CN105832723B - A kind of Ezetimibe atorvastatin and preparation method thereof - Google Patents
A kind of Ezetimibe atorvastatin and preparation method thereof Download PDFInfo
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- CN105832723B CN105832723B CN201610240014.XA CN201610240014A CN105832723B CN 105832723 B CN105832723 B CN 105832723B CN 201610240014 A CN201610240014 A CN 201610240014A CN 105832723 B CN105832723 B CN 105832723B
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- ezetimibe
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- atorvastatin
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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
- A61K31/397—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having four-membered rings, e.g. azetidine
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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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- 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
- A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
- A61K9/2086—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
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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
- A61K9/2806—Coating materials
- A61K9/282—Organic compounds, e.g. fats
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Abstract
The invention discloses a kind of Ezetimibe atorvastatins and preparation method thereof, which is made of Ezetimibe particle and Atorvastatin calcium particle by Double layer pellet, and the Ezetimibe particle includes following components：Ezetimibe, adhesive, surfactant, water-soluble filler, water-insoluble filler, disintegrant and lubricant；When Ezetimibe particle is pelletized, first Ezetimibe and surfactant are dissolved or dispersed in binder solution, add water-soluble filler mixing, other auxiliary materials is then added in and pelletizes.When preparing Ezetimibe layer, auxiliary material is added in by particular order, efficiently solves the problems, such as the release in vitro of Ezetimibe.
Description
Technical field
The present invention relates to a kind of Ezetimibe atorvastatin and preparation methods, belong to pharmaceutical technology field.
Background technology
Ezetimibe atorvastatin is compound preparation, is mainly used for reducing T-CHOL (low-density lipoprotein courage
Sterol and triglycerides) it is horizontal, and High-density Lipoprotein-cholesterol can be improved, the compound drop for United States Merck company exploitation
Fat medicine, trade name " LIPTRZET ", FDA ratified this product on May 3rd, 2013.The compound preparation is generally using two activity
Ingredient is present in separated entity in a single solid dosage forms, i.e. double-layer tablets.The two kinds of active components mechanism of action is different, system
Into compound, there are more preferably curative effect and patient adaptability, there is vast market prospect.
But it is unexpected, it finds, can interact between two active constituents, according to folding during compound preparation is developed
Mai Buhui accelerate Atorvastatin calcium degradation, and Atorvastatin calcium layer must alkaline stabiliser can accelerate according to roll over wheat
The degradation of cloth.And two active constituent solubility it is low, be extremely difficult to good release in vitro, particularly Ezetimibe.
Separated granulation is mentioned in 103340852 A of patent application CN, prepares double-layer tablets, but practice process discovery is existing
Although common method of granulating can delay above-mentioned degradation, but still have partial particulate to contact with each other to a certain degree, it is steady to influence product
It is qualitative.In addition the existing solubilization technique to Ezetimibe have fusion method, coating method, solid dispersion method, but these mode costs compared with
Height to equipment requirement height, is unfavorable for industrialized production；Or using micronizing, dust is very big, is unfavorable for labour protection, and according to folding
Wheat cloth micronization process has certain degradation.
It is mentioned in CN201510055735 and Ezetimibe, hydroxypropyl cellulose is dissolved in diethylene glycol monoethyl ether
In, aerosil absorption is added in, is then uniformly mixed with pharmaceutically acceptable auxiliary material, is suppressed using direct tablet compressing technique
Into Ezetimibe tablet.Compared with prior art, drug-eluting speed is fast, simple for process for the preparation method, does not need to add
Surfactant, it is not required that micronization processes.But the method solvent for use is diethylene glycol monoethyl ether, inflammable micro- malicious solvent,
Also it is unfavorable for industrialized production.
Invention content
The technical problems to be solved by the invention are to overcome the defect of the prior art, provide a kind of Ezetimibe atropic and cut down him
Spit of fland calcium tablet and preparation method thereof, Ezetimibe vitro release is high in the Ezetimibe atorvastatin, and stability
It is good.
A kind of Ezetimibe atorvastatin is pressed by Ezetimibe particle and Atorvastatin calcium particle by double-deck
Piece is made, and the Ezetimibe particle includes following components：Ezetimibe, adhesive, surfactant, water soluble bulk
Agent, water-insoluble filler, disintegrant and lubricant；
When Ezetimibe particle is pelletized, first Ezetimibe and surfactant are dissolved or dispersed in binder solution,
Water-soluble filler mixing is added, other auxiliary materials is then added in and pelletizes.
In the present invention, in Ezetimibe particle pelletization, first main ingredient is fully wrapped up with adhesive material, at this time object
Material state be solution, after disperse in water soluble adjuvant, then using insoluble auxiliary material granulation granulation, can effectively improve according to folding wheat
Cloth in the grain be uniformly distributed and hydrophily, so as to improve its release.
The adhesive is the high molecular material with film forming, preferably, the adhesive is hydroxypropyl fiber
At least one of element, PVP K30 and hydroxypropyl methylcellulose；
The solvent of the binder solution is ethanol water, and the mass percent of the middle ethyl alcohol of ethanol water is
85%~95%, preferably 90%.It is pelletized using high concentration, highly viscous solution, makes the adhesive material with film forming
Ezetimibe surface is wrapped in again by Double layer pellet, so as to which Ezetimibe be made to cut down him with alkaline stabiliser and atropic to greatest extent
Spit of fland calcium isolation increases the stability of two main ingredients.
As a further preference, the binder solution is the ethanol water of PVP K30；
It is 90% wherein for preparing the mass percent of ethyl alcohol in the ethanol water of binder solution, PVP K30
Mass percent in binder solution is 20%, at this point, obtained binder solution is nearly colloidal solution.
Preferably, the mesh number of prepared Ezetimibe particle is 40~60 mesh, by controlling the mesh number of wet granular, reach
To the mobility that not only can guarantee particle, but also the purpose of energy quick release.
When Ezetimibe particle is pelletized, device therefor is top drive formula granulator.
In the present invention, Atorvastatin calcium particle is directly using dry granulation, and granularity control is in the mesh of 30 mesh~40.
As most preferably, the Ezetimibe particle includes the component of following parts by weight：
The Atorvastatin calcium particle includes the component of following parts by weight：
The present invention also provides a kind of preparation method of the Ezetimibe atorvastatin, including following step
Suddenly：
(1) it in drive formula granulator is pushed up, by Ezetimibe, surfactant-dispersed in binder solution, then adds in
Water-soluble filler stirs evenly, and adds water-insoluble filler and disintegrant, and the wet granular of 40~60 mesh is made, dry,
Whole grain adds in lubricant and obtains Ezetimibe particle；
(2) by Atorvastatin calcium and pharmaceutic adjuvant using dry granulation, granularity control adds in lubrication in the mesh of 30 mesh~40
Agent obtains Atorvastatin calcium particle；
(3) two kinds of particles are pressed into two layers up and down, coating soluble in the stomach on a bi-layer tablet press respectively with different feeds bucket,
Obtain the Ezetimibe atorvastatin.
Different from previous low concentration adhesive granulation, the present invention is pelletized using high concentration, highly viscous solution, makes to have
The adhesive material of film forming is wrapped in Ezetimibe surface again by Double layer pellet, so as to make Ezetimibe and alkali to greatest extent
Property stabilizer and Atorvastatin calcium isolation, increase by two main ingredients stability.Binder concn is high simultaneously, can reduce insoluble fill out
Fill the dosage of auxiliary material.Because main ingredient is first fully wrapped up to by adhesive material, and material state is solution at this time for this granulation mode,
The deficiency that can effectively prevent normal wet granulation liquid using drive formula granulator is pushed up and easily flow out.It is bonded simultaneously by first coated water-soluble
Agent material, after disperse in water soluble adjuvant, then using insoluble auxiliary material granulation granulation, can effectively improve Ezetimibe
Being uniformly distributed in grain and hydrophily, so as to improve its release.By controlling the mesh number of wet granular, reach and both can guarantee particle
Mobility, and the purpose of energy quick release.Ezetimibe is both improved to sum up, reaching by technological means of the present invention
Release in vitro, and the stability of Ezetimibe, Atorvastatin calcium can be improved.
Specific embodiment
Embodiment 1
Ezetimibe layer prescription and preparation
| Ingredient | Dosage (mg) | Effect |
| Ezetimibe | 10 | Active constituent |
| PVP K30 | 120 | Adhesive |
| Lauryl sodium sulfate | 8 | Activating agent |
| Lactose | 50 | Water-soluble filler |
| Microcrystalline cellulose 102 | 50 | Water-insoluble filler |
| Croscarmellose sodium | 30 | Disintegrant |
| Magnesium stearate | 2 | Lubricant |
| 90% ethyl alcohol | 0.06ml | Wetting agent |
It will be in the above-mentioned Ezetimibe of prescription ratio, lauryl sodium sulfate, lactose, microcrystalline cellulose 102, cross-linked carboxymethyl
The PVP K30 of sodium cellulosate, 3/4 amount is uniformly mixed, and is pelletized with 20% PVP K30,90% ethanol solution, 40 mesh, dry,
Whole grain adds in magnesium stearate, the Ezetimibe layer of system.
Atorvastatin calcium layer prescription and preparation
| Ingredient | Dosage (mg) | Effect |
| Atorvastatin calcium | 11 | Active constituent |
| Microcrystalline cellulose 102 | 100 | Filler |
| Cross-linked carboxymethyl cellulose is received | 30 | Disintegrant |
| Vertical compression lactose | 50 | Filler |
| Calcium carbonate | 26 | Alkaline stabiliser |
| Talcum powder | 40 | Glidant |
| Magnesium stearate | 3 | Lubricant |
By Atorvastatin calcium, adhesive, disintegrant, alkaline stabiliser, filling auxiliary material, glidant dry granulation, granularity
Control adds in suitable lubricant, as Atorvastatin calcium layer particle in the mesh of 30 mesh~40.
By two kinds of particles respectively with different feeds bucket, it is pressed into two synusia up and down on a bi-layer tablet press, coating soluble in the stomach, i.e.,
Obtain 1 double-layer tablets of embodiment.
Embodiment 2
Ezetimibe layer prescription and preparation
It is in the prescription ratio of embodiment 1 that Ezetimibe, lauryl sodium sulfate is high in proportion in drive formula granulator is pushed up
Degree is dispersed in 20% PVP K30,90% ethanol solution, then adds in lactose, and microcrystalline cellulose 102, cross-linked carboxymethyl are fine
The plain sodium of dimension, stirs evenly, and makes into the wet granular of 40~60 mesh, 40 degree of dryings, whole grain, add in suitable lubricant to get.
Atorvastatin calcium layer prescription and preparation are the same as embodiment 1
By two kinds of particles respectively with different feeds bucket, it is pressed into two synusia up and down on a bi-layer tablet press, coating soluble in the stomach, i.e.,
Obtain 2 double-layer tablets of embodiment.
Embodiment 3
Ezetimibe layer prescription and preparation
It is in the prescription ratio of embodiment 1 that Ezetimibe, lauryl sodium sulfate is high in proportion in drive formula granulator is pushed up
Degree is dispersed in -90% ethanol solution of 20% PVP K30 of concentration, is then gradually adding lactose, is stirred evenly, and it is fine to add in crystallite
Dimension element 102, croscarmellose sodium, make into the wet granular of 40~60 mesh, 40 degree of dryings, and whole grain adds in suitable lubrication
Agent to get.
Atorvastatin calcium layer prescription and preparation are the same as embodiment 1
By two kinds of particles respectively with different feeds bucket, it is pressed into two synusia up and down on a bi-layer tablet press, coating soluble in the stomach, i.e.,
Obtain 3 double-layer tablets of embodiment.
Embodiment 4
Ezetimibe layer prescription and preparation
It is in the prescription ratio of embodiment 1 that Ezetimibe, lauryl sodium sulfate is high in proportion in drive formula granulator is pushed up
Degree is dispersed in -90% ethanol solution of 15% PVP K30 of concentration, is then gradually adding lactose, is stirred evenly, and it is fine to add in crystallite
Dimension element 102, croscarmellose sodium, make into the wet granular of 40~60 mesh, 40 degree of dryings, and whole grain adds in suitable lubrication
Agent to get.
Atorvastatin calcium layer prescription and preparation are the same as embodiment 1
By two kinds of particles respectively with different feeds bucket, it is pressed into two synusia up and down on a bi-layer tablet press, coating soluble in the stomach, i.e.,
Obtain 4 double-layer tablets of embodiment.
Embodiment 5
By double-layer tablets obtained in above-described embodiment, dissolution rate (0.2% tween water, 50rpm, 30min sampling) is measured
And the related substance of 10 days is placed in 60 degree of baking ovens.As a result it see the table below.
Result of the test shows the double-layer tablets prepared by technical scheme of the present invention, and release in vitro and related substance index obtain
Improve to great.Technological means of the present invention can improve the release in vitro of Ezetimibe and improve Ezetimibe, Ah
The stability of atorvastatin calcium.
Claims (5)
1. a kind of Ezetimibe atorvastatin passes through Double layer pellet by Ezetimibe particle and Atorvastatin calcium particle
It is made, which is characterized in that the Ezetimibe particle includes following components：Ezetimibe, adhesive, surfactant, water
Soluble filler, water-insoluble filler, disintegrant and lubricant；
When Ezetimibe particle is pelletized, first Ezetimibe and surfactant are dissolved or dispersed in binder solution, then added
Enter water-soluble filler mixing, then add in other auxiliary materials and pelletize；
The binder solution is the ethanol water of PVP K30；
It is 90% wherein for preparing the mass percent of ethyl alcohol in the ethanol water of binder solution, PVP K30 is viscous
Mass percent in mixture solution is 20%；
The mesh number of prepared Ezetimibe particle is 40~60 mesh；
The Ezetimibe particle includes the component of following parts by weight：
2. Ezetimibe atorvastatin according to claim 1, which is characterized in that Ezetimibe particle is pelletized
When, device therefor is top drive formula granulator.
3. a kind of preparation method of such as claim 1~2 any one of them Ezetimibe atorvastatin, feature exist
In including the following steps：
(1) it in drive formula granulator is pushed up, by Ezetimibe, surfactant-dispersed in binder solution, then adds in water-soluble
Property filler, stir evenly, add water-insoluble filler and disintegrant, the wet granular of 40~60 mesh is made, it is dry, it is whole
Grain adds in lubricant and obtains Ezetimibe particle；
(2) by Atorvastatin calcium and pharmaceutic adjuvant using dry granulation, granularity control adds in lubricant in the mesh of 30 mesh~40,
Obtain Atorvastatin calcium particle；
(3) two kinds of particles are pressed into two layers up and down, coating soluble in the stomach obtains on a bi-layer tablet press respectively with different feeds bucket
The Ezetimibe atorvastatin.
4. the preparation method of Ezetimibe atorvastatin according to claim 3, which is characterized in that step (2)
In, the Atorvastatin calcium particle includes the component of following parts by weight：
5. the preparation method of Ezetimibe atorvastatin according to claim 3, which is characterized in that step (2)
In, the mesh number of prepared Atorvastatin calcium particle is 30~40 mesh.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
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| CN201610240014.XA CN105832723B (en) | 2016-04-15 | 2016-04-15 | A kind of Ezetimibe atorvastatin and preparation method thereof |
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| CN201610240014.XA CN105832723B (en) | 2016-04-15 | 2016-04-15 | A kind of Ezetimibe atorvastatin and preparation method thereof |
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| CN105832723B true CN105832723B (en) | 2018-06-15 |
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Families Citing this family (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN107875129A (en) * | 2017-12-20 | 2018-04-06 | 北京嘉林药业股份有限公司 | A kind of Ezetimibe atorvastatin preparation method |
| CN112294768B (en) * | 2019-07-30 | 2024-02-09 | 重庆华邦制药有限公司 | Ezetimibe tablet and method for improving dissolution rate thereof |
| KR102496243B1 (en) * | 2020-01-14 | 2023-02-07 | 일동제약(주) | A tablet comprising atorvastatin and ezetimibe |
| CN112999178A (en) * | 2021-03-01 | 2021-06-22 | 乐普制药科技有限公司 | Ezetimibe pitavastatin calcium compound double-layer tablet |
| CN113908130B (en) * | 2021-09-22 | 2023-06-27 | 山东省药学科学院 | Chip for treating hypercholesteremia |
| CN114903862B (en) * | 2022-06-15 | 2023-08-22 | 湖北中古生物制药有限公司 | Polypolicosanol atorvastatin calcium compound preparation and preparation method thereof |
Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2007103453A1 (en) * | 2006-03-06 | 2007-09-13 | Teva Pharmaceutical Industries Ltd. | Ezetimibe compositions |
| CN102357096A (en) * | 2011-09-09 | 2012-02-22 | 北京阜康仁生物制药科技有限公司 | Statins zinc salt-containing blood fat-reducing composite |
| CN103340852A (en) * | 2013-07-01 | 2013-10-09 | 北京阜康仁生物制药科技有限公司 | Pharmaceutical composition containing ezetimibe and atorvastatin |
| CN103585157A (en) * | 2013-11-13 | 2014-02-19 | 武汉武药科技有限公司 | Double-layer tablet containing ezetimibe and rosuvastatin and preparation method thereof |
-
2016
- 2016-04-15 CN CN201610240014.XA patent/CN105832723B/en active Active
Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2007103453A1 (en) * | 2006-03-06 | 2007-09-13 | Teva Pharmaceutical Industries Ltd. | Ezetimibe compositions |
| CN102357096A (en) * | 2011-09-09 | 2012-02-22 | 北京阜康仁生物制药科技有限公司 | Statins zinc salt-containing blood fat-reducing composite |
| CN103340852A (en) * | 2013-07-01 | 2013-10-09 | 北京阜康仁生物制药科技有限公司 | Pharmaceutical composition containing ezetimibe and atorvastatin |
| CN103585157A (en) * | 2013-11-13 | 2014-02-19 | 武汉武药科技有限公司 | Double-layer tablet containing ezetimibe and rosuvastatin and preparation method thereof |
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Effective date of registration: 20180504 Address after: 324002 Rainbow Road 4, Xinxin street, Kecheng District, Quzhou, Zhejiang Applicant after: Zhejiang Ju Tai pharmaceutcal corporation, Ltd Applicant after: Shanxi Yosemade Pharmaceutical Co., Ltd. Address before: 324002 Rainbow Road 4, Xinxin street, Kecheng District, Quzhou, Zhejiang Applicant before: Zhejiang Ju Tai pharmaceutcal corporation, Ltd Applicant before: YOSEMADE PHARMACEUTICAL CO., LTD. Applicant before: Shanxi Yosemade Pharmaceutical Co., Ltd. |
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Effective date of registration: 20200414 Address after: 324002 Zhejiang province Kecheng District of Quzhou City New Street Rainbow Road No. 4 Patentee after: ZHEJIANG JUTAI PHARMACEUTICAL Co.,Ltd. Address before: 324002 Zhejiang province Kecheng District of Quzhou City New Street Rainbow Road No. 4 Co-patentee before: Shanxi Yosemade Pharmaceutical Co.,Ltd. Patentee before: ZHEJIANG JUTAI PHARMACEUTICAL Co.,Ltd. |