CN103083275B - Enteric coated tablet of fenofibric acid and physiologically acceptable salts and preparation method of enteric coated tablet - Google Patents
Enteric coated tablet of fenofibric acid and physiologically acceptable salts and preparation method of enteric coated tablet Download PDFInfo
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Abstract
The invention discloses an enteric-coated sustained release tablet of fenofibric acid or physiologically acceptable salts and a preparation method of the enteric-coated sustained release tablet. The enteric-coated sustained release tablet is prepared form the following components: the fenofibric acid or physiologically acceptable salts, a sustained-release material, a filling agent, a lubricant, an enteric coating material and alternatively plasticizer and/or an anti-sticking agent. The enteric-coated sustained release tablet of the fenofibric acid or the physiologically acceptable salts and the preparation method of the enteric-coated sustained release tablet have the advantages of a simple process, taking convenience and the like.
Description
Technical field
The invention belongs to technical field of medicine.Be specifically related to enteric coated preparation containing fenofibric acid and the upper acceptable salt of physiology thereof and preparation method thereof.
Background technology
Fenofibric acid; i.e. 2-[4-(4-chlorobenzene formacyl) phenoxy group]-2-rnethyl-propanoic acid, the salt that conventional itself and choline are formed is a kind of hypolipidemic; coordinate diet control to be used for blood fat disorder patient and reduce triglyceride and low density cholesterol level, increasing high density cholesterol levels.
Fenofibrate is conventional lipid regulating agent, and it is converted into bioactive molecule and fenofibric acid after being absorbed in vivo; The mechanism of action of choline fenofibric acid is identical with fenofibrate, but is only actual active component due to fenofibric acid, and the specification of therefore same therapeutic effect choline fenofibric acid is more much smaller than fenofibrate, and side effect is corresponding minimizing also.
Chinese patent CN1726024C discloses a kind of preparation method of fenofibric acid choline hydrochlorate.The method forms enteric coatel tablets by being mixed with enteric material by fenofibric acid by hot-melt extruded, reaches the object of enteric.But, adopt enteric-coating material to carry out the techniques such as hot-melt extruded and realize enteric, hot-melt extruded device fabrication process need high temperature, medicine stability is had an impact.
Chinese patent CN102172347A discloses a kind of preparation technology of fenofibric acid enteric-soluble controlled-release capsule, by pelletizing press sheet is formed microplate, each microplate diameter is about 3mm, and then enteric coated on microplate, again the microplate after coating is incapsulated, make enteric-soluble controlled-release capsule.But, adopt microplate technique also to need it to be processed further after prepare by microplate and record into capsule and take to facilitate patient, and need to use certain moduli tool and sheeting equipment, the lower and length consuming time of production efficiency.
Chinese patent CN101780049A discloses a kind of preparation method of fenofibric acid enteric coated preparation, and micropill wraps up fenofibric acid active component, and then wraps contagion gown and enteric layer, makes enteric suspensoid.But adopt micropill technique to need to spray packaging technique at the bottom of fluid bed, repeatedly coating on micropill, long processing time, made suspensoid is unfavorable for that patient takes, and dosage is wayward.
Above data does not all mention enteric-coated sustained-release tablet of fenofibric acid and the upper acceptable salt of physiology thereof and preparation method thereof.
And there are the needs to such technique in this area: it adopts tablet dose accurate compared with above technique, and in tablet, medicament contg difference is less; Steady quality, tablet is drying solid, and some oxidizable rotten and deliquescent medicine can borrow coating be protected, and light, air, moisture etc. are less on its impact; Take, carry, transport etc. is more convenient; Mechanization production, output is large, and cost is low, and sanitary standard easily reaches.
Summary of the invention
The present inventor have surprisingly been discovered that enteric-coated sustained-release tablet of a kind of fenofibric acid and preparation method thereof through a large amount of tests, and compared with prior art technique is simple for it, good stability, production efficiency product bioavailability that is high, that make is high and better effects if.
The object of this invention is to provide the enteric-coated sustained-release tablet of a kind of fenofibric acid and the upper acceptable salt of physiology thereof.
Another object of the present invention is to provide the preparation method of the enteric-coated sustained-release tablet of above-mentioned fenofibric acid and the upper acceptable salt of physiology thereof.
Specifically, the invention provides the enteric-coated sustained-release tablet a kind of fenofibric acid or its physiology accepting salt, be grouped into by the one-tenth of following percentage by weight:
Here, the percentage by weight of described fenofibric acid or the upper acceptable salt of its physiology calculates with fenofibric acid.
In a kind of the preferred embodiments of the invention, the invention provides the enteric-coated sustained-release tablet of a kind of fenofibric acid or the upper acceptable salt of its physiology, be grouped into by the one-tenth of following percentage by weight:
Here, the percentage by weight of described fenofibric acid or the upper acceptable salt of its physiology calculates with fenofibric acid.
In embodiments of the invention, the enteric-coated sustained-release tablet of a kind of fenofibric acid provided by the invention or the upper acceptable salt of its physiology, wherein, the upper acceptable salt of physiology of described fenofibric acid is selected from choline salt, or hydrochlorate.
In embodiments of the invention, the enteric-coated sustained-release tablet of a kind of fenofibric acid provided by the invention or the upper acceptable salt of its physiology, wherein, described slow-release material is selected from hypromellose, hydroxypropyl cellulose, methylcellulose, ethyl cellulose, polyvinylpyrrolidone, carbomer, arabic gum, the combination of one or more wherein, preferably hypromellose more preferably, is hypromellose E50 and hypromellose K100LV.
In embodiments of the invention, the enteric-coated sustained-release tablet of a kind of fenofibric acid provided by the invention or the upper acceptable salt of its physiology, wherein, described filler is selected from lactose, microcrystalline Cellulose, starch, mannitol, pregelatinized Starch, Icing Sugar, dextrin, calcium hydrogen phosphate, the combination of one or more wherein, preferably lactose.
In embodiments of the invention, the enteric-coated sustained-release tablet of a kind of fenofibric acid provided by the invention or the upper acceptable salt of its physiology, wherein, described lubricant is selected from Pulvis Talci, magnesium stearate, sodium stearyl fumarate, stearic acid, calcium stearate, the combination of one or more wherein, preferred magnesium stearate.
In embodiments of the invention, the enteric-coated sustained-release tablet of a kind of fenofibric acid provided by the invention or the upper acceptable salt of its physiology, wherein, described antiplastering aid is selected from Pulvis Talci, silicon dioxide, is preferably Pulvis Talci.
In embodiments of the invention, the enteric-coated sustained-release tablet of a kind of fenofibric acid provided by the invention or the upper acceptable salt of its physiology, wherein, enteric-coating material is selected from cellulose phthalate, cellulose acetate succinate, Eudragit L100-55, especially strange L30D-55, especially strange L100, especially strange S100, refined gram of suitable, polyvinyl acetate phthalic acid ester, Kollicoat MAE100P, Kollicoat MAE30DP, the combination of one or more wherein, preferably refined gram suitable.
In embodiments of the invention, the enteric-coated sustained-release tablet of a kind of fenofibric acid provided by the invention or the upper acceptable salt of its physiology, wherein, described plasticizer is selected from triethyl citrate, polyethylene glycol 6000, tributyl citrate, the combination of one or more wherein.
In a preferred embodiment of the present invention, the invention provides a kind of enteric-coated sustained-release tablet of choline fenofibric acid, be grouped into by the one-tenth of following percentage by weight:
Here, the percentage by weight of choline fenofibric acid calculates with fenofibric acid;
Described slow-release material is selected from hypromellose, hydroxypropyl cellulose, methylcellulose, ethyl cellulose, polyvinylpyrrolidone, carbomer, arabic gum, the combination of one or more wherein, preferably hypromellose, more preferably, be hypromellose E50 and hypromellose K100LV;
Described filler is selected from lactose, microcrystalline Cellulose, starch, mannitol, pregelatinized Starch, Icing Sugar, dextrin, calcium hydrogen phosphate, the combination of one or more wherein, preferably lactose;
Described lubricant is selected from Pulvis Talci, magnesium stearate, sodium stearyl fumarate, stearic acid, calcium stearate, the combination of one or more wherein, preferred magnesium stearate;
Described antiplastering aid is selected from Pulvis Talci, silicon dioxide, is preferably Pulvis Talci;
Described enteric-coating material is selected from cellulose phthalate, cellulose acetate succinate, Eudragit L100-55, especially strange L30D-55, especially strange L100, especially strange S100, refined gram of suitable, polyvinyl acetate phthalic acid ester, Kollicoat MAE100P, Kollicoat MAE30DP, wherein one or more combination, preferably refined gram suitable;
Described plasticizer is selected from triethyl citrate, polyethylene glycol 6000, tributyl citrate, the combination of one or more wherein.
On the other hand, the invention provides the preparation method of the enteric-coated sustained-release tablet of above-mentioned fenofibric acid or the upper acceptable salt of its physiology, comprise the steps:
1) by fenofibric acid or its physiology above acceptable salt, slow-release material, filler mixing, carry out granulation and obtain wet granular;
2) wet granular is carried out drying and obtain dry granule;
3) dry granule and lubricant are carried out being mixed to get mixed granule;
4) mixed granule tabletted is obtained slow releasing tablet;
5) in slow releasing tablet with enteric-coating material and optional plasticizer and/or antiplastering aid is enteric coated obtains enteric-coated sustained-release tablet.
Enteric-coated sustained-release tablet provided by the invention adopts the drug release determination method of regulation in Chinese Pharmacopoeia 2010 editions, slurry processes, 50rpm, is determined at the release of in the phosphate buffer of pH3.5 two hours, then the release profiles of six hours in the phosphate buffer being determined at pH6.8.
Compared to existing technology, enteric-coated sustained-release tablet of the upper acceptable salt of fenofibric acid provided by the invention or its physiology and preparation method thereof, technique is simple, good stability, and production efficiency is high, the high and better effects if of the product bioavailability made.In addition, preparation method of the present invention reaches the object of enteric slow release by conventional pharmaceutic adjuvant and wet granulation, tabletting, art for coating.The equipment that the method adopts is common mixer-granulator, tablet machine and seed-coating machine, such as Glatt VG10 mixing granulation machine, Fitow p2020 tablet machine, GlattGMPC II type coating pan etc.
Accompanying drawing explanation
Fig. 1: the release profiles of product in the phosphate buffer of pH3.5 of embodiment 3 ~ 6.
Fig. 2: the release profiles of product in the phosphate buffer of pH6.8 of embodiment 1 ~ 6.
Detailed description of the invention
By following specific embodiment, reader can be helped better to understand the present invention, but following example can not be interpreted as limiting the present invention.
Embodiment 1:
| Material | Mg/ sheet | Ratio |
| Choline fenofibric acid | 178.69 | 59.57% |
| Hypromellose (K100LV) (slow-release material) | 37 | 12.33% |
| Hypromellose (E50) (slow-release material) | 31.5 | 10.50% |
| Lactose (filler) | 49.7 | 16.57% |
| Magnesium stearate (lubricant) | 3.1 | 1.03% |
| Amount to | 300.0 | 100% |
Wherein 178.69mg choline fenofibric acid is equivalent to 135mg fenofibric acid.
Preparation method:
Take each material in prescription, by the choline fenofibric acid, hypromellose (K100LV), hypromellose (E50), the lactose mix homogeneously in granulator that take.In granulator, 95% ethanol is sprayed in stirring.Obtained soft material is crossed pelletizing machine and is sieved, dry, controls pellet moisture below 3%.Recipe quantity magnesium stearate is added in above-mentioned material, mix homogeneously.With the stamping of 9mm scrobicula, obtain slow releasing tablet.
Embodiment 2:
| Material | Mg/ sheet | Ratio |
| Choline fenofibric acid | 59.57 | 57.50% |
| Hypromellose (K100LV) (slow-release material) | 18.6 | 18% |
| Hypromellose (E50) (slow-release material) | 15.5 | 15% |
| Lactose (filler) | 8.3 | 8% |
| Magnesium stearate (lubricant) | 1 | 1% |
| Amount to | 103.0 | 100% |
Wherein 59.57mg choline fenofibric acid is equivalent to 45mg fenofibric acid.
Preparation method:
Take each material in prescription, by the choline fenofibric acid, hypromellose (K100LV), hypromellose (E50), the lactose mix homogeneously in granulator that take.In granulator, 95% ethanol is sprayed in stirring.Obtained soft material is crossed pelletizing machine and is sieved, dry, controls pellet moisture below 3%.The magnesium stearate of recipe quantity is added in above-mentioned material, mix homogeneously.With the stamping of 6mm scrobicula, obtain slow releasing tablet.
Embodiment 3:
Core formulation:
| Material | Mg/ sheet | Ratio |
| Choline fenofibric acid | 178.69 | 59.57% |
| Hypromellose (K100LV) (slow-release material) | 37 | 12.33% |
| Hypromellose (E50) (slow-release material) | 31.5 | 10.50% |
| Lactose (filler) | 49.7 | 16.57% |
| Magnesium stearate (lubricant) | 3.1 | 1.03% |
| Amount to | 300.0 | 100% |
Enteric coating prescription
| Refined gram suitable (enteric-coating material) | 73.44g |
| Water | 293.76g |
| ? | Coating weight gain about 15% |
Enteric coating liquid is prepared: should join refined gram in the water of stirring, continue stirring until abundant mix homogeneously, for subsequent use.
Preparation method:
Take each material in prescription, by the choline fenofibric acid, hypromellose (K100LV), hypromellose (E50), the lactose mix homogeneously in granulator that take.In granulator, 95% ethanol is sprayed in stirring.Obtained soft material is crossed pelletizing machine and is sieved, dry, controls pellet moisture below 3%.Recipe quantity magnesium stearate is added in above-mentioned material, mix homogeneously.With the stamping of 9mm scrobicula, obtain slow releasing tablet.
Enteric layer coating: label is added in coating pan, adjustment coating pan rotating speed 12 revs/min, inlet temperature about 50 DEG C, leaving air temp about 37 DEG C, air mass flow 40m
3/ h, opens spray gun, regulates peristaltic pump speed controlling coating solution spray volume and speed, enteric layer uses 8rpm, makes slice, thin piece remain adhesion, checks coating degree at any time, can coating be stopped when reaching target weightening finish, by dry for the enteric coatel tablets wrapped, obtain enteric-coated sustained-release tablet.
Embodiment 4:
Core formulation:
| Material | Mg/ sheet | Ratio |
| Choline fenofibric acid | 178.69 | 59.57% |
| Hypromellose (K100LV) (slow-release material) | 37 | 12.33% |
| Hypromellose (E50) (slow-release material) | 31.5 | 10.50% |
| Lactose (filler) | 49.7 | 16.57% |
| Magnesium stearate (lubricant) | 3.1 | 1.03% |
| Amount to | 300.0 | 100% |
Enteric coating
| Kollicoat MAE100P(enteric-coating material) | 30.6g |
| 3% propylene glycol solution | 275.4g |
| ? | Coating weight gain 5% |
Enteric coating liquid is prepared: joined in 3% propylene glycol solution of stirring by Kollicoat MAE100P, continue stirring until abundant mix homogeneously, for subsequent use.
Preparation method:
Take each material in prescription, by the choline fenofibric acid, hypromellose (K100LV), hypromellose (E50), the lactose mix homogeneously in granulator that take.In granulator, 95% ethanol is sprayed in stirring.Obtained soft material is crossed pelletizing machine and is sieved, dry, controls pellet moisture below 3%.Recipe quantity magnesium stearate is added in above-mentioned material, mix homogeneously.With the stamping of 9mm scrobicula, obtain slow releasing tablet.
Enteric layer coating: label is added in coating pan, adjustment coating pan rotating speed 12 revs/min, inlet temperature about 50 DEG C, leaving air temp about 37 DEG C, air mass flow 40m
3/ h, opens spray gun, regulates peristaltic pump speed controlling coating solution spray volume and speed, enteric layer uses 8rpm, makes slice, thin piece remain adhesion, checks coating degree at any time, can coating be stopped when reaching target weightening finish, by dry for the enteric coatel tablets wrapped, obtain enteric-coated sustained-release tablet.
Embodiment 5:
Core formulation:
| Material | Mg/ sheet | Ratio |
| Choline fenofibric acid | 178.69 | 59.57% |
| Hypromellose (K100LV) (slow-release material) | 37 | 12.33% |
| Hypromellose (E50) (slow-release material) | 31.5 | 10.50% |
| Lactose (filler) | 49.7 | 16.57% |
| Magnesium stearate (lubricant) | 3.1 | 1.03% |
| Amount to | 300.0 | 100% |
Enteric coating prescription
| Eudragit L100-55 (enteric-coating material) | 50.4g |
| Triethyl citrate (plasticizer) | 10.8g |
| Pulvis Talci (antiplastering aid) | 23.52g |
| 95% ethanol | 915.2g |
| Water | 50.84g |
| ? | Coating weight gain 8% |
Enteric coating liquid is prepared: by second alcohol and water mix and blend, adds especially strange, triethyl citrate and Pulvis Talci successively, continues stirring until full and uniform for subsequent use.
Preparation method:
Take each material in prescription, by the choline fenofibric acid, hypromellose (K100LV), hypromellose (E50), the lactose mix homogeneously in granulator that take.In granulator, 95% ethanol is sprayed in stirring.Obtained soft material is crossed pelletizing machine and is sieved, dry, controls pellet moisture below 3%.Recipe quantity magnesium stearate is added in above-mentioned material, mix homogeneously.With the stamping of 9mm scrobicula, obtain slow releasing tablet.
Enteric layer coating: plain sheet is added in coating pan, adjustment coating pan rotating speed 12 revs/min, inlet temperature about 50 DEG C, leaving air temp about 37 DEG C, air mass flow 70m
3/ h, opens spray gun, regulates peristaltic pump speed controlling coating solution spray volume and speed, enteric layer uses 6rpm, makes slice, thin piece remain adhesion, checks coating degree at any time, can coating be stopped when reaching target weightening finish, by dry for the enteric coatel tablets wrapped, obtain enteric-coated sustained-release tablet.
Embodiment 6:
Core formulation:
| Material | Mg/ sheet | Ratio |
| Choline fenofibric acid | 178.69 | 59.57% |
| Hypromellose (K100LV) (slow-release material) | 37 | 12.33% |
| Hypromellose (E50) (slow-release material) | 31.5 | 10.50% |
| Lactose (filler) | 49.7 | 16.57% |
| Magnesium stearate (lubricant) | 3.1 | 1.03% |
| Amount to | 300.0 | 100% |
Enteric coating prescription
| Cellulose acetate succinate (enteric-coating material) | 60g |
| Polyethylene glycol 6000 (plasticizer) | 6g |
| Pulvis Talci (antiplastering aid) | 15g |
| 95% ethanol | 919g |
| ? | Coating weight gain 10% |
Enteric coating liquid is prepared: cellulose acetate succinate, polyethylene glycol 6000 and Pulvis Talci are joined successively in the ethanol of Keep agitation, be stirred to full and uniform for subsequent use.
Preparation method:
Take each material in prescription, by the choline fenofibric acid, hypromellose (K100LV), hypromellose (E50), the lactose mix homogeneously in granulator that take.In granulator, 95% ethanol is sprayed in stirring.Obtained soft material is crossed pelletizing machine and is sieved, dry, controls pellet moisture below 3%.Recipe quantity magnesium stearate is added in above-mentioned material, mix homogeneously.With the stamping of 9mm scrobicula, obtain slow releasing tablet.
Enteric layer coating: plain sheet is added in coating pan, adjustment coating pan rotating speed 12 revs/min, inlet temperature about 50 DEG C, leaving air temp about 37 DEG C, air mass flow 70m
3/ h, opens spray gun, regulates peristaltic pump speed controlling coating solution spray volume and speed, enteric layer uses 6rpm, makes slice, thin piece remain adhesion, checks coating degree at any time, can coating be stopped when reaching target weightening finish, by dry for the enteric coatel tablets wrapped, obtain enteric-coated sustained-release tablet.
The release profiles of the product of embodiment 1-6 is detected above by the drug release determination method illustrated.Result as illustrated in fig. 1 and 2.Fig. 1 is the release profiles of product in the phosphate buffer of pH3.5 of embodiment 3-6, and Fig. 2 is the release profiles of product in the phosphate buffer of pH6.8 of embodiment 1-6.Fig. 1 shows that the product of embodiment 3 ~ 6 at the low ph all can play good antiacid effect, reaches the enteric effect of expection.Fig. 2 shows that the product of embodiment 3 ~ 6 can slow releasing under high ph-values (pH6.8) condition, reaches the effect of slow release.
The product of embodiment 6 is adopted PVC/PVDC/Al blister package, and products obtained therefrom is placed in 40 DEG C, under 92.5%RH condition, investigates the stability of 1,2,3,6 month.Result refers to following table, and product property does not have significant change compared with 0 month.(wherein content is in fenofibric acid, and release measures in the phosphate-buffered salt of pH6.8 by the drug release determination method illustrated above)
| Time | 0 month | January | February | March | June |
| Content | 99.2% | 98.5% | 98.2% | 98.0% | 98.1% |
| Total impurities | 0.63% | 0.70% | 0.75% | 0.82% | 0.91% |
| 0.5 hour release | 21% | 23% | 20% | 21% | 24% |
| 1.5 hours releases | 51% | 53% | 52% | 54% | 55% |
| 6 hours releases | 99% | 98% | 100% | 99% | 100% |
| Acid-resisting | Qualified | Qualified | Qualified | Qualified | Qualified |
Claims (11)
1. an enteric-coated sustained-release tablet for fenofibric acid or the upper acceptable salt of its physiology, is grouped into by the one-tenth of following percentage by weight:
Wherein, the percentage by weight of described fenofibric acid or the upper acceptable salt of its physiology calculates with fenofibric acid;
Described slow-release material is selected from hypromellose, hydroxypropyl cellulose, methylcellulose, ethyl cellulose, polyvinylpyrrolidone, carbomer, arabic gum, the combination of one or more wherein;
Described filler is selected from lactose, microcrystalline Cellulose, starch, mannitol, pregelatinized Starch, Icing Sugar, dextrin, calcium hydrogen phosphate, the combination of one or more wherein;
Described lubricant is selected from Pulvis Talci, magnesium stearate, sodium stearyl fumarate, stearic acid, calcium stearate, the combination of one or more wherein;
Described enteric-coating material be selected from cellulose phthalate, cellulose acetate succinate, Eudragit L100-55, especially strange L30D-55, especially strange L100, especially strange S100, refined gram should, polyvinyl acetate phthalic acid ester, Kollicoat MAE 100P, Kollicoat MAE 30DP, wherein one or more combination;
Described plasticizer is selected from triethyl citrate, polyethylene glycol 6000, tributyl citrate, the combination of one or more wherein;
Described antiplastering aid is selected from Pulvis Talci, silicon dioxide.
2. enteric soluble coating slow releasing sheet as claimed in claim 1, wherein, described slow-release material is hypromellose.
3. enteric soluble coating slow releasing sheet as claimed in claim 2, wherein, described slow-release material is hypromellose E50 or hypromellose K100LV.
4. enteric-coated sustained-release tablet as claimed in claim 1, wherein, described filler is lactose.
5. enteric-coated sustained-release tablet as claimed in claim 1, wherein, described lubricant is magnesium stearate.
6. enteric-coated sustained-release tablet as claimed in claim 1, wherein, described enteric-coating material be refined gram suitable.
7. enteric-coated sustained-release tablet as claimed in claim 1, wherein, described antiplastering aid is Pulvis Talci.
8. enteric-coated sustained-release tablet as claimed in claim 1, is grouped into by the one-tenth of following percentage by weight:
Wherein, the percentage by weight of choline fenofibric acid calculates with fenofibric acid;
Described slow-release material is selected from hypromellose;
Described filler is selected from lactose;
Described lubricant is selected from Pulvis Talci, magnesium stearate, sodium stearyl fumarate, stearic acid, calcium stearate, the combination of one or more wherein;
Described antiplastering aid is selected from Pulvis Talci;
Described enteric-coating material be selected from cellulose phthalate, cellulose acetate succinate, Eudragit L100-55, especially strange L30D-55, especially strange L100, especially strange S100, refined gram should, polyvinyl acetate phthalic acid ester, Kollicoat MAE 100P, Kollicoat MAE 30DP, wherein one or more combination;
Described plasticizer is selected from triethyl citrate, polyethylene glycol 6000, tributyl citrate, the combination of one or more wherein.
9. enteric-coated sustained-release tablet as claimed in claim 8, wherein, described lubricant is magnesium stearate.
10. enteric-coated sustained-release tablet as claimed in claim 8, wherein, described enteric-coating material be refined gram suitable.
The preparation method of 11. enteric-coated sustained-release tablets according to claim 1, comprises the following steps:
(1) by fenofibric acid or its physiology above acceptable salt, slow-release material, filler mixing, carry out granulation and obtain wet granular;
(2) wet granular is carried out drying and obtain dry granule;
(3) dry granule and lubricant are carried out being mixed to get mixed granule;
(4) mixed granule tabletted is obtained slow releasing tablet;
(5) in slow releasing tablet with enteric-coating material and optional plasticizer and/or antiplastering aid is enteric coated obtains enteric-coated sustained-release tablet.
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| CN201310039397.0A CN103083275B (en) | 2013-01-31 | 2013-01-31 | Enteric coated tablet of fenofibric acid and physiologically acceptable salts and preparation method of enteric coated tablet |
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| CN105769807B (en) * | 2014-12-20 | 2019-03-15 | 长春海悦药业股份有限公司 | A kind of pharmaceutical composition containing Fenofibric Acid choline |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101791353A (en) * | 2010-04-29 | 2010-08-04 | 广东药学院 | Sustained-release matrix type compound Chuanping sustained-release tablet and preparation method and application thereof |
| CN102641254A (en) * | 2012-05-07 | 2012-08-22 | 山东新华制药股份有限公司 | Preparation method of aspirin enteric-coated sustained-release preparation |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101791353A (en) * | 2010-04-29 | 2010-08-04 | 广东药学院 | Sustained-release matrix type compound Chuanping sustained-release tablet and preparation method and application thereof |
| CN102641254A (en) * | 2012-05-07 | 2012-08-22 | 山东新华制药股份有限公司 | Preparation method of aspirin enteric-coated sustained-release preparation |
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Application publication date: 20130508 Assignee: Jiangsu Coast pharmaceutcal corporation, Ltd Assignor: Yangtze River Pharmaceutical Co., Ltd. Contract record no.: 2016320010006 Denomination of invention: Enteric coated tablet of fenofibric acid and physiologically acceptable salts and preparation method of enteric coated tablet Granted publication date: 20150114 License type: Exclusive License Record date: 20160224 |
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