CN107496436A - A kind of Tylosin Tartrate sulfadimidine sustained release pellet and preparation method thereof - Google Patents

A kind of Tylosin Tartrate sulfadimidine sustained release pellet and preparation method thereof Download PDF

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Publication number
CN107496436A
CN107496436A CN201710979283.2A CN201710979283A CN107496436A CN 107496436 A CN107496436 A CN 107496436A CN 201710979283 A CN201710979283 A CN 201710979283A CN 107496436 A CN107496436 A CN 107496436A
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Prior art keywords
sulfadimidine
sustained release
tylosin tartrate
release pellet
dosage
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Inventor
李新
逯荷香
李阳
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LUOYANG RUIHUA ANIMAL HEALTH PRODUCTS Co Ltd
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LUOYANG RUIHUA ANIMAL HEALTH PRODUCTS Co Ltd
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/70Carbohydrates; Sugars; Derivatives thereof
    • A61K31/7042Compounds having saccharide radicals and heterocyclic rings
    • A61K31/7048Compounds having saccharide radicals and heterocyclic rings having oxygen as a ring hetero atom, e.g. leucoglucosan, hesperidin, erythromycin, nystatin, digitoxin or digoxin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/63Compounds containing para-N-benzenesulfonyl-N-groups, e.g. sulfanilamide, p-nitrobenzenesulfonyl hydrazide
    • A61K31/635Compounds containing para-N-benzenesulfonyl-N-groups, e.g. sulfanilamide, p-nitrobenzenesulfonyl hydrazide having a heterocyclic ring, e.g. sulfadiazine
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0002Galenical forms characterised by the drug release technique; Application systems commanded by energy
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50Microcapsules 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
    • A61K9/51Nanocapsules; Nanoparticles
    • A61K9/5107Excipients; Inactive ingredients
    • A61K9/5123Organic compounds, e.g. fats, sugars
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50Microcapsules 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
    • A61K9/51Nanocapsules; Nanoparticles
    • A61K9/5107Excipients; Inactive ingredients
    • A61K9/513Organic macromolecular compounds; Dendrimers
    • A61K9/5161Polysaccharides, e.g. alginate, chitosan, cellulose derivatives; Cyclodextrin

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Physics & Mathematics (AREA)
  • Biomedical Technology (AREA)
  • Nanotechnology (AREA)
  • Optics & Photonics (AREA)
  • Molecular Biology (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

The invention provides a kind of preparation method of Tylosin Tartrate sulfadimidine sustained release pellet, it comprises the following steps:1st, Tylosin Tartrate, sulfadimidine, mixed with filler after add binder; put wet method in granulator and soft ability is made; 2nd, take and soft just put in extruder; strip extrudate is made; 3rd, extrudate is put in spheronizator; it is constantly round as a ball to obtain; circular micropill; 4th, wet micropill is put dries, puts dry, fluidized bed evaporation drying in baking oven at room temperature; produce dry fine pellet core; 5th, capsule core is subjected to spacer layer coating by capsule core with fluid bed, 6, the micropill for wrapping separation layer is subjected to slow release layer coating with fluid bed.Obtain Tylosin Tartrate sulfadimidine sustained release pellet.The pelleting compound preparation of the present invention is stable, easy to use, reduces the toxic side effect of medicine, and technique is simple, easy to operate, is adapted to industrial production and popularization and application.

Description

A kind of Tylosin Tartrate sulfadimidine sustained release pellet and preparation method thereof
Technical field
The present invention is a kind of preparation of Tylosin Tartrate sulfadimidine sustained release pellet.
Background technology
Tylosin Tartrate is because its intestinal absorption is good, and diffusion is fast in vivo, and blood concentration is high, is clinically that treatment branch is former The choice drug of livestock and poultry chronic respiratory tract disease caused by body.Its clinical application method is more, tylosin tartrate soluble powder Its side effect has 1, tylosin to cause animal doctor's contact dermatitis.2nd, Tylosin Tartrate may have hepatotoxicity wind agitation, performance For cholestasis, also it can cause vomiting and suffer from diarrhoea, when especially high dose is administered.3rd, many animals take Tylosin Tartrate orally Often occurs dose dependent gastrointestinal disturbance (vomiting, diarrhoea, intestines pain etc.) afterwards, this is probably by the stimulation to smooth muscle Cause.The symptom of diarrhea of equus is especially serious.
Sulfadimidine is white or yellowish crystallization or powder;It is odorless;It is deep to meet photochromic gradual change.Water is insoluble in, no Quick beneficial to clinic uses and prepared, and its clinical prolonged application can have infringement to kidney, can also cause intestinal bacilli illness.
Tylosin is macrolide antibiotics, mainly acts on bacterium 50s ribosomal subunits, turns peptide work by blocking With with mRNA displacements and suppress bacterioprotein synthesize.Tylosin is to diseases such as gram-positive bacteria, part Gram-negative bacterias Pathogenic microorganism has stronger killing action, especially effective to mycoplasma infection.Sulfadimidine is disulfonamide, mainly By blocking the folic acid metabolism of bacterium, bacteria growing inhibiting breeding.Therefore two medicine use in conjunction can effectively treat livestock and poultry mycoplasma Caused breathing problem.
The content of the invention
The present invention provides a kind of preparation technology of Tylosin Tartrate sulfadimidine sustained release pellet, solves existing skill The gastrointestinal side effect that art mesotartaric acid tylosin occurs by the dose-dependant of burst size and rate of release initiation, sulfanilamide (SN) diformazan Pyrimidine long-term prescription has infringement to cause to intestinal bacilli illness in kidney.
The preparation method of the Tylosin Tartrate sulfadimidine sustained release pellet of the present invention:
(1) preparation of wet feed:
Raw material Tylosin Tartrate and sulfadimidine are well mixed with filler, addition binder is put wet in granulator Method, soft ability is made.
(2) extrusion process:
By it is manufactured it is soft be just placed in extruder, through the pressing method such as screw propulsion or rolling by wet feed by having certain diameter Hole or sieve, it is squeezed into cylindrical strip extrudate.
(3) round as a ball pelletization process:
Above-mentioned extrudate is shirked on the rotation friction plate of spheronizator, extrudate is then dispersed into length equivalent to its diameter Smaller cylinder, due to the effect of frictional force, these plastic cylindrical materials onboard ceaselessly roll, and are gradually rolled into ball Shape.
(4) piller is dried:
Drying mode mainly includes:Dry at room temperature, put dry, fluidized bed evaporation drying in baking oven.
(5) isolation coat layer:
By isolation coat liquid, plasticizer, add in the purified water in stirring, stirring is completely dissolved, and by antitackiness agent, adds purified water In stir, using fluid bed to pellet core carry out hydrojet coating, obtain isolation piller.
(6) sustained-release coating layer:
By Sustained release coating materials, pore-foaming agent, antitackiness agent add stirring purified water in, be stirred to dissolve, using fluid bed to every Hydrojet coating is carried out from piller, produces sustained release pellet.
Brief description of the drawings
The blood concentration figure of Fig. 1 tylosins, series 1 are:Control series 2 are:Embodiment 1 prepares sample series 3:Embodiment 2, which prepare sample series 4, is:Embodiment 3 prepares sample
The blood concentration figure of Fig. 2 sulfadimethoxines, series 1 are:Control series 2 are:Embodiment 1 prepares sample series 3: Embodiment 2 prepares sample series 4:Embodiment 3 prepares sample
Embodiment
The preparation of Tylosin Tartrate sulfadimidine sustained release pellet:
Embodiment 1
Raw material Tylosin Tartrate 5%, sulfadimidine 5%, sucrose 60% and dextrin 10% are well mixed, added Enter pregelatinized starch 20% and put wet method in granulator, softwood is made.
By it is manufactured it is soft be just placed in extruder, wet feed is passed through into hole diameter of sieve (perforated) plate 0.4- through screw propulsion pressing method 0.6mm extruders, it is squeezed into cylindrical strip extrudate.
Above-mentioned extrudate is shirked on the rotation friction plate that spheronizator rotating speed is 1200r/min-2500r/min, extrusion Thing is then dispersed into smaller cylinder of the length equivalent to its diameter, and it is wet micro- to obtain Tylosin Tartrate sulfadimidine Ball.
The wet micropill prepared is dried at room temperature, obtains the dry micropill of Tylosin Tartrate sulfadimidine.
The purifying that isolation coat liquid hydroxypropyl methylcellulose 1% is added in stirring with plasticizer neck dibatyl phithalate 1% In water, stirring is completely dissolved, and by antitackiness agent talcum powder 1%, is added in purified water and is stirred, using fluid bed to pellet core Hydrojet coating is carried out, obtains isolation piller.
By Sustained release coating materials triethyl citrate 1% and pore-foaming agent PEG6000 1%, antitackiness agent talcum powder 1%g is added In the purified water of stirring, it is stirred to dissolve, hydrojet coating is carried out to isolation piller using fluid bed, produces sustained release pellet.
Embodiment 2
Raw material Tylosin Tartrate 10% and sulfadimidine 10% are mixed with sucrose 50% and dextrin 20% It is even, add pregelatinized starch 10% and put wet method in granulator, soft ability is made.
By it is manufactured it is soft be just placed in extruder, wet feed is passed through into hole diameter of sieve (perforated) plate 0.4- through screw propulsion pressing method 0.6mm extruders, it is squeezed into cylindrical strip extrudate.
Above-mentioned extrudate is shirked on the rotation friction plate that spheronizator rotating speed is 1200r/min-2500r/min, extrusion Thing is then dispersed into smaller cylinder of the length equivalent to its diameter, and it is wet micro- to obtain Tylosin Tartrate sulfadimidine Ball.
The wet micropill prepared is put in baking oven and dried, obtains the dry micropill of Tylosin Tartrate sulfadimidine.
The purifying that isolation coat liquid hydroxypropyl methylcellulose 3% is added in stirring with plasticizer neck dibatyl phithalate 5% In water, stirring is completely dissolved, and by antitackiness agent talcum powder 5%, is added in purified water and is stirred, using fluid bed to pellet core Hydrojet coating is carried out, obtains isolation piller.
By Sustained release coating materials triethyl citrate 5% and pore-foaming agent PEG6000 5%, antitackiness agent talcum powder 2%g is added In the purified water of stirring, it is stirred to dissolve, hydrojet coating is carried out to isolation piller using fluid bed, produces sustained release pellet.
Embodiment 3
Raw material Tylosin Tartrate 20% and sulfadimidine 20% are mixed with sucrose 40% and dextrin 10% It is even, add pregelatinized starch 5% and put wet method in granulator, soft ability is made.
By it is manufactured it is soft be just placed in extruder, wet feed is passed through into hole diameter of sieve (perforated) plate 0.4- through screw propulsion pressing method 0.6mm extruders, it is squeezed into cylindrical strip extrudate.
Above-mentioned extrudate is shirked on the rotation friction plate that spheronizator rotating speed is 1200r/min-2500r/min, extrusion Thing is then dispersed into smaller cylinder of the length equivalent to its diameter, and it is wet micro- to obtain Tylosin Tartrate sulfadimidine Ball.
The wet micropill fluidized bed evaporation prepared is dried, obtains the dry micropill of Tylosin Tartrate sulfadimidine.
The purifying that isolation coat liquid hydroxypropyl methylcellulose 5% is added in stirring with plasticizer neck dibatyl phithalate 10% In water, stirring is completely dissolved, and by antitackiness agent talcum powder 10%, is added in purified water and is stirred, using fluid bed to containing pill Core carries out hydrojet coating, obtains isolation piller.
By Sustained release coating materials triethyl citrate 10% and pore-foaming agent PEG6000 10%, antitackiness agent talcum powder 5%g adds In the purified water for entering stirring, it is stirred to dissolve, hydrojet coating is carried out to isolation piller using fluid bed, produces sustained release pellet.
Beneficial effects of the present invention are proved below by way of specific pharmacodynamics test.
The medicine pharmacokinetics experiment of the present invention of test example 1
Reagent and animal
10-20kg pig is randomly divided into 2 groups, every group 8, after packet after fasting 12 hours, disposably orally awarded The tartaric acid of equivalent after 10mg/kg tylosin raw material (control group), sulfadimidine 10mg/kg (control group) and conversion The suspension of tylosin and sulfadimidine sustained release pellet 1,2,3 (test group).After oral respectively at 0.1h, 0.2h, 0.25h, 0.5h, 1h, 2h, 3h, 4h, 5h, 6h, 8h, 12h, 16h gather peripheric venous blood in anticoagulant tube, and separated plasma preserves It is standby.
Sample treatment
(1) the blood plasma 200ul being collected is taken, adds 5ml water, is vortexed after mixing.9000 revolutions per minute centrifuge 10min, take After 0.22um membrane filtrations, subsequent filtrate 50ul sample introductions are taken to analyze.(2) the blood plasma 200ul being collected is taken, adds 5ml (mobile phases 2), it is vortexed after mixing.9000 revolutions per minute centrifuge 10min, after taking 0.22um membrane filtrations, take subsequent filtrate 50ul sample introductions to analyze.
Detection method
Detected using Shimadzu high performance liquid chromatograph, mobile phase is:(1) 1mol/L (is used with 2mol/L sodium perchlorate solutions Hydrochloric acid solution adjusts pH value to 2.5 ± 0.1)-second eyeball (60:40) it is mobile phase;Detection wavelength is 280nm.(2) 0.1mol/L phosphorus Acid dihydride potassium (2% potassium hydroxide solution adjusts pH value to 4.5)-methanol (55:45) it is mobile phase;Detection wavelength is 275nm.Use Shimadzu reverse chromatograms post, flow velocity are respectively 1.0ml/min.
Experimental result
Obtained tylosin, sulfadimidine raw material and Tylosin Tartrate sulfadimidine sustained release will be tested Micropill drug concentration data statistics is average value.(being shown in Table 1 Tylosin Tartrate) (sulfadimidine of table 2).
The drug concentration average of the different time points control group of table 1 and experimental group
The drug concentration average of the different time points control group of table 2 and experimental group
Time Control Embodiment 1 Embodiment 2 Embodiment 3
0 0 0 0 0
0.1 0 0 0.07 0.06
0.2 0.05 0.06 0.69 0.75
0.25 0.52 0.72 1.19 1.52
0.5 1.38 1.14 1.78 1.98
1 2.03 1.69 2.66 2.44
2 2.76 2.47 3.11 2.88
3 3.46 2.8 3.21 3.01
4 2.34 2.88 2.89 2.55
5 0.92 2.55 2.13 1.3
6 0.46 1.87 1.56 0.97
8 0.21 1.22 1.22 0.85
12 0.08 0.83 0.99 0.74
16 0.05 0.54 0.58 0.53
Analysis of conclusion
It was found from blood concentration and Drug-time curve, Tylosin Tartrate sulfadimidine sustained release pellet, highest blood Concentration is lower than control group, and peak time is more late, and its blood concentration decrease speed is significantly lower than control group, and can be longer when Between maintain more stable blood concentration.The drug releasing rate of wherein micropill 2 is more steady, and it is rapid to be more beneficial for blood concentration Reach efficacy result, and maintain steady, prolonged valid density, the fluctuation of blood medicine is small.Therefore the drug ratios more adduction of micropill 2 It is suitable, be advantageous to the performance of drug effect.
The pharmacy experiment of the present invention of test example 2
Experimental animal:Certain plant randomly selects more than 50kg sick pigs, clinical symptoms cough, anorexia, arranges yellow, green white Color loose stools, breathing problem is diagnosed as according to cut open inspection result and pathological analysis.It is randomly divided into three groups, every group 30.
Blank group:The sick pig not being administered.
Control group:Commercially available Tylosin Tartrate sulfadimidine soluble powder, with test group same concentrations, continuously gives Medicine 5 days, it is daily sooner or later each 1 time.
Test group:Tylosin Tartrate sulfadimidine sustained release pellet 2, with control group same concentrations, successive administration 5 My god, it is daily sooner or later each 1 time.
Table 3
Conclusion:By upper table, it is known that identical Tylosin Tartrate sulfadimidine sustained release pellet is to breathing problem Effect is notable, and curative effect is held time length, and the extrusion spheronization that the present invention uses apparently higher than general formulation and medicine Method production equipment is simple, easy to operate, and process stabilizing, is adapted to industrialized production and popularization and application.

Claims (8)

1. a kind of Tylosin Tartrate sulfadimidine sustained release pellet, its main component has the safe happy bacterium of bulk drug tartaric acid Element, sulfadimidine and auxiliary material and prepare micropill filler and binder and isolation coat layer and sustained-release coating layer.
2. such as the Tylosin Tartrate sulfadimidine sustained release pellet in claim 1, wherein micropill particle diameter is 0.5- 2.5mm。
3. such as the Tylosin Tartrate sulfadimidine sustained release pellet in claim 1, the wherein safe happy bacterium of raw material tartaric acid Element, dosage accounting example 5-20%, sulfadimidine, dosage accounting example 5-20%.
4. such as the Tylosin Tartrate sulfadimidine sustained release pellet in claim 1, wherein filler is dextrin and sugarcane The dosage of sugar, wherein dextrin is 40-60%, dosage of sucrose 10-30%.
5. such as the Tylosin Tartrate sulfadimidine sustained release pellet in claim 1, wherein binder forms sediment for pregelatinated Powder, dosage accounting example 5-20%.
6. such as the Tylosin Tartrate sulfadimidine sustained release pellet in claim 1, wherein isolation coat layer has:Isolation Coating material, hydroxypropyl methylcellulose, dosage accounting example 1-5%, plasticizer phthalic acid dibutyl ester, dosage accounting example 1- 10%th, antitackiness agent talcum powder, its dosage accounting example 1-10%, aqueous solvent.
7. such as the Tylosin Tartrate sulfadimidine sustained release pellet in claim 1, wherein sustained-release coating layer has:Sustained release Coating material triethyl citrate, dosage accounting example 1-10%, pore-foaming agent PEG6000, dosage accounting example 1-10%, antitackiness agent are slided Stone flour, dosage accounting example 1-5%.
8. prepare the preparation of the Tylosin Tartrate sulfadimidine sustained release pellet as any one of claim 1-7 Method, it uses the method for extrusion spheronization to be made.
CN201710979283.2A 2017-10-19 2017-10-19 A kind of Tylosin Tartrate sulfadimidine sustained release pellet and preparation method thereof Pending CN107496436A (en)

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2000050009A1 (en) * 1999-02-26 2000-08-31 Idexx Laboratories, Inc. Methods for administering pharmacologically active compounds to vertebrates
CN101450066A (en) * 2007-11-29 2009-06-10 天津瑞普生物技术集团有限公司 Soluble powder for treating poultry bacterial and mycoplasma infection
CN101450069A (en) * 2007-11-29 2009-06-10 天津瑞普生物技术集团有限公司 Soluble powder for treating poultry respiratory infection
CN103271931A (en) * 2013-05-20 2013-09-04 广东大华农动物保健品股份有限公司 Compound acetylisovalery tylosin tartrate pellet and preparation method thereof
CN104983718A (en) * 2015-07-17 2015-10-21 江西博莱大药厂有限公司 Tilmicosin slow release pellet, and preparation method and application thereof
CN106309409A (en) * 2016-09-29 2017-01-11 乐山市瑞和祥动物保健药业有限公司 Tylosin tartrate premix composition and preparation method of tylosin tartrate sustained-released pellets

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2000050009A1 (en) * 1999-02-26 2000-08-31 Idexx Laboratories, Inc. Methods for administering pharmacologically active compounds to vertebrates
CN101450066A (en) * 2007-11-29 2009-06-10 天津瑞普生物技术集团有限公司 Soluble powder for treating poultry bacterial and mycoplasma infection
CN101450069A (en) * 2007-11-29 2009-06-10 天津瑞普生物技术集团有限公司 Soluble powder for treating poultry respiratory infection
CN103271931A (en) * 2013-05-20 2013-09-04 广东大华农动物保健品股份有限公司 Compound acetylisovalery tylosin tartrate pellet and preparation method thereof
CN104983718A (en) * 2015-07-17 2015-10-21 江西博莱大药厂有限公司 Tilmicosin slow release pellet, and preparation method and application thereof
CN106309409A (en) * 2016-09-29 2017-01-11 乐山市瑞和祥动物保健药业有限公司 Tylosin tartrate premix composition and preparation method of tylosin tartrate sustained-released pellets

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
庄越等主编: "《实用药物制剂技术》", 31 January 1999 *

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Application publication date: 20171222