CN101053626B - Traditional Chinese medicine for treating coronary heart disease and angina pectoris and its preparation method - Google Patents
Traditional Chinese medicine for treating coronary heart disease and angina pectoris and its preparation method Download PDFInfo
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Abstract
Disclosed is a Chinese medicinal composition for treating angina pectoris comprising the raw materials in weight ratio: notoginseng 60-130 portions, asiabell 150-450 portions, earthworm 100-350 portions, corydalis tuber (prepared by vinegar) 80-250 portions, peppergrass (fried) 80-330 portions, long stamen onion (fried) 110-300 portions, cassia bark 10-60 portions, menthol 0.2-0.8 portion and borneol 1-3 portions. The medicinal composition can be prepared by routine preparation process into an oral formulation, preferably an oral liquid. The pharmacy and clinical observation prove that the Chinese medicinal composition has confirmed efficacy in treating angina pectoris, the application is safe and no side or toxic effect will be occurred.
Description
Technical field
The present invention relates to a kind of pharmaceutical composition, relating in particular to a kind of is the Chinese medicine composition and preparation method thereof of the treatment angina pectoris that forms of feedstock production with the Chinese herbal medicine, belongs to the field of Chinese medicines.
Background technology
The thoracic obstruction (angina pectoris) is to cause that owing to needs that coronary vasodilator oxygen supply and nutrient substance function, the function of eliminating metabolite can not satisfy cardiomotility clinical manifestation is pained (angina pectoris), arrhythmia, myocardial infarction.This disease is the able-bodied commonly encountered diseases frequently-occurring disease of a kind of harm humans, is one of disease of present person in middle and old age's medical science primary study.Can the thoracic obstruction (angina pectoris) be one of important kind of coronary heart disease, in time control angina pectoris, be directly connected to and avoid myocardial infarction, and the anginal medicine of research treatment is the task of top priority so.
Modern medicine is used nitrate esters medicine treatments such as sorbitrate, though take effect rapidly, the persistent period is short, and part patient has side effect, often causes side effect such as headache, dizziness, palpitating speed, and prolonged application can produce drug resistance.Take a lot of work during traditional Chinese medicine decoction treatment cost, and the quality instability, the inconvenience of taking medicine.
Summary of the invention
Technical problem to be solved by this invention is to overcome the deficiencies in the prior art, the Chinese medicine composition of the treatment angina pectoris that provide a kind of new determined curative effect, has no side effect.
Technical problem to be solved by this invention realizes by following technological approaches:
A kind of Chinese medicine composition for the treatment of angina pectoris, make by following bulk drugs:
60～130 parts of Radix Notoginseng, 150～450 parts of Radix Codonopsis, 100～350 parts of Pheretimas, 80～250 parts of Rhizoma Corydalis (processed with vinegar), 80～330 parts of Semen Lepidii (Semen Descurainiae)s (stir-fry), 110～300 parts of Bulbus Allii Macrostemonis, 10～60 parts of Cortex Cinnamomis, 0.2～0.8 part of Mentholum, 1～3 part of Borneolum Syntheticum.
Preferably, the weight portion of each crude drug is: 99 parts of Radix Notoginseng, 333 parts of Radix Codonopsis, 222 parts of Pheretimas, 166 parts of Rhizoma Corydalis (processed with vinegar), 222 parts of Semen Lepidii (Semen Descurainiae)s (stir-fry), 222 parts of Bulbus Allii Macrostemonis, 33 parts of Cortex Cinnamomis, 0.5 part of Mentholum, 2 parts of Borneolum Syntheticums.
The inventor passes through clinical research for many years, in conjunction with modern achievement in research, sums up the argumentation of the traditional Chinese medical science to the angina pectoris cause of disease, pathogenesis and syndrome characteristics, with blood circulation promoting and blood stasis dispelling, benefiting QI for activating blood circulation, and the chest stuffiness relieving that eliminates the phlegm, the repercussive pain relieving is the rule of treatment, intends Fang Erding.
Compatibility of drugs foundation of the present invention:
We are monarch with the Radix Codonopsis Qi-benefiting and heart-nourishing, and handsome operation helps blood circulation promoting medicine with repercussive; The pseudo-ginseng blood-circulation-invigovating blood stasis dispelling, Rhizoma Corydalis regulating QI to relieve pain, two medicines are the effect that minister is played pain relieving altogether; The Bulbus Allii Macrostemonis activating stagnated YANG, removing dampness is turbid, dissipating blood stasis knot, the capable water of the Semen Lepidii (Semen Descurainiae) the chest stuffiness relieving that eliminates the phlegm, Pheretima collateral dredging spasmolytic, clearing lung, relieving asthma is assistant; The hot sweet big pathogenic heat attacking blood system in febrile diseases of Cortex Cinnamomi, the Wen Tongxin arteries and veins, the turbid cold expelling of dispelling, unimpeded blood fortune, to reach the stagnation resolvation beniol, Borneolum Syntheticum is open to the custom and is had one's ideas straightened out, Mentholum the lucid yang sending up resolving depression, three medicines complement each other for making and usefulness, and turbid damp is warded off in the refreshment of having one's ideas straightened out, regulate the flow of vital energy resolving depression and sorbitrate.Above-mentioned all medicine is formed we, thus the tool benefiting QI for activating blood circulation, a surname's numbness of activating yang, the chest stuffiness relieving that eliminates the phlegm, the effect of repercussive analgesic is applicable to blood stasis due to qi deficiency, the chest pain due to the hypofunction of YANG QI in chest, stagnation of phlegm-damp, the treatment of cardiopalmus, uncomfortable in chest, disease such as breathe hard.
The modern pharmacology evidence: Radix Codonopsis has oxygen lack resistant function, and the mice survival rate under the anaerobic condition is doubled; Radix Notoginseng increases coronary flow, improves myocardial ischemia, shock, dirty arrhythmia, analgesia etc.; Rhizoma Corydalis has analgesic activity, and the treatment ischemic heart desease is respond well; The Semen Lepidii (Semen Descurainiae) ethanol extraction has cardiotonic; Pheretima has protective effect to ischemic cerebral apoplexy, and can improve the metabolism disorder of DA and 5HT in the ischemic rat brain, and has antiarrhythmic effect; Bulbus Allii Macrostemonis has preventive effect to experimental atherosclerosis, and has coronary dilating to control the angina pectoris effect.
The used crude drug of the present invention all can be bought from common pharmacy and obtain, and its specification meets national medical standard.
Medicine activity component of the present invention can add various adjuvants required when preparing different dosage form, for example disintegrating agent, lubricant, adhesive etc., method of Chinese medicinal with routine is prepared into any oral formulations commonly used, can be pill, capsule, tablet, powder, granule or oral liquid etc. for example, be preferably oral liquid.
Preferably, a kind of method for preparing Chinese medicine composition of the present invention may further comprise the steps:
(1) take by weighing each raw material by following weight portion:
60～130 parts of Radix Notoginseng, 150～450 parts of Radix Codonopsis, 100～350 parts of Pheretimas, 80～250 parts of Rhizoma Corydalis (processed with vinegar), 80～330 parts of Semen Lepidii (Semen Descurainiae)s (stir-fry), 110～300 parts of Bulbus Allii Macrostemonis, 10～60 parts of Cortex Cinnamomis, 0.2～0.8 part of Mentholum, 1～3 part of Borneolum Syntheticum;
(2) the cinnamomic distillate of preparation or further with prepared distillate extraction volatile oil, the Cortex Cinnamomi medicinal residues are standby;
(3) Radix Notoginseng, Rhizoma Corydalis extract with 50～90% alcohol heating reflux, and extracting solution reclaims ethanol to there not being the alcohol flavor, adds distilled water, and adjust pH is 4.0～5.0, stirs evenly, and cold preservation filters, and the filtrate airtight preservation of device in addition precipitates standby;
(4) the Cortex Cinnamomi medicinal residues in the above-mentioned steps, Radix Notoginseng medicinal residues and Rhizoma Corydalis medicinal residues are mixed with Radix Codonopsis, Pheretima, Bulbus Allii Macrostemonis, Semen Lepidii (Semen Descurainiae), decoct with water, extracting solution concentrates, add 90% above ethanol and make and contain alcohol and measure and reach 60～80%, stir evenly, leave standstill, filter, filtrate device is in addition preserved, and precipitates standby;
(5) with resulting precipitation merging in step (3) and (4), washing, washing liquid is filtered, gained filtrate merging in filtrate and the step (4), recovery ethanol is not distinguished the flavor of to there being alcohol, filtration or centrifugal, filtrate or supernatant are standby;
(6) resulting extracting solution in the resulting filtrate of step (5) or supernatant and the step (3) is merged, proportion is 1.10～1.15 clear paste when being concentrated into room temperature measuring, with the clear paste drying, add Mentholum, Borneolum Syntheticum, and spray into Cortex Cinnamomi volatile oil, add auxiliary materials and mixing and make the preparation intermediate, make finished product through preparations shaping technology again; Or, add tween 80, antiseptic and distilled water more successively with the resulting filtrate of step (5) or supernatant and Mentholum, Borneolum Syntheticum and Cortex Cinnamomi distillation liquid-phase mixing, and adjust pH is 4.5～5.5, leaves standstill, filtration, fill, sterilization get product.
In the above-mentioned preparation method, preferably Radix Notoginseng, Rhizoma Corydalis are extracted 1～3 time with 50～90% alcohol heating reflux of 4～8 times of weight in the step (3), extracted 1～3 hour at every turn; Extracting solution is reclaimed ethanol after having the alcohol flavor, be not concentrated into the concentrated solution that proportion is 1.05～1.10 (room temperature surveys), add distilled water and sodium benzoate again.
The number of times that decocts with water described in the step (4) is preferably 1～3 time, and more preferably 2 times, when wherein decocting for the 1st time, add 6～10 times of weight water, decocted 1～3 hour; Add 4～8 times of weight water the 2nd time, decocted 0.5～2 hour, merge extracted twice liquid, being concentrated into proportion is 1.25～1.32 (room temperature surveys).
Washing described in the step (5) is preferably with 60～80% ethanol liquid washing that contains 0.1～0.5% hydrochloric acid 2 times.
Show that through pharmacodynamic study Chinese medicine composition energy coronary artery dilator of the present invention increases coronary blood flow, reduces oxygen consumption, improves myocardial ischemia, reduces myocardial ischemia and infarction size, therefore, angina pectoris is had good curative effect.
The function of Chinese medicine composition of the present invention with cure mainly: benefiting QI for activating blood circulation, the collateral dredging that eliminates the phlegm, the chest stuffiness relieving pain relieving is applicable to the blood stasis due to qi deficiency phlegm retention thoracic obstruction, disease sees chest pain, uncomfortable in chest, cardiopalmus, breathes hard, weak, tongue has secretly that ecchymosis, tongue are greasy in vain, stringy and thready pulse or moisten, and angina pectoris is seen above-mentioned patient.
Usage and consumption: the dosage of medicine of the present invention depends on concrete dosage form, and factor such as age of patient, body weight, health status.As guidance: oral liquid, a 20ml (being equivalent to primary crude drug 26g), 3 times on the one, 3 weeks were a course of treatment.
The specific embodiment
Further describe the present invention by the following examples, it should be understood that these embodiment only are used for the purpose of illustration, never limit protection scope of the present invention.
The preparation of embodiment 1 oral liquid
1), takes by weighing each raw material: Radix Notoginseng 99g, Radix Codonopsis 333g, Pheretima 222g, Rhizoma Corydalis (processed with vinegar) 166g, Semen Lepidii (Semen Descurainiae) (stir-fry) 222g, Bulbus Allii Macrostemonis 222g, Cortex Cinnamomi 33g, Mentholum 0.5g, Borneolum Syntheticum 2g by following weight;
2), Cortex Cinnamomi adds 5 times of weight water infiltrations, by steam distillation, collects distillate to 3 times of weight that are equivalent to crude drug, the airtight preservation of device in addition;
3), Radix Notoginseng, fumitory coarse powder are extracted 1 hour/time 3 times with 50～90% alcohol heating reflux of 4 times of weight.Extracting solution reclaims ethanol to there not being the alcohol flavor, and proportion is 1.05 (room temperature surveys), adds the distilled water and the sodium benzoate 0.3g that account for extracting solution gross weight 1/3～2/3, and adjust pH is 4.0-5.0, stirs evenly, and cold preservation 24 hours filters, and the filtrate airtight preservation of device in addition precipitates standby;
4), above-mentioned Cortex Cinnamomi, Radix Notoginseng, Rhizoma Corydalis medicinal residues are mixed with Radix Codonopsis, Pheretima, Bulbus Allii Macrostemonis, Semen Lepidii (Semen Descurainiae), decoct with water 2 times, add 6 times of weight water for the first time, decocted 1 hour; For the second time add 4 times of weight water, decocted 0.5 hour, merge extracted twice liquid, and to be concentrated into proportion be 1.25 (room temperature survey), add 90% above ethanol and make and contain the alcohol amount and reach 60～80%, stir evenly, left standstill 24 hours, filtration, other device preservation of filtrate precipitates standby.
5), with step 3) and 4) in resulting precipitation merge, with the 70% ethanol liquid thorough washing twice that contains 0.1% hydrochloric acid, washing liquid is filtered standby;
6), with step 4) and 5) in resulting filtrate merge, reclaim ethanol to there not being the alcohol flavor, filter, resulting extracting solution merges in filtrate and the step 3), filtration, filtrate for later use.
7), 100g sucrose added the 150ml distilled water boil, filtered while hot, making sugar content is 75% syrup 130ml, solution 1; Borneolum Syntheticum, Mentholum are ground dissolving with 60% ethanol and the 5ml tween 80 of 10ml, get solution 2; The Cortex Cinnamomi distillate is mixed with solution 1,2 and the resulting filtrate of step 6), add tween 80 3ml, stirring and evenly mixing adds sodium benzoate 0.5g again, and stirring and dissolving adds water recently distilled to 1000ml, and adjust pH is 4.5-5.5, leaves standstill, and filters.
8), above-mentioned medicinal liquid is poured in the 10ml bottle, gland, sterilization are promptly.
The preparation of embodiment 2 tablets
1) takes by weighing each raw material by following weight: Radix Notoginseng 60g, Radix Codonopsis 150g, Pheretima 100g, Rhizoma Corydalis (processed with vinegar) 80g, Semen Lepidii (Semen Descurainiae) (stir-fry) 80g, Bulbus Allii Macrostemonis 110g, Cortex Cinnamomi 10g, Mentholum 0.2g, Borneolum Syntheticum 1g;
2), Cortex Cinnamomi is added 8 times of weight water, collect distillate to clear with steam distillation, distillate secondary redistillation to distillate is become clear, leave standstill, divide and take off portion's oil reservoir, collect volatile oil, medicinal residues are standby;
3), Radix Notoginseng, fumitory coarse powder are extracted 3 hours/time 3 times with 50～90% alcohol heating reflux of 4 times of weight.Extracting solution reclaims ethanol to there not being the alcohol flavor, and proportion is 1.10 (room temperature surveys), adds the distilled water and the sodium benzoate 0.3g that account for extracting solution gross weight 1/3, and adjust pH is 4.0-5.0, stirs evenly, and cold preservation 24 hours filters, and the filtrate airtight preservation of device in addition precipitates standby;
4), above-mentioned Cortex Cinnamomi, Radix Notoginseng, Rhizoma Corydalis medicinal residues are mixed with Radix Codonopsis, Pheretima, Bulbus Allii Macrostemonis, Semen Lepidii (Semen Descurainiae), decoct with water 2 times, add 6 times of weight water for the first time, decocted 1 hour; For the second time add 4 times of weight water, decocted 0.5 hour, merge extracted twice liquid, and be concentrated into proportion 1.32 (room temperature surveys), add 90% above ethanol and make and contain the alcohol amount and reach 60～80%, stir evenly, left standstill 24 hours, filtration, other device preservation of filtrate precipitates standby.
5), with step 3) and 4) in resulting precipitation merge, with the 80% ethanol liquid thorough washing twice that contains 0.5% hydrochloric acid, washing liquid is filtered standby;
6) with step 4) and 5) in resulting filtrate merge, reclaim ethanol to there not being the alcohol flavor, filter, resulting extracting solution merging is concentrated into the clear paste that proportion is 1.15 (room temperatures) in filtrate and the step 3), and is standby;
7), with above-mentioned clear paste drying, add the starch that accounts for the dry clear paste gross weight 30% of gained, granulate, with Mentholum, Borneolum Syntheticum powder mixing, spray into Cortex Cinnamomi volatile oil, airtight, add the magnesium stearate that accounts for the carboxymethyl starch sodium of total particle gross weight 0.5% and account for total particle gross weight 0.5%, mixing, tabletting, promptly.
The preparation of embodiment 3 capsules
1) takes by weighing each raw material by following weight: Radix Notoginseng 130g, Radix Codonopsis 450g, Pheretima 350g, Rhizoma Corydalis (processed with vinegar) 250g, Semen Descurainiae (parched) 330g, Bulbus Allii Macrostemonis 300g, Cortex Cinnamomi 60g, Mentholum 0.8g, Borneolum Syntheticum 3g;
2), Cortex Cinnamomi is added 12 times of weight water, collect distillate to clear with steam distillation, distillate secondary redistillation to distillate is become clear, leave standstill, divide and take off portion's oil reservoir, collect volatile oil, medicinal residues are standby;
3), Radix Notoginseng, fumitory coarse powder are extracted 3 hours/time 3 times with 50～90% alcohol heating reflux of 8 times of weight; Extracting solution reclaims ethanol to there not being the alcohol flavor, and proportion is 1.05 (room temperature surveys), adds the distilled water and the sodium benzoate 0.3g that account for 2/3 times of extracting solution gross weight, and adjust pH is 4.0-5.0, stirs evenly, and cold preservation 24 hours filters, and the filtrate airtight preservation of device in addition precipitates standby;
4), above-mentioned Cortex Cinnamomi, Radix Notoginseng, Rhizoma Corydalis medicinal residues are mixed with Radix Codonopsis, Pheretima, Bulbus Allii Macrostemonis, Semen Lepidii (Semen Descurainiae), decoct with water 3 times, add 10 times of weight water for the first time, decocted 3 hours; Add for the second time 8 times of weight water, decocted 2 hours, and added 6 times of weight water for the third time, decocted 1 hour, merge three times extracting solution, and to be concentrated into proportion be 1.32 (room temperature surveys), adds 90% above ethanol and make and contain alcohol and measure and reach 60～80%, stirs evenly, left standstill 24 hours, filter, filtrate device is in addition preserved, and precipitates standby;
5), with step 3) and 4) in resulting precipitation merge, with the 60% ethanol liquid thorough washing twice that contains 0.1% hydrochloric acid, washing liquid is filtered standby;
6) with step 4) and 5) in resulting filtrate merge, reclaim ethanol to there not being the alcohol flavor, filter, resulting extracting solution merging is concentrated into the clear paste that proportion is 1.15 (room temperatures) in filtrate and the step 3), and is standby; With above-mentioned clear paste drying, add the starch that accounts for the dry clear paste gross weight 20% of gained and granulate, with Mentholum, Borneolum Syntheticum powder mixing, spray into Cortex Cinnamomi volatile oil, airtight, add the magnesium stearate that accounts for total particle gross weight 0.6%, mixing, the fill capsule is promptly.
The preparation of embodiment 4 granules
1) takes by weighing each raw material by following weight: Radix Notoginseng 99g, Radix Codonopsis 333g, Pheretima 222g, Rhizoma Corydalis (processed with vinegar) 166g, Semen Lepidii (Semen Descurainiae) (stir-fry) 222g, Bulbus Allii Macrostemonis 222g, Cortex Cinnamomi 33g, Mentholum 0.5g, Borneolum Syntheticum 2g;
2), Cortex Cinnamomi is added 10 times of weight water, collect distillate to clear, distillate secondary redistillation to distillate is become clear, leave standstill, divide and take off portion's oil reservoir, collect volatile oil with steam distillation.Medicinal residues are standby.
3), Radix Notoginseng, fumitory coarse powder 50～90% alcohol heating reflux with 6 times of weight were extracted 3 hours, medicinal residues are standby; Extracting solution reclaims ethanol to there not being the alcohol flavor, and being concentrated into proportion is the extractum of 1.30 (room temperature surveys);
4), above-mentioned Cortex Cinnamomi, Radix Notoginseng, Rhizoma Corydalis medicinal residues are mixed with Radix Codonopsis, Pheretima, Bulbus Allii Macrostemonis, Semen Lepidii (Semen Descurainiae), adding 10 times of weight decoctings boiled 3 hours, decocting liquid is concentrated into proportion 1.32 (room temperature survey), adding 90% above ethanol makes and contains alcohol and measure and reach 60～80%, stir evenly, left standstill 24 hours, filter, filtrate recycling ethanol is not to there being the alcohol flavor, and being concentrated into proportion is 1.30 (room temperature survey) extractum;
5), with step 3) and 4) in resulting extractum merge, add the dextrin that accounts for extractum gross weight 70%, granulate, with Mentholum, Borneolum Syntheticum mixing, spray into Cortex Cinnamomi volatile oil, airtight, granule.
The clinical observation on the therapeutic effect of [test example 1] Drug therapy angina pectoris of the present invention
One, physical data
Accept 474 routine angina pectoris patients altogether for medical treatment, clinical employing parallel control randomization method is carried out, and wherein 360 examples are organized in treatment, matched group 114 examples, and two groups of patients' physical resource is as follows:
1, sex sees Table 1.
Table 1 liang group patient's sex distributes relatively
X
2=0.09, P＞0.05, table 1 shows that two groups of patients' sex distribution no significant difference (P＞0.05) has comparability.
2, the age sees Table 2.
Table 2 liang group patient age distribution (year)
Two groups of patient age distribute relatively: X
2=0.21, P＞0.05, two group patient's mean age compares: t=0.52, P＞0.05.Table 2 shows that two groups of patients' age distribution and average age ratio more all do not have significant difference (P＞0.05), and two groups have comparability.
3, the course of disease sees Table 3.
Table 3 liang group patient's the course of disease distributes
The course of disease distributes two groups of patients relatively, X
2=0.69, P＞0.05, average course of disease two groups of patients compare, t=0.114, P＞0.05.Table 3 shows that two groups the course of disease distributes and average course of disease compares, and does not all have significant difference (P＞0.05), and two groups have comparability.
4, the angina pectoris typing sees Table 4.
Table 4 liang group patient's angina pectoris typing
Treatment group and matched group compare, X
2=0.24, P＞0.05.Table 4 shows that two groups of patients' angina pectoris typing does not have significant difference (P＞0.05), and two groups have comparability.
5, the angina pectoris grading sees Table 5.
Table 5 liang group patient angina pectoris grading
Two groups of patient's angina pectoris gradings compare: X
2=0.34, P＞0.05.Table 5 shows that two groups of patient's angina pectoris gradings relatively do not have significant difference (P＞0.05), and two groups have comparability.
6, the Chinese medical discrimination typing sees Table 6.
Table 6 liang group patient Chinese medical discrimination typing situation
Treatment group and matched group compare: X
2=0.41, P＞0.05.Table 6 shows relatively do not have significant difference (P＞0.05) between two groups of patients' the Chinese medical discrimination typing, and two groups have comparability.
7, the tcm syndrome performance sees Table 7.
Table 7 liang group patient's tcm syndrome, picture of the tongue and pulse condition
Learn by statistics and handle, above-mentioned respectively the group between the tcm syndrome performance all do not have significant difference (P＞0.05), and comparability is arranged.
8, complication sees Table 8.
Table 8 liang group patient's complication
Two groups of patients' complication compares: X
2=0.97, P＞0.05.Table 8 shows that two groups of patients' complication is there was no significant difference (P＞0.05) relatively, and two groups have comparability.
Two, case choice criteria
(1) the dialectical standard of the thoracic obstruction (angina pectoris): with reference to the standard of national coronary heart disease determination of treatment based on pathogenesis obtained through differentiation of symptoms and signs forum formulation in 1980 and " the angina pectoris Chinese medical discrimination tentative standard " of Zhengzhou meeting revision in 1985, in conjunction with Yuan Zizhen professor clinical practice experience, demonstrate,prove as dialectical foundation with common arteries and veins.The primary disease pathological essence is " deficiency in origin and excess in superficiality ", and clinical " deficiency in origin " based on the deficiency of vital energy, mark is real in blood stasis, and the phlegm-damp and the expectorant stasis of blood are seen more.It is as follows to draft the deficiency of vital energy (insufficiency of heart-QI) primary symptom and the dialectical standard of double disease thereof:
Main symptom:
Syndrome of deficiency of heart qi: chest pain (angina pectoris), cardiopalmus, breathe hard, weak, spontaneous perspiration, light red tongue, tongue are white, weak pulse or knot generation.
Accompanied symptoms:
The blood stasis of holding concurrently: localized pain or twinge, dark tongue quality or have ecchymosis, weak pulse carefully puckery.
The phlegm-damp of holding concurrently: chest pain, uncomfortable in chest, dizzy, pale tongue fat (?) or indentation being arranged, tongue is greasy in vain, rolling pulse or moisten.
The double expectorant stasis of blood: the arteries and veins card that meets two kinds of accompanied symptoms of blood stasis and phlegm-damp.
(2) Western medicine diagnose standard: (with reference to International Society of Cardiology and association and World Health Organization's clinical name standardization associating special topic group report " name of ischemic heart desease and diagnostic criteria "
1. fatigue angina pectoris: the anginal feature of fatigue is that behind rest or the sublingual administration nitroglycerin, pain often can rapidly disappear, and can be divided into three major types because the of short duration chest pain that motion or other situations that increases myocardium requirementing keto quantity are brought out is shown effect:
(1) preliminary fatigue angina pectoris: the course of disease is in 1 month.
(2) stable type fatigue angina pectoris: the course of disease is more than one month.
(3) the tired angina pectoris of deterioration type: the number of times that the equal extent fatigue is brought out, the order of severity and persistent period increase the weight of suddenly.
2. spontaneous angina pectoris: the characteristic of spontaneous angina pectoris is that the chest pain outbreak does not have obvious relation with the increase of myocardium requirementing keto quantity.Compare with the fatigue angina pectoris, durante dolors is long, and degree is heavier, and is difficult for alleviating for nitroglycerin, and this type does not have enzymic change, and time property S-T section that electrocardiogram often some occurs is forced down or the T ripple changes.Spontaneous angina pectoris can take place separately or merge existence with the fatigue angina pectoris.
Spontaneous angina pectoris patient pain seizure frequency, persistent period and pain degree can have different clinical manifestations, and the patient can have the chest pain outbreak that continues than long sometimes.Similar myocardial infarction, but do not have the characteristic of electrocardiogram and enzyme to change.
Certain this spontaneous angina pectoris patient temporary S-T section occurs and raises when outbreak, often be called ariant angina.But when myocardial infarction records this electrocardiogram in early days, can not use this title.Just send out the fatigue angina pectoris, progressive angina pectoris and spontaneous angina pectoris often are referred to as " unstable angina pectoris ".
(3) thoracic obstruction weight grade scale: (with reference to therapy of combining Chinese and Western medicine angina pectoris in 1979 and arrhythmia forum " angina pectoris and ECG curative effect evaluation criteria ")
1. slight: the classical angina outbreak is arranged, each persistent period number minute, pain is shown effect 2～3 times at least weekly, or shows effect every day 1～3 time, but pain is heavy, need suck nitroglycerin sometimes.
2. moderate: have every day for several times than the classical angina outbreak, each persistent period number minute was by 10 minutes, and angor is heavier, generally all needs to suck nitroglycerin.
3. than severe: classical angina outbreak is arranged repeatedly every day, thereby influence activities of daily living (for example defecate, wear the clothes etc.).Each outbreak persistent period is longer, need repeatedly suck nitroglycerin.
4. severe: pain attack times and degree, all relatively severe is attached most importance to.
(4) case is included standard in
Have thoracic obstruction primary symptom, diagnosis is clear and definite, meets the Chinese medical discrimination standard.The above angina pectoris patient that shows effect weekly twice had both had angina pectoris symptom, and the electrocardiogram symptom is arranged again, and the state of an illness be slightly to arrive than the severe patient severe patient's discomfort.
(5) get rid of the case standard:
1. be coronary heart disease myocardial infarction and other cardiac disorders on inspection, the severe neurosis, climacteric syndrome, chest pain person due to the cervical spondylosis.
2. primary diseases such as the above hypertension of merging moderate, severe pulmonary insufficiency, severe arrhythmia, liver, kidney, hemopoietic system, the psychotic.
3.18 below year, more than 75 years old, gestation or women breast-feeding their children are to this medicine allergy sufferers.
4. do not meet the standard of including in, not medication in accordance with regulations can't be judged that curative effect or data are not congruent to affect the treatment or safety judgement person.
Three, therapeutic scheme and observation index:
(1) clinical design
1, random method: clinical employing parallel control randomization method is carried out, and the ratio of treatment group and matched group was distributed by 3: 1, totally 474 examples.Be divided into treatment and organize 360 examples, matched group 114 examples.
2, blind method: adopt the method for single blind dual analog, curative and to contrast medicine consistent with separately placebo outward appearance.Make the random assortment card by table of random number, taken off blind after the off-test again.
(2) therapeutic scheme
1, treatment group: 3 of the prepared oral liquid 20ml (10ml/ props up) of the embodiment of the invention 1+comfort sheet (FUFANG DANSHEN PIAN comfort sheet), every day three times, warm water delivery service.
2, matched group: 3+comfort oral liquid 20ml (10ml/ props up) of FUFANG DANSHEN PIAN [as if produced by the western Pharmacy stock Co., Ltd in Henan Province, authentication code: zz-0259-defends in Henan the accurate word (1996) of medicine No. 034049], every day three times, warm water delivery service.
3, the course of treatment: 4 weeks.
4, inactive all antianginal medicines during the treatment, antiplatelet aggregation and anticoagulant, but can take quick-acting antianginal drugs.
(3) observation index:
1, health giving quality is observed
(1) observes clinical symptoms and sign weekly, as variation of tongue and arteries and veins etc.
(2) observe number of times, persistent period and the degree of angina pectoris attacks weekly.
(3) nitroglycerin stops lapse rate and consumption.
(4) myocardial oxygen consumption.
(5) EKE: comprise ∑ ST, NST and NT etc.
(6) hemorheology.
(7) untoward reaction.
2, security inspection:
(1) general health check-up.
(2) blood, urine, stool for routine.
(3) liver function (GPT) and renal function (BuN, Cr) are checked.
Four, efficacy assessment standard
(1) thoracic obstruction symptom criterion of therapeutical effect: (with reference to therapy of combining Chinese and Western medicine angina pectoris in 1979 and arrhythmia forum " angina pectoris and ECG curative effect evaluation criteria ").
1, slight:
(1) produce effects: transference cure or basic the disappearance.
(2) effective: pain attack times, degree and persistent period have obviously and alleviate.
(3) invalid: symptom is preceding identical with treatment substantially.
(4) increase the weight of: pain attack times, degree and persistent period are all increased the weight of the standard of (or reach " moderate ") to some extent.
2, moderate:
(1) produce effects: transference cure or basic the disappearance.
(2) effective: sx is to the standard of " slightly ".
(3) invalid: symptom is preceding identical with treatment substantially.
(4) increase the weight of: the pain attack times, degree and persistent period are all increased the weight of the standard of (or reach " than severe ") to some extent.
3, than severe:
(1) produce effects: symptom disappears substantially or is relieved to the standard of " slightly ".
(2) effective: sx is to the standard of " moderate ".
(3) invalid: symptom is preceding identical with treatment.
(4) increase the weight of: the pain attack times, degree and persistent period are all increased the weight of the standard of (or reach " severe ") to some extent.
4, severe:
(1) produce effects: symptom disappears substantially or is relieved to the standard of " moderate ".
(2) effective: sx is below the mark to " than severe ".
(3) invalid: symptom is preceding identical with treatment.
(2) ECG curative effect evaluation criteria: (with reference to therapy of combining Chinese and Western medicine angina pectoris in 1979 and arrhythmia forum " angina pectoris and ECG curative effect evaluation criteria ")
1, produce effects: electrocardiogram returns to " roughly normal " (i.e. " normal range ") or reaches " normal ECG.”
2, effective: the S-T section reduces, and more than the treatment back rise 0.05mv, but does not reach normal level, and (reaching 25% above person) shoals at the negative T wave that mainly leads; Or the T ripple becomes uprightly chamber or intraventricular block improver by smooth.
3, invalid: electrocardiogram is preceding identical with treatment substantially.
4, increase the weight of: the S-T section is than more than the preceding 0.05mv of reduction of treatment, and negative T wave is deepened (reaching more than 25%) mainly leading; Or upright T popin is smooth, and atrioventricular block or intraventricular block ectopic cardiac rhythm appear.
(3) nitroglycerin stops lapse rate:
1, drug withdrawal: withdraw nitroglycerin after the treatment fully.
Decrement: the treatment back preceding nitroglycerin consumption of treatment is reduced more than 50%.
Constant: treatment back nitroglycerin consumption reduces less than 50%.
2, computational methods:
Nitroglycerin stops lapse rate=(before treating with tablet number-treatments back tablet number)/treat preceding with tablet number * 100%
(4) the tcm syndrome total effects is judged:
Therapeutic index (n)=(integration before treating-treatment back integration)/integration * 100% before treating
Produce effects: n 〉=2/3.
Effectively: 2/3＞n 〉=1/3.
Invalid: n＜1/3.
Increase the weight of: n 〉=-1/3.
Five, safety evaluatio standard:
1 grade: safely, do not have any untoward reaction.
2 grades: compare safety,, need not do any processing, can continue administration if any untoward reaction.
3 grades: safety issue is arranged, moderate untoward reaction is arranged, can continue administration after the processing.
4 grades: because of administration is ended in untoward reaction.
Six, stop and remove the clinical trial standard
(1) stop case:
1, can not adhere to therapist.
2, the person that the serious adverse reaction occurs.
3, other serious concurrent disease patients appear in the process of the test.
4, severity of symptoms must adopt stringent effort person.
(2) drop by the wayside case:
1, the patient proposes to withdraw from test.
2, the patient institute that do not come in time goes to a doctor.
3, other.
(3) reject case:
1, natural seceder in the observation.
2, it is effective to take this medicine, but adds with other similar medicines, so that can't judge curative effect person.
3, last diagnostic does not meet and includes case standard person in.
Seven, statistics
Ranked data are checked with Ridit, the enumeration data X 2 test, and measurement data is checked with t.
Eight, observed result
(1), the comparison of two groups of total effectses, the results are shown in Table 9.
Table 9 liang group patient's thoracic obstruction (angina pectoris) total effects relatively
Table 9 shows that the obvious effective rate of treatment group and total effective rate are 43.89% and 90.83%, and matched group is 15.79% and 60.53%, two group highly significant difference P＜0.01.
(2), two groups of curative effect to treat angina pectoris relatively, the results are shown in Table 10.
The number of times of table 10 liang group patient's thoracic obstruction (angina pectoris) outbreak and persistent period are relatively
The angina pectoris attacks number of times: compare t=10.03 before and after the treatment group is treated, t=9.89 is compared in P＜0.01 before and after the treatment of control group, P＜0.01, and treatment group and matched group compare: t=0.53, P＞0.05; The angina pectoris persistent period: compare t=9.64 before and after the treatment of treatment group, P＜0.01, compare t=8.94 before and after the treatment of control group, P＜0.01, treatment group and matched group compare: t=0.87, and P＞0.05. table 10 shows that angina pectoris attacks number of times and persistent period are all seen minimizing after two groups of patient, before and after the treatment highly significant difference (P＜0.01) is arranged, does not have significant difference (P＞0.05) between two groups.
(3), to the contrast of curative effect to treat angina pectoris in various degree, the results are shown in Table 11.
Table 11 liang group patient's thoracic obstruction (angina pectoris) degree relatively
Compare X before and after the treatment of treatment group
2=7.06, P＜0.05; Compare X before and after the treatment of control group
2=6.82, P＜0.01; Treatment group and matched group be X relatively
2=0.31, P＞0.05.Table 11 shows, anginal degree is all seen and alleviated after two groups of patient, have before and after the treatment significantly and highly significant difference (P＜0.05, P＜0.01=do not have significant difference (P＞0.05) between two groups.
(4), two groups of patient's nitroglycerin stop lapse rate, the results are shown in Table 12.
Table 12 a liang group patient nitroglycerin stops lapse rate relatively
Treatment group and matched group compare: X
2=1.36, P＞0.05.Table 12 shows, treatment group and matched group patient's nitroglycerin stops lapse rate and is respectively 82.50% and 76.32%, two group and do not have significant difference (P＞0.05).
Relevant two groups of patient's nitroglycerin consumption situations see Table 13.
Table 13 liang group patient's nitroglycerin amount ratio
Compare t=10.05 before and after the treatment of treatment group, t=8.31 is compared in P＜0.01 before and after the treatment of control group, P＜0.01, and treatment group and matched group be t=3.92 relatively, P＜0.05.Table 13 shows that the nitroglycerin consumption all has minimizing after two groups of patient, before and after the treatment highly significant difference (P＜0.01) is arranged, and also there were significant differences between two groups (P＜0.05).
(5), two groups of patient's electrocardiogram improvement situation contrasts see Table 14
Table 14 liang group patient ECG curative effect relatively
Treatment group and matched group compare: X
2=1.65, P＞0.05.Table 14 shows that the electrocardiogram obvious effective rate of treatment group and matched group and total effective rate are respectively does not have significant difference (P＞0.05) between 5.00% and 76.94%, 4.39% and 75.44%, two group.
(6), two groups of patient's tcm syndrome curative effects relatively, the results are shown in Table 15.
Table 15 liang group patient tcm syndrome curative effect relatively
Table 15 shows that the obvious effective rate of treatment group is compared with matched group respectively with total effective rate, and utmost point significant difference (P＜0.01) is all arranged, and obviously is better than matched group.Total effective rate between three syndromes of treatment group does not have significant difference (P＞0.05), but better with the deficiency of vital energy blood stasis type curative effect of holding concurrently.
(7), tcm syndrome integration situation, see Table 16.
Table 16 liang group patient tcm syndrome integration relatively
Compare t=10.13, P＜0.01 before and after the treatment of treatment group; Compare t=2.06, P＜0.01 before and after the treatment of control group; Treatment group and matched group be t=9.21 relatively, P＞0.05.Table 16 shows, the tcm syndrome integration after two groups of patient all has minimizing, and (P＜0.01=does not have significant difference (P＞0.05) between two groups before and after the treatment highly significant difference.
(8), treatment organizes other cardinal symptom disappearance situations, sees Table 17.
Other cardinal symptom disappearance situation analysis are organized in table 17 treatment
Table 17 shows that it is 87.27% that disappearance rate uncomfortable in chest is organized in treatment, and cardiopalmus is 71.75%, and weak is 66.45%, and breathing hard is 59.45%, and dizziness is 56.41%, and prompting all has a better role to the disease of holding concurrently of the thoracic obstruction.
Nine, safety detects
1, routine blood test sees Table 18.
Compare before and after table 18 liang group patient hematochrome, erythrocyte, the leukocyte treatment
Hematochrome: compare t=1.35, P＞0.05 before and after the treatment of treatment group; Compare t=1.74, P＞0.05 before and after the treatment of control group.Erythrocyte: compare t=1.29, P＞0.05 before and after the treatment of treatment group; Compare t=1.31, P＞0.05 before and after the treatment of control group.Leukocyte: compare before and after the treatment of treatment group: t=2.51, P＞0.05; Compare t=2.54, P＞0.05 before and after the treatment of control group.Table 18 shows that hematochrome, erythrocyte and leukocyte all do not have significant difference (P＞0.05) before and after two groups of treatments.
2, blood urea nitrogen, creatinine, glutamate pyruvate transaminase see Table 19
Compare before and after table 19 liang group patient blood urea nitrogen, creatinine, the glutamate pyruvate transaminase treatment
Blood urea nitrogen: compare t=0.69, P＞0.05 before and after the treatment of treatment group; Compare t=0.63 before and after the treatment of control group, P＞0.05. creatinine: compare t=0.57, P＞0.05 before and after the treatment of treatment group; Compare t=0.68, P＞0.05 before and after the treatment of control group; Glutamate pyruvate transaminase: compare t=2.91, P＜0.05 before and after the treatment of treatment group; Compare t=0.87 before and after the treatment of control group, P＞0.05. table 19 shows, blood urea nitrogen, creatinine, the equal zero difference of glutamate pyruvate transaminase (P＞0.05) after two groups of treatments. reduction before the anti-treatment of the glutamate pyruvate transaminase of wherein treatment group, there were significant differences (P＜0.05) before and after the treatment.
In addition, treatment group blood urea nitrogen before treatment has 5 examples to raise, and treatment back 3 examples recover normal, 2 routine no changes.Creatinine (?) have 1 example to raise, the treatment back recovers normal.Treatment of control group preceding 2 routine blood urea nitrogens raise, and all do not have after the treatment further and worsen, and 2 routine creatinines raise, and also do not have after the treatment further and worsen.
3, safety evaluatio: treatment group 360 examples and matched group 114 examples all belong to 1 grade, do not have any untoward reaction.
Ten, model case
The patient: Liu * *, man, 76 years old, admission number 36881.
The main suit: uncomfortable in chest repeatedly, chest pain 3 years is surplus, aggravates for two weeks.Accompany weak, cardiopalmus, dizzy.The patient has surplus the hypertension history 30 year, and vexed pain, time being arranged during the front over nearly 3 years is 3-5 minute, and tired or movable back is uncomfortable in chest obviously.Electrocardiogram shows myocardial ischemia, is diagnosed as angina pectoris.Nearly two weeks come, and angina pectoris attacks is about 6 times weekly, and is moderate, persistent period 5-6 minute.Companion's cardiopalmus, weak.Pale tongue is dim, and thin fur is a little less than the stringy and thready pulse.Ekb shows STavl I.v
3-v
5Force down 0.75-1.5mmTIavl, IIavF is low flat, Tv
3-v
5Be inverted 0.5-1.5mm.Through taking medicine oral liquid of the present invention 20ml/ time, every day three times, three weeks back angina pectoris number of times are kept to changes light, pain time 1-2 minute in 2 times/week, degree, the nitroglycerin consumption by weekly 8 be kept to 6.Around the, angina pectoris does not show effect, and the nitroglycerin consumption is 0, check electrocardiogram, ST.lIavl v
3-v
5Force down 0.5-0.75mm, T Iavl v
3-v
5Low flat, before be clearly better.According to thoracic obstruction angina pectoris and the effective standard evaluation of tcm syndrome, be produce effects.The ECG curative effect standard is effective.
11, observe conclusion
1, the clinical test results of Drug therapy angina pectoris of the present invention shows: it is evident in efficacy through clothes medicine oral liquid of the present invention that 360 examples are organized in treatment, obvious effective rate and total effective rate are respectively 43.33% and 90%, and matched group has highly significant difference P＜0.01 for being respectively 14.68% and 59.63%, two group.Anginal degree, angina pectoris attacks number of times and persistent period are all seen minimizing after two groups of patient, all have before and after the treatment significantly and highly significant difference (P＜0.05, P＜0.01).Treatment group and matched group patient's nitroglycerin stops lapse rate and is respectively 81.94% and 75.22%, and the electrocardiogram obvious effective rate and the total effective rate of treatment group and matched group are respectively 3.33% and 78.06%, 3.67% and 77.98%.And the tcm syndrome integration after two groups of patient all has minimizing, before and after the treatment highly significant difference (P＜0.01) arranged, and the obvious effective rate of wherein treatment group tcm syndrome is compared with matched group respectively with total effective rate, and utmost point significant difference P＜0.01 is also all arranged.Illustrate that medicine of the present invention has tangible clinical efficacy to the thoracic obstruction (angina pectoris), and obviously be better than FUFANG DANSHEN PIAN.
2, medicine of the present invention has no adverse reaction, and is safe and reliable
Medicine oral liquid security inspection routine blood test (erythrocyte, hematochrome, leukocyte of the present invention, blood urea nitrogen, creatinine, glutamate pyruvate transaminase), no significant difference (P＞0.05) before and after the treatment of treatment group, the treatment group has 5 routine blood urea nitrogens to raise, 1 routine creatinine raises, treatment back blood urea nitrogen 3 examples recover normal, 2 routine no changes, 1 routine creatinine rising person recovers normal, point out medicine of the present invention that blood, kidney and liver function are not all had influence, treatment is organized 360 examples and is all belonged to 1 level security evaluation, has no adverse reaction, and illustrates that safety of medicine of the present invention is reliable.
Claims (2)
1. preparation method for the treatment of the Chinese medicine composition of angina pectoris, this Chinese medicine composition is made by following bulk drugs: 60～130 parts of Radix Notoginseng, 150～450 parts of Radix Codonopsis, 100～350 parts of Pheretimas, 80～250 parts of Rhizoma Corydalis (processed with vinegar), 80～330 parts of Semen Descurainiae (parched), 110～300 parts of Bulbus Allii Macrostemonis, 10～60 parts of Cortex Cinnamomis, 1～3 part of 0.2～0.8 part of Mentholum and Borneolum Syntheticum; Its preparation method comprises:
(1) the cinnamomic distillate of preparation or further with prepared distillate extraction volatile oil, the Cortex Cinnamomi medicinal residues are standby;
(2) Radix Notoginseng, Rhizoma Corydalis (processed with vinegar) extract 1～3 time with 50～90% alcohol heating reflux of 4～8 times of weight, extract 1～3 hour at every turn; Extracting solution reclaims ethanol to there not being the alcohol flavor, and proportion is 1.05～1.10 concentrated solution when being concentrated into room temperature measuring, adds distilled water and sodium benzoate again, and adjust pH is 4.0～5.0, stirs evenly, and cold preservation filters, and the filtrate airtight preservation of device in addition precipitates standby;
(3) the Cortex Cinnamomi medicinal residues in the above-mentioned steps, Radix Notoginseng medicinal residues and Rhizoma Corydalis (processed with vinegar) medicinal residues are mixed with Radix Codonopsis, Pheretima, Bulbus Allii Macrostemonis and Semen Descurainiae (parched), decoct with water, wherein, decocting with water number of times is 2 times, when decocting for the 1st time, add 6～10 times of weight water, decocted 1～3 hour; Add 4～8 times of weight water, decocted 0.5～2 hour for the 2nd time; Merge extracted twice liquid, proportion is 1.25～1.32 clear paste when being concentrated into room temperature measuring, adds 90% above ethanol and makes and contain the alcohol amount and reach 60～80%, stirs evenly, and leaves standstill, and filters, and filtrate device preservation in addition precipitates standby;
(4) resulting precipitation in step (2) and (3) is merged, with 60～80% ethanol liquid washing that contains 0.1～0.5% hydrochloric acid 2 times, washing liquid is filtered, gained filtrate merges in filtrate and the step (3), recovery ethanol is not distinguished the flavor of to there being alcohol, filtration or centrifugal, and filtrate or supernatant are standby;
(5) resulting filtrate in the resulting filtrate of step (4) or supernatant and the step (2) is merged, get relative density when being concentrated into room temperature measuring and be 1.10～1.15 clear paste, with the clear paste drying, add Mentholum, Borneolum Syntheticum, and spray into Cortex Cinnamomi volatile oil, add auxiliary materials and mixing and make the preparation intermediate, make finished product through preparations shaping technology again; Or, add tween 80, antiseptic and distilled water more successively with the resulting filtrate of step (4) or supernatant and Mentholum, Borneolum Syntheticum and Cortex Cinnamomi distillation liquid-phase mixing, and adjust pH is 4.5-5.5, leaves standstill, filtration, fill, sterilization are promptly.
2. according to the preparation method of claim 1, it is characterized in that the weight portion of each crude drug is: 99 parts of Radix Notoginseng, 333 parts of Radix Codonopsis, 222 parts of Pheretimas, 166 parts of Rhizoma Corydalis (processed with vinegar), 222 parts of Semen Descurainiae (parched), 222 parts of Bulbus Allii Macrostemonis, 33 parts of Cortex Cinnamomis, 0.5 part of Mentholum, 2 parts of Borneolum Syntheticums.
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