CN1557416A - Medicine preparation for treating cardiovascular and cerebrovascular diseases and its preparing process - Google Patents

Medicine preparation for treating cardiovascular and cerebrovascular diseases and its preparing process Download PDF

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Publication number
CN1557416A
CN1557416A CNA2004100160721A CN200410016072A CN1557416A CN 1557416 A CN1557416 A CN 1557416A CN A2004100160721 A CNA2004100160721 A CN A2004100160721A CN 200410016072 A CN200410016072 A CN 200410016072A CN 1557416 A CN1557416 A CN 1557416A
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China
Prior art keywords
calculus bovis
moschus
parts
artificial
pharmaceutical preparation
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CNA2004100160721A
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Inventor
刘志盈
戴瑞鸿
劳三申
丁建弥
康爱仙
陈忠樑
徐瑞林
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HEHUANG PHARMACEUTICAL CO Ltd SHANGHAI
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HEHUANG PHARMACEUTICAL CO Ltd SHANGHAI
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Priority to CNA2004100160721A priority Critical patent/CN1557416A/en
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Abstract

The present invention belongs to the field of Chinese medicine technology, and is one kind of medicine preparation for treating cardiac vascular diseases. Based on Chinese medicine theory, the present invention adopts Chinese medicine materials including musk, ginseng extractive, toad cake, bezoar, cassia, styracin and plum blossom borneol as material to prepare the medicine preparation for treating coronary heart disease as well as angina pectoris, chest stuffiness and myocardial infarction. The medicine has the features of fast acting, lasting effect, small dosage, convenient taking, high safety, less side effect, etc. and is one of the optimal selections for treating cardiac vascular diseases.

Description

A kind of pharmaceutical preparation for the treatment of cardiovascular disease and preparation method thereof
Technical field
The invention belongs to tcm field, relate to a kind of pharmaceutical preparation for the treatment of cardiovascular disease, be specifically related to preparation that contains raw material for treating cardiovascular disease such as Chinese medicine Moschus and preparation method thereof,
Background technology
Along with the social development material abundance, people's living standard improves day by day, and the prevalence of the disease that various serious harm people are healthy is also constantly being climbed to a higher point, and wherein cardiovascular disease is particularly outstanding as coronary heart disease.Clinical treatment coronary heart disease Chinese medicine and western medicine dual-purpose wherein, can be used for treating and the Chinese medicine preparation that prevents just has some kinds, as: Chinese medicine Styrax Pilulae, Styrax Pilulae+Subing drop pills, Radix Ginseng Styrax Pilulae etc.The Chinese medicine Styrax Pilulae comes from " balance The Bureau of People's Welfare Pharmacies side ", mainly contains Styrax, Borneolum Syntheticum, Moschus, Lignum Aquilariae Resinatum, Rhizoma Cyperi, the Radix Aucklandiae, Lignum Santali Albi, the Rhizoma Atractylodis Macrocephalae, Cinnabaris etc.The side is a principal agent with Styrax, Borneolum Syntheticum, Moschus, and fragrance is walked to scurry, eliminating phlegm for resuscitation; Be aided with the logical pain relieving of temperature of regulating the flow of vital energy such as Lignum Aquilariae Resinatum, Rhizoma Cyperi, the Radix Aucklandiae, Lignum Santali Albi; Assistant is with Rhizoma Atractylodis Macrocephalae the spleen strengthening and damp drying; The Cinnabaris tranquillizing and allaying excitement.All medicines share, for eliminating cold for resuscitation is represented agent.Subing drop pills ties up to further research on the storax pill for treating coronary heart disease basis, and medicine is done further to screen and make.The side mainly has been that fragrance is walked to scurry with Styrax, Borneolum Syntheticum, coronary circulation-promoting pain-relieving, and two medicines are harmonious, and can play quick-acting.Pharmacological research shows that this product has coronary artery dilating, effects such as allevating angina pectoris.Clinical in uncomfortable in chest due to the coronary heart disease, the treatment of diseases such as angina pectoris and myocardial infarction, relief of symptoms rapidly.
Summary of the invention
The purpose of this invention is to provide a kind of taking convenience, pharmaceutical preparation of safe treatment cardiovascular disease and preparation method thereof.
The present invention thinks the angina pectoris that " heart arteries and veins is obstructed " causes according to motherland's medical science; possible pathogenesis be " cold-evil enemy intrusion or invasion ", can be by " aromatic herbs activating YANG " method of treatment, reach the theory of " regulating QI to relieve pain ", adopt Chinese crude drug Moschus or artificial Moschus, Radix Ginseng extract, Venenum Bufonis, Calculus Bovis or artificial Calculus Bovis, Calculus Bovis cultivating, In vitro cultured Calculus Bovis, Cortex Cinnamomi, styrax, MEIHUA BINGPIAN or Borneolum Syntheticum (borneolum syntheticum) to make the pharmaceutical preparation for the treatment of cardiovascular disease for raw material.
Raw material of the present invention, wherein Moschus is the dry secretions in the ripe male body note capsule of animal in deer family woods Moschus moschiferous Moschus berezovskiiFlerov, horse Moschus moschiferous Moschus sifanicus Przewalski or former Moschus moschiferous Moschus moschiferusLinnaeus, or artificial Moschus, have blood pressure lowering and decreased heart rate, the excited heart effect of antagonism isoproterenol; Radix Ginseng is the dry root of Araliaceae Radix Ginseng Panax ginseng C.A.Mey., has blood fat reducing, antioxidation, anticoagulant, positive inotropic, and described people makes Radix Ginseng extract through vacuum drying after participating in ethanol extraction and concentrating under reduced pressure; Venenum Bufonis is the dry secretions of big Venenum Bufonis Bufo bufo gargarizans Cantor of animal China of Venenum Bufonis section or black socket of the eye Venenum Bufonis Bufo melanostictusSchneider, has cardiotonic; Calculus Bovis is the exsiccant cholelithiasis of bovid cattle Bos Taurusdomesticus Gmelin, or artificial Calculus Bovis, Calculus Bovis cultivating, In vitro cultured Calculus Bovis, has heart tonifying, strengthens myocardial contraction; Cortex Cinnamomi is the dry bark of canella Cortex Cinnamomi Cinnamomum cassia Presl, and the energy blood vessel dilating improves the Ischemic Heart local microcirculation; Styrax is the balsam that the trunk of Hamamelidaceae plant Styrax tree Liquidambar orientalis Mill. oozes out; MEIHUA BINGPIAN is the natural crystallinity chemical compound of separating out in the resin of Dipterocarpaceae plant borneo camphor tree, or Borneolum Syntheticum (borneolum syntheticum), has decreased heart rate, reduces myocardium keto consumption, alleviates the effect of coronary vasospasm.
Each component weight portion content is in the pharmaceutical preparation of the present invention:
Moschus or artificial Moschus 0.1-1 part, Radix Ginseng extract 15.5-155 part, Calculus Bovis or artificial Calculus Bovis, Calculus Bovis cultivating, In vitro cultured Calculus Bovis 2-20 part, Cortex Cinnamomi 10-100 part, Styrax 0.2-2 part, Venenum Bufonis 0.12-1.2 part, MEIHUA BINGPIAN or Borneolum Syntheticum 7.5-75 part.
Preferred each component weight portion content is in the pharmaceutical preparation of the present invention:
Moschus or artificial Moschus 0.3-1 part, Radix Ginseng extract 15.5-75 part, Calculus Bovis or artificial Calculus Bovis, Calculus Bovis cultivating, In vitro cultured Calculus Bovis 2-10 part, Cortex Cinnamomi 10-50 part, Styrax 0.6-2 part, Venenum Bufonis 0.3-1.2 part, MEIHUA BINGPIAN or Borneolum Syntheticum 7.5-25 part.
In the pharmaceutical preparation of the present invention most preferably each component weight portion content be:
1 part of Moschus or artificial Moschus, 15.5 parts of Radix Ginseng extracts, 2 parts of Calculus Bovis or artificial Calculus Bovis, Calculus Bovis cultivating, In vitro cultured Calculus Boviss, 10 parts of Cortex Cinnamomis, 2 parts of Styrax, 1.2 parts of Venenum Bufoniss, 7.5 parts of MEIHUA BINGPIAN or Borneolum Syntheticums.
In the GMP cleaning shop; prepare this pharmaceutical preparation by conventional herbal pharmaceutical method, wherein the people participates in 75% medicinal alcohol through reflux, extract, three times, each 1 hour; merge the reflux extracting liquid concentrating under reduced pressure; vacuum drying makes Radix Ginseng extract, pulverizes back and Moschus or artificial Moschus, Calculus Bovis or artificial Calculus Bovis, Calculus Bovis cultivating, In vitro cultured Calculus Bovis, Cortex Cinnamomi, Venenum Bufonis, MEIHUA BINGPIAN or Borneolum Syntheticum, grind to form fine powder after; add formula ratio Styrax and Chinese liquor; make pill, tablet, granule and capsule.
Pharmaceutical preparation of the present invention has aromatic herbs activating YANG, the function that invigorates vital energy and reinforce the heart, and its main pharmacological is a coronary artery dilator, improves myocardial ischemia, and the protection vascular endothelial function reduces the heart infarction area, improves left ventricular remodeling, promotes angiogenesis, sets up collateral circulation.Can be used for treating angina pectoris, the uncomfortable in chest and myocardial infarction that myocardial ischemia causes, it is rapid to have the onset of being, effect is lasting, alleviates symptom uncomfortable in chest rapidly, reduces the characteristics of anginal seizure frequency, compare with traditional Chinese patent medicine, using dosage is little, and taking convenience is safe, the side effect incidence rate is low, is one of optimum selection of treatment cardiovascular disease.
The specific embodiment
Embodiment 1 preparation pill of the present invention
In the GMP cleaning shop, take off 1 part of the Moschus of stating weight portion or artificial Moschus respectively, 15.5 parts of Radix Ginseng extracts; 2 parts of Calculus Bovis or artificial Calculus Bovis, Calculus Bovis cultivating, In vitro cultured Calculus Boviss, 10 parts of Cortex Cinnamomis, 2 parts of Styrax; 1.2 parts of Venenum Bufoniss, 7.5 parts of MEIHUA BINGPIAN or Borneolum Syntheticums are with above seven flavors; except that Styrax; all the other Six-elements are ground into 80 order fine powders altogether, and it is an amount of to add Chinese liquor with the formula ratio Styrax, the general ball of making; cold drying, promptly.
Embodiment 2 preparations pill of the present invention
In the GMP cleaning shop, take off 0.3 part of the Moschus of stating weight portion or artificial Moschus respectively, 46.5 parts of Radix Ginseng extracts; 6 parts of Calculus Bovis or artificial Calculus Bovis, Calculus Bovis cultivating, In vitro cultured Calculus Boviss, 30 parts of Cortex Cinnamomis, 0.6 part of Styrax; 0.36 part of Venenum Bufonis, 22.5 parts of MEIHUA BINGPIAN or Borneolum Syntheticums are with above seven flavors; except that Styrax; all the other Six-elements are ground into 80 order fine powders altogether, and it is an amount of to add Chinese liquor with the formula ratio Styrax, the general ball of making; cold drying, promptly.
Embodiment 3 preparations pill of the present invention
In the GMP cleaning shop, take off 0.5 part of the Moschus of stating weight portion or artificial Moschus respectively, 75 parts of Radix Ginseng extracts; 10 parts of Calculus Bovis or artificial Calculus Bovis, Calculus Bovis cultivating, In vitro cultured Calculus Boviss, 50 parts of Cortex Cinnamomis, 1 part of Styrax; 0.6 part of Venenum Bufonis, 75 parts of MEIHUA BINGPIAN or Borneolum Syntheticums are with above seven flavors; except that Styrax; all the other Six-elements are ground into 80 order fine powders altogether, and it is an amount of to add Chinese liquor with the formula ratio Styrax, the general ball of making; cold drying, promptly.
Embodiment 4 preparations tablet of the present invention
In the GMP cleaning shop; get 10 parts of Cortex Cinnamomis, 1.2 parts of Venenum Bufoniss respectively, be ground into 80 order fine powders; Styrax adds appropriate amount of auxiliary materials for 2 parts and absorbs, grinds well; in addition with Moschus or 1 part of artificial Moschus, Calculus Bovis or artificial Calculus Bovis, Calculus Bovis cultivating, 2 parts of In vitro cultured Calculus Boviss, MEIHUA BINGPIAN or 7.5 parts of Borneolum Syntheticums, 15.5 parts of Radix Ginseng extracts; be ground into 80 order fine powders with ball mill; with above-mentioned powder facing-up, mixing.With said medicine powder and adjuvant facing-up, mixing, dry granulation is pressed into 1000, film coating, promptly.
Embodiment 5 preparations tablet of the present invention
In the GMP cleaning shop; get 30 parts of Cortex Cinnamomis, 0.36 part of Venenum Bufonis respectively, be ground into 80 order fine powders; Styrax adds appropriate amount of auxiliary materials for 0.6 part and absorbs, grinds well; in addition with Moschus or 0.3 part of artificial Moschus, Calculus Bovis or artificial Calculus Bovis, Calculus Bovis cultivating, 6 parts of In vitro cultured Calculus Boviss, MEIHUA BINGPIAN or 22.5 parts of Borneolum Syntheticums, 46.5 parts of Radix Ginseng extracts; be ground into 80 order fine powders with ball mill; with above-mentioned powder facing-up, mixing.With said medicine powder and adjuvant facing-up, mixing, dry granulation is pressed into 1000, film coating, promptly.
Embodiment 6 preparations tablet of the present invention
In the GMP cleaning shop; get 50 parts of Cortex Cinnamomis, 0.6 part of Venenum Bufonis respectively, be ground into 80 order fine powders; Styrax adds appropriate amount of auxiliary materials for 1 part and absorbs, grinds well; in addition with Moschus or 0.5 part of artificial Moschus, Calculus Bovis or artificial Calculus Bovis, Calculus Bovis cultivating, 10 parts of In vitro cultured Calculus Boviss, MEIHUA BINGPIAN or 75 parts of Borneolum Syntheticums, 75 parts of Radix Ginseng extracts; be ground into 80 order fine powders with ball mill; with above-mentioned powder facing-up, mixing.With said medicine powder and adjuvant facing-up, mixing, dry granulation is pressed into 1000, film coating, promptly.
Embodiment 7 preparations granule of the present invention
In the GMP cleaning shop; get 10 parts of Cortex Cinnamomis, 1.2 parts of Venenum Bufoniss respectively, be ground into 80 order fine powders; Styrax adds appropriate amount of auxiliary materials for 2 parts and absorbs, grinds well; in addition with Moschus or 1 part of artificial Moschus, Calculus Bovis or artificial Calculus Bovis, Calculus Bovis cultivating, 2 parts of In vitro cultured Calculus Boviss, MEIHUA BINGPIAN or 7.5 parts of Borneolum Syntheticums, 15.5 parts of Radix Ginseng extracts; be ground into 80 order fine powders with ball mill; with above-mentioned powder facing-up, mixing.With said medicine powder and adjuvant facing-up, mixing, dry granulation is packed 1000 bags, promptly.
Embodiment 8 preparations granule of the present invention
In the GMP cleaning shop; get 30 parts of Cortex Cinnamomis, 0.36 part of Venenum Bufonis respectively, be ground into 80 order fine powders; Styrax adds appropriate amount of auxiliary materials for 0.6 part and absorbs, grinds well; in addition with Moschus or 0.3 part of artificial Moschus, Calculus Bovis or artificial Calculus Bovis, Calculus Bovis cultivating, 6 parts of In vitro cultured Calculus Boviss, MEIHUA BINGPIAN or 22.5 parts of Borneolum Syntheticums, 46.5 parts of Radix Ginseng extracts; be ground into 80 order fine powders with ball mill; with above-mentioned powder facing-up, mixing.With said medicine powder and adjuvant facing-up, mixing, dry granulation is packed 1000 bags, promptly.
Embodiment 9 preparations granule of the present invention
In the GMP cleaning shop; get 50 parts of Cortex Cinnamomis, 0.6 part of Venenum Bufonis respectively, be ground into 80 order fine powders; Styrax adds appropriate amount of auxiliary materials for 1 part and absorbs, grinds well; in addition with Moschus or 0.5 part of artificial Moschus, Calculus Bovis or artificial Calculus Bovis, Calculus Bovis cultivating, 10 parts of In vitro cultured Calculus Boviss, MEIHUA BINGPIAN or 75 parts of Borneolum Syntheticums, 75 parts of Radix Ginseng extracts; be ground into 80 order fine powders with ball mill; with above-mentioned powder facing-up, mixing.With said medicine powder and adjuvant facing-up, mixing, dry granulation is packed 1000 bags, promptly.
Embodiment 10 preparations capsule of the present invention
In the GMP cleaning shop; get 10 parts of Cortex Cinnamomis, 1.2 parts of Venenum Bufoniss respectively, be ground into 80 order fine powders; Styrax adds appropriate amount of auxiliary materials for 2 parts and absorbs, grinds well; in addition with Moschus or 1 part of artificial Moschus, Calculus Bovis or artificial Calculus Bovis, Calculus Bovis cultivating, 2 parts of In vitro cultured Calculus Boviss, MEIHUA BINGPIAN or 7.5 parts of Borneolum Syntheticums, 15.5 parts of Radix Ginseng extracts; be ground into 80 order fine powders with ball mill; with above-mentioned powder facing-up, mixing.With said medicine powder and adjuvant facing-up, mixing, dry granulation adds incapsulating 1000 balls, packing, promptly.
Embodiment 11 preparations capsule of the present invention
In the GMP cleaning shop; get 30 parts of Cortex Cinnamomis, 0.36 part of Venenum Bufonis respectively, be ground into 80 order fine powders; Styrax adds appropriate amount of auxiliary materials for 0.6 part and absorbs, grinds well; in addition with Moschus or 0.3 part of artificial Moschus, Calculus Bovis or artificial Calculus Bovis, Calculus Bovis cultivating, 6 parts of In vitro cultured Calculus Boviss, MEIHUA BINGPIAN or 22.5 parts of Borneolum Syntheticums, 46.5 parts of Radix Ginseng extracts; be ground into 80 order fine powders with ball mill; with above-mentioned powder facing-up, mixing.With said medicine powder and adjuvant facing-up, mixing, dry granulation adds incapsulating 1000 balls, packing, promptly.
Embodiment 12 preparations capsule of the present invention
In the GMP cleaning shop; get 50 parts of Cortex Cinnamomis, 0.6 part of Venenum Bufonis respectively, be ground into 80 order fine powders; Styrax adds appropriate amount of auxiliary materials for 1 part and absorbs, grinds well; in addition with Moschus or 0.5 part of artificial Moschus, Calculus Bovis or artificial Calculus Bovis, Calculus Bovis cultivating, 10 parts of In vitro cultured Calculus Boviss, MEIHUA BINGPIAN or 75 parts of Borneolum Syntheticums, 75 parts of Radix Ginseng extracts; be ground into 80 order fine powders with ball mill; with above-mentioned powder facing-up, mixing.With said medicine powder and adjuvant facing-up, mixing, dry granulation adds incapsulating 1000 balls, packing, promptly.
Embodiment 13 acute toxicity tests
Adopt preparation pulverize of the present invention, (CMC) is mixed with 0.35g/ml with 1% sodium carboxymethyl cellulose, to mouse stomach, laboratory animal: 50 of ICR mices, male and female half and half, and body weight 18-22g (extra large western pul-must triumphant laboratory animal company limited, Shanghai is moving closes the card word No. 150), fasting is 12 hours before the test, can't help water.
Gavage each 10 of mices respectively with preparation 3,5 of the present invention, 7g/Kg dosage, male and female half and half, result show 3,5,7g/Kg dosage treated animal has phenomenons such as rapid breathing or jump, especially with 7g/Kg dosage treated animal for very, but not seeing has animal dead, carries out mtd test then.Get 20 of mices, male and female half and half are pressed heap(ed) capacity 7g/Kg gastric infusion after the fasting.Free diet after the administration.The same day and each observation of every day at upper and lower noon later on once continuous seven days, are write down death state and the toxic reaction of animal in seven days.
The result shows, gavages pharmaceutical preparation 7g/Kg of the present invention, finds that at once animal has phenomenons such as rapid breathing or jump, but none death.Show that it is 7g/Kg to the maximum tolerated dose of mice that the present invention irritates stomach, quite clinical application amount (more than 2000 times of 22.5mg * 6/50Kg/ day=2.7mg/Kg).
Embodiment 14 long term toxicity tests
Preparation of the present invention grinds and dilution with 1%CMC, is mixed with 0.35g/ml, and the long term toxicity of observing gavage rat in continuous three months reacts, and taking for a long time and enlarge the clinical scope of application for this medicine provides the safety foundation.
The present invention irritates stomach SD rat (Shanghai west pul-must triumphant laboratory animal company limited, Shanghai is moving closes the card word No. 152), once a day, inferior on every Saturdays, continuous three months, dosage was 8mg/kg, 40mg/kg, 200mg/kg, and the odd-numbered day maximum dose level is 74 times of clinical plan consumption.The result shows that the present invention detects the naked eyes and the pathological tissue of general symptom, body weight, food consumption, blood, biochemistry, urine and the main organs of rat, there is no tangible pathological change.
High, medium and low three dosage medication groups and matched group are established in experiment.30 of every group of rats, female, male half and half.
High dose group (H) 200ml/Kg, 74 times of the suitable clinical dosage of odd-numbered day consumption,
In dosage group (M) 40ml/Kg, 15 times of the suitable clinical dosage of odd-numbered day consumption,
Low dose group (L) 8ml/Kg, 3 times of the suitable clinical dosage of odd-numbered day consumption,
Capacity 1%CMC such as blank group.
The medication approach is irritated stomach; Cycle is once a day, and is inferior on every Saturdays, and continuous three months, drug withdrawal convalescent period observation one month; Capacity is pressed the administration of 20ml/Kg body weight, adjusts dosage with body weight weekly.
Test item:
(1) the general symptom outward appearance sign of observing animal every day, behavioral activity, the situation of ingesting, consumption is weighed, eaten to feces character etc. weekly.
(2) hematology detects: RBC number (RBC), leukocyte count (WBC), hemoglobin (HGB), packed cell volume (HCT), mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCHC), platelet count (PLT), clotting time (CT), reticulocyte (RET), and leukocyte differential count.
(3) serum biochemistry detects: alanine aminotransferase (ALT), aspartic transaminase (AST), alkali phosphatase (ALP), blood urea nitrogen (BUN), creatinine (CRE), total bilirubin (TBIL), total protein (TP), albumin (ALB), T-CHOL (TCHO) and blood glucose (GLU).
(4) urine detection: nitrite (NIT), pH-value (PH), glucose in urine (GLU), urine protein (PRO), occult blood (BLD), ketoboidies (KET), bilirubin (BIL), urobilinogen (URO).
(5) pathological examination: the animal that becomes celestial substantially is with 3% pentobarbital sodium anesthesia back sacrificed by exsanguination, and system becomes celestial, and gets main organs and makes macroscopy.Organ weights and organ coefficient are measured the heart, liver, spleen, lung, kidney, adrenal gland, prostate, testis, uterus, ovary, brain, thyroid.Accurately take by weighing the internal organs weight in wet base and calculate organ coefficient [organ weights (g) ÷ body weight (Kg) * 1,000 ‰].Histology's microscopy heart, liver, spleen, lung, kidney, adrenal gland, thymus, thyroid, stomach, prostate, testis, ovary, uterus, brain.Internal organs are done paraffin section, H.E dyeing, carry out histology's microscopy.Detect around the frequency administration, 13 weeks, drug withdrawal are during five weeks, respectively get 1/3 animal, in the blood-letting of carotid artery place, carry out above-mentioned projects and detect.T check between equal array is adopted in data statistics.
Used detecting instrument of the present invention and reagent: blood analyser SYSMEX F-800, diluent SYSMEX product, biochemistry analyzer BECKMAN 700, biochemical measurement agent Shanghai Long March company product, Urine Analyzer MA-4210 detects reagent paper Guilin and cures electric instrument plant product.
The result shows, the SD rat gavages pharmaceutical preparation of the present invention 3 months continuously, when dosage is 8mg/kg, 40mg/kg, 200mg/kg, administration group activities in rats situation, expression react all no abnormal, average weight increases, the food consumption increases, compare zero difference with control rats, also do not find overt toxicity reaction and dead.Pathological examination results such as rat postmortem substantially, internal organs weight in wet base, organ coefficient mensuration and histology's microscopy show, each medication group and corresponding matched group are than equal no significant difference, animal subject target organ cardiac structure and cardiac muscle fiber are arranged normal, and kidney, spleen structure are not seen yet unusual change.The result proves that long term toxicity test SD rat gavages pharmaceutical preparation of the present invention 3 months continuously, and dosage does not have tangible toxic reaction when being 8mg/kg, 40mg/kg, 200mg/kg.
Embodiment 15 pharmaceutical preparatioies of the present invention are tested in the clinical treatment effect
1, improves the effect of myocardial ischemia
Adopt intravenous injection persantin cardiac muscle radioisotope scan imaging technique (99mTc-MIBI SPECT developing) to estimate the influence of the present invention to myocardial blood flow, the heart sympton that persantin is caused alleviates 85%, among the damaged patient of 11 routine heart muscle perfusions after the 8 routine medications heart muscle perfusion obviously improve total effective rate 70.6%.Clinical symptoms curative effect total effective rate 88.5% after 46 examples worsen the exertional angina pectoris patient treatment, the electrocardiogram effective percentage is 84.6%, treatment back myocardial imaging ischemic areas obviously reduces.Take pharmaceutical preparation of the present invention and measured the active result of acute myocardial infarction patient front and back erythrocyte membrane SOD in 30 days, show that patient's blood plasma lipide peroxide level reduces, the activity of SOD increases.32 routine patient with angina pectoris thromboxane A2s reduce, and prostacyclin improves.
Take pharmaceutical preparation 1-2 grain of the present invention for a long time, every day 3 times, in the 2-5 week course of treatment, can effectively reduce anginal seizure frequency (on average descending 44.1%), the nitroglycerin consumption on average descends 34.4%.Adopt treadmill test to estimate the exercise tolerance of 16 routine patients with coronary heart disease, discovery take total movement time after the pharmaceutical preparation of the present invention, setting in motion to time of angina pectoris attacks, move to the ST section and force down the time of 1mm and all obviously prolong, and obviously shorten exercise end to recovery time of ST section.Prove that pharmaceutical preparation of the present invention has onset rapid (how at 3-5 minute), duration of efficacy is long, characteristics such as (6-7 hours).Relevant studies show that pharmaceutical preparation of the present invention treated for 5 weeks after, the angina pectoris attacks frequency descends 96.5%, the nitroglycerin consumption descends 96.7%.
The generation of post-infarctional angina pectoris can be obviously alleviated in pharmaceutical preparation of the present invention, and protection cardiac muscle, increasing blood flow perfusion reduce ARR incidence rate, obviously improve myocardial infarction patient's survival rate.In 218 routine cases, 12 months follow-up investigation, take pharmaceutical preparation treatment of the present invention and organize again infraction rate, sudden death rate and total death toll and descend, can improve myocardial infarction patient's prognosis.
Pharmaceutical preparation of the present invention can also improve silent myocardial ischemia (SMI), estimate the effect of 52 routine coronary heart disease SMI oral medications with ambulatory electrocardiogram, through 3 times, each 2 of pharmaceutical preparation of the present invention every days, after the treatment in totally 4 weeks, what number of times that own control research prompting ST section is forced down and ST section were forced down all obviously reduces total time, research finds that also pharmaceutical preparation of the present invention has the effect that reduces incidence of arrhythmia, and patients with coronary heart disease treatment back ventricular premature contraction number of times obviously reduces.Behind the heart infarction patient treatment, it is suitable with the propranolol group to prevent and treat ARR effect.Adopt the apply ointment or plaster total effective rate of therapeutic room's premature beat 100 examples of the ear acupoint to reach 90%.
2, improve the effect of cardiac function
The patient of acute myocardial infarction uses pharmaceutical preparation of the present invention can effectively be increased erythrocyte sodium pump activity, reduce oxygen-derived free radicals formation and calcium overload, patient's (getting rid of diseases such as hypertension) of 56 routine coronary heart disease companion left ventricular hypertrophy take pharmaceutical preparation of the present invention every day 3 times each 2 oral, use chamber, echocardiography left side form after March, find that pharmaceutical preparation of the present invention can effectively reverse left ventricular hypertrophy, reduce indexs such as interventricular septal thickness, Left ventricular mass index.Adopt the float catheter method to detect pharmaceutical preparation of the present invention to 22 routine patients with coronary heart disease cardiac function influences, the result after medication, promptly be carved into 30 minutes parameters of left ventricular function such as LVEF be improved significantly, ultrasoundcardiogram shows that the movable amplitude of left locular wall obviously increases.The patient of 39 routine congestive heart failures adopts conventional anti-heart failure treatment and adds with pharmaceutical preparation of the present invention every day 4 times, each 2,14 days courses of treatment, the ultrasoundcardiogram result shows, treatment group cardiac function on average improves the 1-2 level before the treatment, and indexs such as heart stroke, LVEF are obviously improved.The heart failure incidence rate obviously descended after 66 routine Acute Myocardial Infarction Patients were taken pharmaceutical preparation of the present invention, confirmed that pharmaceutical preparation of the present invention can improve left ventricular remodeling and cardiac function, and the auxiliary treatment of heart failure is had effect.
3, to the application of other diseases
The effect of collaborative blood pressure lowering is brought into play in pharmaceutical preparation of the present invention in the treatment of hypertension, can improve chronic obstructive disease of lung patient's pulmonary function.Be used for the treatment of women's post-menopause syndrome, the cardiovascular symptom of alleviating women's post-menopause syndrome is had positive effect.The treatment migraine is also had certain effect, the migraine frequency obviously being reduced, weigh with Headache Unit Index, is 0.39 ± 0.25 before the treatment, be reduced to 0.12 ± 0.13 (P<0.01) after the treatment, wherein 850 routine platelet aggregation rates are reduced to 63 ± 7% by 71 ± 8% before treating.
Pharmaceutical preparation of the present invention can improve myocardial ischemia and cardiac function, clinically can be applicable to treat myocardial ischemia, cardiac function class disease, comprise angina pectoris, myocardial infarction, arrhythmia, ventricular premature contraction, heart failure etc., also can be used for treatment of diseases such as the cardiovascular symptom of chronic obstructive disease of lung, women's post-menopause syndrome and migraine.

Claims (7)

1, a kind of pharmaceutical preparation for the treatment of cardiovascular disease is characterized in that adopting the Chinese crude drug Moschus, Radix Ginseng extract, and Venenum Bufonis, Calculus Bovis, Cortex Cinnamomi, styrax and MEIHUA BINGPIAN are that raw material is made.
2, the pharmaceutical preparation of treatment cardiovascular disease according to claim 1 is characterized in that described Chinese crude drug Moschus also comprises the artificial Moschus; Described Calculus Bovis also comprises artificial Calculus Bovis, Calculus Bovis cultivating, In vitro cultured Calculus Bovis; Described MEIHUA BINGPIAN also comprises Borneolum Syntheticum.
3, the pharmaceutical preparation of treatment cardiovascular disease according to claim 1; it is characterized in that described component weight portion content is Moschus or artificial Moschus 0.1-1 part; Radix Ginseng extract 15.5-155 part; Calculus Bovis or artificial Calculus Bovis, Calculus Bovis cultivating, In vitro cultured Calculus Bovis 2-20 part; Cortex Cinnamomi 10-100 part; Styrax 0.2-2 part, Venenum Bufonis 0.12-1.2 part, MEIHUA BINGPIAN or Borneolum Syntheticum 7.5-75 part.
4, the pharmaceutical preparation of treatment cardiovascular disease according to claim 1; it is characterized in that described component weight portion content is Moschus or artificial Moschus 0.3-1 part; Radix Ginseng extract 15.5-75 part; Calculus Bovis or artificial Calculus Bovis, Calculus Bovis cultivating, In vitro cultured Calculus Bovis 2-10 part; Cortex Cinnamomi 10-50 part; Styrax 0.6-2 part, Venenum Bufonis 0.3-1.2 part, MEIHUA BINGPIAN or Borneolum Syntheticum 7.5-25 part.
5, the pharmaceutical preparation of treatment cardiovascular disease according to claim 1; it is characterized in that described component weight portion content is 1 part of Moschus or artificial Moschus; 15.5 parts of Radix Ginseng extracts; 2 parts of Calculus Bovis or artificial Calculus Bovis, Calculus Bovis cultivating, In vitro cultured Calculus Boviss; 10 parts of Cortex Cinnamomis; 2 parts of Styrax, 1.2 parts of Venenum Bufoniss, 7.5 parts of MEIHUA BINGPIAN or Borneolum Syntheticums.
6, the preparation method of the pharmaceutical preparation of claim 1 is characterized in that Radix Ginseng extract is pulverized, and after Moschus, Calculus Bovis, Cortex Cinnamomi, Venenum Bufonis, borneol and grinding become fine powder, adds Styrax and Chinese liquor, makes pill, tablet, granule and capsule.
7, according to the preparation method of the pharmaceutical preparation of claim 6, it is characterized in that wherein Radix Ginseng extract prepares by following method, the people participates in 75% medicinal alcohol through reflux, extract, three times, and each 1 hour, merge reflux extracting liquid and concentrate, drying makes.
CNA2004100160721A 2004-02-03 2004-02-03 Medicine preparation for treating cardiovascular and cerebrovascular diseases and its preparing process Pending CN1557416A (en)

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Cited By (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1903252B (en) * 2006-08-03 2010-05-12 上海和黄药业有限公司 Fingerprint analysis method for traditional Chinese medicine composition to treat cardiovascular disease
CN104435114A (en) * 2014-03-28 2015-03-25 上海和黄药业有限公司 Method for preparing cardiovascular disease drug micropills
CN105726464A (en) * 2016-03-23 2016-07-06 上海和黄药业有限公司 Preparation method of test sample of musk Baoxinwan slow release gel for pharmacological research
CN107669738A (en) * 2017-10-18 2018-02-09 广东大鹏医药科技有限公司 A kind of promoting blood circulation and removing blood stasis, Chinese medicine preparation for invigorating vital energy and reinforce the heart and preparation method thereof
CN114209804A (en) * 2021-11-29 2022-03-22 德阳市中西医结合医院 Navel patch for treating chronic obstructive pulmonary disease
CN114522190A (en) * 2020-11-20 2022-05-24 上海和黄药业有限公司 Pharmaceutical composition for resisting myocardial ischemia injury and preparation method and application thereof

Cited By (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1903252B (en) * 2006-08-03 2010-05-12 上海和黄药业有限公司 Fingerprint analysis method for traditional Chinese medicine composition to treat cardiovascular disease
CN104435114A (en) * 2014-03-28 2015-03-25 上海和黄药业有限公司 Method for preparing cardiovascular disease drug micropills
CN104435114B (en) * 2014-03-28 2018-04-13 上海和黄药业有限公司 A kind of preparation method of cardiovascular disease medicine particulate ball
CN105726464A (en) * 2016-03-23 2016-07-06 上海和黄药业有限公司 Preparation method of test sample of musk Baoxinwan slow release gel for pharmacological research
CN105726464B (en) * 2016-03-23 2019-10-22 上海和黄药业有限公司 A kind of slow-releasing gel used preparation method of test article for pharmacological research of Shexiang Baoxin Pills
CN107669738A (en) * 2017-10-18 2018-02-09 广东大鹏医药科技有限公司 A kind of promoting blood circulation and removing blood stasis, Chinese medicine preparation for invigorating vital energy and reinforce the heart and preparation method thereof
CN107669738B (en) * 2017-10-18 2020-10-16 广东大鹏医药科技有限公司 Traditional Chinese medicine preparation for promoting blood circulation to remove blood stasis, tonifying qi and strengthening heart and preparation method thereof
CN114522190A (en) * 2020-11-20 2022-05-24 上海和黄药业有限公司 Pharmaceutical composition for resisting myocardial ischemia injury and preparation method and application thereof
CN114209804A (en) * 2021-11-29 2022-03-22 德阳市中西医结合医院 Navel patch for treating chronic obstructive pulmonary disease

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