CN102652746A - Pharmaceutical composition containing clopidogrel and pharmaceutically acceptable salts thereof and preparation method of pharmaceutical composition - Google Patents
Pharmaceutical composition containing clopidogrel and pharmaceutically acceptable salts thereof and preparation method of pharmaceutical composition Download PDFInfo
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- CN102652746A CN102652746A CN2011100508778A CN201110050877A CN102652746A CN 102652746 A CN102652746 A CN 102652746A CN 2011100508778 A CN2011100508778 A CN 2011100508778A CN 201110050877 A CN201110050877 A CN 201110050877A CN 102652746 A CN102652746 A CN 102652746A
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- clopidogrel
- pharmaceutical composition
- atorvastatin calcium
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- cellulose
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Abstract
The invention relates to a compound composition preparation, as well as a preparation method and a use thereof, and particularly relates to a pharmaceutical composition taking clopidogrel and pharmaceutically acceptable salts thereof, as well as atorvastatin calcium as active ingredients, and the preparation method of the pharmaceutical composition. The pharmaceutical composition can be used for preventing and treating cardiovascular and cerebrovascular diseases and performing anti-atherosclerotic and anti-thrombotic treatment, and can further improve the single treatment effect of the clopidogrel and realize the synergy. After the pharmaceutical composition disclosed by the invention is used for preparing a pharmaceutical preparation, the compliance of a patient can be improved.
Description
Technical field
The invention belongs to the pharmaceutical composition of treatment cardiovascular disease, be specifically related to a kind of pharmaceutical composition that contains clopidogrel and pharmaceutically acceptable salt and Atorvastatin calcium thereof as active component.
Background technology
Cardiovascular and cerebrovascular disease comprises hyperlipidemia, hypertension, arteriosclerosis, cerebral thrombosis, coronary heart disease, myocardial infarction, angina pectoris etc., is the first healthy killer of modern humans.Their common pathologic basis all are atherosclerosiss, and the three-hypers (hyperlipidemia, high triglyceride, hypercholesterolemia) in the human vas is the main cause that causes cardiovascular and cerebrovascular disease, and four high more than one characteristics are arranged; Be that sickness rate is high, relapse rate is high, and disability rate is high; Fatality rate is high, and complication is many.
Atherosclerotic thrombosis all is the result of a series of complicated inflammatory reactions of being caused of the original pathologic conditions of blood vessel.It is main shows as the gathering of platelet at the atheromatous plaque position; The blocking remote that comes off of local thrombus formation and thrombosis and speckle causes the disturbance of blood circulation of far-end.Platelet plays crucial effect in this process.Therefore in cardiovascular and cerebrovascular disease clinical prevention and treatment, atherosclerosis and antithrombotic therapy be two basic and be most important treatment measure.
Find also that in recent years the morbidity of platelet function and primary disease is closely related.Primary disease patient platelet function majority is hyperfunction; Various causing gathered the factor sensitivity; Life span shortens; Platelet aggregation rate increases in the blood circulation, and release reaction takes place, and disengages β thromboglobulin, antihemophilic factor V, platelet derived growth factor, adenosine diphosphate (ADP), 5-hydroxy tryptamine, catecholamine, thromboplastin, histamine, TXA2. etc.These materials make more platelet aggregations, form thrombosis; Increase permeability coronarius; Make coronary artery spasm, the injured blood vessel wall; Thereby impel vascular smooth muscle hyperplasia to cause coronary atherosclerosis.Many researchs show the effectively atherosis thrombotic disease of prevention of arterial of antiplatelet drug.
Clopidogrel, chemistry is by name: S (+)-2-(2-chlorphenyl)-2-(4,5,6,7-Tetramethylene sulfide [3,2-c] and pyridine-5) methyl acetate, molecular formula: C
16H
16ClNO
2S, molecular weight: 321.82, chemical constitution is following:
Clopidogrel (Clopidogrel) is a kind of anticoagulant, and selectivity suppresses adenosine diphosphate (ADP) (ADP) and its combining and the activation of the glycoprotein GPIIb/IIIa complex of the ADP mediation of secondary of platelet receptor, but so anticoagulant.Except that ADP, clopidogrel can also suppress the platelet aggregation of other agonist induction through blocking the amplification of the platelet activation that is caused by the ADP that discharges.Can be used for preventing and treating myocardial infarction, ischemic cerebral thrombosis, the complication that thromboangiitis obliterans and atherosclerosis and thromboembolism cause.Be applied to apoplexy, the myocardial infarction that takes place in the recent period or made a definite diagnosis the patient of peripheral arterial disease, can reduce the generation (myocardial infarction, apoplexy and vascular are dead) of atherosclerotic event after the treatment.
Statins (Statins) is HMG CoA (HMG-CoA) reductase inhibitor; This type of medicine is through the synthetic rate-limiting enzyme HMG-CoA reductase of competitive inhibition endogenous cholesterol; Hydroxyl first valeric acid metabolic pathway in the blocking-up cell; Make the synthetic minimizing of cell inner cholesterol, thereby (low density lipoprotein, LDL) acceptor quantity increases, makes serum cholesterol removing increase, level to reduce with active to surperficial (the being mainly hepatocyte) low density lipoprotein, LDL of feedback irritation cell film.Statins also can suppress the synthetic Apolipoprotein B-100 of liver, thereby reduces the synthetic and secretion of being rich in triglyceride AV, lipoprotein.Statins is unusual at blood lipid regulation, prevents atherosclerosis, and inflammation-inhibiting etc. act in the firsts and seconds prevention of coronary heart disease and obtain good clinical benefit, can effectively reduce disability rate and mortality rate.
The HMG-CoA reductase inhibitor can also slow down the effect that cholesterol and LDL-C are produced the blood vessel endothelium tissue injury except the metabolism that influences lipid, these injury effects comprise the cholesterol that macrophage phagocytic is oxidized and the effect of non-viable non-apoptotic cell; Wounded tissue and platelet are disengaged activating substance thereby are promoted platelet aggregation and vascular smooth muscle cell curing, and monocyte is to forming the healing scar tissue on the endothelial cell adhesion.Atherosclerotic lesion initial stage vascular smooth muscle cell curing and athero thereby lipid speckle form on blood vessel wall, and this process is reversible, if the active prevention treatment can be restored, Statins has remarkable drug effect to this course of disease; Simultaneously the atheromatous plaque that is formed by smooth muscle cell, celloglobulin, fat, cell residue had Stabilization.
Atorvastatin calcium, chemistry 7-[2-(4-fluorophenyl)-3-phenyl-4-(anilino-formoxyl)-5-(2-propyl group) pyrroles-1-yl]-3 by name, 5-dihydroxy enanthic acid calcium, molecular formula: (C
33H
34FN
2O
5)
2Ca 3H
2O, molecular weight: 1209.42, chemical constitution is following:
Atorvastatin calcium (Atorvastatin calcium) belongs to a kind of novel 3 hydroxyls-3 methyl glutaryl coenzyme A (HMG-CoA) reductase inhibitor.The non-activity of Atorvastatin calcium own; Hydrolyzate after the oral absorption suppresses the rate-limiting enzyme hydroxyl first glutaryl CoA reductase in the cholesterol building-up process in vivo competitively; Make the synthetic minimizing of cholesterol, also make the synthetic increase of low density lipoprotein receptor, main site of action is at liver; The result reduces cholesterolemia and low-density lipoprotein cholesterol level, and moderate reduces serum triglyceride level and increases the blood hdl level.Thus to the control generation effect of atherosclerosis and coronary heart disease.Atorvastatin calcium is clinical to be used to treat hypercholesterolemia and combined hyperlipidemia familial; Advantages such as the control of coronary heart disease and apoplexy has long half time, and acting duration is long except that effect for reducing fat, can also suppress the low density lipoprotein, LDL peroxide to turn to oxidized low-density lipoprotein, have the protection vascular endothelial function.
Animal experiment study finds that clopidogrel can obviously reduce the platelet that the rabbit injury of carotid artery causes and adhere to, piles up to endothelium.Single oral clopidogrel 25mg/kg can suppress 95% (P＜0.01) of platelet adhesion.And oral 100mg aspirin can not reduce hematoblastic adhesion.Give every day rabbit oral article 25mg/kg, serve on 16d, this effect of inner membrance proliferation of smooth muscle 48% (P＜0.01) that can suppress due to the rabbit injury of carotid artery is a dose dependent, and prolongs with administration time and to strengthen.Under same experimental condition, every day, oral thiophene chloropyridine 200mg/kg suppressed intimal thickening 57% (P＜0.001); And oral aspirin is invalid.These results show that clopidogrel can alleviate the intimal thickening that vascular endothelial injury causes.This is because these article suppress platelet adhesion and the subendothelial layer that is gathered in damaged.And clinical trial confirms that clopidogrel helps to reduce the sickness rate of myocardial infarction, apoplexy and the mortality rate of atherosclerotic blood vessel disease, and can reduce PTCA (PTCA) and arterial bracket implantation postoperative restenosis incidence rate.Can not obtain at single medicine under the situation of ideal treatment, compound recipe and medication combined application often are used to the clinical treatment cardiovascular disease.The Combined application that therefore, statins and clopidogrel are often arranged in the therapeutic scheme of the treatment of coronary heart disease, apoplexy, PTCA and prevention.
Unstable angina pectoris (UAP) is the angina pectoris between stable angina pectoris and acute myocardial infarction (AMI); Be a kind of of acute coronary syndrome (ACS); In recent years there is report UAP patient to use incidence rate and the case fatality rate that the statins therapeutic intervention can significantly reduce cardiovascular event in early days, can improves the prognosis of UAP.
The lot of domestic and international clinical trial confirms to discover not to be used his spit of fland and uses atorvastatin or pravastatin all not to influence the antiplatelet effects of clopidogrel.MITRAPLUS (Wienbergen H; Gitt AK) research is an extensive perspective study of in German myocardial infarction crowd, carrying out; 14 months observed result shows, the late mortality rate and the equal no difference of science of statistics of stroke onset rate of clopidogrel and atorvastatin combination group and other his spit of fland groups of clopidogrel associating.Result of study shows main bad cardiovascular and cerebrovascular vessel incident (MACCE) incidence rate of 30d and the interior equal no difference of science of statistics of incidence of thrombus of support of atorvastatin group and pravastatin group; Prompting coronary stent postoperative share clopidogrel and is safe and effective through the metabolic atorvastatin of CYP3A4; Do not increase the MACCE incidence rate, also do not increase the thrombosis risk simultaneously.
The compound recipe patent of clopidogrel comprises aspirin and clopidogrel, Monas cuspurpureus Went extract and clopidogrel, triflusal and clopidogrel at present; Carbazochrome sodium sulfonate and clopidogrel; Procyanidin and clopidogrel, indobufen and clopidogrel, and with the compound recipe of special type of shellfish.Aspirin also is a kind of anti-platelet aggregation agent, with the clopidogrel coupling, can reduce the danger of acute hat medium-sized artery syndrome greatly.The research report that does not also have at present the compound preparation of clopidogrel and Atorvastatin calcium.Clopidogrel provided by the invention and atorvastatin calcium composition and preparation are applied to cardiovascular disease, can be in different treatment link, and antithrombotic and atherosclerosis help to reduce the generation of bad cardiovascular and cerebrovascular disease incident.
Summary of the invention
The present invention relates to a kind of pharmaceutical composition of treating cardiovascular disease.Compositions of the present invention contains clopidogrel, Atorvastatin calcium and acceptable accessories.Combination treatment cardiovascular disease of the present invention not only can improve the separately effect of treatment of clopidogrel, and has synergism, preparation of pharmaceutical compositions of the present invention is become the compliance that can improve patient after the pharmaceutical preparation.
Pharmaceutical composition of the present invention contains the clopidogrel as active component.The pharmaceutical composition of the present invention of per unit preparation contains the clopidogrel of 25mg-300mg.Preferred 25mg-75mg, most preferably 75mg.
Pharmaceutical composition of the present invention contains the Atorvastatin calcium as active component.The pharmaceutical composition of the present invention of per unit preparation contains the Atorvastatin calcium of 5mg-100mg.Preferred 10mg-40mg, more preferably 10mg-20mg, most preferably 20mg.
Acceptable accessories in the pharmaceutical composition of the present invention can be anyly can be prepared into pharmaceutical preparation with clopidogrel and Atorvastatin calcium, and be used for the adjuvant of clinical treatment.Adjuvant of the present invention includes but not limited to: filler, wetting agent and adhesive, disintegrating agent, lubricant etc.Filler comprises lactose, microcrystalline Cellulose, starch, Icing Sugar, dextrin, mannitol, calcium carbonate, calcium hydrogen phosphate, pregelatinized Starch etc.The preferred lactose of filler, microcrystalline Cellulose, pregelatinized Starch and calcium carbonate.Wetting agent and adhesive comprise hydroxypropyl cellulose, hydroxypropyl emthylcellulose, gelatin, sucrose etc.The preferred hydroxypropyl cellulose of wetting agent and adhesive, hydroxypropyl emthylcellulose.Disintegrating agent comprises crospolyvinylpyrrolidone, cross-linking sodium carboxymethyl cellulose, low-substituted hydroxypropyl cellulose etc.Preferred cross-linking sodium carboxymethyl cellulose of disintegrating agent and low-substituted hydroxypropyl cellulose.Lubricant comprises micropowder silica gel, Pulvis Talci, castor oil hydrogenated oil, polyethylene glycol 6000, stearic acid, magnesium laurylsulfate etc.Lubricant preferably talc powder, castor oil hydrogenated and polyethylene glycol 6000.
Pharmaceutical composition of the present invention preferably contains one or more acceptable accessories in lactose, microcrystalline Cellulose, pregelatinized Starch, hydroxypropyl cellulose, calcium carbonate, mannitol, cross-linking sodium carboxymethyl cellulose, titanium dioxide, Pulvis Talci, ferrum oxide, castor oil hydrogenated, stearic acid, the polyethylene glycol 6000 except that containing clopidogrel and Atorvastatin calcium.
" unit formulation " of description of the present invention refers to the minimum individual of every kind of dosage form, like " sheet " of tablet, capsular " grain ".
The specific embodiment
Embodiment 1
Prescription (per 1000):
Bisulfate clopidogrel 97.9g
Atorvastatin calcium 21.7g
Cross-linking sodium carboxymethyl cellulose 15g
Pregelatinized Starch 100g
Microcrystalline Cellulose 50g
Lactose 20g
Pulvis Talci 10g
Polyethylene glycol 6000 10g
Bisulfate clopidogrel, Atorvastatin calcium were pulverized 80 mesh sieves.According to recipe quantity with the abundant mixing of bisulfate clopidogrel, Atorvastatin calcium and lactose, pregelatinized Starch, microcrystalline Cellulose and cross-linking sodium carboxymethyl cellulose, and with Pulvis Talci, polyethylene glycol 6000 mixing after direct compression, promptly get.
Embodiment 2
Prescription (per 1000):
Bisulfate clopidogrel 97.9g
Atorvastatin calcium 21.7g
Pregelatinized Starch 100g
Low-substituted hydroxypropyl cellulose 20g
Microcrystalline Cellulose 70g
Castor oil hydrogenated 5g
Bisulfate clopidogrel, Atorvastatin calcium were pulverized 80 mesh sieves.According to recipe quantity with the abundant mixing of bisulfate clopidogrel, Atorvastatin calcium and pregelatinized Starch, microcrystalline Cellulose and low-substituted hydroxypropyl cellulose, and with the castor oil hydrogenated mixing after direct compression, promptly get.
Embodiment 3
Prescription (per 1000):
Bisulfate clopidogrel 97.9g
Atorvastatin calcium 21.7g
Cross-linking sodium carboxymethyl cellulose 15g
Pregelatinized Starch 100g
Microcrystalline Cellulose 50g
0.2% hydroxypropyl emthylcellulose alcoholic solution is an amount of
Stearic acid 10g
Micropowder silica gel 5g
Bisulfate clopidogrel, Atorvastatin calcium are crossed 80 mesh sieves.According to recipe quantity with the abundant mixing of bisulfate clopidogrel, Atorvastatin calcium and microcrystalline Cellulose, pregelatinized Starch and cross-linking sodium carboxymethyl cellulose after; Add the hydroxypropyl emthylcellulose alcoholic solution and prepare soft material in right amount; Granulation, oven dry, 18 mesh sieve granulate; With encapsulated behind the abundant mixing of stearic acid, micropowder silica gel of recipe quantity, promptly get.
Embodiment 4
Prescription (per 1000):
This embodiment processes capsule in 1: 1 ratio after Atorvastatin calcium and bisulfate clopidogrel are processed micropill and coating respectively.
The Atorvastatin calcium part:
Atorvastatin calcium 21.7g
Calcium carbonate 40g
Lactose 50g
Microcrystalline Cellulose 53g
Cross-linking sodium carboxymethyl cellulose 8g
Hyprolose 1.7g
Tween 80 1.7g
HPMC coating 5.4g
The bisulfate clopidogrel part:
Bisulfate clopidogrel 97.9g
Mannitol 55g
Microcrystalline Cellulose 60g
Low-substituted hydroxypropyl cellulose 12.5g
Polyethylene glycol 6000 10g
HPMC coating 7.2g
With Atorvastatin calcium, calcium carbonate, microcrystalline Cellulose and lactose mix homogeneously, add 1% hyprolose solution (containing 1% tween) system soft material, extrude preparation 20 order micropills, dry back coating, subsequent use.With bisulfate clopidogrel, mannitol, low-substituted hydroxypropyl cellulose and microcrystalline Cellulose mix homogeneously, add ethanol and make soft material in right amount, extrude preparation 20 order micropills, dry back coating, subsequent use.Mentioned component by encapsulated behind 1: 1 abundant mixing, is promptly got.
Embodiment 5
Prescription (per 1000):
This embodiment processes double-layer tablet with bisulfate clopidogrel again for earlier Atorvastatin calcium being processed ordinary tablet.
The Atorvastatin calcium part:
Atorvastatin calcium 21.7g
Calcium carbonate 49g
Lactose 40g
Microcrystalline Cellulose 55g
Cross-linking sodium carboxymethyl cellulose 10g
Hyprolose 1.7g
Tween 80 1.7g
Pulvis Talci 5g
The bisulfate clopidogrel part:
Bisulfate clopidogrel 97.9g
Mannitol 55g
Microcrystalline Cellulose 60g
Low-substituted hydroxypropyl cellulose 12.5g
Polyethylene glycol 6000 10g
Castor oil hydrogenated 5g
After taking by weighing the abundant mixing of Atorvastatin calcium, calcium carbonate, microcrystalline Cellulose, lactose and cross-linking sodium carboxymethyl cellulose by prescription; Add 1% hyprolose solution (containing 1% tween) system soft material; 18 granulations, oven dry, 18 mesh sieve granulate, with tabletting behind the abundant mixing of the Pulvis Talci of recipe quantity, subsequent use.Take by weighing the abundant mixing of bisulfate clopidogrel, microcrystalline Cellulose, mannitol, low-substituted hydroxypropyl cellulose and polyethylene glycol 6000 by recipe quantity; Make soft material in right amount with dehydrated alcohol; The granulation of 18 orders, oven dry, 18 mesh sieve granulate are processed double-layer tablet with the atorvastatin calcium tablet behind the adding castor oil hydrogenated mixing.
Claims (7)
1. a pharmaceutical composition of treating cardiovascular disease contains clopidogrel and acceptable salt and Atorvastatin calcium.
2. the described compositions of claim 1, wherein per unit preparation medicine compositions contains clopidogrel 25mg-300mg, Atorvastatin calcium 5mg-100mg.
3. the described compositions of claim 1, wherein per unit preparation medicine compositions contains clopidogrel 25mg-75mg, Atorvastatin calcium 10mg-40mg.
4. the described compositions of claim 1, wherein per unit preparation medicine compositions clopidogrel 75mg, Atorvastatin calcium 20mg.
5. any described compositions of claim 1-4, wherein acceptable accessories comprises one or more in filler, wetting agent and adhesive, disintegrating agent, the lubricant.
6. the described compositions of claim 5; Wherein filler is lactose, mannitol, pregelatinized Starch, calcium carbonate or microcrystalline Cellulose; Wetting agent and adhesive are hydroxypropyl cellulose or hydroxypropyl emthylcellulose; Disintegrating agent is cross-linking sodium carboxymethyl cellulose, low-substituted hydroxypropyl cellulose, and lubricant is castor oil hydrogenated, polyethylene glycol 6000, stearic acid or Pulvis Talci.
7. any described compositions of claim 1-4, wherein acceptable accessories comprises one or more in lactose, microcrystalline Cellulose, corn starch, pregelatinized Starch, hydroxypropyl cellulose, hydroxypropyl emthylcellulose, titanium dioxide, stearic acid, Pulvis Talci, ferrum oxide, the cross-linking sodium carboxymethyl cellulose.
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| CN2011100508778A CN102652746A (en) | 2011-03-03 | 2011-03-03 | Pharmaceutical composition containing clopidogrel and pharmaceutically acceptable salts thereof and preparation method of pharmaceutical composition |
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| Application Number | Priority Date | Filing Date | Title |
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| CN2011100508778A CN102652746A (en) | 2011-03-03 | 2011-03-03 | Pharmaceutical composition containing clopidogrel and pharmaceutically acceptable salts thereof and preparation method of pharmaceutical composition |
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103690955A (en) * | 2013-12-27 | 2014-04-02 | 福州乾正药业有限公司 | Ticagrelor-containing drug composition as well as preparation method and application thereof |
| CN105816860A (en) * | 2015-12-03 | 2016-08-03 | 北京百奥药业有限责任公司 | Compound preparation of lumbrukinase and clopidogrel, and preparation method thereof |
| CN109180701A (en) * | 2018-09-07 | 2019-01-11 | 中国药科大学 | A kind of total amorphous substance of compound 2016A0C1 pharmaceutical composition |
| CN114532528A (en) * | 2020-11-26 | 2022-05-27 | 浙江养生堂天然药物研究所有限公司 | Red-pulp apple and cherry plum composition and application thereof in antithrombotic aspect |
-
2011
- 2011-03-03 CN CN2011100508778A patent/CN102652746A/en active Pending
Cited By (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103690955A (en) * | 2013-12-27 | 2014-04-02 | 福州乾正药业有限公司 | Ticagrelor-containing drug composition as well as preparation method and application thereof |
| CN103690955B (en) * | 2013-12-27 | 2016-04-20 | 福州乾正药业有限公司 | Pharmaceutical composition containing ticagrelor and preparation method thereof and medicinal application |
| CN105816860A (en) * | 2015-12-03 | 2016-08-03 | 北京百奥药业有限责任公司 | Compound preparation of lumbrukinase and clopidogrel, and preparation method thereof |
| CN109180701A (en) * | 2018-09-07 | 2019-01-11 | 中国药科大学 | A kind of total amorphous substance of compound 2016A0C1 pharmaceutical composition |
| CN114532528A (en) * | 2020-11-26 | 2022-05-27 | 浙江养生堂天然药物研究所有限公司 | Red-pulp apple and cherry plum composition and application thereof in antithrombotic aspect |
| CN114532528B (en) * | 2020-11-26 | 2023-12-12 | 浙江养生堂天然药物研究所有限公司 | Red apple and cherry plum composition and application thereof in antithrombotic aspect |
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Application publication date: 20120905 |