CN101108171A - Budesonide intestines sustained release dextromethorphan pellets and method of manufacturing the same - Google Patents
Budesonide intestines sustained release dextromethorphan pellets and method of manufacturing the same Download PDFInfo
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- CN101108171A CN101108171A CNA200610029025XA CN200610029025A CN101108171A CN 101108171 A CN101108171 A CN 101108171A CN A200610029025X A CNA200610029025X A CN A200610029025XA CN 200610029025 A CN200610029025 A CN 200610029025A CN 101108171 A CN101108171 A CN 101108171A
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Abstract
The invention belongs to the technical field of medicinal preparation and relates to an enteric preparation and sustained or controlled release preparation, in particular to an enteric controlled release micro-granule with budesonide and its preparation method. The invention, which comprises a quick release celphere, a controlled release layer and an enteric layer, takes budesonide as active ingredient of the drug to coordinate with medicinal carrier supplementary materials. After the release level testing, it is proved that the enteric controlled release micro-granule, which adopts different enteric materials, controlled release material and different coating conditions, does not release in stomach but began to release slowly after entering the small intestine with even release level. Therefore, the enteric controlled release micro-granule in the invention can effectively prevent the release in stomach, ensure the slow release in small intestine and the release of drug in the affected section of small incestine, ileocecus and colon.
Description
Technical field
The invention belongs to field of pharmaceutical preparations, relate to medicament enteric-coated formulation and sustained-release preparation, be specifically related to a kind of enteric sustained-release pellet that contains budesonide and preparation method thereof.
Background technology
Budesonide (Budesonide) is a kind of non-halogeno-sugar 17-hydroxy-11-dehydrocorticosterone with efficient local anti-inflammatory effect, has the effect of antiinflammatory, antiallergic, antipruritic and exudation.The aerosol of budesonide, spray, powder spray etc. are widely used in the bronchial asthma and the asthmatic bronchitis of glucocorticoid dependence or dependent/non-dependent clinically, and October calendar year 2001, the capsule of its enteric coated micropill of drugs approved by FDA was used to keep that treatment relates to ileum and/or colon ascendens light, moderate Crohn disease is the Crohn disease.In addition, there are some researches show budesonide in the treatment ulcerative colitis, the effect of inflammatory bowel aspects such as collagenous colitis is worth certainly.
The Crohn disease is a kind of chronic granulomatous inflammation, and pathological changes is saltatory segmental, asymmetry and saturating wall more, all may take place at any position of digestive tract, sees that so that small intestinal more (wherein 60% involves terminal ileum 10～20cm) to account for 70%; The colon affected individual accounts for 30%; Small intestinal and colon affected individual simultaneously account for 30%.Clinical stomachache, diarrhoea, fistula, anus pathological changes and the General Symptoms in various degree of mainly showing as.
Ulcerative colitis is a kind of chronic nonspecific colitis disease, and ulcer takes place weight person, and pathological changes is mainly involved mucous membrane of colon and tela submucosa; Scope is many to begin from section colon far away, can drive in the wrong direction near section development, even involve total colectomy and latter end ileum, is seriality and distributes; Clinical diarrhoea, stomachache and the mucopurulent bloody stool of mainly showing as.
The clinical treatment of above-mentioned disease requires pharmaceutical preparation not release under one's belt, enter small intestinal and begin slow release again, and most of medicine should be in affected area releases such as small intestine distal end, ileocecus, colons, the performance local therapeutic effects.At present the domestic market does not still have the budesonide enteric-coated sustained-release preparation, if the external similar medicine of import, then cost is too high, cost an arm and a leg and clinical effectiveness not as can be known yet.
Summary of the invention
The purpose of this invention is to provide a kind of budesonide enteric sustained-release pellet that can satisfy the clinical treatment requirement, this micropill can not release in simulated gastric fluid, change simulated intestinal fluid over to and just begin slow release, can guarantee most of medicine at affected area release medicines such as small intestine distal end, ileocecus, colons, the performance local therapeutic effects.
Further purpose of the present invention provides the preparation method of this enteric sustained-release pellet.
The said budesonide enteric sustained-release pellet of the present invention, is equipped with the pharmaceutical carrier adjuvant and forms as active constituents of medicine with budesonide.Because budesonide is insoluble in water, dissolubility is very low, and the present invention adds the dissolubility that water soluble adjuvant improves medicine, and said water soluble adjuvant is simultaneously as binding agent.
Described enteric sustained-release pellet is made up of pastille rapid release ball core, slow release layer and enteric layer three parts from inside to outside.Wherein:
The adjuvant that pastille rapid release ball core is selected for use has: filler is lactose, sucrose, starch and/or microcrystalline Cellulose; Binding agent is lactose, sucrose, methylcellulose, hypromellose, polyvinylpyrrolidone and/or Polyethylene Glycol; Lubricant is magnesium stearate, stearic acid, colloidal silica or Pulvis Talci;
The adjuvant that slow release layer is selected for use has: blocker is an ethyl cellulose; Porogen is polyethylene glycols, lactose, sucrose, hypromellose, polyvinylpyrrolidone, sodium lauryl sulphate, Tween 80, Pulvis Talci or silicon dioxide; Plasticizer is triethyl citrate, tributyl citrate, dibutyl sebacate, dimethyl phthalate, diethyl phthalate, dibutyl phthalate, polyethylene glycols or hypromellose; Antiplastering aid is Pulvis Talci, magnesium stearate or glyceryl monostearate.
Selecting polyacrylic resin class (Eudragit L, Eudragit S, Eudragit FS), cellulose acetate phthalate ester, polyvinyl acetate phthalic acid ester, phthalic acid hypromellose ester or succinic acid acetic acid hydroxypropyl methylcellulose in the enteric layer for use is enteric material; Selecting triethyl citrate, tributyl citrate, dibutyl sebacate, dimethyl phthalate, diethyl phthalate, dibutyl phthalate, polyethylene glycols or hypromellose for use is plasticizer; Selecting Pulvis Talci, magnesium stearate or glyceryl monostearate for use is antiplastering aid.
The active constituents of medicine of enteric sustained-release pellet of the present invention and pharmaceutical carrier are by following weight proportion, wherein:
(1) pastille rapid release ball core
Budesonide 0.1-3%
Filler 10-80%
Binding agent 2-20%
Lubricant 5-15%
(2) slow release layer clothing film composition
Blocker 50-80%
Porogen 6-30%
Plasticizer 2-8%
Antiplastering aid 10-20%
(3) enteric layer clothing film composition
Enteric material 60-80%
Plasticizer 5-10%
Antiplastering aid 15-35%
Prepare by following method and step:
(1) preparation pastille rapid release ball core
With the filler mix homogeneously; add binding agent; play female also pill-rolling to required order with comminutor or coating pan and count the 15-30 order; pill-rolling limit, limit adds lubricant; oven dry makes the blank micropill of smooth ball, adds medicine to air suspension fluidized bed coating or pan coating method on the celphere surface then; coating solution adopts medicine to add the organic solution of suitable amount of adhesive, and the gained micropill is drying to obtain pastille rapid release ball core:
Or, add binding agent and lubricant with micronized medicine and filler mix homogeneously, and preparing required order and count 15-30 purpose micropill with rolling into ball method or extruding-spheronization or centrifugal fluidized granulation method, oven dry makes smooth ball medicine carrying fast release micropill.
(2) preparation slow-release micro-pill
Pastille rapid release ball core is placed fluid bed or coating pan, the temperature of micropill is controlled at 25-40 ℃, blocker, porogen, plasticizer, antiplastering aid are mixed with the skin that mixed liquor is sprayed at pastille rapid release ball core with the ethanol of water or 30-95% make slow-release micro-pill, make its weightening finish be controlled at the 3-30% percentage by weight.
(3) preparation enteric coated micropill
The slow-release micro-pill of above-mentioned preparation is placed fluid bed or coating pan, the temperature of micropill is controlled at 25-40 ℃, enteric material, plasticizer, antiplastering aid are mixed with mixed liquor with the ethanol of water or 30-95% are sprayed at the micropill skin and make enteric sustained-release pellet, make its weightening finish be controlled at the 5-30% percentage by weight.
The sustained release coating material that the budesonide enteric sustained-release pellet of the present invention's preparation is adopted is an ethyl cellulose, and is water insoluble, has good filming performance and mechanical performance.The porogen that adds in slow release layer mostly is the material of water solublity or highly osmotic substance, after water dissolution or swelling, can on coating membrane, form many ducts, because the water passing hole channel enters drug depot, the inside and outside drug concentrations pressure differential that forms of release membranes discharges the medicine passing hole channel of coating inboard.By regulating kind, the consumption of slow-release material, regulate the different proportion, the consumption that mix slow-release material, regulate kind, the consumption of porogen, the rate of release that can regulate the film controlling type slow-release micro-pill.
The enteric material that the budesonide enteric sustained-release pellet of the present invention's preparation is adopted can be selected Eudragit L100, Eudragit L 100-55, Eudragit L 30D-55, Eudragit S100, Eudragit FS 30D, it dissolves required pH and is respectively＞6,＞5.5,＞5.5,＞7,＞7, selecting the Eudragit L 100 of different proportion and Eudragit S100 to mix to prepare needs at pH dissolved enteric coating between 6～7.
Prepared enteric sustained-release pellet is loaded in hard capsule or the medicinal folliculus, and specification is for containing active component budesonide 0.5-10mg, and optimum content is active component budesonide 3mg.
The present invention measures above-mentioned enteric sustained-release pellet release:
The drug release determination condition:
Instrument: ZRS-4 medicament dissolution instrument.
Solvent: discharge 2h among the simulated gastric fluid 0.1M HCl, change over to immediately among the simulated intestinal fluid PBS6.8 then and discharge 8～14h, dissolution medium is 600mL.
Method: change the basket method.
Rotating speed: respectively 50, estimate under the 100rpm/min condition.
Respectively at 2,2.5,3,4,6,8,10, the 14h sampling and measuring; Assay method HPLC, chromatographic column: Diamonsil C18 (4.6mm250mm, 5 μ m); Mobile phase: acetonitrile/water=70/30 (v/v); Flow velocity: 1.0mL/min; Column temperature: 30 ℃; The detection wavelength is 240nm; Retention time is 5.2min.
Measurement result shows, selects different enteric material, slow-release material, adopts different coating conditions, and prepared micropill does not all discharge under one's belt, enters the slow release of beginning behind the small intestinal, and release result is even.
Description of drawings
Fig. 1, Fig. 2, Fig. 3 and Fig. 4 are respectively the release in vitro curve of the enteric sustained-release pellet of embodiment 1～4.
The specific embodiment
The present invention is further illustrated below in conjunction with embodiment.
Embodiment 1
The celphere prescription
Microcrystalline Cellulose 80g
Starch 60g
Hypromellose 20g
Silicon dioxide 20g
Magnesium stearate 20g
The coating solution of medicament prescription
Celphere 80g
Budesonide 1g
Hypromellose 2g
50% ethanol 50g
The slow release layer coating fluid prescription
Pastille rapid release ball core 100g
Ethyl cellulose 3g
Sodium lauryl sulphate 0.3g
Tributyl citrate 0.3
Pulvis Talci 0.9g
95% ethanol 60g
The enteric layer coating fluid prescription
Slow-release micro-pill 100g
Eudragit?L100 16.5g
Triethyl citrate 1.65g
Pulvis Talci 4.125g
95% ethanol 250g
By above-mentioned each layer formula amount, microcrystalline Cellulose, starch mix homogeneously with the celphere recipe quantity, the binding agent that adds the hypromellose preparation, play female and round as a ball extremely required order with comminutor or coating pan and count the 15-30 order, round as a ball limit, limit adds silicon dioxide and magnesium stearate, best 20-30 order celphere is sifted out in oven dry;
The 2g hydroxypropyl methylcellulose is dissolved in 50% alcoholic solution, adds 1g medicine ultrasonic dissolution then; Celphere is put into coating pan or the medicine-feeding of fluid bed coating, be drying to obtain pastille rapid release ball core;
The pastille rapid release ball core of gained is put into fluid bed or coating pan, make the temperature of micropill be controlled at 25～30 ℃.The ethyl cellulose powder is dissolved in the 30g solvent, sodium lauryl sulphate, tributyl citrate, Pulvis Talci are poured in the remaining solvent, with the abundant homogenize 5～10min of high-shear homogenate machine, pour in the ethyl cellulose solution, fully stir 30min, the coating process continues to stir, and the skin that is sprayed at above-mentioned pastille fast release micropill is made slow-release micro-pill;
The slow-release micro-pill of gained is put into fluid bed or coating pan, makes the temperature of micropill remain on 25～30 ℃.Eudragit L100 is dissolved in the 125g solvent, add triethyl citrate, Pulvis Talci is poured in the remaining solvent in addition, with the abundant homogenize 5～10min of high-shear homogenate machine, after pour in the Eudragit L100 solution, fully stir 30min, the coating process continues to stir, and the skin that is sprayed at above-mentioned slow-release micro-pill is made enteric sustained-release pellet.Coating is put into 40 ℃ of baking oven heat treatment 6h after finishing.
The release in vitro curve of prepared enteric sustained-release pellet is seen accompanying drawing 1.
The celphere prescription
Lactose 100g
Starch 30g
Sucrose 40g
Pulvis Talci 20g
Magnesium stearate 10g
The coating solution of medicament prescription
Celphere 80g
Budesonide 1g
Polyethylene pyrrole Lip river alkane ketone 2g
80% ethanol 50g
The slow release layer coating fluid prescription
Pastille rapid release ball core 100g
Aquacoat Surelease 8g (solids content is 2g)
Hypromellose 1g
Water 10g
The enteric layer coating fluid prescription
Slow-release micro-pill 100g
Eudragit L30D-55 55g (solids content is 16.5g)
Triethyl citrate 1.65g
Pulvis Talci 4.125g
Water 50g
By above-mentioned each layer formula amount, lactose, starch mix homogeneously with the celphere recipe quantity, the binding agent that adds the sucrose preparation, play female and round as a ball extremely required order with comminutor or coating pan and count the 15-30 order, round as a ball limit, limit adds Pulvis Talci and magnesium stearate, best 20-30 order celphere is sifted out in oven dry;
2g polyethylene pyrrole Lip river alkane ketone is dissolved in 80% alcoholic solution, adds 1g medicine ultrasonic dissolution then; Celphere is put into coating pan or the medicine-feeding of fluid bed coating, be drying to obtain pastille rapid release ball core;
The pastille rapid release ball core of gained is put into fluid bed or coating pan, makes the temperature of micropill remain on 34～37 ℃.Add hypromellose in Aquacoat Surelease, the suitable quantity of water dilution stirs, and the coating process continues to stir, and the skin that is sprayed at the pastille fast release micropill is made slow-release micro-pill;
The slow-release micro-pill of gained is put into fluid bed or coating pan, make the temperature of micropill be controlled at 25～30 ℃.The triethyl citrate and the Pulvis Talci of recipe quantity are added water high-shear homogenate machine homogenize 10min, then the Pulvis Talci suspension is poured in the Eudragit L 30D-55 aqueous dispersion, stir 30min, the coating process continues to stir, and the skin that is sprayed at above-mentioned slow-release micro-pill is made enteric sustained-release pellet.Coating is put into 40 ℃ of baking oven heat treatment 6h after finishing.
The release in vitro curve of prepared enteric sustained-release pellet is seen accompanying drawing 2.
Embodiment 3,
Pastille rapid release ball core prescription
Lactose 90g
Starch 30g
Polyethylene pyrrole Lip river alkane ketone 40g
Pulvis Talci 20g
Micronization budesonide 3g
The slow release layer coating fluid prescription
Pastille rapid release ball core 100g
Aquacoat Aquacoat 15g (solids content is 4.5g)
Water 15g
The enteric layer coating fluid prescription
Slow-release micro-pill 100g
Eudragit?S100 5.5g
Eudragit?L100 11g
Polyethylene glycol 6000 1.65g
Pulvis Talci 4.125g
95% ethanol 250g
By above-mentioned each layer formula amount, lactose, starch, polyethylene pyrrole Lip river alkane ketone, Pulvis Talci mix homogeneously with micronized medicine and recipe quantity, prepare required order and count 15-30 purpose micropill with rolling into ball method or extruding-spheronization or centrifugal fluidized granulation method, oven dry makes smooth ball pastille rapid release ball core;
The pastille rapid release ball core of gained is put into fluid bed or coating pan, makes the temperature of micropill remain on 34～37 ℃.Add Tween 80 in Aquacoat Aquacoat, stir after an amount of water dilution, the coating process continues to stir, and the skin that is sprayed at the pastille fast release micropill is made slow-release micro-pill;
The slow-release micro-pill of gained is put into fluid bed or coating pan, makes the temperature of micropill remain on 25～30 ℃.Eudragit S100, Eudragit L100 are dissolved in the solvent, add polyethylene glycol 6000, Pulvis Talci is poured in the remaining solvent in addition, with the abundant homogenize 5～10min of high-shear homogenate machine, after pour in EudragitS100 and the Eudragit L100 solution, fully stir 30min, the coating process continues to stir, and the skin that is sprayed at above-mentioned slow-release micro-pill is made enteric sustained-release pellet.Coating is put into 40 ℃ of baking oven heat treatment 6h after finishing.
The release in vitro curve of prepared enteric sustained-release pellet is seen accompanying drawing 3.
Pastille rapid release ball core prescription
Microcrystalline Cellulose 80g
Starch 60g
Hypromellose 20g
Silicon dioxide 20g
Micronization budesonide 3g
The slow release layer coating fluid prescription
Pastille rapid release ball core 100g
Aquacoat Surelease 8g (solids content is 2g)
Polyethylene pyrrole Lip river alkane ketone 1g
Water 10g
The enteric layer coating fluid prescription
Slow-release micro-pill 100g
Polyvinyl acetate phthalic acid ester 15g
Triethyl citrate 1.5g
Stearic acid 3g
88% alcohol 95 g
By above-mentioned each layer formula amount, microcrystalline Cellulose, starch, hypromellose, silicon dioxide mix homogeneously with micronized medicine and recipe quantity, prepare required order and count 15-30 purpose micropill with rolling into ball method or extruding-spheronization or centrifugal fluidized granulation method, oven dry makes smooth ball pastille rapid release ball core;
The pastille rapid release ball core of gained is put into fluid bed or coating pan, makes the temperature of micropill remain on 34～37 ℃.Add polyethylene pyrrole Lip river alkane ketone in Aquacoat Surelease, the suitable quantity of water dilution stirs, and the coating process continues to stir, and the skin that is sprayed at the pastille fast release micropill is made slow-release micro-pill;
The slow-release micro-pill of gained is put into fluid bed or coating pan, makes the temperature of micropill remain on 25～30 ℃.The polyvinyl acetate phthalic acid ester is dissolved in the solvent, add triethyl citrate, stearic acid is poured in the remaining solvent in addition, with the abundant homogenize 5～10min of high-shear homogenate machine, after pour in the polyvinyl acetate phthalic acid ester solution, fully stir 30min, the coating process continues to stir, and the skin that is sprayed at above-mentioned slow-release micro-pill is made enteric sustained-release pellet.Coating is put into 40 ℃ of baking oven heat treatment 6h after finishing.
The release in vitro curve of prepared enteric sustained-release pellet is seen accompanying drawing 4.
Claims (11)
1. a budesonide enteric sustained-release pellet is characterized in that being made up of pastille rapid release ball core, slow release layer and enteric layer, and the pharmaceutically active of described enteric sustained-release pellet and pharmaceutical carrier composition are by following weight proportion, wherein:
(1) pastille rapid release ball core
Budesonide 0.1-3%
Filler 10-80%
Binding agent 2-20%
Lubricant 5-15%
(2) slow release layer clothing film component
Blocker 50-80%
Porogen 6-30%
Plasticizer 2-8%
Antiplastering aid 10-20%
(3) enteric layer clothing film component
Enteric material 60-80%
Plasticizer 5-10%
Antiplastering aid 15-35%.
2. press the preparation method of the enteric sustained-release pellet of claim 1, it is characterized in that comprising the following steps:
(1) preparation pastille rapid release ball core
Press formula ratio, with the filler mix homogeneously, add binding agent, play female also pill-rolling to required order number with comminutor or coating pan, add lubricant, oven dry, after making the blank micropill of smooth ball, with air suspension fluidized bed coating or the medicine-feeding of pan coating method coating, the gained micropill is drying to obtain pastille rapid release ball core on the celphere surface, and described coating solution adopts medicine to add the organic solution of binding agent;
Or micronized medicine mixed with filler, add binding agent and lubricant, with rolling into ball method or extruding-spheronization or the centrifugal fluidized granulation legal system is equipped with micropill, oven dry must pastille rapid release ball core;
(2) preparation slow-release micro-pill
Above-mentioned pastille rapid release ball core is placed fluid bed or coating pan, temperature is 25-40 ℃, blocker, porogen, plasticizer, antiplastering aid are mixed with the skin that mixed liquor is sprayed at pastille rapid release ball core with the ethanol of water or 30-95% make slow-release micro-pill, make its weightening finish be controlled at the 3-30% percentage by weight;
(3) preparation enteric coated micropill
The above-mentioned slow-release micro-pill that makes is placed fluid bed or coating pan, temperature is 25-40 ℃, enteric material, plasticizer, antiplastering aid are mixed with mixed liquor with the ethanol of water or 30-95% are sprayed at the micropill skin and make enteric sustained-release pellet, make its weightening finish be controlled at the 5-30% percentage by weight.
3. by the enteric sustained-release pellet of claim 1, it is characterized in that the relevant auxiliary materials filler of described pastille rapid release ball core is selected from lactose, sucrose, starch or microcrystalline Cellulose; Binding agent is selected from lactose, sucrose, methylcellulose, hypromellose, polyvinylpyrrolidone or polyethylene glycols; Lubricant is selected from magnesium stearate, stearic acid, colloidal silica or Pulvis Talci.
4. by the enteric sustained-release pellet of claim 1, it is characterized in that described slow release layer, wherein blocker is an ethyl cellulose; Porogen is selected from polyethylene glycols, lactose, sucrose, hypromellose, polyvinylpyrrolidone, sodium lauryl sulphate, Tween 80, Pulvis Talci or silicon dioxide; Plasticizer is selected from triethyl citrate, tributyl citrate, dibutyl sebacate, dimethyl phthalate, diethyl phthalate, dibutyl phthalate, polyethylene glycols or hypromellose; Antiplastering aid is selected from Pulvis Talci, magnesium stearate, glyceryl monostearate.
5. press the enteric sustained-release pellet of claim 1, it is characterized in that described enteric layer, wherein enteric material is selected from polyacrylic resin class, cellulose acetate phthalate ester, polyvinyl acetate phthalic acid ester, phthalic acid hypromellose ester or succinic acid acetic acid hydroxypropyl methylcellulose; Plasticizer is selected from triethyl citrate, tributyl citrate, dibutyl sebacate, dimethyl phthalate, diethyl phthalate, dibutyl phthalate, polyethylene glycols or hypromellose; Antiplastering aid is selected from Pulvis Talci, magnesium stearate or glyceryl monostearate.
6. by the enteric sustained-release pellet of claim 1 or 3, it is characterized in that described pastille rapid release ball core binding agent wherein is selected from hypromellose or polyvinylpyrrolidone.
7. by the enteric sustained-release pellet of claim 1 or 4, it is characterized in that described slow release layer blocker wherein is an ethyl cellulose; Porogen is selected from polyethylene glycols, hypromellose, polyvinylpyrrolidone, sodium lauryl sulphate or Tween 80.
8. by the enteric sustained-release pellet of claim 5, it is characterized in that described enteric layer polyacrylic resin class enteric material wherein is Eudragit L or Eudragit S.
9. by the enteric sustained-release pellet of claim 4, it is characterized in that described slow release layer blocker ethyl cellulose wherein is ethyl cellulose powder or Aquacoat.
10. by the enteric sustained-release pellet of claim 1, it is characterized in that being loaded on hard capsule or medicinal folliculus, specification is for containing active component budesonide 0.5-10mg.
11. the enteric sustained-release pellet by claim 10 is characterized in that being loaded on hard capsule or medicinal folliculus, specification is for containing active component budesonide 3mg.
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| CNA200610029025XA CN101108171A (en) | 2006-07-17 | 2006-07-17 | Budesonide intestines sustained release dextromethorphan pellets and method of manufacturing the same |
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| CNA200610029025XA CN101108171A (en) | 2006-07-17 | 2006-07-17 | Budesonide intestines sustained release dextromethorphan pellets and method of manufacturing the same |
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| WO2012006959A1 (en) * | 2010-07-16 | 2012-01-19 | Zhong Shuguang | Controlled release preparation |
| CN105412904A (en) * | 2014-06-17 | 2016-03-23 | 深圳翰宇药业股份有限公司 | Linaclotide enteric controlled-release pellet capsule preparation and preparing method and application thereof |
| CN105663091A (en) * | 2016-01-28 | 2016-06-15 | 上海信谊百路达药业有限公司 | Budesonide enteric-coated sustained-release capsules and preparation method thereof |
| CN106176684A (en) * | 2015-05-04 | 2016-12-07 | 深圳翰宇药业股份有限公司 | Sodium ferulate enteric slow releasing preparation and preparation method thereof |
| CN110507627A (en) * | 2019-09-29 | 2019-11-29 | 重庆医药高等专科学校 | A kind of oral controlled release medicine composition of budesonide |
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- 2006-07-17 CN CNA200610029025XA patent/CN101108171A/en active Pending
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| WO2012006959A1 (en) * | 2010-07-16 | 2012-01-19 | Zhong Shuguang | Controlled release preparation |
| CN105412904A (en) * | 2014-06-17 | 2016-03-23 | 深圳翰宇药业股份有限公司 | Linaclotide enteric controlled-release pellet capsule preparation and preparing method and application thereof |
| CN106176684A (en) * | 2015-05-04 | 2016-12-07 | 深圳翰宇药业股份有限公司 | Sodium ferulate enteric slow releasing preparation and preparation method thereof |
| CN105663091A (en) * | 2016-01-28 | 2016-06-15 | 上海信谊百路达药业有限公司 | Budesonide enteric-coated sustained-release capsules and preparation method thereof |
| US11173121B2 (en) * | 2018-08-24 | 2021-11-16 | Dr. Falk Pharma Gmbh | Pellets having a multi-layer structure for delayed release of the active substance in the distal colon |
| CN112512513A (en) * | 2018-08-24 | 2021-03-16 | 福尔克博士药物有限责任公司 | Pellet with a multilayer structure for delaying the release of active substances in the distal colon |
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