A kind of Xinmaikang medicine Chinese medicine composition and preparation method thereof
Technical field
The present invention relates to a kind of Chinese medicine composition and preparation method thereof, relate in particular to a kind of Xinmaikang medicine Chinese medicine composition and preparation method thereof with promoting flow of QI and blood, eleminating phlegm and freeing channels, pain relieving effect.
Technical background
Angina pectoris is a coronary insufficiency, the clinical syndrome that rapid, temporary transient ischemia of cardiac muscle and anoxia cause.Be characterized in that the primary disease pilosity is born in more than 40 years old, every growth of age 10 years old, morbidity just rise and double, and the male is more than the women, and M-F is roughly 2: 1, and in the majority with the brain worker.
Since the 1950's, crowd's prevalence of coronary heart disease and mortality rate are the trend that rises year by year, and be particularly outstanding in American-European countries.According to ACC in 1981, this year have 1,500,000 people and suffer from myocardial infarction, wherein 650,000 people's death.The data of the U.S. that NCHS in 1988 announces death toll in 1987 and cause of death order shows that heart disease accounts for 35% of total death, and wherein coronary heart disease death accounts for 24.1%, occupies cause of the death first place.The Incidence of CHD difference of China each department does not wait to minimum 0.6% by the highest 14.29%.The city coronary heart disease death rate in natural crowd of China's Ministry of Public Health announcement in 1989 is 36.9/10 ten thousand, and the rural area is 15.6/10 ten thousand, and the number that coronary heart disease is died from the estimation whole nation every year is 20-30/10 ten thousand.Therefore coronary heart disease has become one of important diseases of harm people of the world life and health, is the big problem of pendulum in face of the medical personnel to the positive control of coronary heart disease.
At present, doctor trained in Western medicine is used nitrate esters, calcium antagonist, receptor blocking agent three big foundation class medicines usually to the treating coronary heart disease and angina pectoris treatment, and share with antiplatelet drug and anticoagulant medicine as one sees fit.More than a few class medicines in anginal treatment, though better action is arranged, but syndrome after postural hypotension, cardiopalmus, arrhythmia, dizziness, headache, GI irritation, asthma, the drug withdrawal can appear, even cause heart failure, severe patient causes a series of side effect such as death, taboo is more when making clinical application, brings certain degree of difficulty for the control angina pectoris.
The traditional Chinese medical science think coronary heart disease basic pathogenesis duty in " deficiency in origin and excess in superficiality ".Pay attention to the treating both the principal and the secondary aspects of a disease at the same time to disease in the treatment, be particular about symptomatic treatment in acute condition, the rule of treatment of relieving the primary symptom in a chronic case has formed some and has treated the prescription of angina pectoris tool good efficacy.As SHENGMAI YIN: function Yiqi and vein recovery, YIN nourishing and the production of body fluid promoting; Grow the heart-yin oral liquid: function is nourished the heart-yin, promoting blood circulation and stopping pain; Coronary disease Styrax Pilulae: function regulate the flow of vital energy the chest stuffiness relieving, pain relieving; Jingzhi Guanxin tablet: function blood circulation promoting and blood stasis dispelling; LEMAI KELI: function promoting flow of QI and blood, blood stasis dispelling are promoted blood circulation; DIAOXINXUE KANG: function blood circulation promoting and blood stasis dispelling, promoting the circulation of QI to relieve pain, dilating coronary blood vessel improves myocardial ischemia; FUFANG DANSHEN PIAN and FUFANG DANSHEN DIWAN: function blood circulation promoting and blood stasis dispelling, regulating QI to relieve pain; GUANXIN DANSHEN PIAN: function blood circulation promoting and blood stasis dispelling, regulating QI to relieve pain; The treating coronary heart disease granule: the function promoting flow of QI and blood, blood stasis dispelling is promoted blood circulation; Yixintong sheet: function blood circulation promoting and blood stasis dispelling, the logical heart arteries and veins of a surname, the easypro network of regulating the flow of vital energy.
From above-mentioned kind as can be seen, emphasis QI invigorating, the yin nourishing that has in the medicine of the treatment coronary heart disease of existing national standard at present, the emphasis that has is regulated the flow of vital energy, and the emphasis that has is invigorated blood circulation, and more is that vital energy regualting and blood circulation-promoting is taken into account.Because these medicines all can be at a certain pathogenesis performance therapeutical effect of coronary heart disease, so all can obtain certain curative effect.
Yet in recent years, along with improving constantly of living standards of the people, great variety has taken place in people's dietary structure, the surfeit delicious food, and impairing the spleen and stomach fortuneization function, spleen loses key fortune, and the defeated cloth imbalance of bringing about the spread of body fluid is condensed into expectorant, stagnating heart meridian.Expectorant is turbid not only directly related with the morbidity of obstruction of qi in the chest and cardialgia, and trouble factor easy with it such as obesity, and the generation of hyperlipemia also has substantial connection; Physical work reduces in addition, and life is too easy, lacks physical training again, the how quiet few moving and aged tendency of population of people, and it is not smooth to cause QI-blood circulation, qi depression to blood stasis.Cause qi depression to blood stasis and stagnation of phlegm heart arteries and veins increasing for the obstruction of qi in the chest and cardialgia patient who suffers from jointly.Using tonification YIN nourishing and so on for this class patient, to encourage expectorant on the contrary turbid, and aggravate disease; List can not be obtained good curative effect with Therapeutic Method such as promoting flow of QI and blood.
Summary of the invention
Increasing for the angina pectoris patient who suffers from jointly at qi depression to blood stasis and stagnation of phlegm heart arteries and veins, one of purpose of the present invention provides a kind of Xinmaikang medicine Chinese medicine composition with promoting flow of QI and blood, eleminating phlegm and freeing channels, pain relieving effect.
Two of purpose of the present invention provides the preparation method of Xinmaikang medicine Chinese medicine composition.
The objective of the invention is to be achieved by following technical proposals:
It is mainly made by following raw medicaments in portion by weight:
Vinegar Rhizoma Corydalis 400-600 part Rhizoma Chuanxiong 400-600 part Rhizoma Curcumae Longae 300-500 part
Radix Ilicis Pubescentis 300-500 part Herba Erigerontis 300-500 part Pericarpium Trichosanthis 300-500 part
Bulbus Allii Macrostemonis 200-400 part Borneolum Syntheticum 1-20 part
Wherein preferred weight part is:
Vinegar Rhizoma Corydalis 450-550 part Rhizoma Chuanxiong 450-550 part Rhizoma Curcumae Longae 350-450 part
Radix Ilicis Pubescentis 350-450 part Herba Erigerontis 350-450 part Pericarpium Trichosanthis 350-450 part
Bulbus Allii Macrostemonis 250-350 part Borneolum Syntheticum 5-15 part
Wherein optimum weight part is:
400 parts in 500 portions of Rhizoma Curcumae Longaes of 500 parts of Rhizoma Chuanxiongs of vinegar Rhizoma Corydalis
400 parts of 400 parts of Pericarpium Trichosanthiss of 400 parts of Herba Erigerontiss of Radix Ilicis Pubescentis
10 parts of 300 parts of Borneolum Syntheticums of Bulbus Allii Macrostemonis
Wherein the vinegar Rhizoma Corydalis is the dry tuber of papaveraceae plant corydalis Corydalis yanhusuo W.T.Wang;
Rhizoma Chuanxiong is the dry rhizome of samphire Rhizoma Chuanxiong Ligusticnm chuanxiong Hort.;
Herba Erigerontis is the herb of feverfew Erigeron breviscapus (Vant.) Hand.-Mazz. Erigeronbr5evisapus (Vant.) Hand.-Mazz.;
Rhizoma Curcumae Longae is the dry rhizome of zingiberaceous plant Rhizoma Curcumae Longae Curcuma Longa L.;
Radix Ilicis Pubescentis is root and the leaf of holly plant Ilicis Purpureae Ilex pubescens Hook et Am.;
Pericarpium Trichosanthis is the hot peel that is dried to that cucurbitaceous plant is drawn together building Tchosanthes Kinlowi maxim. or trichosanthes rosthornii Harms Trichosamthes rosthemii Harms;
Bulbus Allii Macrostemonis is the dry phosphorus stem of liliaceous plant Allium macrostemon Allium macrostcmon Bge or Chinese onion Alliamchinens`s G.Don;
Borneolum Syntheticum should meet pertinent regulations under 2000 editions 113 pages of Borneolum Syntheticum items of Chinese Pharmacopoeia.
Wherein Radix Ilicis Pubescentis and oil lamp carefulness should meet Chinese Pharmacopoeia version pertinent regulations in 1977, and other medical material all should meet Chinese Pharmacopoeia version pertinent regulations in 2000.
Preparation method of the present invention is as follows:
1. take by weighing above eight flavor crude drug by above-mentioned weight portion;
2. Rhizoma Chuanxiong power is broken into coarse powder, adds 15 times of water gagings, distilled 6 hours, collect volatile oil, water liquid filters standby;
3. Borneolum Syntheticum and the 2. middle gained volatile oil of step are merged, the anhydrous alcohol solution that adds 1 times of amount, under 40 ℃ of conditions, slowly add in the saturated aqueous solution that contains 6 times of amount beta-schardinger dextrin-s, stirred 3 hours, 4 ℃ of following cold preservations 24 hours, the leaching clathrate, 40 ℃ of dryings get the dry clathrate of beta-schardinger dextrin-, and are standby;
4. vinegar Rhizoma Corydalis, Rhizoma Curcumae Longae, Radix Ilicis Pubescentis, macrostem onion powder are broken into coarse powder, merge, add 6 times of amounts of ethanol of 80%, reflux, extract, 2 times with Herba Erigerontis, Pericarpium Trichosanthis, each 2 hours, merge pure liquid, filter, decompression recycling ethanol gets ethanol extract such as vinegar Rhizoma Corydalis to doing, and is standby;
5. with step 4. Chinese medicine slag add 5 times in water amount and decocted 1.5 hours, filter, with step 2. in Rhizoma Chuanxiong water extract merge, be evaporated to relative density 1.10 (80 ℃), add ethanol and make and contain the alcohol amount and reach 60%, placement is spent the night, and filters, decompression recycling ethanol gets water extracts such as Rhizoma Chuanxiong to doing, and is standby;
6. with step 4. in ethanol extract such as gained vinegar Rhizoma Corydalis and step 5. in water extract such as gained Rhizoma Chuanxiong, mix homogeneously is also pulverized, and crosses 40 mesh sieves, again with the 3. middle gained Benexate Hydrochloride of step, starch mix homogeneously, adorns capsule No. 0, promptly.
The merit of tool promoting flow of QI and blood of the present invention, eleminating phlegm and freeing channels, pain relieving is used for qi depression to blood stasis, stagnation of phlegm heart feeling pulse obstruction of qi in the chest and cardialgia.The present invention develops on the basis of clinical experience side, and clinical practice for many years shows that this medicine is to alleviating coronary heart disease symptom, and minimizing angina pectoris attacks number of times etc. has good result.Secondly, it is stable, quality controllable that the study of pharmacy situation shows that this pharmaceutical worker plants.Pharmacological toxicology studies show that, the effect that the present invention has obvious protection cardiac muscle, resists myocardial ischemia, and do not see overt toxicity.
Specific embodiment
Embodiment 1: pharmacodynamic study
Xinmaikang medicine capsule (XMK) is used for obstruction of qi in the chest and cardialgia, and the effect of tool promoting flow of QI and blood, eleminating phlegm and freeing channels, pain relieving has been carried out cardiac hemodynamic according to the study of tcm new drug specification requirement, the research of correlation tests such as myocardial infarction and ischemia model, myocardial oxygen consumption, coronary flow.By observing the influence of XMK to every indexs such as the electrocardiogram of acute myocardial ischemia animal pattern, myocardium enzyme, coronary flow, myocardial infarction areas, research this product is to the preventive and therapeutic effect of myocardial ischemia, for clinical practice provides experimental basis.The result is as follows:
1. utilize RM-6000 type physiology to lead instrument more and measure XMK normal health hybrid dog cardiac function, hemodynamic influence, result of the test shows: be subjected to reagent thing XMK high dose can make blood pressure (BP), cardiac output (CO), left indoor pressure (LVSP), easypro end, left chamber press (± dp/dtmin) the slightly increase of (LVEDP), the maximum rate of change of left indoor pressure, but not statistically significant is to heart rate (HR), stroke work index, then not obvious to the total peripheral resistance influence.
2. cause the Model Rats with Acute Myocardial Ischemia test for Mus sublingual vein injection of pituitrin and show, XMK has the effect of myocardial ischemia due to the better antagonism pituitrin, and electrocardiogram has obvious change.
3. observe the influence of XMK by the coronary ligation myocardial infarction and ischemia model to myocardial ischemia animal heart rate, electrocardiogram, myocardium enzyme and infarct size.The result shows, is subjected to reagent thing XMK that the Electrocardiographic change effect of myocardial ischemia due to the good antagonism coronary ligation is arranged, and obviously reduces LDH, CPK and infarct size, and can obviously reduce the ischemic heart oxygen consumption and increase its coronary flow.
4.XMK can obviously prolong lumbar injection isoprenaline mice hypoxia endurance time, experimental study shows that the Xinmaikang medicine capsule can prolong the clotting time of mice in addition, suppress the formation of rat arteriovenous shut thrombosis, obviously prolong rats PT, APTT time, Fgb is had reduction trend.
Above experimental result shows the merit of the stronger promoting flow of QI and blood of Xinmaikang medicine capsule tool, eleminating phlegm and freeing channels, pain relieving, and ischemic myocardial is had obvious protective effect, can be used for qi depression to blood stasis, stagnation of phlegm heart feeling pulse obstruction of qi in the chest and cardialgia.
Embodiment 2: acute toxicity and long term toxicity test research
1, acute toxicity test research
Xinmaikang medicine is mixed with the Cmax of suitable filling stomach and gives the mouse stomach administration by 0.4ml/10g with pure water, twice on the one accumulated dose is 576.0g/kg, phenomenons such as just rare, movable minimizing, food-intake minimizing appear in most mices after the administration for the second time, but basic recovery is normal after 24 hours.Observe after seven days continuously and do not see animal dead, mice was put to death in the back of weighing on 8, carried out the anatomic observation main organs, and it is as seen unusual all not have naked eyes.As seen to irritate the stomach maximum dosage-feeding be 576.0g/kg (be equivalent to approximately clinical consumption per day 960 times) to Xinmaikang medicine, belongs to no cytotoxic drug.
2, long term toxicity test research
Xinmaikang medicine capsule (XMK) rat long term toxicity test, draft design high, medium and low three the dosage groups of XMK and a blank group, dosage is respectively 72g crude drug/kg, 36g crude drug/kg, 12g crude drug/kg, is equivalent to clinical plan 136,68,24 times with dosage (0.5g/kg).Administration is 6 times weekly, continuously 26 weeks of gastric infusion and do convalescent period in 4 weeks of drug withdrawal and observe.Result of the test shows: the outward appearance of each administration group rat during administration, behavior, activity, the mental status, hair color etc. relatively there is no obvious change with blank, and the body weight of administration group rat is not seen significant difference than matched group.Dosage group hemoglobin obviously raises in medication is during 13 weeks, and middle and high dosage group T-CHOL obviously reduces; Medication 26 during week in the dosage clotting time obviously prolong, middle and high dosage group T-CHOL obviously reduces, high dose group blood glucose also is lower than the normal control group.Organ coefficient and histopathological examination result have drug-induced toxic reaction and hysteresis quality toxicity.The safe dose of above this test of results suggest XMK rat is 72g/kg, is equivalent to 136 times of people's consumption.
Show that by above main pharmacodynamics, acute and long-term malicious result of the test the Xinmaikang medicine capsule has promoting flow of QI and blood, eleminating phlegm and freeing channels, analgesic effect does not have tangible toxicity to mice, rat.
Embodiment 3:
1. take by weighing 500 parts of vinegar Rhizoma Corydalis, 500 parts of Rhizoma Chuanxiongs, 400 parts in Rhizoma Curcumae Longae, 400 parts of Radix Ilicis Pubescentiss, 400 parts of Herba Erigerontiss, 400 parts of Pericarpium Trichosanthiss, 300 parts of Bulbus Allii Macrostemonis, 10 parts of Borneolum Syntheticums by weight;
2. Rhizoma Chuanxiong power is broken into coarse powder, adds 15 times of water gagings, distilled 6 hours, collect volatile oil, water liquid filters, and is standby;
3. Borneolum Syntheticum and the 2. middle gained volatile oil of step are merged, the anhydrous alcohol solution that adds 1 times of amount, under 40 ℃ of conditions, slowly add in the saturated aqueous solution that contains 6 times of amount beta-schardinger dextrin-s, stirred 3 hours, 4 ℃ of following cold preservations 24 hours, the leaching clathrate, 40 ℃ of dryings get the dry clathrate of beta-schardinger dextrin-, and are standby;
4. vinegar Rhizoma Corydalis, Rhizoma Curcumae Longae, Radix Ilicis Pubescentis, macrostem onion powder are broken into coarse powder, merge, add 6 times of amounts of ethanol of 80%, reflux, extract, 2 times with Herba Erigerontis, Pericarpium Trichosanthis, each 2 hours, merge pure liquid, filter, decompression recycling ethanol gets ethanol extract such as vinegar Rhizoma Corydalis to doing, and is standby;
5. with step 4. Chinese medicine slag add 5 times in water amount and decocted 1.5 hours, filter, with step 2. in Rhizoma Chuanxiong water extract merge, be evaporated to relative density 1.10 (80 ℃), add ethanol and make and contain the alcohol amount and reach 60%, placement is spent the night, and filters, decompression recycling ethanol gets water extracts such as Rhizoma Chuanxiong to doing, and is standby;
6. with step 4. in ethanol extract such as gained vinegar Rhizoma Corydalis and step 5. in water extract such as gained Rhizoma Chuanxiong, mix homogeneously is also pulverized, and crosses 40 mesh sieves, again with the 3. middle gained Benexate Hydrochloride of step, starch mix homogeneously, adorns capsule No. 0, promptly.
Embodiment 4:
As embodiment 3 described preparation methoies, the different persons of institute are for taking by weighing following raw medicaments in portion by weight:
400 parts in 500 portions of Rhizoma Curcumae Longaes of 600 parts of Rhizoma Chuanxiongs of vinegar Rhizoma Corydalis
500 parts of 300 parts of Pericarpium Trichosanthiss of 400 parts of Herba Erigerontiss of Radix Ilicis Pubescentis
20 parts of 200 parts of Borneolum Syntheticums of Bulbus Allii Macrostemonis
Embodiment 5:
As embodiment 3 described preparation methoies, the different persons of institute are for taking by weighing following raw medicaments in portion by weight:
300 parts in 600 portions of Rhizoma Curcumae Longaes of 400 parts of Rhizoma Chuanxiongs of vinegar Rhizoma Corydalis
300 parts of 500 parts of Pericarpium Trichosanthiss of 500 parts of Herba Erigerontiss of Radix Ilicis Pubescentis
1 part of 300 parts of Borneolum Syntheticum of Bulbus Allii Macrostemonis
Embodiment 6:
As embodiment 3 described preparation methoies, the different persons of institute are for taking by weighing following raw medicaments in portion by weight:
500 parts in 550 portions of Rhizoma Curcumae Longaes of 450 parts of Rhizoma Chuanxiongs of vinegar Rhizoma Corydalis
400 parts of 350 parts of Pericarpium Trichosanthiss of 300 parts of Herba Erigerontiss of Radix Ilicis Pubescentis
15 parts of 250 parts of Borneolum Syntheticums of Bulbus Allii Macrostemonis
Embodiment 7:
As embodiment 3 described preparation methoies, the different persons of institute are for taking by weighing following raw medicaments in portion by weight:
350 parts in 400 portions of Rhizoma Curcumae Longaes of 500 parts of Rhizoma Chuanxiongs of vinegar Rhizoma Corydalis
450 parts of 400 parts of Pericarpium Trichosanthiss of 450 parts of Herba Erigerontiss of Radix Ilicis Pubescentis
5 parts of 400 parts of Borneolum Syntheticums of Bulbus Allii Macrostemonis