CN105343024B - A kind of atorvastatin agent and preparation method thereof - Google Patents
A kind of atorvastatin agent and preparation method thereof Download PDFInfo
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- 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
- A61K9/2806—Coating materials
- A61K9/2833—Organic macromolecular compounds
- A61K9/286—Polysaccharides, e.g. gums; Cyclodextrin
- A61K9/2866—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- 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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- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
- A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
- A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
- A61K47/186—Quaternary ammonium compounds, e.g. benzalkonium chloride or cetrimide
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- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/20—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic acids
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
- A61K47/38—Cellulose; Derivatives thereof
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Abstract
The present invention relates to a kind of atorvastatin agent and preparation method thereof, belong to pharmaceutical technology field.The atorvastatin agent, is made up of label and coating, and the label is prepared by Atorvastatin calcium, protective agent, filler, disintegrant, lubricant；The coating is prepared by Opadry YS 1 7040, pore-foaming agent, purified water.Atorvastatin agent of the present invention through 36 months study on the stability, character, dissolution rate, content, about material compared with 0 day without significant difference, in acceptability limit, conform to quality requirements.Therefore, atorvastatin agent of the present invention is matched with specific prescription, specific preparation technology achieves good technique effect, is provided a kind of different technical scheme for the preparation of atorvastatin agent, can more be met clinical demand.
Description
Technical field
The present invention relates to a kind of tablet and preparation method thereof, is specifically related to a kind of atorvastatin agent and its preparation
Method, belong to pharmaceutical technology field.
Background technology
With the quickening of social senilization's paces, it is fatal that coronary heart diseases and angina pectoris, " three high diseases " chronic diseases have turned into people
Killer, how effectively to treat chronic disease turns into the subject under discussion that receives much concern.The traditional therapy clinically used is as used west
He is treated at azoles piece for Lip river, and usual DeGrain and adverse reaction rate are high, and chronic disease it is another as be mainly in person in middle and old age
People, the physiological function decline of such patient, complication are more, it is easier to cause the generation of adverse reaction, so accurate selection is clinical
Medication is the key for the treatment of.Atorvastatin is a kind of by suppressing the biology of HMG-CoA reductase and cholesterol in liver
Synthesize to reduce the HMG-CoA reductase selective depressant of plasma cholesterol and lipoprotein levels, it can make high density fat
Protein cholesterol (HDL-C) is horizontal to be risen, and is consolidated for homozygote and heterozygote heredity hypercholesterolemia, the high courage of non-familial
The total plasma cholesterol of alcoholemia and Combination disorder of lipid metabolism patient, Very Low Density Lipoprotein (VLDL) and glycerine three
Vinegar (TG) level has obvious reduction to act on.
It is to treat primary hyperlipidemia to reduce blood lipid level, the typical treatment side of one kind of prevention of arterial atherosis
Method.Atorvastatin can reduce the content of cholesterol and lipoprotein by reducing the biosynthesis of cholesterol in vivo,
Reverse while the blood pressure caused by AT2 raises, inhibitory action is produced to Rac and suppresses nitrogen oxides indirectly, suppresses a mistake
Property peroxidization caused by ischaemic region, to increase internal nitric oxide production bioactivity, reduce thrombotic
Probability, so as to reach the effect for reducing blood fat.Treated by using Atorvastatin, the high acute coronary of blood fat is comprehensive
The blood lipid level of simulator sickness patient declines substantially, and recovery effects are good, and treatment is effective.
Atorvastatin also has good effect in treatment hypertension, diabetic nephropathy etc..Hypertension produces
Life is triggered by the unbalance of body vessel active material, and NO can pass through shadow as a kind of small molecule vaso-active substance
Ring the exchange of extra vascular sodium ion and calcium ion makes vascular smooth muscle relaxation to reach, so as to alleviate high blood pressure onset
Effect, Atorvastatin can increase NO content, drop in blood pressure.In addition, he is being cut down using atropic to Diabetic Nephropathy patients
Spit of fland finds that the inflammatory reaction of patient substantially mitigates, and blood fat function is improved after being treated；Atorvastatin can also pass through suppression
The growth of a variety of intrinsic cells and signal transduction, retarding action is played to renal failure in kidney processed.In summary, atropic
Cutting down statin treatment coronary syndrome has good reducing blood lipid, adjusts blood vessel, anti-infectious effect, adverse reaction rate
It is low, safely and effectively, can the popularization and application in clinic.
Atorvastatin 1997 lists in the U.S. first, and developer is Pfizer, trade name Lipitor, and specification is
10mg, 20mg, 40mg and 80mg, at present in multinational list marketing.Atorvastatin calcium is HMG-CoA reductase (HMG-CoA
Effect be that Hydroxymethylglutaryl list acyl coenzyme A is changed into mevalonic acid, i.e., the steroid precursor including cholesterol.) choosing
Selecting property, competitive inhibitor, consolidated by suppressing HMG-CoA reductase and cholesterol in the biosynthesis of liver to reduce blood plasma courage
Alcohol and lipoprotein levels, and LDL intake can be increased by increasing surface of hepatocytes low-density lipoprotein (LDL) receptor number
And catabolism.
Prevention of the Atorvastatin calcium to angiocardiopathy, anglo Shandong-Scandinavia heart terminal research of Britain
(ASCOT) it have evaluated the effect of Atorvastatin calcium is to lethal and non-lethality coronary heart disease.Atorvastatin calcium also significantly lowers
The relative risk of reconstructive vascular operation is up to 42%.It significantly reduces the incidence of major cardiovascular events (Primary Endpoint event).Ah
Atorvastatin calcium reduction hypercholesterolemia and the T-CHOL of mixed dyslipidemia patient, LDL-C,
C-VLDL, apolipoprotein B, and triglycerides, and increasing high density lipoprotein cholesterol.
Secondly to the effect in hypertriglyceridemia (Fredrickcon IV types), beta Lipoprotein exception mass formed by blood stasis
(Fredrickcon type IIIs), homozygote familial hypercholesterolemia, heterozygote familial form hyperlipidemia child patient are uniform
The effect of fine.
In a word, second generation medicine of the Atorvastatin calcium as Statins, clinically be used for treat hypercholesterolemia and
Coronary heart disease, it is a kind of selectivity of HMG-CoA reductase, competitive inhibitor.Atorvastatin can be consolidated by reducing courage
The biosynthesis of alcohol in vivo reduces the content of cholesterol and lipoprotein, is reversing the blood pressure caused by AT2 elevated same
When, inhibitory action is produced to Rac and suppresses nitrogen oxides indirectly, suppresses peroxidation caused by transient ischaemic region
Should, to increase internal nitric oxide production bioactivity, thrombotic probability is reduced, so as to reach the effect for reducing blood fat.It is logical
Cross and treated using Atorvastatin, the blood lipid level of the high Protein in Patients With Acute Coronary Syndrome of blood fat declines substantially, extensive
Work well again, treatment is effective.
Atorvastatin is safe and effective, and adverse reaction is relatively low, and patient tolerability and compliance are preferable.Therefore,
Exploitation atorvastatin agent is the focus of numerous producer's research and development at present to expand its clinical practice.
The content of the invention
The technical problems to be solved by the invention are to provide a kind of atorvastatin agent, the atorvastatin agent
Have the advantages that stability is high.In addition, the present invention further provides the preparation method of the atorvastatin agent.
Technical problem of the present invention is realized by following technical scheme.
A kind of atorvastatin agent, is made up of label and coating, and the label is prepared by the component of following parts by weight
Form：Atorvastatin calcium in terms of Atorvastatin 10~40, protective agent 5~20, filler 110~140, disintegrant 6~9,
Lubricant 1~4；The coating is prepared by the component of following parts by weight：Opadry YS-1-70403~6, pore-foaming agent 12~
15th, purified water 35~38.
Preferably, above-mentioned atorvastatin agent, the protective agent are acetic acid hydroxypropyl methylcellulose succinate and grass
Sour ammonium is with weight than 1:0.5 mixture；The filler is lactose FlowLac100；The disintegrant is hydroxypropylcellulose；
The lubricant is magnesium stearate；The pore-foaming agent is lauryl sodium sulfate and DDAO with weight ratio
1:2 mixture.
A kind of preparation method of above-mentioned atorvastatin agent, comprises the following steps：
(1) pre-process：Protective agent, filler, disintegrant, lubricant and Opadry YS-1-7040 are crossed into 40 mesh sieves, and according to
Weighed according to recipe quantity, it is standby；
(2) it is total mixed：Atorvastatin calcium, protective agent, filler, disintegrant, lubricant are taken, 15 points are mixed in mixer
Clock；
(3) tabletting：Tabletting is carried out with Highspeedrotarytabletpress, obtains label；
(4) it is coated：Opadry YS-1-7040, pore-foaming agent are taken, Coating Solution is made with purified water, label is placed in coating
In pot, rotating speed is adjusted, Coating Solution, while blowing hot-air are sprayed into pot, when tablet weightening is 2.0%~3.0%, stop bag
Clothing, continue air blast air drying 20~30 minutes, 2~4Hz of peristaltic pump, 65 ± 5 DEG C of EAT, obtain atorvastatin
Agent.
Atorvastatin agent of the present invention, caused by passing through to add in protective agent and coating in Core formulation
Hole agent etc., achieve good stabilizing effect.It is acetic acid hydroxypropyl methylcellulose succinate and grass especially when using protective agent
Sour ammonium is with weight than 1:0.5 mixture, pore-foaming agent are lauryl sodium sulfate and DDAO with weight
Than 1:During 0.3 mixture, under the conditions of 25 DEG C ± 2 DEG C of temperature, relative humidity 60% ± 10%, examined through 36 months stability
Examine, character, dissolution rate, content, about material compared with 0 day without significant difference, in acceptability limit, conform to quality requirements.
Atorvastatin agent provided by the invention unlike the prior art, shows specific composition, specific proportioning, and take
Obtained extraordinary technique effect.Therefore, atorvastatin agent of the present invention is matched with specific prescription, is specific
Preparation technology achieves good technique effect, and a kind of different technical side is provided for the preparation of atorvastatin agent
Case, it can more meet clinical demand.
Embodiment
The present invention is embodied by following examples, and following examples can be used for explaining the present invention but not as this hair
The restriction of bright protection domain.
The preparation (specification 10mg/ pieces, 1000) of the atorvastatin agent of the present invention of embodiment 1
Label forms：
Coating composition：
Preparation method：
(1) pre-process：By acetic acid hydroxypropyl methylcellulose succinate, ammonium oxalate, lactose FlowLac100, hydroxypropyl fiber
Element, magnesium stearate and Opadry YS-1-7040 cross 40 mesh sieves, and are weighed according to recipe quantity, standby；
(2) it is total mixed：Take Atorvastatin calcium, acetic acid hydroxypropyl methylcellulose succinate, ammonium oxalate, lactose
FlowLac100, hydroxypropylcellulose, magnesium stearate, mixed 15 minutes in mixer；
(3) tabletting：Tabletting is carried out with Highspeedrotarytabletpress, obtains label；
(4) it is coated：Opadry YS-1-7040, lauryl sodium sulfate, DDAO are taken, with purifying
Coating Solution is made in water, and label is placed in coating pan, adjusts rotating speed, Coating Solution, while blowing hot-air are sprayed into pot, works as tablet
Increase weight for 2.0%~3.0% when, stop coating, continue air blast air drying 20~30 minutes, 2~4Hz of peristaltic pump, enter wind-warm syndrome
65 ± 5 DEG C of degree, obtains atorvastatin agent.
The preparation (specification 20mg/ pieces, 1000) of the atorvastatin agent of the present invention of embodiment 2
Label forms：
Coating composition：
Preparation method：
(1) pre-process：By acetic acid hydroxypropyl methylcellulose succinate, ammonium oxalate, lactose FlowLac100, hydroxypropyl fiber
Element, magnesium stearate and Opadry YS-1-7040 cross 40 mesh sieves, and are weighed according to recipe quantity, standby；
(2) it is total mixed：Take Atorvastatin calcium, acetic acid hydroxypropyl methylcellulose succinate, ammonium oxalate, lactose
FlowLac100, hydroxypropylcellulose, magnesium stearate, mixed 15 minutes in mixer；
(3) tabletting：Tabletting is carried out with Highspeedrotarytabletpress, obtains label；
(4) it is coated：Opadry YS-1-7040, lauryl sodium sulfate, DDAO are taken, with purifying
Coating Solution is made in water, and label is placed in coating pan, adjusts rotating speed, Coating Solution, while blowing hot-air are sprayed into pot, works as tablet
Increase weight for 2.0%~3.0% when, stop coating, continue air blast air drying 20~30 minutes, 2~4Hz of peristaltic pump, enter wind-warm syndrome
65 ± 5 DEG C of degree, obtains atorvastatin agent.
The preparation (specification 30mg/ pieces, 1000) of the atorvastatin agent of the present invention of embodiment 3
Label forms：
Coating composition：
Preparation method：
(1) pre-process：By acetic acid hydroxypropyl methylcellulose succinate, ammonium oxalate, lactose FlowLac100, hydroxypropyl fiber
Element, magnesium stearate and Opadry YS-1-7040 cross 40 mesh sieves, and are weighed according to recipe quantity, standby；
(2) it is total mixed：Take Atorvastatin calcium, acetic acid hydroxypropyl methylcellulose succinate, ammonium oxalate, lactose
FlowLac100, hydroxypropylcellulose, magnesium stearate, mixed 15 minutes in mixer；
(3) tabletting：Tabletting is carried out with Highspeedrotarytabletpress, obtains label；
(4) it is coated：Opadry YS-1-7040, lauryl sodium sulfate, DDAO are taken, with purifying
Coating Solution is made in water, and label is placed in coating pan, adjusts rotating speed, Coating Solution, while blowing hot-air are sprayed into pot, works as tablet
Increase weight for 2.0%~3.0% when, stop coating, continue air blast air drying 20~30 minutes, 2~4Hz of peristaltic pump, enter wind-warm syndrome
65 ± 5 DEG C of degree, obtains atorvastatin agent.
The preparation (specification 40mg/ pieces, 1000) of the atorvastatin agent of the present invention of embodiment 4
Label forms：
Coating composition：
Preparation method：
(1) pre-process：By acetic acid hydroxypropyl methylcellulose succinate, ammonium oxalate, lactose FlowLac100, hydroxypropyl fiber
Element, magnesium stearate and Opadry YS-1-7040 cross 40 mesh sieves, and are weighed according to recipe quantity, standby；
(2) it is total mixed：Take Atorvastatin calcium, acetic acid hydroxypropyl methylcellulose succinate, ammonium oxalate, lactose
FlowLac100, hydroxypropylcellulose, magnesium stearate, mixed 15 minutes in mixer；
(3) tabletting：Tabletting is carried out with Highspeedrotarytabletpress, obtains label；
(4) it is coated：Opadry YS-1-7040, lauryl sodium sulfate, DDAO are taken, with purifying
Coating Solution is made in water, and label is placed in coating pan, adjusts rotating speed, Coating Solution, while blowing hot-air are sprayed into pot, works as tablet
Increase weight for 2.0%~3.0% when, stop coating, continue air blast air drying 20~30 minutes, 2~4Hz of peristaltic pump, enter wind-warm syndrome
65 ± 5 DEG C of degree, obtains atorvastatin agent.
The stability test of test example 1
Atorvastatin agent prepared by the embodiment of the present invention 1 to 4 is positioned over 25 DEG C ± 2 DEG C of temperature, relatively wet
Under the conditions of degree 60% ± 10%, character, dissolution rate, the situation of change about material are investigated, result of the test see the table below：
The above results are shown：Atorvastatin agent prepared by the embodiment of the present invention 1 to 4 was examined through 36 months stability
Examine, character, dissolution rate, content, about material compared with 0 day without significant difference, in acceptability limit, conform to quality requirements.
Therefore, atorvastatin agent of the present invention matched with specific prescription, specific preparation technology achieve it is good
Technique effect, a kind of different technical scheme is provided for the preparation of atorvastatin agent, can more meet clinical demand.
The technical concept and advantage of above-described embodiment only to illustrate the invention, the present invention can also have other forms to become
Change, as well known to the skilled person, above-described embodiment is functioned only as to the exemplary role in foregoing invention protection domain, right
For those of ordinary skill in the art, there are many conventional deformations and other implementations in the protection domain that the present invention is limited
Example, these deformations and embodiment are all by within the pending protection domain of the present invention.
Claims (2)
1. a kind of atorvastatin agent, is made up of label and coating, it is characterised in that the label is by following parts by weight
Component is prepared：Atorvastatin calcium in terms of Atorvastatin 10~40, protective agent 5~20, filler 110~140, disintegration
Agent 6~9, lubricant 1~4；The coating is prepared by the component of following parts by weight：Opadry YS-1-7040 3~6, cause
Hole agent 12~15, purified water 35~38；The protective agent is acetic acid hydroxypropyl methylcellulose succinate and ammonium oxalate with weight ratio
1:0.5 mixture；The filler is lactose FlowLac100；The disintegrant is hydroxypropylcellulose；The lubricant is
Magnesium stearate；The pore-foaming agent be lauryl sodium sulfate and DDAO with weight than 1:2 mixture.
2. a kind of preparation method of atorvastatin agent according to claim 1, it is characterised in that including following step
Suddenly：
(1) pre-process：Protective agent, filler, disintegrant, lubricant and Opadry YS-1-7040 are crossed into 40 mesh sieves, and according to place
Side's amount weighs, standby；
(2) it is total mixed：Atorvastatin calcium, protective agent, filler, disintegrant, lubricant are taken, is mixed 15 minutes in mixer；
(3) tabletting：Tabletting is carried out with Highspeedrotarytabletpress, obtains label；
(4) it is coated：Opadry YS-1-7040, pore-foaming agent are taken, Coating Solution is made with purified water, label is placed in coating pan,
Rotating speed is adjusted, Coating Solution, while blowing hot-air are sprayed into pot, when tablet weightening is 2.0%~3.0%, stops coating, continues
Air blast air drying 20~30 minutes, 2~4Hz of peristaltic pump, 65 ± 5 DEG C of EAT, obtains atorvastatin agent.
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| US20180153993A1 (en) * | 2016-12-07 | 2018-06-07 | The Chinese University Of Hong Kong | Compositions and methods for treatment and prevention of cardiovascular diseases |
| CN113230225B (en) * | 2021-05-17 | 2022-10-14 | 海南锦瑞制药有限公司 | Atorvastatin calcium tablet and preparation method and application 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 |
Citations (2)
| 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 |
| CN103705484A (en) * | 2014-01-03 | 2014-04-09 | 华北制药集团新药研究开发有限责任公司 | Stable atorvastatin calcium tablet and preparation methods thereof |
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| KR20080062430A (en) * | 2006-12-29 | 2008-07-03 | 에스케이케미칼주식회사 | Stabilized pharmaceutical drug of atorvastatin |
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Patent Citations (2)
| 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 |
| CN103705484A (en) * | 2014-01-03 | 2014-04-09 | 华北制药集团新药研究开发有限责任公司 | Stable atorvastatin calcium tablet and preparation methods thereof |
Non-Patent Citations (1)
| Title |
|---|
| 阿托伐他汀的药理作用及临床应用进展;王震宇 等;《中国新药杂志》;20101231;第19卷(第18期);第1684-1687页 * |
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