CN106466304A - Fenofibrate solid preparation and preparation method thereof - Google Patents
Fenofibrate solid preparation and preparation method thereof Download PDFInfo
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- CN106466304A CN106466304A CN201610657169.3A CN201610657169A CN106466304A CN 106466304 A CN106466304 A CN 106466304A CN 201610657169 A CN201610657169 A CN 201610657169A CN 106466304 A CN106466304 A CN 106466304A
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- Prior art keywords
- layer
- slow release
- preparation
- solid preparation
- enteric
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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
- A61K31/21—Esters, e.g. nitroglycerine, selenocyanates
- A61K31/215—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids
- A61K31/216—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids of acids having aromatic rings, e.g. benactizyne, clofibrate
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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
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
- A61K9/5005—Wall or coating material
- A61K9/5021—Organic macromolecular compounds
- A61K9/5026—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
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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
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
- A61K9/5005—Wall or coating material
- A61K9/5021—Organic macromolecular compounds
- A61K9/5036—Polysaccharides, e.g. gums, alginate; Cyclodextrin
- A61K9/5042—Cellulose; Cellulose derivatives, e.g. phthalate or acetate succinate esters of hydroxypropyl methylcellulose
- A61K9/5047—Cellulose ethers containing no ester groups, e.g. hydroxypropyl methylcellulose
-
- 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
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
- A61K9/5073—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals having two or more different coatings optionally including drug-containing subcoatings
- A61K9/5078—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals having two or more different coatings optionally including drug-containing subcoatings with drug-free core
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- Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Epidemiology (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
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- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Emergency Medicine (AREA)
- Medicinal Preparation (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Abstract
The invention discloses fenofibrate solid preparation and preparation method thereof.Specifically, the present invention relates to a kind of solid preparation containing the special construction with fenofibrate and its salt as active component, described preparation includes kernel, medicated layer and function clothing layer etc., realizes slow release and enteric characteristics simultaneously, is prepared using fluidized bed coating equipment.Said preparation slow release effect and stability all show well, are easy to preparation and clinical application.
Description
Technical field
The invention belongs to medical sustained-release preparation technical field, the enteric of more particularly, to a kind of fenofibrate or its salt delays
Release the solid preparation of micropill, and preparation method thereof.
Background technology
Fenofibrate choline salt is PPAR alfa agonists, with Statins therapeutic alliance mixed dyslipidemia, seriously high trigalloyl
Glycerol mass formed by blood stasis, constitutional hypertriglyceridemia or mixed dyslipidemia, put goods on the market for a long time.
U.S. FDA in December, 2008 approval Abbott's fenofibrate choline salt sustained release capsules (Trilipix) is in the U.S.
City is used for treating mixed dyslipidemia
Sustained-release preparation, due to its distinctive superiority, becomes the more important side of domestic and international medical industry development in recent years
To.
Patent documentation CN102172347A explanation Trilipix is a kind of skeleton enteric slow release microplate, and preparation technology includes wet
Method granulation, tabletting, enteric coated, fill capsule, bottling.Matrix preparations refer to medicine and one or more inert solid skeleton
Material makes the preparation of lamellar, granule or other forms by compacting or integration technology.Most of framework materials are water insoluble. its
In have can lentamente imbibition.Matrix preparations are mainly used in controlling the rate of releasing drug of preparation, typically play controlled release, slow release
Effect.
Trilipix skeleton enteric slow release microplate preparation process is higher to equipment requirements.Clinically to acquisition one kind, there is class
Like even better slow release effect, but preparation technology is simpler, and safe and stable slow releasing preparation is full of to be expected.
Content of the invention
It is an object of the invention to overcoming the shortcoming and defect of prior art, provide a kind of had good sustained release effect, preparation more steady
Fixed and be more suitable for the solid preparation of fenofibrate choline salt enteric sustained-release pellet promoted at home.
The present invention is a kind of solid preparation of special construction, and described preparation includes kernel, medicated layer and function clothing layer, wherein
Function clothing layer comprises slow release layer.
Preferably, described kernel is selected from Mannitol capsule core, sucrose capsule core, Microcrystalline Cellulose capsule core, preferably sucrose capsule core.
Preferably, described sucrose capsule core particle diameter is 180～1000 μm, preferably 500～700 μm.
Preferably, in described solid preparation, active component is fenofibrate or its salt, and in unit dose, fenofibrate contains
Measure as 20～60%, preferably 35～55%.
Preferably, described slow release layer comprises slow release layer material, selected from EUDRAGIT NE 30 D EUDRAGIT NE 30D water
Dispersion or Aquacoat.
Preferably, described slow release layer also comprises release regulator and/or antitackiness agent, described release regulator and/or anti-glutinous
Agent is selected from one or more of silicon dioxide, sodium stearyl fumarate, Pulvis Talci, magnesium stearate, Polyethylene Glycol or potassium chloride,
Slow release layer accounts for the 3～30% of non-bag slow release layer micropill gross weight.
Preferably, described function clothing layer including but not limited to slow release layer, taste mask layer, sealing coat, damp-proof layer, enteric layer or
Chromatograph.
Preferably, described function clothing layer comprises sealing coat and enteric layer；Described sealing coat comprises Hypromellose, poly- dimension
One or more of ketone, Copolyvidone, hydroxypropyl cellulose and OPADRY；Described enteric layer comprises Hypromellose neighbour's benzene
Dicarboxylic acid esters, cellulose acetate phthalate, cellulose acetate succinate, methacrylic acid copolymer, (methyl) third
Olefin(e) acid (ethyl ester) and one or more of (methyl) alkyl acrylate copolymer, preferably methacrylic acid copolymer, more preferably
Eudragit L100D55 or Methacrylic Acid Copolymer Type C.
Preferably, described sealing coat accounts for the 2～20% of non-bag sealing coat micropill gross weight, and enteric layer accounts for non-bag enteric layer micropill
The 10～50% of gross weight.
Preferably, described enteric layer also comprises antitackiness agent, plasticizer, coloring agent and/or pH adjusting agent.
Preferably, described solid preparation includes the component of following percentage by weight：
(1) medicated layer
(2) sealing coat
Insolated layer materials 1%～20%
Antitackiness agent 0.5%～10%
(3) slow release layer
Slow release layer material (dry weight) 1%～20%
Antitackiness agent 0.1%～10%
(4) enteric layer
Enteric layer material 1%～20%
Plasticizer 0.5%～10%
Antitackiness agent 1%～20%
It is further preferred that described solid preparation includes the component of following percentage by weight：
(1) medicated layer
(2) sealing coat
Insolated layer materials 1%～10%
Antitackiness agent 0.5%～5%
(3) slow release layer
Slow release layer material (dry weight) 1%～10%
Antitackiness agent 0.1%～5%
(4) enteric layer
Enteric layer material 5%～15%
Plasticizer 0.5%～5%
Antitackiness agent 1%～10%
Preferably, on kernel, the technique of cladding medicated layer and function clothing layer includes centrifugal granulation, fluidized bed coating,
Preferably fluidized bed coating.
On the one hand, the fenofibrate choline salt enteric sustained-release pellet of the present invention is had the following advantages compared with microplate：1. take
Afterwards extensively, it is evenly distributed in gastrointestinal tract, big in gastrointestinal surface distributed area, thus improving bioavailability, being reduced or eliminated
Medicine stimulates to gastrointestinal；2. pellet transports, in gastrointestinal, the impact that unable to take food thing conveys the rhythm and pace of moving things, gastric emptying；3. delay control
, compared with tablet favorable reproducibility, unit micropill is little to the overall drug release behavior influence degree of preparation for the release rule releasing micropill；4. can be by
The micropill of different rate of releasing drug dresses up capsule in proportion, to meet different needs；5. the compound capsule being made up of different micropills,
There is preferable stability, reduce the interaction between medicine；6. micropill mobility preferably, is conducive to preparation subpackage or further
Molding；7. the slow controlled release of preparation and good stability.Further, since domestic microplate production line is not temporarily popularized, therefore, made using centrifugation
Grain method and or liquid-layering method the technique of medicated layer, slow release layer and one or more other functions clothing layer is coated on kernel more
It is suitable for promoting at home, compared with the framework material wet granulation of Trilipix pressure microplate, technique is simpler, and operability is higher.
On the other hand, the present invention passes through the selection of particular formulations structure and the prescription screening of compositionss, efficiently controls
Drug release；Further, the anti-of compositionss draws moist effect and is preferably optimized, and so that product stability is significantly carried
High.
Brief description
Fig. 1 embodiment 3 fenofibrate choline enteric sustained-release pellet cumulative release curve；
Fig. 2 embodiment 4 fenofibrate choline enteric sustained-release pellet cumulative release curve.
Specific embodiment
In order to the present invention and its acquired effect are better described, to do furtherly below in conjunction with specific embodiment
Bright, but the scope of the present invention is not limited to the concrete scheme of embodiment.
Embodiment 1：
(1) prescription：
(2) preparation technology：
1. medicated layer：Prepare medicated layer coating solution according to upper table prescription, kernel is placed in centrifugal granulator, liquid to be coated
Stop coating after spraying into completely.
2. pellet core bag contagion gown：Prepare spacer layer coating liquid according to upper table prescription, the pellet core being obtained in 1.
It is placed in centrifugal granulator, coating weight gain 2～4% stops coating.
3. micropill bag extended release coatings are isolated：Prepare slow release layer coating solution according to upper table prescription, the isolation micropill being obtained in 2.
It is placed in centrifugal granulator, coating weight gain 8～12% stops coating.
4. slow-release micro-pill is enteric coated：Prepare enteric layer coating solution according to upper table prescription, the isolation micropill being obtained in 3.
It is placed in centrifugal granulator, coating weight gain 18～22% stops coating.
Embodiment 2：
(1) prescription：
(2) preparation technology：
1. medicated layer：Prepare medicated layer coating solution according to upper table prescription, kernel is placed in centrifugal granulator, liquid to be coated
Stop coating after spraying into completely.
2. pellet core bag contagion gown：Prepare spacer layer coating liquid according to upper table prescription, the pellet core being obtained in 1.
It is placed in centrifugal granulator, coating weight gain 6～9% stops coating.
3. micropill bag extended release coatings are isolated：Prepare slow release layer coating solution according to upper table prescription, the isolation micropill being obtained in 2.
It is placed in centrifugal granulator, coating weight gain 18～22% stops coating.
4. slow-release micro-pill is enteric coated：Prepare enteric layer coating solution according to upper table prescription, the isolation micropill being obtained in 3.
It is placed in centrifugal granulator, coating weight gain 18～22% stops coating.
Embodiment 3：
(1) prescription：
(2) preparation technology：
1. medicated layer：Prepare medicated layer coating solution according to upper table prescription, kernel is placed in centrifugal granulator, liquid to be coated
Stop coating after spraying into completely.
2. pellet core bag contagion gown：Prepare spacer layer coating liquid according to upper table prescription, the pellet core being obtained in 1.
It is placed in fluidized-bed coating machine, coating weight gain 6～9% stops coating.
3. micropill bag extended release coatings are isolated：Prepare slow release layer coating solution according to upper table prescription, the isolation micropill being obtained in 2.
It is placed in fluidized-bed coating machine, coating weight gain 14～20% stops coating.
4. slow-release micro-pill is enteric coated：Prepare enteric layer coating solution according to upper table prescription, the isolation micropill being obtained in 3.
It is placed in fluidized-bed coating machine, coating weight gain 18～22% stops coating.
Embodiment 4：
(1) prescription：
(2) preparation technology：
1. medicated layer：Prepare medicated layer coating solution according to upper table prescription, kernel is placed in centrifugal granulator, liquid to be coated
Stop coating after spraying into completely.
2. pellet core bag contagion gown：Prepare spacer layer coating liquid according to upper table prescription, the pellet core being obtained in 1.
It is placed in centrifugal granulator, coating weight gain 6～9% stops coating.
3. micropill bag extended release coatings are isolated：Prepare slow release layer coating solution according to upper table prescription, the isolation micropill being obtained in 2.
It is placed in centrifugal granulator, coating weight gain 18～22% stops coating.
4. slow-release micro-pill is enteric coated：Prepare enteric layer coating solution according to upper table prescription, the isolation micropill being obtained in 3.
It is placed in centrifugal granulator, coating weight gain 18～22% stops coating.
Embodiment 5：
(1) prescription：
(2) preparation technology：
1. pellet core：Fenofibrate choline salt and sucrose are crossed 120 mesh sieves, weighs recipe quantity respectively, with recipe quantity
Silicon dioxide and Crospovidone put into mixing for standby use in hopper mixer；Medicinal fine pellet core is added in centrifugal granulator
Preheating, reach temperature required after spray into binding agent, moistening enough after lower powder, spray into speed and lower powder speed by adjusting binding agent
Reach balance, until powder has all been gone up, sieve takes the micropill between 18～30 mesh.
2. pellet core bag contagion gown：Prepare spacer layer coating liquid according to upper table prescription, the pellet core being obtained in 1.
It is placed in fluidized-bed coating machine, coating weight gain 6～9% stops coating.
3. micropill bag extended release coatings are isolated：Prepare slow release layer coating solution according to upper table prescription, the isolation micropill being obtained in 2.
It is placed in fluidized-bed coating machine, coating weight gain 11～14% stops coating.
4. slow-release micro-pill is enteric coated：Prepare enteric layer coating solution according to upper table prescription, the isolation micropill being obtained in 3.
It is placed in fluidized-bed coating machine, coating weight gain 18～22% stops coating.
Experimental example 1：Release is tested
Preparation prepared by with the embodiment of the present invention 3 and 4 as sample, using drug release determination method (Chinese Pharmacopoeia 2010
Two annex Ⅹ D the second methods of version) second device, with pH3.5 buffer solution of sodium phosphate 500ml for release medium I (acidic phase),
Rotating speed is 50 turns per minute, operates in accordance with the law, during through 120 minutes, adds the pH value about 11.5 being preheated to 37 DEG C in each container
Sodium radio-phosphate,P-32 solution 400ml, mix, as release medium II (buffer stage), continue release 480 minutes, respectively at acid rank
Section release 120 minutes, buffer stage discharge 15 minutes, 60 minutes, 120 minutes, 240 minutes, 360 minutes, 480 minutes when take molten
Liquid measures uv absorption, and Detection wavelength is 300nm.Result such as Fig. 1-2.
Experimental example 2：Stability experiment
According to《Crude drug and pharmaceutical preparation stability test guideline》(2010 editions two annex XIX C of Chinese Pharmacopoeia)
Carry out reference preparation (Trilipix) and the study on the stability of self-control preparation (embodiment 3), result is as follows：
Reference preparation and self-control preparation stability are investigated
Result shows, self-control preparation stability is good, has no about material (maximum single miscellaneous and always miscellaneous) and rises appreciably, has no
Substantially moisture absorption phenomenon, but the growth of reference preparation relevant material is more, and moisture absorption phenomenon is obvious.
Claims (15)
1. a kind of solid preparation of special construction is it is characterised in that described solid preparation includes kernel, medicated layer and function clothing
Layer.
2. solid preparation as claimed in claim 1 is it is characterised in that described function clothing layer comprises slow release layer.
3. solid preparation as claimed in claim 1 it is characterised in that described kernel be selected from Mannitol capsule core, sucrose capsule core or
Microcrystalline Cellulose capsule core is it is preferred that described kernel is sucrose capsule core.
4. solid preparation as claimed in claim 3 is it is characterised in that described sucrose capsule core particle diameter is 180～1000 μm, preferably
For 500～700 μm.
5. solid preparation as claimed in claim 1 it is characterised in that in described preparation active component be fenofibrate or its
Salt, in unit dose, Determination of Fenofibrate is 20～60%, preferably 35～55%.
6. solid preparation as claimed in claim 2 is it is characterised in that described slow release layer comprises slow release layer material, selected from propylene
Acetoacetic ester-methylmethacrylate copolymer aqueous dispersion or Aquacoat.
7. solid preparation as claimed in claim 2 is it is characterised in that described slow release layer also comprises release regulator and/or resists
Glutinous agent, described release regulator and/or antitackiness agent are selected from silicon dioxide, sodium stearyl fumarate, Pulvis Talci, magnesium stearate, gather
One or more of ethylene glycol or potassium chloride, slow release layer accounts for the 3～30% of non-bag slow release layer micropill gross weight.
8. solid preparation as claimed in claim 1 it is characterised in that described function clothing layer including but not limited to slow release layer, cover
Taste layer, sealing coat, damp-proof layer, enteric layer or dyed layer.
9. solid preparation as claimed in claim 1 is it is characterised in that described function clothing layer comprises sealing coat, slow release layer and intestinal
Soluble layer.
10. the solid preparation as described in claim 1 or 9 is it is characterised in that described sealing coat comprises Hypromellose, gathers
One or more of dimension ketone, Copolyvidone, hydroxypropyl cellulose and OPADRY；It is adjacent that described enteric layer comprises Hypromellose
Phthalic acid ester, cellulose acetate phthalate, cellulose acetate succinate, methacrylic acid copolymer, (methyl)
Acrylic acid (ethyl ester) and one or more of (methyl) alkyl acrylate copolymer, preferably methacrylic acid copolymer, more excellent
Select Eudragit L100D55 or Methacrylic Acid Copolymer Type C.
11. solid preparations as described in claim 1 or 9 are it is characterised in that described sealing coat accounts for non-bag sealing coat micropill gross weight
2～20%, enteric layer accounts for the 10～50% of non-bag enteric layer micropill gross weight.
12. solid preparations as described in claim 1 or 9 it is characterised in that described enteric layer also comprise antitackiness agent, plasticizer,
Coloring agent and/or pH adjusting agent.
13. solid preparations as claimed in claim 1 are it is characterised in that comprise the component of following percentage by weight：
(1) medicated layer
(2) sealing coat
Insolated layer materials 1%～20%
Antitackiness agent 0.5%～10%
(3) slow release layer
Slow release layer material (dry weight) 1%～20%
Antitackiness agent 0.1%～10%
(4) enteric layer
Enteric layer material 1%～20%
Plasticizer 0.5%～10%
Antitackiness agent 1%～20%.
14. solid preparations as claimed in claim 1 are it is characterised in that comprise the component of following percentage by weight：
(1) medicated layer
(2) sealing coat
Insolated layer materials 1%～10%
Antitackiness agent 0.5%～5%
(3) slow release layer
Slow release layer material (dry weight) 1%～10%
Antitackiness agent 0.1%～5%
(4) enteric layer
Enteric layer material 5%～15%
Plasticizer 0.5%～5%
Antitackiness agent 1%～10%.
15. solid preparations as claimed in claim 1 are it is characterised in that coat medicated layer and the work of function clothing layer on kernel
Skill includes centrifugal granulation, fluidized bed coating, preferably fluidized bed coating.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201510504392 | 2015-08-17 | ||
| CN201510504392X | 2015-08-17 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN106466304A true CN106466304A (en) | 2017-03-01 |
Family
ID=58229980
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201610657169.3A Pending CN106466304A (en) | 2015-08-17 | 2016-08-11 | Fenofibrate solid preparation and preparation method thereof |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN106466304A (en) |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN113230205A (en) * | 2021-05-22 | 2021-08-10 | 绍兴鸿瑞生物科技有限公司 | Gynecological gel preparation and preparation method and application thereof |
-
2016
- 2016-08-11 CN CN201610657169.3A patent/CN106466304A/en active Pending
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN113230205A (en) * | 2021-05-22 | 2021-08-10 | 绍兴鸿瑞生物科技有限公司 | Gynecological gel preparation and preparation method and application thereof |
| CN113230205B (en) * | 2021-05-22 | 2023-07-07 | 绍兴鸿瑞生物科技有限公司 | Gynecological gel preparation and preparation method and application thereof |
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