CN1762353A - Pharmaceutical composition containing amiodipine besylate and nisvastatin calcium and its preparation method - Google Patents
Pharmaceutical composition containing amiodipine besylate and nisvastatin calcium and its preparation method Download PDFInfo
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- CN1762353A CN1762353A CN 200510094722 CN200510094722A CN1762353A CN 1762353 A CN1762353 A CN 1762353A CN 200510094722 CN200510094722 CN 200510094722 CN 200510094722 A CN200510094722 A CN 200510094722A CN 1762353 A CN1762353 A CN 1762353A
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- calcium
- nilvastatin
- amlodipine besylate
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- besylate tablet
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Abstract
The invention relates to an pharmaceutical composition containing amlodipine besylate and pitavastatin calcium and its preparation, wherein the formula comprises amlodipine besylate 5-40 wt%, pitavastatin calcium 5-40wt%, and medicinal auxiliary materials 20-90 wt% including lactose, crystalline cellulose, sodium carboxymethylstarch, polyplasdone K30 and magnesium stearate.
Description
Technical field:
The present invention relates to a kind of pharmaceutical composition that contains Amlodipine Besylate Tablet and nilvastatin 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 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.
In sum, adopt and reduce hypertensive Amlodipine Besylate Tablet and the addition of nilvastatin calcium compound preparation and the synergism that reduce 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 nilvastatin calcium and preparation method thereof,, and make this compound preparation by the main drug regimen and the preparation of Amlodipine Besylate Tablet and nilvastatin calcium.
A kind of pharmaceutical composition that contains Amlodipine Besylate Tablet and nilvastatin 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 symptom and the patient of cardiac risk symptom.
Adopt to reduce preparation that the compositions of nilvastatin calcium of the cholesterol of hypertensive Amlodipine Besylate Tablet and blood fat reducing makes and can reduce patient's hypertension and hyperlipidemia, hypercholesterolemia simultaneously, they not only have the synergism of addition, 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 nilvastatin calcium, it is characterized in that prescription is: Amlodipine Besylate Tablet is the 5-40% weight portion, and nilvastatin 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 nilvastatin calcium is:
Get Amlodipine Besylate Tablet, nilvastatin 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 conformance with standard regulation, this preparation technology is applicable to industrialized great production.
The pharmaceutical composition of Amlodipine Besylate Tablet of the present invention and nilvastatin 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 nilvastatin calcium sheet.Specification is: 1 milligram of 10 milligrams/nilvastatin calcium of Amlodipine Besylate Tablet, and the proportioning that is pressed into 1000 is: Amlodipine Besylate Tablet: 10 grams; Nilvastatin calcium: 1 gram; Lactose: 35 grams; Microcrystalline Cellulose 20 grams, carboxymethylstach sodium: 3 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 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 nilvastatin calcium sheet detects, and is every all up to specification.
Embodiment two: the capsular preparation of the left-handed Amlodipine Besylate Tablet nilvastatin calcium of compound recipe.Specification is: 2 milligrams of 5 milligrams/nilvastatin calciums of left-handed Amlodipine Besylate Tablet, the proportioning of making 1000 is: left-handed Amlodipine Besylate Tablet 5 grams, nilvastatin calcium 2 grams, lactose 25 grams, microcrystalline Cellulose 20 grams, carboxymethylstach sodium 3 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 this product is drafted by the left-handed Amlodipine Besylate Tablet nilvastatin calcium of compound recipe capsule detects, and is every all up to specification.
Embodiment three: the particulate preparation of the left-handed Amlodipine Besylate Tablet nilvastatin calcium of compound recipe.
Specification is: 2 milligrams of 5 milligrams/nilvastatin calciums of left-handed Amlodipine Besylate Tablet, the proportioning of making 1000 bags is: Amlodipine Besylate Tablet 5 gram, nilvastatin calcium 2 grams, lactose 160 grams, microcrystalline Cellulose 70 grams, carboxymethylstach sodium 8 grams, correctives stevioside 2 grams, 10% 30 POVIDONE K 30 BP/USP, 30 solution are an amount of and magnesium stearate 2 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 this product is drafted by the left-handed Amlodipine Besylate Tablet nilvastatin calcium of compound recipe capsule detects, and is every all up to specification.
Claims (3)
1, a kind of pharmaceutical composition that contains Amlodipine Besylate Tablet and nilvastatin calcium, it is characterized in that prescription is: Amlodipine Besylate Tablet is the 5-40% weight portion, and nilvastatin calcium is the 5-40% weight portion, and pharmaceutic adjuvant is the 20-90% weight portion.
2, a kind of pharmaceutical composition that contains Amlodipine Besylate Tablet and nilvastatin calcium according to claim 1, it is characterized in that this preparation of pharmaceutical compositions method is: get Amlodipine Besylate Tablet, nilvastatin 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, a kind of pharmaceutical composition that contains Amlodipine Besylate Tablet and nilvastatin 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 200510094722 CN1762353A (en) | 2005-09-28 | 2005-09-28 | Pharmaceutical composition containing amiodipine besylate and nisvastatin calcium and its preparation method |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200510094722 CN1762353A (en) | 2005-09-28 | 2005-09-28 | Pharmaceutical composition containing amiodipine besylate and nisvastatin calcium and its preparation method |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN1762353A true CN1762353A (en) | 2006-04-26 |
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Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN 200510094722 Pending CN1762353A (en) | 2005-09-28 | 2005-09-28 | Pharmaceutical composition containing amiodipine besylate and nisvastatin calcium and its preparation method |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN1762353A (en) |
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2005
- 2005-09-28 CN CN 200510094722 patent/CN1762353A/en active Pending
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