Process for preparing tilmicosin enteric-coated pellet by centrifuge method

A technology of tilmicosin and centrifugal pellet making, which is applied in the technical field of preparation of tilmicosin enteric-coated pellets by centrifugal method, which can solve the problems of poor palatability of tilmicosin, uneven coating thickness, and exclusion of raw materials In vitro and other problems, to achieve the effect of convenient centrifugal pellet making process, solving adverse reactions and low cost

Active Publication Date: 2015-07-22
WEIDA HUNAN TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Because the injection is not taken orally, there is no problem of poor palatability, but due to the complicated clinical application and relatively high toxicity and side effects, tilmicosin cannot actually exert its maximum effect during a large-scale outbreak of the disease; other preparations such as oral liquid, Premixes, etc. are all conventional oral preparations, which fail to solve the problem of poor palatability of tilmicosin
[0004] Most of the existing tilmicosin pelleting methods adopt the extrusion spheronization process, which is not only cumbersome to operate and high in cost, but also the prepared granules are in the shape of rice with slightly pointed ends, and the true sphericity is far inferior to the granules produced by the centrifugal pelletizing process , resulting in poor coating efficiency, uneven coating thickness on the surface of the particles, easy to be degraded and absorbed in the stomach after oral administration, and irritating to the stomach (the coated particles are required not to dissolve in the stomach, but to dissolve in the intestinal tract)
In addition, the granules prepared by the extrusion spheronization process are difficult to completely dissolve and release in the small intestine due to high-intensity extrusion, resulting in most of the raw materials being excreted from the body, causing environmental pollution, which is also a very serious problem

Method used

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  • Process for preparing tilmicosin enteric-coated pellet by centrifuge method
  • Process for preparing tilmicosin enteric-coated pellet by centrifuge method
  • Process for preparing tilmicosin enteric-coated pellet by centrifuge method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0049] Each raw material is weighed according to the finished product containing the following mass percentages:

[0050] Tilmicosin: 23.3%;

[0051] Adhesive: 20% (formulated into 40% sucrose solution);

[0052] Microcrystalline cellulose: 17.2%;

[0053] Corn starch: 24.5%;

[0054] Coating solution: use 30% polyacrylic acid resin latex solution to prepare the coating solution according to the weight gain of the finished granules by 15%.

[0055] Grind the microcrystalline cellulose and cornstarch through an 80-mesh sieve and add tilmicosin to obtain a uniform powder. Then take 5Kg of the powder and gradually add it to the centrifugal pellet machine. At the same time, turn on the turntable and gradually spray it into the bonding agent. agent solution, the initial host speed is 100r / min, the spray speed is 200ml / min, the powder supply speed is 400g / min, and the damper is opened at 100m 3 / min; the time lasts for 6-8min to form a 60-80 mesh granule masterbatch. Then conti...

Embodiment 2

[0057] Each raw material is weighed according to the finished product containing the following mass percentages:

[0058] Tilmicosin: 25.8%;

[0059] Adhesive: 15% (formulated into 40% sucrose solution);

[0060] Microcrystalline cellulose: 24.2%;

[0061] Corn starch: 20%;

[0062] Coating solution: use 40% polyacrylic acid resin latex solution to prepare the coating solution according to the weight gain of the finished granules by 15%.

[0063] Grind the microcrystalline cellulose and cornstarch through an 80-mesh sieve and add tilmicosin to obtain a uniform powder. Then take 5Kg of the powder and add it to the centrifugal pellet machine. At the same time, turn on the turntable and gradually spray the adhesive solution, the initial host speed is 100r / min, the spray speed is 200ml / min, the powder supply speed is 400g / min, and the damper is opened at 100-120m 3 / min; the time lasts for 6-8min to form a 60-80 mesh granule masterbatch. Then continuously add the previously m...

Embodiment 3

[0065] According to the method described in Example 1, the obtained micropill finished product is carried out to morphology investigation, the mensuration of drug loading, the mensuration of encapsulation efficiency and the stripping release experiment under different environments; The dissolved pellets are 30-60 mesh spherical pellets with high true sphericity and uniform particle size (see figure 1 ), the drug loading is 20-25%, which is equivalent to the dosage, and the encapsulation efficiency is 100%. The pellets produced by the extrusion granulation method have irregular spherical shape and non-uniform particle size (see image 3 ), the drug loading is 20-25%, which is equivalent to the dosage, and the encapsulation thickness is not uniform. The pellets formed by the drying method in the liquid are ellipsoidal, and the particle size is uneven, (see figure 2 ), the drug loading is 20-25%, which is equivalent to the dosage, and the pellets prepared by the in-liquid dryi...

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Abstract

The invention discloses a process for preparing a tilmicosin enteric-coated pellet by a centrifuge method. The tilmicosin enteric-coated pellet is prepared from the following raw materials in percentage by mass: 21-26% of tilmicosin, 10-20% of an adhesive, 23-30% of microcrystalline cellulose and 10-20% of a coating material, and is prepared through the following steps: performing centrifugal pelleting on the raw materials, and coating the pellet obtained through centrifugal pelleting. The tilmicosin enteric-coated pellet is high in encapsulation efficiency, can mask the bitter taste of tilmicosin well, is dissolved out in an intestinal environment, can be used as an enteric-coated sustained-release reagent, solves the adverse reaction caused after the tilmicosin enteric-coated pellet is absorbed in stomach, is simple in preparation process, and is suitable for industrial large-scale production, thereby having a very wide application prospect; besides, the raw materials are cheap and easy to obtain.

Description

technical field [0001] The invention relates to a process for preparing tilmicosin enteric-coated pellets by a centrifugation method, and belongs to the technical field of veterinary drug preparation. Background technique [0002] Tilmicosin is a derivative of tylosin after acid hydrolysis. It is a semi-synthetic macrolide antibiotic for animals. Its molecular formula is C 46 h 80 N 2 o 13 , with a molecular weight of 869.15, which has been approved for clinical use in Australia, Brazil, France, Malaysia, Italy, Spain, the United States and other countries. Tilmicosin has similar antibacterial activity to macrolides, and is effective against Gram-positive bacteria, some Gram-negative bacteria and mycoplasma. Especially for Actinobacillus pleuropneumoniae, Pasteurella, Staphylococcus aureus, Streptococcus pyogenes, Streptococcus pneumoniae, Corynebacterium pyogenes and mycoplasma of livestock and poultry, the activity is stronger than tylosin. Clinically, it is mainly us...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/16A61K31/706A61P31/04A61P11/00A61P15/14
Inventor 汪镇南刘云福周玉生宁春艳王学平曾宪荣
Owner WEIDA HUNAN TECH
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