CN103656012B - A kind of preparation method treating treating coronary heart disease and angina pectoris compositions - Google Patents
A kind of preparation method treating treating coronary heart disease and angina pectoris compositions Download PDFInfo
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- CN103656012B CN103656012B CN201310691103.2A CN201310691103A CN103656012B CN 103656012 B CN103656012 B CN 103656012B CN 201310691103 A CN201310691103 A CN 201310691103A CN 103656012 B CN103656012 B CN 103656012B
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Abstract
The invention discloses one and treat treating coronary heart disease and angina pectoris compositions, described compositions is that crude drug is processed into through extracting by Pollen Tyjphae, Rhizoma Pinelliae Preparatum, Radix Salviae Miltiorrhizae, Pericarpium Citri Reticulatae, Radix Notoginseng, Radix Polygoni Multiflori Preparata, Thallus Laminariae (Thallus Eckloniae), Rhizoma Chuanxiong, Rhizoma Alismatis, Fructus Lycii, Semen Cassiae, Fructus Crataegi, said composition has phlegm reduction of blood circulation promoting, effect of the turbid descending pain relieving, for obstruction of qi in the chest and cardialgia caused by phlegm stagnation in collateral, disease sees stabbing pain over the chest, chest distress, shortness of breath and palpitation, limbs are heavy, obesity；Angina pectoris is shown in above-mentioned patient.
Description
Technical field
The present invention relates to a kind of Chinese medicine composition, be specifically related to one and treat treating coronary heart disease and angina pectoris compositions.
Background technology
Cardiovascular disease is clinically important commonly encountered diseases and frequently-occurring disease, and the whole world has nearly 1/4th populations to be cardiovascular and phase
Related disorders is threatened, and is the heat subject of medical circle research.Doctor trained in Western medicine is in the treatment to cardiovascular disease, and nitrate esters, calcium are short of money
Anti-agent, beta blocker and angiotensin-convertion enzyme inhibitor (ACEI) etc. are to reduce coronary heart disease death rate to be most directed to pathogenesis
Active drug.But in recent years to nitrate esters, especially the therapeutical effect of calcium antagonist (fugitive and long-acting) is disputed on a lot of.
Data shows that this big class medicine is removed name from the rolls outside contraindication certainly, also needs to pay close attention to: arrhythmia, conduction block, cardiac insufficiency even promote
The negative effects such as myocardial ischemia；Also can produce AS plaque stability, the low inferior ill effect of dyslipidemias, carbohydrate tolerance.Same anti-
Platelet drug effect is undesirable, and antithrombotic drug selects and application confusion, individual widely different to therapeutic response, secondary hemorrhage
Fatal reactions, makes dose be difficult to maintain preferable anticoagulation levels to affect the treatment, and the benefit at a specified future date of direct thrombin inhibitor is still
Wait to approve.
Coronary heart disease belongs to Chinese medicine obstruction of qi in the chest and cardialgia category.Primary disease is early recognized by motherland's medical science, has complete in terms for the treatment of
Theoretical system and abundant clinical experience, have the unique advantage of oneself, also exist advantageous in objectively China simultaneously
Natural resources of Chinese medicinal materials, therefore the traditional Chinese medical science has wide prospect in terms for the treatment of cardiovascular disease.
Summary of the invention
One of the present invention treats treating coronary heart disease and angina pectoris compositions, and safely and effectively, it is possible to phlegm reduction of blood circulation promoting, the turbid descending is only
Bitterly.For obstruction of qi in the chest and cardialgia caused by phlegm stagnation in collateral.The present invention furthermore provides several concrete application of described formula.
For achieving the goal, the present invention provide one to treat treating coronary heart disease and angina pectoris compositions it is to be joined by following weight
The crude drug of ratio is made:
Pollen Tyjphae 10～200 parts, Rhizoma Pinelliae Preparatum 10～200 parts, Radix Salviae Miltiorrhizae 10～200 parts, Pericarpium Citri Reticulatae 10～200 parts, Radix Polygoni Multiflori Preparata
10～200 parts, Thallus Laminariae (Thallus Eckloniae) 10～200 parts, Rhizoma Chuanxiong 10～200 parts, Rhizoma Alismatis 10～200 parts, Fructus Lycii 10～200 parts, Semen Cassiae 10
～200 parts, Fructus Crataegi 10～200 parts
Preferred: the pharmaceutical composition of the present invention, it is made up of the crude drug of following weight proportion:
Pollen Tyjphae 40～160 parts, Rhizoma Pinelliae Preparatum 45～180 parts, Radix Salviae Miltiorrhizae 40～160 parts, Pericarpium Citri Reticulatae 45～180 parts, Radix Polygoni Multiflori Preparata
40～160 parts, Thallus Laminariae (Thallus Eckloniae) 40～160 parts, Rhizoma Chuanxiong 45～180 parts, Rhizoma Alismatis 45～180 parts, Fructus Lycii 45～180 parts, Semen Cassiae 50
～200 parts, Fructus Crataegi 40～160 parts
Most preferably, the pharmaceutical composition of the present invention, it is made up of the crude drug of following weight proportion:
Pollen Tyjphae 80 parts, Rhizoma Pinelliae Preparatum 90 parts, Radix Salviae Miltiorrhizae 80 parts, Pericarpium Citri Reticulatae 90 parts, Radix Polygoni Multiflori Preparata 80 parts, Thallus Laminariae (Thallus Eckloniae) 80 parts, Rhizoma Chuanxiong 90
Part, Rhizoma Alismatis 90 parts, Fructus Lycii 90 parts, Semen Cassiae 100 parts, Fructus Crataegi 80 parts
In composition described above, weight calculates with crude drug, if in grams, composition described above can be made into pharmaceutical preparation 1000
Agent, described 1000 doses of fingers, the final drug preparation made, as made capsule preparations 1000,1000, tablet, granule 1000
Gram, oral liquid 1000ml etc..
Composition described above, if in grams, can be made into the preparation of 50-1000 taking dose, as tablet, makes
1000, each taking dosage can be 1-20 sheet, can take 50-1000 time altogether.As granule, make 125 bags, every time
Take 1-2 bag, can take 62.5-125 time altogether.
Composition described above is by weight as proportioning, can increase according to corresponding proportion when producing or reduce, such as big rule
Mould produce can by kilogram in units of, or in units of ton, small-scale production can also be in units of milligram, and weight can increase
Big or reduce, but the constant rate of the raw medicinal herbs weight proportion between each composition.
The ratio of above weight proportion obtains through science screening, for especial patient, such as serious symptom or mild, obesity
Or the patient of slight of stature, the proportioning of the amount of composition can be adjusted accordingly, be increased or decreased less than 100%, drug effect is constant.
Single medicinal material in composition described above, especially ministerial drug and adjuvant drug, it is also possible to had in the identical property of medicine by suitable
Medicine is replaced, and its medicine effect of the Chinese medicine preparation after replacement is constant.
The pharmaceutical composition of the present invention, is that the raw material of Chinese medicine by being formed by above-mentioned formula adds through extraction or other modes
Work, makes pharmaceutically active substance, subsequently, with this material as raw material, adds pharmaceutically acceptable carrier, according to galenic pharmacy when needing
Routine techniques make.Described active substance can obtain by extracting raw material of Chinese medicine respectively, it is also possible to is extracted by common
Raw material of Chinese medicine obtains, it is also possible to obtain by other means, such as: by pulverizing, squeeze, calcine, grind, sieving, percolation, extraction
Take, water carries, alcohol extraction, ester carries, the method such as ketone carries, chromatography obtains, these active substances can be to be the material of extractum form, Ke Yishi
Dry extract can also be fluid extract, determines to make different concentration according to different needs of preparation.
Pharmaceutically active substance in the pharmaceutical composition of the present invention, its in the formulation shared percentage by weight can be 0.1-
99.9%, remaining is pharmaceutically acceptable carrier.The pharmaceutical preparation of the present invention, exists in a unit, described unit dose
Form refers to the unit of preparation, such as every of tablet, and every seed lac capsule of capsule, every bottle of oral liquid, granule every bag etc..
The pharmaceutical composition of the present invention can be any pharmaceutically useful dosage form, and these dosage forms include: tablet, sugar coated tablet,
Film coated tablet, enteric coated tablet, capsule, hard capsule, soft capsule, oral liquid, suck agent, granule, electuary, ball
Agent, powder, unguentum, sublimed preparation, suspensoid, powder, solution, injection, suppository, ointment, plaster, cream, spray, drip
Agent, patch.The preparation of the present invention, preferably peroral dosage form, such as: capsule, tablet, oral liquid, granule, pill, powder,
Sublimed preparation, unguentum etc..Most preferably granule.
The pharmaceutical composition of the present invention, the preparation of its oral administration can be containing conventional excipient, such as binding agent, filling
Agent, diluent, tablet agent, lubricant, disintegrating agent, coloring agent, flavoring agent and wetting agent, can be coated tablet if desired.
The filler being suitable for includes the filler that cellulose, mannitol, lactose are similar with other.Suitable disintegrating agent bag
Include starch, polyvinylpyrrolidone and starch derivatives, such as sodium starch glycollate.Suitable lubricant includes, the most firmly
Fatty acid magnesium.Suitable pharmaceutically acceptable wetting agent includes sodium lauryl sulphate.
Can be filled by mixing, the method that tabletting etc. is commonly used prepares solid oral composition.Repeatedly mix and can make to live
Property material is distributed in those compositionss of a large amount of filler of whole use.
The form of oral liquid can be such as aqueous or oily suspensions, solution, Emulsion, syrup or elixir,
Or can be the compounding dry products of a kind of available water before use or other suitable carrier.This liquid preparation can contain
Conventional additive, such as suspending agent, such as sorbitol, syrup, methylcellulose, gelatin, hydroxyethyl cellulose, carboxymethyl fibre
Dimension element, aluminium stearate gel or hydrogenated edible fats, emulsifying agent, such as lecithin, anhydro sorbitol monooleate or Arab
Glue；Non-aqueous carrier (they can include edible oil), the oily ester of the such as ester of almond oil, fractionated coconut oil, such as glycerol,
Propylene glycol or ethanol；Preservative, such as para hydroxybenzene methyl ester or propyl p-hydroxybenzoate or sorbic acid, and if it is required,
Can be containing conventional flavouring agent or coloring agent.
For injection, the fluid unit dosage form of preparation contains active substance and the sterile carrier of the present invention.According to carrier
And concentration, this compound can be suspended or dissolve.The preparation of solution is typically by active substance is dissolved in a kind of load
In body, filter-sterilized before being loaded into a kind of suitable bottle or ampoule, then seal.Such as a kind of local anesthesia of adjuvant
Agent, preservative and buffer agent can also be dissolved in this carrier.In order to improve its stability, can be by this after loading bottle
Plant compositions frost, and under vacuo water is removed.
The pharmaceutical composition of the present invention, optionally adds applicable pharmaceutically acceptable load when being prepared as medicament
Body, described pharmaceutically acceptable carrier is selected from: mannitol, sorbitol, sodium pyrosulfite, sodium sulfite, sodium thiosulfate, salt
Acid cysteine, TGA, methionine, injection Vitamin B_6 DTA disodium, Ethylenediaminetetraacetic Acid Calcium Salt, the alkali-metal carbonate of monovalence, acetic acid
Salt, phosphate or its aqueous solution, hydrochloric acid, acetic acid, sulphuric acid, phosphoric acid, aminoacid, sodium chloride, potassium chloride, sodium lactate, xylitol, wheat
Bud sugar, glucose, fructose, dextran, glycine, starch, sucrose, lactose, mannitol, silicon derivative, cellulose and
Derivant, alginate, gelatin, polyvinylpyrrolidone, glycerol, POLYSORBATE 80, agar, calcium carbonate, calcium bicarbonate, surface activity
Agent, Polyethylene Glycol, cyclodextrin, beta-schardinger dextrin-, phospholipid material, Kaolin, Pulvis Talci, calcium stearate, magnesium stearate etc..
The pharmaceutical composition of the present invention determines usage and dosage according to the situation of patient in use, can often taken three times per day, often
Secondary 1-20 agent, such as: 1-20 bag or grain or sheet.
The present invention also provides for the method for the pharmaceutical composition of the present invention, and preferred preparation method is as follows:
(1) Pollen Tyjphae, Radix Salviae Miltiorrhizae, Rhizoma Alismatis, Radix Notoginseng four taste are added 90% appropriate amount of ethanol backflow secondary, each 2 hours, merge alcohol
Extracting solution, is concentrated into the clear paste in 80 DEG C of relative densities 1.1～1.3, standby；
(2) Pericarpium Citri Reticulatae, Rhizoma Chuanxiong two taste are added 20 times amount water extraction volatile oil 8 hours, collect volatile oil, use beta-cyclodextrin inclusion compound
Standby；
(3) by (1), the medicinal residues of (2) and Rhizoma Pinelliae Preparatum, Radix Polygoni Multiflori Preparata, Thallus Laminariae (Thallus Eckloniae), Fructus Lycii, Semen Cassiae, Fructus Crataegi Six-element medical material
Boiling three times, each 2～3 hours, filters, and filtrate is concentrated in 80 DEG C of relative densities 1.20～1.25, with alcohol concentrated solution
Mixing, obtains clear paste.
(4) with this clear paste as pharmaceutically active substance, add when (2) standby Benexate Hydrochloride needs and add medicine
Acceptable carrier, makes pharmaceutical preparations composition according to the routine techniques of galenic pharmacy.
As, the preparation method being prepared as granule is as follows:
Separately taking dextrin, sweeting agent and clear paste uses spray drying marumerization to make granule, granulate, adds (2) institute standby
Benexate Hydrochloride, mixing, make granule, to obtain final product.
In inventive formulation, each medical material to cure mainly function as follows:
Pollen Tyjphae: there is " removing heat from blood, the merit of all pains of trusted subordinate of invigorating blood circulation, stop." modern pharmacology research show: Pollen Tyjphae extract can
Strengthen Bufo siccus isolated heart contractility, can make not cause fibrillation or cause the extrasomatic rabbit heart coronary flow of fibrillation through electricity irritation and substantially increase
Adding, Golden Hamster folder capsule microcirculation small artery blood flow rate can be made to accelerate, capillary open number increases, and follows mouse heart is micro-
Ring also has improvement result.Cardiac muscle and the brain toleration to anoxia can also be improved.Pollen Typhae also has significant effect for reducing blood fat, and can
Alleviate the formation of speckle on rabbit bait atherosclerosis, aorta wall.Clinical research shows: Pollen Tyjphae can not only reduce
Platelet adhesion rate and aggregation, simultaneously effect protected to vascular endothelial cell, and suppress the formation of atherosclerotic plaque
Radix Salviae Miltiorrhizae: Radix Salviae Miltiorrhizae has resisting blood coagulation and promotes fibrinolysis activity, also has inhibitory action to ex vivo thrombosis, it is possible to anti-
Only the formation of thrombus in vivo, is that thrombosis length substantially shortens.Modern pharmacology experiment show: Main Compositions of Radix Salviae Miltiorrhizae have TANSHINONES,
Salviol, danshensu etc..Danshensu energy substantially coronary artery dilator, makes coronary artery blood flow dramatically increase, and can promote side
Branch circulation.
Rhizoma Chuanxiong: Rhizoma Chuanxiong has a reduction surface activity of blood platelet, suppresses platelet aggregation, can the formation of pre-preventing thrombosis, have and change
Kind microcirculatory effect.
Pericarpium Citri Reticulatae: there is regulating qi-flowing for strengthening spleen, the merit of drying dampness to eliminate phlegm.Pericarpium Citri Reticulatae decoct also can coronary artery dilating.
Radix Notoginseng: there is promoting blood circulation to remove blood stasis effect, energy antiplatelet aggregation, antithrombus formation.Modern pharmacology, Radix Notoginseng total arasaponins
For the main active ingredient of Radix Notoginseng, there is the oxygen consumption reducing body, improve the body tolerance to anoxia.Suppression is drawn by ADP
The Platelet Aggregation in Rabbits risen.Expansion of cerebral vascular, makes cerebral blood flow increase.Antithrombotic and blood coagulation resisting function.
The Rhizoma Pinelliae: there is drying dampness to eliminate phlegm, the merit of dissolving lump and resolving mass.
Radix Polygoni Multiflori: " Kaibao Bencao " is recorded: " the most pained, benefit vim and vigour ... " modern pharmacology shows, Radix Polygoni Multiflori has reduction
The effect of total plasma cholesterol, triglyceride and beta Lipoprotein, and have in reduction aorta triglyceride in cholesterol level and liver
The effect of content
Rhizoma Alismatis: this product has the effect of removing damp and turbid blood fat reducing.Rabbit experimental hypercholesterolemicrabbits is had bright by Rhizoma Alismatis extract
Aobvious cholesterol reducing effect, its mechanism may disturb the absorption of exogenous cholesterol and endogenous cholesterol metabolism relevant with it.
Semen Cassiae: have suppressing the hyperactive liver pathogenic fire reducing, changes turbid blood fat reducing, effect of loosening bowel to relieve constipation.Animal can be made to shrink pressure and diastole is pressed with
Reduce.
Thallus Laminariae (Thallus Eckloniae): there is eliminating phlegm and softening indurated mass effect.
Fructus Crataegi: Fructus Crataegi have coronary artery dilator, resist myocardial ischemia, heart tonifying, anti-rhythm of the heart effect.Fructus Crataegi ethanol extract pair
Experimental Hyperlipemia has reduction effect.
Fructus Lycii: there is the merit of nourishing the liver, nourishing kidney, lung moistening.
After being assembled by above-mentioned 12 taste medical materials, there is phlegm reduction of blood circulation promoting, effect of the turbid descending pain relieving.It is applicable to phlegm stagnation in collateral
Caused obstruction of qi in the chest and cardialgia.The coronary heart disease heart that the cards such as disease sees stabbing pain over the chest, chest distress, shortness of breath and palpitation, and limbs are heavy, obesity are false
Angor patient.
The Chinese medicine composition of the present invention, its Recipe obtains through screening, has following process characteristic: this product is sharp
By inclusion essential oil technology, the volatile oil extracted in Pericarpium Citri Reticulatae, Rhizoma Chuanxiong is used beta-cyclodextrin inclusion compound, remaining medicine alcohol extraction, decocting.In system
Grain aspect, have employed spray drying one step and feeds intake technology, have industrialized production degree high, make granule have more stable
Disintegrative and dissolution, thus overcome the shortcomings such as the solvent residual of wet granulation technology, variable color, storage be unstable.
Chinese medicine composition of the present invention preparation treatment treating coronary heart disease and angina pectoris is applied；
Pharmacological toxicology and the clinical experimental study result of the Chinese medicine composition that the present invention prepares show:
One, pharmacological toxicology research
1, pharmacodynamic study: effect experiment research display: this product has: (1) coronary dilating, alleviate load before and after heart, strengthens
Blood supply of cardiac muscle, for oxygen and reduce oxygen consumption resist myocardial ischemia.And alleviate Lschemic Myocardium.(2) antiplatelet, anti-blood
Bolt generates and improves blood viscosity.(3) adjust dyslipidemia, and have tune fat spectrum more comprehensively.(4) intervene endogenous anti-oxidative enzyme and
Anti peroxidation of lipid, and effect of reflection protection blood vessel inner skin cell function.
2, studies on acute toxicity: according to the pertinent regulations of study of tcm new drug, carried out mice with the granule of the present invention anxious
Property Toxicity Test, because measuring LD50, therefore has carried out the mensuration of maximum dosage-feeding.Mouse stomach is administered, accumulated dose
For 350g crude drug/kg, being 323 times of clinical application, animal has no overt toxicity effect, and result shows once daily of the present invention
It is safe.
3, long term toxicity research: with Wistart kind rat, if matched group and granule 94g, 47g, 23.5g crude drug of the present invention/
Kg dosage group (respectively the 50 of quantity, 25,12.5 times), continuous gastric infusion 26 weeks, observe the granule of the present invention to dynamic
Thing brain, the heart, liver, spleen, lung, kidney, stomach, small intestinal, large intestine, hypophysis, thyroid, thymus, pancreas, adrenal gland, uterus, ovary, testis,
The impact of the every instruction of prostate.As a result, it was confirmed that each administration group 3 months upon administration, 6 months and drug withdrawal 2 weeks, have no bad
Reaction, every Index for examination is all within normal range.The each internal organs of pathologic finding are showed no the obvious toxic pathology that this guiding drug rises
Changing, animal does not finds untoward reaction and death.And from animal life, the detection of profile to hematology, blood biochemistry, electrocardiogram disease
Physical examination is showed no untoward reaction and dealed with medicine went, and it is safe that result is administered in showing clinical context
Two, clinical experimental study
II clinical trial phase: by the granule of the present invention and treating coronary heart disease granule randomized controlled treatment angina pectoris (expectorant stasis blocking
Network is demonstrate,proved) randomized, double-blind dual analog, (State Food and Drug Administration new drug is clinical for parallel control multicenter II clinical trial phase
Research official written reply number: 2004L01172), actual enter group 238 examples, granule 120 example of the present invention, treating coronary heart disease granule 116 example is opposed
According to.
Curative effect result:
Angina pectoris symptom curative effect: FAS crowd's result: the angina pectoris symptom for the treatment of coronary heart disease granule group and granule group of the present invention shows
Efficiency is respectively 33.03% and 39.82%, and effective percentage 38.53% and 38.94%, through considering that the CMH of center effect checks two groups of differences
Not statistically significant (P=0.184).Two groups of total effective rates are respectively 71.56% and 78.76%, 95% credibility interval of difference between group
For (-18.54,4.1384).
ECG change effective percentage: FAS result: the ECG curative effect for the treatment of coronary heart disease granule group and granule group of the present invention is effective
Rate is respectively 9.26% and 20.35%, and effective percentage is respectively 40.74% and 31.86%, through considering the CMH inspection two of center effect
Group no significant difference (P > 0.05).Two groups of total effective rates are respectively 50.00% and 52.21%, the 95% of difference can between group
Letter interval is (-15.39,10.97).
Secondary efficacy result
Nitroglycerin gradient curative effect: FAS crowd's result: after treating 4 weeks, matched group nitroglycerin stops lapse rate and is
29.09%, test group is 40.71%, and test group is higher than matched group, through considering the CMH inspection of center effect, two groups of nitroglycerin
Stopping comparing difference between lapse rate group statistically significant (P < 0.05), granule curative effect of the present invention is better than treating coronary heart disease granule.
Tcm syndrome curative effect: FAS result: after treating 4 weeks, matched group obvious effective rate is 28.44%, and test group is 37.17%,
Effective percentage matched group is 60.55%, and test group is 52.21%, through consider center effect CMH inspection, two groups compare difference without
Statistical significance (P > 0.05).
Blood lipid level curative effect: FAS result: two groups of patient treatments blood fat indices after 4 weeks, including T-CHOL, glycerol
Three fat, high density lipoprotein and low density lipoprotein, LDL and the equal not statistically significant of comparing difference (P > 0.05) in baseline group, two groups
Relative to comparing difference also not statistically significant (P > 0.05) between the group of baseline change after treatment.
Dyslipidemia person's blood lipid level curative effect: FAS result: Individual blood lipid Indexes Abnormality person is analyzed for baseline, controls
Matched group total cholesterol level and baseline comparing difference statistically significant (P=0.008), baseline low density lipoprotein, LDL after treating 4 weeks
In exception person, two groups of low-density lipoprotein white levels are compared compared with baseline and are declined statistically significant (P=0.002, P=0.031), two groups
Low density lipoprotein, LDL the most statistically significant compared with comparing difference in baseline group of decreased (P < 0.05).In Individual blood lipid exception person respectively
The equal not statistically significant of comparing difference (P > 0.05) between the group that each time point of index compares and each time point changes relative to baseline.
Exercise treadmill test curative effect: FAS result: exercise treadmill test negative conversion rate after the treatment for the treatment of coronary heart disease granule group
32.14%, granule group of the present invention 29.31% liang group no significant difference (P=0.6430).
Venous oxygen consumption index: FAS crowd's result: after treating 4 weeks, between two groups of venous oxygen consumption index groups, comparing difference is without system
Meaning (P > 0.05) learned by meter, and before and after comparing and treat between the group of difference front with treatment after treatment, in group, comparing difference is also anticipated without statistics
Justice (P > 0.05).
Levels of motion: FAS result: test group has statistics relative to comparing difference in the group of baseline change after treating 4 weeks
Meaning (P=0.016), comparing difference not statistically significant in the group that matched group changes relative to baseline.Between two groups treatment after each time
Point compares and relative to the equal not statistically significant of comparing difference (P > 0.05) between the group of baseline change.
Exercise equivalent: FAS result: after treating 4 weeks, comparing difference not statistically significant between two groups of exercise equivalent groups (P >
0.05), interior comparing difference also not statistically significant (P > 0.05) is organized with before and after comparing and treat between the group treating front difference after treatment.
Movement time: FAS result: after treating 4 weeks, compares in the group that two groups of movement times change with baseline, and difference all has
Statistical significance (P < 0.001), between two groups treatment after each time point compare and and baseline change group between comparing difference all without add up
Learn meaning (P > 0.05).
Angina pectoris symptom total score: treat 2 weeks, decline, relative to baseline before angina pectoris symptom scoring relatively treatment after 4 weeks for two groups
Comparing difference the most statistically significant (P < 0.05) in the group of change, but after two groups of treatments, each time point compares and versus baseline becomes
The equal not statistically significant of comparing difference (P > 0.05) between the group changed.
The each individual scores of angina pectoris symptom: FAS result: each individual scores of angina pectoris symptom, including pain degree, outbreak time
Number, persistent period, nitroglycerin consumption, nitroglycerin containing comparing difference between index the most each time point group such as dosing without statistics
Learn meaning.After treatment two groups relative to baseline change group between the equal not statistically significant of comparing difference (P > 0.05).
Tcm syndrome total score: FAS result: two groups treat 2 weeks, after 4 weeks, TCM syndrome evaluation relatively treats front decline, but each time point
Comparing difference not statistically significant between group；Two groups relative to baseline change group in comparing difference the most statistically significant (P <
0.05), but compare comparing difference not statistically significant (P > 0.05) between two groups between the group of versus baseline.
The each individual scores of tcm syndrome: FAS result: each individual scores of tcm syndrome, including chest pain, feel suffocated, breathe hard, the heart
Throb with fear, limbs are stranded comparing difference not statistically significant between index the most each time point groups such as weight, obesity.Two groups of traditional Chinese medical science individual events
Comparing difference not statistically significant (P > 0.05) between the group that each time point of symptom changes relative to baseline.
Safety evaluatio result:
There is adverse events 10 example, wherein matched group 6 example in this test, adverse events incidence rate is 5.08%, except 1 example altogether
Outside the Pass leukopenia and trial drug are judged as having, remaining is all judged as unrelated with trial drug；Test group occurs 4 altogether
Example adverse events, incidence rate is 3.3%, all unrelated with trial drug through judging.
Conclusion:
Grains of the present invention treatment angina pectoris (phlegm-stasis in channels) II clinical trial phase result is tentatively pointed out: this
Invention granule is alleviating angina pectoris symptom integration, is improving angina pectoris symptom, reduction pain of angina attacks degree, persistent period, outbreak
Number of times, reduces nitroglycerin consumption, improve chest pain, feel suffocated, breathe hard, cardio palmus shape aspect has effect in various degree, the most excellent
In treating coronary heart disease granule, and there is preferable safety.
Detailed description of the invention
Below in conjunction with specific embodiment, the invention will be further described.
Embodiment 1
Taking Pollen Tyjphae 10 parts, Radix Salviae Miltiorrhizae 10 parts, Rhizoma Alismatis 11 parts, Radix Notoginseng 10 parts, four Chinese medicine material adds 90% appropriate amount of ethanol backflow two
Secondary, each 2 hours, merge alcohol extract, be concentrated into the clear paste in 80 DEG C of relative densities 1.1～1.3, standby；Take Pericarpium Citri Reticulatae 11 parts,
11 part of two taste medical material of Rhizoma Chuanxiong, adds 20 times amount water extraction volatile oil 8 hours, collects volatile oil, standby with beta-cyclodextrin inclusion compound；By upper
The medicinal residues stated and Rhizoma Pinelliae Preparatum 11 parts, Radix Polygoni Multiflori Preparata 10 parts, Thallus Laminariae (Thallus Eckloniae) 10 parts, Fructus Lycii 11 parts, Semen Cassiae 10 parts, Fructus Crataegi 10 part six
Taste medical material boiling three times, each 2～3 hours, filters, and filtrate is concentrated in 80 DEG C of relative densities 1.20～1.25, with alcohol
Concentrated solution mixes, and obtains clear paste.Separately take dextrin, sweeting agent and above-mentioned standby clear paste use and are spray-dried marumerization and make
Grain, granulate, add standby Benexate Hydrochloride, mixing, make granule, to obtain final product.
Embodiment 2
Taking Pollen Tyjphae 20 parts, Radix Salviae Miltiorrhizae 20 parts, Rhizoma Alismatis 22 parts, Radix Notoginseng 20 parts, four Chinese medicine material adds 90% appropriate amount of ethanol backflow two
Secondary, each 2 hours, merge alcohol extract, be concentrated into the clear paste in 80 DEG C of relative densities 1.1～1.3, standby；Take Pericarpium Citri Reticulatae 22 parts,
22 part of two taste medical material of Rhizoma Chuanxiong, adds 20 times amount water extraction volatile oil 8 hours, collects volatile oil, standby with beta-cyclodextrin inclusion compound；By upper
The medicinal residues stated and Rhizoma Pinelliae Preparatum 22 parts, Radix Polygoni Multiflori Preparata 20 parts, Thallus Laminariae (Thallus Eckloniae) 20 parts, Fructus Lycii 22 parts, Semen Cassiae 20 parts, Fructus Crataegi 20 part six
Taste medical material boiling three times, each 2～3 hours, filters, and filtrate is concentrated in 80 DEG C of relative densities 1.20～1.25, with alcohol
Concentrated solution mixes, and obtains clear paste.Separately take dextrin, sweeting agent and above-mentioned standby clear paste use and are spray-dried marumerization and make
Grain, granulate, add standby Benexate Hydrochloride, mixing, make granule, to obtain final product.
Embodiment 3
Taking Pollen Tyjphae 40 parts, Radix Salviae Miltiorrhizae 40 parts, Rhizoma Alismatis 45 parts, Radix Notoginseng 40 parts, four Chinese medicine material adds 90% appropriate amount of ethanol backflow two
Secondary, each 2 hours, merge alcohol extract, be concentrated into the clear paste in 80 DEG C of relative densities 1.1～1.3, standby；Take Pericarpium Citri Reticulatae 45 parts,
45 part of two taste medical material of Rhizoma Chuanxiong, adds 20 times amount water extraction volatile oil 8 hours, collects volatile oil, standby with beta-cyclodextrin inclusion compound；By upper
The medicinal residues stated and Rhizoma Pinelliae Preparatum 45 parts, Radix Polygoni Multiflori Preparata 40 parts, Thallus Laminariae (Thallus Eckloniae) 40 parts, Fructus Lycii 45 parts, Semen Cassiae 40 parts, Fructus Crataegi 40 part six
Taste medical material boiling three times, each 2～3 hours, filters, and filtrate is concentrated in 80 DEG C of relative densities 1.20～1.25, with alcohol
Concentrated solution mixes, and obtains clear paste.Separately take dextrin, sweeting agent and above-mentioned standby clear paste use and are spray-dried marumerization and make
Grain, granulate, add standby Benexate Hydrochloride, mixing, make granule, to obtain final product.
Embodiment 4
Taking Pollen Tyjphae 80 parts, Radix Salviae Miltiorrhizae 80 parts, Rhizoma Alismatis 90 parts, Radix Notoginseng 90 parts, four Chinese medicine material adds 90% appropriate amount of ethanol backflow two
Secondary, each 2 hours, merge alcohol extract, be concentrated into the clear paste in 80 DEG C of relative densities 1.1～1.3, standby；Take Pericarpium Citri Reticulatae 90
Part, 90 part of two taste medical material of Rhizoma Chuanxiong, add 20 times amount water extraction volatile oil 8 hours, collects volatile oil, standby with beta-cyclodextrin inclusion compound；
By above-mentioned medicinal residues and Rhizoma Pinelliae Preparatum 90 parts, Radix Polygoni Multiflori Preparata 80 parts, Thallus Laminariae (Thallus Eckloniae) 80 parts, Fructus Lycii 90 parts, Semen Cassiae 90 parts, Fructus Crataegi 90
Part Six-element medical material boiling three times, each 2～3 hours, filters, and filtrate is concentrated in 80 DEG C of relative densities 1.20～1.25,
Mix with alcohol concentrated solution, obtain clear paste.Separately taking dextrin, sweeting agent and above-mentioned standby clear paste uses spray drying marumerization to make
Granule, granulate, add standby Benexate Hydrochloride, mixing, make granule, to obtain final product.
Embodiment 5
Taking Pollen Tyjphae 200 parts, Radix Salviae Miltiorrhizae 200 parts, Rhizoma Alismatis 200 parts, Radix Notoginseng 200 parts, four Chinese medicine material adds 90% appropriate amount of ethanol backflow
Secondary, each 2 hours, merges alcohol extract, is concentrated into the clear paste in 80 DEG C of relative densities 1.1～1.3, standby；Take Pericarpium Citri Reticulatae 200
Part, 200 part of two taste medical material of Rhizoma Chuanxiong, add 20 times amount water extraction volatile oil 8 hours, collects volatile oil, standby with beta-cyclodextrin inclusion compound；
By above-mentioned medicinal residues and Rhizoma Pinelliae Preparatum 200 parts, Radix Polygoni Multiflori Preparata 200 parts, Thallus Laminariae (Thallus Eckloniae) 200 parts, Fructus Lycii 200 parts, Semen Cassiae 200 parts, life
200 parts of Six-element medical material boilings of Fructus Crataegi three times, each 2～3 hours, filter, and filtrate is concentrated into 80 DEG C of relative densities 1.20
～1.25, mix with alcohol concentrated solution, obtain clear paste.Separately take dextrin, sweeting agent and above-mentioned standby clear paste and use the step system of spray drying
Grain method makes granule, granulate, adds standby Benexate Hydrochloride, and granule is made in mixing, loads capsule.
Embodiment 6
Taking Pollen Tyjphae 160 parts, Radix Salviae Miltiorrhizae 160 parts, Rhizoma Alismatis 180 parts, Radix Notoginseng 180 parts, four Chinese medicine material adds 90% appropriate amount of ethanol backflow
Secondary, each 2 hours, merges alcohol extract, is concentrated into the clear paste in 80 DEG C of relative densities 1.1～1.3, standby；Take Pericarpium Citri Reticulatae 180
Part, 180 part of two taste medical material of Rhizoma Chuanxiong, add 20 times amount water extraction volatile oil 8 hours, collects volatile oil, standby with beta-cyclodextrin inclusion compound；
By above-mentioned medicinal residues and Rhizoma Pinelliae Preparatum 180 parts, Radix Polygoni Multiflori Preparata 160 parts, Thallus Laminariae (Thallus Eckloniae) 160 parts, Fructus Lycii 180 parts, Semen Cassiae 180 parts, life
180 parts of Six-element medical material boilings of Fructus Crataegi three times, each 2～3 hours, filter, and filtrate is concentrated into 80 DEG C of relative densities 1.20
～1.25, mix with alcohol concentrated solution, obtain clear paste.Separately take dextrin, sweeting agent and above-mentioned standby clear paste and use the step system of spray drying
Grain method makes granule, granulate, adds standby Benexate Hydrochloride, mixes, makes granule, tabletting and get final product.
Embodiment 7
Taking Pollen Tyjphae 80 parts, Radix Salviae Miltiorrhizae 80 parts, Rhizoma Alismatis 90 parts, Radix Notoginseng 90 parts, four Chinese medicine material adds 90% appropriate amount of ethanol backflow two
Secondary, each 2 hours, merge alcohol extract, be concentrated into the clear paste in 80 DEG C of relative densities 1.1～1.3, standby；Take Pericarpium Citri Reticulatae 90 parts,
90 part of two taste medical material of Rhizoma Chuanxiong, adds 20 times amount water extraction volatile oil 8 hours, collects volatile oil, standby with beta-cyclodextrin inclusion compound；By upper
The medicinal residues stated and Rhizoma Pinelliae Preparatum 90 parts, Radix Polygoni Multiflori Preparata 80 parts, Thallus Laminariae (Thallus Eckloniae) 80 parts, Fructus Lycii 90 parts, Semen Cassiae 90 parts, Fructus Crataegi 90 part six
Taste medical material boiling three times, each 2～3 hours, filters, and filtrate is concentrated in 80 DEG C of relative densities 1.20～1.25, with alcohol
Concentrated solution mixes, and obtains clear paste.Add sucrose and water mix homogeneously, be prepared as oral liquid.
Claims (1)
1. treating a preparation method for treating coronary heart disease and angina pectoris compositions, described compositions is former by following weight proportion
Material medicine is made:
Pollen Tyjphae 80 parts, Rhizoma Pinelliae Preparatum 90 parts, Radix Salviae Miltiorrhizae 80 parts, Pericarpium Citri Reticulatae 90 parts, Radix Notoginseng 80 parts, Radix Polygoni Multiflori Preparata 80 parts, Thallus Laminariae (Thallus Eckloniae) 80 parts, river
Rhizome of chuanxiong 90 parts, Rhizoma Alismatis 90 parts, Fructus Lycii 90 parts, Semen Cassiae 100 parts, Fructus Crataegi 80 parts
Its preparation method is as follows:
(1) Pollen Tyjphae, Radix Salviae Miltiorrhizae, Rhizoma Alismatis, Radix Notoginseng four Chinese medicine material are added 90% appropriate amount of ethanol backflow secondary, each 2 hours, merge alcohol
Extracting solution, is concentrated into the clear paste 80 DEG C of relative densities 1.2, standby；
(2) Pericarpium Citri Reticulatae, Rhizoma Chuanxiong two taste are added 20 times amount water extraction volatile oil 8 hours, collect volatile oil, standby with beta-cyclodextrin inclusion compound
With；
(3) (1), the medicinal residues of (2) and Rhizoma Pinelliae Preparatum, Radix Polygoni Multiflori Preparata, Thallus Laminariae (Thallus Eckloniae), Fructus Lycii, Semen Cassiae, Fructus Crataegi Six-element medical material are added water
Decocting three times, each 2 hours, filter, filtrate is concentrated into 80 DEG C of relative densities 1.25, mixes with alcohol concentrated solution, obtains clear paste；
(4) separately taking dextrin, sweeting agent and clear paste uses spray drying marumerization to make granule, granulate, adds (2) institute standby
Benexate Hydrochloride, mixing, make granule, to obtain final product.
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