CN105616383A - Acetylisovaleryl tylosion tartrate enteric pellet and preparation method thereof - Google Patents
Acetylisovaleryl tylosion tartrate enteric pellet and preparation method thereof Download PDFInfo
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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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- 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
- A61K9/5026—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
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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
- A61K9/5047—Cellulose ethers containing no ester groups, e.g. hydroxypropyl methylcellulose
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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
- A61K9/5073—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 having two or more different coatings optionally including drug-containing subcoatings
- A61K9/5078—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 having two or more different coatings optionally including drug-containing subcoatings with drug-free core
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Abstract
The invention discloses an acetylisovaleryl tylosion tartrate enteric pellet and a preparation method thereof. The pellet comprises a blank pellet core, a medicine carrying layer, an isolation layer and an enteric layer, wherein the weight of the medicine carrying layer is 10-30% of the weight of the blank pellet core; the weight of the isolation layer is 5-15% of the total weight of the blank pellet core and the medicine carrying layer; the weight of the enteric layer is 20-30% of the total weight of the blank pellet core, the medicine carrying layer and the isolation layer; the diameter of the blank pellet core is 0.8-1.0mm; the particle diameter of the acetylisovaleryl tylosion tartrate enteric pellet is 20-30 meshes. The acetylisovaleryl tylosion tartrate enteric pellet prepared by the method can only release a large quantity of medicines under high-pH condition, so that the damage of acidic stomach environment to medicine is reduced; the stability of the preparation in the acid is ensured; the bioavailability is improved.
Description
Technical field
The present invention relates to safe ten thousand rhzomorph enteric coated micropills of a kind of tartaric acid and preparation method thereof, belong to technical field of veterinary.
Background technology
Safe ten thousand rhzomorphs of tartaric acid are the commercial brand-new macrolide antibiotics of Yi Ke animal health company of Britain, and its chemical name is acetylisovaleryl tylosin (AcetylisovalerylTylosinTartrate). It is the derivant that generates through chemical improvement of Tylosin A, mainly acts on gram positive bacteria and mycoplasma, and part gram negative bacteria is all had obvious inhibitory action. It is mainly used in the treatment Proliferative Enteritis of pig, dysentery, mycoplasmal pneumonia (mycoplasma pneumoniae of swine) and the mycoplasma of chicken, perfringens bacillus cereus disease, nose trachea ornithosis bacillus, is the ideal medicament of poultry mycoplasma.
Safe ten thousand rhzomorphs of tartaric acid are unstable under sour environment, degrade particularly rapid. At present, safe ten thousand rhzomorphs of common on market tartaric acid have two kinds of dosage forms. One is pre-mixing agent, it is adaptable to pig; Another kind is soluble powder, adopts mixed drink administration, it is adaptable to chicken. Existing preparation process is simple, but still is subject to the impact of gastric acid, destroys medicine stability so that the bioavailability of medicine reduces. On the other hand, the safe ten thousand rhzomorph powder of the tartaric acid of powder are tiny, and easily disperse formation dust, and the health of operator is easily caused infringement.
Therefore, clinic needs stable, the safe ten thousand rhzomorph novel formulation of efficient tartaric acid badly, to ensure its clinical efficacy.
Summary of the invention
The technical problem to be solved is: for the deficiencies in the prior art, it is provided that safe ten thousand rhzomorph enteric coated micropills of a kind of tartaric acid and preparation method thereof, it is ensured that preparation is stability in acid, to improve bioavailability; Good fluidity simultaneously, reduces dust.
The preparation method of the safe ten thousand rhzomorph enteric coated micropills of tartaric acid of the present invention is as follows:
The safe ten thousand rhzomorph enteric coated micropills of a kind of tartaric acid, include celphere, drug-loaded layer, sealing coat and enteric layer from inside to outside. Wherein, one or more in sucrose, starch, lactose, dextrin and microcrystalline Cellulose of described celphere. The drug-loaded layer piller obtained after described celphere parcel drug-loaded layer, its drug loading is 10-30%. A kind of in water, the ethanol of the solvent of described drug-loaded layer solution or both arbitrary proportion mixture. Described sealing coat contains the hydroxypropyl methyl cellulose of 20-60%, the lubricant of 40-60%, for the 5-15% of drug-loaded pellets quality. Described enteric layer contains the film former of 40-60%, the plasticizer of 5-15%, 20-40% lubricant, enteric layer coating weight gain be parcel sealing coat piller 20-30%.
Wherein, one or more in sucrose, starch, lactose, dextrin and microcrystalline Cellulose of described celphere, it is preferable that sucrose, diameter is 0.8��1.0 millimeter.
A kind of in water, the ethanol of the solvent of described drug-loaded layer solution or both arbitrary proportion mixture, it is preferable that water.
Wherein, described lubricant is one or more in Pulvis Talci, magnesium stearate, it is preferable that Pulvis Talci.
Wherein, the film former in described enteric layer is one or more of acrylic resin, hydroxypropylmethyl cellulose phthalate, polyacrylic resin and polyacrylic acid resin emulsion, it is preferable that acrylic resin.
Wherein, the plasticizer in described enteric layer is one or more in propylene glycol, triethyl citrate, diethyl phthalate, Polyethylene Glycol, it is preferable that triethyl citrate.
Present invention also provide that
The safe ten thousand rhzomorph enteric coated micropill preparation methoies of a kind of tartaric acid, it comprises the following steps:
(1) drug-loaded layer: add a certain amount of water and make safe ten thousand rhzomorphs of tartaric acid be completely dissolved, obtain drug-loaded layer drug solution. Open fluidized-bed coating machine, put into celphere, carry out drug-loaded layer medicine-feeding, after terminating, prepare drug-loaded pellets through dry;
(2) sealing coat: hydroxypropyl methyl cellulose and lubricant Pulvis Talci are joined in suitable quantity of water, stirs, obtain sealing coat coating solution. Drug-loaded pellets step (1) obtained puts in fluid bed and carries out sealing coat coating, prepares sealing coat piller through dry after terminating, and increase weight the 5-15% into drug-loaded pellets;
(3) enteric layer: film former, plasticizer, lubricant are dissolved in appropriate water, make enteric layer coating solution. Being put in fluid bed by the sealing coat piller of step (2) gained and carry out enteric layer coating, prepare enteric pellet through dry after terminating, increase weight the 20-30% into sealing coat piller.
Coating parameter described in above-mentioned preparation method is particularly as follows: the inlet temperature of fluid bed is set as 50 DEG C-60 DEG C, and leaving air temp is set as 30 DEG C-40 DEG C, and blower fan frequency setting is 20-40Hz, after coating terminates, and discharging after the dry 30-60min of continuation.
Compared with prior art, the safe ten thousand rhzomorph enteric coated micropills of the tartaric acid of the present invention possess stability in good acid, and medicine can be made from the impact of gastric acid; Possessing higher bioavailability, drug effect is good. Additionally, the safe ten thousand rhzomorph enteric coated micropill good fluidities of the tartaric acid of the present invention, decreasing dust, medication is convenient.
Accompanying drawing explanation
Fig. 1 is the blood concentration-time curve synoptic diagram of the embodiment of the present invention 2.
Detailed description of the invention
Below in conjunction with embodiment, the present invention is described in further detail. But the invention is not restricted to given example. Agents useful for same of the present invention and raw material all commercially maybe can be prepared by literature method.
Embodiment 1
The safe ten thousand rhzomorph enteric coated micropills of tartaric acid are prepared according to following formula:
Concrete preparation process is as follows:
(1) drug-loaded layer: safe for tartaric acid ten thousand rhzomorphs are added to the water and are completely dissolved, obtain drug-loaded layer drug solution. Opening fluidized-bed coating machine, put into celphere, carry out drug-loaded layer medicine-feeding, medicine-feeding continues the prepared drug loading of dry 30min after terminating be the drug-loaded pellets of 30%;
(2) sealing coat: hydroxypropyl methyl cellulose and Pulvis Talci are added to the water, stir, obtains sealing coat coating solution. Drug-loaded pellets step (1) obtained puts in fluid bed and carries out sealing coat coating, and coating is dry 30min after terminating, and discharging is weighed, and prepares the sealing coat piller that weightening finish is for the 5% of drug-loaded pellets;
(3) enteric layer: acrylic resin, triethyl citrate, Pulvis Talci are dissolved in appropriate water, make enteric layer coating solution. Being put in fluid bed by the sealing coat piller of step (2) gained and carry out enteric layer coating, coating is dry 30min after terminating, and discharging is weighed, and prepares the safe ten thousand rhzomorph enteric pellet of tartaric acid that weightening finish is sealing coat piller 30%.
Coating parameter described in above-mentioned preparation method is particularly as follows: the inlet temperature of fluid bed is set as 50 DEG C-60 DEG C, and leaving air temp is set as 30 DEG C-40 DEG C, and blower fan frequency setting is 20-40Hz, after coating terminates, and discharging after the dry 30-60min of continuation.
Embodiment 2
The safe ten thousand rhzomorph enteric coated micropills of tartaric acid are prepared according to following formula:
Concrete preparation process is as follows:
(1) drug-loaded layer: safe for tartaric acid ten thousand rhzomorphs are added to the water and are completely dissolved, obtain drug-loaded layer drug solution. Opening fluidized-bed coating machine, put into celphere, carry out drug-loaded layer medicine-feeding, medicine-feeding continues the prepared drug loading of dry 30min after terminating be the drug-loaded pellets of 30%;
(2) sealing coat: hydroxypropyl methyl cellulose and Pulvis Talci are added to the water, stir, obtains sealing coat coating solution. Drug-loaded pellets step (1) obtained puts in fluid bed and carries out sealing coat coating, and coating is dry 30min after terminating, and discharging is weighed, and prepares the sealing coat piller that weightening finish is for the 10% of drug-loaded pellets;
(3) enteric layer: acrylic resin, triethyl citrate, Pulvis Talci are dissolved in appropriate water, make enteric layer coating solution. Being put in fluid bed by the sealing coat piller of step (2) gained and carry out enteric layer coating, coating is dry 30min after terminating, and discharging is weighed, and prepares the safe ten thousand rhzomorph enteric pellet of tartaric acid that weightening finish is sealing coat piller 25%.
Coating parameter described in above-mentioned preparation method is particularly as follows: the inlet temperature of fluid bed is set as 50 DEG C-60 DEG C, and leaving air temp is set as 30 DEG C-40 DEG C, and blower fan frequency setting is 20-40Hz, after coating terminates, and discharging after the dry 30-60min of continuation.
Embodiment 3
The safe ten thousand rhzomorph enteric coated micropills of tartaric acid are prepared according to following formula:
Concrete preparation process is as follows:
(1) drug-loaded layer: safe for tartaric acid ten thousand rhzomorphs are added to the water and are completely dissolved, obtain drug-loaded layer drug solution. Opening fluidized-bed coating machine, put into celphere, carry out drug-loaded layer medicine-feeding, medicine-feeding continues the prepared drug loading of dry 30min after terminating be the drug-loaded pellets of 30%;
(2) sealing coat: hydroxypropyl methyl cellulose and Pulvis Talci are added to the water, stir, obtains sealing coat coating solution. Drug-loaded pellets step (1) obtained puts in fluid bed and carries out sealing coat coating, and coating is dry 30min after terminating, and discharging is weighed, and prepares the sealing coat piller that weightening finish is for the 12% of drug-loaded pellets;
(3) enteric layer: acrylic resin, triethyl citrate, Pulvis Talci are dissolved in appropriate water, make enteric layer coating solution. Being put in fluid bed by the sealing coat piller of step (2) gained and carry out enteric layer coating, coating is dry 30min after terminating, and discharging is weighed, and prepares the safe ten thousand rhzomorph enteric pellet of tartaric acid that weightening finish is sealing coat piller 20%.
Coating parameter described in above-mentioned preparation method is particularly as follows: the inlet temperature of fluid bed is set as 50 DEG C-60 DEG C, and leaving air temp is set as 30 DEG C-40 DEG C, and blower fan frequency setting is 20-40Hz, after coating terminates, and discharging after the dry 30-60min of continuation.
Embodiment 4
The safe ten thousand rhzomorph enteric coated micropills of tartaric acid are prepared according to following formula:
Concrete preparation process is as follows:
(1) drug-loaded layer: safe for tartaric acid ten thousand rhzomorphs are added to the water and are completely dissolved, obtain drug-loaded layer drug solution. Opening fluidized-bed coating machine, put into celphere, carry out drug-loaded layer medicine-feeding, medicine-feeding continues the prepared drug loading of dry 30min after terminating be the drug-loaded pellets of 25%;
(2) sealing coat: hydroxypropyl methyl cellulose and Pulvis Talci are added to the water, stir, obtains sealing coat coating solution. Drug-loaded pellets step (1) obtained puts in fluid bed and carries out sealing coat coating, and coating is dry 30min after terminating, and discharging is weighed, and prepares the sealing coat piller that weightening finish is for the 10% of drug-loaded pellets;
(3) enteric layer: acrylic resin, triethyl citrate, Pulvis Talci are dissolved in appropriate water, make enteric layer coating solution. Being put in fluid bed by the sealing coat piller of step (2) gained and carry out enteric layer coating, coating is dry 30min after terminating, and discharging is weighed, and prepares the safe ten thousand rhzomorph enteric pellet of tartaric acid that weightening finish is sealing coat piller 20%.
Coating parameter described in above-mentioned preparation method is particularly as follows: the inlet temperature of fluid bed is set as 50 DEG C-60 DEG C, and leaving air temp is set as 30 DEG C-40 DEG C, and blower fan frequency setting is 20-40Hz, after coating terminates, and discharging after the dry 30-60min of continuation.
Embodiment 5
The safe ten thousand rhzomorph enteric coated micropills of tartaric acid are prepared according to following formula:
Concrete preparation process is as follows:
(1) drug-loaded layer: safe for tartaric acid ten thousand rhzomorphs are added to the water and are completely dissolved, obtain drug-loaded layer drug solution. Opening fluidized-bed coating machine, put into celphere, carry out drug-loaded layer medicine-feeding, medicine-feeding continues the prepared drug loading of dry 30min after terminating be the drug-loaded pellets of 20%;
(2) sealing coat: hydroxypropyl methyl cellulose and Pulvis Talci are added to the water, stir, obtains sealing coat coating solution. Drug-loaded pellets step (1) obtained puts in fluid bed and carries out sealing coat coating, and coating is dry 30min after terminating, and discharging is weighed, and prepares the sealing coat piller that weightening finish is for the 10% of drug-loaded pellets;
(3) enteric layer: acrylic resin, triethyl citrate, Pulvis Talci are dissolved in appropriate water, make enteric layer coating solution. Being put in fluid bed by the sealing coat piller of step (2) gained and carry out enteric layer coating, coating is dry 30min after terminating, and discharging is weighed, and prepares the safe ten thousand rhzomorph enteric pellet of tartaric acid that weightening finish is sealing coat piller 20%.
Coating parameter described in above-mentioned preparation method is particularly as follows: the inlet temperature of fluid bed is set as 50 DEG C-60 DEG C, and leaving air temp is set as 30 DEG C-40 DEG C, and blower fan frequency setting is 20-40Hz, after coating terminates, and discharging after the dry 30-60min of continuation.
Embodiment 6
The safe ten thousand rhzomorph enteric coated micropills of tartaric acid are prepared according to following formula:
Concrete preparation process is as follows:
(1) drug-loaded layer: safe for tartaric acid ten thousand rhzomorphs are added to the water and are completely dissolved, obtain drug-loaded layer drug solution. Opening fluidized-bed coating machine, put into celphere, carry out drug-loaded layer medicine-feeding, medicine-feeding continues the prepared drug loading of dry 30min after terminating be the drug-loaded pellets of 30%;
(2) sealing coat: hydroxypropyl methyl cellulose and Pulvis Talci are added to the water, stir, obtains sealing coat coating solution. Drug-loaded pellets step (1) obtained puts in fluid bed and carries out sealing coat coating, and coating is dry 30min after terminating, and discharging is weighed, and prepares the sealing coat piller that weightening finish is for the 15% of drug-loaded pellets;
(3) enteric layer: acrylic resin, triethyl citrate, Pulvis Talci are dissolved in appropriate water, make enteric layer coating solution. Being put in fluid bed by the sealing coat piller of step (2) gained and carry out enteric layer coating, coating is dry 30min after terminating, and discharging is weighed, and prepares the safe ten thousand rhzomorph enteric pellet of tartaric acid that weightening finish is sealing coat piller 20%.
Coating parameter described in above-mentioned preparation method is particularly as follows: the inlet temperature of fluid bed is set as 50 DEG C-60 DEG C, and leaving air temp is set as 30 DEG C-40 DEG C, and blower fan frequency setting is 20-40Hz, after coating terminates, and discharging after the dry 30-60min of continuation.
Embodiment 7
Adopt the safe ten thousand rhzomorph enteric coated micropills of embodiment 2 tartaric acid, measure its release.
According to one annex drug release determination method the second method (for enteric coated preparation) method 1 of " People's Republic of China's veterinary drug allusion quotation " version in 2010, simulate stomach, enteric liquid respectively with the hydrochloric acid solution of 0.1mol/L, pH6.8 phosphate buffered solution, measure in the acid of the safe ten thousand rhzomorph enteric coated micropills of embodiment 2 tartaric acid 45min burst size in 2h burst size and buffer; Meet in acid 2h stripping quantity less than 10%, and in buffer 45min stripping quantity be not less than the requirement of 70% be qualified.
It is measured according to the high performance liquid chromatography under the assay item of " People's Republic of China's veterinary drug allusion quotation " version in 2010 safe ten thousand rhzomorphs of one tartaric acid when measuring content.
Measurement result shows: the safe ten thousand rhzomorph enteric coated micropills of embodiment 2 tartaric acid are without substantially destroying in simulated gastric fluid, and shape keeps complete. The safe ten thousand rhzomorph enteric coated micropill 2h not dissolutions in simulated gastric fluid of embodiment 2 tartaric acid, and the dissolution rate of 45min reaches 93.5% in simulated intestinal fluid, meet related request, there is stability in good acid, medicine can be made from the impact of gastric acid, and possess good enteric characteristics.
Embodiment 8
Adopt the safe ten thousand rhzomorph enteric coated micropills of embodiment 2 tartaric acid as by reagent, adopting the safe ten thousand rhzomorph pre-mixing agents of commercially available common tartaric acid to carry out pharmacokinetics test as control formulation.
Test method:
Adopt 60 different age in days Landraces, will by reagent and control formulation respectively with oral administration gavage mode single-dose, dosage is in the safe ten thousand rhzomorph 20mg/kg the weight of animals of tartaric acid.
Taking a blood sample through vena cava anterior after single-dose, take a blood sample 5ml every time. Blank plasma is gathered before administration, after administration 15,30,45min, 1,2,4,6,8,12,24h gather plasma sample respectively, be placed in advance with in the polyethylene tube of anticoagulant heparin, 4000r/min is centrifuged 5min, separated blood plasma puts-20 DEG C of Refrigerator stores, to be measured.
During detection, accurately take blood plasma 0.5ml, put in 5ml centrifuge tube with cover, add 1mL acetonitrile, vortex 5min, 10000r/min are centrifuged 10min, Aspirate supernatant (all transfer), nitrogen stream dries up, and redissolves with mobile phase, enters HPLC and detects blood drug level (�� g/ml). Chromatographic condition is as follows: chromatographic column is AgilentTC-C18; Mobile phase is 0.15M ammonium acetate aqueous solution-second eyeball-acetic acid (45: 45: 10, V/V/V); Flow velocity is 1.0ml/min; Column temperature is 40 DEG C; Detection wavelength is 290nm; Sample size is 20 �� l.
The safe ten thousand rhzomorph enteric coated pellets formulations of tartaric acid and common commercial preparation determination of plasma concentration result in pig body are as shown in Figure 1. This result shows: in pig body in pharmacokinetic studies, compared with control formulation, and invention formulation relative bioavailability is 138.3%. This illustrates, adopts the safe ten thousand rhzomorph enteric coated micropills of tartaric acid prepared by this law to be remarkably improved bioavailability.
In addition to the implementation, the invention is not limited to described embodiment. Those of ordinary skill in the art also can make all equivalent modification or replacement, these equivalent modification or replacement under the premise without prejudice to the invention spirit and be all contained in the application claim limited range.
Claims (8)
1. the safe ten thousand rhzomorph enteric coated micropills of tartaric acid, include celphere, drug-loaded layer, sealing coat and enteric layer from inside to outside.
Wherein, one or more in sucrose, starch, lactose, dextrin and microcrystalline Cellulose of described celphere; Obtaining drug-loaded pellets after described celphere parcel drug-loaded layer, its drug loading is 10-30%; Described sealing coat contains the hydroxypropyl methyl cellulose of 20-60%, the lubricant of 40-60%, for the 5-15% of drug-loaded pellets quality; Described enteric layer contains the film former of 40-60%, the plasticizer of 5-15%, the lubricant of 20-40%, and enteric layer coating weight gain is the 20-30% of parcel sealing coat piller.
2. safe ten thousand rhzomorph enteric coated micropills of tartaric acid according to claim 1, is characterized in that, described celphere is sucrose, and diameter is 0.8��1.0 millimeter.
3. safe ten thousand rhzomorph enteric coated micropills of tartaric acid according to claim 1, is characterized in that, described drug-loaded layer solvent is a kind of in water, ethanol or both arbitrary proportion mixture.
4. safe ten thousand rhzomorph enteric coated micropills of tartaric acid according to claim 1, is characterized in that, described lubricant is one or more in Pulvis Talci, magnesium stearate.
5. safe ten thousand rhzomorph enteric coated micropills of tartaric acid according to claim 1, it is characterized in that, the film former in described enteric layer is one or more of acrylic resin, hydroxypropylmethyl cellulose phthalate, polyacrylic resin and polyacrylic acid resin emulsion.
6. safe ten thousand rhzomorph enteric coated micropills of tartaric acid according to claim 1, is characterized in that, the plasticizer in described enteric layer is one or more in propylene glycol, triethyl citrate, diethyl phthalate, Polyethylene Glycol.
7. the safe ten thousand rhzomorph enteric coated micropill preparation methoies of tartaric acid, is characterized in that, comprise the following steps:
(1) drug-loaded layer: add a certain amount of solvent and make safe ten thousand rhzomorphs of tartaric acid be completely dissolved, obtain drug-loaded layer drug solution. Open fluidized-bed coating machine, put into celphere, carry out drug-loaded layer medicine-feeding, after terminating, prepare drug-loaded pellets through dry;
(2) sealing coat; Hydroxypropyl methyl cellulose and lubricant Pulvis Talci are joined in suitable quantity of water, stirs, obtain sealing coat coating solution. Drug-loaded pellets step (1) obtained puts in fluid bed and carries out sealing coat coating, prepares sealing coat piller through dry after terminating, and increase weight the 5-15% into drug-loaded pellets;
(3) enteric layer: film former, plasticizer, lubricant are dissolved in appropriate water, make enteric layer coating solution. Being put in fluid bed by the sealing coat piller of step (2) gained and carry out enteric layer coating, prepare enteric pellet through dry after terminating, increase weight the 20-30% into sealing coat piller.
8. safe ten thousand rhzomorph enteric coated micropill preparation methoies of tartaric acid according to claim 7, it is characterized in that, above-mentioned coating parameter is particularly as follows: the inlet temperature of fluid bed is set as 50 DEG C-60 DEG C, leaving air temp is set as 30 DEG C-40 DEG C, blower fan frequency setting is 20-40Hz, after coating terminates, discharging after the dry 30-60min of continuation.
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| CN201511028422.0A CN105616383A (en) | 2015-12-30 | 2015-12-30 | Acetylisovaleryl tylosion tartrate enteric pellet and preparation method thereof |
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Cited By (5)
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| 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 |
| CN110604725A (en) * | 2019-11-06 | 2019-12-24 | 山东胜利生物工程有限公司 | Tylosin tartrate preparation and preparation method thereof |
| CN114642641A (en) * | 2022-05-24 | 2022-06-21 | 山东国邦药业有限公司 | Tylosin tartrate water-soluble granules and preparation method thereof |
| CN116687877A (en) * | 2023-08-07 | 2023-09-05 | 山东国邦药业有限公司 | Taqniamycin tartrate dry suspension and preparation method thereof |
| CN117205179A (en) * | 2023-07-31 | 2023-12-12 | 沈阳伟嘉生物技术有限公司 | Amorphous spherical enteric granule of tylosin tartrate and preparation method thereof |
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2015
- 2015-12-30 CN CN201511028422.0A patent/CN105616383A/en active Pending
Cited By (8)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| 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 |
| CN106309409B (en) * | 2016-09-29 | 2019-05-24 | 乐山市瑞和祥动物保健药业有限公司 | A kind of sustained release pellet preparation method of Tylosin Tartrate pre-mixing agent composition |
| CN110604725A (en) * | 2019-11-06 | 2019-12-24 | 山东胜利生物工程有限公司 | Tylosin tartrate preparation and preparation method thereof |
| CN114642641A (en) * | 2022-05-24 | 2022-06-21 | 山东国邦药业有限公司 | Tylosin tartrate water-soluble granules and preparation method thereof |
| CN114642641B (en) * | 2022-05-24 | 2022-07-26 | 山东国邦药业有限公司 | Tylosin tartrate water-soluble granules and preparation method thereof |
| CN117205179A (en) * | 2023-07-31 | 2023-12-12 | 沈阳伟嘉生物技术有限公司 | Amorphous spherical enteric granule of tylosin tartrate and preparation method thereof |
| CN116687877A (en) * | 2023-08-07 | 2023-09-05 | 山东国邦药业有限公司 | Taqniamycin tartrate dry suspension and preparation method thereof |
| CN116687877B (en) * | 2023-08-07 | 2023-11-10 | 山东国邦药业有限公司 | Taqniamycin tartrate dry suspension and preparation method thereof |
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