CN102688220B - Tilmicosin micro-capsule preparation and preparation method thereof - Google Patents
Tilmicosin micro-capsule preparation and preparation method thereof Download PDFInfo
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- CN102688220B CN102688220B CN201210185792.5A CN201210185792A CN102688220B CN 102688220 B CN102688220 B CN 102688220B CN 201210185792 A CN201210185792 A CN 201210185792A CN 102688220 B CN102688220 B CN 102688220B
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Abstract
The invention relates to a tilmicosin micro-capsule preparation, and in particular relates to a tilmicosin micro-capsule preparation and a preparation method of the tilmicosin micro-capsule preparation, belonging to the technical field of veterinary medicine. The tilmicosin micro-capsule preparation comprises an inner core layer and a coating layer, wherein the inner core layer comprises a tilmicosin raw material and macromolecule auxiliary materials, the macromolecule auxiliary materials are selected from one or more than one of 12-carbon fatty acid-18-carbon fatty acid, paraffins and vegetable wax; and the coating layer comprises an inner coating layer and an outer coating layer, wherein the material of the inner coating layer is one or more than one of starch, calcium carbonate and calcium hydrophosphate, and the material of the outer coating layer is acrylic resin. The tilmicosin micro-capsule preparation disclosed by the invention is tasteless, enteric, and good in palatability. According to the invention, the tilmicosin is packed by the macromolecule auxiliary materials, a layer of enteric coating layer is sprayed on the surfaces of the tilmicosin grains in the process of rolling circle when the materials are prepared, and the strong bitter taste and odor of the tilmicosin can be completely covered due to the double-layer package, and the preparation method is simple in technology, and low in cost.
Description
Technical field
The present invention relates to a kind of tilmicosin preparation, particularly a kind of tilmicosin microcapsule formulation and preparation method thereof, belongs to veterinary drug technical field.
Background technology
Tilmicosin (Timicosin) is the special antibiotic of semi-synthetic Macrolide poultry of the exploitation eighties in 20th century, and gram positive bacteria, some gram negative bacteria, mycoplasma, spirillum etc. are all had to inhibitory action; Pleuropneumonia actinomycetes, pasteurellosis bacillus are had to the antibacterial activity stronger than tylosin.Be mainly used in preventing and treating the mastitis of domestic animal pneumonia (being caused by infection such as Actinobacillus pleuropneumoniae, pasteurellosis bacillus, mycoplasmas), avian mycoplasmas disease and lactogenic animal.Recent study finds that it has certain inhibitory action to reproductive and respiratory syndrome, so tilmicosin has the wide market space.But because tilmicosin is very bitter, and scent of, when spice is fed, can affect palatability on the one hand, on the other hand the stomach of animal be had to stimulation, serious time, cause vomiting, the taste that even some animal smells tilmicosin just be unwilling to be taken food, and has had a strong impact on applying of tilmicosin.
CN101879141 (2010-11-10) discloses a kind of taste-masking tilmicosin gastric-soluble particle preparation, but said preparation has zest to the stomach of animal.
CN102319181 (2011-9-8) discloses a kind of coated technique of microcapsule-type animal drug, by taking material, soft material processed, extrude spheronization granulation, animal drug that the step such as fluid bed drying, coating, polishing, fluid bed drying, screening, product detection is prepared microcapsule-type, complex process, cost are high, and the microcapsule of preparation is single coats, its microcrystalline cellulose excipients serves as filler or binding agent, animal easily bites coating into pieces while food and has the bitterness of major ingredient tilmicosin, affects palatability.
Summary of the invention
One of object of the present invention is to provide the tilmicosin microcapsule formulation of a kind of tasteless, enteric, good palatability.
The first technical purpose of the present invention is achieved by the following technical programs: a kind of tilmicosin microcapsule formulation, comprise inner nuclear layer and coatings, described inner nuclear layer comprises tilmicosin raw material and high polymer adjuvant, and described adjuvant is one or more in 12 carbon fatty acids～18 carbon fatty acid, paraffin or vegetable wax; Described coatings comprises interior coatings and outer coatings layer, and described interior coatings material is one or more in starch, calcium carbonate or calcium hydrogen phosphate, and described outer coatings layer material is acrylic resin.
Beneficial effect of the present invention is:
1) tilmicosin raw material and high polymer adjuvant in conjunction with time, polymer substance adjuvant wraps up tilmicosin, can cover the bitterness of tilmicosin after parcel and inside and outside coatings completely;
2) outer coatings layer material is enteric coating, and product is not dissolved under one's belt, in intestinal, progressively dissolves, and reaches the object of slow release, has extended the action time of tilmicosin;
3), when spice is fed, even if animal bites inside and outside coatings into pieces, due to the character of high polymer adjuvant and the combination of tilmicosin raw material and high polymer adjuvant, animal can not had bitterness, the good palatability of animal.
As preferably, the mass ratio of described tilmicosin, adjuvant, interior coatings material and outer coatings layer material is 30～50:20～50:15～20:5～10.
More preferably, the mass ratio of described tilmicosin, adjuvant, interior coatings material and outer coatings layer material is 40～45:35～40:15～20:5～8.
As preferably, described interior coatings material is starch.
As preferably, the diameter of described microcapsule formulation is 200～850 μ m.
More preferably, the diameter of described microcapsule formulation is 500～650 μ m.
As preferably, described acrylic resin is any one or a few in methyl methacrylate, ethyl methacrylate, butyl methacrylate, butyl acrylate, isobutyl methacrylate, dodecylacrylate, acrylic acid stearyl, methacrylic acid, acrylic acid, acrylamide, acrylonitrile, Methacrylamide, styrene.
As preferably, the moisture of described microcapsule formulation is 2-4%.
The second technical purpose of the present invention is to provide a kind of preparation method of described tilmicosin microcapsule formulation, comprises the following steps:
(1) weigh: 30～50:20～50:15～20:10～25 weigh respectively tilmicosin, high polymer adjuvant, interior coatings material and acrylic resin soln in mass ratio, described adjuvant is one or more in 12 carbon fatty acids～18 carbon fatty acid, paraffin or vegetable wax, described interior coatings material is one or more in starch, calcium carbonate or calcium hydrogen phosphate, and the solid content of described acrylic resin soln is 40～50%;
(2) mix: by step (1) weigh tilmicosin and adjuvant at 65～120 DEG C heating and melting and shear agitation even, be cooled to room temperature, make the mixture of adjuvant and tilmicosin;
(3) ground floor is coated: in the mixture making in step (2), add described interior coatings material to granulate with round as a ball, form and have the coated granule of ground floor;
(4) second layer is coated: the particle surface spraying acrylic resin soln making in step (3), makes spherical microcapsule granule;
(5) dry: the spherical microcapsule granule that step (4) is made is dried, and obtains microcapsule formulation finished product.
The present invention first wraps up tilmicosin with polymer substance adjuvant, in the round as a ball process of system material, again in tilmicosin particle surface spraying one deck enteric coating agents, makes tilmicosin and external environment isolation.After bilayer is coated, can cover strong bitterness and the abnormal smells from the patient of tilmicosin completely, and due to the characteristic of second layer enteric coating agents acrylic resin, product is not dissolved under one's belt, in intestinal, progressively dissolve, reach the object of slow release, extended the action time of tilmicosin.Interior coatings material of the present invention has simultaneously fills and molding effect, and the cost of material is low for adjuvant and interior coatings, and technique is simple, and cost is low.
As preferably, the temperature in described step (2) is 80-100 DEG C.
As preferably, the mass ratio of described tilmicosin, adjuvant, interior coatings material and acrylic resin solid content is 40～45:35～40:15～20:5～8.
As preferably, described interior coatings material is starch.
As preferably, the diameter of described microcapsule formulation is 200～850 μ m.
More preferably, the diameter of described microcapsule formulation is 500～650 μ m.
As preferably, described acrylic resin is any one or a few in methyl methacrylate, ethyl methacrylate, butyl methacrylate, butyl acrylate, isobutyl methacrylate, dodecylacrylate, acrylic acid stearyl, methacrylic acid, acrylic acid, acrylamide, acrylonitrile, Methacrylamide, styrene.
The 3rd object of the present invention is to provide the application of a kind of described tilmicosin microcapsule formulation in pregnancy period or sow in lactation cultivation.
The mode keeping healthy by sow, described tilmicosin compound preparation can suppress the reproductive and respiratory syndrome virus content in sow body, from reducing the band poison amount of reproductive and respiratory syndrome virus in nascent piglets body, improve the immunity of organisms of sow and suckling piglets, effectively improve piglets fertility performance indices, produce good benefit.
Sow infects reproductive and respiratory syndrome virus, after pneumonia or mastitis, main manifestations is in-pig stillborn fetus clinically, miscarriage, mummy tire, weak young, piglet respiratory symptom, multiple organ dysfunction syndrome and high mortality, the sow symptoms such as postponement of oestrusing again, piglets Abwehrkraft des Koepers is low, more easily infected by parent, cause the easier secondary of infected piglets and concurrent various virus, antibacterial, parasitic disease, often cause swine fever, porcine circovirus II type, the multiple epidemic disease such as colibacillosis is mixed or secondary infection, cause the large quantities of death of piglets, pig industry is caused to significant economic loss.
Compared with prior art, the invention has the beneficial effects as follows: tilmicosin microcapsule formulation composition provided by the invention is simple, safe, by suppressing the reproductive and respiratory syndrome virus content in sow body, reduce the band poison amount of the interior reproductive and respiratory syndrome virus of nascent piglets body or pneumonia, improve piglets immunity of organisms simultaneously, improve the indices of piglets fertility performance, reduce costs raising culture benefit.
Detailed description of the invention
Embodiment mono-
First take 30kg tilmicosin, 50kg 12 carbon fatty acids, under 65 DEG C of molten conditions, shear agitation is even, is cooled to room temperature, makes the mixture of tilmicosin and above-mentioned adjuvant.Add 15kg starch to granulate with round as a ball above-mentioned mixture, in round as a ball process, spray at particle surface the methyl methacrylate solution that 10kg solid content is 50%, obtain the microcapsule granule of almost spherical.The tilmicosin microcapsule granule semi-finished product of the tasteless enteric obtaining are dried, obtain final finished, microcapsule granule diameter is 200 μ m, and moisture is 2%.
Embodiment bis-
First take 40kg tilmicosin, 30kg 15 carbon fatty acids, under 100 DEG C of molten conditions, shear agitation is even, is cooled to room temperature, makes the mixture of tilmicosin and adjuvant 15 carbon fatty acids.Add 20kg starch to granulate with round as a ball above-mentioned mixture, in round as a ball process, the butyl acrylate solution that is 40% at particle surface spraying 25kg solid content, obtain the microcapsule granule of almost spherical, the tilmicosin microcapsule granule semi-finished product of the tasteless enteric obtaining are dried, obtain final finished, microcapsule granule diameter is 500 μ m, and moisture is 4%.
Embodiment tri-
First take 50kg tilmicosin, 20kg 18 carbon fatty acids, under 120 DEG C of molten conditions, shear agitation is even, is cooled to room temperature, makes the mixture of tilmicosin and above-mentioned adjuvant.Add 20kg calcium carbonate to granulate with round as a ball above-mentioned mixture, in round as a ball process, spray at particle surface the acrylic acid octadecyl ester solution that 22.2kg solid content is 45%, obtain the microcapsule granule of almost spherical.The tilmicosin microcapsule granule semi-finished product of the tasteless enteric obtaining are dried, obtain final finished, microcapsule granule diameter is 650 μ m, and moisture is 3%.
Embodiment tetra-
First take 43kg tilmicosin, 35kg 18 carbon fatty acids, under 80 DEG C of molten conditions, shear agitation is even, is cooled to room temperature, makes the mixture of tilmicosin and above-mentioned adjuvant.Add 15kg calcium hydrogen phosphate to granulate with round as a ball above-mentioned mixture, in round as a ball process, the methacryl amine aqueous solution that is 50% at particle surface spraying 14kg solid content, obtain the microcapsule granule of almost spherical, the tilmicosin microcapsule granule semi-finished product of the tasteless enteric obtaining are dried, obtain final finished, microcapsule granule diameter is 850 μ m, and moisture is 3.5%.
Comparative example one
With embodiment mono-, different is that frit reaction temperature is 40 DEG C.
Comparative example two
With embodiment bis-, different is to adopt microcrystalline Cellulose to replace 15 carbon fatty acids wherein as adjuvant.
Comparative example three
With embodiment tri-, different is that frit reaction temperature is 150 DEG C.
Comparative example four
1.1 capsule-core medicated powder formulas: 25 parts of tilmicosins by weight, 25 parts of microcrystalline Cellulose, 30 parts of starch;
1.2 coating powders: be 200 object acrylic resin micropowders, consumption is 18% of capsule-core medicated powder gross weight;
1.3 polishing powders: consumption accounts for 2% of capsule-core medicated powder gross weight;
1.4 purified water: be 60 parts by the measurement criteria of capsule-core medicated powder formula;
The first step: take material
By above-mentioned formula take each component three-dimensional mixer mix 30 minutes for subsequent use, take purified water, coating powder, polishing powder for subsequent use;
Second step: soft material processed
The above-mentioned capsule-core medicated powder of mix homogeneously is placed in to trough type mixing machine, divides and 3 times purified water is added, after adding water, stir 15 minutes at every turn, obtain soft capsule-core medicated powder;
The 3rd step: extrude spheronization and granulate
Above-mentioned soft capsule-core medicated powder is put into extrude in spheronizator and carry out pelletize, make capsule-core;
The 4th step: fluid bed drying
To make capsule-core and be placed in fluid bed inner drying, inlet temperature is controlled at 50 DEG C, and the dry time of fourth is controlled at 50min, makes temperature of charge reach 35 DEG C, obtains dry capsule-core;
The 5th step: coating
By above-mentioned dry capsule-core; be placed in spheronizator; open spheronizator, spray purified water with spray gun on dry capsule-core, injection flow rate is to be dried 3% of capsule-core; 5min has sprayed; until capsule-core surface wettability, and adhesion, coating powder is slowly evenly shed on the moistening capsule-core in rotation status; rotating speed is controlled at the main n of 200rjm, makes coating powder evenly be wrapped in capsule-core surface;
The 6th step: polishing
Complete after the 5th step operation, and then polishing powder is slowly evenly shed on the moistening capsule-core of ten rotation status everywhere, rotating speed is controlled at 200r/min, makes polishing powder evenly be wrapped in capsule-core surface; Obtain polishing capsule-core.
The 7th step: fluid bed drying
Above-mentioned polishing capsule-core is placed in to fluid bed inner drying, and 50 DEG C of inlet temperature, make temperature of charge reach 40 DEG C, are controlled at 90min drying time.
The 8th step: screening
With 24 mesh sieves, screening obtains intermediate products, cannot reclaim by the large capsule-core of 24 mesh sieves, pulverizes, and waits to utilize;
The 9th step: intermediate products detect, detecting water divides≤and 5%, content is labelled amount 90-110%, grain degree≤24 order are qualified products, qualified products divide packing.
Tilmicosin microcapsule formulation clinical trial:
900 of in-pigs, are divided into the 1st, 2,3,4,5,6,7,8 groups, 100 every group at random.Between 9 groups, except throwing something and feeding feedstuff difference, all the other conditions are all identical; The basis of 9 kinds of feedstuffs is identical, is conventional sow feed, the difference that difference is whether add medicine and adds medicine.
The 1st group, mono-group of embodiment, adds the tilmicosin microcapsule formulation that embodiment mono-produces in feedstuff, and every 500g tilmicosin microcapsule formulation is added in feedstuff total amount per ton.
The 2nd group, bis-groups of embodiment, add the tilmicosin microcapsule formulation that embodiment bis-produces in feedstuff, and every 500g tilmicosin microcapsule formulation is added in feedstuff total amount per ton.
The 3rd group, tri-groups of embodiment, add the tilmicosin microcapsule formulation that embodiment tri-produces in feedstuff, and every 500g tilmicosin microcapsule formulation is added in feedstuff total amount per ton.
The 4th group, tetra-groups of embodiment, add the tilmicosin microcapsule formulation that embodiment tetra-produces in feedstuff, and every 500g tilmicosin microcapsule formulation is added in feedstuff total amount per ton.
The 5th group, one group of comparative example, adds the tilmicosin microcapsule formulation that comparative example one produces in feedstuff, and every 500g tilmicosin microcapsule formulation is added in feedstuff total amount per ton.
The 6th group, two groups of comparative examples, add the tilmicosin microcapsule formulation that comparative example two produces in feedstuff, and every 500g tilmicosin microcapsule formulation is added in feedstuff total amount per ton.
The 7th group, three groups of comparative examples, add the tilmicosin microcapsule formulation that comparative example three produces in feedstuff, and every 500g tilmicosin microcapsule formulation is added in feedstuff total amount per ton.
The 8th group, four groups of comparative examples, add the tilmicosin microcapsule formulation that comparative example four produces in feedstuff, and every 500g tilmicosin microcapsule formulation is added in feedstuff total amount per ton.
The 9th group, blank group, does not add any medicine in feedstuff.
Each group sow all entered delivery room first 7 days of expected date of confinement, then used respectively corresponding forage feed, until piglets is born 21 days.
Investigate index: the abnormal production incidence rate of sow (%), produce strong young number (head), every nest is strong young number (head) on average, weak young incidence rate (%), stillborn fetus incidence rate (%), mummy incidence rate (%), nascent average weight (kg), wean average weight (kg), average small weaning pig number (head), daily gain (g), rutting rate (%) in 7 days, the average feed intake of sow (kg/ days), mastitis immunity qualification rates (%), pneumonia immunity qualification rate (%), reproductive and respiratory syndrome immunity qualification rate (%).
Testing result is in table 1.
As can be seen from Table 1, the average feed intake of sow that 1-4 group mixes the tilmicosin microcapsule formulation of eating embodiment mono--embodiment tetra-is higher, sow good palatability, and mastitis immunity qualification rate, pneumonia immunity qualification rate and reproductive and respiratory syndrome immunity qualification rate are higher, good drug efficacy.
This specific embodiment is only explanation of the invention; it is not limitation of the present invention; those skilled in the art are reading after this description and can make to the present embodiment the amendment that there is no creative contribution as required, but as long as within the scope of claim of the present invention, are all subject to the protection of Patent Law.
Claims (8)
1. a tilmicosin microcapsule formulation, comprises inner nuclear layer and coatings, it is characterized in that: described inner nuclear layer comprises tilmicosin raw material and high polymer adjuvant, and described adjuvant is 12 carbon fatty acids, 15 carbon fatty acids or 18 carbon fatty acids; Described coatings comprises interior coatings and outer coatings layer, and described interior coatings material is one or more in starch, calcium carbonate or calcium hydrogen phosphate, and described outer coatings layer material is acrylic resin;
The mass ratio of described tilmicosin, adjuvant, interior coatings material and outer coatings layer material is 30～50:20～50:15～20:5～10;
Described tilmicosin microcapsule formulation is after described tilmicosin and adjuvant are mixed at 65～120 DEG C, to carry out two-layer coated and oven dry to make.
2. a kind of tilmicosin microcapsule formulation according to claim 1, is characterized in that: the mass ratio of described tilmicosin, adjuvant, interior coatings material and outer coatings layer material is 40～45:35～40:15～20:5～8.
3. a kind of tilmicosin microcapsule formulation according to claim 2, is characterized in that: described interior coatings material is starch.
4. a kind of tilmicosin microcapsule formulation according to claim 1, is characterized in that: the diameter of described microcapsule formulation is 200～850 μ m.
5. a kind of tilmicosin microcapsule formulation according to claim 2, is characterized in that: described acrylic resin is any one or a few in methyl methacrylate, ethyl methacrylate, butyl methacrylate, butyl acrylate, isobutyl methacrylate, dodecylacrylate, acrylic acid stearyl.
6. a kind of tilmicosin microcapsule formulation according to claim 1, is characterized in that: the moisture of described microcapsule formulation is 2-4%.
7. a preparation method for tilmicosin microcapsule formulation, is characterized in that: comprise the following steps:
(1) weigh: 30～50:20～50:15～20:10～25 weigh respectively tilmicosin, high polymer adjuvant, interior coatings material and acrylic resin soln in mass ratio, described adjuvant is 12 carbon fatty acids, 15 carbon fatty acids or 18 carbon fatty acids, described interior coatings material is one or more in starch, calcium carbonate or calcium hydrogen phosphate, and the solid content of described acrylic resin soln is 40～50%;
(2) mix: by step (1) weigh tilmicosin and adjuvant at 65～120 DEG C heating and melting and shear agitation even, be cooled to room temperature, make the mixture of adjuvant and tilmicosin;
(3) ground floor is coated: in the mixture making in step (2), add described interior coatings material to granulate with round as a ball, form and have the coated granule of ground floor;
(4) second layer is coated: the particle surface spraying acrylic resin soln making in step (3), makes spherical microcapsule granule;
(5) dry: the spherical microcapsule granule that step (4) is made is dried, and obtains microcapsule formulation finished product.
8. the preparation method of a kind of tilmicosin microcapsule formulation according to claim 7, is characterized in that: the temperature in described step (2) is 80-100 DEG C.
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| CN201210185792.5A CN102688220B (en) | 2012-06-07 | 2012-06-07 | Tilmicosin micro-capsule preparation and preparation method thereof |
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Families Citing this family (9)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN103083281B (en) * | 2013-01-15 | 2015-01-07 | 广州格雷特生物科技有限公司 | Enteric-coated tilmicosin slow-release micro-capsule preparation and preparation method thereof |
| CN103070830B (en) * | 2013-01-22 | 2014-08-13 | 无锡正大畜禽有限公司 | Production method for 20-percent tilmicosin granules |
| CN105012958A (en) * | 2014-04-17 | 2015-11-04 | 芜湖神农百草生物科技有限公司 | Production method for coating tilmicosin by agar |
| CN106176671A (en) * | 2016-08-30 | 2016-12-07 | 天津市中升挑战生物科技有限公司 | A kind of tasteless tilmicosin granule and preparation method thereof |
| CN109985019B (en) * | 2017-12-29 | 2021-05-11 | 瑞普（天津）生物药业有限公司 | Controlled-release tilmicosin enteric microcapsule and preparation method thereof |
| CN108553449A (en) * | 2018-02-14 | 2018-09-21 | 浙江万方生物科技有限公司 | A kind of taste masking sustained release Tilmicosin pre-mixing agent and preparation method thereof |
| CN108524466A (en) * | 2018-07-02 | 2018-09-14 | 合肥中龙神力动物药业有限公司 | A kind of florfenicol microcapsule preparation and preparation method thereof |
| CN108524467A (en) * | 2018-07-02 | 2018-09-14 | 合肥中龙神力动物药业有限公司 | A kind of composite sulfamonomethoxine sodium microcapsule formulation and preparation method thereof |
| CN108969496A (en) * | 2018-09-07 | 2018-12-11 | 江苏恒丰强生物技术有限公司 | A kind of pet benazepril hydrochloride chewable tablets and preparation method thereof |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN101879141B (en) * | 2009-05-05 | 2013-07-17 | 烟台绿叶动物保健品有限公司 | Taste-masking tilmicosin gastric-soluble particle preparation |
| CN102319181B (en) * | 2011-09-08 | 2014-07-16 | 广东大华农动物保健品股份有限公司 | Enveloping process for micro-capsule animal medicament |
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