CN103494788A - Pharmaceutical composition of rosuvastatin calcium tablets and preparation method of pharmaceutical composition - Google Patents
Pharmaceutical composition of rosuvastatin calcium tablets and preparation method of pharmaceutical composition Download PDFInfo
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- CN103494788A CN103494788A CN201310469441.1A CN201310469441A CN103494788A CN 103494788 A CN103494788 A CN 103494788A CN 201310469441 A CN201310469441 A CN 201310469441A CN 103494788 A CN103494788 A CN 103494788A
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Abstract
The invention belongs to the field of pharmaceutical preparations and particularly relates to a pharmaceutical composition of rosuvastatin calcium tablets and a preparation method of the pharmaceutical composition. The pharmaceutical composition consists of an active medicine tablet core and a controlled-release layer wrapped outside the active medicine tablet core, wherein an alkaline substance calcium hydrophosphate is added in the tablet core, and the controlled-release layer consists of ethylcellulose, polyethylene glycol and polyacrylic resin III. According to the pharmaceutical composition, the stable and controlled-release rosuvastatin calcium tablets are obtained.
Description
Technical field
The invention belongs to field of pharmaceutical preparations,, be specifically related to pharmaceutical composition of a kind of rosuvastatin calcium tablets and preparation method thereof
Background technology
Hyperlipemia is high morbidity in mid-aged population, and along with the raising of people's living standard, the change of living habit, the sickness rate of hyperlipemia increases year by year, and patient's age is tending towards rejuvenation.There is hyperlipidemia patient 8,000 ten thousand in China, and with ten thousand people's quantity, increases every day, and hyperlipemia, just as time bomb, is threatening people's health at any time.It is the arteriosclerosis that causes whole body that hyperlipemia is the most directly damaged, and then causes relevant disease, as the arteriosclerosis of heart and brain can cause the diseases such as coronary heart diseases and angina pectoris, myocardial infarction and cerebrovascular accident.
Rosuvastain calcium is blood lipid-lowering medicine, through clinical trial, proves, for the light moderate hyperlipidemia patient in Asia, no matter whether the patient is first medication, and rosuvastain calcium all shows strong lipid-lowering effect and high safety.
Rosuvastain calcium is by the exploitation of Britain AstraZeneca pharmaceutical Co. Ltd, and at first in Holland's listing, obtain the U.S. FDA approval in August, 2003, China food and medicine Surveillance Authority in 2006 approval of import in November, 2002.
Rosuvastain calcium chemistry by name two-[the fluorine-based phenyl of (E)-7-[4-(4-)-6-isopropyl-2-[methyl (mesyl) amino]-pyrimidine-5-yl] (3R, 5S)-3,5-dihydroxy-6-heptenoic acid] calcium salt.
Physicochemical property: soluble,very slightly in water, almost insoluble in methanol or ethanol.
Rosuvastain calcium is stable under alkali condition, unstable under high temperature and illumination, acid, oxidizing condition, produces a certain amount of impurity.Document money report rosuvastain calcium is easy to degraded in high temperature or higher levels of humidity environment, the primary product formed is (3R, 5S) lactone catabolite and oxidative breakdown product, thereby cause its stability test result of compositions that adopts conventional preparation technology to obtain undesirable, this unstable be to be determined by its structure itself, β in the rosuvastain calcium molecule on the heptenoic acid chain, δ-hydroxyl is very unstable, and the hydroxyl that wherein carbon-to-carbon double bond is adjacent is easy to be oxidized to ketone.Also molecule inner ring condensation can occur, generate lactone.
Disclose the stabilization medicines compositions that contains statins in Chinese patent CN93100650, said composition is that the pH value by adding a kind of aqueous solution that can make said composition or dispersion liquid at least remains on 8 alkaline medium and reaches stable purpose.
Chinese patent CN200780034516 discloses in the compositions cut down his spit of fland calcium of relaxing the stable problem that adds alkaline magnesium hydroxide and/or calcium acetate or calcium gluconate or calcium glycerophosphate or aluminium hydroxide, can solve the Rosuvastatin calcium composition.
Disclose the stabilization medicines compositions that contains statins in Chinese patent CN93100650, said composition is that the pH value by adding a kind of aqueous solution that can make said composition or dispersion liquid at least remains on 8 alkaline medium and reaches stable purpose.
In Chinese patent CN00122484, disclosing relaxes cuts down the compositions of Ta Ting or its pharmaceutically useful salt, and said composition is by adding the cationic three alkali valency phosphate as stabilizing agent to reach stable purpose.
Above-mentioned patent, all by adding alkaline matter, making easypro his the spit of fland calcium that cuts down stablize under alkali condition, has reduced the generation of impurity.But above-mentioned patent is all cut down the problem of his spit of fland calcium drug release less than solve relaxing, relax that to cut down his spit of fland calcium be blood lipid-lowering medicine, need long-term taking, drug release contributes to reduce drug side effect stably.
So Chinese patent CN201010237681 discloses a kind of relax and has cut down slow releasing preparation of his spit of fland calcium and preparation method thereof, will relax and cut down his spit of fland calcium, sustained-release matrix material and other pharmaceutic adjuvants and prepare burden in proportion, press conventional tablet, granule, capsule preparation method thereof and prepare.According to said method the slow releasing preparation of preparation, avoided the untoward reaction such as the excessive striped muscle hemolytic disease caused of drug dose, albuminuria, nephropathy.After making drug administration, can maintain the treatment due blood drug level of disease and time simultaneously, effectively avoid the peak valley phenomenon of blood drug level.
What but CN201010237681 was used is the sustained-release matrix material, press the preparation of conventional tablet preparation method, the active pharmaceutical ingredient of tablet surface easily makes moist, oxidation, do not use basic auxiliary in addition, the tablet active pharmaceutical ingredient relaxes and to cut down his spit of fland calcium and play pendulum, and very easily produces impurity after placement.
Therefore, prepare a kind of stablely, easypro his the spit of fland calcium tablet that cuts down of slow release, be the problem that we should solve.
Summary of the invention
Purpose preparation of the present invention is a kind of stable, easypro his the spit of fland calcium tablet that cuts down of slow release.
We find: a kind of pharmaceutical composition of rosuvastatin calcium tablets comprises the active medicine label, is wrapped in the outer slow release layer of active medicine label and forms: can obtain a kind of stable, easypro his the spit of fland calcium tablet that cuts down of slow release.
This be because: added the alkaline matter calcium hydrogen phosphate in the active medicine label, guaranteed in label that the active medicine rosuvastain calcium is in alkaline environment, more stable, simultaneously, the label outsourcing one deck slow release layer, not only make the active medicine sheet slowly discharge, and label and moisture, oxygen is isolated, has more avoided the generation of impurity.
We find: the active medicine label is comprised of better rosuvastain calcium, low-substituted hydroxypropyl cellulose, magnesium stearate, polyvinylpolypyrrolidone, lactose monohydrate, calcium hydrogen phosphate, and the weight percent content of its composition is:
| The name of an article | Percentage ratio |
| Rosuvastain calcium | 6～10％ |
| Low-substituted hydroxypropyl cellulose | 10％ |
| Magnesium stearate | 0.7％ |
| Polyvinylpolypyrrolidone | 7～9％ |
| Lactose monohydrate | 50％ |
| Calcium hydrogen phosphate | 22～26％ |
It is good that above-mentioned composition can obtain molding, the label of disintegrate effect.
We find: the outer slow release layer of label is comprised of better ethyl cellulose, Polyethylene Glycol, polyacrylic resin Ⅲ, and the weight percent content of outer its composition of slow release layer of label is:
| The name of an article | Percentage ratio |
| Ethyl cellulose | 80～85％ |
| Polyethylene Glycol | 8～12％ |
| Polyacrylic resin Ⅲ | 5～8％ |
Its preparation method comprises:
(1) prepare label: supplementary material rosuvastain calcium, low-substituted hydroxypropyl cellulose, polyvinylpolypyrrolidone, lactose monohydrate, the calcium hydrogen phosphate that will form the active medicine label are pulverized, cross 80 mesh sieves, 80% ethanol is added, soft material processed, cross 40 mesh sieves and granulate, 50 ℃ of dryings, 40 mesh sieve granulate, add magnesium stearate, mix, tabletting;
(2) bag slow release layer: after ethyl cellulose, polyacrylic resin Ⅲ are added to dissolve with ethanol respectively, mix, mixed liquor adds Polyethylene Glycol again, mix, obtain sustained release coating liquid, label prepared by (1) is put in coating pan, spray into quantitative sustained release coating liquid, label weightening finish 3-5%, drying;
(3) detect coated tablet prepared by (3), qualified after, packing.
The beneficial effect of the pharmaceutical composition of rosuvastatin calcium tablets of the present invention is shown in experiment 1,2.
The pharmaceutical composition of experiment 1, rosuvastatin calcium tablets of the present invention and the release of other rosuvastatin calcium tablets compare:
(1) sample: sample A: by the rosuvastatin calcium tablets of the embodiment of the present invention 1 preparation;
Sample B: tablet prepared by the sustained-release matrix material used by CN201010237681 embodiment 1:
Its preparation method:
Prescription: rosuvastain calcium 5.2mg, HPMC K4M 72mg,
Lactose 82mg, 10% polyvinylpyrrolidone is appropriate, 60% appropriate amount of ethanol, magnesium stearate 1.6mg,
Preparation technology; Rosuvastain calcium was pulverized to 80 mesh sieves, mix with HPMC K4M, lactose, with 10% polyvinylpyrrolidone, the moistening rear granulation of 60% ethanol, granulate after 50 ℃ of dryings, add the magnesium stearate mix homogeneously, and tabletting, obtain.
Sample C: the rosuvastatin calcium tablets of pressing CN200780034516 embodiment 10 preparations:
Prescription (weight percent content of its composition):
| The name of an article | Percentage ratio |
| Rosuvastain calcium | 6.93％ |
| Lactose | 55.00％ |
| Magnesium stearate | 1.00％ |
| Polyvinylpolypyrrolidone | 5.00％ |
| Microcrystalline Cellulose | 27.07％ |
| Calcium acetate | 5.00％ |
Preparation technology; Rosuvastain calcium was pulverized to 80 mesh sieves, with polyvinylpolypyrrolidone, lactose,
Microcrystalline Cellulose, calcium acetate mix, and then add the magnesium stearate mix homogeneously, and dry powder sheeting, obtain.
(2) 3 samples are carried out to release relatively:
Experimental technique: according to Chinese Pharmacopoeia two appendix XC in 2010, first method (blue laws), take water 900ml as dissolution medium, rotating speed is per minute 100 to turn, and operation in accordance with the law, respectively at sampling in 0.5,1,2,6,12,16,20,24 hour, with organic filter membrane, filter, getting subsequent filtrate is need testing solution
With high performance liquid chromatography (Chinese Pharmacopoeia two appendix VD in 2010), in the 242nm place, detect,
The release of calculation sample.3 sample releases see the following form 1:
(3) experiment conclusion: sample C does not have slow releasing function, sample B had slow releasing function in 24 hours, rosuvastatin calcium tablets sample A by the embodiment of the present invention 1 preparation had slow releasing function in 24 hours, with sample B, compare, release amount of medicine in 2 hours is greater than sample B, reaches as early as possible the blood drug level for the treatment of after being conducive to the patient and taking.
The pharmaceutical composition of experiment 2, rosuvastatin calcium tablets of the present invention and the stability of other rosuvastatin calcium tablets compare:
(1) laboratory sample: laboratory sample is with experiment 1.
(2) 3 samples are carried out to stability relatively:
Experimental technique: accelerated test:
3 samples are carried out respectively to aluminium-plastic bubble plate packing, place under 40 ℃ ± 2 ℃ relative humidity 75% ± 5% constant temperature and humidity conditions, respectively at 0,1,2,3, the sampling in June detects, testing result sees the following form 2:
(3) experiment conclusion: sample C is more stable,, sample B is very unstable, highly stable by the rosuvastatin calcium tablets sample A of the embodiment of the present invention 1 preparation, has illustrated that rosuvastatin calcium tablets prepared by the present invention stablizes fine.
Attached: the rosuvastatin calcium tablets assay:
According to high performance liquid chromatography (two appendix V D of Chinese Pharmacopoeia version in 2010).
Chromatographic condition and system suitability octadecylsilane chemically bonded silica are filler; Water-acetonitrile-1% trifluoroacetic acid solution (62:37:1) of take is mobile phase; The detection wavelength is 242nm.Get rosuvastain calcium reference substance 20mg, put in the 200ml measuring bottle, add water 100ml jolting and make to dissolve, the hydrochloric acid solution 20ml that adds 1mol/L, shake up, put in 60 ℃ of water-baths and heat 2 hours, add the sodium hydroxide solution 20ml of 1mol/L, shake up, let cool, add acetonitrile 50ml, be diluted with water to scale, shake up, as diastereomer test stock solution.Measure this solution 5ml, put in the 10ml measuring bottle, add acetonitrile-aqueous solution (25:75) and be diluted to scale, shake up, be the diastereo-isomerism liquid solution, as system suitability solution, get 20 μ l injection liquid chromatographies, record chromatogram, the separating degree at Rosuvastatin peak and Rosuvastatin diastereomer peak should meet the requirements, and number of theoretical plate calculates and is not less than 2000 by the Rosuvastatin peak.
Algoscopy is got 20 of this product, accurately weighed, porphyrize, precision takes in right amount (approximately being equivalent to Rosuvastatin 25mg), puts in the 100ml measuring bottle, and solubilizer [acetonitrile-aqueous solution (25:75)] is appropriate, jolting is dissolved rosuvastain calcium, and is diluted to scale, shakes up, filter, precision measures subsequent filtrate 10ml, puts in the 100ml measuring bottle,, shake up to scale with solvent dilution, filter, precision measures subsequent filtrate 20 μ l injection liquid chromatographies, records chromatogram; Separately get the rosuvastain calcium reference substance appropriate, accurately weighed, solubilizer dissolves, and makes every 1ml approximately containing the solution of Rosuvastatin 25 μ g, is measured in the same method.Take calculated by peak area (the rosuvastain calcium molecular weight is 1001.14, and the Rosuvastatin molecular weight is 481.54) by external standard method, obtain.
The specific embodiment
Following embodiment narrates the present invention for further, but does not impose any restrictions.
The preparation of embodiment 1 rosuvastatin calcium tablets
1, prescription:
Active medicine ball core:
| The name of an article | Percentage ratio | True weight (kilogram) |
| Rosuvastain calcium | 7％ | 1.00 |
| Low-substituted hydroxypropyl cellulose | 10％ | 1.43 |
| Magnesium stearate | 0.7％ | 0.10 |
| Polyvinylpolypyrrolidone | 7％ | 1.00 |
| Lactose monohydrate | 50％ | 7.14 |
| Calcium hydrogen phosphate | 25.3％ | 3.61 |
Slow release layer:
| The name of an article | Percentage ratio | True weight (kilogram) |
| Ethyl cellulose | 80％ | 0.80 |
| Polyethylene Glycol | 12％ | 0.12 |
| Polyacrylic resin Ⅲ | 8％ | 0.08 |
Preparation technology:
(1) prepare label: the supplementary material rosuvastain calcium of recipe quantity, low-substituted hydroxypropyl cellulose, polyvinylpolypyrrolidone, lactose monohydrate, calcium hydrogen phosphate are pulverized, cross 80 mesh sieves, 80% appropriate amount of ethanol is added, make the soft material of suitable hardness, cross 40 mesh sieves and granulate, 50 ℃ of dryings, 40 mesh sieve granulate, add magnesium stearate, mix, tabletting;
(2) bag slow release layer: after the ethyl cellulose of recipe quantity, polyacrylic resin Ⅲ are added to the 10L80% dissolve with ethanol, mix, mixed liquor adds Polyethylene Glycol again, mix, obtain sustained release coating liquid, label prepared by (1) is put in coating pan, sprays into quantitative sustained release coating liquid, label weightening finish 4%, drying;
(3) detect coated tablet prepared by (3), qualified after, packing.
The preparation of embodiment 2 rosuvastatin calcium tablets
1, prescription:
Active medicine ball core:
| The name of an article | Percentage ratio | True weight (kilogram) |
| Rosuvastain calcium | 10％ | 1.43 |
| Low-substituted hydroxypropyl cellulose | 10％ | 1.43 |
| Magnesium stearate | 0.7％ | 0.10 |
| Polyvinylpolypyrrolidone | 7％ | 1.00 |
| Lactose monohydrate | 50％ | 7.14 |
| Calcium hydrogen phosphate | 22.3％ | 3.18 |
Slow release layer:
| The name of an article | Percentage ratio | True weight (kilogram) |
| Ethyl cellulose | 85％ | 0.85 |
| Polyethylene Glycol | 10％ | 0.10 |
| Polyacrylic resin Ⅲ | 5％ | 0.05 |
Preparation technology:
1) prepare label: the supplementary material rosuvastain calcium of recipe quantity, low-substituted hydroxypropyl cellulose, polyvinylpolypyrrolidone, lactose monohydrate, calcium hydrogen phosphate are pulverized, cross 80 mesh sieves, 80% appropriate amount of ethanol is added, make the soft material of suitable hardness, cross 40 mesh sieves and granulate, 50 ℃ of dryings, 40 mesh sieve granulate, add magnesium stearate, mix, tabletting;
(2) bag slow release layer: after the ethyl cellulose of recipe quantity, polyacrylic resin Ⅲ are added to the 10L80% dissolve with ethanol, mix, mixed liquor adds Polyethylene Glycol again, mix, obtain sustained release coating liquid, label prepared by (1) is put in coating pan, sprays into quantitative sustained release coating liquid, label weightening finish 5%, drying;
(3) detect coated tablet prepared by (3), qualified after, packing.
The preparation of embodiment 3 rosuvastatin calcium tablets
1, prescription:
Active medicine ball core:
| The name of an article | Percentage ratio | True weight (kilogram) |
| Rosuvastain calcium | 8％ | 1.14 |
| Low-substituted hydroxypropyl cellulose | 10％ | 1.43 |
| Magnesium stearate | 0.7％ | 0.10 |
| Polyvinylpolypyrrolidone | 9％ | 1.29 |
| Lactose monohydrate | 50％ | 7.14 |
| Calcium hydrogen phosphate | 22.3％ | 3.18 |
Slow release layer:
| Name of an article percentage ratio true weight (kilogram) ethyl cellulose 82%0.82 Polyethylene Glycol 12%0.12 polyacrylic resin Ⅲ 6%0.06 |
Preparation technology:
1) prepare label: the supplementary material rosuvastain calcium of recipe quantity, low-substituted hydroxypropyl cellulose, polyvinylpolypyrrolidone, lactose monohydrate, calcium hydrogen phosphate are pulverized, cross 80 mesh sieves, 80% appropriate amount of ethanol is added, make the soft material of suitable hardness, cross 40 mesh sieves and granulate, 50 ℃ of dryings, 40 mesh sieve granulate, add magnesium stearate, mix, tabletting;
(2) bag slow release layer: after the ethyl cellulose of recipe quantity, polyacrylic resin Ⅲ are added to the 10L80% dissolve with ethanol, mix, mixed liquor adds Polyethylene Glycol again, mix, obtain sustained release coating liquid, label prepared by (1) is put in coating pan, sprays into quantitative sustained release coating liquid, label weightening finish 3%, drying;
(3) detect coated tablet prepared by (3), qualified after, packing.
Claims (6)
1. the pharmaceutical composition of a rosuvastatin calcium tablets, is characterized in that: comprise the active medicine label, be wrapped in the outer slow release layer composition of active medicine label.
2. pharmaceutical composition according to claim 1, it is characterized in that: the active medicine label is comprised of rosuvastain calcium, low-substituted hydroxypropyl cellulose, magnesium stearate, polyvinylpolypyrrolidone, lactose monohydrate, calcium hydrogen phosphate.
3. pharmaceutical composition according to claim 3, it is characterized in that: the weight percent content of its composition of active medicine label is:
4. pharmaceutical composition according to claim 1 is characterized in that: the outer slow release layer of label is comprised of ethyl cellulose, Polyethylene Glycol, polyacrylic resin Ⅲ.
5. pharmaceutical composition according to claim 4 is characterized in that: the weight percent content of outer its composition of slow release layer of label is:
6. the described pharmaceutical composition according to claim 1 to 5 any one, its preparation method comprises:
(1) prepare label: supplementary material rosuvastain calcium, low-substituted hydroxypropyl cellulose, polyvinylpolypyrrolidone, lactose monohydrate, the calcium hydrogen phosphate that will form the active medicine label are pulverized, cross 80 mesh sieves, 80% ethanol is added, soft material processed, cross 40 mesh sieves and granulate, 50 ℃ of dryings, 40 mesh sieve granulate, add magnesium stearate, mix, tabletting;
(2) bag slow release layer: after ethyl cellulose, polyacrylic resin Ⅲ are added to 80% dissolve with ethanol, mix, mixed liquor adds Polyethylene Glycol again, mix, obtain sustained release coating liquid, label prepared by (1) is put in coating pan, spray into quantitative sustained release coating liquid, label weightening finish 3-5%, drying;
(3) detect coated tablet prepared by (3), qualified after, packing.
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| 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 |
| CN109996545A (en) * | 2016-11-15 | 2019-07-09 | 株式会社Lg化学 | For treating the medicinal composition of diabetes B and diabetic keratopathy dyslipidemia |
| CN111135149A (en) * | 2018-11-04 | 2020-05-12 | 鲁南制药集团股份有限公司 | Rosuvastatin calcium tablet and preparation method thereof |
| TWI749204B (en) * | 2018-04-02 | 2021-12-11 | 強生化學製藥廠股份有限公司 | A pharmaceutical composition capable of improving the bioavailability of oral statins and its use |
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| CN101516349A (en) * | 2006-09-18 | 2009-08-26 | 里克特格登有限公司 | Pharmaceutical compositions containing rosuvastatin calcium |
| CN101889975A (en) * | 2010-07-27 | 2010-11-24 | 北京虹湾医药技术有限公司 | Rosuvastatin calcium sustained-release preparation and preparation method thereof |
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| CN101516349A (en) * | 2006-09-18 | 2009-08-26 | 里克特格登有限公司 | Pharmaceutical compositions containing rosuvastatin calcium |
| CN101889975A (en) * | 2010-07-27 | 2010-11-24 | 北京虹湾医药技术有限公司 | Rosuvastatin calcium sustained-release preparation and preparation method thereof |
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Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| 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 |
| CN109996545A (en) * | 2016-11-15 | 2019-07-09 | 株式会社Lg化学 | For treating the medicinal composition of diabetes B and diabetic keratopathy dyslipidemia |
| TWI749204B (en) * | 2018-04-02 | 2021-12-11 | 強生化學製藥廠股份有限公司 | A pharmaceutical composition capable of improving the bioavailability of oral statins and its use |
| CN111135149A (en) * | 2018-11-04 | 2020-05-12 | 鲁南制药集团股份有限公司 | Rosuvastatin calcium tablet and preparation method thereof |
| CN111135149B (en) * | 2018-11-04 | 2021-05-11 | 张家港市中医医院 | Rosuvastatin calcium tablet and preparation method thereof |
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| CN103494788B (en) | 2015-08-05 |
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