CN104721148A - Enteric-coated slow release pellet or particle solid preparation and production method thereof - Google Patents
Enteric-coated slow release pellet or particle solid preparation and production method thereof Download PDFInfo
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Abstract
The invention relates to an enteric-coated slow release pellet or particle solid preparation and a production method thereof, and concretely relates to a solid preparation containing an enteric-coated pellet or particle with fenofibric acid or salt thereof as an active component. The preparation is composed of a medicated pellet core and a mono-functional or multifunctional coat, simultaneously realizes enteric coating and slow release characteristics, and is prepared through adopting a centrifuge granulation, extrusion spheronization and fluidized bed coating technology. The preparation has the advantages of good slow release effect and stability, and convenience for production and clinic popularization application.
Description
Technical field
The invention belongs to medical sustained-release preparation technical field, particularly relate to the enteric sustained-release pellet or granular solids preparation and preparation method thereof of a kind of fenofibrate or its salt.
Background technology
Fenofibrate choline salt is PPAR alfa agonists, with the serious hypertriglyceridemia of Statins therapeutic alliance, constitutional hypertriglyceridemia or mixed dyslipidemia, puts goods on the market for a long time.
U.S. FDA is used for the treatment of mixed dyslipidemia in the fenofibrate choline salt slow releasing capsule (Trilipix) of in December, 2008 approval Abbott in U.S.'s listing.
Patent documentation CN102172347A illustrates that Trilipix is a kind of skeleton enteric slow release microplate, and preparation technology comprises wet granulation, tabletting, enteric coated, fill capsule, bottling.The preparation process of Trilipix is higher to equipment requirements.
Summary of the invention
The object of the invention is to the shortcoming and defect overcoming prior art, provide a kind of had good sustained release effect, preparation more stable and be more suitable for the solid preparation of fenofibrate choline salt enteric sustained-release pellet or the granule promoted at home.
Solid preparation of the present invention comprises containing pill core and one or more function clothing layers, and the active component in described ball core is fenofibrate or its salt, and the Determination of Fenofibrate in described preparation unit dosage is 15 ~ 75%, is preferably 20 ~ 60%.
Preferably, describedly also comprise the pharmaceutically acceptable excipient of at least one containing pill core, described excipient be selected from filler, lubricant, fluidizer, disintegrating agent, binding agent, wetting agent one or more; Preferred, described excipient be selected from sucrose, mannitol, microcrystalline Cellulose, hyprolose, lactose, hypromellose, polyvidone, polyvinylpolypyrrolidone and carboxymethyl starch sodium one or more.
Preferably, described ball core comprises fenofibrate choline salt, lactose, microcrystalline Cellulose and polyvinylpolypyrrolidone; Preferred, in described ball core, the weight ratio of fenofibrate choline salt, lactose, microcrystalline Cellulose and polyvinylpolypyrrolidone is 20:3-10:6-15:1, particularly preferably 20:10:15:1 or 60:10:20:3.
Preferably, described function clothing layer is including but not limited to taste masking clothing layer, sealing coat, slow release layer, damp-proof layer, enteric layer and dyed layer.
Preferably, described function clothing layer comprises sealing coat, slow release layer and enteric layer; Preferred, described slow release layer comprises cellulose acetate phthalate, cellulose acetate succinate, Hydroxypropyl methyl cellulose phtalate, ethyl acrylate, methyl methacrylate and methacrylic acid trimethyl ammonium chloride base methacrylate copolymers, EUDRAGIT L100-55 aqueous dispersion, (methyl) ethyl acrylate and (methyl) methyl acrylate copolymer, one or more in ethyl cellulose; Described enteric layer comprises Hydroxypropyl methyl cellulose phtalate, cellulose acetate phthalate, cellulose acetate succinate, Eudragit L100D55, (methyl) acrylic acid (ethyl ester) and (methyl) alkyl acrylate copolymer one or more; Described sealing coat comprise in hypromellose, polyvidone, copolyvidone, hydroxypropyl cellulose and Opadry one or more.
Preferably, described sealing coat accounts for 2 ~ 20% of non-bag sealing coat micropill gross weight, and slow release layer accounts for 3 ~ 30% of non-bag slow release layer micropill gross weight, and enteric layer accounts for 10 ~ 50% of non-bag enteric layer micropill gross weight.
Preferably, described slow release layer also comprises release regulator and/or antitackiness agent, and described release regulator and/or antitackiness agent are selected from one or more in silicon dioxide colloid, sodium stearyl fumarate, Pulvis Talci, magnesium stearate, Polyethylene Glycol, potassium chloride.
Preferably, described enteric layer also comprises antitackiness agent, plasticizer, coloring agent and/or pH adjusting agent.
Preferably, the described preparation technology containing pill core comprises centrifugal granulation, extrusion spheronization method and liquid-layering method.
Preferably, centrifugal granulation, fluidized bed coating is being comprised, more preferably fluidized bed coating containing the technique of coated function clothing layer on pill core.
Fenofibrate choline salt enteric sustained-release pellet of the present invention has the following advantages compared with microplate: 1. take and extensively, be equably distributed in gastrointestinal tract afterwards, large at gastrointestinal surface distributed area, thus improves bioavailability, and reducing or eliminating medicine stimulates gastrointestinal; 2. pellet is in the impact of the gastrointestinal transhipment unable to take food thing conveying rhythm and pace of moving things, gastric emptying; 3. the release rule comparatively tablet favorable reproducibility of slow controlled release micro pill, the overall drug release behavior influence degree of unit micropill to preparation is little; 4. the micropill of different rate of releasing drug can be dressed up capsule in proportion, to meet different needs; 5. the compound capsule be made up of different micropill, has good stability, reduces the interaction between medicine; 6. micropill mobility is better, is conducive to preparation subpackage or molding further; 7. the slow controlled release of preparation and good stability.In addition, because domestic microplate production line is not popularized temporarily, therefore, adopt centrifugal granulating, extrusion spheronization method and or liquid-layering method prepare pastille micropill, the technique of fluid bed packet function clothing is more suitable for promoting at home, compared with pressing microplate with the framework material wet granulation of Trilipix, technique is simpler, and operability is stronger.
Accompanying drawing explanation
Fig. 1 is the cumulative release curve of fenofibrate choline enteric sustained-release pellet in embodiment 1;
Fig. 2 is the cumulative release curve of fenofibrate choline enteric sustained-release pellet in embodiment 2;
Fig. 3 is the cumulative release curve of fenofibrate choline enteric sustained-release pellet in embodiment 3;
Fig. 4 is the cumulative release curve of fenofibrate choline enteric sustained-release pellet in embodiment 4;
Fig. 5 is the cumulative release curve of fenofibrate choline enteric sustained-release pellet in embodiment 5.
Detailed description of the invention
In order to the present invention and acquired effect thereof are described better, be described further below in conjunction with specific embodiment, but scope of the present invention is not limited to the concrete scheme of embodiment.
Embodiment 1:
(1) prescription:
(2) preparation technology:
1. containing pill core: get fenofibrate choline salt, cross 120 mesh sieves, take recipe quantity, cross 60 mesh sieves with the lactose of recipe quantity, microcrystalline Cellulose and polyvinylpolypyrrolidone and mix; In above-mentioned material, slowly drip 3% hyprolose aqueous solution make dry wet moderate soft material; That selects 0.8cm aperture extrudes sieve, in extrusion spheronization machine, make micropill; Obtained micropill is put into 40 DEG C of oven drying 4h, sieve to obtain 18 ~ 30 object micropills, micropill uniform particle sizes, roundness is good.
2. containing pill core bag contagion gown: according to upper table prescription preparation sealing coat coating solution, be placed in fluidized-bed coating machine by obtained in 1. containing pill core, coating weight gain 2 ~ 4% stops coating.
3. isolate micropill bag extended release coatings: according to upper table prescription preparation slow release layer coating solution, obtained isolation micropill in is 2. placed in fluidized-bed coating machine, and coating weight gain 8 ~ 12% stops coating.
4. slow-release micro-pill is enteric coated: according to upper table prescription preparation enteric layer coating solution, and obtained isolation micropill in is 3. placed in fluidized-bed coating machine, and coating weight gain 18 ~ 22% stops coating.
(3) release experiment: adopt drug release determination method (Chinese Pharmacopoeia version in 2010 two annex X D second methods) the second device, with pH3.5 buffer solution of sodium phosphate 500ml for release medium I(acidic phase), rotating speed is 50 turns per minute, operate in accordance with the law, through 120 minutes time, the sodium radio-phosphate,P-32 solution 400ml of the pH value about 11.5 being preheated to 37 DEG C is added in each container, mixing, as release medium II(buffer stage), continue release 480 minutes, 120 minutes are discharged respectively at acidic phase, buffer stage discharges 15 minutes, 60 minutes, 120 minutes, 240 minutes, 360 minutes, measured in solution uv absorption is got when 480 minutes, determined wavelength is 300nm.Result as shown in Figure 1.
Embodiment 2:
(1) prescription:
(2) preparation technology:
1. containing pill core: get fenofibrate choline salt, cross 120 mesh sieves, take recipe quantity, cross 60 mesh sieves with the lactose of recipe quantity, microcrystalline Cellulose and polyvinylpolypyrrolidone and mix; In above-mentioned material, slowly drip 3% hyprolose aqueous solution make dry wet moderate soft material; That selects 0.8cm aperture extrudes sieve, in extrusion spheronization machine, make micropill; Obtained micropill is put into 40 DEG C of oven drying 4h, sieve to obtain 18 ~ 30 object micropills, micropill uniform particle sizes, roundness is good.
2. containing pill core bag contagion gown: according to upper table prescription preparation sealing coat coating solution, be placed in fluidized-bed coating machine by obtained in 1. containing pill core, coating weight gain 6 ~ 9% stops coating.
3. isolate micropill bag extended release coatings: according to upper table prescription preparation slow release layer coating solution, obtained isolation micropill in is 2. placed in fluidized-bed coating machine, and coating weight gain 18 ~ 22% stops coating.
4. slow-release micro-pill is enteric coated: according to upper table prescription preparation enteric layer coating solution, and obtained isolation micropill in is 3. placed in fluidized-bed coating machine, and coating weight gain 18 ~ 22% stops coating.
(3) release experiment: adopt drug release determination method (Chinese Pharmacopoeia version in 2010 two annex X D second methods) the second device, with pH3.5 buffer solution of sodium phosphate 500ml for release medium I(acidic phase), rotating speed is 50 turns per minute, operate in accordance with the law, through 120 minutes time, the sodium radio-phosphate,P-32 solution 400ml of the pH value about 11.5 being preheated to 37 DEG C is added in each container, mixing, as release medium II(buffer stage), continue release 480 minutes, 120 minutes are discharged respectively at acidic phase, buffer stage discharges 15 minutes, 60 minutes, 120 minutes, 240 minutes, 360 minutes, measured in solution uv absorption is got when 480 minutes, determined wavelength is 300nm.Result as shown in Figure 2.
Embodiment 3:
(1) prescription:
(2) preparation technology:
1. containing pill core: get fenofibrate choline salt, cross 120 mesh sieves, take recipe quantity, cross 60 mesh sieves with the lactose of recipe quantity, microcrystalline Cellulose and polyvinylpolypyrrolidone and mix; In above-mentioned material, slowly drip 3% hyprolose aqueous solution make dry wet moderate soft material; That selects 0.8cm aperture extrudes sieve, in extrusion spheronization machine, make micropill; Obtained micropill is put into 40 DEG C of oven drying 4h, sieve to obtain 18 ~ 30 object micropills, micropill uniform particle sizes, roundness is good.
2. containing pill core bag contagion gown: according to upper table prescription preparation sealing coat coating solution, be placed in fluidized-bed coating machine by obtained in 1. containing pill core, coating weight gain 6 ~ 9% stops coating.
3. isolate micropill bag extended release coatings: according to upper table prescription preparation slow release layer coating solution, obtained isolation micropill in is 2. placed in fluidized-bed coating machine, and coating weight gain 14 ~ 20% stops coating.
4. slow-release micro-pill is enteric coated: according to upper table prescription preparation enteric layer coating solution, and obtained isolation micropill in is 3. placed in fluidized-bed coating machine, and coating weight gain 18 ~ 22% stops coating.
(3) release experiment: adopt drug release determination method (Chinese Pharmacopoeia version in 2010 two annex X D second methods) the second device, with pH3.5 buffer solution of sodium phosphate 500ml for release medium I(acidic phase), rotating speed is 50 turns per minute, operate in accordance with the law, through 120 minutes time, the sodium radio-phosphate,P-32 solution 400ml of the pH value about 11.5 being preheated to 37 DEG C is added in each container, mixing, as release medium II(buffer stage), continue release 480 minutes, 120 minutes are discharged respectively at acidic phase, buffer stage discharges 15 minutes, 60 minutes, 120 minutes, 240 minutes, 360 minutes, measured in solution uv absorption is got when 480 minutes, determined wavelength is 300nm.Result as shown in Figure 3.
Embodiment 4:
(1) prescription:
(2) preparation technology:
1. containing pill core: fenofibrate choline salt and mannitol are crossed 120 mesh sieves, takes recipe quantity respectively, hopper mixer mixing for standby use is put into the silicon dioxide of recipe quantity and polyvinylpolypyrrolidone; Medicinal fine pellet core is joined preheating in centrifugal granulator, reach temperature required after spray into binding agent, enough moistening rear lower powder, by regulating binding agent to spray into speed and lower powder speed makes it reach balance, until powder all go up, the micropill that sieve is got between 18 ~ 30 orders.
2. containing pill core bag contagion gown: according to upper table prescription preparation sealing coat coating solution, be placed in fluidized-bed coating machine by obtained in 1. containing pill core, coating weight gain 6 ~ 9% stops coating.
3. isolate micropill bag extended release coatings: according to upper table prescription preparation slow release layer coating solution, obtained isolation micropill in is 2. placed in fluidized-bed coating machine, and coating weight gain 8 ~ 12% stops coating.
4. slow-release micro-pill is enteric coated: according to upper table prescription preparation enteric layer coating solution, and obtained isolation micropill in is 3. placed in fluidized-bed coating machine, and coating weight gain 18 ~ 22% stops coating.
(3) release experiment: adopt drug release determination method (Chinese Pharmacopoeia version in 2010 two annex X D second methods) the second device, with pH3.5 buffer solution of sodium phosphate 500ml for release medium I(acidic phase), rotating speed is 50 turns per minute, operate in accordance with the law, through 120 minutes time, the sodium radio-phosphate,P-32 solution 400ml of the pH value about 11.5 being preheated to 37 DEG C is added in each container, mixing, as release medium II(buffer stage), continue release 480 minutes, 120 minutes are discharged respectively at acidic phase, buffer stage discharges 15 minutes, 60 minutes, 120 minutes, 240 minutes, 360 minutes, measured in solution uv absorption is got when 480 minutes, determined wavelength is 300nm.Result as shown in Figure 4.
Embodiment 5:
(1) prescription:
(2) preparation technology:
1. containing pill core: fenofibrate choline salt and mannitol are crossed 120 mesh sieves, takes recipe quantity respectively, hopper mixer mixing for standby use is put into the silicon dioxide of recipe quantity and polyvinylpolypyrrolidone; Medicinal fine pellet core is joined preheating in centrifugal granulator, reach temperature required after spray into binding agent, enough moistening rear lower powder, by regulating binding agent to spray into speed and lower powder speed makes it reach balance, until powder all go up, the micropill that sieve is got between 18 ~ 30 orders.
2. containing pill core bag contagion gown: according to upper table prescription preparation sealing coat coating solution, be placed in fluidized-bed coating machine by obtained in 1. containing pill core, coating weight gain 6 ~ 9% stops coating.
3. isolate micropill bag extended release coatings: according to upper table prescription preparation slow release layer coating solution, obtained isolation micropill in is 2. placed in fluidized-bed coating machine, and coating weight gain 11 ~ 14% stops coating.
4. slow-release micro-pill is enteric coated: according to upper table prescription preparation enteric layer coating solution, and obtained isolation micropill in is 3. placed in fluidized-bed coating machine, and coating weight gain 18 ~ 22% stops coating.
(3) release experiment: adopt drug release determination method (Chinese Pharmacopoeia version in 2010 two annex X D second methods) the second device, with pH3.5 buffer solution of sodium phosphate 500ml for release medium I(acidic phase), rotating speed is 50 turns per minute, operate in accordance with the law, through 120 minutes time, the sodium radio-phosphate,P-32 solution 400ml of the pH value about 11.5 being preheated to 37 DEG C is added in each container, mixing, as release medium II(buffer stage), continue release 480 minutes, 120 minutes are discharged respectively at acidic phase, buffer stage discharges 15 minutes, 60 minutes, 120 minutes, 240 minutes, 360 minutes, measured in solution uv absorption is got when 480 minutes, determined wavelength is 300nm.Result as shown in Figure 5.
(4) stability experiment: carry out reference preparation (Trilipix) according to " crude drug and pharmaceutical preparation stability test guideline " (Chinese Pharmacopoeia 2010 editions two annex XIX C) and make the study on the stability of preparation (embodiment 3) by oneself, result is as follows:
Reference preparation and self-control preparation stability are investigated
Result shows, and self-control preparation stability is good, and related substance has no and rises appreciably, and has no obvious moisture absorption phenomenon, but reference preparation related substance has growth, and has moisture absorption phenomenon.
Claims (10)
1. the solid preparation of an enteric sustained-release pellet or granule, it is characterized in that, described preparation comprises containing pill core and one or more function clothing layers, active component in described ball core is fenofibrate or its salt, Determination of Fenofibrate in described preparation unit dosage is 15 ~ 75%, is preferably 20 ~ 60%.
2. solid preparation as claimed in claim 1, it is characterized in that, describedly also comprise the acceptable excipient of at least one pharmacy containing pill core, described excipient be selected from filler, lubricant, fluidizer, disintegrating agent, binding agent, wetting agent one or more; Preferably, described excipient is selected from one or more in sucrose, mannitol, microcrystalline Cellulose, hyprolose, lactose, hypromellose, polyvidone, polyvinylpolypyrrolidone and carboxymethyl starch sodium.
3. solid preparation as claimed in claim 2, it is characterized in that, described ball core comprises fenofibrate choline salt, lactose, microcrystalline Cellulose and polyvinylpolypyrrolidone; Preferably, in described ball core, the weight ratio of fenofibrate choline salt, lactose, microcrystalline Cellulose and polyvinylpolypyrrolidone is 20:3-10:6-15:1, more preferably 20:10:15:1 or 60:10:20:3.
4. solid preparation as claimed in claim 1, it is characterized in that, described function clothing layer is including but not limited to taste masking clothing layer, sealing coat, slow release layer, damp-proof layer, enteric layer and dyed layer.
5. solid preparation as claimed in claim 4, it is characterized in that, described function clothing layer comprises sealing coat, slow release layer and enteric layer; Preferably, described slow release layer comprises cellulose acetate phthalate, cellulose acetate succinate, Hydroxypropyl methyl cellulose phtalate, ethyl acrylate, methyl methacrylate and methacrylic acid trimethyl ammonium chloride base methacrylate copolymers, EUDRAGIT L100-55 aqueous dispersion, (methyl) ethyl acrylate and (methyl) methyl acrylate copolymer, one or more in ethyl cellulose; Described enteric layer comprises Hydroxypropyl methyl cellulose phtalate, cellulose acetate phthalate, cellulose acetate succinate, Eudragit L100D55, (methyl) acrylic acid (ethyl ester) and (methyl) alkyl acrylate copolymer one or more; Described sealing coat comprise in hypromellose, polyvidone, copolyvidone, hydroxypropyl cellulose and Opadry one or more.
6. solid preparation as claimed in claim 5, it is characterized in that, described sealing coat accounts for 2 ~ 20% of non-bag sealing coat micropill gross weight, and slow release layer accounts for 3 ~ 30% of non-bag slow release layer micropill gross weight, and enteric layer accounts for 10 ~ 50% of non-bag enteric layer micropill gross weight.
7. solid preparation as claimed in claim 5, it is characterized in that, described slow release layer also comprises release regulator and/or antitackiness agent, and described release regulator and/or antitackiness agent are selected from one or more in silicon dioxide colloid, sodium stearyl fumarate, Pulvis Talci, magnesium stearate, Polyethylene Glycol, potassium chloride.
8. solid preparation as claimed in claim 5, it is characterized in that, described enteric layer also comprises antitackiness agent, plasticizer, coloring agent and/or pH adjusting agent.
9. the solid preparation according to any one of claim 1-8, is characterized in that, the described preparation technology containing pill core comprises centrifugal granulation, extrusion spheronization method and liquid-layering method.
10. the solid preparation according to any one of claim 1-8, is characterized in that, is comprising centrifugal granulation, fluidized bed coating, preferred fluidized bed coating containing the technique of coated function clothing layer on pill core.
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| CN201310700041.7A CN104721148A (en) | 2013-12-18 | 2013-12-18 | Enteric-coated slow release pellet or particle solid preparation and production method thereof |
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN105748445A (en) * | 2016-03-31 | 2016-07-13 | 武汉药谷生物工程有限公司 | Preparation method of choline fenofibrate acid sustained release capsule |
| CN108294317A (en) * | 2018-01-31 | 2018-07-20 | 无限极（中国）有限公司 | A kind of walnut peptide enteric-coated micro-pill and preparation method thereof |
| CN109566874A (en) * | 2018-12-03 | 2019-04-05 | 卢亮 | A kind of preparation method of enteric slow release type microelement particle |
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| CN101780049A (en) * | 2009-01-20 | 2010-07-21 | 北京利乐生制药科技有限公司 | Enteric solid preparation using feinuobeite acid and feinuobeite salt as major ingredients and preparation method thereof |
| CN102058544A (en) * | 2010-12-10 | 2011-05-18 | 山东省医药工业研究所 | Method for preparing enteric slow release pellet containing fenofibric acid choline salt |
| CN103211786A (en) * | 2012-01-18 | 2013-07-24 | 北京天衡药物研究院 | Choline fenofibrate film-controlled enteric slow-release pellet capsule |
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN105748445A (en) * | 2016-03-31 | 2016-07-13 | 武汉药谷生物工程有限公司 | Preparation method of choline fenofibrate acid sustained release capsule |
| CN108294317A (en) * | 2018-01-31 | 2018-07-20 | 无限极（中国）有限公司 | A kind of walnut peptide enteric-coated micro-pill and preparation method thereof |
| CN109566874A (en) * | 2018-12-03 | 2019-04-05 | 卢亮 | A kind of preparation method of enteric slow release type microelement particle |
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Effective date of registration: 20160324 Address after: 222047 Lianyungang economic and Technological Development Zone, Jiangsu Applicant after: JIANGSU HANSOH PHARMACEUTICAL GROUP Co.,Ltd. Address before: Tenth Industrial Zone, Lianyungang, Jiangsu, China, 222047 Applicant before: JIANGSU HANSOH PHARMACEUTICAL GROUP Co.,Ltd. Applicant before: Lianyungang Hongchuang Pharmaceutical Co.,Ltd. |
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Application publication date: 20150624 |