CN101721385A - Mesalazine oral controlled release medicine composition - Google Patents
Mesalazine oral controlled release medicine composition Download PDFInfo
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- CN101721385A CN101721385A CN200810232858A CN200810232858A CN101721385A CN 101721385 A CN101721385 A CN 101721385A CN 200810232858 A CN200810232858 A CN 200810232858A CN 200810232858 A CN200810232858 A CN 200810232858A CN 101721385 A CN101721385 A CN 101721385A
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Abstract
The invention relates to a mesalazine oral colon-targeted sustained release medicine composition which is characterized by containing: (a) a sustained release table core containing mesalazine or medicinal salts or solvates thereof and hydrophilic stroma, wherein the mesalazine or the medicine salts thereof are dispersed in the hydrophilic stroma; and (b) a coating wrapped outside the table core and containing acid-resistant materials; wherein the one-hour release of the composition in simulated intestinal fluid with the pH of 7.2 is less than 20 percent, the four-hour release thereof is 30-60 percent, and the eight-hour release thereof is greater than 70 percent. The composition has simple manufacturing process and low cost, slowly releases the mesalazine in small intestines and colons, and achieves the colon-targeted medicine delivery once a day and the local curative effect.
Description
Technical field
The invention belongs to field of pharmaceutical preparations, be specifically related to the segmented intestine targeted sustained release pharmaceutical composition of Mesalazine oral, the controlled release label that contains mesalazine or its pharmaceutical salts or its solvate and hydrophilic matrix, label external packets one deck contains the coating of acid resisting material, said composition discharged less than 20% in the simulated intestinal fluid of pH7.2 in 1 hour, discharged 30-60% in 4 hours, discharged greater than 70% in 8 hours.Said composition discharges mesalazine gradually at small intestinal and colon, is used for the colitis of intestinal target administration treatment once-a-day.
Background technology
Inflammatory enteritis is the general designation of ulcerative conjunctivitis and Crohn disease, and their totals have influence on 0.5～1.0% of west population, and the U.S. has more than 1,000,000 approximately, and there are 4,000,000 patients of surpassing in the whole world.Chinese sickness rate was about 40,/10 ten thousand in 2004.Ulcerative colitis is a kind of knot, rectal mucosal diffuse inflammation, and its clinical characters is agnogenic, in-and-out stomachache, diarrhoea, mucopurulent bloody stool.In recent years should the disease sickness rate have and obviously increase trend, be subjected to the generally attention of medical circle.Sickness rate has and obviously increases trend, and according to World Health Organization's statistics, Chinese sickness rate was about 40,/10 ten thousand in 2004.
Mesalazine (5-aminosalicylic acid) is the classical medication of treatment inflammation colitis.The product of listing has mesalazine delayed-release tablet Asacol and mesalazine delayed-release tablet Pentasa at present, and mesalazine slow releasing tablet Lialda.Asacol adopts Eudragit S100 coating, one day oral 3-4 time, no slow releasing function; Pentasa adopts ethyl cellulose coating, one day oral 3-4 time; Lialda is the mesalazine slow releasing preparation that adopts the MMX technology, only needs once, and is characterized in adopting close ester and hydrophilic two kinds of materials as substrate in one day, but its arts demand adopts the technology of melt granulation, its complicated process of preparation needs the special installation of melt granulation, and production cost is higher.
Chinese patent CN1568954 discloses a kind of mesalazine colon positioning release pellet preparations and preparation method thereof, and it has to absorb on gastrointestinal tract lacks, and keeps the characteristics of the effective drug level of pathological changes intestinal segment.It is to be effective pharmaceutical component in conjunction with the site-specific drug delivery mini-pill of excipient and diluent preparation with mesalazine.Wherein the percentage by weight of mesalazine, excipient, diluent composition is as follows: mesalazine 300-600 weight portion, excipient 100-300 weight portion, diluent 50-200 weight portion.Excipient is a microcrystalline Cellulose, and diluent is starch, dextrin etc.To sieve mix homogeneously behind medicine and excipient, the diluent pulverize separately.The system soft material is extruded wet micropill and is got the ball core, hands over ball core coating, with hot-air dry promptly.
WO0076478 (Cosmer S.R.L), disclose and contained the controlled release oral pharmaceutical compositions of 5-aminosalicylic acid as active component, employing is lower than 90 ℃ material by fusing point and forms, wherein be inclusive with the inside lipotropy substrate of active component to small part, wherein be dispersed with the tablet that lipotropy substrate and outside hydrophilic matrix and optional other excipient are made, this sheet is also by the acid proof polymer coating of bag one deck.This coating is immersed in and is released into many 90% activating agent in the simulated intestinal fluid after 8 hours.The embodiment of this patent shows, adopts the technology of hot melt extrusion granulator, the equipment that needs hot melt to granulate in the production.
The inventor is through a large amount of tests, the intestinal targeting mesalazine controlled release pharmaceutical compositions that obtains, only pass through wet granulation technology, mesalazine is dispersed in the hydrophilic substrate, do not need by fused granulation, by general equipment, low-cost just can have the mesalazine controlled release tablet of good external slow release release behavior in preparing the simulation colonic fluid.
Summary of the invention
The invention provides a kind of Mesalazine oral controlled release compositions, it is characterized in that:
A) contain the controlled release label of mesalazine or its pharmaceutical salts or its solvate and hydrophilic matrix, wherein, mesalazine or its pharmaceutical salts are scattered in the hydrophilic matrix;
B) label external packets one deck contains the coating of acid resisting material;
C) release in 1 hour in the simulated intestinal fluid of pH7.2 of described compositions discharged 30-60% less than 20%, 4 hour, discharged greater than 70% in 8 hours.
Compositions of the present invention, its label adopts single hydrophilic matrix, can be provided in small intestinal or/and the pharmaceutical composition of colon position sustained release, it specifically can be pharmaceutical composition as slow release, or the pharmaceutical composition of zero level release, according to the linear equation match, regression coefficient is more than 0.98.
The present invention also provides a kind of high-load mesalazine tablet, and the content of single dose mesalazine reaches as high as 95%.
Mesalazine oral controlled release compositions of the present invention, wherein, mesalazine or the weight content of its officinal salt in described compositions are 50-95%, preferred 70-95%, more preferably 80-95%, wherein, said weight is the weight in label.
Mesalazine oral controlled release compositions of the present invention, wherein said hydrophilic matrix mainly is made up of the chemical compound that forms hydrogel, this chemical compound is selected from one or more in the following material: the polymer of acrylic or methacrylic acid or copolymer, the alkyl vinyl polymer, hydroxy alkyl cellulose, carboxyalkyl cellulose, polysaccharide, dextrin, pectin, starch and derivant thereof, alginic acid, natural or synthetic natural gum, polyvinylpyrrolidone and carbomer, preferred hydroxy alkyl cellulose, carboxyalkyl cellulose, the polymer of starch and derivant and acrylic or methacrylic acid or copolymer, wherein, said hydroxy alkyl cellulose is hydroxypropyl emthylcellulose (HPMC), hydroxypropyl cellulose or hydroxyethyl-cellulose, carboxyalkyl cellulose is a Sodium Tvlose, starch derivatives is a carboxymethyl starch sodium, and the polymer of acrylic or methacrylic acid or copolymer are Eudragit L100 or Eudragit S100.Here said " multiple " is meant two kinds, more than three kinds or three kinds, promptly contains two kinds, the chemical compound that can form hydrogel more than three kinds or three kinds.
Mesalazine oral controlled release compositions of the present invention, the preferred chemical compound that forms hydrogel is hydroxypropyl emthylcellulose, hydroxypropyl cellulose, hydroxyethyl-cellulose, carboxymethyl starch sodium, Sodium Tvlose, polyacrylic resin II number or III number (Eudragit L100 and Eudragit S100), carbomer, polyvinylpyrrolidone or their mixture, more preferably hydroxypropyl emthylcellulose, carboxymethyl starch sodium, Sodium Tvlose, carbomer, Eudragit S100 are selected from a kind of in them or two or more.
Mesalazine oral controlled release compositions of the present invention when essential, also can comprise other pharmaceutically acceptable other adjuvant: binding agent such as water, polyvidone etc., lubricant such as Pulvis Talci, magnesium stearate etc., filler such as dextran, starch etc. in the hydrophilic matrix.
Mesalazine oral controlled release compositions of the present invention, wherein, said acid resisting material is selected from: the polymer of acrylic or methacrylic acid or copolymer, fiber-like derivant (as acetyl cellulose phthalate etc.), the chemical compound of preferred acid resisting material is the polymer or the copolymer of acrylic or methacrylic acid, the polymer of said acrylic or methacrylic acid or copolymer are polyacrylic resin III number, polyacrylic resin II number or its mixture, as Eudragit S100, Eudragit L100, the mixture of Eudragit S100 and Eudragit L100, the mixture of preferred Eudragit S100 or Eudragit S100 and EudragitL100, when selecting the mixture of Eudragit S100 and Eudragit L100 for use, Eudragit L100 can be any ratio with the ratio of Eudragit S100, may be selected to be 1: 0.5-1: 4, preferred 1: 1-1: 3 more preferably 1: 1-1: 2 or 1: 0.5-1: 2.
Said coating of the present invention also further comprises other adjuvant, as an amount of coloring agent, cover photo etching, plasticizer or their mixture, here said is the consumption of this area routine in right amount, said coloring agent, covers adjuvant that photo etching, plasticizer all are this area routines such as aluminium hydroxide, Pulvis Talci, iron oxide red, titanium dioxide, triacetin, triethyl citrate, phthalic acid ester, PEG etc.
Mesalazine oral controlled release compositions of the present invention is a kind of main enteric controlled-release preparation at the slow release of active agent in intestinal position, the mesalazine that is scattered in the hydrophilic matrix (hydrogel matrix) spreads in the substrate water-setting glue that slowly imbibition forms, thereby slowly is discharged into small intestinal to the intestinal juice at colon position and reach local therapeutic effects.Be administered once in 1st, and compared with ordinary tablet, reduce administration number of times, improve the compliance of patient's long-term prescription, the controlled release preparation Lialda once-a-day that goes on the market with the U.S. compares, and manufacturing process is simple, and cost is low, reaches identical at least therapeutic effect.
The concrete scheme that realizes Mesalazine oral controlled release compositions of the present invention is as follows:
The preparation of label, the main technology that adopts is wet granulation technology, is the tablet manufacturing technology of this area routine.As mesalazine or its officinal salt is even with the compound that can form hydrogel, the adding distilled water is an amount of, granulates drying; Add lubricant, mix homogeneously or be uniformly dispersed is measured granule content, and tabletting obtains label.
The preparation of coating solution, adopt the compound method preparation of the conventional coating solution in this area: acid proof polymer be dissolved in or be dispersed in the solvent, can add the coloring agent that ground as required again and/or cover photo etching and/or plasticizer, stir coating solution.
Coating: adopt high-efficiency coating machine that coating solution is applied to sheet nuclear surface, make sheet nuclear weightening finish 5-8%, promptly get the Mesalazine oral controlled release compositions.
In the such scheme, lubricant can be magnesium stearate or Pulvis Talci, solvent can be water, with the miscible organic solvent of water such as ethanol, acetone, or their mixed solvent.Said coloring agent, cover adjuvant that photo etching, plasticizer all are this area routines such as aluminium hydroxide, Pulvis Talci, iron oxide red, titanium dioxide, triacetin, triethyl citrate, phthalic acid ester, PEG etc., preferably talc powder, iron oxide red, titanium dioxide, triethyl citrate.
The mensuration of release in vitro degree:
Compositions of the present invention discharges in the simulated intestinal fluid of pH7.2, discharges less than 20%, 4 hour release 30-60% in 1 hour, discharged greater than 70% in 8 hours,
Discharge in the simulated intestinal fluid of the pH7.2 of being released in of the present invention, release conditions is: the phosphate buffer 900ml of pH7.2, slurry method, rotating speed, 50r/min, temperature: 36.5-37.5.
Mesalazine oral controlled release compositions of the present invention is an enteric-coated sustained-release tablet once-a-day, and every contains mesalazine 1.2g, and this sheet mainly is being positioned at small intestinal to colon or only at the slow release of active agent mesalazine at colon position.Utilize coating in the dissolving of small intestinal or colon position, intestinal juice immerses mainly in the slow releasing tablet of being made up of hydrophilic matrix, forms the water-setting glue, and mesalazine slowly discharges from hydrogel, directly acts on the colon position, treats colitis.External dissolution test proves that mesalazine oral controlled release compositions of the present invention (tablet) has good linear release profiles, wait at least when in or be better than listing product Lialda.
Description of drawings
Figure is the release curve of mesalazine controlled release pharmaceutical compositions.
Specific embodiment
Following embodiment is used for explaining that further this is bright, is not represent that the present invention only limits to following examples.
Embodiment 1:
The label prescription:
Mesalazine 1200g
Sodium carboxymethyl cellulose 96g
Carboxymethyl starch sodium 48g
Magnesium stearate 13.4g
1000
The preparation technology of label: mesalazine, sodium carboxymethyl cellulose, carboxymethyl starch sodium mix homogeneously, the adding distilled water is an amount of, granulates drying.Add magnesium stearate, mix homogeneously is measured granule content, tabletting, every drug content 1.2g.
Coating fluid prescription:
Coating material weight
Eudragit?S100 200g
Eudragit?L100 100g
Triethyl citrate 60g
Pulvis Talci 10g
Titanium dioxide 30g
Iron oxide red 30g
Ethanol 4750ml
Water 250ml
Art for coating: prepare above coating solution according to a conventional method, high-efficiency coating machine coated cores, coating weightening finish 5-8%.
The label prescription
Mesalazine 1200g
Hydroxypropyl methylcellulose K 100 80g
Carboxymethyl starch sodium 30g
Magnesium stearate 13.0g
1000
Label preparation technology: mesalazine, hypromellose K100 are even, and it is an amount of to add distilled water, granulates drying.Add magnesium stearate, mix homogeneously is measured granule content, tabletting, every drug content 1.2g.
Coating fluid prescription:
Coating material weight
Eudragit?S100 300g
Triethyl citrate 60g
Pulvis Talci 6g
Titanium dioxide 30g
Iron oxide red 30g
Ethanol 4750ml
Water 250ml
Art for coating: prepare above coating solution according to a conventional method, adopt the high-efficiency coating machine coating, coating weightening finish 3-6%.
The label prescription:
Mesalazine 1200g
Carbomer 971 25g
Dextran-40 75g
Magnesium stearate 13.0g
1000
The preparation technology of label: mesalazine, carbomer 971, dextran-40, to add distilled water an amount of, granulates drying.Add magnesium stearate, mix homogeneously is measured granule content, tabletting, every drug content 1.2g.
Coating fluid prescription:
Coating material weight
Eudragit?S100 200g
Eudragit?L100 150g
Triethyl citrate 60g
Pulvis Talci 6g
Titanium dioxide 30g
Iron oxide red 30g
Ethanol 4750ml
Water 250ml
Art for coating: prepare above coating solution according to a conventional method, high-efficiency coating machine coating, coating weightening finish 4-8%
The label prescription:
Mesalazine 1200g
Eudragit?L100 15g
Pectin 45g
Polyvinylpyrrolidone 80g
Magnesium stearate 13.1g
1000
Label preparation technology: mesalazine, Eudragit L100, pectin, polyvinylpyrrolidone mix homogeneously, the adding distilled water is an amount of, granulates drying.Add magnesium stearate, mix homogeneously is measured granule content, tabletting, every drug content 1.2g.
Coating fluid prescription:
Coating material weight
Eudragit?S100 300g
Triethyl citrate 60g
Pulvis Talci 7g
Titanium dioxide 20g
Iron oxide red 20g
Ethanol 4750ml
Water 250ml
Art for coating: prepare above coating solution according to a conventional method, high-efficiency coating machine coating, coating weightening finish 3-5%.
Embodiment 5
The label prescription
Mesalazine 600g
Hydroxypropyl methylcellulose E5 300g
Magnesium stearate 13.0g
1000
Label preparation technology: mesalazine, hypromellose E5 mix homogeneously, the adding distilled water is an amount of, granulates drying.Add magnesium stearate, mix homogeneously is measured granule content, tabletting, every drug content 0.6g.
Coating fluid prescription
Coating material weight
Eudragit?S100 150g
Eudragit?L100 100g
Triethyl citrate 60g
Pulvis Talci 10g
Titanium dioxide 30g
Iron oxide red 30g
Ethanol 4750ml
Water 250ml
Art for coating: method is routinely prepared above coating solution, high-efficiency coating machine coating, coating weightening finish 3-5%.
The mensuration of release
With the sample of embodiment 1-5, in the phosphate medium of 900ml pH7.2, slurry method, 50r/min did release for 37 ℃, respectively at 1 hour, 2 hours, 4 hours and sampling in 8 hours, measure its release, release profiles and linear equation thereof and regression coefficient are as Figure 1-1.
The linear equation of embodiment 1 and regression coefficient: y=12.255t-3.7888 R
2=0.9948;
The linear equation of embodiment 2 and regression coefficient: y=12.719t-0.9425 R
2=0.9972
The linear equation of embodiment 3 and regression coefficient: y=11.946t-1.8879 R
2=0.9988
The linear equation of embodiment 4 and regression coefficient: y=10.853t-3.8175 R2=0.9928
The linear equation of embodiment 5 and regression coefficient: y=11.832t-3.0772 R2=0.9943
The linear equation of Lialda and regression coefficient: y=12.021t-5.0737 R
2=0.9908
Y: release (%); T: time (h)
As seen, have good release in vitro behavior by mesalazine controlled release tablet of the present invention, release profiles has favorable linearity, is zero level and discharges.
Comprehensively above-mentioned, technology of the present invention is simple, does not need special equipment, and general tablet manufacturing line can both be produced; Be fit to suitability for industrialized production.The present invention simultaneously has favorable linearity and good release behavior in simulated intestinal fluid.
Claims (12)
1. Mesalazine oral tablet controlled release composition is characterized in that comprising:
A) contain the controlled release label of mesalazine or its pharmaceutical salts or its solvate and hydrophilic matrix, wherein mesalazine or its pharmaceutical salts are scattered in the hydrophilic matrix;
B) contain the coating of acid resisting material at label external packets one deck;
C) release in 1 hour in the simulated intestinal fluid of pH7.2 of described compositions discharged 30-60% less than 20%, 4 hour, discharged greater than 70% in 8 hours.
2. compositions according to claim 1, wherein the weight content of mesalazine in described compositions is 50-95%.
3. require 2 described compositionss according to aforesaid right, the content of mesalazine or its pharmaceutical salts or its solvate is 70-95%.
4. compositions according to claim 1, wherein said hydrophilic matrix mainly is made up of the chemical compound that forms hydrogel.
5. compositions according to claim 4, the chemical compound of wherein said formation hydrogel is selected from one or more in the following material: the polymer of acrylic or methacrylic acid or copolymer, alkyl vinyl polymer, hydroxy alkyl cellulose, carboxyalkyl cellulose, polyvinylpyrrolidone, dextrin, pectin, starch and derivant thereof, alginic acid, carbomer.
6. compositions according to claim 5, the chemical compound of wherein said formation hydrogel is selected from one or more: the polymer of hydroxy alkyl cellulose, carboxyalkyl cellulose, starch or derivatives thereof, acrylic or methacrylic acid or copolymer and carbomer.
7. compositions according to claim 6, wherein said hydroxy alkyl cellulose is a hydroxypropyl methylcellulose; Carboxyalkyl cellulose is a Sodium Tvlose, and starch derivatives is a carboxymethyl starch sodium, and the polymer of acrylic or methacrylic acid or copolymer are Eudragit L100, Eudragit S100 or their mixture.
8. compositions according to claim 1, said acid resisting material is: the polymer of acrylic or methacrylic acid or copolymer, or fiber-like derivant.
9. compositions according to claim 8, said acid resisting material are the polymer or the copolymer of acrylic or methacrylic acid.
10. compositions according to claim 8, the polymer of said acrylic or methacrylic acid or copolymer are EudragitS100, Eudragit L100 or its mixture.
11. compositions according to claim 1, said coating also further comprise an amount of coloring agent, cover photo etching, plasticizer or their mixture.
12. according to claim 1 compositions, acid resisting material coating weightening finish 3-8%.
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|---|---|---|---|
| CN200810232858A CN101721385B (en) | 2008-10-13 | 2008-10-13 | Mesalazine oral controlled release medicine composition |
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Cited By (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102784154A (en) * | 2012-09-01 | 2012-11-21 | 朱文军 | Mesalazine enteric coatel tablet and preparation method thereof |
| CN104922090A (en) * | 2015-07-03 | 2015-09-23 | 湖南方盛制药股份有限公司 | Mesalazine enteric-coated sustained-release pellet and preparation method thereof |
| CN105616386A (en) * | 2016-01-21 | 2016-06-01 | 贝沃特医药技术(上海)有限公司 | Pellet preparation for treating delayed and extended release of intestinal diseases and preparation method of pellet preparation |
| CN105828807A (en) * | 2013-12-11 | 2016-08-03 | 莫戈恩药物有限公司 | Modified-release therapeutic systems for oral administration of menthol in the treatment of intestinal disorders |
| WO2017084486A1 (en) * | 2015-11-19 | 2017-05-26 | 北京罗诺强施医药技术研发中心有限公司 | Simple preparation method for high drug-loading capacity sustained release preparation for treating colitis and crohn's disease |
| CN112315929A (en) * | 2019-07-20 | 2021-02-05 | 辽宁华瑞联合制药有限公司 | Composition of four-layer coating system mesalazine enteric-coated tablet and preparation method thereof |
Family Cites Families (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN100571694C (en) * | 2004-04-26 | 2009-12-23 | 沈阳药科大学 | Mesalazine colon positioning release pellet preparations and preparation method thereof |
| CN100562322C (en) * | 2005-08-11 | 2009-11-25 | 中国科学院过程工程研究所 | Colon targeting preparation of a kind of 5-aminosalicylic acid and preparation method thereof |
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2008
- 2008-10-13 CN CN200810232858A patent/CN101721385B/en active Active
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN102784154A (en) * | 2012-09-01 | 2012-11-21 | 朱文军 | Mesalazine enteric coatel tablet and preparation method thereof |
| CN105828807A (en) * | 2013-12-11 | 2016-08-03 | 莫戈恩药物有限公司 | Modified-release therapeutic systems for oral administration of menthol in the treatment of intestinal disorders |
| CN105828807B (en) * | 2013-12-11 | 2021-02-02 | 莫戈恩药物有限公司 | Modified release therapeutic system for oral administration of menthol in the treatment of intestinal disorders |
| CN104922090A (en) * | 2015-07-03 | 2015-09-23 | 湖南方盛制药股份有限公司 | Mesalazine enteric-coated sustained-release pellet and preparation method thereof |
| CN104922090B (en) * | 2015-07-03 | 2017-11-14 | 湖南方盛制药股份有限公司 | Mesalazine enteric sustained-release pellet |
| WO2017084486A1 (en) * | 2015-11-19 | 2017-05-26 | 北京罗诺强施医药技术研发中心有限公司 | Simple preparation method for high drug-loading capacity sustained release preparation for treating colitis and crohn's disease |
| CN105616386A (en) * | 2016-01-21 | 2016-06-01 | 贝沃特医药技术(上海)有限公司 | Pellet preparation for treating delayed and extended release of intestinal diseases and preparation method of pellet preparation |
| CN105616386B (en) * | 2016-01-21 | 2018-11-09 | 贝沃特医药技术(上海)有限公司 | It is a kind of to treat delaying with the pellet preparations of extended release and preparation method thereof for enteropathy |
| CN112315929A (en) * | 2019-07-20 | 2021-02-05 | 辽宁华瑞联合制药有限公司 | Composition of four-layer coating system mesalazine enteric-coated tablet and preparation method thereof |
| CN112315929B (en) * | 2019-07-20 | 2022-10-28 | 辽宁华瑞联合制药有限公司 | Composition of four-layer coating system mesalazine enteric-coated tablet and preparation method thereof |
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| CN101721385B (en) | 2012-10-24 |
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