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CN106309409A - Tylosin tartrate premix composition and preparation method of tylosin tartrate sustained-released pellets - Google Patents

Tylosin tartrate premix composition and preparation method of tylosin tartrate sustained-released pellets Download PDF

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Publication number
CN106309409A
CN106309409A CN201610862377.7A CN201610862377A CN106309409A CN 106309409 A CN106309409 A CN 106309409A CN 201610862377 A CN201610862377 A CN 201610862377A CN 106309409 A CN106309409 A CN 106309409A
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Prior art keywords
tylosin tartrate
enteric
tylosin
tartrate
release
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CN106309409B (en
Inventor
李竹
王莉
田刚
曹程明
谌京梅
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Leshan Baierte Bioengineering Partnership LP
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Leshan Recondex Animal Health Care Pharmaceutical Co Ltd
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    • 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
    • A61K9/5005Wall or coating material
    • A61K9/5021Organic macromolecular compounds
    • A61K9/5026Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • 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
    • 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
    • A61K9/5005Wall or coating material
    • A61K9/5015Organic 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
    • A61K9/5089Processes

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Epidemiology (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Molecular Biology (AREA)
  • Medicinal Preparation (AREA)

Abstract

The invention relates to a tylosin tartrate premix composition and a preparation method of tylosin tartrate sustained-released pellets, aiming at solving the problems in the prior art that the encapsulation efficiency of tylosin tartrate is low, the light-shielding property and the palatability are poor, the releasing efficiency of the tylosin tartrate cannot be effectively controlled and industrial production is not easy to realize and the like. The preparation method comprises: firstly crushing a solid component and sieving; mixing the tylosin tartrate and a filling agent; adding an adhesive and covering an enteric coating layer and a sustained-released layer on the tylosin tartrate through a granulator. According to the tylosin tartrate premix composition and the preparation method of the tylosin tartrate sustained-released pellets, provided by the invention, whole encapsulation is realized and the palatability is good; the releasing efficiency of the tylosin tartrate can be effectively controlled and the industrial production can be realized.

Description

A kind of tylosin tartrate pre-mixing agent compositions and slow-release micro-pill preparation method thereof
Technical field
The present invention relates to a kind of tylosin tartrate pre-mixing agent compositions and slow-release micro-pill preparation method thereof, belong to veterinary drug Preparing technical field.
Background technology
Tylosin tartrate belongs to macrolide antibiotic, for the antibiotic that birds is special, is that treatment birds and beasts are former The ideal medicament that body is sick.The common using method of tylosin tartrate is the drinking-water admixed and be administered or put into animal in feedstuff In, but tartaric acid tylosin crude drug abnormal smells from the patient is relatively big, bitter in the mouth, and easily disperse so that it is palatability is poor, affects feed intake, Needing to increase administration number of times, be unfavorable for reaching efficient therapeutic effect, prior art CN103301144B discloses a kind of for animals Tartaric acid acetylisovaleryl tylosin pre-mixing agent preparation method, uses tartaric acid acetylisovaleryl tylosin to be combined with carrier Thing mixing acquisition is coated carrier mixture, adds carboxymethyl cellulose, D-glucitol and dehydrated alcohol mixing and obtains half inclusion Medicine, add polyethylene glycol 200 mixing improve envelop rate, vacuum drying make dehydrated alcohol volatilize, add Pulvis Talci mix, so After be diluted to the 20% of percentage by weight, it is thus achieved that tartaric acid acetylisovaleryl tylosin pre-mixing agent, this preparation method uses nothing The organic solvents such as water-ethanol, and preparation technology is loaded down with trivial details, is not suitable for industrialized production.
Summary of the invention
The present invention provides a kind of tylosin tartrate pre-mixing agent compositions and slow-release micro-pill preparation method thereof, solves existing Technology mesotartaric acid tylosin envelop rate is low, and lucifuge, palatability are poor, it is impossible to effectively control tylosin tartrate release effect Rate, and it is difficult to the problems such as industrialized production.
In order to realize the purpose of the present invention, technical scheme discloses a kind of tylosin tartrate pre-mixing agent compositions, presses Percentage by weight said composition is composed of the following components:
Tylosin tartrate: 2%~10%;
Filler: 74%~84.7%;
Binding agent: 1%~4.5%;
Enteric material: 5%~15%;
Enteric antitackiness agent: 3.5%~6.5%;
Enteric plasticizer: 0.5%~1.5%;
Slow-release material: 2%~8%;
Slow release antitackiness agent: 0.5%~5%;
Slow release plasticizer: 0.3%~2%.
In the present invention, described filler is in starch, sucrose, lactose, microcrystalline Cellulose, cross-linking sodium carboxymethyl cellulose one Plant or multiple.
In the present invention, described binding agent be mass concentration be polyvidon aqueous solution, the mass concentration of 2%~10% Be 2%~10% hydroxypropyl cellulose aqueous solution, mass concentration be 2%~10% hydroxypropylcellulose in one or more.
In the present invention, described enteric material is methacrylic acid copolymer A type, methacrylic acid copolymer Type B, methyl-prop In olefin(e) acid copolymer c-type, HP-55 one or more.
In the present invention, described enteric antitackiness agent and described slow release antitackiness agent are a kind of in glyceryl monostearate, Pulvis Talci Or two kinds.
In the present invention, described enteric plasticizer and described slow release plasticizer are propylene glycol, triethyl citrate, Polyethylene Glycol In 6000 one or more.
In the present invention, described slow-release material be season ammonio methacrylate resin copolymer Type B with A type mixture, season amino In the aqueous dispersion mixture of methacrylic acid resin copolymer Type B and A type one or both.
Based on tylosin tartrate pre-mixing agent compositions, in order to realize the purpose of the present invention, technical scheme also discloses that A kind of tylosin tartrate slow-release micro-pill preparation method, the method is made up of following processing step:
(1) each component of tylosin tartrate pre-mixing agent compositions is weighed by weight percentage, by solid in each component Component is pulverized, and makes powder body be sieved through 60 mesh~100 mesh sieve subnettings respectively, and each component individually stores, and then takes tartaric acid Thailand happy Rhzomorph adds in wet granulator with filler, and wet granulator rotating speed is 500r/min~1000r/min, and mixing time is 1min~3min, makes tylosin tartrate mix homogeneously with filler, it is thus achieved that tylosin tartrate filler mixture;
(2) in step (1) obtains tylosin tartrate filler mixture, binding agent is added, in wet granulator Mix homogeneously, speed of agitator is 800r/min~1800r/min, and shearing rotating speed is 1200r/min~2500r/min, during stirring Between be 2min~3min, it is thus achieved that tylosin tartrate soft material;
(3) tylosin tartrate soft material step (2) made, prepares strip material, hole diameter of sieve (perforated) plate with extruder 0.4mm~0.6mm, by shot-blasting machine, shot-blasting machine rotating speed is 1200r/min~2500r/min, it is thus achieved that tylosin tartrate is wet Micropill;
(4) being placed in fluid bed dry by obtaining the wet micropill of tylosin tartrate in step (3), temperature of charge is 40 DEG C ~48 DEG C, blower fan frequency 25HZ~40HZ, at 60 DEG C~80 DEG C, it is dried 15min~30min, it is thus achieved that tylosin tartrate is done Micropill;
(5) by enteric material, enteric antitackiness agent and enteric plasticizer mix homogeneously in slurry commanding tank, speed of agitator is 500r/min~600r/min, mixing time is 0.5h~1.5h, it is thus achieved that enteric coating liquid, will obtain tartaric acid in step (4) Tylosin micropill adds in Multifunction granulating machine, controls temperature of charge 40 DEG C~48 DEG C, blower fan frequency 25HZ~40HZ, atomization Pressure is 0.1MPa~0.3MPa, and peristaltic pump frequency is 2HZ~16HZ, sprays into enteric coating liquid, and hydrojet completes, at 60 DEG C~80 15min~30min it is dried so that it is moisture Control is within 3%, it is thus achieved that enteric tylosin tartrate micropill at DEG C;
(6) by slow-release material, slow release antitackiness agent, slow release plasticizer mix homogeneously in slurry commanding tank, speed of agitator is 500r/ Min~600r/min, mixing time is 0.5h~1.5h, it is thus achieved that sustained release coating liquid, safe by obtaining enteric tartaric acid in step (5) Happy rhzomorph micropill adds in Multifunction granulating machine, controls temperature of charge 40 DEG C~48 DEG C, blower fan frequency 25HZ~40HZ, atomization pressure Power is 0.1MPa~0.3MPa, and peristaltic pump frequency is 2HZ~16HZ, sprays into enteric coating liquid, and hydrojet completes, at 60 DEG C~80 DEG C Under be dried 15min~30min so that it is moisture Control is within 3%, it is thus achieved that tylosin tartrate slow-release micro-pill.
Beneficial effects of the present invention:
1, tylosin tartrate is made the micropill of easily release by the present invention, i.e. at the tartaric acid tylosin of uniform particle sizes Element surface first covers binding agent, adds fluidizer, the most again with granulator coating enteric layer and slow release layer, thus realizes winestone The total incapsulation rate of acid tylosin, encapsulation ratio is high, good palatability, effectively controls tylosin tartrate rate of release and efficiency, Reach the release effect of stable release;
2, the tylosin tartrate slow-release micro-pill that prepared by the present invention, can be divided by 40 mesh~50 mesh sieves, releasing of pre-mixing agent Overall preparation drug release behavior generation will not be had a strong impact on, therefore in preparation defect by the summation of medicine behavior because of indivedual pre-mixing agent microspheres Repeatability and the concordance aspect of release are better than existing slow releasing preparation;
3, the tylosin tartrate slow-release micro-pill that prepared by the present invention, has lucifuge, taste masking, is destroyed in gastric acid environment Amount is less than 10%, and i.e. by the protection of sustained-release coating layer in gastric acid, the destroyed amount of pre-mixing agent microsphere is few, enters intestinal Time, enteric layer dissolves, and blood levels is fluctuated little, and the difference between product is little, steady quality.
Detailed description of the invention
Hereinafter with reference to example, the present invention is described in further detail, but the invention is not restricted to these instantiations.
Tylosin tartrate pre-mixing agent compositions, said composition by weight percentage is composed of the following components:
Tylosin tartrate: 2%~10%;
Filler: 74%~84.7%;
Binding agent: 1%~4.5%;
Enteric material: 5%~15%;
Enteric antitackiness agent: 3.5%~6.5%;
Enteric plasticizer: 0.5%~1.5%;
Slow-release material: 2%~8%;
Slow release antitackiness agent: 0.5%~5%;
Slow release plasticizer: 0.3%~2%.
The tylosin tartrate slow-release micro-pill prepared based on said components, embodiment 1:
(1) each component of tylosin tartrate pre-mixing agent compositions is weighed by weight percentage, by solid in each component Component is pulverized, and makes powder body be sieved through 60 mesh~100 mesh sieve subnettings respectively, and each component individually stores, and then takes tartaric acid Thailand happy Rhzomorph adds in wet granulator with microcrystalline Cellulose, and speed of agitator is 500r/min~1000r/min, and mixing time is 1min ~3min, make tylosin tartrate mix homogeneously with filler, it is thus achieved that tylosin tartrate filler mixture;
(2) adding mass concentration in step (1) obtains tylosin tartrate filler mixture is 2%~10% Hydroxypropyl cellulose aqueous solution, mix homogeneously in wet granulator, speed of agitator is 800r/min~1800r/min, shears Rotating speed is 1200r/min~2500r/min, and mixing time is 2min~3min, it is thus achieved that tylosin tartrate soft material;
(3) tylosin tartrate soft material step (2) made, prepares strip material, hole diameter of sieve (perforated) plate with extruder 0.4mm~0.6mm, by shot-blasting machine, shot-blasting machine rotating speed is 1200r/min~2500r/min, it is thus achieved that tylosin tartrate is wet Micropill;
(4) being placed in fluid bed dry by obtaining the wet micropill of tylosin tartrate in step (3), temperature of charge is 40 DEG C ~48 DEG C, blower fan frequency 25HZ~40HZ, at 60 DEG C~80 DEG C, it is dried 15min~30min, it is thus achieved that tylosin tartrate is done Micropill;
(5) methacrylic acid copolymer A type, glyceryl monostearate and triethyl citrate are mixed in slurry commanding tank all Even, speed of agitator is 500r/min~600r/min, and mixing time is 0.5h~1.5h, it is thus achieved that enteric coating liquid, by step (4) Middle acquisition tylosin tartrate micropill adds in Multifunction granulating machine, controls temperature of charge 40 DEG C~48 DEG C, blower fan frequency 25HZ~40HZ, atomizing pressure is 0.1MPa~0.3MPa, and peristaltic pump frequency is 2HZ~16HZ, sprays into enteric coating liquid, hydrojet Complete, at 60 DEG C~80 DEG C, be dried 15min~30min so that it is moisture Control is within 3%, it is thus achieved that enteric tartaric acid Thailand is happy Rhzomorph micropill;
(6) by season ammonio methacrylate resin copolymer Type B and A type mixture, glyceryl monostearate, Fructus Citri Limoniae triethylenetetraminehexaacetic acid Ester is mix homogeneously in slurry commanding tank, and speed of agitator is 500r/min~600r/min, and mixing time is 0.5h~1.5h, it is thus achieved that slow Release coating solution, add in Multifunction granulating machine by step (5) obtains enteric tylosin tartrate micropill, control temperature of charge 40 DEG C~48 DEG C, blower fan frequency 25HZ~40HZ, atomizing pressure is 0.1MPa~0.3MPa, and peristaltic pump frequency is 2HZ~16HZ, Spraying into enteric coating liquid, hydrojet completes, at 60 DEG C~80 DEG C be dried 15min~30min so that it is moisture Control within 3%, Obtain tylosin tartrate slow-release micro-pill.
Embodiment 2:
(1) each component of tylosin tartrate pre-mixing agent compositions is weighed by weight percentage, by solid in each component Component is pulverized, and makes powder body be sieved through 60 mesh~100 mesh sieve subnettings respectively, and each component individually stores, and then takes tartaric acid Thailand happy Rhzomorph adds in wet granulator with cross-linking sodium carboxymethyl cellulose, and speed of agitator is 500r/min~1000r/min, during stirring Between be 1min~3min, make tylosin tartrate mix homogeneously with filler, it is thus achieved that tylosin tartrate filler mix Thing;
(2) adding mass concentration in step (1) obtains tylosin tartrate filler mixture is 2%~10% Polyvidon aqueous solution, mix homogeneously in wet granulator, speed of agitator is 800r/min~1800r/min, shears Rotating speed 1200r/min~2500r/min, mixing time is 2min~3min, it is thus achieved that tylosin tartrate soft material;
(3) tylosin tartrate soft material step (2) made, prepares strip material, hole diameter of sieve (perforated) plate with extruder 0.4mm~0.6mm, by shot-blasting machine, shot-blasting machine rotating speed is 1200r/min~2500r/min, it is thus achieved that tylosin tartrate is wet Micropill;
(4) being placed in fluid bed dry by obtaining the wet micropill of tylosin tartrate in step (3), temperature of charge is 40 DEG C ~48 DEG C, blower fan frequency 25HZ~40HZ, at 60 DEG C~80 DEG C, it is dried 15min~30min, it is thus achieved that tylosin tartrate is done Micropill;
(5) methacrylic acid copolymer c-type, glyceryl monostearate and triethyl citrate are mixed in slurry commanding tank all Even, speed of agitator is 500r/min~600r/min, and mixing time is 0.5h~1.5h, it is thus achieved that enteric coating liquid, by step (4) Middle acquisition tylosin tartrate micropill adds in Multifunction granulating machine, controls temperature of charge 40 DEG C~48 DEG C, blower fan frequency 25HZ~40HZ, atomizing pressure is 0.1MPa~0.3MPa, and peristaltic pump frequency is 2HZ~16HZ, sprays into enteric coating liquid, hydrojet Complete, at 60 DEG C~80 DEG C, be dried 15min~30min so that it is moisture Control is within 3%, it is thus achieved that enteric tartaric acid Thailand is happy Rhzomorph micropill;
(6) by season ammonio methacrylate resin copolymer Type B and A type mixture, glyceryl monostearate, Fructus Citri Limoniae triethylenetetraminehexaacetic acid Ester is mix homogeneously in slurry commanding tank, and speed of agitator is 500r/min~600r/min, and mixing time is 0.5h~1.5h, it is thus achieved that slow Release coating solution, add in Multifunction granulating machine by step (5) obtains enteric tylosin tartrate micropill, control temperature of charge 40 DEG C~48 DEG C, blower fan frequency 25HZ~40HZ, atomizing pressure is 0.1MPa~0.3MPa, and peristaltic pump frequency is 2HZ~16HZ, Spraying into enteric coating liquid, hydrojet completes, at 60 DEG C~80 DEG C be dried 15min~30min so that it is moisture Control within 3%, Obtain tylosin tartrate slow-release micro-pill.
Embodiment 3:
(1) each component of tylosin tartrate pre-mixing agent compositions is weighed by weight percentage, by solid in each component Component is pulverized, and makes powder body be sieved through 60 mesh~100 mesh sieve subnettings respectively, and each component individually stores, and then takes tartaric acid Thailand happy Rhzomorph and lactose add in wet granulator, and speed of agitator is 500r/min~1000r/min, mixing time be 1min~ 3min, makes tylosin tartrate mix homogeneously with filler, it is thus achieved that tylosin tartrate filler mixture;
(2) adding mass concentration in step (1) obtains tylosin tartrate filler mixture is 2%~10% Hydroxypropylcellulose, mix homogeneously in wet granulator, speed of agitator is 800r/min~1800r/min, shears rotating speed 1200r/min~2500r/min, mixing time is 2min~3min, it is thus achieved that tylosin tartrate soft material;
(3) tylosin tartrate soft material step (2) made, prepares strip material, hole diameter of sieve (perforated) plate with extruder 0.4mm~0.6mm, by shot-blasting machine, shot-blasting machine rotating speed is 1200r/min~2500r/min, it is thus achieved that tylosin tartrate is wet Micropill;
(4) being placed in fluid bed dry by obtaining the wet micropill of tylosin tartrate in step (3), temperature of charge is 40 DEG C ~48 DEG C, blower fan frequency 25HZ~40HZ, at 60 DEG C~80 DEG C, it is dried 15min~30min, it is thus achieved that tylosin tartrate is done Micropill;
(5) methacrylic acid copolymer A type, glyceryl monostearate and triethyl citrate are mixed in slurry commanding tank all Even, speed of agitator is 500r/min~600r/min, and mixing time is 0.5h~1.5h, it is thus achieved that enteric coating liquid, by step (4) Middle acquisition tylosin tartrate micropill adds in Multifunction granulating machine, controls temperature of charge 40 DEG C~48 DEG C, blower fan frequency 25HZ~40HZ, atomizing pressure is 0.1MPa~0.3MPa, and peristaltic pump frequency is 2HZ~16HZ, sprays into enteric coating liquid, hydrojet Complete, at 60 DEG C~80 DEG C, be dried 15min~30min so that it is moisture Control is within 3%, it is thus achieved that enteric tartaric acid Thailand is happy Rhzomorph micropill;
(6) by season ammonio methacrylate resin copolymer Type B and A type mixture, glyceryl monostearate, Fructus Citri Limoniae triethylenetetraminehexaacetic acid Ester is mix homogeneously in slurry commanding tank, and speed of agitator is 500r/min~600r/min, and mixing time is 0.5h~1.5h, it is thus achieved that slow Release coating solution, add in Multifunction granulating machine by step (5) obtains enteric tylosin tartrate micropill, control temperature of charge 40 DEG C~48 DEG C, blower fan frequency 25HZ~40HZ, atomizing pressure is 0.1MPa~0.3MPa, and peristaltic pump frequency is 2HZ~16HZ, Spraying into enteric coating liquid, hydrojet completes, at 60 DEG C~80 DEG C be dried 15min~30min so that it is moisture Control within 3%, Obtain tylosin tartrate slow-release micro-pill.
Embodiment 4:
(1) each component of tylosin tartrate pre-mixing agent compositions is weighed by weight percentage, by solid in each component Component is pulverized, and makes powder body be sieved through 60 mesh~100 mesh sieve subnettings respectively, and each component individually stores, and then takes tartaric acid Thailand happy Rhzomorph and sucrose add in wet granulator, and speed of agitator is 500r/min~1000r/min, mixing time be 1min~ 3min, makes tylosin tartrate mix homogeneously with filler, it is thus achieved that tylosin tartrate filler mixture;
(2) adding mass concentration in step (1) obtains tylosin tartrate filler mixture is 2%~10% Polyvidon aqueous solution, mix homogeneously in wet granulator, speed of agitator is 800r/min~1800r/min, shears Rotating speed 1200r/min~2500r/min, mixing time is 2min~3min, it is thus achieved that tylosin tartrate soft material;
(3) tylosin tartrate soft material step (2) made, prepares strip material, hole diameter of sieve (perforated) plate with extruder 0.4mm~0.6mm, by shot-blasting machine, shot-blasting machine rotating speed is 1200r/min~2500r/min, it is thus achieved that tylosin tartrate is wet Micropill;
(4) being placed in fluid bed dry by obtaining the wet micropill of tylosin tartrate in step (3), temperature of charge is 40 DEG C ~48 DEG C, blower fan frequency 25HZ~40HZ, at 60 DEG C~80 DEG C, it is dried 15min~30min, it is thus achieved that tylosin tartrate is done Micropill;
(5) HP-55, glyceryl monostearate and triethyl citrate are mixed in slurry commanding tank all Even, speed of agitator is 500r/min~600r/min, and mixing time is 0.5h~1.5h, it is thus achieved that enteric coating liquid, by step (4) Middle acquisition tylosin tartrate micropill adds in Multifunction granulating machine, controls temperature of charge 40 DEG C~48 DEG C, blower fan frequency 25HZ~40HZ, atomizing pressure is 0.1MPa~0.3MPa, and peristaltic pump frequency is 2HZ~16HZ, sprays into enteric coating liquid, hydrojet Complete, at 60 DEG C~80 DEG C, be dried 15min~30min so that it is moisture Control is within 3%, it is thus achieved that enteric tartaric acid Thailand is happy Rhzomorph micropill;
(6) by season ammonio methacrylate resin copolymer Type B with the aqueous dispersion mixture of A type, glyceryl monostearate, Triethyl citrate is mix homogeneously in slurry commanding tank, and speed of agitator is 500r/min~600r/min, mixing time be 0.5h~ 1.5h, it is thus achieved that sustained release coating liquid, adds in Multifunction granulating machine by obtaining enteric tylosin tartrate micropill in step (5), Controlling temperature of charge 40 DEG C~48 DEG C, blower fan frequency 25HZ~40HZ, atomizing pressure is 0.1MPa~0.3MPa, peristaltic pump frequency For 2HZ~16HZ, spraying into enteric coating liquid, hydrojet completes, and is dried 15min~30min so that it is moisture control at 60 DEG C~80 DEG C System is within 3%, it is thus achieved that tylosin tartrate slow-release micro-pill.
The tylosin tartrate slow-release micro-pill that will obtain in embodiment 1~4, is respectively put into the hydrochloric acid solution of 0.1mol/L In, in 37 DEG C of thermostat water baths, place 2 hours and as follows with dissolution analyzer detection dissolution results:
Embodiment Dissolution
Embodiment 1 5%
Embodiment 2 7%
Embodiment 3 5%
Embodiment 4 8%

Claims (8)

1. a tylosin tartrate pre-mixing agent compositions, by weight percentage said composition are composed of the following components:
Tylosin tartrate: 2%~10%;
Filler: 74%~84.7%;
Binding agent: 1%~4.5%;
Enteric material: 5%~15%;
Enteric antitackiness agent: 3.5%~6.5%;
Enteric plasticizer: 0.5%~1.5%;
Slow-release material: 2%~8%;
Slow release antitackiness agent: 0.5%~5%;
Slow release plasticizer: 0.3%~2%.
Tylosin tartrate pre-mixing agent compositions the most according to claim 1, it is characterised in that: described filler is for forming sediment In powder, sucrose, lactose, microcrystalline Cellulose, cross-linking sodium carboxymethyl cellulose one or more.
Tylosin tartrate pre-mixing agent compositions the most according to claim 1, it is characterised in that: described binding agent is matter Amount concentration be 2%~10% polyvidon aqueous solution, mass concentration be 2%~10% hydroxypropyl cellulose water-soluble Liquid, mass concentration be 2%~10% hydroxypropylcellulose in one or more.
Tylosin tartrate pre-mixing agent compositions the most according to claim 1, it is characterised in that: described enteric material is Methacrylic acid copolymer A type, methacrylic acid copolymer Type B, methacrylic acid copolymer c-type, hypromellose phthalandione In ester one or more.
Tylosin tartrate pre-mixing agent compositions the most according to claim 1, it is characterised in that: described enteric antitackiness agent With described slow release antitackiness agent be in glyceryl monostearate, Pulvis Talci one or both.
Tylosin tartrate pre-mixing agent compositions the most according to claim 1, it is characterised in that: described enteric plasticizer It is one or more in propylene glycol, triethyl citrate, polyethylene glycol 6000 with described slow release plasticizer.
Tylosin tartrate pre-mixing agent compositions the most according to claim 1, it is characterised in that: described slow-release material is Season ammonio methacrylate resin copolymer Type B with A type mixture, season ammonio methacrylate resin copolymer Type B with the moisture of A type In prose style free from parallelism mixture one or both.
8. the tylosin tartrate slow-release micro-pill system of preparation tylosin tartrate pre-mixing agent compositions described in claim 1 Preparation Method, it is characterised in that: the method is made up of following processing step:
(1) each component of tylosin tartrate pre-mixing agent compositions is weighed by weight percentage, by solid constituent in each component Pulverizing, make powder body be sieved through 60 mesh~100 mesh sieve subnettings respectively, each component individually stores, and then takes tylosin tartrate Adding in wet granulator with filler, wet granulator rotating speed is 500r/min~1000r/min, mixing time be 1min~ 3min, makes tylosin tartrate mix homogeneously with filler, it is thus achieved that tylosin tartrate filler mixture;
(2) in step (1) obtains tylosin tartrate filler mixture, add binding agent, mix in wet granulator Uniformly, speed of agitator is 800r/min~1800r/min, and shearing rotating speed is 1200r/min~2500r/min, and mixing time is 2min~3min, it is thus achieved that tylosin tartrate soft material;
(3) tylosin tartrate soft material step (2) made, prepares strip material, hole diameter of sieve (perforated) plate 0.4mm with extruder ~0.6mm, by shot-blasting machine, shot-blasting machine rotating speed is 1200r/min~2500r/min, it is thus achieved that the wet micropill of tylosin tartrate;
(4) being placed in fluid bed dry by obtaining the wet micropill of tylosin tartrate in step (3), temperature of charge is 40 DEG C~48 DEG C, blower fan frequency 25HZ~40HZ, at 60 DEG C~80 DEG C, it is dried 15min~30min, it is thus achieved that tylosin tartrate is done micro- Ball;
(5) by enteric material, enteric antitackiness agent and enteric plasticizer mix homogeneously in slurry commanding tank, speed of agitator is 500r/min ~600r/min, mixing time is 0.5h~1.5h, it is thus achieved that enteric coating liquid, will obtain tylosin tartrate in step (4) Micropill adds in Multifunction granulating machine, controls temperature of charge 40 DEG C~48 DEG C, and blower fan frequency 25HZ~40HZ, atomizing pressure is 0.1MPa~0.3MPa, peristaltic pump frequency is 2HZ~16HZ, sprays into enteric coating liquid, and hydrojet completes, dry at 60 DEG C~80 DEG C Dry 15min~30min so that it is moisture Control is within 3%, it is thus achieved that enteric tylosin tartrate micropill;
(6) by slow-release material, slow release antitackiness agent, slow release plasticizer mix homogeneously in slurry commanding tank, speed of agitator is 500r/min ~600r/min, mixing time is 0.5h~1.5h, it is thus achieved that sustained release coating liquid, by happy for acquisition enteric tartaric acid Thailand in step (5) Rhzomorph micropill adds in Multifunction granulating machine, controls temperature of charge 40 DEG C~48 DEG C, blower fan frequency 25HZ~40HZ, atomizing pressure For 0.1MPa~0.3MPa, peristaltic pump frequency is 2HZ~16HZ, sprays into enteric coating liquid, and hydrojet completes, at 60 DEG C~80 DEG C It is dried 15min~30min so that it is moisture Control is within 3%, it is thus achieved that tylosin tartrate slow-release micro-pill.
CN201610862377.7A 2016-09-29 2016-09-29 A kind of sustained release pellet preparation method of Tylosin Tartrate pre-mixing agent composition Expired - Fee Related CN106309409B (en)

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CN107496436A (en) * 2017-10-19 2017-12-22 洛阳瑞华动物保健品有限公司 A kind of Tylosin Tartrate sulfadimidine sustained release pellet and preparation method thereof
CN107595785A (en) * 2017-10-31 2018-01-19 成都乾坤动物药业股份有限公司 A kind of new tylosin pre-mixing agent and its preparation technology and application
CN111419823A (en) * 2020-04-30 2020-07-17 上海公谊药业有限公司 Tiamulin fumarate enteric-coated pellet as well as preparation method and application thereof
CN115475150A (en) * 2022-10-14 2022-12-16 江西高胜动物保健品有限公司 Novel enteric coated tylosin tartrate product and preparation method thereof

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CN105616383A (en) * 2015-12-30 2016-06-01 中国药科大学 Acetylisovaleryl tylosion tartrate enteric pellet and preparation method thereof
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Publication number Priority date Publication date Assignee Title
CN107496436A (en) * 2017-10-19 2017-12-22 洛阳瑞华动物保健品有限公司 A kind of Tylosin Tartrate sulfadimidine sustained release pellet and preparation method thereof
CN107595785A (en) * 2017-10-31 2018-01-19 成都乾坤动物药业股份有限公司 A kind of new tylosin pre-mixing agent and its preparation technology and application
CN107595785B (en) * 2017-10-31 2019-10-22 成都乾坤动物药业股份有限公司 A kind of tylosin pre-mixing agent and the preparation method and application thereof
CN111419823A (en) * 2020-04-30 2020-07-17 上海公谊药业有限公司 Tiamulin fumarate enteric-coated pellet as well as preparation method and application thereof
CN111419823B (en) * 2020-04-30 2022-03-29 上海公谊药业有限公司 Tiamulin fumarate enteric-coated pellet as well as preparation method and application thereof
CN115475150A (en) * 2022-10-14 2022-12-16 江西高胜动物保健品有限公司 Novel enteric coated tylosin tartrate product and preparation method thereof

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