CN105055750A - Kamailitong capsules for treating cardiovascular and cerebrovascular diseases and preparation method of capsules - Google Patents
Kamailitong capsules for treating cardiovascular and cerebrovascular diseases and preparation method of capsules Download PDFInfo
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Abstract
The invention relates to kamailitong capsules for treating cardiovascular and cerebrovascular diseases and a preparation method of the capsules. The preparation method includes the following steps: adding ethyl alcohol to radix ginseng rubra, salvia miltiorrhiza, angelicae sinensis, ligusticum chuanxiong and hawthorn for reflux extraction; filtering to obtain extracting solution and herb residue; concentrating the extracting solution to obtain extracting paste; mixing astragalus membranaceus with the herb residue, adding water for decoction, and filtering; concentrating the filtrate to obtain thick paste; drying the extracting paste and the thick paste, crushing and mixing to obtain fine powder X; taking and mixing leech, lumbricus and dragon's blood, crushing into fine powder Y; mixing the fine powder X and the fine powder Y uniformly, sieving, pelletizing and straightening; spraying an ethanol solution of borneol to prepare the capsules. The capsules provided by the invention can separate out the effective constituents of different raw medicinal materials to the maximum extent, effectively remain the active constituents, improve the drug efficacy and quickly reduce the symptom; the patient with coronary heart disease feels better on the following aspects: the angina pectoris symptom is alleviated, the electrocardiogram is improved, the Chinese medicinal syndrome is improved, hyperlipemia is alleviated, and the blood viscosity is reduced; the total effective rate reaches 89.8%, the long-term follow-up result is stable, and the capsules are free of toxic and side effects.
Description
[technical field]
The invention belongs to the field of Chinese medicines being used for the treatment of cardiovascular and cerebrovascular disease, card arteries and veins profit open capsule particularly relating to treatment cardiovascular and cerebrovascular disease and preparation method thereof.
[background technology]
Coronary heart disease, apoplexy are all worldwide height harm frequently-occurring diseases, and patient groups is numerous; Its pathologic basis is also all atherosclerotic lesion.For coronary heart disease, according to Epidemiological study and the estimation of postmortem statistics, in China more than 40 years old crowd, the people at least more than 30% has coronary atherosclerosis.The U.S. dies from coronary disease patient every year more than 600,000 people; The annual death toll of China also for 26-39 ten thousand people (wherein more than 70% due to not and prevent and treat and die from outside institute).In China and East Asia, incidence of coronary heart disease is still in rising trend, estimates will peak at 2010 ~ the year two thousand twenty.American-European western countries peaked in the sixties in last century.Afterwards, there is control trend in morbidity.But up-to-date assessment display, the U.S. still has 1,100,000 myocardial infarctions (MI) patient every year, wherein only has about half patient (550,000) to survive and arrives hospitalization.And the Coronary Heart Disease Patients just having 60 ~ 80 routine other types below of each routine MI inpatient.So the quantity of the actual Coronary Heart Disease Patients of the U.S., conservative estimation is also about 3,800 ten thousand people.Research in recent years finds, asymptomatic coronary heart disease crowd proportion is much larger than there being symptom, moreover primary disease is once occur, and treatment difficulty, spends high.So become worldwide research topic about primary disease preventative strategies can.The market demand of control is large especially, at present, though it is many market to be treated this type of disease medicament, but determined curative effect, persistent person are very few, the medicine with prophylactic function is then less, or because of expensive, or because of toxic and side effects comparatively large, or because of curative effect not good enough, still difficulty meets vast diseased colonies demand.Therefore, to effective protective agents exhale change still very urgent.
[summary of the invention]
The object of the invention is to overcome problems of the prior art, provide a kind of card arteries and veins profit open capsule for the treatment of cardiovascular and cerebrovascular disease and preparation method thereof, effective percentage is high, has no side effect.
In order to achieve the above object, capsule of the present invention is by the following technical solutions:
Comprise content and capsule shells, count by weight, content is made up of following component: the Radix Astragali 600 ~ 700 parts, Radix Ginseng Rubra 50 ~ 70 parts, Radix Salviae Miltiorrhizae 190 ~ 250 parts, Radix Angelicae Sinensis 120 ~ 180 parts, Rhizoma Chuanxiong 120 ~ 180 parts, Fructus Crataegi 120 ~ 180 parts, Hirudo 80 ~ 120 parts, Pheretima 80 ~ 120 parts, Sanguis Draxonis 40 ~ 60 parts and Borneolum Syntheticum 25 ~ 35 parts.
The preparation method of capsule of the present invention is by the following technical solutions: comprise the following steps:
(1) according to the mass fraction, get Radix Ginseng Rubra 50 ~ 70 parts, Radix Salviae Miltiorrhizae 190 ~ 250 parts, Radix Angelicae Sinensis 120 ~ 180 parts, Rhizoma Chuanxiong 120 ~ 180 parts and Fructus Crataegi 120 ~ 180 parts, add alcohol reflux, filter and obtain extracting solution and medicinal residues, extracting solution is condensed into the extractum that relative density is 1.31 ~ 1.33;
(2) according to the mass fraction, get the Radix Astragali 600 ~ 700 parts and mix with the medicinal residues in step (1), decoct with water rear filtration, concentrate filtrate to the thick paste that relative density is 1.31 ~ 1.33;
(3) by after the thick paste of the extractum of step (1) and step (2) respectively drying, fine powder X is pulverized and mixed into;
(4) according to the mass fraction, water intaking trematodiasis 80 ~ 120 parts, Pheretima 80 ~ 120 parts and Sanguis Draxonis 40 ~ 60 parts, adopt mixing flushing method to be ground into fine powder Y;
(5) by the fine powder Y mix homogeneously of the fine powder X of step (3) and step (4), obtain powder, powder is sieved, carry out granulating and granulate, then spray the alcoholic solution of Borneolum Syntheticum, according to the mass fraction, containing the Borneolum Syntheticum of 25 ~ 35 parts in the alcoholic solution of Borneolum Syntheticum, obtain content, content is incapsulated in shell, the card arteries and veins profit open capsule of the cardiovascular and cerebrovascular disease that obtains medical treatment.
Further, in step (1), ethanol adopts volume fraction to be the ethanol of 72% ~ 78%.
Further, reflux, extract, twice in step (1) is wherein the alcohol reflux 2h adding 7 times amount for the first time, and second time is the alcohol reflux 2h adding 6 times amount, and decompression recycling ethanol after merge extractive liquid.
Further, decoct twice, be wherein add 12 times of water gagings for the first time, soak 20 minutes, decoct 1.5 hours in step (2), second time adds 10 times of water gagings, decocts 1.5 hours, merges decoction liquor.
Further, the relative density in step (1) and step (2) all records at 60 DEG C.
Further, be in 58 ~ 62 DEG C of vacuum dryings or forced air drying in step (3).
Further, spray the alcoholic solution of Borneolum Syntheticum in step (5) by nebulization, stir in sprinkling process.
Further, the alcoholic solution of Borneolum Syntheticum in step (5), be by Borneolum Syntheticum volume fraction be 95% dissolve with ethanol formed, and the mass ratio of Borneolum Syntheticum and ethanol is 1:1.5.
Further, in step (5), 80 ~ 100 mesh sieves crossed by powder, adopt dry granulation, 60 mesh sieve granulate.
Compared with prior art, the present invention has following useful technique effect:
The present invention deeply seeks the pathogenesis of ischemic heart desease (coronary heart disease) from Chinese theory of medicine, dialectical is that the turbid stasis of blood of fat is amassed, the resistance of breast sun numbness, deficiency in origin and excess in superficiality, namely because blood fat increases, cholesterol deposits in coronary arterial wall, cause coronary stricture or blocking, with " fat the turbid descending of dispelling, except long-pending soft pulse, benefiting QI for activating blood circulation, disperse blood stasis and dredge collateral " stand and control, i.e. blood fat reducing, anticoagulant, prevent and melt coronary artery thrombosis, increase blood supply, by adopting Radix Ginseng, the kinds of traditional Chinese medicines such as the Radix Astragali and Rhizoma Chuanxiong, be made up of fully natural green medical material, medicine source is wide, cost is low, be mainly used in clinical prevention cardiovascular and cerebrovascular vessel thrombotic disease and bring out basic pathology state---the atherosclerosis of this disease, giving consideration to both the incidental and fundamental, can prevent controlling, there is blood fat reducing Shu Mai, invigorate vital energy and reinforce the heart, blood stasis dispelling anticoagulant, the effects such as eliminating thrombus and removing obstruction in channels.Clinical practice confirms, it is fast that the present invention improves symptom, patients with coronary heart disease all has obvious optimum change at aspects such as angina pectoris symptom alleviation, electrocardiogram improvement, Syndrome in TCM group improvement, hyperlipidemia reduction and blood viscosity reductions, total effective rate can reach 89.8%, late result is stablized, and use safety, has no side effect, prevention effect is all very remarkable, can be widely used in the treatment of coronary heart disease and one-level high-risk group and secondary prevention.
Adopt ethanol extraction and water extraction can separate out the effective ingredient of different material medical material to greatest extent in preparation method of the present invention, the steps such as low temperature flushing method co-grinding effectively can retain again the active component of biological medical material, thus raising drug effect, be better than similar drug, clinical proof, the capsule total effective rate that the present invention prepares can reach 89.8%, and adopts the matched group total effective rate of sorbitrate to be only 69.2%.
[detailed description of the invention]
Capsule of the present invention comprises content and capsule shells, count by weight, content is made up of following component: the Radix Astragali 600 ~ 700 parts, Radix Ginseng Rubra 50 ~ 70 parts, Radix Salviae Miltiorrhizae 190 ~ 250 parts, Radix Angelicae Sinensis 120 ~ 180 parts, Rhizoma Chuanxiong 120 ~ 180 parts, Fructus Crataegi 120 ~ 180 parts, Hirudo 80 ~ 120 parts, Pheretima 80 ~ 120 parts, Sanguis Draxonis 40 ~ 60 parts and Borneolum Syntheticum 25 ~ 35 parts.
The specification of capsule of the present invention: every fills 0.34 ~ 0.36g, 60 every bottle.
The preparation method of capsule of the present invention comprises the following steps:
1, Radix Ginseng Rubra, Radix Salviae Miltiorrhizae, Radix Angelicae Sinensis, Rhizoma Chuanxiong and Fructus Crataegi 5 taste decoction pieces is accurately taken by above-mentioned formula, add the alcohol reflux 2 times that volume fraction is 72% ~ 78%, first time adds 7 times amount (referring to crude drug weight) alcohol reflux 2 hours, second time 6 times amount ethanol (referring to crude drug weight) reflux, extract, 2 hours, filter, merge extractive liquid, decompression recycling ethanol, and be concentrated into 60 DEG C heat survey relative densities be 1.31 ~ 1.33 extractum for subsequent use.
2, accurately take Radix Astragali decoction pieces by formula, merge with the medicinal residues in step 1, decoct with water 2 times, first time adds 12 times amount (medicinal residues in the Radix Astragali and step 1 merge after weight) water, soaks 20 minutes, decocts 1.5 hours; Second time adds 10 times amount (medicinal residues in the Radix Astragali and step 1 merges after weight) water, decocts 1.5 hours, filters, merging decoction liquor, be evaporated to 60 DEG C of hot survey relative densities be 1.31 ~ 1.33 thick paste for subsequent use.
3, by the extractum of step 1 and the thick paste of step 2 respectively at 58 ~ 62 DEG C of vacuum dryings or forced air drying, then dry extract is pulverized and mixed into fine powder X with dry thick paste, for subsequent use.
4, accurately take Hirudo, Pheretima and Sanguis Draxonis decoction pieces by formula, eliminate impurity, become fine powder Y according to mixing flushing method dry pulverization process, for subsequent use.
5, the fine powder Y of the fine powder X of step 3 and step 4 is mixed, obtain powder, powder is crossed 80 ~ 100 mesh sieves, carry out dry granulation, 60 mesh sieve granulate, in powder, then spray the alcoholic solution of Borneolum Syntheticum by nebulization, stir while spray, the alcoholic solution of Borneolum Syntheticum is according to the mass fraction, be that the dissolve with ethanol of 95% is formed, and the mass ratio of Borneolum Syntheticum and ethanol is 1:1.5 by the Borneolum Syntheticum volume fraction of 25 ~ 35 parts; Obtain content, content is incapsulated in shell, the card arteries and veins profit open capsule of the cardiovascular and cerebrovascular disease that obtains medical treatment.
The content of capsule of the present invention is made up of Ten Herbs such as the Radix Astragali, Radix Ginseng Rubra, Radix Salviae Miltiorrhizae, Radix Angelicae Sinensis, Rhizoma Chuanxiong, Fructus Crataegi, Pheretima, Hirudo, Sanguis Draxonis, Borneolum Syntheticums, wherein:
Radix Astragali slightly warm in nature; Taste is micro-sweet, and that chews micro-ly has beany flavor; Return spleen, lung meridian.Function with cure mainly: invigorating QI to consolidate the body surface resistance, diuresis poison holding, evacuation of pus, expelling pus and promoting granulation.Weak for the deficiency of vital energy, anorexia and loose stool, sinking of QI of middle-JIAO, chronic diarrhea proctoptosis, metrorrhagia of having blood in stool, exterior deficiency spontaneous perspiration, deficiency of vital energy edema etc.Pharmacological research: cardiotonic, coronary artery dilator, blood vessel dilating and hypotensive effect, can protect and significantly improve the deformability of human body Rbc; Reduce blood specific viscosity and obviously reduce thrombosis.
Radix Ginseng Rubra, slightly warm in nature; Feeble QI is fragrant and special, sweet in the mouth, micro-hardship; GUIXIN, lung, spleen channel.Function with cure mainly: invigorating primordial QI, multiple arteries and veins takes off admittedly, nourishing qi to stop.For weak body and prostration, cold extremities faint pulse, QI failing to control blood, metrostaxis; Heart failure, cardiogenic shock etc.Pharmacological research: 1, to action of the heart: (1) cardiotonic: strengthen myocardial contraction, increases cardiac output; (2) coronary flow is increased; (3) decreasing heart rate, arrhythmia.2, to the effect of blood vessel: (1) Radix Ginseng Rubra has dilating effect to the coronary artery of whole animal, cerebrovascular, optical fundus blood vessel; (2) Radix Ginseng Rubra is different to the blood vessel function under variety classes, different fuselage state, and this may be that Radix Ginseng Rubra can one of the reason of two-ways regulation blood pressure.Its ginsenoside contained impact on cardiac hemodynamic is conducive to function of resisting myocardial ischemia, for treatment coronary heart disease of hypertension provides pharmacological basis, myocardium anti-anoxia ability can be improved, reduce whole blood viscosity and plasma viscosity, anticoagulant and fibrinolytic, thus there is anti-thrombosis function; Radix Ginseng Rubra also has all multiactions such as blood fat reducing, atherosclerosis.
Radix Salviae Miltiorrhizae, cold nature; Mildly bitter flavor is puckery; GUIXIN, Liver Channel.Function with cure mainly: stasis-dispelling and pain-killing, promoting blood circulation to restore menstrual flow, clear away heart-fire relieving restlessness.For menoxenia, amenorrhea dysmenorrhea, lump in the abdomen, dysphoria and insomnia; Hepatosplenomegaly, angina pectoris.Pharmacological research: l, coronary artery dilator, reduce coronary resistance, significantly increase coronary flow, accelerates the foundation of arteria coronaria collateral circulation.2, Radix Salviae Miltiorrhizae has protective effect to myocardial ischemia and myocardial infarction; 3, periphery and internal organs microcirculation disturbance can be improved, 4, Radix Salviae Miltiorrhizae also has blood vessel dilating and hypotensive effect; 5, the effect of blood fat and atherosclerosis Mottling formation is reduced; 6, improve hemorheology exception, anticoagulation, suppression platelet adhesion, stablize the effects such as erythrocyte membrane, therefore can inhibition thrombosis.7, protective effect is had to hypoxic cardiac muscle.
Radix Angelicae Sinensis, warm in nature; There is strong fragrance, sweet in the mouth, pungent, micro-hardship; Return liver, the heart, spleen channel.[function with cure mainly] is enriched blood and is invigorated blood circulation, menstruction regulating and pain relieving, loosening bowel to relieve constipation.For blood deficiency and yellow complexion, dizzy cardiopalmus, menoxenia, amenorrhea dysmenorrhea.[pharmacological research] 1, energy significantly coronary artery dilator, increases coronary flow, myocardial oxygen consumption can be made again significantly to decline simultaneously; 2, obviously can suppress platelet aggregation, reduce blood viscosity, prevent thrombosis; Radix Angelicae Sinensis injection can increase Fibrinolysin activity, has dissolution to established thrombosis; 3, the solid ferment of blood gallbladder and triglyceride can be reduced, have the atherosclerotic effect of control; 4, arrhythmia is had, expansion peripheral blood vessel and hypotensive effect.
Rhizoma Chuanxiong, warm in nature; Gas giving off a strong fragrance, bitter in the mouth, pungent; Return liver, gallbladder habit bag warp.Slightly numb feeling in the tongue, micro-Hui Tian.[function with cure mainly] blood-activating and qi-promoting, wind-expelling pain-stopping.For menoxenia, amenorrhea dysmenorrhea, obstruction of qi in the chest and cardialgia.The effect that [pharmacological research] 1, Rhizoma Chuanxiong and extract thereof all have coronary artery dilating, increase coronary flow, reduce heart oxygen consumption; 2, Rhizoma Chuanxiong decoct can improve laboratory animal myocardial nutritional flow, alleviates myocardial ischemia reperfusion injury, therefore has function of resisting myocardial ischemia; 3, myocardial contraction can be strengthened, decreased heart rate and maintain cardiac output; And have antiarrhythmic effect; 4, can blood viscosity be reduced, accelerate erythrocyte and platelet electrophoresis, reduce fibronectin, therefore anticoagulant and thrombus effect can be played; 5, be improved cerebral circulation, expansion peripheral blood vessel, improves the effects such as microcirculation.
Fructus Crataegi, slightly warm in nature; Sour, sweet; Return spleen, stomach, Liver Channel.[function with cure mainly] promoting digestion and invigorating the stomach, circulation of qi promoting dissipating blood stasis leaf is used for meat stagnation, gastral cavilty distension, and dysentery is suffered from abdominal pain, blood stasis amenorrhea, postpartum stagnation, trusted subordinate's twinge, hernia pain; Hyperlipemia.[pharmacological action] 1, Fructus Crataegi extract have reduction blood fat and the study of anti-atherogenic effect of affirmative; 2, there is increase myocardial contraction, increase cardiac output, the effect of decreased heart rate; 3, more lasting hypotensive effect is had.
Pheretima, cold in nature, gas raw meat, salty in the mouth; Return liver, spleen, urinary bladder channel.[function with cure mainly] heat clearing away is calmed the frightened, and dredging collateral, relievings asthma, diuresis.For unconsciousness due to high fever, infantile convulsion is twitched, arthralgia; Numb limbs and tense tendons, hemiplegia, dyspnea and cough due to lung-heat, oliguria edema, vascular hypertension etc.[pharmacological research] 1, anticoagulant, antithrombotic: can blood viscosity be reduced, inhibition thrombosis; Tool fibrinolysis activity, can make established thromboembolism.2, there is antiarrhythmic effect.3, the several formulations of Pheretima has definite hypotensive effect.
Hirudo, property is put down, salty, bitter; Feeble QI raw meat is poisonous; Return liver, spleen, urinary bladder channel.[function with cure mainly] removing blood stasis, removing blood stasis, stimulates the menstrual flow.For lump in the abdomen mass in the abdomen, blood stasis amenorrhea, traumatic injury.[pharmacological research] 1, anticoagulant, inhibition thrombosis: energy significant prolongation fibronectin pool time, anticoagulant is factors activated; Reduce whole blood contrast viscosity and plasma viscosity, obvious anticoagulant, is formed with significant inhibitory action to the effect of laboratory animal coronary artery thrombosis.2, thrombolytic effect: the decocting liquid of Hirudo has very strong fibrinolysis activity, can make thromboembolism.3, blood triglyceride and beta lipoprotein can be reduced, have Prevention and Curation effect to atherosclerosis.
Sanguis Draxonis, property is put down, sweet in the mouth and salty, the sand sample of chewing; GUIXIN, Liver Channel.[function with cure mainly] dissipating blood stasis analgesic therapy, expelling pus and promoting granulation.Lose for traumatic injury, ecchymoma due to internal injury, scrofula skin infection.[pharmacological research] 1, Sanguis Draxonis energy obviously anticoagulant, and accelerate platelet electrophoresis speed, impel blood flow unimpeded, prevent thrombosis; 2, Sanguis Draxonis can reduce blood and plasma viscosity.
Borneolum Syntheticum, cold nature; There is taste fragrance clearly, acrid in the mouth, cool; GUIXIN, spleen, lung meridian.Tool volatility, [function with cure mainly] refreshment of having one's ideas straightened out, clearing away heat to alleviate pain.Faint for calentura coma, convulsion, apoplexy syncope due to accumulation of phlegm, stagnation of QI sudden syncope, attacked by pestiferous factors is gone into a coma, and conjunctival congestion, aphtha, laryngopharynx swelling and pain, auditory meatus is suppurated.[pharmacological research] 1, Borneolum Syntheticum have decreased heart rate to Canis familiaris L. Myocardial Infarction, improve coronary flow and reduce myocardial oxygen consumption effect.2, obvious protective effect is had to experiment mice myocardial ischemic injury.3, the effects such as pain relieving, calmness, antibacterial and antiinflammatory are had.
Content of the present invention is chocolate brown powder shape; Feeble QI is pungent, slightly fishy smell, bitter in the mouth, and the present invention is simultaneously relevant every regulation (China's coastal port annex IL) under meeting capsule, capsule sealing storage of the present invention.
Function with curing mainly is: benefiting QI for activating blood circulation, disperse blood stasis and dredge collateral; Expansion and tremulous pulse, anticoagulant embolism extinguishing.Cure mainly Qi deficiency blood stasis type (thoracic obstruction), that is: coronary heart disease, cerebral thrombosis and sequela thereof etc.
Below in conjunction with specific embodiment, the present invention is described in further details.
Embodiment one
Count by weight, content comprises Radix Astragali 660g, Radix Ginseng Rubra 70g, Radix Salviae Miltiorrhizae 250g, Radix Angelicae Sinensis 150g, Rhizoma Chuanxiong 150g, Fructus Crataegi 150g, Hirudo 100g, Pheretima 100g, Sanguis Draxonis 50g and Borneolum Syntheticum 30g.
Concrete preparation process is as follows:
1, Radix Ginseng Rubra, Radix Salviae Miltiorrhizae, Radix Angelicae Sinensis, Rhizoma Chuanxiong and Fructus Crataegi 5 taste decoction pieces is accurately taken by above-mentioned formula, add the alcohol reflux 2 times that volume fraction is 75%, first time adds 7 times amount (referring to crude drug weight) alcohol reflux 2 hours, second time adds 6 times amount alcohol reflux 2 hours, merge extractive liquid, filter, decompression recycling ethanol, and be concentrated into 60 DEG C heat survey relative densities be 1.32 extractum for subsequent use.
2, accurately take Radix Astragali decoction pieces by formula, merge with the medicinal residues in step 1, decoct with water 2 times, first time adds 12 times of water gagings, soaks 20 minutes, decocts 1.5 hours; Second time add 10 times of water gagings, decocts 1.5 hours, merge decoction liquor, filter, be evaporated to 60 DEG C heat survey relative densities be 1.32 thick paste for subsequent use.
3, by the extractum of step 1 and the thick paste of step 2 respectively at 58 ~ 62 DEG C of forced air dryings, then dry extract is pulverized and mixed into fine powder X with dry thick paste, for subsequent use.
4, accurately take Hirudo, Pheretima and Sanguis Draxonis decoction pieces by formula, eliminate impurity, become fine powder Y according to mixing flushing method dry pulverization process, for subsequent use.
5, the fine powder Y of the fine powder X of step 3 and step 4 is mixed, obtain powder, powder is crossed 80 ~ 100 mesh sieves, carry out dry granulation, 60 mesh sieve granulate, in powder, then spray the alcoholic solution of Borneolum Syntheticum by nebulization, stir while spray, the alcoholic solution of Borneolum Syntheticum is according to the mass fraction, be that the dissolve with ethanol of 95% is formed, and the mass ratio of Borneolum Syntheticum and ethanol is 1:1.5 by the Borneolum Syntheticum volume fraction of 30g; Obtain content, content is incapsulated in shell, the card arteries and veins profit open capsule of the cardiovascular and cerebrovascular disease that obtains medical treatment.
It is more than the amount of making 1000 capsules.
Capsule of the present invention is as hospital preparation in existing more than the 15 years history of clinical practice, and the capsule adopting the embodiment of the present invention one obtained is clinical in asymptomatic coronary ischemia patient 520 example, and within 5 years, follow up a case by regular visits to, thunder bolt incidence rate is only 0.19%; For there being symptom coronary heart disease 206 example, and compare with nifedipine (nifedipine) matched group 52 example, specific as follows:
Be case selection standard about " guideline of clinical investigations of the new Chinese medicine treatment thoracic obstruction (angina pectoris) " in " new Chinese medicine guideline of clinical investigations " that 1.1 case selections are developed and published according to Ministry of Health of the People's Republic of China for 1993.
1.2 select case 258 example altogether by standard, are divided into two groups at random.Treatment group 206 example, man 105 example, female 101 example; 37 ~ 83 years old age, average 54.6 years old; Complicated hypertension patient 79 example, hyperlipemia person 72 example, glycosuria patient 16 example, cerebral infarction sequela person 5 example, old heart infarction person 4 example.Matched group 52 example, man 25 example, female 27 example; 39 ~ 80 years old age, average 52.8 years old; Complicated hypertension person 19 example, hyperlipemia person 14 example, glycosuria patient 5 example, old heart infarction person 1 example.
1.3 liang of group cases are substantially identical in sex, age, complication etc., and statistical procedures, has comparability.
2 Therapeutic Method
The card arteries and veins profit open capsule treatment that 2.1 treatment groups adopt the present embodiment obtained.Every day three times, each 5 (0.35 gram every), oral, serve on 6 weeks, drug withdrawal is made contrast before and after treatment and is observed.
2.2 matched groups adopt the treatment of nifedipine (nifedipine) sheet.Every day three times, each l0rng, oral, serve on 6 weeks, drug withdrawal is made contrast before and after treatment and is observed.
The all cases of 2.3 treatment groups and matched group, does not all re-use the medicine of other influences observe the curative effect.
3 interpretations of result
" angina pectoris and ECG curative effect evaluation criteria " that 3.1 efficacy assessment standard principles are formulated with reference to Angina Pectoris from Coronary Artery Disease with Therapy of Combination of TCM with Western Medicines in 1979 and arrhythmia forum.
Effective: pain disappears or substantially disappears, ECG ST section, T ripple recover or return to roughly normal;
Effective: pain degree alleviates, attack times reduce, decreased duration, ECG ST section more than rise 0.05mv, the negative T wave that mainly leads shoal or T ripple by smooth straighten vertical;
Invalid: substantially without changing before pain and electrocardiogram and treatment.
In addition, also with regard to Syndrome in TCM group (cardiopalmus, breathe hard, uncomfortable in chest, chest pain), blood fat, blood rheology parameter etc. compare analysis.
3.2 curative effect to treat angina pectoris compare (see table 1)
Table 1 angina pectoris treatment effectiveness comparison number of cases (%)
From table 1, treatment group total effective rate is 89.8%, and matched group is that 69.2%, two groups of contrasts have significant difference (P<0.01).
3.3 ECG curative effect compare (see table 2)
Table 2 electrocardiogram therapeutic effect compares number of cases (%)
From table 2, treatment group total effective rate is 57.3%, and matched group is that 40.4%, two groups of contrasts have significant difference (P<0.05)
3.4 Syndrome in TCM group comparitive study
With " cardiopalmus, breathe hard, uncomfortable in chest, chest pain " for primary symptom, treatment group and matched group are carried out comparative analysis before and after treatment, after two groups of treatments, symptoms are all improved, but treatment group symptom is improved comprehensively, significantly, curative effect is higher than matched group.
3.5 hyperlipidemia comparitive study (see table 3)
Table 3 hyperlipidemia therapeutic effect compares
From table 3, compare before and after treatment, cholesterol and the triglyceride for the treatment of group all have reduction, tool significant difference (P<0.05); And matched group is without significant change (P>0.05).
3.6 blood rheology parameter compare (see table 4)
After table 4 liang group treatment, blood rheology parameter compares
From table 4, before and after treatment group treatment, hemorheological indexes compares, and all individual there were significant differences (P<0.01), and matched group is equal no significant difference (P>0.05) then.
In addition in observation process, there is headache person 16 example in matched group, flushing, perspiration, person 6 example of feeling sick, drug eruption 1 example; Treatment group does not find toxic and side effects or untoward reaction.
4 discuss
4.1 concept clinical researchs show, card arteries and veins of the present invention profit open capsule is used for the treatment of coronary heart disease 206 example, and treat 52 examples with nifedipine and compare, and the logical treatment group of outcome card arteries and veins profit, total effective rate is 89.8%, and sorbitrate matched group total effective rate is 69.2%.Therapeutic effect is better than nifedipine.
4.2 by subanalysis and statistical procedures, show after card arteries and veins profit open capsule of the present invention treatment, patients with coronary heart disease all has obvious optimum change at aspects such as angina pectoris symptom alleviation, electrocardiogram improvement, Syndrome in TCM group improvement, hyperlipidemia reduction and blood viscosity reductions, and display card arteries and veins profit open capsule has many-sided Comprehensive Treatment effect to coronary heart disease.
4.3 treatment groups compare with matched group untoward reaction, card arteries and veins profit open capsule clinical practice 206 example, do not find untoward reaction or toxic and side effects, show its use safety.
4.4 is various for treating coronary heart disease Chinese and western drugs in the market, and curative effect difficulty can people's will; Herbal species is quite a few, opinion is controlled and is differed, the present situations such as different people, different views, card arteries and veins profit open capsule of the present invention research is seted forth one's views from " coronary heart disease is make hematogenous blockage because insufficiency of heart-QI declines; be detained in network, turbid blood clotting tears, and stasis blocking heart venation is caused ", dialectical with " deficiency in origin and excess in superficiality ", with " strengthening heart and replenishing qi, operation painstaking effort; Activating blood circulation and dissipating blood stasis, removing obstruction in the collateral to relieve pain " opinion controls prescription, giving consideration to both the incidental and fundamental, vertical control comparatively thorough, therefore evident in efficacy.
4.5 card arteries and veins profit open capsule processing technology of the present invention are investigated: ethanol extraction and water extraction can separate out the effective ingredient of different material medical material to greatest extent, the pulverizing of low temperature flushing and temperature-controlled drying effectively can retain again the active component of biological medical material, thus raising drug effect, be better than similar drug.
In sum, card arteries and veins profit open capsule medicine source of the present invention is extensive, and cost is low, component is precise and appropriate rigorous, preparation process is investigated science, has effect of benefiting QI for activating blood circulation, disperse blood stasis and dredge collateral, cures mainly coronary heart disease Qi deficiency blood stasis type, therapeutic effect is remarkable, application safety is nontoxic, and effective percentage is high, belongs to fully natural green medicine, there is good compliance and development prospect, there is the great market competitiveness and economic rate of return.
Embodiment two
Count by weight, content comprises Radix Astragali 600g, Radix Ginseng Rubra 60g, Radix Salviae Miltiorrhizae 200g, Radix Angelicae Sinensis 130g, Rhizoma Chuanxiong 120g, Fructus Crataegi 120g, Hirudo 80g, Pheretima 80g, Sanguis Draxonis 40g and Borneolum Syntheticum 25g.
Concrete preparation process is as follows:
1, Radix Ginseng Rubra, Radix Salviae Miltiorrhizae, Radix Angelicae Sinensis, Rhizoma Chuanxiong and Fructus Crataegi 5 taste decoction pieces is accurately taken by above-mentioned formula, add the alcohol reflux 2 times that volume fraction is 72%, first time adds 7 times amount (referring to crude drug weight) alcohol reflux 2 hours, second time adds 6 times amount alcohol reflux 2 hours, merge extractive liquid, filter, decompression recycling ethanol, and be concentrated into 60 DEG C heat survey relative densities be 1.31 extractum for subsequent use.
2, accurately take Radix Astragali decoction pieces by formula, merge with the medicinal residues in step 1, decoct with water 2 times, first time adds 12 times of water gagings, soaks 20 minutes, decocts 1.5 hours; Second time add 10 times of water gagings, decocts 1.5 hours, merge decoction liquor, filter, be evaporated to 60 DEG C heat survey relative densities be 1.31 thick paste for subsequent use.
3, by the extractum of step 1 and the thick paste of step 2 respectively at 60 DEG C of forced air dryings, then dry extract is pulverized and mixed into fine powder X with dry thick paste, for subsequent use.
4, accurately take Hirudo, Pheretima and Sanguis Draxonis decoction pieces by formula, eliminate impurity, become fine powder Y according to mixing flushing method dry pulverization process, for subsequent use.
5, the fine powder Y of the fine powder X of step 3 and step 4 is mixed, obtain powder, powder is crossed 80 mesh sieves, carry out dry granulation, 60 mesh sieve granulate, in powder, then spray the alcoholic solution of Borneolum Syntheticum by nebulization, stir while spray, the alcoholic solution of Borneolum Syntheticum is according to the mass fraction, be that the dissolve with ethanol of 95% is formed, and the mass ratio of Borneolum Syntheticum and ethanol is 1:1.5 by the Borneolum Syntheticum volume fraction of 25g; Obtain content, content is incapsulated in shell, the card arteries and veins profit open capsule of the cardiovascular and cerebrovascular disease that obtains medical treatment.
Embodiment three
Count by weight, content comprises Radix Astragali 700g, Radix Ginseng Rubra 65g, Radix Salviae Miltiorrhizae 240g, Radix Angelicae Sinensis 180g, Rhizoma Chuanxiong 180g, Fructus Crataegi 180g, Hirudo 120g, Pheretima 120g, Sanguis Draxonis 60g and Borneolum Syntheticum 35g.
Concrete preparation process is as follows:
1, Radix Ginseng Rubra, Radix Salviae Miltiorrhizae, Radix Angelicae Sinensis, Rhizoma Chuanxiong and Fructus Crataegi 5 taste decoction pieces is accurately taken by above-mentioned formula, add the alcohol reflux 2 times that volume fraction is 78%, first time adds 7 times amount (referring to crude drug weight) alcohol reflux 2 hours, second time adds 6 times amount alcohol reflux 2 hours, merge extractive liquid, filter, decompression recycling ethanol, and be concentrated into 60 DEG C heat survey relative densities be 1.33 extractum for subsequent use.
2, accurately take Radix Astragali decoction pieces by formula, merge with the medicinal residues in step 1, decoct with water 2 times, first time adds 12 times of water gagings, soaks 20 minutes, decocts 1.5 hours; Second time add 10 times of water gagings, decocts 1.5 hours, merge decoction liquor, filter, be evaporated to 60 DEG C heat survey relative densities be 1.33 thick paste for subsequent use.
3, by the extractum of step 1 and the thick paste of step 2 respectively at 61 DEG C of forced air dryings, then dry extract is pulverized and mixed into fine powder X with dry thick paste, for subsequent use.
4, accurately take Hirudo, Pheretima and Sanguis Draxonis decoction pieces by formula, eliminate impurity, become fine powder Y according to mixing flushing method dry pulverization process, for subsequent use.
5, the fine powder Y of the fine powder X of step 3 and step 4 is mixed, obtain powder, powder is crossed 100 mesh sieves, carry out dry granulation, 60 mesh sieve granulate, in powder, then spray the alcoholic solution of Borneolum Syntheticum by nebulization, stir while spray, the alcoholic solution of Borneolum Syntheticum is according to the mass fraction, be that the dissolve with ethanol of 95% is formed, and the mass ratio of Borneolum Syntheticum and ethanol is 1:1.5 by the Borneolum Syntheticum volume fraction of 30g; Obtain content, content is incapsulated in shell, the card arteries and veins profit open capsule of the cardiovascular and cerebrovascular disease that obtains medical treatment.
Embodiment four
Count by weight, content comprises Radix Astragali 640g, Radix Ginseng Rubra 55g, Radix Salviae Miltiorrhizae 230g, Radix Angelicae Sinensis 140g, Rhizoma Chuanxiong 140g, Fructus Crataegi 140g, Hirudo 95g, Pheretima 90g, Sanguis Draxonis 48g and Borneolum Syntheticum 30g.
By the card arteries and veins profit open capsule of the step preparation treatment cardiovascular and cerebrovascular disease of above embodiment one to embodiment three.
Embodiment five
Count by weight, content comprises Radix Astragali 680g, Radix Ginseng Rubra 68g, Radix Salviae Miltiorrhizae 240g, Radix Angelicae Sinensis 160g, Rhizoma Chuanxiong 160g, Fructus Crataegi 160g, Hirudo 110g, Pheretima 110g, Sanguis Draxonis 55g and Borneolum Syntheticum 35g.
By the card arteries and veins profit open capsule of the step preparation treatment cardiovascular and cerebrovascular disease of above embodiment one to embodiment three.
Embodiment six
Count by weight, content comprises Radix Astragali 620g, Radix Ginseng Rubra 50g, Radix Salviae Miltiorrhizae 190g, Radix Angelicae Sinensis 120g, Rhizoma Chuanxiong 130g, Fructus Crataegi 130g, Hirudo 90g, Pheretima 85g, Sanguis Draxonis 44g and Borneolum Syntheticum 25g.
By the card arteries and veins profit open capsule of the step preparation treatment cardiovascular and cerebrovascular disease of above embodiment one to embodiment three.
Claims (10)
1. treat the card arteries and veins profit open capsule of cardiovascular and cerebrovascular disease, it is characterized in that: comprise content and capsule shells, count by weight, content is made up of following component: the Radix Astragali 600 ~ 700 parts, Radix Ginseng Rubra 50 ~ 70 parts, Radix Salviae Miltiorrhizae 190 ~ 250 parts, Radix Angelicae Sinensis 120 ~ 180 parts, Rhizoma Chuanxiong 120 ~ 180 parts, Fructus Crataegi 120 ~ 180 parts, Hirudo 80 ~ 120 parts, Pheretima 80 ~ 120 parts, Sanguis Draxonis 40 ~ 60 parts and Borneolum Syntheticum 25 ~ 35 parts.
2. treat the preparation method of the card arteries and veins profit open capsule of cardiovascular and cerebrovascular disease, it is characterized in that: comprise the following steps:
(1) according to the mass fraction, get Radix Ginseng Rubra 50 ~ 70 parts, Radix Salviae Miltiorrhizae 190 ~ 250 parts, Radix Angelicae Sinensis 120 ~ 180 parts, Rhizoma Chuanxiong 120 ~ 180 parts and Fructus Crataegi 120 ~ 180 parts, add alcohol reflux, filter and obtain extracting solution and medicinal residues, extracting solution is condensed into the extractum that relative density is 1.31 ~ 1.33;
(2) according to the mass fraction, get the Radix Astragali 600 ~ 700 parts and mix with the medicinal residues in step (1), decoct with water rear filtration, concentrate filtrate to the thick paste that relative density is 1.31 ~ 1.33;
(3) by after the thick paste of the extractum of step (1) and step (2) respectively drying, fine powder X is pulverized and mixed into;
(4) according to the mass fraction, water intaking trematodiasis 80 ~ 120 parts, Pheretima 80 ~ 120 parts and Sanguis Draxonis 40 ~ 60 parts, adopt mixing flushing method to be ground into fine powder Y;
(5) by the fine powder Y mix homogeneously of the fine powder X of step (3) and step (4), obtain powder, powder is sieved, carry out granulating and granulate, then spray the alcoholic solution of Borneolum Syntheticum, according to the mass fraction, containing the Borneolum Syntheticum of 25 ~ 35 parts in the alcoholic solution of Borneolum Syntheticum, obtain content, content is incapsulated in shell, the card arteries and veins profit open capsule of the cardiovascular and cerebrovascular disease that obtains medical treatment.
3. the preparation method of the card arteries and veins profit open capsule for the treatment of cardiovascular and cerebrovascular disease according to claim 2, is characterized in that: in step (1), ethanol adopts volume fraction to be the ethanol of 72% ~ 78%.
4. the preparation method of the card arteries and veins profit open capsule of the treatment cardiovascular and cerebrovascular disease according to Claims 2 or 3, it is characterized in that: reflux, extract, twice in step (1), wherein the alcohol reflux 2h adding 7 times amount for the first time, second time is the alcohol reflux 2h adding 6 times amount, and decompression recycling ethanol after merge extractive liquid.
5. the preparation method of the card arteries and veins profit open capsule for the treatment of cardiovascular and cerebrovascular disease according to claim 2, it is characterized in that: decoct twice in step (2), wherein add 12 times of water gagings for the first time, soak 20 minutes, decoct 1.5 hours, second time adds 10 times of water gagings, decocts 1.5 hours, merges decoction liquor.
6. the preparation method of the card arteries and veins profit open capsule for the treatment of cardiovascular and cerebrovascular disease according to claim 2, is characterized in that: the relative density in step (1) and step (2) all records at 60 DEG C.
7. the preparation method of the card arteries and veins profit open capsule for the treatment of cardiovascular and cerebrovascular disease according to claim 2, is characterized in that: be in 58 ~ 62 DEG C of vacuum dryings or forced air drying in step (3).
8. the preparation method of the card arteries and veins profit open capsule for the treatment of cardiovascular and cerebrovascular disease according to claim 2, is characterized in that: the alcoholic solution spraying Borneolum Syntheticum in step (5) by nebulization, stirs in sprinkling process.
9. the preparation method of the card arteries and veins profit open capsule for the treatment of cardiovascular and cerebrovascular disease according to claim 2, it is characterized in that: the alcoholic solution of Borneolum Syntheticum in step (5), be by Borneolum Syntheticum volume fraction be 95% dissolve with ethanol formed, and the mass ratio of Borneolum Syntheticum and ethanol is 1:1.5.
10. the preparation method of the card arteries and veins profit open capsule for the treatment of cardiovascular and cerebrovascular disease according to claim 2, is characterized in that: in step (5), 80 ~ 100 mesh sieves crossed by powder, adopts dry granulation, 60 mesh sieve granulate.
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN115475238A (en) * | 2022-09-07 | 2022-12-16 | 上海涌莱医疗技术服务有限公司 | A kind of traditional Chinese medicine composition for treating cardiovascular and cerebrovascular diseases |
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| CN1119116A (en) * | 1995-08-08 | 1996-03-27 | 王文惠 | Medicine for curing angiocardiopathy and cerebrovascular diseases and preparing process thereof |
| CN1334121A (en) * | 2001-08-31 | 2002-02-06 | 石家庄以岭药业有限公司 | Medicinal composition for restoring cardiac collaterals and its application |
| CN101884661A (en) * | 2009-05-14 | 2010-11-17 | 御盛隆堂药业有限责任公司 | Traditional Chinese medical preparation containing leeches and astragalus and used for treating cardiovascular and cerebrovascular diseases |
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Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1119116A (en) * | 1995-08-08 | 1996-03-27 | 王文惠 | Medicine for curing angiocardiopathy and cerebrovascular diseases and preparing process thereof |
| CN1334121A (en) * | 2001-08-31 | 2002-02-06 | 石家庄以岭药业有限公司 | Medicinal composition for restoring cardiac collaterals and its application |
| CN101884661A (en) * | 2009-05-14 | 2010-11-17 | 御盛隆堂药业有限责任公司 | Traditional Chinese medical preparation containing leeches and astragalus and used for treating cardiovascular and cerebrovascular diseases |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN115475238A (en) * | 2022-09-07 | 2022-12-16 | 上海涌莱医疗技术服务有限公司 | A kind of traditional Chinese medicine composition for treating cardiovascular and cerebrovascular diseases |
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