CN109464413A - A kind of Tilmicosin pellet and preparation method thereof - Google Patents
A kind of Tilmicosin pellet and preparation method thereof Download PDFInfo
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- CN109464413A CN109464413A CN201811473522.8A CN201811473522A CN109464413A CN 109464413 A CN109464413 A CN 109464413A CN 201811473522 A CN201811473522 A CN 201811473522A CN 109464413 A CN109464413 A CN 109464413A
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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
- A61K31/7052—Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides
- A61K31/706—Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides containing six-membered rings with nitrogen as a ring hetero atom
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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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2013—Organic compounds, e.g. phospholipids, fats
- A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
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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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2054—Cellulose; Cellulose derivatives, 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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2059—Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
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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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2068—Compounds of unknown constitution, e.g. material from plants or animals
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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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2806—Coating materials
- A61K9/2833—Organic macromolecular compounds
- A61K9/286—Polysaccharides, e.g. gums; Cyclodextrin
- A61K9/2866—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P31/04—Antibacterial agents
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Abstract
The present invention provides a kind of Tilmicosin pellets, based on parts by weight, including following components: capsule core: 10~25 parts of Tilmicosin, 5~20 parts of microcrystalline cellulose, 5~15 parts of Icing Sugar, 15~40 parts of flour, 15~40 parts of starch；Coating: 20~150ppm parts of phagostimulant, 5-28 parts of hypromellose.In addition, the present invention provides a kind of preparation methods of Tilmicosin pellet, it is required in strict accordance with relevant criterion, by comparing various process recipes, coating material and its coating weight gain ratio, and pass through trial-production, dissolution test, a kind of optimum formula is chosen, the Tilmicosin pellet of preparation not only effectively masks bitter taste, but also can fully meet the related request of " Republic of China Veterinary Pharmacopoeia " about Tilmicosin pre-mixing agent simultaneously.
Description
Technical field
The invention belongs to technical field of veterinary, and in particular to a kind of Tilmicosin pellet and preparation method thereof.
Background technique
It is well known that Tilmicosin is macrolides animal specific antibiotic, and it is the derivative of tylosin, it is blue to leather
Family name's positive bacteria and some Gram-negative bacterias and mycoplasma are effective, especially to pleuropneumonia actinomyces, pasteurella, golden yellow
Color staphylococcus, streptococcus pyogenes, streptococcus pneumonia, corynebacterium pyogenes and livestock and poultry mycoplasma activity more than tylosin
By force, clinically it is mainly used for treating animals infectious diseases as caused by sensitive bacteria such as ox, goat, sheep, milk cow, pig, chicken, it is special
It is not livestock and poultry respiratory tract infection and every microbial mastitis for milk cows of sense.
Although Tilmicosin, because its is significant in efficacy, the palatability of Tilmicosin is mutually on duty, and taste is extremely bitter, have one to stomach
Fixed stimulation, thus occur the phenomenon that food refusal is even vomitted often in animal mixed feeding, it has seriously affected it and has prevented in livestock and poultry
With the application in treatment.For this characteristic, lot of domestic and foreign scientific research institution and manufacturer expand preparation process research, to
Achieve the effect that can effectively taste masking, enteric-coated micro-pill most typically is made in Tilmicosin.However, at present in veterinary drug national standard
Only dosage forms, the enteric such as Tilmicosin pre-mixing agent, Tilmicosin soluble powder, Tilmicosin injection, tilmicosin solution is micro-
Ball need to be executed to apply on the market by Tilmicosin pre-mixing agent standard, and still, enteric-coated micro-pill causes because it is coated taste masking
Release slowly, is detected, content is lower, does not reach requirement and can be judged into counterfeit drug or substandard drug by relevant criterion.
On the one hand Tilmicosin pre-mixing agent prepared by the prior art not can be carried out effective taste masking, palatability is bad, shadow
Ring animal ingestion amount；On the other hand, the prior art is using Tilmicosin pre-mixing agent made of hybrid mode, and material is in powdery,
It is uneven to will lead to mixing when spice, but also serious discomfort can be brought to operator because of the bitter taste of Tilmicosin dust
Sense.For these disadvantages, the prior art is usually that enteric-coated micro-pill is made in Tilmicosin, masks the hardship of Tilmicosin well
Taste, but it is used using coating material is improper or coating material is suitable and usage amount excessively make product dissolution release compared with
Slowly, cause product content when being detected according to relevant criterion relatively low without up to standard.
Summary of the invention
Technical problem to be solved by the invention is to provide a kind of Tilmicosin pellets and preparation method thereof, in strict accordance with phase
Standard requirements are closed, by comparing various process recipes, coating material and its coating weight gain ratio, and pass through trial-production, dissolution test,
A kind of optimum formula is chosen, the Tilmicosin pellet of preparation not only effectively masks bitter taste, but also can fully meet veterinary drug simultaneously
The requirement of allusion quotation standard.
To achieve the goals above, the technical solution used in the present invention is: a kind of Tilmicosin pellet, including capsule core and
Coating, the capsule core includes following components based on parts by weight:
Capsule core: 10~25 parts of Tilmicosin, 5~20 parts of microcrystalline cellulose, 5~15 parts of Icing Sugar, 15~40 parts of flour, starch
15~40 parts；
The coating includes following components: 0.00002~0.00015 part of (20~150ppm of phagostimulant based on parts by weight
Part), 5-28 parts of hypromellose.The ppm i.e. hundred a ten thousandths.
Wherein, the starch is other starch such as cornstarch, wheaten starch, potato starch.
Wherein, the phagostimulant is ethylmaltol, can also be replaced with fennel, monosodium glutamate, saccharin, molasses, betel nut.
Wherein, the hypromellose is selected from E5~E50 type.
In the formula of the present invention for crossing inspection taste-masking tilmicosin pellet, microcrystalline cellulose used plays diluent, profit
The effect of lubrication prescription and disintegrating agent can make product have certain lubricity, be convenient for wet granulation.Simultaneously because its disintegrating property is preferable,
Drug can be made to be easy to be released effectively in gastrointestinal tract after animal feed, to increase the bioavilability of drug.
Icing Sugar used in the formula of the present invention for crossing inspection taste-masking tilmicosin pellet mainly plays sweetener,
Play the palatability for adjusting product.
Flour and starch used in the formula of the present invention for crossing inspection taste-masking tilmicosin pellet as filler, glue
On the one hand mixture, diluent are due to it is easy to be digested and assimilated by animal as nutrition；On the other hand, the two has one
Viscosity, ratio properly then can be convenient for being made wet softwood, wet granular.Wet is prepared because its viscosity is excessive using flour merely
Blocking mesh is be easy to cause when grain.Cornstarch is used merely, then because viscosity is slightly smaller, obtained wet granular viscosity is not enough, more loose
It dissipates, particle is thinner.Thus needing the two, collocation uses according to a certain percentage.
Phagostimulant used in the formula of the present invention for crossing inspection taste-masking tilmicosin pellet also makes fumet, fragrance change
Good dose, to increase ingesting for animal.
Hypromellose used in the formula of the present invention for crossing inspection taste-masking tilmicosin pellet, needs using low
The model of viscosity is as coating material, such as E5~E50, preferably E5.First is that considering the dissolution of hypromellose in water
Speed is general, taste masking but also can have slow release effect convenient for reaching.But the coating dosage of hydroxypropyl methylcellulose is to taste masking and effectively
Release plays very crucial effect again, and dosage is few to be then not achieved effective taste masking effect；Dosage is more, product can be made to dissolve
Release is slower, and content is not up to standard when causing to detect by standards of pharmacopoeia requirement.Second is that the hypromellose of low viscosity is in water
Solubility it is higher, the aqueous solution of higher concentration can be prepared, not only make to save the ingredient time in the actual production process, but also can subtract
Few Coating times, achieve the purpose that energy-saving, cost efficiency.
Based on the above technical solution, the present invention also provides the preparation method of above-mentioned Tilmicosin pellet, packets
Include following steps:
1) the capsule core component is uniformly mixed, water is added to be soaked, softwood is made；
2) the step 1) softwood is successively pelletized, is round as a ball, dry, coating and whole grain obtain finished product；
Wherein the coating solution used that is coated is the hypromellose aqueous solution containing the phagostimulant.
Wherein, the hypromellose aqueous solution that the coating is 2~6% using mass fraction, 10 are weighed with capsule core~
20% ratio coating.The whole grain is sieving whole grain, crosses No. 2 sieves (24 mesh), and the pellet partial size is 850 ± 29 μm.
Described plus water is soaked, and when softwood is made, in terms of solid component mass fraction, the moisture of 5-10% is added, and is enabled
Manufactured softwood humidity with hand pinch it is agglomerating, unclamp i.e. scattered be advisable.The granulation, round as a ball, dry, coating and whole grain use ball respectively
Face extrusion mechanism carries out round as a ball, fluidized bed fluidized drying pelletizer drying at wet grain, spheronizator, seed-coating machine is sprayed at fluidized bed bottom, on
The conventional practices and conventional parameter that operation is all those skilled in the art are stated, will not repeat them here.
It should be noted that, although joined water and coating solution use in the capsule core preparation process of Tilmicosin pellet
Aqueous solution, but subsequent drying nest can evaporate moisture, remaining water is very micro to be can be ignored.
Compared with prior art, the beneficial effects of the present invention are:
1, the preparation of dressing process formula had the Tilmicosin pellet of inspection taste masking function, reaches and fully meets veterinary drug allusion quotation pass
In the requirement of the relevant criterions such as bulk pharmaceutical chemicals content, while the bitter taste of Tilmicosin can be effectively covered again, improve animal ingestion amount.
2, moist wood and capsule core after mixing, then with suitable water is made using proper ratio in the Tilmicosin pellet,
Consistency and viscosity are suitable, and capsule core hardness is also moderate, are convenient for industrial applications.
3, capsule core uses the hypromellose of low viscosity (≤100mPa.s) for coating material after drying, wherein also
Containing a small amount of ethylmaltol (about 80-120ppm), can achieve can effective taste masking and product cross inspection, reach " middle Chinese
People republic veterinary drug allusion quotation " related request about Tilmicosin pre-mixing agent.
Detailed description of the invention
Fig. 1 is the preparation method process flow chart of Tilmicosin pellet of the invention.
Specific embodiment
For a better understanding of the present invention, with reference to the accompanying drawing and the specific embodiment content that the present invention is furture elucidated,
But the contents of the present invention are not limited solely to the following examples.
Embodiment 1:
Tilmicosin 230g, Icing Sugar 100g, microcrystalline cellulose 100g, flour 200g, cornstarch 250g, mixing is equal
It is even, add suitable quantity of water to stir into uniform moist wood, humidity with hand pinch it is agglomerating, unclamp i.e. scattered be advisable.Moist wood is squeezed through spherical surface extruder
Out, spheronizator is round as a ball, obtains the wet capsule core of Tilmicosin, then wet capsule core is passed through seed-coating machine drying, 5% hypromellose
(contain ethylmaltol 100ppm) aqueous solution is coated, whole grain, finally obtains in the Tilmicosin pellet of inspection taste masking with matter
Score meter is measured, Tilmicosin 20% is contained.
Embodiment 2:
Tilmicosin 115g, Icing Sugar 100g, microcrystalline cellulose 100g, flour 260g, wheaten starch 295g are uniformly mixed,
Add suitable quantity of water to stir into uniform moist wood, humidity with hand pinch it is agglomerating, unclamp i.e. scattered be advisable.Moist wood is squeezed out through spherical surface extruder,
Spheronizator is round as a ball, obtains the wet capsule core of Tilmicosin, then dry, 2% hypromellose (contains second by seed-coating machine by wet capsule core
Base maltol 80ppm) aqueous solution coating, whole grain, finally obtained inspection taste masking Tilmicosin pellet based on mass fraction, contain
Tilmicosin 10%.
Embodiment 3:
Tilmicosin 46kg, Icing Sugar 20kg, microcrystalline cellulose 20kg, flour are added in 400 type high efficiency wet granulators
50kg, it potato starch 50kg, is uniformly mixed, then suitable quantity of water is sprayed by spray hole while stirring, be uniformly mixing to obtain moist wood.It will
Moist wood is squeezed out through E-150 type twin-screw spherical surface extruder, then round as a ball through S-1000 type spheronizator, obtains the wet capsule core of Tilmicosin,
By round as a ball resulting wet capsule core, by FL-300 type fluidized bed fluidized drying pelletizer, dry, the type fluidized bed bottom WBF-250 is sprayed again
Seed-coating machine is coated with 6% hypromellose (containing betel nut 150ppm) aqueous solution, will finally be coated resulting pico- ball
Whole grain is carried out, the Tilmicosin pellet that inspection taste masking is obtained based on mass fraction, contains Tilmicosin 20%.
Embodiment 4:
Tilmicosin 23kg, Icing Sugar 25kg, microcrystalline cellulose 23kg, flour are added in 400 type high efficiency wet granulators
55kg, it cornstarch 60kg, is uniformly mixed, then suitable quantity of water is sprayed by spray hole while stirring, be uniformly mixing to obtain moist wood.It will be wet
Material is squeezed out through E-150 type twin-screw spherical surface extruder, then round as a ball through S-1000 type spheronizator, obtains the wet capsule core of Tilmicosin, then
Round as a ball resulting wet capsule core is dry by FL-300 type fluidized bed fluidized drying pelletizer, the type fluidized bed bottom WBF-250 spray packet
Clothing machine is coated with 5% hypromellose (containing molasses 20ppm) aqueous solution, and it is whole will to be finally coated resulting pellet progress
Grain, the Tilmicosin pellet that inspection taste masking is obtained based on mass fraction, contain Tilmicosin 10%.
Tilmicosin pellet obtained in the embodiment 1-4 is subjected to the experiment of pig food ration, result is as shown in the table:
| Group | Average feed intake g/ days |
| Blank group | 275 |
| Control group | 213 |
| Experimental group 1 | 326 |
| Experimental group 2 | 319 |
| Experimental group 3 | 330 |
| Experimental group 4 | 306 |
Wherein, the blank group feeding chow diet, chow diet component include corn, soya-bean cake, rice bran, bone meal, eggshell
Powder etc..The control group fed chow diet adds the Tilmicosin pellet of commercially available acquisition (purchased from Alibaba's platform).The reality
Test the Tilmicosin pellet that group feeding chow diet adds the present invention to obtain.Using 18 health pigs points three groups, every group 3 carry out it is flat
Row experiment.The additional amount of Tilmicosin pellet about 200ppm based on parts by weight in the control group and experimental group.
It is demonstrated experimentally that Tilmicosin pellet provided by the invention has better taste masking effect, taking the photograph for domestic animal can be improved
Appetite.
The foregoing is merely presently preferred embodiments of the present invention, is not intended to limit the invention, it is all in spirit of the invention and
Within principle, any modification, equivalent replacement, improvement and so on be should all be included in the protection scope of the present invention.
Claims (7)
1. a kind of Tilmicosin pellet, which is characterized in that including capsule core and coating, the capsule core includes following based on parts by weight
Component: 10~25 parts of Tilmicosin, 5~20 parts of microcrystalline cellulose, 5~15 parts of Icing Sugar, 15~40 parts of flour, starch 15~40
Part；The coating includes following components: 0.00002~0.00015 part of phagostimulant, hypromellose 5- based on parts by weight
28 parts.
2. a kind of Tilmicosin pellet according to claim 1, it is characterised in that: the starch is cornstarch, wheat
Starch or potato starch.
3. a kind of Tilmicosin pellet according to claim 1, it is characterised in that: the phagostimulant be ethylmaltol,
Fennel, monosodium glutamate, saccharin, molasses or betel nut.
4. a kind of Tilmicosin pellet according to claim 1, it is characterised in that: the hypromellose is selected from E5
~E50 type.
5. a kind of preparation method of such as described in any item Tilmicosin pellets of Claims 1-4, which is characterized in that including such as
Lower step:
1) the capsule core component is uniformly mixed, water is added to be soaked, softwood is made；
2) the step 1) softwood is successively pelletized, is round as a ball, dry, coating and whole grain obtain finished product；
Wherein the coating solution used that is coated is the hypromellose aqueous solution containing the phagostimulant.
6. the preparation method of Tilmicosin pellet according to claim 5, which is characterized in that the coating solution is quality point
The hypromellose aqueous solution that number is 2~6% weighs 10~20% ratio coating with capsule core.
7. the preparation method of Tilmicosin pellet according to claim 5, which is characterized in that the whole grain is that sieving is whole
Grain, the sieve are 24 mesh.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201811473522.8A CN109464413A (en) | 2018-12-04 | 2018-12-04 | A kind of Tilmicosin pellet and preparation method thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201811473522.8A CN109464413A (en) | 2018-12-04 | 2018-12-04 | A kind of Tilmicosin pellet and preparation method thereof |
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| CN109464413A true CN109464413A (en) | 2019-03-15 |
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| CN201811473522.8A Pending CN109464413A (en) | 2018-12-04 | 2018-12-04 | A kind of Tilmicosin pellet and preparation method thereof |
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Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2007016153A2 (en) * | 2005-07-28 | 2007-02-08 | Eli Lilly And Company | Tilmicosin formulation |
| 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 |
| CN104606141A (en) * | 2013-11-01 | 2015-05-13 | 瑞普（天津）生物药业有限公司 | Tilmicosin enteric micro pellet |
| CN105125524A (en) * | 2015-10-20 | 2015-12-09 | 中牧南京动物药业有限公司 | Tilmicosin enteric-coated pellets and preparation method thereof |
| CN108653230A (en) * | 2018-06-24 | 2018-10-16 | 王琴 | Coating type veterinary drug pill and preparation method thereof |
-
2018
- 2018-12-04 CN CN201811473522.8A patent/CN109464413A/en active Pending
Patent Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2007016153A2 (en) * | 2005-07-28 | 2007-02-08 | Eli Lilly And Company | Tilmicosin formulation |
| 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 |
| CN104606141A (en) * | 2013-11-01 | 2015-05-13 | 瑞普（天津）生物药业有限公司 | Tilmicosin enteric micro pellet |
| CN105125524A (en) * | 2015-10-20 | 2015-12-09 | 中牧南京动物药业有限公司 | Tilmicosin enteric-coated pellets and preparation method thereof |
| CN108653230A (en) * | 2018-06-24 | 2018-10-16 | 王琴 | Coating type veterinary drug pill and preparation method thereof |
Non-Patent Citations (1)
| Title |
|---|
| 王继华等编著: "《鸡饲料配方设计技术》", 31 July 2005, 中国农业大学出版社 * |
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