CN105534950A - Production method for kitasamycin solid micro-capsules for feed - Google Patents
Production method for kitasamycin solid micro-capsules for feed Download PDFInfo
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- CN105534950A CN105534950A CN201610003754.1A CN201610003754A CN105534950A CN 105534950 A CN105534950 A CN 105534950A CN 201610003754 A CN201610003754 A CN 201610003754A CN 105534950 A CN105534950 A CN 105534950A
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
- A61K9/5005—Wall or coating material
- A61K9/5021—Organic macromolecular compounds
- A61K9/5036—Polysaccharides, e.g. gums, alginate; Cyclodextrin
- A61K9/5042—Cellulose; Cellulose derivatives, e.g. phthalate or acetate succinate esters of hydroxypropyl methylcellulose
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/70—Carbohydrates; Sugars; Derivatives thereof
- A61K31/7042—Compounds having saccharide radicals and heterocyclic rings
- A61K31/7048—Compounds having saccharide radicals and heterocyclic rings having oxygen as a ring hetero atom, e.g. leucoglucosan, hesperidin, erythromycin, nystatin, digitoxin or digoxin
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Abstract
The invention discloses a production method for kitasamycin solid micro-capsules for feed. The method comprises the following steps that 1, kitasamycin, plastic materials and a solvent are mixed to form pill cores; 2, the pill cores are wrapped by an inner enteric coating layer and an outer enteric coating layer; the inner enteric coating layer and the outer enteric coating layer are formed by mixing inner enteric coating layer materials with the solvent and mixing outer enteric coating layer materials with the solvent respectively, and then the pill cores are sequentially wrapped to form granules. According to the method, the phenomenon that pessimal stimulation is caused to the stomach by unprocessed kitasamycin which has the bitter taste can be avoided, meanwhile, it can be ensured that effective ingredients can completely and accurately reach the intestinal tract, the dissolution rate of intestinal drugs is improved, the concentration of the intestinal drugs and the drug effect intensity are greatly improved, and therefore the using performance of the kitasamycin is improved.
Description
Technical field
The present invention relates to feedstuff and field of feed additive technology, especially relate to a kind of production method of feedstuff kitasamycin solid microcapsule.
Background technology
Kitasamycin is divided into Kitasamycin tartrate and kitasamycin alkali, and for feed additive is kitasamycin alkali.Because kitasamycin alkali has better bioavailability, and Kitasamycin tartrate only does drinking agent use, and relatively low for feedstuff interpolation bioavailability, use cost is relatively high.Kitasamycin is in alkalescence; it is when pH < 5.5; active obviously decline; degradation rate is up to 40%; and the stomach of all animals (especially pig) is all in sour environment; no matter be in empty stomach or after searching for food; its pH value is all less than 5.5; so the former powder of direct kitasamycin and simple pre-mixing agent or do not make enteric bag quilt granule granulationization through gastric environment; its effective ingredient can be subject to severely degrade and destroy; the active component that can arrive intestinal obviously declines, and only has the effective ingredient of about 60% can reach intestinal and plays a role.The former powder of kitasamycin is because of its complicated components and different components presents different lenticulars, is difficult to ensure that its active component can fully contact with pathogen, obviously can affect its action effect like this.And there is strong bitterness due to kitasamycin, directly use the preparation of the former powder of kitasamycin or simple premixing can have a strong impact on the feed intake of animal (especially suckling piglet).Based on above-mentioned influence factor, kitasamycin fails to reach desirable application on China's feed industry always.
Summary of the invention
For the problems referred to above that prior art exists, the applicant provides a kind of production method of feedstuff kitasamycin solid microcapsule.This method can avoid undressed kitasamycin to the pessimal stimulation of stomach and strong bitterness thereof, can ensure that effective ingredient all can arrive intestinal exactly simultaneously, and improve the dissolution of enteric drug, increase substantially intestinal concentration and efficacy strength, thus improve the serviceability of kitasamycin.
Technical scheme of the present invention is as follows:
A production method for feedstuff kitasamycin solid microcapsule, comprises the steps:
(1) kitasamycin and plastic material and solvent are mixed and made into ball core, by mass fraction 100%, comprise the kitasamycin of 5 ~ 15% and the plastic material of 85 ~ 95%; In ball core preparation process, solvent for use is ethanol and purified water mixed solution;
The raw material of described plastic material and the percentage by weight of each raw material are: filler 65 ~ 85%, adhesive 6 ~ 20% and disintegrating agent 4 ~ 15%;
(2) the coated internal layer enteric coating layer of difference and outer enteric coating layer outside described ball core; Described internal layer enteric coating layer and outer enteric coating layer are mixed with solvent with solvent and outer enteric coating material by internal layer enteric coating material respectively, then wrap successively and are made graininess by ball core;
The weight ratio of described ball core, internal layer enteric coating material and outer enteric coating material is 1:0.02 ~ 0.03:0.04 ~ 0.05;
Described internal layer enteric coating material and outer enteric coating material include enteric-coating material, plasticizer, antiplastering aid, porogen; With dry thing weight percent meter, each raw material composition is respectively: enteric-coating material 50 ~ 90%, plasticizer 1 ~ 20%, antiplastering aid 1 ~ 35%, porogen 1 ~ 25%.
The particle size distribution of described ball core is 0.1 ~ 1.5mm.Preferably, the particle size distribution of described ball core is 0.2 ~ 1.2mm.
Described filler is selected from one or more in starch, dextrin, microcrystalline Cellulose, Powderd cellulose, manna alcoholase, lactose or chitosan;
Described adhesive is selected from one or more of hydroxypropyl cellulose, hypromellose, methylcellulose and polyvidone;
Described disintegrating agent is selected from one or more of cross-linking sodium carboxymethyl cellulose, carboxymethyl starch sodium, polyvinylpolypyrrolidone or low-substituted hydroxypropyl cellulose;
Enteric-coating material in described internal layer enteric coating layer is acrylic resin or cellulose derivative; Plasticizer in described internal layer enteric coating layer is one or more in triethyl citrate, Polyethylene Glycol, glyceryl triacetate, dibutyl sebacate, diethyl phthalate; Antiplastering aid in described internal layer enteric coating layer is one or more in Pulvis Talci, titanium dioxide, glyceryl stearate, magnesium stearate, silicon dioxide; Porogen in described internal layer enteric coating layer is hydroxypropyl cellulose, hydroxypropyl emthylcellulose, polyvidone, Polyethylene Glycol or sucrose;
Enteric-coating material in described outer enteric coating layer is acrylic resin or cellulose derivative; Plasticizer in described outer enteric coating layer is one or more in triethyl citrate, Polyethylene Glycol, glyceryl triacetate, dibutyl sebacate, diethyl phthalate; Antiplastering aid in described outer enteric coating layer is one or more in Pulvis Talci, titanium dioxide, glyceryl stearate, magnesium stearate, silicon dioxide; In described outer enteric coating layer, porogen is hydroxypropyl cellulose, hydroxypropyl emthylcellulose, polyvidone, Polyethylene Glycol or sucrose.
In step (2), internal layer enteric coating layer solvent used is ethanol, and outer enteric coating layer solvent used is purified water or organic solvent.
Preferably, described is especially strange L12.5 or one or both especially in strange L100 for the acrylic resin in internal layer enteric coating layer; Described is one or more in CAP, phthalic acid hydroxypropyl cellulose or 1,2,4-benzenetricarboxylic acid cellulose acetate for the cellulose derivative in internal layer enteric coating layer.
Preferably, described is one or both especially in strange L30D-55 aqueous dispersion and Eudragit L100-55 for the acrylic resin in outer enteric coating layer; Described is CAP, HPMCP, acetate succinate cellulose, HPMCAS and 1 for the cellulose derivative in outer enteric coating layer, one or more in 2,4-benzenetricarboxylic acid cellulose acetate.
Described kitasamycin solid microcapsule is the kitasamycin novel form processed by solid dispersion technology and microcapsule technology.
Preferably, the production method of described feedstuff kitasamycin solid microcapsule, concrete steps are:
(1) adopt extrusion spheronization legal system for ball core
Get the mixing of kitasamycin, plastic material and solvent, obtained soft material in high-speed mixing granulating machine; Soft material is placed in extruder, uses screen cloth to extrude the bar of thickness, uniform length; Bar is placed in spheronizator, under round as a ball frequency 10 ~ 30Hz condition, round as a ball 2 ~ 30 minutes, obtains spherical or near-spherical piller; Piller is placed in fluid bed dry, the piller of screening suitable particle diameter is for subsequent use;
(2) coating
Enteric-coating material, plasticizer and antiplastering aid being dissolved is scattered in solvent, and the enteric coating liquid being mixed with inside and outside two-layer enteric coating layer is respectively for subsequent use; Piller after screening is placed in fluid bed, and controlling temperature of charge is 25 DEG C, carries out internal layer enteric coating, and the piller of bag internal layer enteric coating layer is placed in fluid bed, and controlling temperature of charge is 25 DEG C, carries out outer enteric coating;
(3) solidify
By enteric-coated pellets in 40 ~ 60 DEG C of solidification 2 ~ 24h, obtain kitasamycin solid microcapsule.
Mesh size in described step (1) is 1.0mm; Round as a ball frequency is 20Hz, and the round as a ball time is 15 minutes.
In ball core preparation process, solvent for use is ethanol and purified water mixed solution, and solvent can avoid the hydrolysis of kitasamycin in coating process
Suitable filler is not only conducive to extruding, and can be prepared into that roundness is good, friability is low, ganoid ball core.Adding disintegrating agent can the rate of release of regulating drug, finally makes medicine discharge completely.Enteric coating layer can avoid active component kitasamycin to discharge under one's belt, makes kitasamycin discharge absorption in intestinal.
All need to add solvent in the coating preparation process of ball core and enteric coating layer, in ball core preparation process, solvent for use is ethanol and purified water mixed solution, and solvent can avoid the hydrolysis of kitasamycin in coating process; In the coating preparation process of enteric coating layer, enteric material, antiplastering aid and plasticizer need be added in solvent after being mixed with coating solution and use, internal layer enteric coating layer solvent used is organic solvent, preferred alcohol, outer enteric coating layer solvent used is one or more of purified water or organic solvent.In coating process and subsequent step, solvent seasoning removing used, does not show significant solvent in the final product.
The technique effect that the present invention is useful is:
But the invention provides and a kind ofly have the kitasamycin solid microcapsule that a small amount of coating has the dissolution of control in water, this solid microcapsule kitasamycin is all scattered in adjuvant with molecularity.This medicine bearing mode because adjuvant to the retardation of drug molecule, effectively can suppress its stripping in animal oral cavity, thus makes its sense of taste significantly improve; The protection of the microcapsule layer formed by adjuvant effectively prevents the contact of kitasamycin and gastric acid, thus can significantly improve the stability of medicine; And the existence form of molecularity dispersion facilitates the stripping of kitasamycin in intestinal, kitasamycin ties up to digestion in small intestinal and stripping with solid dispersal, forms enteric drug concentration.
Detailed description of the invention
Below in conjunction with embodiment, the present invention is specifically described.
Embodiment 1 ~ 3
Each raw material dosage of embodiment 1 ~ 3 is as shown in table 1:
Table 1 (unit: kg)
Above-mentioned 95% ethanol is weight fraction.
The preparation technology of embodiment 1 ~ 3 is:
(1) precise kitasamycin, plastic material, 95% ethanol and purified water weigh separately.
(2) by 95% ethanol and purified water mix homogeneously, for subsequent use.Plastic material is dissolved in above-mentioned alcoholic solution.
(3) open high-speed mixing granulating machine, add each raw material of ball core, mixing, slowly adds raw material, mixes to obtain soft material in high-speed mixing granulating machine.
(4) soft material is placed in extruder, selects aperture to be the screen cloth of 1.0mm, extrude the bar of thickness, uniform length.
(5) bar is placed in spheronizator, adjusting round as a ball frequency is 20Hz, round as a ball 15 minutes, and extrudate, under the combined effect of centrifugal force and shearing force, cuts off and round as a ball globulate piller.
(6) ball core is placed in fluid bed, arranging temperature of charge is 35 DEG C, dry 40 minutes.Piller sieved through sieve after drying is gone out the piller between 16 ~ 30 orders, for subsequent use.
(7) each for internal layer enteric coating layer material dissolution is scattered in 95% ethanol, for subsequent use.Piller after screening is placed in fluid bed, and controlling temperature of charge is 25 DEG C, carries out internal layer enteric coating.
(8) by each for outer enteric coating layer stock dispersion in alcoholic solution, for subsequent use.The piller of bag internal layer enteric coating layer is placed in fluid bed, and controlling temperature of charge is 25 DEG C, carries out outer enteric coating.
(9) piller after inside and outside layer enteric coating is placed in 40 DEG C of baking oven solidifications 24 hours.Obtain kitasamycin solid microcapsule.
Test case: the test of intestinal absolute acid stability, intestinal dissolution test and the application test applicant of product on pig farm have carried out the test of intestinal absolute acid stability and intestinal dissolution test at company's laboratory, each test is divided into 4 groups, the kitasamycin microcapsule of what sample 1 was outsourcing with paraffin is adjuvant, sample 2 is embodiment 1, sample 3 is embodiment 2, and sample 4 is embodiment 3.Select the length of 144 weight about 10kg × large × Du piglet in the test of pig farm, Yixing, close by weight, the principle of male and female half and half, is divided into 6 groups at random, i.e. matched group, former powder group, an outsourcing kitasamycin microcapsule group and solid microcapsule experimental example 3 groups.Often organize 3 repetitions, each repetition 8 pigs, raise in enclosing with house 18 respectively.Matched group feeds basal diet, former powder group adds the former powder 100g/t of kitasamycin in basal diet, groups of grains adds 100g/t granular preparation (containing kitasamycin), and solid microcapsule group adds kitasamycin enteric coating agents 60g/t (kitasamycin) in basal diet.Specific experiment result is as follows:
Table 2 stability test parameter and intestinal release parameter
Table 3 kitasamycin solid microcapsule is amount retained % under Gl tract condition in vitro
The release % of table 4 kitasamycin solid microcapsule in intestinal
The effective release of kitasamycin in intestinal be evaluate medicine in vivo can the most effective means of availability, can see from table 2 ~ 4, the intestinal dissolution that sample is 2,3,4 groups is obviously better than 1 group, sample, this illustrates that the innovation of this patent has actual effect, after intestinal pH 7.2 (4h), sample 1 group of filtering residue retention ratio is 13.76%, and sample 2,3,4 groups of filtering residue mean residence rates are 1.09%.The intestinal release impact of visible adjuvant on kitasamycin is larger.
Table 5 kitasamycin solid microcapsule is on the impact of Growth Performance of Weaning Piglets
Note: total head number/experimental period of suffering from diarrhoea diarrhea rate=experimental period raises total head number of days * 100;
Feedstuff-meat ratio=experimental period total feed intake (kg)/experimental period total augment weight (kg)
As can be seen from Table 5, this kitasamycin solid microcapsule in reduction piglet diarrhea rate, improve daily gain, improve in feedstuff-meat ratio and serve good effect, add the test group death rate of kitasamycin all lower than matched group, illustrate that kitasamycin can reduce the death rate of piglet at weaning stage, increase economic efficiency.Wherein, the death rate of three groups is lower than first three groups, and illustrate that the kitasamycin solid microcapsule prepared through this patent is in resist the disease, effect is better than former powder group and plain particles preparation group, this is because microcapsule process can improve the dose by stomach, enhances drug effect.
Claims (10)
1. a feedstuff production method for kitasamycin solid microcapsule, is characterized in that comprising the steps:
(1) kitasamycin and plastic material and solvent are mixed and made into ball core, by mass fraction 100%, comprise the kitasamycin of 5 ~ 15% and the plastic material of 85 ~ 95%; In ball core preparation process, solvent for use is ethanol and purified water mixed solution;
The raw material of described plastic material and the percentage by weight of each raw material are: filler 65 ~ 85%, adhesive 6 ~ 20% and disintegrating agent 4 ~ 15%;
(2) the coated internal layer enteric coating layer of difference and outer enteric coating layer outside described ball core; Described internal layer enteric coating layer and outer enteric coating layer are mixed with solvent with solvent and outer enteric coating material by internal layer enteric coating material respectively, then wrap successively and are made graininess by ball core;
The weight ratio of described ball core, internal layer enteric coating material and outer enteric coating material is 1:0.02 ~ 0.03:0.04 ~ 0.05;
Described internal layer enteric coating material and outer enteric coating material include enteric-coating material, plasticizer, antiplastering aid, porogen; With dry thing weight percent meter, each raw material composition is respectively: enteric-coating material 50 ~ 90%, plasticizer 1 ~ 20%, antiplastering aid 1 ~ 35%, porogen 1 ~ 25%.
2. production method according to claim 1, is characterized in that: the particle size distribution of described ball core is 0.1 ~ 1.5mm.
3. production method according to claim 1, is characterized in that: the particle size distribution of described ball core is 0.2 ~ 1.2mm.
4. production method according to claim 1, is characterized in that:
Described filler is selected from one or more in starch, dextrin, microcrystalline Cellulose, Powderd cellulose, manna alcoholase, lactose or chitosan;
Described adhesive is selected from one or more of hydroxypropyl cellulose, hypromellose, methylcellulose and polyvidone;
Described disintegrating agent is selected from one or more of cross-linking sodium carboxymethyl cellulose, carboxymethyl starch sodium, polyvinylpolypyrrolidone or low-substituted hydroxypropyl cellulose;
Enteric-coating material in described internal layer enteric coating layer is acrylic resin or cellulose derivative; Plasticizer in described internal layer enteric coating layer is one or more in triethyl citrate, Polyethylene Glycol, glyceryl triacetate, dibutyl sebacate, diethyl phthalate; Antiplastering aid in described internal layer enteric coating layer is one or more in Pulvis Talci, titanium dioxide, glyceryl stearate, magnesium stearate, silicon dioxide; Porogen in described internal layer enteric coating layer is hydroxypropyl cellulose, hydroxypropyl emthylcellulose, polyvidone, Polyethylene Glycol or sucrose;
Enteric-coating material in described outer enteric coating layer is acrylic resin or cellulose derivative; Plasticizer in described outer enteric coating layer is one or more in triethyl citrate, Polyethylene Glycol, glyceryl triacetate, dibutyl sebacate, diethyl phthalate; Antiplastering aid in described outer enteric coating layer is one or more in Pulvis Talci, titanium dioxide, glyceryl stearate, magnesium stearate, silicon dioxide; In described outer enteric coating layer, porogen is hydroxypropyl cellulose, hydroxypropyl emthylcellulose, polyvidone, Polyethylene Glycol or sucrose.
5. production method according to claim 1, is characterized in that: in step (2), and internal layer enteric coating layer solvent used is ethanol, and outer enteric coating layer solvent used is purified water or organic solvent.
6. production method according to claim 4, is characterized in that: described is especially strange L12.5 or one or both especially in strange L100 for the acrylic resin in internal layer enteric coating layer; Described is one or more in CAP, phthalic acid hydroxypropyl cellulose or 1,2,4-benzenetricarboxylic acid cellulose acetate for the cellulose derivative in internal layer enteric coating layer.
7. production method according to claim 4, is characterized in that: described is one or both especially in strange L30D-55 aqueous dispersion and Eudragit L100-55 for the acrylic resin in outer enteric coating layer; Described is CAP, HPMCP, acetate succinate cellulose, HPMCAS and 1 for the cellulose derivative in outer enteric coating layer, one or more in 2,4-benzenetricarboxylic acid cellulose acetate.
8. the production method according to any one of claim 1 ~ 7, is characterized in that: described kitasamycin solid microcapsule is the kitasamycin novel form processed by solid dispersion technology and microcapsule technology.
9. the production method according to any one of claim 1 ~ 7, is characterized in that concrete steps are:
(1) adopt extrusion spheronization legal system for ball core
Get the mixing of kitasamycin, plastic material and solvent, obtained soft material in high-speed mixing granulating machine; Soft material is placed in extruder, uses screen cloth to extrude the bar of thickness, uniform length; Bar is placed in spheronizator, under round as a ball frequency 10 ~ 30Hz condition, round as a ball 2 ~ 30 minutes, obtains spherical or near-spherical piller; Piller is placed in fluid bed dry, the piller of screening suitable particle diameter is for subsequent use;
(2) coating
Enteric-coating material, plasticizer and antiplastering aid being dissolved is scattered in solvent, and the enteric coating liquid being mixed with inside and outside two-layer enteric coating layer is respectively for subsequent use; Piller after screening is placed in fluid bed, and controlling temperature of charge is 25 DEG C, carries out internal layer enteric coating, and the piller of bag internal layer enteric coating layer is placed in fluid bed, and controlling temperature of charge is 25 DEG C, carries out outer enteric coating;
(3) solidify
By enteric-coated pellets in 40 ~ 60 DEG C of solidification 2 ~ 24h, obtain kitasamycin solid microcapsule.
10. production method according to claim 9, is characterized in that: the mesh size in described step (1) is 1.0mm; Round as a ball frequency is 20Hz, and the round as a ball time is 15 minutes.
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN106173265A (en) * | 2016-07-13 | 2016-12-07 | 湖南晶天科技实业有限公司 | A kind of feed additive enteric coating formic acid and preparation method thereof and a kind of feedstuff |
| CN106265595A (en) * | 2016-09-29 | 2017-01-04 | 甘肃瑞和祥生物科技有限公司 | A kind of enteric kitasamycin sustained-release micro-spheres and preparation method thereof |
| CN108143720A (en) * | 2016-12-02 | 2018-06-12 | 中国科学院大连化学物理研究所 | Anti-infectious sustained release pharmaceutical composition of biodegradation type hemostasis and preparation method thereof |
| CN111493229A (en) * | 2020-03-18 | 2020-08-07 | 荣海生物科技有限公司 | Coated mycotoxin degrading enzyme and preparation method and application thereof |
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| US20070292509A1 (en) * | 2006-06-16 | 2007-12-20 | Shin-Etsu Chemical Co., Ltd. | Enteric coated granule and method for preparing the same |
| CN101611766A (en) * | 2009-07-16 | 2009-12-30 | 无锡正大畜禽有限公司 | A kind of production method of enteric-coated kitasamycin for feed |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN106173265A (en) * | 2016-07-13 | 2016-12-07 | 湖南晶天科技实业有限公司 | A kind of feed additive enteric coating formic acid and preparation method thereof and a kind of feedstuff |
| CN106265595A (en) * | 2016-09-29 | 2017-01-04 | 甘肃瑞和祥生物科技有限公司 | A kind of enteric kitasamycin sustained-release micro-spheres and preparation method thereof |
| CN108143720A (en) * | 2016-12-02 | 2018-06-12 | 中国科学院大连化学物理研究所 | Anti-infectious sustained release pharmaceutical composition of biodegradation type hemostasis and preparation method thereof |
| CN111493229A (en) * | 2020-03-18 | 2020-08-07 | 荣海生物科技有限公司 | Coated mycotoxin degrading enzyme and preparation method and application thereof |
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Application publication date: 20160504 |