CN115844964A - A Chinese medicinal composition for treating cardiovascular and cerebrovascular diseases - Google Patents

Abstract

The invention discloses a traditional Chinese medicine composition for treating cardiovascular and cerebrovascular diseases, which is prepared by extracting the following raw materials in parts by weight: 30-40 parts of astragalus membranaceus, 20-30 parts of codonopsis pilosula, 5-10 parts of cinnamon, 1-3 parts of asarum, 10-20 parts of safflower, 20-30 parts of angelica sinensis, 18-22 parts of radix bupleuri, 15-25 parts of fructus aurantii, 10-20 parts of inula flower, 20-30 parts of platycodon grandiflorum, 10-15 parts of poria cocos, 18-25 parts of polygala tenuifolia, 8-12 parts of spina date seed and 12-16 parts of schisandra chinensis, and a preparation method and application thereof in preparation of coronary heart disease for treating heart-qi deficiency are disclosed.

Description

A Chinese medicinal composition for treating cardiovascular and cerebrovascular diseases

Technical Field

The invention belongs to the technical field of traditional Chinese medicines, and particularly relates to a traditional Chinese medicine composition for preventing and treating cardiovascular and cerebrovascular diseases and a preparation method thereof.

Background

Cardiovascular and cerebrovascular diseases are the general term for cardiovascular and cerebrovascular diseases. The cardiovascular and cerebrovascular diseases have the characteristics of high morbidity, high disability rate, high mortality rate, high recurrence rate and more complications, namely more than four and one, and at present, the cardiovascular and cerebrovascular disease patients in China exceed 2.7 hundred million people! Nearly 300 million people die of cardiovascular and cerebrovascular diseases in China every year, and the death causes account for 51 percent of the total death causes of China every year. The traditional Chinese medicine is named as 'cardiodynia', 'heart failure' and the like, and modern medicine considers that cardiovascular and cerebrovascular diseases have fifteen categories, namely essential hypertension, atherosclerosis, coronary heart disease, angina pectoris, chronic heart failure, ventricular premature beat, paroxysmal atrial fibrillation, sick sinus syndrome, atrioventricular block, sinus bradycardia, hyperlipidemia, viral myocarditis, chronic pulmonary heart disease, rheumatic heart disease, dilated cardiomyopathy and cardiac neurosis. The traditional Chinese medicine considers that the causes of cardiovascular and cerebrovascular diseases comprise: according to statistics of big data and clinical experience, the heart-brain vascular diseases show that the heart-qi deficiency is in the late stage, and the heart-qi deficiency is generally presented. At present, the medicines for promoting blood circulation and removing blood stasis for treating cardiovascular and cerebrovascular diseases are used for easily causing bleeding or a large amount of warm medicines are used for causing aggravation of the disease, and the market lacks a treatment scheme for treating the coronary heart disease with heart-qi deficiency.

At present, the conventional traditional Chinese medicine granules (the name of the invention is traditional Chinese medicine granules for treating coronary heart disease and a preparation method thereof, the application number is 202010649529.1, the name of the invention is traditional Chinese medicine granules for treating coronary heart disease and angina pectoris and a preparation method thereof, the application number is 200910023964.7) are all wet granulation, ethanol, syrup or honey is used as a binding agent, and the drying has the problems of poor dissolubility, poor fluidity, forming rate and the like.

Disclosure of Invention

The purpose of the invention is as follows: the first purpose of the invention is to provide a traditional Chinese medicine composition (trade name: xinnaokang granules) for preventing and treating cardiovascular and cerebrovascular diseases, which aims at coronary heart disease caused by insufficient heart qi.

The second purpose of the invention is to provide a preparation method and application of the traditional Chinese medicine composition for preventing and treating cardiovascular and cerebrovascular diseases.

Technical scheme

A traditional Chinese medicine composition for treating cardiovascular and cerebrovascular diseases is prepared by extracting the following raw materials in parts by weight: 30-40 parts of astragalus membranaceus, 20-30 parts of codonopsis pilosula, 5-10 parts of cinnamon, 1-3 parts of asarum, 10-20 parts of safflower, 20-30 parts of angelica sinensis, 18-22 parts of radix bupleuri, 15-25 parts of fructus aurantii, 10-20 parts of inula flower, 20-30 parts of platycodon grandiflorum, 10-15 parts of poria cocos, 18-25 parts of polygala tenuifolia, 8-12 parts of spina date seeds and 12-16 parts of schisandra chinensis.

The traditional Chinese medicine composition for treating cardiovascular and cerebrovascular diseases is prepared by extracting the following raw materials in parts by weight: 30 parts of astragalus membranaceus, 30 parts of codonopsis pilosula, 5 parts of cinnamon, 3 parts of asarum, 10 parts of safflower, 30 parts of angelica sinensis, 18 parts of radix bupleuri, 25 parts of fructus aurantii, 10 parts of inula flower, 30 parts of platycodon grandiflorum, 10 parts of poria cocos, 25 parts of polygala tenuifolia, 8 parts of spina date seed and 16 parts of schisandra chinensis.

The traditional Chinese medicine composition for treating cardiovascular and cerebrovascular diseases is prepared by extracting the following raw materials in parts by weight: 40 parts of astragalus membranaceus, 20 parts of codonopsis pilosula, 10 parts of cinnamon, 1 part of asarum, 20 parts of safflower, 20 parts of angelica sinensis, 22 parts of radix bupleuri, 15 parts of fructus aurantii, 20 parts of inula flower, 20 parts of platycodon grandiflorum, 15 parts of poria cocos, 18 parts of polygala tenuifolia, 12 parts of spina date seed and 12 parts of schisandra chinensis.

The traditional Chinese medicine composition for treating cardiovascular and cerebrovascular diseases is prepared by extracting the following raw materials in parts by weight: 35 parts of astragalus membranaceus, 25 parts of codonopsis pilosula, 8 parts of cinnamon, 2 parts of asarum, 15 parts of safflower, 25 parts of angelica sinensis, 20 parts of radix bupleuri, 20 parts of fructus aurantii, 15 parts of inula flower, 25 parts of platycodon grandiflorum, 12 parts of poria cocos, 20 parts of polygala tenuifolia, 10 parts of spina date seed and 14 parts of schisandra chinensis.

The traditional Chinese medicine composition for treating cardiovascular and cerebrovascular diseases is in the form of granules.

The preparation method of the traditional Chinese medicine composition for treating cardiovascular and cerebrovascular diseases comprises the following steps:

a. weighing cinnamon, asarum, safflower, angelica and fructus aurantii in each weight ratio, and extracting volatile oil for 4 hours for later use;

b. adding other medicinal materials into the residue after volatile oil extraction, extracting with water, adding 10 times of water of the total medicinal materials, reflux extracting for 2 times, each time for 1 hr, concentrating the obtained extractive solution to density of 1.20g/ml, collecting extractive solution, and concentrating;

c. adding 95% v/v ethanol aqueous solution to the concentrated solution until the ethanol concentration reaches 85% v/v, standing, filtering, collecting ethanol precipitation solution, and concentrating;

d. and (3) spray drying the concentrated alcohol precipitation solution, wherein the spray condition is as follows: c, feeding the obtained spray-dried powder into a granulator, adding filler modified starch 4 times the weight of the spray-dried powder, filler maltodextrin 2.5 times the weight of the spray-dried powder, disintegrant microcrystalline cellulose 2 times the weight of the spray-dried powder and binder polyvinylpyrrolidone 1 time the weight of the spray-dried powder into the granulator, granulating, drying, uniformly spraying the volatile oil obtained in the step a, and uniformly mixing to obtain the spray-dried powder.

The application of the traditional Chinese medicine composition for treating cardiovascular and cerebrovascular diseases in preparing the coronary heart disease with heart-qi deficiency is provided.

The above medicinal materials are all pharmacopeia standards.

Radix astragali is root of Astragalus membranaceus (Fisch.) bge. Of Astragalus of Leguminosae, hsiao or Astragalus membranaceus (Fisch.) bge. Has effects in invigorating spleen, strengthening middle warmer, invigorating yang, lifting sink, invigorating defensive qi, consolidating superficial resistance, promoting urination, removing toxic materials, and promoting granulation. It is mainly indicated for spleen qi deficiency syndrome, lung qi deficiency syndrome, qi deficiency spontaneous sweating syndrome, qi and blood deficiency, ulcer and sore difficult to ulcerate and rot, or difficult to heal for a long time.

The radix Codonopsis is dried root of radix Codonopsis, radix Codonopsis Lanceolatae or radix Codonopsis Pilosulae of Campanulaceae. Dang Shen is sweet in flavor and neutral in nature. Has effects in invigorating spleen, replenishing qi, quenching thirst, invigorating spleen, tonifying lung, nourishing blood, and promoting salivation. Can be used for treating deficiency of spleen-lung qi, anorexia, listlessness, cough, asthma, deficiency of qi and blood, sallow complexion, palpitation, short breath, thirst due to body fluid consumption, and internal heat. [1] Laziness in speaking, weakness of limbs, poor appetite, deficiency of qi, deficiency of both qi and fluid, deficiency of both qi and blood, and sallow complexion due to blood deficiency. However, the exterior syndrome is not relieved but the interior syndrome is full of pathogenic factors. The product has similar efficacy to Ginseng radix, but weak potency. For general deficiency syndrome, it can be used in place of Ginseng radix; for severe deficiency syndrome, ginseng should be used.

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, with large heat in nature. 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, cold pain of waist and knee, asthma due to kidney deficiency, floating of deficient yang, giddiness, conjunctival congestion, cold pain of heart and abdomen, vomiting and diarrhea due to deficiency cold, cold hernia, abdominal pain, dysmenorrhea, and amenorrhea.

The herba asari is perennial herb of Asarum of Aristolochiaceae of dicotyledonae; the rhizome is upright or transverse, the diameter is 2-3 mm, the internode is 1-2 cm long, and there are many fibrous roots. 2 leaves are usually in a heart shape or an oval heart shape, the tip of each leaf is gradually sharp or sharply pointed, the base of each leaf is deep in the heart shape, the top of each leaf is round, short hairs are scattered on the leaf surface, the veins are dense, and the back of each leaf is only provided with the hair on the veins; in the middle of the stamen ovary, the filament and anther are nearly equal in length or slightly longer, the drug partition is protruded, and the shape of the short cone is adopted; the ovary is half-inferior or nearly superior, spherical and shorter, and the stigma is lateral. The fruit is approximately spherical, about 1.5 cm in diameter, and brownish yellow. The flowering period is 4-5 months. The herba asari has effects of dispelling pathogenic wind, dispelling cold, promoting diuresis, and inducing resuscitation. And has the functions of treating wind cold headache, nasosinusitis, toothache, phlegm and fluid retention cough, rheumatism, etc.

The Carthami flos is dried flower of Carthamus tinctorius L. Collected in the shade or dried in the sun when the flowers turn yellow and red in summer. The cultivation is widely carried out all over the country. Has the functions of promoting blood circulation to restore menstrual flow, eliminating blood stasis and relieving pain. Can be used for treating amenorrhea, dysmenorrhea, lochiorrhea, abdominal mass, thoracic obstruction, cardialgia, abdominal pain due to blood stasis, pricking pain in chest and hypochondrium, traumatic injury, and pyocutaneous disease with swelling and pain.

Angelica sinensis 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.

The bupleuri radix is dried root of Bupleurum scorzonerifolium or Bupleurum scorzonerifolium of Umbelliferae. Collected in spring and autumn, removed stems and leaves and silt, and dried. Bupleurum root, radix bupleuri is a commonly used exterior syndrome relieving drug. Is also called as Diwu, potherb mustard, mushroom grass and firewood, is bitter in nature and taste, slightly cold, and enters liver and gallbladder meridians. Has the functions of harmonizing exterior and interior, soothing liver and invigorating yang. Can be used for treating common cold, fever, malaria, stagnation of qi due to depression of the liver, distending pain of chest and hypochondrium, rectocele, uterine prolapse, and menoxenia.

The fructus Aurantii is dried immature fruit of Citrus aurantium L. Of Rutaceae and its cultivar. Harvesting when 7 months of pericarp is green, transversely cutting into two halves from the middle part, and drying in the sun or at low temperature. Has the effects of regulating qi, relieving epigastric distention, activating stagnancy and relieving flatulence. It is commonly indicated for qi stagnation in chest and hypochondrium, fullness and pain, indigestion, phlegm-fluid retention, and prolapse of viscera.

Inula flower is a perennial herb of Inula genus of Compositae family. The rootstock is short, transverse or oblique, and there are some stout fibrous roots. The stem grows singly, sometimes 2-3 cluster grows, the diameter of the head-shaped inflorescence is 3-4 cm, and most or a few of the head-shaped inflorescences are arranged into the evacuated cymose inflorescences; the length of the lean fruit is 1-1.2 mm, the shape of the fruit is cylindrical, the flowering phase is 6-10 months, and the fruit phase is 9-11 months. Inula flower is distributed in northern, northeast, middle and east provinces of China. Growing on hillside roadside, moist grasslands, river banks and ridges with an altitude of 150-2400 m. Inulae flos is mainly used for treating cough due to wind-cold evil and accumulation of phlegm and fluid. Chest fullness, cough, asthma, excessive phlegm, emesis, belching, and epigastric fullness.

The radix Platycodi is dried root of Platycodon grandiflorus (Jacq.) of Campanulaceae. Collected in spring and autumn, cleaned, and then the fibrous root is removed, and the husk is stripped or not stripped when the fibrous root is fresh, and then dried. Growing in grass slopes, forest edges or in cultivation. Distributed in various regions throughout the country. Has effects of dispersing lung qi, relieving sore throat, eliminating phlegm, and expelling pus. Can be used for treating cough with excessive phlegm, chest distress, pharyngalgia, hoarseness, lung carbuncle, and purulent vomiting.

Poria is dried sclerotium of Wolf of Poria cocos (Schw.) Cocos (a fungus of Polyporaceae). Digging for more than 7-9 months, removing silt after digging, piling up to generate sweat, spreading and drying to dry the surface, generating sweat again, repeating for several times until wrinkles appear and most of internal water is lost, and drying in the shade to obtain Poria cocos; or cutting fresh Poria according to different parts, and drying in the shade to obtain Poria block and Poria tablet.

Polygala tenuifolia also known as \33917, juanzhou, 34112, \33964c, etc.. Producing northeast, northwest, central and Sichuan; perennial herbs, strong and strong taproots, and phloem flesh. Has effects in tranquilizing mind, improving intelligence, eliminating phlegm, and relieving swelling, and can be used for treating insomnia, dreaminess, amnesia, palpitation, absentmindedness, expectoration, skin sore, swelling and toxin, and breast swelling and pain caused by imbalance between heart-yang and kidney-yin.

The semen Ziziphi Spinosae is dry mature seed of Ziziphus jujuba Mill.var. Spinosa (Bunge) Hu ex H.F.Chou belonging to Rhamnaceae. Has the effects of nourishing heart, tonifying liver, calming heart, tranquilizing mind, arresting sweating and promoting fluid production. It is commonly indicated for restlessness of deficiency type, insomnia, palpitation, dreaminess, asthenia, hyperhidrosis, body fluid consumption and thirst.

Fructus Schisandrae is dried mature fruit of Schisandra chinensis (Turcz.) Baill. It is known as Bei Wu Wei Zi. Picking in autumn when the fruit is ripe, sun-drying or steaming, sun-drying, and removing fruit stalks and impurities. Tang et al, in the book of Xin Xiu Ben Cao, carry that "Wu Wei Pi gan sui and He Zi is pungent and bitter in the kernel and salty in flavor", so it is named as Wu Wei Zi. The schisandra fruit is divided into two kinds, south and north. The ancient medical book called him 33614c, mysterious union 34127, mysterious union, confluence, the earliest listed in the Shennong herbal meridian top-grade traditional Chinese medicines can nourish and strengthen the strength, has extremely high medicinal value and the effect of strengthening the body, and is used together with Qiongzhen lucid ganoderma to treat insomnia.

Advantageous effects

1. Chest stuffiness and pain are the main symptoms of chest stuffiness and pain, mild chest stuffiness and shortness of breath and severe pain like prickling due to insufficiency of chest yang, coldness of yin and phlegm staying in chest or insufficiency of heart-qi, and the symptoms of qi and blood stagnation and heart malnutrition are that the heart stuffiness and pain leads to insufficiency of heart yang, insufficiency of yang and qi, weakness of the spleen and stomach, deficiency of qi and blood, and malnutrition of the heart and blood, and heart qi deficiency, and the symptoms of heart qi and blood deficiency, weakness of the heart and blood vessels, yang-clearing and blood stasis, and heart pain. The invention adopts astragalus, codonopsis pilosula, cinnamon and asarum to tonify qi, activate yang, dispel cold and return kidney, is a monarch drug, safflower and angelica to nourish blood and remove stasis, radix bupleuri, fructus aurantii, inula flower and platycodon grandiflorum to ascend and descend orderly to regulate qi activity, strengthen middle warmer and descend qi, promote qi circulation and invigorate blood circulation, is a ministerial drug, and poria cocos and polygala tenuifolia to strengthen spleen and stomach and calm nerves, is an adjuvant drug, and spina date seed and schisandra chinensis to nourish heart and astringe heart qi, and is a messenger drug, and the whole formula jointly tonifies heart qi, improves chest yang and treats coronary heart disease caused by heart-qi deficiency.

2. The invention adopts modified starch and maltodextrin as filling agents, microcrystalline cellulose as disintegrating agents and polyvinylpyrrolidone as binding agents, can prevent the traditional Chinese medicine granules from absorbing moisture, and improves the moisture absorption rate, the angle of repose, the forming rate and the dissolubility of the granules.

Detailed Description

The invention will be further illustrated with reference to specific embodiments. It should be understood that these examples are for illustrative purposes only and are not intended to limit the scope of the present invention. Further, it should be understood that various changes or modifications can be made by those skilled in the art after reading the present disclosure, but these equivalents also fall within the scope defined by the appended claims of the present application.

Example 1:

taking 35g of astragalus, 25g of codonopsis pilosula, 8g of cinnamon, 2g of asarum, 15g of safflower, 25g of angelica, 20g of radix bupleuri, 20g of fructus aurantii, 15g of inula flower, 25g of platycodon grandiflorum, 12g of poria cocos, 20g of polygala tenuifolia, 10g of spina date seed and 14g of schisandra chinensis, and preparing the traditional Chinese medicine composition:

a. weighing cinnamon, asarum, safflower, angelica and fructus aurantii in each weight ratio, and extracting volatile oil for 4 hours for later use;

b. adding other medicinal materials into the residue after volatile oil extraction, adding water for extraction, adding 10 times of water to the total medicinal materials, reflux-extracting for 2 times, each time for 1 hr, concentrating the obtained extractive solution to density of 1.20g/ml, collecting extractive solution, and concentrating;

c. adding 95% v/v ethanol aqueous solution to the concentrated solution until the ethanol concentration reaches 85% v/v, standing, filtering, collecting ethanol precipitation solution, and concentrating;

d. and (3) spray drying the concentrated alcohol precipitation solution, wherein the spray condition is as follows: b, putting the obtained spray-dried powder into a granulator, adding filler modified starch 4 times the weight of the spray-dried powder, filler maltodextrin 2.5 times the weight of the spray-dried powder, disintegrant microcrystalline cellulose 2 times the weight of the spray-dried powder and binder polyvinylpyrrolidone 1 time the weight of the spray-dried powder into the granulator, granulating, drying, uniformly spraying the volatile oil obtained in the step a, and uniformly mixing to obtain the spray-dried powder.

Example 2

Taking 30g of astragalus, 30g of codonopsis pilosula, 5g of cinnamon, 3g of asarum, 10g of safflower, 30g of angelica, 18g of radix bupleuri, 25g of fructus aurantii, 10g of inula flower, 30g of platycodon grandiflorum, 10g of poria cocos, 25g of polygala tenuifolia, 8g of spina date seed and 16g of schisandra chinensis, and preparing the traditional Chinese medicine composition:

a. weighing cinnamon, asarum, safflower, angelica and fructus aurantii in each weight ratio, and extracting volatile oil for 4 hours for later use;

b. adding other medicinal materials into the residue after volatile oil extraction, adding water for extraction, adding 10 times of water to the total medicinal materials, reflux-extracting for 2 times, each time for 1 hr, concentrating the obtained extractive solution to density of 1.20g/ml, collecting extractive solution, and concentrating;

c. adding 95% v/v ethanol aqueous solution to the concentrated solution until the ethanol concentration reaches 85% v/v, standing, filtering, collecting ethanol precipitation solution, and concentrating;

d. and (3) spray drying the concentrated alcohol precipitation solution, wherein the spray condition is as follows: c, feeding the obtained spray-dried powder into a granulator, adding filler modified starch 4 times the weight of the spray-dried powder, filler maltodextrin 2.5 times the weight of the spray-dried powder, disintegrant microcrystalline cellulose 2 times the weight of the spray-dried powder and binder polyvinylpyrrolidone 1 time the weight of the spray-dried powder into the granulator, granulating, drying, uniformly spraying the volatile oil obtained in the step a, and uniformly mixing to obtain the spray-dried powder.

Example 3

Taking 40g of astragalus membranaceus, 20g of codonopsis pilosula, 10g of cinnamon, 1g of asarum, 20g of safflower, 20g of angelica sinensis, 22g of radix bupleuri, 15g of fructus aurantii, 20g of inula flower, 20g of platycodon grandiflorum, 15g of poria cocos, 18g of polygala tenuifolia, 12g of spina date seed and 12g of schisandra chinensis, and carrying out preparation method:

a. weighing cinnamon, asarum, safflower, angelica and fructus aurantii in each weight ratio, and extracting volatile oil for 4 hours for later use;

b. adding other medicinal materials into the residue after volatile oil extraction, extracting with water, adding 10 times of water of the total medicinal materials, reflux extracting for 2 times, each time for 1 hr, concentrating the obtained extractive solution to density of 1.20g/ml, collecting extractive solution, and concentrating;

c. adding 95% v/v ethanol aqueous solution to the concentrated solution until the ethanol concentration reaches 85% v/v, standing, filtering, collecting ethanol precipitation solution, and concentrating;

d. and (3) spray drying the concentrated alcohol precipitation solution, wherein the spray condition is as follows: c, feeding the obtained spray-dried powder into a granulator, adding filler modified starch 4 times the weight of the spray-dried powder, filler maltodextrin 2.5 times the weight of the spray-dried powder, disintegrant microcrystalline cellulose 2 times the weight of the spray-dried powder and binder polyvinylpyrrolidone 1 time the weight of the spray-dried powder, granulating, drying, uniformly spraying the volatile oil obtained in the step a, and uniformly mixing to obtain the spray-dried powder.

Comparative example 1

Taking 35g of astragalus, 25g of codonopsis pilosula, 8g of cinnamon, 2g of asarum, 15g of safflower, 25g of angelica, 20g of radix bupleuri, 20g of fructus aurantii, 15g of inula flower, 25g of platycodon grandiflorum, 12g of poria cocos, 20g of polygala tenuifolia, 10g of spina date seed and 14g of schisandra chinensis, and preparing the traditional Chinese medicine composition:

a. weighing cinnamon, asarum, safflower, angelica and fructus aurantii in each weight ratio, and extracting volatile oil for 4 hours for later use;

b. adding other medicinal materials into the residue after volatile oil extraction, adding water for extraction, adding 10 times of water to the total medicinal materials, reflux-extracting for 2 times, each time for 1 hr, concentrating the obtained extractive solution to density of 1.20g/ml, collecting extractive solution, and concentrating;

c. adding 95% v/v ethanol aqueous solution to the concentrated solution until the ethanol concentration reaches 85% v/v, standing, filtering, collecting ethanol precipitation solution, and concentrating;

d. and (3) spray drying the concentrated alcohol precipitation solution, wherein the spray condition is as follows: c, feeding the obtained spray-dried powder into a granulator, adding 6.5 times of the weight of the filler lactose, 2 times of the weight of the disintegrant alginic acid and 1 time of the weight of the binder syrup into the spray-dried powder, granulating, drying, uniformly spraying the volatile oil obtained in the step a, and uniformly mixing to obtain the spray-dried powder.

Comparative example 2

Taking 35g of astragalus, 25g of codonopsis pilosula, 8g of cinnamon, 2g of asarum, 15g of safflower, 25g of angelica, 20g of radix bupleuri, 20g of fructus aurantii, 15g of inula flower, 25g of platycodon grandiflorum, 12g of poria cocos, 20g of polygala tenuifolia, 10g of spina date seed and 14g of schisandra chinensis, and preparing the traditional Chinese medicine composition:

a. weighing cinnamon, asarum, safflower, angelica and fructus aurantii in each weight ratio, and extracting volatile oil for 4 hours for later use;

b. adding other medicinal materials into the residue after volatile oil extraction, extracting with water, adding 10 times of water of the total medicinal materials, reflux extracting for 2 times, each time for 1 hr, concentrating the obtained extractive solution to density of 1.20g/ml, collecting extractive solution, and concentrating;

c. adding 95% v/v ethanol aqueous solution to the concentrated solution until the ethanol concentration reaches 85% v/v, standing, filtering, collecting ethanol precipitation solution, and concentrating;

d. and (3) spray drying the concentrated alcohol precipitation solution, wherein the spray condition is as follows: c, feeding the obtained spray-dried powder into a granulator, adding 6.5 times of filler starch, 2 times of disintegrant cross-linked hydroxymethyl cellulose and 1 time of adhesive 75% ethanol into the spray-dried powder, granulating, drying, uniformly spraying the volatile oil obtained in the step a, and uniformly mixing to obtain the finished product, wherein the air inlet temperature is 105 ℃, the atomization pressure is 0.2MPa, and the outlet temperature is 68 ℃.

Comparative example 3

Taking 35g of astragalus, 25g of codonopsis pilosula, 8g of cinnamon, 2g of asarum, 15g of safflower, 25g of angelica, 20g of radix bupleuri, 20g of fructus aurantii, 15g of inula flower, 25g of platycodon grandiflorum, 12g of poria cocos, 20g of polygala tenuifolia, 10g of spina date seed and 14g of schisandra chinensis, and preparing the traditional Chinese medicine composition:

a. weighing cinnamon, asarum, safflower, angelica and fructus aurantii in each weight ratio, and extracting volatile oil for 4 hours for later use;

b. adding other medicinal materials into the residue after volatile oil extraction, extracting with water, adding 10 times of water of the total medicinal materials, reflux extracting for 2 times, each time for 1 hr, concentrating the obtained extractive solution to density of 1.20g/ml, collecting extractive solution, and concentrating;

c. adding 95% v/v ethanol aqueous solution to the concentrated solution until the ethanol concentration reaches 85% v/v, standing, filtering, collecting ethanol precipitation solution, and concentrating;

d. and (3) spray drying the concentrated alcohol precipitation solution, wherein the spray condition is as follows: c, feeding the obtained spray-dried powder into a granulator, adding 6.5 times of filler mannitol by weight of the spray-dried powder, 2 times of disintegrant dry starch by weight of the spray-dried powder and 1 time of adhesive 75% ethanol by weight of the spray-dried powder, granulating, drying, uniformly spraying the volatile oil obtained in the step a, and uniformly mixing to obtain the spray-dried powder.

Example 4: the moisture absorption rate, angle of repose, molding rate and solubility of the granules of the invention are measured

The following methods were used to determine the moisture absorption rate, angle of repose, molding rate, and solubility of the granules of the present invention, and the results are shown in Table 1.

Moisture absorption measurement: weighing 1g of the prepared particles, spreading the particles in a weighing bottle, and precisely weighing the mass of an original sample.

Placing the open end of the weighing bottle in a constant temperature and humidity box under the conditions as follows: the sample mass was weighed at different time intervals at a temperature of 25 ℃ and a relative humidity of 65%, and the moisture absorption rate for 24 hours was calculated according to the following formula.

Moisture absorption rate = (mass of particles after moisture absorption-mass of particles before moisture absorption)/mass of particles before moisture absorption × 100%

And (3) fluidity measurement: 50g of the prepared granules are slowly added from an upper funnel, so that the auxiliary materials are gradually stacked on the base plate through the buffer of the funnel to form a cone until the highest cone is obtained. The height H of the cone is measured, and the angle of repose is calculated as follows, α = arctg (H/R), where α is the angle of repose and R is the radius of the chassis. Wherein, the repose angle is less than 40 degrees, which shows that the fluidity meets the requirement of preparation molding in the production process.

Forming rate: weighing the prepared particles by a sieve No. 1 (10 meshes) and then a sieve No. 5 (80 meshes), collecting the particles which can pass through the sieve No. 1 but cannot pass through the sieve No. 5, weighing the particles, and calculating the molding rate by a formula of molding rate = (the mass of the particles after sieving/the mass of the particles before sieving) × 100%, and scoring = (25/maximum molding rate) × molding rate.

Solubility: about 2g of the granules were dissolved in 40 ml of hot water, stirred, and the state of the solution was observed.

TABLE 1 moisture absorption, angle of repose, molding rate, and solubility of the granules of the invention

Sample (I)	Moisture absorption Rate (%)	Angle of repose (°)	Molding ratio (%)	Solubility in water
					Example 1	8.54	29.6	91.5	Qualified
Example 2	9.23	35.4	89.5	Qualified
					Example 3	7.89	28.5	93.5	Qualified
Comparative example 1	14.54	43.5	87.3	Fail to be qualified
					Comparative example 2	15.12	47.1	67.9	Qualified
Comparative example 3	17.43	51.0	71.2	Fail to be qualified

Because the extractum extracted from the traditional Chinese medicine has larger hygroscopicity, the invention uses the filler modified starch, the maltodextrin, the disintegrant which adopts microcrystalline cellulose and the adhesive which adopts polyvinylpyrrolidone, and obtains good effect, which indicates that the formula of the invention is reasonable. And if auxiliary materials such as lactose as a filler, mannitol as a filler, alginic acid as a disintegrating agent, syrup as a binder, 75% ethanol as a binder and the like are used, the hygroscopicity is strong, the mobile phase is poor, and the dissolubility is easily unqualified.

Example 5: the effect of the granules on rat myocardial ischemia caused by pituitrin

1. Experimental Material

1. Reagent testing: the granules prepared by the method described in examples 1-3 were prepared with distilled water to different concentrations for use immediately before use; the doses used in the experiment were rats: 0.6g/kg.

2. Positive control drug: the positive medicine adopts compound red sage root dripping pills as a commercial product, and the batch number is as follows: 20201208, tianshili pharmaceutical group, inc., chinese medicine Standard Z10950111, which is prepared to the desired concentration with distilled water just before use.

3. Reagent: posterior pituitary injection, 6u/ml × 10 pieces, lot number: 20191104, shanghai Hefeng pharmaceuticals, inc.; reagents such as sodium pentobarbital are commercially available.

4. The instrument comprises the following steps: an LMB-2B type two-channel physiological recorder (produced by Chengdu instrument factory); RM-6280 multichannel intelligent physiological signal collecting and processing system (produced by Japan photoelectric company and Chengdu instrument factory cooperation).

5. Experimental animals: SD rats, 180-220 g in body mass, are provided by Nanjing university of traditional Chinese medicine laboratory animal center.

2. Observation indexes are as follows: ST-segment occurrence, T-wave changes (low or high, etc.), arrhythmia, and heart rate.

3. The experimental process comprises the following steps: 60 SD rats were randomly divided into 5 groups, namely a control group (filled with physiological saline), an example 1 group (dose of 1 g/kg), an example 2 group (dose of 1 g/kg), an example 3 group (dose of 1 g/kg) and a compound Salvia miltiorrhiza dripping pill group (dose of 1 g/kg), continuously for 14 days, were subjected to intraperitoneal injection (ip) of 30mg/kg of 1% sodium pentobarbital for anesthesia within 10 minutes after the last administration, were fixed on a rat plate in the supine position, and were subjected to separation of a common carotid artery (A) and an external jugular vein (V) and were respectively intubated. The neck total A is connected with a two-lead physiological recorder blood pressure sensor to measure blood pressure; v administration outside the neck. After the normal electrocardiogram is measured by connecting standard II leads, 0.5u/kg hypophyseal posterior lobe element (100 mu l volume) is injected from a V cannula outside the neck, the electrocardiogram is recorded immediately after the injection is finished within 10 seconds, and the indexes of ST segment occurrence rate (including ST segment rising or falling, fusion and the like), T wave change (low level or rising and the like), arrhythmia, heart rate and the like within 5 minutes are continuously observed, and the results are shown in a table 2.

Table 2 effect of the granules of the invention on myocardial ischemia in experimental rats (n = 12)

Note: * P <0.05,. P <0.01, compared to pre-ischemia; # P <0.05, # P <0.01, compared to the control group.

The traditional Chinese medicine composition provided by the embodiments 1-3 of the invention can obviously resist myocardial ischemia symptoms caused by pituitrin after being administrated for 14 days, which shows that the traditional Chinese medicine composition granules have obvious protective effect on the myocardial ischemia symptoms.

Example 6: effect of the granules of the present invention on platelet aggregation

1. Experimental Material

1. Reagent testing: the granules prepared by the method described in examples 1-3 were prepared with distilled water to different concentrations for use immediately before use; the doses used in the experiment were rats: 0.6g/kg.

2. Positive control drug: the positive medicine adopts aspirin as a commercial product, and is prepared into required concentration by using distilled water before use.

3. Experimental animals: SD rats, 180-220 g in body mass, are provided by Nanjing university of traditional Chinese medicine laboratory animal center.

2. Experimental methods

The test drugs were the samples of examples 1-3; male SD rats were randomly divided into 5 groups of 12 animals by body weight, and the groups were a blank control group, an example 1 group (dose of 1 g/kg), an example 2 group (dose of 1 g/kg), an example 3 group (dose of 1 g/kg), and an aspirin group (dose of 100 mg/kg). Each administration group is administered by intragastric administration according to corresponding dose, 1 time per day for 7 days; the placebo group was gavaged with equal amounts of drinking water. After 1h of the last administration, 3.5% chloral hydrate is anesthetized, the abdominal aorta is subjected to blood sampling, two centrifuge tubes with 3.5% sodium citrate (with the blood volume of 1. Respectively and precisely sucking 500 mu L of PPP and PRP of each rat of each group, adding the PPP into a test cup, adjusting the light transmittance to 100 percent, adding 5 mu L (final concentration is 5 mu mol/L) of an inducer ADP solution with the concentration of 0.155 mu mol/L after the PRP is incubated in a preheating temperature tank at 37 ℃ for 5min, and measuring the maximum aggregation rate of the platelets within 5min by a platelet aggregation coagulation factor analyzer according to the instruction of an instrument, wherein the results are shown in Table 3.

TABLE 3 Effect of test samples on ADP-induced platelet aggregation in vitro

Group of	Rate of aggregation (%)
		Control group	56.7±5.6
Example 1	34.8±4.2**
		Example 2	37.9±5.2*
Example 3	35.0±4.8*
		Positive drug group	41.6±6.2*

Note: p <0.05, p <0.01 compared to the blank control group.

The experimental results show that: compared with a blank control group, each sample of the test group can obviously inhibit ADP-induced in-vitro platelet aggregation (the average P is less than 0.01) and shows a better anti-platelet aggregation effect. The blood viscosity is closely related to the cardiovascular and cerebrovascular diseases, the blood viscosity is increased, the blood flow rate is reduced, the arterial blood vessel is hardened to form plaques, the blood vessel becomes narrow, and finally the cardiovascular and cerebrovascular blockage is caused.

Example 7: clinical research

Selecting 100 patients with coronary heart disease, wherein the age is 40-70 years, the disease course is 5-10 years, the western medicine aims at the coronary heart disease, and the traditional Chinese medicine diagnoses the coronary heart disease with heart-qi deficiency, and the symptoms are as follows: dull pain in the chest and chest, chest distress, shortness of breath, panting, palpitation, lassitude, or laziness in speaking, a white complexion, or a tendency to sweat. Pale-red and swollen tongue with teeth marks, thin coating, and deficient, thready, slow or intermittent pulse.

And (3) evaluating the curative effect: the effect is shown: chest distress, short breath, palpitation and other symptoms disappear, and the ST segment of the electrocardiogram recovers to be normal; the method has the following advantages: chest distress, short breath, palpitation, etc. are relieved, and the T wave of the electrocardiogram is recovered to be normal or low level from inversion; and (4) invalidation: the symptoms are not obviously improved, and the electrocardiogram is not obviously changed.

The administration method comprises the following steps: the granules prepared in example 1 of the present invention were taken three times a day, two bags each time, 15g each bag.

The clinical test results are as follows: the invention has remarkable effect on the coronary heart disease with deficiency of heart qi, 67 cases of the traditional Chinese medicine are effective, 28 cases are effective, 5 cases are ineffective, and the total effective rate is 95%.

Typical cases are:

certain Zhao, male and age 78, diagnosed as "coronary atherosclerotic heart disease" and "unstable angina pectoris", belonging to heart-qi deficiency type, dull pain in heart-chest matrix, chest distress and shortness of breath, wheezing when moving, palpitation and flustered, lassitude and hypodynamia, or laziness of speaking, white complexion, and paroxysmal attack.

When a certain woman is in 48 years old, the patient has paroxysmal attack due to precordial distress and asthma, the symptoms are aggravated, precordial pain appears, and the paroxysm can be relieved automatically after the patient has tired activity and sometimes has a rest, and belongs to the heart-qi deficiency type.

Although embodiments of the present invention have been shown and described, it will be appreciated by those skilled in the art that various changes, modifications, substitutions and alterations can be made in these embodiments without departing from the principles and spirit of the invention, the scope of which is defined in the appended claims and their equivalents.

Claims (7)

1. A traditional Chinese medicine composition for treating cardiovascular and cerebrovascular diseases is characterized by being prepared by extracting the following raw materials in parts by weight: 30-40 parts of astragalus membranaceus, 20-30 parts of codonopsis pilosula, 5-10 parts of cinnamon, 1-3 parts of asarum, 10-20 parts of safflower, 20-30 parts of angelica sinensis, 18-22 parts of radix bupleuri, 15-25 parts of fructus aurantii, 10-20 parts of inula flower, 20-30 parts of platycodon grandiflorum, 10-15 parts of poria cocos, 18-25 parts of polygala tenuifolia, 8-12 parts of spina date seed and 12-16 parts of schisandra chinensis.

2. The traditional Chinese medicine composition for treating cardiovascular and cerebrovascular diseases according to claim 1, which is prepared by extracting the following raw materials in parts by weight: 30 parts of astragalus membranaceus, 30 parts of codonopsis pilosula, 5 parts of cinnamon, 3 parts of asarum, 10 parts of safflower, 30 parts of angelica sinensis, 18 parts of radix bupleuri, 25 parts of fructus aurantii, 10 parts of inula flower, 30 parts of platycodon grandiflorum, 10 parts of poria cocos, 25 parts of polygala tenuifolia, 8 parts of spina date seed and 16 parts of schisandra chinensis.

3. The traditional Chinese medicine composition for treating cardiovascular and cerebrovascular diseases according to claim 1, which is prepared by extracting the following raw materials in parts by weight: 40 parts of astragalus membranaceus, 20 parts of codonopsis pilosula, 10 parts of cinnamon, 1 part of asarum, 20 parts of safflower, 20 parts of angelica sinensis, 22 parts of radix bupleuri, 15 parts of fructus aurantii, 20 parts of inula flower, 20 parts of platycodon grandiflorum, 15 parts of poria cocos, 18 parts of polygala tenuifolia, 12 parts of spina date seed and 12 parts of schisandra chinensis.

4. The traditional Chinese medicine composition for treating cardiovascular and cerebrovascular diseases according to claim 1, which is prepared by extracting the following raw materials in parts by weight: 35 parts of astragalus, 25 parts of codonopsis pilosula, 8 parts of cinnamon, 2 parts of asarum, 15 parts of safflower, 25 parts of angelica, 20 parts of radix bupleuri, 20 parts of fructus aurantii, 15 parts of inula flower, 25 parts of platycodon grandiflorum, 12 parts of poria cocos, 20 parts of polygala tenuifolia, 10 parts of spina date seed and 14 parts of schisandra chinensis.

5. The Chinese medicinal composition for treating cardiovascular and cerebrovascular diseases according to claim 1, wherein the dosage form is granules.

6. The traditional Chinese medicine composition for treating cardiovascular and cerebrovascular diseases according to claim 1, which is prepared by the following steps:

a. weighing cinnamon, asarum, safflower, angelica and fructus aurantii in each weight ratio, and extracting volatile oil for 4 hours for later use;

b. adding other medicinal materials into the residue after volatile oil extraction, extracting with water, adding 10 times of water of the total medicinal materials, reflux extracting for 2 times, each time for 1 hr, concentrating the obtained extractive solution to density of 1.20g/ml, collecting extractive solution, and concentrating;

c. adding 95% v/v ethanol aqueous solution to the concentrated solution until the ethanol concentration reaches 85% v/v, standing, filtering, collecting ethanol precipitation solution, and concentrating;

d. and (3) spray drying the concentrated alcohol precipitation solution, wherein the spray condition is as follows: c, feeding the obtained spray-dried powder into a granulator at an air inlet temperature of 100-105 ℃, an atomization pressure of 0.2-0.4MPa and an outlet temperature of 68-72 ℃, adding filler modified starch 4 times the weight of the spray-dried powder, filler maltodextrin 2.5 times the weight of the spray-dried powder, disintegrant microcrystalline cellulose 2 times the weight of the spray-dried powder, and binder polyvinylpyrrolidone 1 time the weight of the spray-dried powder, granulating, drying at low temperature, uniformly spraying the volatile oil obtained in the step a, and uniformly mixing to obtain the spray-dried powder.

7. The use of the Chinese medicinal composition for treating cardiovascular and cerebrovascular diseases according to claim 1 in the preparation of a medicament for treating coronary heart disease with heart-qi deficiency.