CN104274411B - Tilmicosin micron preparation and preparation method thereof - Google Patents
Tilmicosin micron preparation and preparation method thereof Download PDFInfo
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- CN104274411B CN104274411B CN201410585345.8A CN201410585345A CN104274411B CN 104274411 B CN104274411 B CN 104274411B CN 201410585345 A CN201410585345 A CN 201410585345A CN 104274411 B CN104274411 B CN 104274411B
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Abstract
The invention discloses a tilmicosin micron preparation and a preparation method thereof. The tilmicosin micron preparation is prepared from the following components in parts by weight: 5-20 parts of tilmicosin, 5-20 parts of styrene-maleic acid copolymer, 5-20 parts of zein, 2-5 parts of ethylcellulose, 10-40 parts of one or two of medicinal ethanol and propylene glycol, 5-15 parts of one or several of methyl acetate, acetic ether and butyl acetate and 20-80 parts of one or several maltodextrin, sucrose powder of 80 meshes and glucose. The tilmicosin, the styrene-maleic acid copolymer, the zein and ethylcellulose carrier materials are fused to form emulsion, the carrier can be used for effectively encapsulating tilmicosin, the tilmicosin is uniformly dispersed in the carrier material, the original medicinal bitter taste is covered, and the effect of improving the bioavailability is achieved. The preparation method is simple, economic, low in cost, environment-friendly, safe and high in reproducibility. The product is high in bioavailability, convenient in administration and good in bitter taste masking effect, and the palatability of the medicine is improved.
Description
Technical field
The present invention relates to a kind of veterinary drug production technology preparation, be specifically related to a kind of tilmicosin micron preparation and preparation side thereof
Method.
Background technology
Tilmicosin (Tilmicosin) be Lilly Co., Eli. in Elanco company of subordinate branch company in 80 years 20th century
Generation exploitation by the tylosin semisynthetic Macrolide special antibiotic of poultry.The antimicrobial spectrum of tilmicosin and tylosin
Similar, both are to gram negative bacteria, eggs crack detection, erysipelothrix ruhsiopathiae, Actinobacillus pleuropneumoniae and chicken poison
Mycoplasma all has stronger fungistatic effect, and other bacterium then show as fungistatic effect is more weak or Drug resistance.But at hemorrhage deteriorated blood
Property pasteurella and pasteurella hemolytica aspect have potentiation.Internal and external test the most all confirms and examines for rice
Star is to pasteurella multocida and the antibacterial action of pasteurella hemolytica.Tilmicosin is used for preventing and treating pig Mycoplasma
During pneumonia, the main mode using spice to feed.When prevention and treatment avian mycoplasmas disease, then many addition drinking-water medications.
At present, the dosage form recorded in People's Republic of China's veterinary drug allusion quotation have tilmicosin injection, tilmicosin pre-mixing agent,
Three kinds of dosage forms of tilmicosin solution.Tilmicosin is water insoluble, and its injection there are certain defect: tilmicosin
Development and the production process of injection are complex, and because injection requires aseptic without thermal source, production process is strict, needs higher
Appointed condition, also ratio solid preparation poor stability in storage process.It addition, the injection of tilmicosin has potential kidney to pig
Toxicity.The production technology of tilmicosin pre-mixing agent is simple, only by the preparation that is simply mixed with adjuvant, but exists during using
With feedstuff mixing time and effort consuming, easily cause the shortcomings such as mixing is uneven, mixed feeding dosage is inaccurate, and its bitterness be overweight,
Cannot use by recommended dose in pharmacopeia (200～400g/ ton feedstuffs calculate according to tilmicosin active substance), have a strong impact on
The feed intake of pig, bioavailability is low.The veterinary dosage form that modern large-scale cultivation factory more gladly accepts be not only can with mixed feeding but also
The powder of drink can be mixed.
In prior art, it is solvable that the Chinese invention patent of Application No. 201210173727.0 discloses a kind of tilmicosin
Property powder and preparation method thereof, this preparation method can make soluble powder, facilitates feasible time prepared by laboratory, but industry is raw
Produce a large amount of use organic solvent and on the one hand add production cost, on the other hand can cause environmental pollution.Application No.
The Chinese invention patent of 201310021437.9 discloses the production method of a kind of 20% tilmicosin granule, and the method is through twice
Pelletization, produces relatively complicated, increases production cost.Application No. 201310301120.0 discloses a kind of compound recipe and examines for rice
Star soluble powder and its preparation method and application, it is tilmicosin, Radix Glycyrrhizae extract, carrier to be mixed through simple physics
Conjunction is prepared from, and water solublity effect is unsatisfactory.
Summary of the invention
It is an object of the invention to overcome the defect of above-mentioned prior art, it is provided that a kind of tilmicosin micron preparation and system thereof
Preparation Method, its production technology is simple, Environmental Safety, and preparation cost is low, and medicine stability is strong, encapsulates effective, biological profit
Expenditure is high, and mouthfeel is without bad smell and bitterness, and medication is convenient.
For achieving the above object, the present invention adopts the following technical scheme that a kind of tilmicosin micron preparation, and it is by weight
Meter is made up of following components: tilmicosin 5-20 part, styrol maleic acid copolymers 5-20 part, zein 5-20 part,
Ethyl cellulose 2-5 part, medicinal alcohol, the one of propylene glycol or two kinds of 10-40 parts, methyl acetate, ethyl acetate, butyl acetate
One or more 5-15 parts, one or more the 20-80 parts in maltodextrin, the cane sugar powder of 80 mesh, glucose.The present invention
Tilmicosin be dispersed in carrier material, product is solid, it is easy to preserves and transports.
Based on technique scheme, it is preferred that the weight portion of above-mentioned each component is: tilmicosin 5 parts, styrene maleic acid
Copolymer 5 parts, zein 10 parts, ethyl cellulose 2 parts, medicinal alcohol, the one of propylene glycol or two kinds 20 parts, acetic acid
Methyl ester, ethyl acetate, one or more 5 parts of butyl acetate, one in maltodextrin, the cane sugar powder of 80 mesh, glucose or
Several 28 parts.
A kind of preparation method of tilmicosin micron preparation, the method comprises the following steps:
Step one, gets the raw materials ready: prepare raw material according to the following ratio: tilmicosin 5-20 part, carrier material: styrene maleic acid is common
Polymers 5-20 part, zein 5-20 part and ethyl cellulose 2-5 part, solvent: medicinal alcohol, the one of propylene glycol or two
Plant 10-40 part, non-solvent: methyl acetate, ethyl acetate, one or more 5-15 parts of butyl acetate, maltodextrin, 80 purposes
One or more 20-80 parts in cane sugar powder, glucose；
Step 2, first by standby raw material carrier material and solvent-medicinal alcohol, the one of propylene glycol or two kinds be mixed
Carrier solution；
Step 3, adds tilmicosin mix homogeneously, makes emulsion；
Step 4, adds one or more mixture of non-solvent-methyl acetate, ethyl acetate, butyl acetate, makes load
Body dissolubility reduces, and causes separated, and microporous filter separates to obtain micron；
Step 5, adds one or more in maltodextrin, the cane sugar powder of 80 mesh, glucose, mixing granulation；
Step 6, granule drying under reduced pressure 2-3 hour at 50-60 DEG C that will prepare in step 5,30-50 mesh carries out whole
Grain, obtains tilmicosin micron preparation.
Based on technique scheme, described in above-mentioned preparation method, in step 4, the fineness of microporous filter is 0.45 micron of filter
Film.
Based on technique scheme, described in above-mentioned preparation method, the proportioning of getting the raw materials ready in step one is: tilmicosin 5 parts,
Styrol maleic acid copolymers 5 parts, zein 10 parts, ethyl cellulose 2 parts, medicinal alcohol, the one of propylene glycol or
Two kinds 20 parts, methyl acetate, ethyl acetate, one or more 5 parts of butyl acetate, maltodextrin, the cane sugar powder of 80 mesh, Fructus Vitis viniferae
One or more in sugar 28 parts.
Beneficial effects of the present invention: carrier selected by the present invention is styrol maleic acid copolymers, zein and second
Base cellulose, this carrier can effectively encapsulate tilmicosin, be respectively provided with nontoxic, non-carcinogenesis, not with medicine generation chemical change, no
The chemical stability that affects principal agent, the drug effect not affecting medicine and content detection, medicine can be made to obtain optimum dispersion state, inexpensive
The advantage such as be easy to get, and tilmicosin is dispersed in carrier material, plays raising raw while covering its original bitter taste of drug
The effect of thing availability.Preparation method simplicity economy of the present invention, low cost, Environmental Safety, existing property are good.The biology of obtained product
Availability is high, and medication is convenient, and taste masking effect is preferable, improves the palatability of medicine.
Detailed description of the invention
Below in conjunction with specific embodiment, the invention will be further described.
Embodiment 1: a kind of tilmicosin micron preparation, said preparation is made up of following components by weight: tilmicosin 5
Part, carrier material: styrol maleic acid copolymers 5 parts, zein 10 parts and ethyl cellulose 2 parts, solvent: medicinal second
Alcohol 20 parts, non-solvent: methyl acetate 5 parts, adjuvant: the cane sugar powder of maltodextrin and 80 mesh adds up to 28 parts.
The preparation method of above-mentioned tilmicosin micron preparation, comprises the concrete steps that:
1) first carrier material total 17 parts is joined 5 parts of medicinal alcohol solvents, stir, dissolve.
2) add 5 parts of tilmicosins while stirring, make tilmicosin and carrier material solution make emulsion；
3) non-solvent material is added--ethyl acetate 5 parts, make carrier solubility reduce, cause separated；
4) microporous filter (0.45 micron membrane filter), separates to obtain micron；Filtrate recycles and reuses；
5) micron adds adjuvant: the cane sugar powder of maltodextrin and 80 mesh adds up to 28 parts, mixing granulation；
6) 55 DEG C of drying under reduced pressure of granule 2.5 hours, 40 mesh carry out granulate, obtain tilmicosin micron preparation.
Embodiment 2: a kind of tilmicosin micron preparation, said preparation is made up of following components by weight: tilmicosin
20 parts；Carrier material: styrol maleic acid copolymers 20 parts, zein 5 parts, ethyl cellulose 5 parts；Solvent: medicinal
Ethanol 25 parts, propylene glycol 15 parts；Non-solvent: methyl acetate 8 parts, butyl acetate 7 parts, glucose 65 parts.
The preparation method of above-mentioned tilmicosin micron preparation, comprises the concrete steps that:
1) first carrier material total 40 parts is joined 25 parts of medicinal alcohols and in solvent that 15 parts of propylene glycol are made, stirring
Uniformly, dissolve；
2) add 20 parts of tilmicosins while stirring, make tilmicosin and carrier material solution make emulsion；
3) non-solvent material is added--methyl acetate 8 parts, butyl acetate 7 parts, make carrier solubility reduce, cause and divide mutually
From；
4) microporous filter (0.45 micron membrane filter), separates to obtain micron；Filtrate recycles and reuses；
5) in step 4 gained micron, glucose 65 parts, mixing granulation are added；
6) 50-60 DEG C of drying under reduced pressure of granule 2 hours, 30 mesh carry out granulate, obtain tilmicosin micron preparation.
Embodiment 3: a kind of tilmicosin micron preparation, said preparation is made up of following components by weight: tilmicosin
10 parts；Carrier material: styrol maleic acid copolymers 10 parts, zein 20 parts, ethyl cellulose 4 parts；Solvent: medicinal
Each 10 parts of ethanol, propylene glycol；Non-solvent: each 5 parts of ethyl acetate, butyl acetate；Adjuvant: maltodextrin, the cane sugar powder of 80 mesh, Portugal
Each 20 parts of grape sugar.
The preparation method of above-mentioned tilmicosin micron preparation, comprises the concrete steps that:
1) first all carrier materials 34 parts are joined 10 parts of medicinal alcohols and in solvent that 10 parts of propylene glycol are made, stirring
Uniformly, dissolve；
2) add 10 parts of tilmicosins while stirring, make tilmicosin and carrier material solution make emulsion；
3) non-solvent material is added--ethyl acetate 5 parts and butyl acetate 5 parts, make carrier solubility reduce, cause phase
Separate；
4) microporous filter (0.45 micron membrane filter), separates to obtain micron；Filtrate recycles and reuses；
5) micron adds in maltodextrin, the cane sugar powder of 80 mesh, glucose each 20 parts, mixing granulation；
6) 50-60 DEG C of drying under reduced pressure of granule 3 hours, 40 mesh carry out granulate, obtain tilmicosin micron preparation.
Embodiment 4: a kind of tilmicosin micron preparation, said preparation is made up of following components by weight::
Tilmicosin 15 parts；Carrier material: styrol maleic acid copolymers 5 parts, zein 15 parts, ethyl is fine
Dimension element 5 parts；Solvent: propylene glycol 30 parts；Non-solvent: methyl acetate 5 parts, ethyl acetate 5 parts；Adjuvant: maltodextrin and glucose
Each 20 parts.
The preparation method of above-mentioned tilmicosin micron preparation, comprises the concrete steps that:
1) first all carrier materials 25 parts are joined 30 parts of propylene glycol solvent, stir, dissolve；
2) add 10 parts of tilmicosins while stirring, make tilmicosin and carrier material solution make emulsion；
3) non-solvent material is added--methyl acetate 5 parts, ethyl acetate 5 parts, make carrier solubility reduce, cause phase
Separate；
4) microporous filter (0.45 micron membrane filter), separates to obtain micron；Filtrate recycles and reuses；
5) micron addition adjuvant: maltodextrin and each 20 parts of glucose, mixing granulation；
6) 50-60 DEG C of drying under reduced pressure of granule 2 hours, 40 mesh carry out granulate, obtain tilmicosin micron preparation.
Embodiment 5: product is at the palatability testing on pig farm
Test method: the applicant carries out palatability examination on Mu Yuan pig farm, Neixiang County, Henan Province to above-mentioned tilmicosin micron preparation
Test, particularly as follows: choose healthy fattening pig 45, be randomly divided into A, B, C 3 groups, often group 15.A group is blank group, does not gives
Medicine only feeding feed stuff；B group give embodiment 1 preparation tilmicosin micron preparation (Zhengzhou He Run Biology Pharmacy Co., Ltd carries
Confession, lot number 20140822), by 0.1% mixed feeding, C group gives common pre-mixing agent (the 10% tilmicosin pre-mixing agent city bought on market
Buy certain animal pharmaceutical factory on field to produce, lot number 20140805) by 0.1% mixed feeding；3 groups of feedings and managements of A, B, C are identical, A, B in 4h
The material of two groups is all eaten up, and about the material of C group residue half.
Experiment conclusion: the palatability of pig feed is not affected by tilmicosin micron of the present invention.
Embodiment 6: the tilmicosin micron preparation of the present invention clinical trial to pig pleuropneumonia, specific as follows:
Material: A:10% tilmicosin micron preparation, the product of embodiment 1 preparation
B:10% tilmicosin pre-mixing agent, purchased from market products
Test method: choose Mu Yuan pig farm, Neixiang County, Henan Province from numerous autotrophy, age in days is close, feeding and management condition is essentially identical,
It is diagnosed as respiratory tract disease, the fattening pig of recent non-administration 60, it is randomly divided into 2 groups, i.e. experimental group, matched group, often group 30.
Experimental group presses 0.1% spice, gives the tilmicosin micron preparation A(Zhengzhou He Run bio-pharmaceuticals by the embodiment of the present invention 1 preparation
Company limited provides), it is used in conjunction 5 days；Matched group presses 0.1% spice, and the common pre-mixing agent B(10% giving to buy on market examines for rice
Star pre-mixing agent, market is bought certain animal pharmaceutical factory and produces, lot number 20140805), it is used in conjunction 5 days, two groups of feedings and managements are identical.
Outcome measure method is as follows:
Cure rate: during medication, is administered pig clinical symptoms and is wholly absent, and spirit, appetite, body temperature, feces, breathes, coughs
It is healing normally Deng recovery, cures number according to each treated animal and calculate its cure rate.
Effective percentage: during medication, is administered pig spirit, appetite takes a turn for the better, and symptom alleviates, and cough substantially alleviates as effectively, according to
Significant figure in every treated animal calculates its effective percentage.
Inefficiency: during test, after medication, clinical symptoms has no that the pig alleviating or continuing deterioration and death is all judged to nothing
Effect, calculates its inefficiency according to the invalid number in every treated animal.
The table 1 tilmicosin micron preparation clinical trial result to pig pleuropneumonia:
Tabular analysis: 10% tilmicosin pre-mixing agent group is because of the bitterness of tilmicosin, and the feed intake of pig has declined, from examination
Test result it can be seen that the therapeutic effect of 10% tilmicosin micron preparation is better than the therapeutic effect of 10% tilmicosin pre-mixing agent.
Experiment conclusion: the effective percentage of experimental group and cure rate are all high than matched group, it can be seen that the tilmicosin of the present invention
Micron preparation embodies good clinical effectiveness in terms for the treatment of porcine respiratory disease.
Conclusion: compared with tilmicosin pre-mixing agent, tilmicosin micron preparation of the present invention is without the extremely hardship of tilmicosin raw material
Taste, after improve poultry morbidity, feed intake declines and the problem that affects ingestion of medicines；Simultaneously because it is slow releasing preparation, make for rice
Examining star to be more easy in vivo absorb, effective blood drug concentration is held time longer, and bioavailability is higher, is conducive to improving treatment effect
Really.
In sum, tilmicosin micron preparation production technique of the present invention is simple, there is not environmental pollution, good palatability,
Medicament slow release, clinical application effect is notable.
Claims (4)
1. a tilmicosin micron preparation, is characterized in that: said preparation is made up of following components by weight: tilmicosin 5-
20 parts, styrol maleic acid copolymers 5-20 part, zein 5-20 part, ethyl cellulose 2-5 part, medicinal alcohol, third
The one of glycol or two kinds of 10-40 parts, methyl acetate, ethyl acetate, one or more 5-15 parts of butyl acetate, Fructus Hordei Germinatus is stuck with paste
One or more 20-80 parts in essence, the cane sugar powder of 80 mesh, glucose.
Tilmicosin micron preparation the most according to claim 1, is characterized in that: the weight portion of each component of said preparation is: replace
Meter Kao Xing 5 parts, styrol maleic acid copolymers 5 parts, zein 10 parts, ethyl cellulose 2 parts, medicinal alcohol, the third two
The one of alcohol or two kinds 20 parts, methyl acetate, ethyl acetate, one or more 5 parts of butyl acetate, maltodextrin, 80 purposes
One or more in cane sugar powder, glucose 28 parts.
3. a preparation method for tilmicosin micron preparation, is characterized in that: the method comprises the following steps:
Step one, gets the raw materials ready: prepare raw material according to the following ratio: tilmicosin 5-20 part, carrier material: styrol maleic acid copolymers
5-20 part, zein 5-20 part and ethyl cellulose 2-5
Part, solvent: medicinal alcohol, the one of propylene glycol or two kinds of 10-40 parts, non-solvent: methyl acetate, ethyl acetate, acetic acid
One or more 5-15 parts of butyl ester, one or more the 20-80 parts in maltodextrin, the cane sugar powder of 80 mesh, glucose；
Step 2, first by standby raw material carrier material and solvent-medicinal alcohol, the one of propylene glycol or two kinds be mixed and made into carrier
Solution；
Step 3, adds tilmicosin mix homogeneously, makes emulsion；
Step 4, adds one or more mixture of non-solvent-methyl acetate, ethyl acetate, butyl acetate, makes carrier molten
Xie Du reduces, and causes separated, and microporous filter, the fineness of microporous filter is 0.45 micron membrane filter, separates to obtain micron；
Step 5, adds one or more in maltodextrin, the cane sugar powder of 80 mesh, glucose, mixing granulation；
Step 6, granule drying under reduced pressure 2-3 hour at 50-60 DEG C that will prepare in step 5,30-50 mesh carries out granulate, i.e.
Obtain tilmicosin micron preparation.
The preparation method of tilmicosin micron preparation the most according to claim 3, is characterized in that: standby in described step one
Material proportioning is: tilmicosin 5 parts, styrol maleic acid copolymers 5 parts, zein 10 parts, ethyl cellulose 2 parts, medicine
With ethanol, the one of propylene glycol or two kinds 20 parts, methyl acetate, ethyl acetate, one or more 5 parts of butyl acetate, Fructus Hordei Germinatus
One or more in dextrin, the cane sugar powder of 80 mesh, glucose 28 parts.
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Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4824675A (en) * | 1987-07-13 | 1989-04-25 | Alza Corporation | Dispenser with movable matrix comprising a plurality of tiny pills |
| CN101879141A (en) * | 2009-05-05 | 2010-11-10 | 烟台绿叶动物保健品有限公司 | Taste-masking tilmicosin gastric-soluble particle preparation |
| CN102670516A (en) * | 2012-05-29 | 2012-09-19 | 广东大华农动物保健品股份有限公司 | Tilmicosin soluble powder and preparation method thereof |
-
2014
- 2014-10-28 CN CN201410585345.8A patent/CN104274411B/en active Active
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4824675A (en) * | 1987-07-13 | 1989-04-25 | Alza Corporation | Dispenser with movable matrix comprising a plurality of tiny pills |
| CN101879141A (en) * | 2009-05-05 | 2010-11-10 | 烟台绿叶动物保健品有限公司 | Taste-masking tilmicosin gastric-soluble particle preparation |
| CN102670516A (en) * | 2012-05-29 | 2012-09-19 | 广东大华农动物保健品股份有限公司 | Tilmicosin soluble powder and preparation method thereof |
Non-Patent Citations (1)
| Title |
|---|
| 高分子载体材料在药用微球中的应用及进展;王建华，黄永中;《高分子通报》;20110731(第7期);全文 * |
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