CN102309462A - Atorvastatin calcium tablet - Google Patents
Atorvastatin calcium tablet Download PDFInfo
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- CN102309462A CN102309462A CN201110199004A CN201110199004A CN102309462A CN 102309462 A CN102309462 A CN 102309462A CN 201110199004 A CN201110199004 A CN 201110199004A CN 201110199004 A CN201110199004 A CN 201110199004A CN 102309462 A CN102309462 A CN 102309462A
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- atorvastatin calcium
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- calcium tablet
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- disintegrating agent
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Abstract
The invention which relates to an atorvastatin calcium tablet for treating hyperlipidemia belongs to the technical field of western medicine preparations. In the tablet, the weight ratio of atorvastatin calcium: a filler: a disintegrant: a lubricant is 1:8-15:0.5-1.5:0.1-0.3. The tablet of the present invention has the advantages of stable quality, rapid disintegration and leaching, moderate tablet hardness, and simple preparation technology.
Description
Technical field
The invention belongs to the Western medicine prepn technical field, particularly a kind of atorvastatin calcium tablet of treating hyperlipidemia.
Background technology
Along with the continuous development of life sciences, it is widely acknowledged cholesterol, fatty equal size too high be the basic cause of disease that cardiovascular disease takes place, hyperlipidemia is that coronary heart disease and hypertensive main hazard factor take place.Therefore, research worker begins the exploitation of blood lipid regulation medicine as the emphasis of preventing and treating cardiovascular disease.From late 1980s, blood lipid-lowering medicine is released in a large number, and wherein statins receives people's favorable comment, and its clinical efficacy good is that other all kinds of blood lipid regulation medicines institute is incomparable.During the last ten years; The completion of several worlds extensive coronary heart disease control test; Confirm that statins can reduce evidence of coronary heart diseases and mortality rate, and the atheromatous plaque development that has formed is slowed down, even go down; Thereby broken the irreversible traditional view of coronary heart disease, risen in the whole world by the blood fat revolution that cause in " his spit of fland ".At present, the world of medicine is filled with unbounded confidence in the effect that prevents and treats aspect the cardiovascular disease to fat regulation medicine, transfers the fat therapy will become the main method of 21 century angiocardiopathy preventing.
Atorvastatin (Atorvastatin) is a third generation Statins fat regulation medicine; It is a kind of complete synthesis hydroxyl first glutaryl coenzyme A (HMG-CoA) reductase inhibitor; The form listing in the U.S. first with calcium salt; Can effectively reduce homozygote and heterozygote familial hypercholesterolemia, non-familial hypercholesterolemia and mixed type lipid metabolism impaired patients total plasma cholesterol, low-density lipoprotein cholesterol, apolipoprotein and triglyceride levels, the while is high density lipoprotein increasing cholesterol and ApoA to some extent
lLevel.
Generally speaking, Atorvastatin calcium is meant the calcium salt trihydrate of atorvastatin, and its chemical name is: [
R-(
R',
R')]-2-(4-fluorophenyl)-
β δ-dihydroxy-5-(1-Methylethyl)-3-phenyl-4-[(aniline) carbonyl]-1-hydrogen-pyrroles-1-enanthic acid calcium trihydrate, structural formula is:
The clinical efficacy of Atorvastatin calcium is definite, effect is remarkable, yet this medical instrument has stronger bitterness, and is atomic water-soluble, and poor stability, all extremely sensitive to moist, heat, light and sour environment.Especially under sour environment, atorvastatin can be degraded into corresponding lactone, reduces pharmacologically active.For example; CN1911209A (quick-disintegration tablets of calcium atovastatine, and its prepn. method; Open day on 02 14th, 2007) disclosed a kind of quickly disintegrated atorvastatin calcium tablet, by the 5-25% Atorvastatin calcium, the 45-55% disintegrating agent; The 1-5% correctives, 25-50% filler and 1-3% lubricant are formed.Its preparation method adopts wet granulation, and has used a large amount of disintegrating agents, causes the tablet stability of its preparation relatively poor, produces more related substance, under the room temperature condition during long term storage process related substance increase also very fast relatively.CN1630510A (Atorvastatin calcium of medicament forms, its compositions and comprise the pharmaceutical formulation of Atorvastatin calcium; Open on 06 22nd, 2005 day) disclosed a kind of atorvastatin calcium tablet that adopts wet granulation; And through adding the alkaline matter calcium carbonate as stabilizing agent; With the assurance stability of formulation, yet the affiliation that adds of calcium carbonate causes medication person untoward reaction such as constipation, flatulence, dyspepsia and stomachache to occur.This shows, when the solid oral dosage forms such as tablet of preparation Atorvastatin calcium, consider above-mentioned factor from aspects such as adjuvant screening and process optimizations, thereby prepare steady quality and the little preparation of side effect.
What use clinically at present all is the tablet of Atorvastatin calcium basically because tablet needs extrusion forming, therefore a lot of listing tablets exist prolonged disintegration, stripping slowly, problem such as bioavailability is lower.In order to address these problems; Prior art discloses Atorvastatin calcium has been prepared into solid quick-release tablets such as disperseing sheet, oral cavity disintegration tablet; Disintegrate and stripping problem have been overcome; Yet following problem but occurred: tablet is prone to fragment in the process of transportation, need the extra package material to pack, and has increased considerably the production cost of medicine.For example; CN101791297A (atorvastatin calcium oral disintegrating tablet and preparation method thereof; Open day on 08 04th, 2010) disclosed a kind of orally disintegrating tablet prescription and method for preparing of Atorvastatin calcium, its prescription is formed and is comprised Atorvastatin calcium, bitterness covering agent, filler, disintegrating agent, lubricant etc.The hardness of the atorvastatin calcium tablet for preparing is merely 30-50N, is prone to fragment during transportation.
In sum, study and develop the atorvastatin calcium tablet that a kind of steady quality, disintegrate and stripping are rapid, bioavailability is high, slice, thin piece hardness is moderate and seem particularly urgent.
Summary of the invention
In order to overcome the deficiency of prior art, the present invention to adjuvant screening and process optimization, provides a kind of atorvastatin calcium tablet through a large amount of tests.The steady quality of this tablet, disintegrate and stripping are rapid, and bioavailability is high, and slice, thin piece hardness is moderate, and preparation technology is simple.
The objective of the invention is to realize like this:
A kind of atorvastatin calcium tablet comprises Atorvastatin calcium, filler, disintegrating agent and lubricant.
Described atorvastatin calcium tablet, wherein the weight ratio of Atorvastatin calcium, filler, disintegrating agent and lubricant is 1:8-15:0.5-1.5:0.1-0.3.
Preferably, described filler is selected from following one or more: starch, lactose, Icing Sugar, mannitol, dextrin, cyclodextrin, microcrystalline Cellulose and sucrose.
Preferably, described disintegrating agent is selected from following one or more: carboxymethyl starch sodium, polyvinylpolypyrrolidone, cross-linking sodium carboxymethyl cellulose, crosslinked carboxymethyl fecula sodium, pregelatinized Starch and low-substituted hydroxypropyl cellulose.
Preferably, described lubricant is selected from following one or more: magnesium stearate, Pulvis Talci and micropowder silica gel.
Further preferably; Described atorvastatin calcium tablet; Be made up of Atorvastatin calcium, filler, disintegrating agent, lubricant and correctives, described correctives is selected from following one or more: sodium glutamate, orange flavor, cocoanut flavour, milk flavour, green apple essence and Fructus Citri Limoniae essence.
Further preferably, described filler is selected from following one or more: Icing Sugar, cyclodextrin and microcrystalline Cellulose.
Further preferably, described disintegrating agent is selected from polyvinylpolypyrrolidone or/and low-substituted hydroxypropyl cellulose.
Further preferably, described lubricant is a magnesium stearate.
Most preferably, described atorvastatin calcium tablet, form by the component of following weight portion:
| Atorvastatin calcium | 1 part |
| Filler | 8-15 part |
| Disintegrating agent | 0.5-1.5 part |
| Correctives | 0.4-1 part |
| Magnesium stearate | 0.1-0.3 part |
Wherein, described filler is the mixture of Icing Sugar and microcrystalline Cellulose or the mixture of Icing Sugar and cyclodextrin, and described disintegrating agent is the mixture of polyvinylpolypyrrolidone and low-substituted hydroxypropyl cellulose.
Atorvastatin calcium tablet of the present invention can be prepared from as follows:
(1) take by weighing the supplementary material of above-mentioned recipe quantity, except that lubricant, with carrying out the dry granulation first time behind all supplementary material mixings, 40 orders, 80 orders sieve respectively, collect the dried granule A between 40 orders-80 order.
The back pulverized by the above material of (2) 40 orders and the following material of 80 orders carries out the secondary granulation, and the gained granule sieves, and the above material crushing and pelletizing of 40 orders is collected all granule B of secondary granulation back.
(3) with the granule A that makes, B and with mix lubricant 30min after, tabletting, slice, thin piece hardness is 50-60N.
Compared with prior art, the atorvastatin calcium tablet that the present invention relates to has following beneficial technical effects:
(1) stability is high.Through accelerated test research, the atorvastatin calcium tablet of the present invention's preparation is after quickening 6 months, and its related substances is no more than 0.70%, and this shows its steady quality, significantly is superior to prior art.
(2) disintegrate and stripping are rapid.Investigate experimental study through disintegration and dissolution, the atorvastatin calcium tablet hardness of the present invention's preparation reaches 50-60N, and in 15～25 ℃ of water, whole disintegrates are also through No. 2 sieves in the 80s; And the dissolution in pH1.2 hydrochloric acid and water and commercially available do not have significant difference.This shows that tablet of the present invention disintegrate when possessing big hardness is fast with dissolution rate, is indicating the bioavailability height.
(3) packing cost is low.The slice, thin piece hardness of the atorvastatin calcium tablet of the present invention's preparation reaches more than the 50N, is difficult for producing fragment, need not adopt the extra package material, greatly reduces packing cost.
(4) preparation technology is simple.The prescription of the atorvastatin calcium tablet of the present invention screening can adopt direct compression behind the dry granulation, can obtain steady quality, disintegrate and stripping tablet rapidly, is fit to industrialized great production.
The specific embodiment
Below through the embodiment form foregoing of the present invention is remake further detailed description; But should this be interpreted as that the scope of the above-mentioned theme of the present invention only limits to following instance, all technology that realizes based on foregoing of the present invention all belong to scope of the present invention.
The preparation of embodiment 1 atorvastatin calcium tablet
| Component | Dosage 1 (mg) | Dosage 2 (mg) | Dosage 3 (mg) |
| Atorvastatin calcium | 10 | 20 | 40 |
| Icing Sugar | 71 | 142 | 284 |
| Microcrystalline Cellulose | 38 | 76 | 152 |
| Low-substituted hydroxypropyl cellulose | 6 | 12 | 24 |
| Polyvinylpolypyrrolidone | 3 | 6 | 12 |
| Magnesium stearate | 2 | 4 | 8 |
| Sheet is heavy | 130 | 260 | 520 |
Preparation technology:
(1) take by weighing the supplementary material of above-mentioned recipe quantity, except that magnesium stearate, with carrying out the dry granulation first time behind all supplementary material mixings, 40 orders, 80 orders sieve respectively, collect the dried granule A between 40 orders-80 order.
The back pulverized by the above material of (2) 40 orders and the following material of 80 orders carries out the secondary granulation, and the gained granule sieves, and the above material crushing and pelletizing of 40 orders is collected all granule B of secondary granulation back.
(3) with the granule A that makes, B with after magnesium stearate is mixed 30min, tabletting, slice, thin piece hardness is 50-60N.
The preparation of embodiment 2 atorvastatin calcium tablets
| Component | Dosage 1 (mg) | Dosage 2 (mg) | Dosage 3 (mg) |
| Atorvastatin calcium | 10 | 20 | 40 |
| Icing Sugar | 63 | 126 | 252 |
| Beta-schardinger dextrin- | 22 | 44 | 88 |
| Low-substituted hydroxypropyl cellulose | 3 | 6 | 12 |
| Polyvinylpolypyrrolidone | 3 | 6 | 12 |
| Magnesium stearate | 1 | 2 | 4 |
| Sheet is heavy | 102 | 204 | 408 |
Preparation technology:
(1) take by weighing the supplementary material of above-mentioned recipe quantity, except that magnesium stearate, with carrying out the dry granulation first time behind all supplementary material mixings, 40 orders, 80 orders sieve respectively, collect the dried granule A between 40 orders-80 order.
The back pulverized by the above material of (2) 40 orders and the following material of 80 orders carries out the secondary granulation, and the gained granule sieves, and the above material crushing and pelletizing of 40 orders is collected all granule B of secondary granulation back.
(3) with the granule A that makes, B with after magnesium stearate is mixed 30min, tabletting, slice, thin piece hardness is 50-60N.
The preparation of embodiment 3 atorvastatin calcium tablets
| Component | Dosage 1 (mg) | Dosage 2 (mg) | Dosage 3 (mg) |
| Atorvastatin calcium | 10 | 20 | 40 |
| Icing Sugar | 58 | 116 | 232 |
| Microcrystalline Cellulose | 74 | 148 | 296 |
| Low-substituted hydroxypropyl cellulose | 8 | 16 | 32 |
| Polyvinylpolypyrrolidone | 6 | 12 | 24 |
| Sodium glutamate | 0.2 | 0.4 | 0.8 |
| Fructus Citri Limoniae essence | 0.5 | 1.0 | 2.0 |
| Orange flavor | 0.3 | 0.6 | 1.2 |
| Magnesium stearate | 2 | 4 | 8 |
| Sheet is heavy | 159 | 318 | 636 |
Preparation technology:
(1) take by weighing the supplementary material of above-mentioned recipe quantity, except that magnesium stearate, with carrying out the dry granulation first time behind all supplementary material mixings, 40 orders, 80 orders sieve respectively, collect the dried granule A between 40 orders-80 order.
The back pulverized by the above material of (2) 40 orders and the following material of 80 orders carries out the secondary granulation, and the gained granule sieves, and the above material crushing and pelletizing of 40 orders is collected all granule B of secondary granulation back.
(3) with the granule A that makes, B with after magnesium stearate is mixed 30min, tabletting, slice, thin piece hardness is 50-60N.
The preparation of embodiment 4 atorvastatin calcium tablets
| Component | Dosage 1 (mg) | Dosage 2 (mg) | Dosage 3 (mg) |
| Atorvastatin calcium | 10 | 20 | 40 |
| Icing Sugar | 42 | 84 | 168 |
| Microcrystalline Cellulose | 60 | 120 | 240 |
| Low-substituted hydroxypropyl cellulose | 5 | 10 | 20 |
| Polyvinylpolypyrrolidone | 4 | 8 | 16 |
| Orange flavor | 0.2 | 0.4 | 0.8 |
| Milk flavour | 1.2 | 2.4 | 4.8 |
| Magnesium stearate | 1.6 | 3.2 | 6.4 |
| Sheet is heavy | 124 | 260 | 520 |
Preparation technology:
(1) take by weighing the supplementary material of above-mentioned recipe quantity, except that magnesium stearate, with carrying out the dry granulation first time behind all supplementary material mixings, 40 orders, 80 orders sieve respectively, collect the dried granule A between 40 orders-80 order.
The back pulverized by the above material of (2) 40 orders and the following material of 80 orders carries out the secondary granulation, and the gained granule sieves, and the above material crushing and pelletizing of 40 orders is collected all granule B of secondary granulation back.
(3) with the granule A that makes, B with after magnesium stearate is mixed 30min, tabletting, slice, thin piece hardness is 50-60N.
The stability study of embodiment 5 atorvastatin calcium tablets
The tablet (specification 20mg) of embodiment of the invention 1-4 preparation is placed on (40 ℃ of temperature, relative humidity 75% ± 5%) under the acceleration environment with the tablet (matched group) that CN1911209A embodiment 1 prepares respectively by commercially available back, carried out study on the stability 6 months.
The related substance detection method is according to HPLC (2010 editions appendix V of Chinese Pharmacopoeia D).Wherein, Chromatographic condition and system suitability test: use octyl silane group silica gel to be filler; Acetonitrile-0.05mol/L citric acid (50:50) (transferring pH4.0 with ammonia) is a mobile phase, detects wavelength 244nm, and theoretical cam curve is not less than 4000 by atorvastatin.Algoscopy: the fine powder of getting these article (is equivalent to C in right amount approximately
33H
35FN
2O
512.5mg), put in the 25ml measuring bottle, make dissolving with acetonitrile-0.05mol/L citric acid (50:50) (transferring pH7.4 with ammonia) is ultrasonic, put coldly, add above-mentioned solvent dilution to scale, shake up, filter with 0.45 μ m filter membrane, get subsequent filtrate and make need testing solution; Precision is measured need testing solution 3ml, puts in the 100ml measuring bottle, adds above-mentioned solvent dilution to scale, reference substance solution; Measure contrast solution 20 μ l and inject chromatograph of liquid; Regulate detection sensitivity; The peak height that makes the main constituent peak is 25% of a monitor full scale, measures each 20 μ l of need testing solution and reference substance solution in precision and injects chromatograph of liquid respectively, 3 times of record chromatogram to atorvastatin peak retention time; As showing impurity peaks, each impurity peaks peak area sum must not be greater than the main peak area (3.0%) of reference substance solution in the chromatogram of need testing solution.After the accelerated test investigation, the result of the related substance of atorvastatin calcium tablet is referring to table 1.
Its related substances of atorvastatin calcium tablet (%) after table 1 accelerated test
| Group | The 0th day | Quickened 3 months | Quickened 6 months |
| Matched group | 0.58 | 0.91 | 1.58 |
| Embodiment 1 | 0.27 | 0.40 | 0.62 |
| Embodiment 2 | 0.31 | 0.51 | 0.66 |
| Embodiment 3 | 0.35 | 0.52 | 0.65 |
| Embodiment 4 | 0.32 | 0.48 | 0.70 |
Result of the test according to table 1 can find out that the atorvastatin calcium tablet of the present invention's preparation is after quickening 6 months, and its related substances is no more than 0.70%, and this shows its steady quality, significantly is superior to prior art.
The disintegration of embodiment 6 atorvastatin calcium tablets and dissolution are investigated
(1) mensuration of disintegration
Get 6 of the atorvastatin calcium tablets (specification 20mg) of embodiment of the invention 1-4 preparation, put in the 250ml beaker, add 15～25 ℃ water 100ml, disintegration is measured in jolting 3 minutes.Result of the test is referring to table 2.
The disintegration of table 2 atorvastatin calcium tablet
| Sample | Slice, thin piece hardness (N) | Disintegration (s) |
| Embodiment 1 | 55-60 | 68-74 |
| Embodiment 2 | 53-58 | 71-75 |
| Embodiment 3 | 55-59 | 72-81 |
| Embodiment 4 | 54-56 | 68-76 |
Result of the test according to table 2 can find out that the atorvastatin calcium tablet hardness of the present invention's preparation reaches 50-60N, and in 15～25 ℃ of water, whole disintegrates are also through No. 2 sieves in the 80s.This shows that tablet of the present invention disintegrate when possessing big hardness is rapid.
(2) determination of dissolution rate
Measure according to dissolution method (2010 editions two appendix X C of Chinese Pharmacopoeia, second method).Get the atorvastatin calcium tablet (specification 20mg) and the commercially available atorvastatin calcium tablet (lipitor of embodiment of the invention 1-4 preparation; Specification 20mg) each 12; Be solvent with pH1.2 hydrochloric acid, water respectively, rotating speed is 75 rev/mins, in accordance with the law operation; Got solution respectively at 5,10,15,30 minutes and filter in right amount, as need testing solution; In addition precision takes by weighing the about 25mg of Atorvastatin calcium reference substance, puts in the 25ml measuring bottle, adds that acetonitrile is ultrasonic in right amount to make dissolving, and is diluted to scale, shakes up.Precision is measured 1ml and is put in the 100ml measuring bottle, adds the stripping medium to scale, shakes up, as reference substance solution.Get need testing solution and reference substance solution respectively,, measure absorbance, calculate dissolution at the 241nm place according to 2010. editions (appendix IV A) ultraviolet visible spectrophotometry of Chinese Pharmacopoeia.Result of the test is seen table 3, table 4.
The dissolution of table 3 atorvastatin calcium tablet in pH1.2 hydrochloric acid
| Group | 5 minutes | 10 minutes | 15 minutes | 30 minutes |
| Commercially available | 11.02% | 35.85% | 51.45% | 65.22% |
| Embodiment 1 | 10.76% | 33.34% | 50.22% | 68.62% |
| Embodiment 2 | 11.47% | 34.76% | 52.10% | 69.03% |
| Embodiment 3 | 10.60% | 34.89% | 49.94% | 64.34% |
| Embodiment 4 | 10.94% | 36.03% | 52.63% | 67.05% |
The dissolution of table 4 atorvastatin calcium tablet in water
| Group | 5 minutes | 10 minutes | 15 minutes | 30 minutes |
| Commercially available | 91.27% | 98.64% | 99.92% | 100.23% |
| Embodiment 1 | 89.79% | 96.57% | 99.61% | 99.69% |
| Embodiment 2 | 90.75% | 97.85% | 99.70% | 99.82% |
| Embodiment 3 | 88.86% | 95.91% | 99.25% | 99.50% |
| Embodiment 4 | 89.90% | 96.49% | 99.60% | 99.71% |
Experimental result according to table 3, table 4 can find out, dissolution and commercially available slice of the atorvastatin calcium tablet of the present invention's preparation in pH1.2 hydrochloric acid and water do not have significant difference.This shows that tablet of the present invention stripping when possessing big hardness is rapid.
Claims (10)
1. an atorvastatin calcium tablet is characterized in that: comprise Atorvastatin calcium, filler, disintegrating agent and lubricant.
2. atorvastatin calcium tablet according to claim 1 is characterized in that: by weight, and Atorvastatin calcium: filler: disintegrating agent: lubricant=1:8-15:0.5-1.5:0.1-0.3.
3. according to the atorvastatin calcium tablet of claim 1 or 2, it is characterized in that: described filler is selected from following one or more: starch, lactose, Icing Sugar, mannitol, dextrin, cyclodextrin, microcrystalline Cellulose and sucrose.
4. according to the atorvastatin calcium tablet of claim 1 or 2, it is characterized in that: described disintegrating agent is selected from following one or more: carboxymethyl starch sodium, polyvinylpolypyrrolidone, cross-linking sodium carboxymethyl cellulose, crosslinked carboxymethyl fecula sodium, pregelatinized Starch and low-substituted hydroxypropyl cellulose.
5. according to the atorvastatin calcium tablet of claim 1 or 2, it is characterized in that: described lubricant is selected from following one or more: magnesium stearate, Pulvis Talci and micropowder silica gel.
6. according to the atorvastatin calcium tablet of claim 1 or 2; It is characterized in that: be made up of Atorvastatin calcium, filler, disintegrating agent, lubricant and correctives, described correctives is selected from following one or more: sodium glutamate, orange flavor, cocoanut flavour, milk flavour, green apple essence and Fructus Citri Limoniae essence.
7. according to the atorvastatin calcium tablet of claim 3, it is characterized in that: described filler is selected from following one or more: Icing Sugar, cyclodextrin and microcrystalline Cellulose.
8. according to the atorvastatin calcium tablet of claim 4, it is characterized in that: described disintegrating agent is selected from polyvinylpolypyrrolidone or/and low-substituted hydroxypropyl cellulose.
9. according to the atorvastatin calcium tablet of claim 5, it is characterized in that: described lubricant is a magnesium stearate.
10. according to each atorvastatin calcium tablet of claim 6, it is characterized in that: the component by following weight portion is formed:
1 part of Atorvastatin calcium; Filler 8-15 part, disintegrating agent 0.5-1.5 part, correctives 0.4-1 part; Magnesium stearate 0.1-0.3 part; Wherein, described filler is the mixture of Icing Sugar and microcrystalline Cellulose or the mixture of Icing Sugar and cyclodextrin, and described disintegrating agent is the mixture of polyvinylpolypyrrolidone and low-substituted hydroxypropyl cellulose.
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2011101990043A CN102309462B (en) | 2011-07-16 | 2011-07-16 | Atorvastatin calcium tablet |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2011101990043A CN102309462B (en) | 2011-07-16 | 2011-07-16 | Atorvastatin calcium tablet |
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|---|---|
| CN102309462A true CN102309462A (en) | 2012-01-11 |
| CN102309462B CN102309462B (en) | 2012-12-12 |
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102920675A (en) * | 2012-11-29 | 2013-02-13 | 河南润弘制药股份有限公司 | Atorvastatin calcium tablet and preparation method thereof |
| CN104546775A (en) * | 2015-02-03 | 2015-04-29 | 山东新时代药业有限公司 | Atorvastatin calcium tablet |
| CN107625735A (en) * | 2016-07-13 | 2018-01-26 | 长春海悦药业股份有限公司 | A kind of pharmaceutical composition containing Atorvastatin calcium |
| CN111281854A (en) * | 2020-03-27 | 2020-06-16 | 福建东瑞制药有限公司 | Atorvastatin calcium tablet and preparation process thereof |
Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1911209A (en) * | 2006-08-25 | 2007-02-14 | 石家庄欧意药业有限公司 | Quick-disintegration tablets of calcium atovastatine, and its prepn. method |
| WO2007071012A1 (en) * | 2005-12-23 | 2007-06-28 | Orbus Pharma Inc. | Stabilized pharmaceutical compositions comprising an hmg-coa reductase inhibitor |
| JP2009114113A (en) * | 2007-11-06 | 2009-05-28 | Nipro Corp | Intraorally disintegrable tablet and method for producing the same |
-
2011
- 2011-07-16 CN CN2011101990043A patent/CN102309462B/en active Active
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2007071012A1 (en) * | 2005-12-23 | 2007-06-28 | Orbus Pharma Inc. | Stabilized pharmaceutical compositions comprising an hmg-coa reductase inhibitor |
| CN1911209A (en) * | 2006-08-25 | 2007-02-14 | 石家庄欧意药业有限公司 | Quick-disintegration tablets of calcium atovastatine, and its prepn. method |
| JP2009114113A (en) * | 2007-11-06 | 2009-05-28 | Nipro Corp | Intraorally disintegrable tablet and method for producing the same |
Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102920675A (en) * | 2012-11-29 | 2013-02-13 | 河南润弘制药股份有限公司 | Atorvastatin calcium tablet and preparation method thereof |
| CN102920675B (en) * | 2012-11-29 | 2016-03-23 | 河南润弘制药股份有限公司 | A kind of atorvastatin and preparation method thereof |
| CN104546775A (en) * | 2015-02-03 | 2015-04-29 | 山东新时代药业有限公司 | Atorvastatin calcium tablet |
| CN107625735A (en) * | 2016-07-13 | 2018-01-26 | 长春海悦药业股份有限公司 | A kind of pharmaceutical composition containing Atorvastatin calcium |
| CN111281854A (en) * | 2020-03-27 | 2020-06-16 | 福建东瑞制药有限公司 | Atorvastatin calcium tablet and preparation process thereof |
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| Publication number | Publication date |
|---|---|
| CN102309462B (en) | 2012-12-12 |
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