risk factors of high ages, but also are easy to suffer from various diseases, and the diseases coexist, so that the dysfunction of viscera, the endogenous toxicity, the deterioration of physique and the falling of plaques are more easily caused. The dropping of carotid plaque and stroke have certain correlation, therefore, the traditional Chinese medicine composition for removing the vascular plaque is provided, and the unexpected discovery that the traditional Chinese medicine composition is compatible with nattokinase, has obvious effect on promoting the ablation of the carotid plaque, and is particularly suitable for the plaque formed by the senile carotid atherosclerosis with liver-kidney yin deficiency.

Disclosure of Invention

The invention aims to provide a traditional Chinese medicine composition for removing vascular plaques and a preparation method thereof.

In order to achieve the purpose, the invention provides the following technical scheme: the traditional Chinese medicine composition for removing the vascular plaque is prepared from the following raw material medicines 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 allium macrostemon, 8-12 parts of medlar, 4-8 parts of dogwood, 3-8 parts of cinnamon and 10-14 parts of Chinese date.

The traditional Chinese medicine composition for removing the vascular plaque comprises 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 allium macrostemon, 8 parts of wolfberry fruit, 8 parts of dogwood, 3 parts of cinnamon and 14 parts of Chinese date.

The traditional Chinese medicine composition for removing the vascular plaque comprises 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 allium macrostemon, 12 parts of wolfberry fruit, 4 parts of dogwood, 8 parts of cinnamon and 10 parts of Chinese date.

The traditional Chinese medicine composition for removing the vascular plaque comprises 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 allium macrostemon, 10 parts of wolfberry fruit, 6 parts of dogwood, 6 parts of cinnamon and 12 parts of Chinese date.

The traditional Chinese medicine composition for removing the vascular plaque comprises 10 parts of nattokinase, 12 parts of kudzuvine root, 12 parts of hawthorn, 6 parts of allium macrostemon, 3 parts of cinnamon and 12 parts of Chinese date.

The preparation method of the traditional Chinese medicine composition for removing the vascular plaque comprises the following steps: (1) Extracting flos Lonicerae, semen Persicae, fructus Citri, cortex Cinnamomi and radix Angelicae sinensis by steam distillation, and extracting volatile oil from flos Lonicerae, semen Persicae, fructus Citri, cortex Cinnamomi and radix Angelicae sinensis; (2) Filtering the water solution obtained by steam distillation extraction of honeysuckle, peach kernel, citron, cinnamon and angelica to obtain the water solution obtained by distillation of honeysuckle, peach kernel, citron, cinnamon and angelica, heating for concentration, and carrying out alcohol precipitation to obtain supernatant which is the water extraction and alcohol precipitation concentrated solution obtained by steam distillation of honeysuckle, peach kernel, citron, cinnamon and angelica for later use; keeping the residue of the water vapor distillation extraction of honeysuckle, peach kernel, citron, cinnamon and angelica for later use; (3) Mixing the residues obtained in the step (2) after steam distillation extraction of honeysuckle, peach kernel, citron fruit, cinnamon and angelica with medicinal materials of chrysanthemum, dandelion, kudzu root, fingered citron, hawthorn, allium macrostemon, medlar, dogwood and jujube, adding water with the weight of 10 times of the medicinal materials, decocting twice for 2 hours each time, filtering to obtain a water extract, concentrating, precipitating with ethanol to obtain a supernatant, and extracting with water and precipitating with ethanol to obtain a concentrated solution; (4) And (3) mixing the water extraction and alcohol precipitation concentrated solution obtained in the step (3) and the water extraction and alcohol precipitation concentrated solution obtained after distillation of the honeysuckle, the peach kernel, the citron, the cinnamon and the angelica obtained in the step (2), spray-drying, adding the honeysuckle, the peach kernel, the citron, the cinnamon and the angelica volatile oil obtained in the step (1) and nattokinase, and preparing a preparation to obtain the traditional Chinese medicine preparation.

The preparation method of the traditional Chinese medicine composition for removing the vascular plaque comprises the following steps: (1) Extracting cortex Cinnamomi by steam distillation to obtain volatile oil; (2) Filtering the water solution obtained after steam distillation and extraction of cinnamon to obtain the water solution obtained after distillation of cinnamon, heating, concentrating, and precipitating with ethanol to obtain supernatant, which is the water extraction and ethanol precipitation concentrated solution obtained after steam distillation of cinnamon for later use; keeping the dregs of decoction of cinnamon after steam distillation extraction for later use; (3) Mixing the dregs obtained after steam distillation extraction of the cinnamon obtained in the step (2) with the medicinal materials of the kudzu root, the hawthorn, the allium macrostemon and the Chinese date, adding water with the weight which is 10 times that of the medicinal materials, decocting twice for 2 hours each time, filtering to obtain a water extract, concentrating, precipitating with ethanol to obtain a supernatant, and extracting with water and precipitating with ethanol to obtain a concentrated solution; (4) And (3) mixing the water extraction and alcohol precipitation concentrated solution obtained in the step (3) and the water extraction and alcohol precipitation concentrated solution obtained in the step (2) after distillation of the cinnamon, carrying out spray drying, adding the cinnamon volatile oil obtained in the step (1) and nattokinase, and preparing into a preparation.

The traditional Chinese medicine composition for removing the vascular plaque is prepared into one of tablets, capsules and granules.

The traditional Chinese medicine composition for removing the vascular plaque has the following two alcohol precipitation conditions: adding 95% ethanol, stirring to make ethanol content of the medicinal liquid reach 70%, closing alcohol precipitation tank cover, and standing for 24 hr.

The traditional Chinese medicine composition for removing the vascular plaque is applied to preparing a carotid plaque health care product for eliminating the formation of senile carotid atherosclerosis, wherein the carotid atherosclerosis is of liver-kidney yin deficiency type.

Nattokinase, see patent application No.: 201310547971.3 prepared by the method shown in example 1, the natto kinase activity is 375 ten thousand U/g.

The flos Chrysanthemi is head-shaped inflorescence of Chrysanthemum morifolium of Chrysanthemum of Compositae. The chrysanthemum flower is mainly named as white chrysanthemum in the market, and comprises Bo chrysanthemum in Bo county of Anhui province, huai chrysanthemum in Henan, chuan chrysanthemum in Sichuan and Qiqi chrysanthemum in Hebei. Bitter and sweet in taste, slightly cold in nature. It enters lung and liver meridians. Dispel wind and clear heat, pacify liver and improve vision, clear heat and remove toxicity. The present invention uses Bo-Chrysanthemum.

Taraxacum mongolicum hand-Mazz, taraxacum mongolicum hand, compositae, and Taraxacum perennial herb. The head-shaped inflorescence, the seeds are provided with pompon formed by white crown hairs, and the pompon floats to a new place along with wind after the flowers bloom to inoculate new life. It is dried whole plant of Taraxacum officinale Kitag, or several plants of the same genus. Bitter, sweet and cold. It is mainly used for furuncle, swelling and toxin, acute mastitis, scrofula, conjunctival congestion, pharyngalgia, pulmonary abscess, intestinal abscess, jaundice due to damp-heat pathogen, stranguria with heat and pain, etc.

The flos Lonicerae is dried bud or flower with initial bloom of Lonicera japonica Thunb. The honeysuckle is mostly distributed in east China, south China, southwest China, hebei, shanxi, liaoning, shaanxi, gansu and other places; lonicera confusa is mostly distributed in Guangdong, guangxi and Hainan; the lonicera aegypti is distributed in Zhejiang, anhui, fujian, jiangxi, hubei, hunan, guangdong, guangxi, sichuan, guizhou, yunnan, taiwan and the like; lonicera fulvescens is distributed in Guangxi, guizhou and Yunnan. Has the effects of clearing away heat and toxic materials. It can be used for treating fever due to affection of exogenous wind-heat or epidemic febrile disease, heatstroke, toxic heat, dysentery, carbuncle, furuncle, pharyngitis, and various infectious diseases.

The fructus Citri Sarcodactylis is dry fruit of Rutaceae plant fructus Citri Sarcodactylis Citrus medica Lvar. Harvesting before or after the fruit turns yellow in autumn, slitting into slices, and drying in the sun or at low temperature. Pungent, bitter and sour in nature and warm in nature. It enters liver, spleen, stomach and lung meridians. Soothe the liver, regulate qi, harmonize stomach, alleviate pain, dry dampness and resolve phlegm. Can be used for treating stagnation of qi of liver and stomach, distending pain in chest and hypochondrium, fullness and distention in gastric cavity, anorexia, emesis, cough, and excessive phlegm.

The fructus Citri is mature fruit of Citrus citri Citrus medica L. Or Citrus wilsonii Tanaka of Rutaceae. Harvesting in autumn when the fruit is mature, slicing the fruit while the fruit is fresh, and drying the fruit in the sun or at low temperature. The whole or half of the incense ball can be dried in the sun or at low temperature. Pungent, bitter, sour and warm in nature. It enters liver, spleen and lung meridians. To soothe the liver, regulate qi, relieve epigastric distention and resolve phlegm. Can be used for treating qi stagnation of liver and stomach, distending pain in chest and hypochondrium, fullness and distention in stomach and abdomen, emesis, belching, excessive phlegm and cough.

Peach kernel is dried mature seed of Prunus persica (L.) Batsch or Prunus davidiana (Carr.) Franch of Rosaceae. Harvesting after the fruits are ripe, removing pulp and nucleocapsid, taking out seeds, and drying in the sun. Is generally cultivated all over the country. Has the effects of promoting blood circulation, removing blood stasis, loosening bowel to relieve constipation, and relieving cough and asthma. Can be used for treating amenorrhea, dysmenorrhea, abdominal mass, pulmonary abscess, acute appendicitis, traumatic injury, intestinal dryness, constipation, cough, and asthma.

Angelica sinensis (oliv.) Diels is dried root of Angelica sinensis (oliv.) Diels of Umbelliferae. The major production of southeast part of Gansu province has high yield and good quality in Min county, and is cultivated in Yunnan province, sichuan province, shanxi province, hubei province and the like. Has the functions of enriching blood, promoting blood circulation, regulating menstruation, relieving pain, moistening intestine and relaxing bowels. It is commonly indicated for blood deficiency and sallow complexion, vertigo and palpitation, irregular menstruation, amenorrhea and dysmenorrhea, deficiency cold and abdominal pain, rheumatic arthralgia, traumatic injury, carbuncle, deep-rooted carbuncle, pyocutaneous disease, constipation due to intestinal dryness. The wine angelica sinensis can activate blood and promote menstruation. Can be used for treating amenorrhea, dysmenorrhea, rheumatalgia, and traumatic injury.

Fructus Lycii is mature fruit of Lycium chinense Miller of Solanaceae. Picking in summer and autumn when the fruit is ripe, removing fruit stalks, drying in the shade until the peel wrinkles, and insolating until the outer skin is dry and hard and the pulp is soft. Drying with slow fire in rainy days. The medlar has various health care efficacies and is a medicine and food dual-purpose food approved by the Ministry of health. The chrysanthemum and wolfberry tea is beneficial to health when being eaten in a proper amount, and has the effects of clearing liver and improving vision when being matched with the chrysanthemum and wolfberry tea.

The Corni fructus is dried mature pulp of Cornus officinalis Sieb. Is distributed in Shanxi, jiangsu, zhejiang, anhui, jiangxi, shandong, henan, hunan, sichuan, shaanxi, gansu, etc. Has the efficacies of tonifying liver and kidney, astringing and relieving depletion. It is commonly used for vertigo, tinnitus, soreness and pain of waist and knees, impotence, spermatorrhea, enuresis, frequent micturition, metrorrhagia, leukorrhagia, profuse sweating, exhaustion, internal heat, and diabetes.

Radix Puerariae is dried Root of Pueraria lobata Lobed Kudzuvine Root of Leguminosae, and is called Pueraria lobata. Collected in autumn and winter, and cut into thick slices or small pieces when fresh; and (5) drying. Sweet, pungent and cool. Has the functions of expelling pathogenic factors from muscles, allaying fever, promoting eruption, promoting the production of body fluid to quench thirst, invigorating yang and stopping diarrhea. It is commonly indicated for exterior syndrome with fever, stiffness and pain of neck and back, measles without adequate eruption, thirst due to fever, diabetes due to yin deficiency, dysentery due to heat-purging and diarrhea due to spleen deficiency.

The fructus crataegi is dry mature fruit of Crataegus pinnatifida (Rosaceae) pin, natiia Bge, var. Majorn, E.Br, or Crataegus pinnatifida Bge. Collected in autumn when the fruit is ripe, sliced and dried. Sour and sweet in nature and slightly warm in nature. It enters spleen, stomach and liver meridians. Promoting digestion, invigorating stomach, promoting qi circulation, removing blood stasis, eliminating turbid pathogen, and reducing blood lipid. Can be used for treating meat stagnation, gastric cavity distention, dysentery, abdominal pain, blood stasis, amenorrhea, puerperal stagnation, heart and abdominal pain, thoracic obstruction, heart pain, hernia pain, and hyperlipidemia. The charred fructus crataegi has effects of resolving food stagnation. Can be used for treating food stagnation and diarrhea and dysentery.

Bulbus Allii Macrostemi is dried bulb of Bulbus Allii Macrostemi or Bulbus Allii Macrostemi Macrostemonis Bunge of Liliaceae. Collected in summer and autumn, washed, and then the fibrous root is removed, steamed or scalded in boiled water and dried in the sun. Pungent, bitter and warm in nature. It enters heart, lung, stomach and large intestine meridians. Activate yang and dissipate nodulation, move qi and remove stagnation. Can be used for treating thoracic obstruction, cardialgia, abdominal distention, fullness, distention and pain, dysentery, and tenesmus.

Cinnamon is the dried bark of cinnamon, cinnamomum cassia Presl, a Lauraceae plant. In autumn, the seeds are peeled off and dried in the shade. Pungent and sweet in flavor and strong hot in property. It enters kidney, spleen, heart and liver meridians. Has the effects of tonifying fire, supporting yang, guiding fire to the origin, dispelling cold, relieving pain, and warming and dredging channels and collaterals. Can be used for treating sexual impotence, cold womb, psychroalgia of waist and knee, asthma due to kidney deficiency, floating of deficient yang, giddiness, conjunctival congestion, psychroalgia of heart and abdomen, vomiting and diarrhea due to deficiency cold, abdominal pain due to cold hernia, dysmenorrhea, and amenorrhea.

The fructus Jujubae is mature fruit of Zizyphi fructus (Ziziphus jujuba Mill.) belonging to Rhamnaceae. Collected in autumn when the fruit is ripe. Impurities are removed and dried in the sun. Or baking to soft skin, and sun drying. Or boiling with water, taking out when the pulp is soft and the skin is not shrunk, and drying in the sun. The main functional indications are as follows: invigorating spleen and regulating stomach function, benefiting qi and promoting fluid production, regulating yingfen and weifen, and removing drug toxicity. It is indicated for deficiency of stomach and food, spleen weakness, loose stool, qi, blood and body fluids deficiency, disharmony between ying and wei, palpitation. The women are dirty and manic. (1) The book Jing: governing heart and abdomen pathogenic qi, pacifying spleen and assisting twelve meridians. Pacify stomach qi, unblock nine orifices, nourish qi and fluids, deficiency of body and middle energizer, severe convulsion, heaviness of limbs, and Bai Yao. (2) The book Ben Cao Jing Ji Zhu: the poison of Aconitum carmichaeli Debx. (3) The bibliography: tonify middle-jiao and Qi, strengthen, remove vexation, treat the subcardial suspention, and the strange nettle (4) in the drug Pair: killing aconite root and Tianxiong poison. (5) Meng: nourishing body fluid, washing heart and abdomen to remove pathogenic qi, and removing toxic substance, unblocking nine orifices, tonifying deficiency qi, tonifying intestines and stomach by boiling, benefiting qi for the first time by fattening, children suffering from autumn dysentery, and good for eating with Chongzao. (6) Rihuazi Bencao: moisten heart and lung, and relieve cough. Tonify five internal organs, treat deficiency and strain, and remove qi of intestine and stomach. (7) Pearl sacs: warming the stomach. (8) The Li Gao: warm to tonify spleen meridian, sweet to relieve yin and blood, harmonize yin and yang, regulate ying and wei, and promote body fluid production. (9) "Yi Yao Hua Yi" (meaning of pharmaceutical products): nourish blood and tonify liver. R "materia medica renewal": tonify middle energizer and qi, nourish kidney and warm stomach, treat yin deficiency.

Chinese medicine implantation for identification: treating allergic purpura, anemia and hyperpyrexiaBlood pressure.

Compared with the prior art, the invention has the beneficial effects that:

1. the carotid atherosclerotic plaque belongs to the concept of western medicine, and the name of the carotid atherosclerotic plaque does not appear in the classic of the traditional Chinese medicine. It can be classified as "Maibi" according to its clinical manifestations. Mai Bi Zhi is reported in Min asking Bibi Lun (book of Bi Bing), which is: "this is the case in summer, which is marked by vessel impediment, arthralgia \8230, 8230, blood coagulation but not flow. Heart is usually in the blood vessels due to summer qi, and wind-cold-dampness is apt to be absorbed in the vessels in summer, resulting in vessel obstruction and blood stagnation. Research shows that liver-kidney yin deficiency is the most common in the traditional Chinese medicine syndrome differentiation of carotid atherosclerosis. The liver and kidney yin deficiency is the basis of the kidney deficiency, the liver and kidney are homologous, the kidney yin is insufficient, the liver yin is deficient, the yin deficiency generates internal heat, the heat is yang pathogen, yin fluid in the body can be burned, the liver channel is burned, the yin of the liver and the kidney can be further damaged, and the reciprocating and malignant circulation can finally cause the dysfunction of the viscera, the internal generation of toxic pathogen, the toxic heat due to the yin deficiency, the deterioration of the physique and the loss of plaques. The invention considers that phlegm stasis is a pathological basis for plaque formation, and the 'change from toxicity' is a main reason for pathological evolution of the plaque due to phlegm stasis and phlegm-blood stasis combination, and meanwhile, the carotid atherosclerosis plaque also has inflammatory factors. The clinical manifestations of yin deficiency of liver and kidney are: dizziness, tinnitus, soreness and weakness of the loins and knees, feverish sensation in the chest, palms and soles, amnesia, insomnia, dry mouth, red tongue with little coating, and thready and rapid pulse. Therefore, the heat-clearing and detoxifying drugs are used for stabilizing the plaques, the phlegm-reducing and plaque-ablating drugs are used for melting the plaques, then the blood-activating and stasis-removing drugs are used for taking away the small ablated plaques, and the method of nourishing yin and tonifying liver and kidney is used for strengthening the physique, so the therapeutic rule of the invention is as follows: 1. the heat-clearing and detoxifying drugs are adopted to diminish inflammation and sterilize, inhibit inflammatory reaction of plaques and stabilize the plaques; 2. ablating plaques by adopting a phlegm dissolving medicine; thirdly, wang qing ren discusses that "chronic disease entering collaterals is stasis", leaf tianshi is also cloudy: the chronic diseases enter collaterals, the chronic pain enters collaterals, the major meridian governs qi and blood, the chronic diseases lead to blood stasis, and the chronic diseases are treated by blood, so the traditional Chinese medicine belongs to the categories of blood stasis and mass, and adopts blood-activating and stasis-resolving medicines to improve the hemorheology; and fourthly, the traditional Chinese medicine preparation has the effects of nourishing liver and kidney, so that kidney essence is sealed and preserved, and liver yin is nourished. The chrysanthemum, the dandelion, the honeysuckle and the radix puerariae clear away heat and toxic materials, the fingered citron and the citron eliminate phlegm and melt, and are monarch drugs, the peach kernel, the angelica, the hawthorn and the allium macrostemon are ministerial drugs, and the Chinese herbal medicines have the effects of promoting digestion, strengthening the spleen, promoting the circulation of qi, removing blood stasis, activating yang, dissipating stagnation, promoting the circulation of qi and removing food stagnation; the medlar, the dogwood, the cinnamon and the Chinese date are assistant and guide medicines for nourishing liver and kidney, tonifying primordial yang and promoting blood circulation, can eliminate plaque in the whole formula and improve carotid atherosclerosis, and particularly has an effect of eliminating carotid plaque formed by the carotid atherosclerosis of the old with deficiency of liver-yin and kidney-yin, and the effect is good.

2. The nattokinase has thrombolytic activity in vivo, and brings out the best in each other with the traditional Chinese medicine composition to play a synergistic effect.

Detailed Description

All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention.

Example 1: taking 8g of nattokinase, 12g of chrysanthemum, 6g of dandelion, 10g of honeysuckle, 6g of kudzu root, 4g of fingered citron, 10g of citron, 4g of peach kernel, 14g of angelica, 12g of hawthorn, 10g of allium macrostemon, 8g of medlar, 8g of dogwood, 3g of cinnamon and 14g of Chinese date, and the preparation method comprises the following steps: (1) Extracting flos Lonicerae, semen Persicae, fructus Citri, cortex Cinnamomi and radix Angelicae sinensis by steam distillation to obtain volatile oil of flos Lonicerae, semen Persicae, fructus Citri, cortex Cinnamomi and radix Angelicae sinensis; (2) Filtering the water solution obtained by steam distillation extraction of honeysuckle, peach kernel, citron, cinnamon and angelica to obtain the water solution obtained by distillation of honeysuckle, peach kernel, citron, cinnamon and angelica, heating for concentration, and carrying out alcohol precipitation to obtain supernatant which is the water extraction and alcohol precipitation concentrated solution obtained by steam distillation of honeysuckle, peach kernel, citron, cinnamon and angelica for later use; keeping the residue of the water vapor distillation extraction of honeysuckle, peach kernel, citron, cinnamon and angelica for later use; (3) Mixing the residues obtained in the step (2) after steam distillation extraction of honeysuckle, peach kernel, citron fruit, cinnamon and angelica with the medicinal materials of chrysanthemum, dandelion, kudzu root, fingered citron, hawthorn, allium macrostemon, medlar, dogwood and Chinese date, adding water with the weight of 10 times of the medicinal materials, decocting for two times, 2 hours each time, combining water extract, filtering to obtain water extract, concentrating, precipitating with ethanol to obtain supernatant, namely water extraction and ethanol precipitation concentrated solution; (4) And (3) mixing the concentrated water extraction and alcohol precipitation solution obtained in the step (3) and the concentrated water extraction and alcohol precipitation solution obtained after distillation of the honeysuckle, the peach kernel, the citron, the cinnamon and the angelica obtained in the step (2), spray-drying, adding the honeysuckle, the peach kernel, the citron, the cinnamon and the angelica volatile oil obtained in the step (1) and nattokinase, adding starch, and preparing into tablets. The conditions of the two times of alcohol precipitation are as follows: adding 95% ethanol, stirring to make ethanol content of the medicinal liquid reach 70%, closing alcohol precipitation tank cover, and standing for 24 hr.

Example 2: taking 8g of nattokinase, 12g of chrysanthemum, 6g of dandelion, 10g of honeysuckle, 6g of kudzu root, 4g of fingered citron, 10g of citron, 4g of peach kernel, 14g of angelica, 12g of hawthorn, 10g of allium macrostemon, 8g of medlar, 8g of dogwood, 3g of cinnamon and 14g of Chinese date, and the preparation method comprises the following steps: (1) Extracting flos Lonicerae, semen Persicae, fructus Citri, cortex Cinnamomi and radix Angelicae sinensis by steam distillation to obtain volatile oil of flos Lonicerae, semen Persicae, fructus Citri, cortex Cinnamomi and radix Angelicae sinensis; (2) Filtering the water solution obtained by steam distillation extraction of honeysuckle, peach kernel, citron, cinnamon and angelica to obtain the water solution obtained by distillation of honeysuckle, peach kernel, citron, cinnamon and angelica, heating for concentration, and carrying out alcohol precipitation to obtain supernatant which is the water extraction and alcohol precipitation concentrated solution obtained by steam distillation of honeysuckle, peach kernel, citron, cinnamon and angelica for later use; keeping the residue of the water vapor distillation extraction of honeysuckle, peach kernel, citron, cinnamon and angelica for later use; (3) Mixing the residues obtained in the step (2) after steam distillation extraction of honeysuckle, peach kernel, citron fruit, cinnamon and angelica with the medicinal materials of chrysanthemum, dandelion, kudzu root, fingered citron, hawthorn, allium macrostemon, medlar, dogwood and Chinese date, adding water with the weight of 10 times of the medicinal materials, decocting twice for 2 hours each time, filtering to obtain a water extract, concentrating, precipitating with ethanol to obtain a supernatant, namely a water extraction and ethanol precipitation concentrated solution; (4) And (3) carrying out water extraction and alcohol precipitation on the concentrated solution obtained in the step (3) and the distilled concentrated solution of the honeysuckle, the peach kernels, the citron, the cinnamon and the angelica obtained in the step (2), merging, carrying out spray drying, adding the honeysuckle, the peach kernels, the citron, the cinnamon and the angelica volatile oil obtained in the step (1) and nattokinase, adding starch, and preparing the capsule. The conditions of the two times of alcohol precipitation are as follows: adding 95% ethanol, stirring to make ethanol content of the medicinal liquid reach 70%, closing alcohol precipitation tank cover, and standing for 24 hr.

Example 3: taking 10g of nattokinase, 10g of chrysanthemum, 8g of dandelion, 8g of honeysuckle, 8g of kudzu root, 6g of fingered citron, 8g of citron, 6g of peach kernel, 12g of angelica, 12g of hawthorn, 8g of allium macrostemon, 10g of medlar, 6g of dogwood, 6g of cinnamon and 12g of Chinese date, and the preparation method comprises the following steps: (1) Distilling flos Lonicerae, semen Persicae, fructus Citri, cortex Cinnamomi and radix Angelicae sinensis with steam to obtain volatile oil of flos Lonicerae, semen Persicae, fructus Citri, cortex Cinnamomi and radix Angelicae sinensis; (2) Filtering the water solution obtained by steam distillation extraction of honeysuckle, peach kernel, citron, cinnamon and angelica to obtain the water solution obtained by distillation of honeysuckle, peach kernel, citron, cinnamon and angelica, heating for concentration, and carrying out alcohol precipitation to obtain supernatant which is the water extraction and alcohol precipitation concentrated solution obtained by steam distillation of honeysuckle, peach kernel, citron, cinnamon and angelica for later use; keeping the residue of the water vapor distillation extraction of honeysuckle, peach kernel, citron, cinnamon and angelica for later use; (3) Mixing the residues obtained in the step (2) after steam distillation extraction of honeysuckle, peach kernel, citron fruit, cinnamon and angelica with the medicinal materials of chrysanthemum, dandelion, kudzu root, fingered citron, hawthorn, allium macrostemon, medlar, dogwood and Chinese date, adding water with the weight of 10 times of the medicinal materials, decocting twice for 2 hours each time, filtering to obtain a water extract, concentrating, precipitating with ethanol to obtain a supernatant, namely a water extraction and ethanol precipitation concentrated solution; (4) And (3) mixing the concentrated water extraction and alcohol precipitation solution obtained in the step (3) and the concentrated water extraction and alcohol precipitation solution obtained after distillation of the honeysuckle, the peach kernel, the citron, the cinnamon and the angelica obtained in the step (2), spray-drying, adding the honeysuckle, the peach kernel, the citron, the cinnamon and the angelica volatile oil obtained in the step (1) and nattokinase, adding starch, and preparing into granules. The conditions of the two times of alcohol precipitation are as follows: adding 95% ethanol, stirring to make ethanol content of the medicinal liquid reach 70%, closing alcohol precipitation tank cover, and standing for 24 hr.

Example 4: 10g of nattokinase, 12g of kudzu vine root, 12g of hawthorn, 6g of allium macrostemon, 3g of cinnamon and 12g of Chinese date, and the preparation method comprises the following steps: (1) Steam distilling cortex Cinnamomi to obtain cortex Cinnamomi volatile oil; (2) Filtering the water solution of cortex Cinnamomi obtained by steam distillation to obtain distilled water solution of cortex Cinnamomi, heating, concentrating, and precipitating with ethanol to obtain supernatant as water extraction and ethanol precipitation concentrated solution of cortex Cinnamomi obtained by steam distillation; reserving dregs after steam distillation extraction of cinnamon for later use; (3) Mixing the dregs obtained in the step (2) after steam distillation extraction of the cinnamon with the medicinal materials of the kudzu root, the hawthorn, the allium macrostemon and the Chinese date, adding 10 times of water by weight of the medicinal materials, decocting for two times, 2 hours each time, filtering to obtain a water extract, concentrating, precipitating with ethanol to obtain a supernatant, namely a water extraction and ethanol precipitation concentrated solution; (4) And (3) mixing the water extraction and alcohol precipitation concentrated solution obtained in the step (3) and the water extraction and alcohol precipitation concentrated solution obtained after distilling the cinnamon obtained in the step (2), spray-drying, adding the cinnamon volatile oil obtained in the step (1) and nattokinase, adding starch, and preparing into granules. The conditions of the two times of alcohol precipitation are as follows: adding 95% ethanol, stirring to make ethanol content of the medicinal liquid reach 70%, closing alcohol precipitation tank cover, and standing for 24 hr.

Comparative example 1: taking 10g of chrysanthemum, 8g of dandelion, 8g of honeysuckle, 8g of kudzu root, 6g of fingered citron, 8g of citron, 6g of peach kernel, 12g of angelica, 12g of hawthorn, 8g of allium macrostemon, 10g of medlar, 6g of dogwood, 6g of cinnamon and 12g of Chinese date, and the preparation method comprises the following steps: (1) Extracting flos Lonicerae, semen Persicae, fructus Citri, cortex Cinnamomi and radix Angelicae sinensis by steam distillation to obtain volatile oil of flos Lonicerae, semen Persicae, fructus Citri, cortex Cinnamomi and radix Angelicae sinensis; (2) Extracting flos Lonicerae, semen Persicae, fructus Citri, cortex Cinnamomi and radix Angelicae sinensis by steam distillation, filtering to obtain water solution of flos Lonicerae, semen Persicae, fructus Citri, cortex Cinnamomi and radix Angelicae sinensis by distillation, heating, concentrating, precipitating with ethanol to obtain supernatant as water extraction and ethanol precipitation concentrate of flos Lonicerae, semen Persicae, fructus Citri, cortex Cinnamomi and radix Angelicae sinensis by steam distillation; keeping the residue of the water vapor distillation extraction of honeysuckle, peach kernel, citron, cinnamon and angelica for later use; (3) Mixing the residues obtained in the step (2) after steam distillation extraction of honeysuckle, peach kernel, citron fruit, cinnamon and angelica with medicinal materials of chrysanthemum, dandelion, kudzu root, fingered citron, hawthorn, allium macrostemon, medlar, dogwood and jujube, adding water with the weight of 10 times of that of the medicinal materials, decocting twice for 2 hours each time, filtering to obtain a water extract, concentrating, precipitating with ethanol to obtain a supernatant, and extracting with water and precipitating with ethanol to obtain a concentrate; (4) And (3) mixing the concentrated water extraction and alcohol precipitation solution obtained in the step (3) and the concentrated water extraction and alcohol precipitation solution obtained after distillation of the honeysuckle, the peach kernel, the citron, the cinnamon and the angelica obtained in the step (2), spray-drying, adding the honeysuckle, the peach kernel, the citron, the cinnamon and the angelica volatile oil obtained in the step (1), adding starch, and preparing into granules. The conditions of the two times of alcohol precipitation are as follows: adding 95% ethanol, stirring to make ethanol content of the medicinal liquid reach 70%, closing alcohol precipitation tank cover, and standing for 24 hr.

Example 5: research on functional experiments

General data: selecting inpatients which are diagnosed by an outpatient department of school and have bilateral carotid artery plaque formation and are classified into an example 3 group, an example 4 group, a comparative example 1 group and a nattokinase group according to a random number table method, wherein 30 patients in each group comprise 120 patients, 66 men and 54 women; age 68-75 years old; pre-and post-dose comparisons were performed.

Diagnostic criteria: the carotid atherosclerosis diagnostic standard is defined according to the vascular ultrasonic examination guideline formulated by the ultrasonic physicians division of the Chinese physician Association in 2009, carotid intima-media thickness and plaque, and the plaque is defined by the intima thickening limitation IMT of more than or equal to 1.0mm, or the plaque is defined by the intima thickening limitation IMT of more than or equal to 1.5mm or more than 50% of the peripheral area. The traditional Chinese medicine composition meets the diagnosis standard and has no active plaques, and the number of the plaques is not more than 3, and the traditional Chinese medicine composition is characterized in that: vertigo, tinnitus, soreness and weakness of waist and knees, dysphoria with smothery sensation in chest, amnesia, insomnia, dry mouth, red tongue with little coating, and thready and rapid pulse due to liver and kidney yin deficiency.

The treatment process comprises the following steps: the granules prepared by the groups 3 and 4 of the invention and the group 1 of the comparative example are taken 3 times a day, 2 bags each time, each bag contains 15 g of traditional Chinese medicine and the group of nattokinase (the activity of the nattokinase is 375 ten thousand U/g), 3 times a day and 3g each time, and the granules are taken for 1 month.

Observation indexes are as follows: the patient is instructed to fully expose the neck before and after the carotid plaque ultrasonography procedure, and both carotid arteries are probed using color Doppler ultrasound (Philips, model: IUelite). Continuously scanning longitudinal sections and transverse sections, and sequentially probing vascular plaques of common carotid arteries and bifurcations, external carotid arteries and internal carotid arteries to obtain plaque areas; carotid intima-media thickness (IMT) was measured at 1cm from the internal carotid artery, the carotid bulb, at the bilateral 1cm distal bifurcation of the common carotid artery. And (4) performing plaque scoring by referring to a Crouse integral method of the carotid atherosclerotic plaque, namely adding the maximum thicknesses (mm) of isolated carotid plaques at the same side respectively to obtain plaque integrals of the carotid artery at the side, wherein the sum of the plaque integrals at the two sides of each side is the total plaque integral of the patient at the side.

TABLE 1 comparison of IMT, plaque area, crouse integral before and after treatment for three groups of patients (x. + -.s)

Comparison with present pretreatment: * P <0.05, P <0.01

As a result: according to the invention, through comparison of oral administration of the group 3 of the embodiment, the group 4 of the embodiment, the group 1 of the comparative embodiment and the natto kinase group, color Doppler ultrasonic detection shows that IMT and plaque area can be reduced, and plaque Crouse integral can be reduced, compared with the group 3 of the embodiment, the group 4 of the embodiment has a simple prescription, but the effect is still obvious, and after the natto kinase is matched with the traditional Chinese medicine in the traditional Chinese medicine composition, the effect is obviously better than that of singly using the traditional Chinese medicine composition (without the natto kinase) or the natto kinase, which shows that the traditional Chinese medicine in the traditional Chinese medicine composition has a synergistic effect with the natto kinase.

While the invention has been described in terms of specific embodiments, it will be appreciated by those skilled in the art that the invention may be embodied in other specific forms without departing from the spirit or essential attributes thereof as described herein.

Claims (10)

1. A traditional Chinese medicine composition for removing vascular plaque is characterized in that: the traditional Chinese medicine composition for removing the vascular plaque is prepared from the following raw material medicines 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 allium macrostemon, 8-12 parts of medlar, 4-8 parts of dogwood, 3-8 parts of cinnamon and 10-14 parts of Chinese date.

2. The traditional Chinese medicine composition for removing the vascular plaque according to claim 1, wherein: 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 allium macrostemon, 8 parts of medlar, 8 parts of dogwood, 3 parts of cinnamon and 14 parts of Chinese date.

3. The traditional Chinese medicine composition for removing the vascular plaque according to claim 1, which is 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 allium macrostemon, 12 parts of medlar, 4 parts of dogwood, 8 parts of cinnamon and 10 parts of Chinese date.

4. The traditional Chinese medicine composition for removing the vascular plaque according to claim 1, which is 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 allium macrostemon, 10 parts of medlar, 6 parts of dogwood, 6 parts of cinnamon and 12 parts of Chinese date.

5. The traditional Chinese medicine composition for removing the vascular plaque according to claim 1, wherein: 10 parts of nattokinase, 12 parts of kudzu root, 12 parts of hawthorn, 6 parts of allium macrostemon, 3 parts of cinnamon and 12 parts of Chinese date.

6. The traditional Chinese medicine composition for removing the vascular plaque according to claim 1, 2, 3 or 4, characterized in that: the preparation method comprises the following steps: (1) Extracting flos Lonicerae, semen Persicae, fructus Citri, cortex Cinnamomi and radix Angelicae sinensis by steam distillation, and extracting volatile oil from flos Lonicerae, semen Persicae, fructus Citri, cortex Cinnamomi and radix Angelicae sinensis; (2) Filtering the water solution obtained by steam distillation extraction of honeysuckle, peach kernel, citron, cinnamon and angelica to obtain the water solution obtained by distillation of honeysuckle, peach kernel, citron, cinnamon and angelica, heating for concentration, and carrying out alcohol precipitation to obtain supernatant which is the water extraction and alcohol precipitation concentrated solution obtained by steam distillation of honeysuckle, peach kernel, citron, cinnamon and angelica for later use; the dregs of decoction after the honeysuckle, the peach kernel, the citron, the cinnamon and the angelica are distilled and extracted by steam are reserved for standby; (3) Mixing the residues obtained in the step (2) after steam distillation extraction of honeysuckle, peach kernel, citron fruit, cinnamon and angelica with the medicinal materials of chrysanthemum, dandelion, kudzu root, fingered citron, hawthorn, allium macrostemon, medlar, dogwood and Chinese date, adding water with the weight of 10 times of the medicinal materials, decocting twice for 2 hours each time, filtering to obtain a water extract, concentrating, precipitating with ethanol to obtain a supernatant, namely a water extraction and ethanol precipitation concentrated solution; (4) And (3) mixing the water extraction and alcohol precipitation concentrated solution obtained in the step (3) and the water extraction and alcohol precipitation concentrated solution obtained after distillation of the honeysuckle, the peach kernel, the citron, the cinnamon and the angelica obtained in the step (2), spray-drying, adding the honeysuckle, the peach kernel, the citron, the cinnamon and the angelica volatile oil obtained in the step (1) and nattokinase, and preparing a preparation to obtain the traditional Chinese medicine preparation.

7. The traditional Chinese medicine composition for removing the vascular plaque according to claim 5, wherein: the preparation method comprises the following steps: (1) Extracting cortex Cinnamomi by steam distillation to obtain volatile oil; (2) Filtering the water solution obtained after steam distillation and extraction of cinnamon to obtain the water solution obtained after distillation of cinnamon, heating, concentrating, and precipitating with ethanol to obtain supernatant, which is the water extraction and ethanol precipitation concentrated solution obtained after steam distillation of cinnamon for later use; reserving dregs after steam distillation extraction of cinnamon for later use; (3) Mixing the dregs obtained in the step (2) after steam distillation extraction of the cinnamon with the medicinal materials of the kudzu root, the hawthorn, the allium macrostemon and the Chinese date, adding water with the weight of 10 times of the medicinal materials, decocting twice for 2 hours each time, filtering to obtain a water extract, concentrating, precipitating with ethanol to obtain a supernatant, namely a water extraction and ethanol precipitation concentrated solution; (4) Mixing the water extraction and alcohol precipitation concentrated solution obtained in the step (3) and the water extraction and alcohol precipitation concentrated solution obtained in the step (2) after distillation of cinnamon, carrying out spray drying, adding the cinnamon volatile oil obtained in the step (1) and nattokinase, and preparing into a preparation to obtain the traditional Chinese medicine preparation; the conditions of the two times of alcohol precipitation are as follows: adding 95% ethanol, stirring to make ethanol content of the medicinal liquid reach 70%, closing alcohol precipitation tank cover, and standing for 24 hr.

8. The traditional Chinese medicine composition for removing the vascular plaque according to claim 1 or 5, characterized in that: the preparation is one of tablet, capsule and granule.

9. The traditional Chinese medicine composition for removing the vascular plaque according to claim 6, wherein: the conditions of the two times of alcohol precipitation are as follows: adding 95% ethanol, stirring to make ethanol content of the medicinal liquid reach 70%, closing alcohol precipitation tank cover, and standing for 24 hr.

10. The use of the traditional Chinese medicine composition for removing vascular plaques according to claim 1 or 2 in the preparation of a carotid plaque health care product for eliminating the formation of senile carotid atherosclerosis, wherein the carotid atherosclerosis is of the liver-kidney yin deficiency type.