CN106727579A - A kind of Irbesartan/Rosuvastatin compound preparation and preparation method thereof - Google Patents
A kind of Irbesartan/Rosuvastatin compound preparation and preparation method thereof Download PDFInfo
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- CN106727579A CN106727579A CN201510798813.4A CN201510798813A CN106727579A CN 106727579 A CN106727579 A CN 106727579A CN 201510798813 A CN201510798813 A CN 201510798813A CN 106727579 A CN106727579 A CN 106727579A
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- irbesartan
- rosuvastatin
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- main ingredient
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
- A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
- A61K31/4164—1,3-Diazoles
- A61K31/4184—1,3-Diazoles condensed with carbocyclic rings, e.g. benzimidazoles
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2059—Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
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- General Health & Medical Sciences (AREA)
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- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
A kind of Irbesartan/Rosuvastatin compound preparation and preparation method thereof, by weight percentage, main ingredient 20-65%, filler 20-60%, disintegrant 3-15%, adhesive 0.1-30%, lubricant 0.05-1%, glidant 0.5-5%；The main ingredient by 150 parts of Irbesartan,
Rosuvastatin
5
Part or 10 parts or 20 parts compositions；Its preparation method includes：Get the raw materials ready, sieve, mixing, pelletizing, drying, compressing tablet.A kind of Irbesartan/Rosuvastatin compound preparation of the invention,
The treatment of cardiovascular patient is more suitable for, the compliance of patient is improved
, steady quality is convenient to take.
Description
Technical field
The present invention relates to pharmaceutical field, more particularly to a kind of Irbesartan/Rosuvastatin compound preparation and preparation method thereof.
Background technology
Cardiovascular and cerebrovascular disease is the general designation of angiocardiopathy and cranial vascular disease, refers to the heart caused by hyperlipidemia, sticky blood, atherosclerosis, hypertension etc., brain and body tissue and the common name of ischemic or hemorrhagic disease occurs.Cardiovascular and cerebrovascular disease is a kind of serious threat mankind, particularly more than the 50 years old common disease of the elderly's health, even if using treatment means most advanced, perfect at present, the cerebrovas-cularaccident survivor life that can still have more than 50% can not take care of oneself completely!The number that cardiovascular and cerebrovascular disease is died from the whole world every year is up to 15,000,000 people, occupies the various causes of the death the first.Cardiovascular and cerebrovascular disease has turned into human death's cause of disease highest number one killer, is also " the noiseless demon " of health of people！The characteristics of cardiovascular and cerebrovascular disease is " more than four high one " with " incidence of disease is high, disability rate is high, the death rate is high, high recurrence rate, and complication is more ", at present, China's Patients with Cardiovascular/Cerebrovascular Diseases alreadys exceed 2.7 hundred million people！China dies from nearly 3,000,000 people of cardiovascular and cerebrovascular disease every year, accounts for the 51% of the annual total Death causes of China.And the different degrees of disability of patient 75% for surviving, 40% is heavy residual！The recurrence rate of First Year is 30% after China's patient with cerebral apoplexy discharge, and the high recurrence rate of the 5th year is up to 59%, and it is only 10% that secondary prevention is made the preferable U.S..Due to China medical insurance covering people group of mean people, the recurrence rate of patient with cerebral apoplexy will be higher by 1 times compared with international average level！Long-term hypertension can make cerebral artery vessel wall thickening or be hardened, and tube chamber attenuates.When blood pressure rises sharply, the cerebrovascular is easily broken generation cerebral hemorrhage；Or the brain parteriole for having hardened forms a kind of aneurysms of chestnut grain size, when fluctuations in blood, arteriole stream ruptures and causes cerebral hemorrhage；Or hypertension accelerates artery sclerosis process, arterial endothelial cell liquid sustains damage, and blood platelet is easily assembled in injury, and easily forms brain blood pressure bolt, triggers cardiovascular and cerebrovascular disease.
Modern life rhythm is nervous, family, cause pressure it is increasing, the anxious state of mind of people is larger；Simultaneously, excessive consumption of alcohol, take in too many food fat, lack necessary motion, in addition the pollution of living environment, the anion concentration in air drastically declines, and takes in internal anion also just not enough, these factors directly result in human metabolism's speed and slow down, velocity of blood flow can slow down, and blood viscosity is raised rapidly, cause cardiac and cerebral blood supply insufficiency, if preventing not in time, nursing one's health, it will trigger the cardiovascular and cerebrovascular diseases such as coronary heart disease, hypertension, cerebral thrombus, fatty liver.
It is the most important thing for preventing cardiovascular and cerebrovascular disease by controlling of blood pressure in a more satisfactory scope.Data shows, adheres to the incidence of disease of hyperpietic's cardiovascular and cerebrovascular disease of long-term treatment, does not adhere to the 1/10 of curer only.That is, as long as long-term adhere to controlling blood pressure, cardiovascular and cerebrovascular disease can decline 90%.If hyperlipemia, " blood is thick " is easily caused, deposited on vascular wall, gradually form small patch, be exactly the atherosclerosis that we often say, trigger various cardiovascular and cerebrovascular diseases.Dyslipidemia is the independent hazard factor of cardiovascular and cerebrovascular disease, and control blood fat also turns into the most important thing of cardiovascular disease prevention.
The content of the invention
It is used for it is an object of the invention to provide one kind
Treatment
The Irbesartan of angiocardiopathy/Rosuvastatin compound preparation and preparation method thereof,
Suitable for the treatment of cardiovascular patient, the compliance of patient is improved
, steady quality is convenient to take.
The purpose of the present invention is achieved through the following technical solutions：
A kind of Irbesartan/Rosuvastatin compound preparation
,
By weight percentage, main ingredient 20-65%, filler 20-60%, disintegrant 3-15%, adhesive 0.1-30%, lubricant 0.05-1%, glidant 0.5-5%；The main ingredient by 150 parts of Irbesartan,
Rosuvastatin
5
Part or 10 parts or 20 parts compositions.
Described filler is the mixing of one or more in microcrystalline cellulose, starch, pregelatinized starch, lactose.
Described disintegrant is the mixing of one or more in low-substituted hydroxypropyl cellulose, carboxyrnethyl starch sodium, Ac-Di-Sol.
Described adhesive is the one kind in 2-10% PVP k30 ethanol solutions, 0.5-5% Hydroxypropyl methylcellulose ethanol solutions.
The lubricant is one or two the mixing in magnesium stearate, lauryl sodium sulfate.
The glidant is one or two the mixing in silica, talcum powder.
A kind of described Irbesartan/Rosuvastatin compound preparation
,
Its preparation method includes：
1
, by weight percentage, take main ingredient, filler, disintegrant, lubricant, glidant, main ingredient is crossed into 100 mesh sieves, other raw materials cross 80 mesh sieves, standby；
2
, by weight percentage, prepare adhesive, it is standby；
3
, by weight percentage, take main ingredient, filler, disintegrant, the method progressively increased using equivalent is well mixed, and obtains mixed material；
4
, during the material that will mix puts wet granulator, spray into adhesive softwood, set device parameter is：Stirring 30Hz, shears 25Hz, shear time 3min；Pelletized with 14-18 mesh nylon screens oscillating granulator after shearing；
5
, take the wet granular for making, be placed in dryer, 50 DEG C of EAT, fluidized drying obtains dry particl；
6
, take dried particle, using 16-20 mesh steel sieve whole grain；Lubricant, glidant is added to mix 30 minutes in putting three-dimensional mixer after whole grain；Compressing tablet, finished product are carried out using rotary pelleting machine after mixing.
In the main ingredient raw material press preferred weight number, 150 parts of Irbesartan,
Rosuvastatin
5
Part.
In the main ingredient raw material press preferred weight number, 150 parts of Irbesartan,
Rosuvastatin
10
Part.
In the main ingredient raw material press preferred weight number, 150 parts of Irbesartan,
Rosuvastatin
20
Part.
Beneficial effects of the present invention：A kind of Irbesartan/Rosuvastatin compound preparation of the invention
, by
Irbesartan,
Rosuvastatin constitutes compound preparation, is more suitable for the treatment of cardiovascular patient, improves the compliance of patient.Irbesartan is angiotensinⅡ (Angiotensin II, Ang II) acceptor inhibitor, Ang I can be suppressed and be converted into Ang II, can the specifically acceptor of antagonizing angiotensin converting Enzyme 1 (AT1), antagonism to AT1 is more than AT28500 times, by optionally blocking the combination of Ang II and AT1 acceptors, suppress the release of vessel retraction and aldosterone, produce antihypertensive effect.Rosuvastatin is lipid regulating agent, it is adaptable to through diet control and other non-drug therapies（Such as：Exercise therapy, lose weight）Still it is unable to the primary hypercholesterolemia of suitable control dyslipidemia（IIa types, including heterozygote familial hypercholesterolemia）Or mixed dyslipidemia disease（IIb types）.
Through two groups of clinical verifications, one of which is treatment group to the present invention, eats the present invention, the edible present invention 2 times daily, the morning and evening is each after meal once, is within 7 days a course for the treatment of, another group of control group takes Danshen Tablets, takes once a day, and the morning and evening is each after meal once, it is within 7 days a course for the treatment of, every group selection outpatient 120, wherein male 60, women 60, max age 70 years old, minimal ages 25 years old, clinical manifestation is
It is uncomfortable in chest
、
Pectoralgia
、
Gas is tight
、
Purplish tongue
、
Hemidysesthesia
、
Limb adynamia
、
Aconuresis
, table one is to take the contrasting data after a course for the treatment of：
Table 1 takes front and rear two groups of courses for the treatment of and compares (unit:People)
The effective percentage for the treatment of group and control group has notable difference, is not difficult to find out the significant curative effect in clinical practice of the present invention.
Specific embodiment
Embodiment 1
A kind of Irbesartan/Rosuvastatin compound preparation
,
By weight percentage, main ingredient 20-65%, filler 20-60%, disintegrant 3-15%, adhesive 0.1-30%, lubricant 0.05-1%, glidant 0.5-5%；The main ingredient by 150 parts of Irbesartan,
Rosuvastatin
5
Part or 10 parts or 20 parts compositions.
Embodiment 2
Described filler is the mixing of one or more in microcrystalline cellulose, starch, pregelatinized starch, lactose.
Embodiment 3
Described disintegrant is the mixing of one or more in low-substituted hydroxypropyl cellulose, carboxyrnethyl starch sodium, Ac-Di-Sol.
Embodiment 4
Described adhesive is the one kind in 2-10% PVP k30 ethanol solutions, 0.5-5% Hydroxypropyl methylcellulose ethanol solutions.
Embodiment 5
The lubricant is one or two the mixing in magnesium stearate, lauryl sodium sulfate.
Embodiment 6
The glidant is one or two the mixing in silica, talcum powder.
Embodiment 7
A kind of described Irbesartan/Rosuvastatin compound preparation
,
Its preparation method includes：
1
, by weight percentage, take main ingredient, filler, disintegrant, lubricant, glidant, main ingredient is crossed into 100 mesh sieves, other raw materials cross 80 mesh sieves, standby；
2
, by weight percentage, prepare adhesive, it is standby；
3
, by weight percentage, take main ingredient, filler, disintegrant, the method progressively increased using equivalent is well mixed, and obtains mixed material；
4
, during the material that will mix puts wet granulator, spray into adhesive softwood, set device parameter is：Stirring 30Hz, shears 25Hz, shear time 3min；Pelletized with 14-18 mesh nylon screens oscillating granulator after shearing；
5
, take the wet granular for making, be placed in dryer, 50 DEG C of EAT, fluidized drying obtains dry particl；
6
, take dried particle, using 16-20 mesh steel sieve whole grain；Lubricant, glidant is added to mix 30 minutes in putting three-dimensional mixer after whole grain；Compressing tablet, finished product are carried out using rotary pelleting machine after mixing.
Embodiment 8
In the main ingredient raw material press preferred weight number, 150 parts of Irbesartan,
Rosuvastatin
5
Part.
Embodiment 9
In the main ingredient raw material press preferred weight number, 150 parts of Irbesartan,
Rosuvastatin
10
Part.
Embodiment 10
In the main ingredient raw material press preferred weight number, 150 parts of Irbesartan,
Rosuvastatin
20
Part.
Claims (10)
1. a kind of Irbesartan/Rosuvastatin compound preparation, it is characterised in that：By weight percentage, main ingredient 20-65%, filler 20-60%, disintegrant 3-15%, adhesive 0.1-30%, lubricant 0.05-1%, glidant 0.5-5%；The main ingredient is made up of 150 parts of Irbesartan, 5 parts or 10 parts or 20 parts of Rosuvastatin.
2. a kind of Irbesartan/Rosuvastatin compound preparation according to claim 1, it is characterised in that：Described filler is the mixing of one or more in microcrystalline cellulose, starch, pregelatinized starch, lactose.
3. a kind of Irbesartan/Rosuvastatin compound preparation according to claim 1, it is characterised in that：Described disintegrant is the mixing of one or more in low-substituted hydroxypropyl cellulose, carboxyrnethyl starch sodium, Ac-Di-Sol.
4. a kind of Irbesartan/Rosuvastatin compound preparation according to claim 1, it is characterised in that：Described adhesive is the one kind in 2-10% PVP k30 ethanol solutions, 0.5-5% Hydroxypropyl methylcellulose ethanol solutions.
5. a kind of Irbesartan/Rosuvastatin compound preparation according to claim 1, it is characterised in that：The lubricant is one or two the mixing in magnesium stearate, lauryl sodium sulfate.
6. a kind of Irbesartan/Rosuvastatin compound preparation according to claim 1, it is characterised in that：The glidant is one or two the mixing in silica, talcum powder.
7. a kind of Irbesartan/Rosuvastatin compound preparation according to claim 1-6 any one, it is characterised in that：Its preparation method includes：
1st, by weight percentage, main ingredient, filler, disintegrant, lubricant, glidant are taken, main ingredient is crossed into 100 mesh sieves, other raw materials cross 80 mesh sieves, standby；
2nd, by weight percentage, adhesive is prepared, it is standby；
3rd, by weight percentage, main ingredient, filler, disintegrant are taken, the method progressively increased using equivalent is well mixed, and obtains mixed material；
4th, during the material that will be mixed puts wet granulator, adhesive softwood is sprayed into, set device parameter is：Stirring 30Hz, shears 25Hz, shear time 3min；Pelletized with 14-18 mesh nylon screens oscillating granulator after shearing；
5th, the wet granular for making is taken, is placed in dryer, 50 DEG C of EAT, fluidized drying obtains dry particl；
6th, dried particle is taken, whole grain is sieved using 16-20 mesh steel；Lubricant, glidant is added to mix 30 minutes in putting three-dimensional mixer after whole grain；Compressing tablet, finished product are carried out using rotary pelleting machine after mixing.
8. a kind of Irbesartan/Rosuvastatin compound preparation according to claim 1 or 7, it is characterised in that：Raw material presses preferred weight number, 150 parts of Irbesartan, 5 parts of Rosuvastatin in the main ingredient.
9. a kind of Irbesartan/Rosuvastatin compound preparation according to claim 1 or 7, it is characterised in that：Raw material presses preferred weight number, 150 parts of Irbesartan, 10 parts of Rosuvastatin in the main ingredient.
10. a kind of Irbesartan/Rosuvastatin compound preparation according to claim 1 or 7, it is characterised in that：Raw material presses preferred weight number, 150 parts of Irbesartan, 20 parts of Rosuvastatin in the main ingredient.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201510798813.4A CN106727579A (en) | 2015-11-19 | 2015-11-19 | A kind of Irbesartan/Rosuvastatin compound preparation and preparation method thereof |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201510798813.4A CN106727579A (en) | 2015-11-19 | 2015-11-19 | A kind of Irbesartan/Rosuvastatin compound preparation and preparation method thereof |
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| CN106727579A true CN106727579A (en) | 2017-05-31 |
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| CN201510798813.4A Withdrawn CN106727579A (en) | 2015-11-19 | 2015-11-19 | A kind of Irbesartan/Rosuvastatin compound preparation and preparation method thereof |
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Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101618215A (en) * | 2009-08-16 | 2010-01-06 | 王丽燕 | Pharmaceutical composition containing calcium blocker, AII receptor blocker and statins |
| CN104220068A (en) * | 2012-03-30 | 2014-12-17 | 大熊制药株式会社 | Pharmaceutical composition comprising olmesartan medoxomil and rosuvastatin or its salt |
| CN104739833A (en) * | 2015-02-16 | 2015-07-01 | 江苏欧信医药化工有限公司 | Compound double-layer tablet with Telmisartan and Rosuvastatin calcium and preparation method of compound double-layer tablet with Telmisartan and Rosuvastatin calcium |
-
2015
- 2015-11-19 CN CN201510798813.4A patent/CN106727579A/en not_active Withdrawn
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101618215A (en) * | 2009-08-16 | 2010-01-06 | 王丽燕 | Pharmaceutical composition containing calcium blocker, AII receptor blocker and statins |
| CN104220068A (en) * | 2012-03-30 | 2014-12-17 | 大熊制药株式会社 | Pharmaceutical composition comprising olmesartan medoxomil and rosuvastatin or its salt |
| CN104739833A (en) * | 2015-02-16 | 2015-07-01 | 江苏欧信医药化工有限公司 | Compound double-layer tablet with Telmisartan and Rosuvastatin calcium and preparation method of compound double-layer tablet with Telmisartan and Rosuvastatin calcium |
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| WW01 | Invention patent application withdrawn after publication |
Application publication date: 20170531 |
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| WW01 | Invention patent application withdrawn after publication |