CN109453135A - Atorvastatin and preparation method thereof - Google Patents
Atorvastatin and preparation method thereof Download PDFInfo
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- CN109453135A CN109453135A CN201811630301.7A CN201811630301A CN109453135A CN 109453135 A CN109453135 A CN 109453135A CN 201811630301 A CN201811630301 A CN 201811630301A CN 109453135 A CN109453135 A CN 109453135A
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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
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
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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
- A61K31/40—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
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- 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
- A61K9/2009—Inorganic compounds
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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
- A61K9/2013—Organic compounds, e.g. phospholipids, fats
- A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
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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
- A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
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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
- A61K9/2095—Tabletting processes; Dosage units made by direct compression of powders or specially processed granules, by eliminating solvents, by melt-extrusion, by injection molding, by 3D printing
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P3/00—Drugs for disorders of the metabolism
- A61P3/06—Antihyperlipidemics
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Abstract
The present invention relates to atorvastatins and preparation method thereof, by 10 ~ 20 parts of Atorvastatin calciums, 20 ~ 40 parts of microcrystalline cellulose 101,30 ~ 50 parts of stabilizers, 2 ~ 4 parts of cross-linked carboxymethyl cellulose sodium/crospovidone Place grinding machine, ball milling is uniformly mixed after for 24 hours with 30 ~ 70 parts of lactose；Then it takes 1 ~ 10 part of hydroxypropylcellulose/hydroxypropyl methylcellulose to be configured to 3 ~ 10% dispersion liquids with water, adds 0.1 ~ 2 part of poly- mountain plough poly- mountain of ester 20/ plough ester 80 after mixing as adhesive；It takes up the ball above-mentioned product and is mixed into the uniform softwood of dry and wet, then pelletized using 300 mesh；Being dried at a temperature of 50 DEG C ~ 60 DEG C to granule moisture level is 2 ~ 5%；By dry particl and 0.1 ~ 2 part of magnesium stearate, 2 ~ 8 portions of disintegrating agents, it is uniformly mixed and is pressed into label；0.1 ~ 2 part of poly- mountain plough poly- mountain of ester 20/ plough ester 80 is dissolved with water, coating powder is added and is sufficiently stirred and be dispersed into coating solution；It is coated with the label that above-mentioned coating solution obtains compacting, this coating tablet, that is, finished product.The present invention can solve dissolution and the stability problem of atorvastatin long-standing problem.
Description
Technical field
The present invention relates to a kind of preparation methods of hyperlipidemia therapeutic agent preparation, and in particular to a kind of atorvastatin
And preparation method thereof.
Background technique
Hyperlipemia refers to that the concentration of the lipid compositions such as plasma cholesterol, triglycerides, total rouge is more than arm's length standard.High blood
The main harm of rouge disease is the related disease for leading to atherosclerosis, and then leading to numerous, and one of the most common one kind is fatal
Property disease is exactly coronary heart disease, and serious hyperlipemia can lead to acute pancreatitis, be another fatal disease.In addition, hyperlipidemia
Disease is also to promote hypertension, impaired glucose tolerance, an important risk factor of diabetes.Hyperlipemia can also result in fatty liver,
Cirrhosis, cholelithiasis, pancreatitis, fundus hemorrhage, blindness, peripheral vascular disease, limping, hyperuricemia.Some primary and
Familial hyperlipemia is it may also occur that xanthoma, embryotoxon etc. around tendon shape, nodositas, palm plane and eye socket.
Atorvastatin calcium (Atorvastatin calcium) is Statins regulating plasma lipid medicine.Atorvastatin calcium is main
Site of action can reduce the synthesis of cholesterol in liver, increase LDL receptor synthesis, make cholesterolemia and low-density
Lipoprotein cholesterol level reduces, and moderate reduces serum triglyceride level and increases blood hdl level.This product egg
White Percentage bound is 98%, most of to be discharged in the form of metabolin through bile.It is suitable for: the danger such as coronary heart disease coronary heart disease or coronary heart disease
Disease (such as: diabetes, symptomatic atherosclerotic disease) merges the patient of hypercholesterolemia or mixed dyslipidemia,
The risk of non-fatal myocardial infarction is reduced, the risk of lethal and non-lethality stroke is reduced, reduces the wind of reconstructive vascular operation
Danger reduces the risk being hospitalized by congestive heart failure, reduces anginal risk.
Drawback of the prior art is that: the dissolution rate and stability of Atorvastatin calcium are lower, so that clinical application
It is ineffective.
Summary of the invention
It is an object of the invention to overcome the deficiencies of the prior art and provide a kind of atorvastatin and its preparation sides
Method, to solve dissolution and the stability problem of atorvastatin long-standing problem.
The purpose of the present invention is achieved through the following technical solutions:
Atorvastatin, including following components by weight percent:
10 ~ 20 parts of Atorvastatin calcium；
20 ~ 40 parts of microcrystalline cellulose 101；
30 ~ 50 parts of stabilizer；
6 ~ 10 parts of disintegrating agent；
30 ~ 70 parts of lactose；
1 ~ 10 part of adhesive；
0.1 ~ 2 part of magnesium stearate；
0.1 ~ 2 part of surfactant；
1 ~ 5 part of coating agent.
Preferably, the stabilizer is calcium carbonate or calcium phosphate.
Preferably, the disintegrating agent is cross-linked carboxymethyl cellulose sodium or crospovidone.
Preferably, described adhesive is hydroxypropylcellulose or hydroxypropyl methylcellulose.
Preferably, the surfactant is that ester 20 is ploughed on poly- mountain and ester 80 is ploughed on poly- mountain.
Preferably, the coating agent is stomach dissolution type film coating agent.
Atorvastatin preparation method, includes the following steps:
1) mixing and ball milling: 10 ~ 20 parts of Atorvastatin calciums, 20 ~ 40 parts of microcrystalline cellulose 101,30 ~ 50 parts of stabilizers, 2 ~ 4 parts of friendships
Join carmethose/crospovidone Place grinding machine, is uniformly mixed by 800r/min speed ball milling is rear for 24 hours with 30 ~ 70 parts of lactose；
2) adhesive is prepared: being taken 1 ~ 10 part of hydroxypropylcellulose/hydroxypropyl methylcellulose to be configured to 3 ~ 10% dispersion liquids with water, is added
0.1 ~ 2 part of poly- mountain plough poly- mountain of ester 20/ plough ester 80 is used as adhesive after mixing；
3) softwood processed: being mixed into the uniform softwood of dry and wet for step 1) and step 2, is then pelletized using 300 mesh；
4) dry: being dried at a temperature of 50 DEG C ~ 60 DEG C to granule moisture level is 2 ~ 5%；
5) it tabletting: by dry particl and 0.1 ~ 2 part of magnesium stearate, 2 ~ 8 portions of disintegrating agents, is uniformly mixed and is pressed into label；
6) coating solution is prepared: 0.1 ~ 2 part of poly- mountain plough poly- mountain of ester 20/ plough ester 80 being dissolved with water, coating powder is added and is sufficiently stirred
It is dispersed into coating solution；
7) it is coated: being coated with the label that above-mentioned coating solution obtains compacting, this coating tablet, that is, finished product.
Preferably, the microcrystalline cellulose 101 is prepared using fluidized-bed process.
The beneficial effects of the present invention are: use ball-milling technology by Atorvastatin calcium with as calcium carbonate/phosphorus of stabilizer
Sour calcium comes into full contact with, and partial adsorbates produce in fluidized-bed process and have on porous microcrystalline cellulose, while disintegrating agent is handed over
Connection carmethose/crospovidone is also sufficiently contacted with Atorvastatin calcium, is conducive to Atorvastatin calcium and is discharged, surface is living
Property agent different adding manners (using in adhesive with part is respectively added in coating solution), dividing in such coating solution quickly
It dissipates, facilitates drug Fast Stripping.
Specific embodiment
Technical solution of the present invention is described in further detail combined with specific embodiments below, but protection scope of the present invention is not
It is confined to as described below.
Embodiment 1
A kind of atorvastatin and preparation method thereof；Wherein atorvastatin each component is as follows:
1 Atorvastatin calcium 10g
2 microcrystalline cellulose 101 (preparation process: fluidized-bed process) 30g
3 calcium carbonate 40g
4 cross-linked carboxymethyl cellulose sodium 6g (the interior plus additional 4g of 2g+)
5 lactose 50g
6 hydroxypropylcelluloses (height replaces) 5g
7 magnesium stearate 1g
Plough 80 1g of ester in 8 poly- mountains
9 stomach dissolution type film coating agents (Ka Lekang Y-1-7000) 3g
Preparation method:
1, mixing and ball milling: 4 Place grinding machine of the above component 1 ~ 3 and 2g component, by 800r/min speed ball milling, rear and lactose is mixed for 24 hours
It closes uniform；
2, adhesive is prepared: hydroxypropylcellulose 5g is configured to 5% aqueous dispersions with water, and it is abundant to add the poly- mountain plough ester 80 of 0.4g
It is uniformly mixed as adhesive
3, softwood processed: above 1 and 2 are mixed into the uniform softwood of dry and wet
4, the above softwood is pelletized with 30 mesh,
5, dry: the dry particle of 55 DEG C of dryings to moisture 3.7%；
6, tabletting: dry particl is uniformly mixed with addition magnesium stearate, 4g component 4 and is pressed into label；
7, coating solution is prepared: first being dissolved with water the poly- mountain plough remaining 0.6g of ester 80, is added coating powder and be sufficiently stirred and be dispersed into
Coating solution
8, it is coated: being coated with the label that above-mentioned coating solution obtains compacting, this coating tablet, that is, finished product
Embodiment 2
A kind of atorvastatin and preparation method thereof；Wherein atorvastatin each component is as follows:
1 Atorvastatin calcium 20g
2 microcrystalline cellulose 101 (preparation process: fluidized-bed process) 30g
3 calcium phosphate 30g
4 cross-linked carboxymethyl cellulose sodium 10g (the interior plus additional 6g of 4g+)
5 lactose 50g
6 hydroxypropyl methylcelluloses (K100) 5g
7 magnesium stearate 1g
Plough 20 1g of ester in 8 poly- mountains
Plough 80 1g of ester in 9 poly- mountains
9 stomach dissolution type film coating agents (Ka Lekang Y-1-7000) 3g
Preparation method:
1, mixing and ball milling: 4 Place grinding machine of the above component 1 ~ 3 and 4g component, by 800r/min speed ball milling, rear and lactose is mixed for 24 hours
It closes uniform；
2, adhesive is prepared: hydroxypropyl methylcellulose (K100) 5g is configured to 5% aqueous dispersions with water, and poly- mountain plough ester 80 is added and mixes
Adhesive is used as after uniformly
3, softwood processed: above 1 and 2 are mixed into the uniform softwood of dry and wet
4, the above softwood is pelletized with 30 mesh,
5, dry: the dry particle of 60 DEG C of dryings to moisture 3.3%；
6, tabletting: dry particl is uniformly mixed with addition magnesium stearate, 6g component 4 and is pressed into label；
7, coating solution is prepared: first being dissolved poly- mountain plough ester 20 with water, is added coating powder and be sufficiently stirred and be dispersed into coating solution
8, it is coated: being coated with the label that above-mentioned coating solution obtains compacting, this coating tablet, that is, finished product.
Embodiment 3
A kind of atorvastatin and preparation method thereof；Wherein atorvastatin each component is as follows:
1 Atorvastatin calcium 10g
2 microcrystalline cellulose 101 (preparation process: fluidized-bed process) 30g
3 calcium carbonate 40g
4 cross-linked carboxymethyl cellulose sodium 8g (the interior plus additional 6g of 2g+)
5 lactose 50g
6 hydroxypropylcelluloses (height replaces) 2g
7 magnesium stearate 1g
Plough 80 1.5g of ester in 8 poly- mountains
9 stomach dissolution type film coating agents (Ka Lekang Y-1-7000) 3g
Preparation method:
1, mixing and ball milling: 4 Place grinding machine of the above component 1 ~ 3 and 2g component, by 800r/min speed ball milling, rear and lactose is mixed for 24 hours
It closes uniform；
2, adhesive is prepared: hydroxypropylcellulose is configured to 2% aqueous dispersions with water, adds the poly- mountain plough ester 80 of 0.7g and sufficiently stirs
It mixes and is uniformly mixed as adhesive
3, softwood processed: above 1 and 2 are mixed into the uniform softwood of dry and wet
4, the above softwood is pelletized with 30 mesh,
5, dry: the dry particle of 55 DEG C of dryings to moisture 3.8%；
6, tabletting: dry particl is uniformly mixed with addition magnesium stearate, 6g component 4 and is pressed into label；
7, coating solution is prepared: first being dissolved with water the poly- mountain plough remaining 0.8g of ester 80, is added coating powder and be sufficiently stirred and be dispersed into
Coating solution
8, it is coated: being coated with the label that above-mentioned coating solution obtains compacting, this coating tablet, that is, finished product.
Dissolution Rate Testing method is according to CP2015, in which: dissolution medium PH6.8, revolving speed 50rmp, original grind Lipitor, Pfizer
Pharmaceutical Co. Ltd's production, lot number: T44813, dissolution rate are as follows:
| Time point | Embodiment 1 | Embodiment 2 | Embodiment 3 | Original grinds Lipitor |
| 5min | 56.24% | 58.22% | 54.23% | 60.77% |
| 10min | 73.51% | 77.97% | 72.33% | 75.38% |
| 15min | 83.15% | 88.71% | 80.79% | 81.28% |
| 20min | 88.59% | 94.03% | 85.66% | 85.16% |
| 30min | 93.57% | 98.24% | 91.21% | 89.60% |
| 45min | 96.62% | 100.02% | 94.96% | 93.49% |
| 60min | 97.77% | 100.84% | 96.97% | 95.36% |
Study on the stability: show that embodiment sample investigates project and has no significant change from stability data variation tendency, and change
Trend is ground with original and is no different, and illustrates that embodiment sample is ground extremely similar to original, there is high consistency.
The above is only a preferred embodiment of the present invention, it should be understood that the present invention is not limited to described herein
Form should not be regarded as an exclusion of other examples, and can be used for other combinations, modifications, and environments, and can be at this
In the text contemplated scope, modifications can be made through the above teachings or related fields of technology or knowledge.And those skilled in the art institute into
Capable modifications and changes do not depart from the spirit and scope of the present invention, then all should be in the protection scope of appended claims of the present invention
It is interior.
Claims (8)
1. atorvastatin, it is characterised in that including following components by weight percent:
10 ~ 20 parts of Atorvastatin calcium；
20 ~ 40 parts of microcrystalline cellulose 101；
30 ~ 50 parts of stabilizer；
6 ~ 10 parts of disintegrating agent；
30 ~ 70 parts of lactose；
1 ~ 10 part of adhesive；
0.1 ~ 2 part of magnesium stearate；
0.1 ~ 2 part of surfactant；
1 ~ 5 part of coating agent.
2. atorvastatin according to claim 1, which is characterized in that the stabilizer is calcium carbonate or phosphoric acid
Calcium.
3. atorvastatin according to claim 1, which is characterized in that the disintegrating agent is Croscarmellose
Sodium or crospovidone.
4. atorvastatin according to claim 1, which is characterized in that described adhesive is hydroxypropylcellulose or hydroxyl
Third methylcellulose.
5. atorvastatin according to claim 1, which is characterized in that the surfactant is that ester 20 is ploughed on poly- mountain
Ester 80 is ploughed with poly- mountain.
6. atorvastatin according to claim 1, which is characterized in that the coating agent is stomach dissolution type film coating
Agent.
7. atorvastatin preparation method, it is characterised in that include the following steps:
1) mixing and ball milling: 10 ~ 20 parts of Atorvastatin calciums, 20 ~ 40 parts of microcrystalline cellulose 101,30 ~ 50 parts of stabilizers, 2 ~ 4 parts of friendships
Join carmethose/crospovidone Place grinding machine, is mixed by 800r/min speed ball milling is rear for 24 hours with 30 ~ 70 parts of lactose
It is even；
2) adhesive is prepared: being taken 1 ~ 10 part of hydroxypropylcellulose/hydroxypropyl methylcellulose to be configured to 3 ~ 10% dispersion liquids with water, is added
0.1 ~ 2 part of poly- mountain plough poly- mountain of ester 20/ plough ester 80 is used as adhesive after mixing；
3) softwood processed: being mixed into the uniform softwood of dry and wet for step 1) and step 2, is then pelletized using 300 mesh；
4) dry: being dried at a temperature of 50 DEG C ~ 60 DEG C to granule moisture level is 2 ~ 5%；
5) it tabletting: by dry particl and 0.1 ~ 2 part of magnesium stearate, 2 ~ 8 portions of disintegrating agents, is uniformly mixed and is pressed into label；
6) coating solution is prepared: 0.1 ~ 2 part of poly- mountain plough poly- mountain of ester 20/ plough ester 80 being dissolved with water, coating powder is added and is sufficiently stirred
It is dispersed into coating solution；
7) it is coated: being coated with the label that above-mentioned coating solution obtains compacting, this coating tablet, that is, finished product.
8. atorvastatin according to claim 7 and preparation method thereof, which is characterized in that the microcrystalline cellulose
101 are prepared using fluidized-bed process.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
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| CN201811630301.7A CN109453135A (en) | 2018-12-29 | 2018-12-29 | Atorvastatin and preparation method thereof |
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| CN201811630301.7A CN109453135A (en) | 2018-12-29 | 2018-12-29 | Atorvastatin and preparation method thereof |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN113230225A (en) * | 2021-05-17 | 2021-08-10 | 海南锦瑞制药有限公司 | Atorvastatin calcium tablet and preparation method and application thereof |
| CN113546050A (en) * | 2021-07-07 | 2021-10-26 | 海南锦瑞制药有限公司 | Atorvastatin calcium tablet and preparation method thereof |
Citations (1)
| 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 |
-
2018
- 2018-12-29 CN CN201811630301.7A patent/CN109453135A/en active Pending
Patent Citations (1)
| 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 |
Non-Patent Citations (2)
| Title |
|---|
| 庞振华: "阿托伐他汀片处方工艺研究", 《科技创新与应用》 * |
| 王海等: "阿托伐他汀钙片生产批量成倍放大工艺研究", 《药学研究》 * |
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN113230225A (en) * | 2021-05-17 | 2021-08-10 | 海南锦瑞制药有限公司 | Atorvastatin calcium tablet and preparation method and application thereof |
| CN113546050A (en) * | 2021-07-07 | 2021-10-26 | 海南锦瑞制药有限公司 | Atorvastatin calcium tablet and preparation method thereof |
| CN113546050B (en) * | 2021-07-07 | 2022-11-29 | 海南锦瑞制药有限公司 | Atorvastatin calcium tablet and preparation method thereof |
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