CN1762361A - Pharmaceutical composition containing amiodipine besylate and rosuvastatin calcium, and its preparation method - Google Patents
Pharmaceutical composition containing amiodipine besylate and rosuvastatin calcium, and its preparation method Download PDFInfo
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- CN1762361A CN1762361A CN 200510094723 CN200510094723A CN1762361A CN 1762361 A CN1762361 A CN 1762361A CN 200510094723 CN200510094723 CN 200510094723 CN 200510094723 A CN200510094723 A CN 200510094723A CN 1762361 A CN1762361 A CN 1762361A
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- amlodipine besylate
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- besylate tablet
- pharmaceutical composition
- rosuvastain calcium
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Abstract
The invention relates a medicinal composition containing Amlodipine benzenesulfonate and Rosuvastatin calcium, and its preparing process. The formulation of the medicinal composition comprises Amlodipine benzenesulfonate 5-40 wt%, Rosuvastatin calcium 5-40 wt%, and medicinal adjuvant 20-90 wt%. The medicinal adjuvant includes lactose, microcrystalline cellulose, carboxymethylstarch sodium, Povidone K30 and magnesium stearate.
Description
Technical field:
The present invention relates to a kind of pharmaceutical composition that contains Amlodipine Besylate Tablet and rosuvastain calcium and preparation method thereof.
Background technology:
Along with human living standard's the continuous deterioration with human environment of improving constantly, the cardiovascular patient of suffering from hypertension, hyperlipidemia, hypercholesterolemia class is also in continuous increase.According to interrelated data, by the end of the year in 2003, China hyperpietic has reached 1.5 hundred million people, and increase with annual 5000000 people's speed, and hyperlipemic patients is considerably beyond this number, the maimed mortality rate of China's cardiovascular and cerebrovascular disease has accounted for 56% of Died Of Disease population, also has very high disability rate, therefore, hyperlipidemia, hypertension have become a serious social concern, begun to cause increasing people's attention, for this reason, just need development can blood lipid regulation again can blood pressure regulation outstanding compound preparation.
Angina cordis is the pain in intrathoracic violent contraction, usually is mapped to left side shoulder from the pit of the stomach width of cloth, and down to left arm.Usually angina cordis is owing to heart ischemia causes, and usually caused by coronary heart disease.
At present; between the treatment various countries to the symptom angina cordis is visibly different; in the U.S.; operation commonly used or the treatment of PTCA method suffer from the patient of stable angina pectoris symptom; but the patient usually can the association complication; lobe restenosis after one's own heart, this restenosis both can show as the short-term proliferation response of the wound that angioplasty is caused, also can show as the long-run development process at grafting vessel and the Atherosclerosis in the angiopoietic stage.
Amlodipine is by reducing the myocardial ischemia that total Peripheral resistance or load help to prevent to suffer from the fatigue patient with angina pectoris, but amlodipine changing down pressure product, thus be reduced in the demand of myocardium oxygen under any specific temper competence.For suffering from the anginal patient of vasospasm, verified, amlodipine can stop contraction, the supply that recovers myocardium oxygen.In addition, amlodipine shown can by coronary artery dilator increase myocardial oxygen should.Levamlodipine Besylate and amlodipine are all third generation dihydropyridines medicine, therefore, have similar action and efficacy.
Hypertension usually with the hyperlipemia coexistence, they the two all be considered to develop into the main hazard factor that heart disease also finally causes disadvantageous heart attack.This this risk factor is mainly owing to common mechanism.In addition, the patient who carries out hypertension therapeutic generally is better than the patient who carries out the hyperlipemia treatment.Therefore, these two kinds of diseases being carried out single therapy is favourable to the patient.
In sum, adopt and reduce hypertensive Amlodipine Besylate Tablet and the addition of rosuvastain calcium compound preparation and the synergism that fall blood ester, cholesterol reducing, can be used for treatment and suffer from angina pectoris, atherosclerosis, the patient of the patient of compressibility hypertension and hyperlipemia and cardiac risk symptom.
Summary of the invention:
The purpose of this invention is to provide a kind of pharmaceutical composition that contains Amlodipine Besylate Tablet and rosuvastain calcium and preparation method thereof,, and make this compound preparation by the main drug regimen and the preparation of Amlodipine Besylate Tablet and rosuvastain calcium.
A kind of pharmaceutical composition that contains Amlodipine Besylate Tablet and rosuvastain calcium provided by the invention and preparation method thereof, be used for the treatment of suffer from angina pectoris, atherosclerosis, compressibility hypertension and the patient of hyperlipemia and the patient of cardiac risk symptom.
The preparation that adopts the compositions of the rosuvastain calcium of the Amlodipine Besylate Tablet of antihypertensive and blood fat reducing and cholesterol to make can reduce patient's hypertension and hyperlipidemia, hypercholesterolemia simultaneously, they not only have addition and synergism, also are convenient to clinical practice simultaneously.
Technical scheme of the present invention is as follows:
A kind of pharmaceutical composition that contains Amlodipine Besylate Tablet and rosuvastain calcium, it is characterized in that prescription is: Amlodipine Besylate Tablet is the 5-40% weight portion, and rosuvastain calcium is the 5-40% weight portion, and pharmaceutic adjuvant is the 20-90% weight portion.
Drug combination preparation of the present invention comprises tablet, capsule, granule etc.
The preparation of pharmaceutical compositions method of Amlodipine Besylate Tablet of the present invention and rosuvastain calcium is:
Get Amlodipine Besylate Tablet, rosuvastain calcium and pharmaceutic adjuvant pulverize separately, cross the 60-100 mesh sieve, with 5-20% slurry system soft material, the 20-50 order is granulated, and is dry under 50 ℃-90 ℃, adds the moderate lubrication agent, and mix homogeneously is made corresponding preparation.
The used pharmaceutic adjuvant of the present invention mainly contains lactose, microcrystalline Cellulose, carboxymethylstach sodium, 30 POVIDONE K 30 BP/USP 30 and magnesium stearate etc., wherein lactose is a diluent, and microcrystalline Cellulose is the disintegrating agent diluent of holding concurrently, and carboxymethylstach sodium is a disintegrating agent, 30 POVIDONE K 30 BP/USP 30 is a binding agent, and magnesium stearate is a lubricant.With the preparation that this law is made, quality meets the standard code of working out, and this preparation technology is applicable to industrialized great production.
The pharmaceutical composition of Amlodipine Besylate Tablet of the present invention and rosuvastain calcium and preparation method thereof technology is simple, and production cost is low, is applicable to industrialized great production; Its medicine makes patient's taking convenience, good effect.
The specific embodiment:
Embodiment one: the preparation of compound recipe Amlodipine Besylate Tablet Rosuvastatin calcium tablet.Specification is: 10 milligrams of 10 milligrams/rosuvastain calciums of Amlodipine Besylate Tablet, and the proportioning that is pressed into 1000 is: Amlodipine Besylate Tablet: 10 grams; Rosuvastain calcium: 10 grams; Lactose: 30 grams; Microcrystalline Cellulose: 20 grams, carboxymethylstach sodium: 2 grams; An amount of and the magnesium stearate of 10% 30 POVIDONE K 30 BP/USP, 30 solution: 0.5 gram.
Its preparation process is with the supplementary material pulverize separately, crosses the 60-100 mesh sieve, takes by weighing the supplementary material mix homogeneously by above-mentioned recipe quantity, make soft material with 10% 30 POVIDONE K 30 BP/USP, 30 solution, cross 24 mesh sieves and granulate, granule is in hot air drying below 90 ℃, moisture Control is in 3%, the magnesium stearate that adds recipe quantity, mix homogeneously, granulate, detect intermediate content, it is heavy to calculate every sheet, and tabletting promptly gets this product.The quality standard that product is worked out by our company's compound recipe Amlodipine Besylate Tablet Rosuvastatin calcium tablet detects, and is every all up to specification.
Embodiment two: the capsular preparation of the left-handed Amlodipine Besylate Tablet rosuvastain calcium of compound recipe.Specification is: 10 milligrams of 5 milligrams/rosuvastain calciums of left-handed Amlodipine Besylate Tablet, the proportioning of making 1000 is: Amlodipine Besylate Tablet 5 grams, rosuvastain calcium 10 grams, lactose 25 grams, microcrystalline Cellulose 20 grams, carboxymethylstach sodium 2 restrain, 10% 30 POVIDONE K 30 BP/USP, 30 solution are an amount of and magnesium stearate 0.5 gram.Its preparation process is with the supplementary material pulverize separately, crosses the 60-100 mesh sieve, takes by weighing the supplementary material mix homogeneously by recipe quantity, make soft material with 10% 30 POVIDONE K 30 BP/USP, 30 solution, 24 mesh sieves are granulated, and granule is in hot air drying below 90 ℃, and moisture Control is in 3%, the magnesium stearate that adds recipe quantity, mix homogeneously, granulate detects intermediate content, calculate every loading amount, filling, promptly get product.The quality standard that product is drafted by the left-handed Amlodipine Besylate Tablet Rosuvastatin of our company's compound recipe calcium capsule detects, and is every all up to specification.
Embodiment three: the particulate preparation of the left-handed Amlodipine Besylate Tablet rosuvastain calcium of compound recipe.
Specification is: 20 milligrams of 10 milligrams/rosuvastain calciums of left-handed Amlodipine Besylate Tablet, the proportioning of making 1000 bags is: Amlodipine Besylate Tablet 10 gram, rosuvastain calcium 20 grams, lactose 300 grams, microcrystalline Cellulose 140 grams, carboxymethylstach sodium 20 grams, correctives stevioside 5 grams, 10% 30 POVIDONE K 30 BP/USP, 30 solution are an amount of and magnesium stearate 5 grams.Its preparation process is with the supplementary material pulverize separately, crosses the 60-100 mesh sieve, takes by weighing the supplementary material mix homogeneously by recipe quantity, make soft material with 10% 30 POVIDONE K 30 BP/USP, 30 solution, 24 mesh sieves are granulated, and granule is in hot air drying below 90 ℃, and moisture Control is in 3%, the magnesium stearate and the stevioside that add recipe quantity, mix homogeneously, granulate detects intermediate content, calculate every packed amount, fill, promptly get product.The quality standard that product is drafted by the left-handed Amlodipine Besylate Tablet Rosuvastatin of our company's compound recipe calcium capsule detects, and is every all up to specification.
Claims (3)
1, a kind of pharmaceutical composition that contains Amlodipine Besylate Tablet and rosuvastain calcium is characterized in that prescription is; Amlodipine Besylate Tablet is the 5-40% weight portion, and rosuvastain calcium is the 5-40% weight portion, and pharmaceutic adjuvant is the 20-90% weight portion.
2, the pharmaceutical composition that contains Amlodipine Besylate Tablet and rosuvastain calcium according to claim 1, it is characterized in that its preparation method is: get Amlodipine Besylate Tablet, rosuvastain calcium and pharmaceutic adjuvant pulverize separately, cross the 60-100 mesh sieve, with 5%-20% slurry system soft material, the 20-50 order is granulated, and is dry under 50 ℃-90 ℃, adds the moderate lubrication agent, mix homogeneously is made corresponding preparation.
3, the pharmaceutical composition that contains Amlodipine Besylate Tablet and rosuvastain calcium according to claim 1 is characterized in that pharmaceutic adjuvant is lactose, microcrystalline Cellulose, carboxymethylstach sodium, 30 POVIDONE K 30 BP/USP 30 and magnesium stearate.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200510094723 CN1762361A (en) | 2005-09-28 | 2005-09-28 | Pharmaceutical composition containing amiodipine besylate and rosuvastatin calcium, and its preparation method |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200510094723 CN1762361A (en) | 2005-09-28 | 2005-09-28 | Pharmaceutical composition containing amiodipine besylate and rosuvastatin calcium, and its preparation method |
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| Publication Number | Publication Date |
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| CN1762361A true CN1762361A (en) | 2006-04-26 |
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| CN 200510094723 Pending CN1762361A (en) | 2005-09-28 | 2005-09-28 | Pharmaceutical composition containing amiodipine besylate and rosuvastatin calcium, and its preparation method |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2008048084A1 (en) * | 2006-10-17 | 2008-04-24 | World-Trade Import-Export, Wtie, Ag. | Pharmaceutical combinations for the treatment of dyslipidemia accompanied by high blood pressure |
| WO2010009619A1 (en) * | 2008-07-24 | 2010-01-28 | 鲁南制药集团股份有限公司 | Pharmaceutical composition for treating hypertension and metabolic syndrome and use thereof |
-
2005
- 2005-09-28 CN CN 200510094723 patent/CN1762361A/en active Pending
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2008048084A1 (en) * | 2006-10-17 | 2008-04-24 | World-Trade Import-Export, Wtie, Ag. | Pharmaceutical combinations for the treatment of dyslipidemia accompanied by high blood pressure |
| WO2010009619A1 (en) * | 2008-07-24 | 2010-01-28 | 鲁南制药集团股份有限公司 | Pharmaceutical composition for treating hypertension and metabolic syndrome and use thereof |
| US8722697B2 (en) | 2008-07-24 | 2014-05-13 | Lunan Pharmaceutical Group Corporation | Pharmaceutical composition for treating hypertension and metabolic syndrome and use thereof |
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