CN114099458A - Coated florfenicol particle, preparation method and application thereof - Google Patents
Coated florfenicol particle, preparation method and application thereof Download PDFInfo
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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
- A61K9/5015—Organic compounds, e.g. fats, sugars
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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
- A61K31/16—Amides, e.g. hydroxamic acids
- A61K31/165—Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- 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
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- 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
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
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- A61P17/02—Drugs for dermatological disorders for treating wounds, ulcers, burns, scars, keloids, or the like
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- 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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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P33/00—Antiparasitic agents
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- Y02A40/70—Adaptation technologies in agriculture, forestry, livestock or agroalimentary production in livestock or poultry
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Abstract
The invention discloses a coated florfenicol particle, a preparation method and application thereof, and belongs to the field of animal breeding drugs. The invention comprises vegetarian pills and coated granules, wherein each 100 parts of vegetarian pills comprise the following components in parts by weight: 5-30 parts of florfenicol, 20-30 parts of disintegrating agent, 1-5 parts of adhesive, 40-80 parts of filler and the balance of water; every 100 parts of the coated florfenicol particles comprise the following components in proportion: 50-80 parts of vegetarian pill, 0.5-10 parts of phagostimulant and the balance of coating material. 0.2-1 part of anti-blocking agent is added to each 100 parts of the coated florfenicol particles. The unique structure of the coated florfenicol particles on aquaculture enables the products to float on the water surface and induce aquatic animals to ingest, reduces the damage of the florfenicol to the water environment, and improves the bioavailability of the florfenicol; clove oil is introduced into the coated florfenicol particles in livestock breeding, parasites of livestock can be removed, and the coated florfenicol particles have strong antibacterial activity, effectively reduce the damage of the parasites to the bred animals and promote wound healing.
Description
Technical Field
The invention belongs to the field of animal breeding drugs, and particularly relates to a coated florfenicol particle, a preparation method and application thereof.
Background
Florfenicol is an amide alcohol antibiotic, is a common antibiotic for animal breeding, and can effectively treat diseases caused by the infection of pasteurella, escherichia coli and the like of the bred animals. At present, antibiotics specially used for aquaculture animals in the market are few in types, most of the antibiotics are used by mixing and sprinkling, the ingestion proportion of the antibiotics by the aquaculture animals is low, the effect is not obvious, most of the antibiotics are wasted in water environment, and the antibiotics greatly damage the environment; florfenicol in livestock breeding is generally mixed with feed for use, dust is easily generated, respiratory tract health is affected, drug loss is large, and the mixed infection effect on parasites and bacteria is poor when the florfenicol is singly used.
The florfenicol enteric coated particles are available in the market, the main coating material is polyacrylic resin, the cost is high, part of the coating can sink in water, the palatability is poor, the coating is not beneficial to the ingestion of aquatic animals, and the coating is quite different from the product; compared with common enteric-coated granules in the livestock market, the enteric-coated granule has the characteristics of good palatability, capability of expelling parasites and the like.
Disclosure of Invention
The invention aims to provide a coating type florfenicol particle with outstanding comprehensive benefits in the process of animal breeding.
The invention also aims to provide a preparation method of the coated florfenicol particles.
The invention also aims to provide a coated florfenicol particle for treating bacterial septicemia, enteritis, red skin disease and the like caused by pasteurella, vibrio, staphylococcus aureus, aeromonas hydrophila and the like of aquatic animals in the animal breeding process; in the livestock breeding process, parasites in vivo and in vitro are removed, the damage of the parasites to the bred animals is effectively reduced, and the wound healing is promoted. In order to achieve the purpose, the invention adopts the following technical scheme:
a process for preparing said coated florfenicol particles, characterized by comprising the steps of:
1) preparation of Kernel pill
A) Adding water, mixing to obtain soft material, granulating with granulator
B) Round throwing of spherical shot blasting machine
C) Drying by baking
2) Preparation of coated particles
A) Dissolving coating material, mixing phagostimulant and preparing coating liquid
B) Adding core pill into fluidized bed, and spraying coating
3) Adding an anti-blocking agent
Adding the anti-blocking agent into the coated granules, and uniformly mixing.
Preferably, the further technical scheme of the invention is as follows:
the mesh number of the granulator screen in the step 1) is 24 meshes, and the drying temperature in the step 1) C) is 60 ℃. The coating material in step 2) A) is heated to 100 ℃ and the compressed air inlet temperature in step 2) B) is 120 ℃.
More preferably, the further technical solution of the present invention is:
(1) preparing a core element pill:
A) weighing, premixing florfenicol, microcrystalline cellulose, dextrin and corn starch in a mixer
B) Adding the mixed powder in the step A) into a wet high-speed mixer, adding water, and mixing uniformly to obtain a soft material
C) Granulating with a swinging granulator, wherein the mesh number of the screen is 24 meshes
D) Added into a spherical shot blasting machine for polishing round
E) Drying at 60 deg.C for 2 hr in a dryer
F) Sieving, sieving with 24 mesh sieve, sieving with 40 mesh sieve
(2) Preparation of coated granules:
A) weighing machine
B) Heating hydrogenated palm oil to 100 deg.C for melting, adding oleum Caryophylli, and mixing to obtain coating solution
C) Heating the compressed air to 120 deg.C
D) Spraying coating in fluidized bed
(3) Adding an anti-blocking agent:
A) weighing machine
B) Adding talcum powder into the coated granules, and mixing uniformly.
The invention has the beneficial effects that:
1) the coated florfenicol particle which can be hardly released in a water environment is provided, so that the pollution of the florfenicol to the water environment is avoided;
2) the ingestion proportion of the cultured animals to the drugs is improved, the feeding amount of the drugs is reduced, the ingestion amount of the drugs is improved, and the culture cost is reduced;
3) the hydrogenated palm oil coating can enable the medicine to float on the water surface and be easily ingested by aquaculture animals;
4) the coating material mixed with the clove oil can play a food calling role for aquaculture animals;
5) a 24-mesh sieve is used in the granulation process, and the prepared particle size is proper, so that the palatability of the cultured animals is ensured to be good;
6) finally, talcum powder and the like are used as anti-adhesion agents to ensure stable properties of the products after the products are sold on the market;
7) the coated florfenicol granule mixed with clove oil can repel the parasites of livestock, reduce the damage of the parasites to the livestock and promote wound healing.
Detailed Description
The technical solutions of the present invention will be described clearly and completely below, and it should be apparent that the described embodiments are some, but not all, embodiments of the present invention. All other embodiments, which can be obtained by a person skilled in the art without any inventive step based on the embodiments of the present invention, are within the scope of the present invention.
Example 1
1) Preparation of Kernel pill
Weighing 0.6kg of florfenicol, 2.5kg of microcrystalline cellulose, 0.1kg of dextrin and 6.8kg of corn starch, uniformly mixing, adding water, uniformly mixing to prepare a soft material, and granulating by using a 24-mesh screen in a swing granulator. And adding the wet granules into a spherical shot blasting machine for polishing. The pellets are placed into a dryer to be dried for 2 hours at 60 ℃. Sieving with a shaking sieve, and collecting the 24-mesh lower material and the 40-mesh upper material to obtain a core extract pill;
2) preparation of coated particles
Weighing 10kg of core element pills, heating 1.95kg of hydrogenated palm oil to 100 ℃, adding 0.05kg of clove oil, and uniformly mixing to prepare a coating solution. The compressed air was heated to 120 ℃. Adding the core element pills into a bottom-spraying fluidized bed for coating, and feeding coating liquid into a peristaltic pump at 80rpm for coating to obtain coated particles;
3) adding an anti-blocking agent
Weighing 10kg of coated granules, adding 0.02kg of talcum powder, and uniformly mixing.
Example 2
1) Preparation of Kernel pill
Weighing 0.75kg of florfenicol, 3kg of microcrystalline cellulose, 0.1kg of dextrin and 6.15kg of corn starch, uniformly mixing, adding water, uniformly mixing to prepare a soft material, and granulating by using a 24-mesh screen through a swing granulator. And adding the wet granules into a spherical shot blasting machine for polishing. The pellets are placed into a dryer to be dried for 2 hours at 60 ℃. Sieving with a shaking sieve, and collecting the 24-mesh lower material and the 40-mesh upper material to obtain a core extract pill;
2) preparation of coated particles
Weighing 10kg of core element pills, heating 4.5kg of hydrogenated palm oil to 100 ℃, adding 0.5kg of clove oil, and uniformly mixing to prepare a coating solution. The compressed air was heated to 120 ℃. Adding the core element pills into a bottom-spraying fluidized bed for coating, and feeding coating liquid into a peristaltic pump at 40rpm for coating to obtain coated particles;
3) adding an anti-blocking agent
Weighing 10kg of the coated particles, adding 0.02kg of aerosil, and mixing uniformly.
Example 3
1) Preparation of Kernel pill
Weighing 1kg of florfenicol, 2.5kg of microcrystalline cellulose, 0.1kg of dextrin and 6.4kg of corn starch, uniformly mixing, adding water, uniformly mixing to prepare a soft material, and granulating by using a 24-mesh screen through a swing granulator. And adding the wet granules into a spherical shot blasting machine for polishing. The pellets are placed into a dryer to be dried for 2 hours at 60 ℃. Sieving with a shaking sieve, and collecting the 24-mesh lower material and the 40-mesh upper material to obtain a core extract pill;
2) preparation of coated particles
Weighing 10kg of core element pills, heating 9.9kg of hydrogenated palm oil to 100 ℃, adding 0.1kg of clove oil, and uniformly mixing to prepare the coating liquid. The compressed air was heated to 120 ℃. Adding the core element pills into a bottom-spraying fluidized bed for coating, and feeding coating liquid into a peristaltic pump at 80rpm for coating to obtain coated particles;
3) adding an anti-blocking agent
Weighing 10kg of coated granules, adding 0.05kg of talcum powder, and mixing uniformly.
Example 4
1) Preparation of Kernel pill
Weighing 1.2kg of florfenicol, 2.5kg of microcrystalline cellulose and 6.3kg of corn starch, uniformly mixing, adding water, uniformly mixing to prepare a soft material, and granulating by using a 24-mesh screen in a swing granulator. And adding the wet granules into a spherical shot blasting machine for polishing. The pellets are placed into a dryer to be dried for 2 hours at 60 ℃. Sieving with a shaking sieve, and collecting the 24-mesh lower material and the 40-mesh upper material to obtain a core extract pill;
2) preparation of coated particles
Weighing 10kg of core element pills, heating 1.95kg of hydrogenated palm oil to 100 ℃, adding 0.05kg of clove oil, and uniformly mixing to prepare a coating solution. The compressed air was heated to 120 ℃. Adding the core element pills into a bottom-spraying fluidized bed for coating, and feeding coating liquid into a peristaltic pump at 80rpm for coating to obtain coated particles;
3) adding an anti-blocking agent
Weighing 10kg of the coated particles, adding 0.1kg of aerosil, and mixing uniformly.
Example 5
1) Preparation of Kernel pill
Weighing 1.5kg of florfenicol, 3kg of microcrystalline cellulose, 0.1kg of hydroxypropyl methyl cellulose and 5.4kg of corn starch, uniformly mixing, adding water, uniformly mixing to prepare a soft material, and granulating by using a 24-mesh screen through a swinging granulator. And adding the wet granules into a spherical shot blasting machine for polishing. The pellets are placed into a dryer to be dried for 2 hours at 60 ℃. Sieving with a shaking sieve, and collecting the 24-mesh lower material and the 40-mesh upper material to obtain a core extract pill;
2) preparation of coated particles
Weighing 10kg of core element pills, heating 4.9kg of hydrogenated palm oil to 100 ℃, adding 0.1kg of clove oil, and uniformly mixing to prepare a coating solution. The compressed air was heated to 120 ℃. Adding the core element pills into a bottom-spraying fluidized bed for coating, and feeding coating liquid into a peristaltic pump at 80rpm for coating to obtain coated particles;
3) adding an anti-blocking agent
Weighing 10kg of coated granules, adding 0.1kg of talcum powder, and mixing uniformly.
Example 6
1) Preparation of Kernel pill
Weighing 3kg of florfenicol, 2.8kg of crospovidone, 0.1kg of hydroxypropyl methyl cellulose and 4.1kg of corn starch, uniformly mixing, adding water, uniformly mixing to prepare a soft material, and granulating by using a 24-mesh screen in a swing granulator. And adding the wet granules into a spherical shot blasting machine for polishing. The pellets are placed into a dryer to be dried for 2 hours at 60 ℃. Sieving with a shaking sieve, and collecting the 24-mesh lower material and the 40-mesh upper material to obtain a core extract pill;
2) preparation of coated particles
Weighing 10kg of core element pills, heating 4.9kg of hydrogenated palm oil to 100 ℃, adding 0.1kg of clove oil, and uniformly mixing to prepare a coating solution. The compressed air was heated to 120 ℃. Adding the core element pills into a bottom-spraying fluidized bed for coating, and feeding coating liquid into a peristaltic pump at 80rpm for coating to obtain coated particles;
3) adding an anti-blocking agent
Weighing 10kg of coated granules, adding 0.02kg of talcum powder, and uniformly mixing.
Stability test method of example 1: 3 batches (19032101, 19032501, 19032701) were prepared as in example 1, packaged on the market, left to stand at 40 ℃. + -. 1 ℃ and 75%. + -. 5% relative humidity for 6 months, and sampled 1 time at the end of 0, 1, 2, 3, 6 months, respectively, to examine the properties and contents of the samples according to the stability emphasis test items. The stability test results are shown in table 1;
table 1 stability test results for coated florfenicol particles
Stability test method of example 2: 3 batches (19050601, 19051301, 19051501) were prepared as in example 2, packaged on the market, placed at 40 ℃. + -. 1 ℃ and 75%. + -. 5% relative humidity for 6 months, sampled 1 time at the end of 0, 1, 2, 3, 6 months, and examined for properties and contents according to stability stress. The stability test results are shown in table 2;
table 2 stability test results for coated florfenicol particles
Clinical trial conditions for coated florfenicol particles prepared in example 1 of the present invention
Test drugs: the coated florfenicol particles prepared in example 1 of the present invention; the reference drug is uncoated florfenicol powder with the same specification;
the test method comprises the following steps: the grass carp breeding factory in Tianjingnan has symptoms of grass carp enteritis, septicemia and red skin disease, the feed intake is reduced, and 60 grass carps with the same symptoms are fished out and randomly divided into three groups of 20 grass carps. Since the effect of florfenicol is in a positive correlation with the content of the drug ingested and absorbed into tissues by grass carp, the evaluation standard adopts a method for measuring a blood concentration-time curve to calculate the relative bioavailability. Group A was fed 0.3g of coated florfenicol granules per kg of body weight and 50g of ordinary feed. The group B is fed with 0.3g of florfenicol powder and 50g of common feed per kilogram of body weight after mixing. Group C was a blank group (no drug was administered, only the same amount of feed was administered) fed with 50g of ordinary feed per kg of body weight. The feed is taken once a day for 5 days continuously, and the feeding conditions of the three groups of test subjects are the same;
clinical effect judgment standard: the cure standard is that the red skin symptom disappears after 5 days of medication, the appetite is recovered to be normal, and no enteritis and septicemia symptoms are observed after fish is dissected. Determining the concentration and the relative bioavailability of the florfenicol in the water body;
TABLE 3 clinical trial Effect of coated florfenicol particles 1
Group of | Number of animals (Tail) | Total body weight (kg) before administration | After 5 days, the feed is visible whether the feed is left or not | Amount of cure (tail) | Number of deaths (tail) | Florfenicol content (g/ml) in water | Relative bioavailability (%) |
A | 20 | 10.65 | Is free of | 19 | 1 | 8.3225*10-8 | 161.7 |
B | 20 | 10.91 | Is free of | 10 | 5 | 1.0548*10-3 | 100 |
C | 20 | 10.22 | Is provided with | 1 | 16 | 0 | / |
And (4) test conclusion: the test results show that the food intake of the group A and the food intake of the group B are both obviously increased, and the group C still has residual materials; the cure amount is higher in group A compared with group B, which shows that the practical use effect of the coated florfenicol particles is better than that of florfenicol powder, and a self-healing case appears in group C, and the self-healing capability of the fish body is considered to play a role; comparing A, B, C the number of deaths, it can be observed that the coated florfenicol particles are able to significantly reduce the mortality rate; comparing the florfenicol residue in A, B two groups of aquaculture water bodies, the group A has less loss in the water body, less drug residue in the water body, less damage to the environment and more friendly aquaculture environment; the relative bioavailability is measured in a blood concentration-time curve within 24 hours, and the florfenicol powder of the group B is used as a control, so that the relative bioavailability of the coated florfenicol particles is higher, and the drug effect is more obvious. In conclusion, the coated florfenicol particle provided by the invention can protect the environment and improve the utilization rate of the drug, and has obvious comprehensive benefits.
Clinical trial conditions for coated florfenicol particles prepared in example 2 of the present invention
Test drugs: the coated florfenicol particles prepared in example 2 of the present invention; the control drug is florfenicol enteric-coated particles with the same specification, and the other control drug is a common anthelmintic for cultivation;
the test method comprises the following steps: the fattening pigs bred in a certain pig farm of Shijiazhuang have parasitic ascarid, the feed intake is reduced, and the pigs are only emaciated. Randomly selecting 24 parasitic ascaris pigs, dividing the pigs into 3 groups, wherein each group has 8 pigs, and feeding the group A with coated florfenicol particles of 600mg per kilogram of body weight; feeding 600mg of florfenicol enteric-coated particles per kilogram of body weight in the group B; feeding group C with levamisole hydrochloride 10mg twice daily, and feeding three groups with feed in the same proportion at 3% of body weight. Observing whether the feces have ascaris or not after feeding for 5 days as an index, observing whether the feces have bleeding or not, and calculating the food intake on the initial day and the 5 th day;
TABLE 4 clinical trial Effect of coated florfenicol particles 2
And (4) test conclusion: from the test results, it can be seen that A, C two groups of A, B, C three groups have better anthelmintic effect, and group B has no anthelmintic effect, compared with group C, group a has better treatment effect on intestinal bleeding caused by roundworms while expelling worms, after the parasites are expelled, the feed intake of the pigs in group A, C can be improved, the feed in the trough is almost not remained, and the residual feed in group B is more, which indicates that roundworm parasitism is the main factor causing the low feed intake of the pigs. The weight gain of the pigs is lower as the whole weight gain of the pigs is only in the disease period, but the coated florfenicol particles are better than the florfenicol enteric-coated particles in data. The comparison shows that the coating type florfenicol particle has the effect on treating the parasites which is equivalent to levamisole hydrochloride, has better effect on the bleeding of the pigs caused by the parasites and has certain effect on the recovery of the feed intake of the pigs.
Claims (10)
1. The coated florfenicol particle is characterized in that a core, namely a vegetarian pill (1), is composed of the following components in parts by weight per 100 parts of vegetarian pill: 5-30 parts of florfenicol, 20-30 parts of disintegrating agent, 1-5 parts of adhesive, 40-80 parts of filling agent, the balance of water and a coating layer (2) serving as a coating, wherein each 100 parts of coated florfenicol particles are composed of the following components in parts by weight: 50-90 parts of Suwan pill, 0.5-10 parts of phagostimulant, the balance of coating material and anti-blocking agent (3), wherein 0.2-1 part of anti-blocking agent is added to each 100 parts of coated florfenicol particles.
2. The coated florfenicol particle of claim 1 wherein the disintegrant is one or more of microcrystalline cellulose, crospovidone, silicon dioxide, sodium lauryl sulfate, preferably microcrystalline cellulose.
3. The coated florfenicol particle as claimed in claim 1 wherein the binder is one or more of dextrin, ethyl cellulose, hydroxypropyl methyl cellulose, florfenicol aqueous solution, preferably dextrin.
4. The coated florfenicol particle of claim 1 wherein the bulking agent is one or more of corn starch, bran powder, water soluble starch, sucrose, preferably corn starch.
5. The coated florfenicol particle as claimed in claim 1 wherein the phagostimulant is one or more of clove oil, garlic oil, onion oil, eucalyptus oil, preferably clove oil.
6. The coated florfenicol particle of claim 1 wherein the coating material is one or more of hydrogenated palm oil, polyacrylic resin, hydroxypropyl methylcellulose, shellac, preferably hydrogenated palm oil.
7. The coated florfenicol particle as claimed in claim 1 wherein the anti-blocking agent is one or more of talc, aerosil, calcium silicate, leucine, preferably talc.
8. A process for the preparation of coated florfenicol particles as claimed in any one of claims 1-7, characterized in that the process comprises the steps of:
(1) preparing a core element pill:
A) weighing, premixing florfenicol, disintegrating agent, adhesive and filler in a mixer
B) Adding water into the mixed powder in the A) and mixing evenly
C) Granulating with 24 mesh screen
D) Round throwing
E) Drying in a dryer
(2) Preparation of coated granules:
A) weighing machine
B) Dissolving the coating material, adding phagostimulant, and mixing to obtain coating solution
C) Heating compressed air
D) Coating the core pill in fluidized bed
(3) Adding an anti-blocking agent:
A) weighing machine
B) Adding the anti-blocking agent into the coated granules, and uniformly mixing.
9. Use of the coated florfenicol particles of claims 1-8 in aquaculture: can be used for treating bacterial septicemia, enteritis, and red skin disease caused by Pasteurella, Vibrio, Staphylococcus aureus, and Aeromonas hydrophila of aquatic livestock.
10. Use of the coated florfenicol particles of claims 1-8 in livestock farming: it can be used for repelling parasites such as mite, tick, and roundworm of domestic animals and promoting healing of wound caused by parasite.
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