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Tilmicosin phosphate enteric granules and preparation method thereof

A technology of tilmicosin phosphate and granules, which is applied in the direction of pharmaceutical formulas, medical preparations with non-active ingredients, medical preparations containing active ingredients, etc., which can solve the problem of being unable to cover up the therapeutic effect of tilmicosin phosphate and affect the therapeutic effect , reduce the treatment effect of tilmicosin phosphate and other problems, achieve the effect of uniform drug effect, improve the treatment effect, and avoid the effect of gastric acid damage

Inactive Publication Date: 2014-03-12
HUBEI LONGXIANG PHARMA TECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] The taste of tilmicosin phosphate is extremely bitter. If it is directly administered as a simple premix, it will cause adverse symptoms such as anorexia, nausea and vomiting in livestock and poultry, which will affect the therapeutic effect.
At the same time, tilmicosin phosphate will be destroyed by gastric acid in the stomach of animals, which will reduce the therapeutic effect of tilmicosin phosphate
[0004] Most domestic tilmicosin phosphate enteric-coated granules are directly mixed with excipients, which cannot cover the bitter taste of tilmicosin phosphate and affect its therapeutic effect

Method used

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  • Tilmicosin phosphate enteric granules and preparation method thereof

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0022] 1. Preparation of prime granules

[0023] 1) The mass percentages of preparative granule raw materials are as follows: 5% tilmicosin phosphate, 55% microcrystalline cellulose, 5% sodium carboxymethyl starch, 30% starch, 1% sodium lauryl sulfate and hydroxypropyl Methyl cellulose 4%, after above-mentioned each component crosses 100 mesh sieves to sieve respectively, according to the mass percent of preparative granule raw material, take by weighing particle diameter and be each component of 100 mesh;

[0024] 2) After mixing the components, add enough water and stir evenly to obtain a soft material. The soft material is granulated with a double-spherical extruder with a diameter of 0.6mm orifice. A 400r / min spheronizer is used for spheronizing for 10 minutes. After spheronization, the wet pellets are taken out and dried, and the dried pellets are sieved to obtain granules with a particle size of 30 meshes.

[0025] 2. Preparation of coating solution

[0026] 1) Weigh 7...

Embodiment 2

[0032] 1. Preparation of prime granules

[0033] 1) The mass percentages of preparative granule raw materials are as follows: 40% tilmicosin phosphate, 30% microcrystalline cellulose, 1% sodium carboxymethyl starch, 26.9% starch, 0.1% sodium lauryl sulfate and hydroxypropyl Methylcellulose 2%. After each of the above-mentioned components is sieved through a 60-mesh sieve, each component whose particle size is 60-mesh is weighed according to the mass percentage of the raw material of Suparin Granules;

[0034] 2) After mixing the components, add enough water and stir evenly to obtain a soft material. The soft material is granulated with a double-spherical extruder with a diameter of 0.6mm orifice. The spheronizer at 1000r / min was used for spheronizing for 5 minutes, and after spheronization, the wet pellets were taken out and dried, and the dried pellets were sieved, and the pellets with a particle size of 60 meshes were obtained to obtain plain pellets.

[0035] 2. Preparati...

Embodiment 3

[0042] 1. Preparation of prime granules

[0043] 1) The mass percentages of the raw materials of preparative granules are as follows: 30% tilmicosin phosphate, 34% microcrystalline cellulose, 5% sodium carboxymethyl starch, 27% starch, 1% sodium lauryl sulfate and hydroxypropyl Methyl cellulose 3%, after above-mentioned each component crosses 200 mesh sieves to sieve respectively, take by weighing the particle diameter and be each component of 200 mesh by the mass percentage of preparative granule raw material;

[0044] 2) After mixing the components, add enough water and stir evenly to obtain a soft material. The soft material is granulated with a double-spherical extruder with a diameter of 0.6mm orifice. The 600r / min spheronizer is used for spheronizing for 8 minutes. After spheronization, the wet spheroids are taken out and dried, and the dried spheroids are sieved, and the particles with a particle size of 50 meshes are obtained as plain granules.

[0045] 2. Preparation...

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Abstract

The invention discloses tilmicosin phosphate enteric granules and a preparation method thereof. The enteric granules comprise 70-80 wt% of elemental granule and 20-30 wt% of coating, wherein the elemental granules are at least prepared from the following components in percentage by mass: 5-40% of tilmicosin phosphate, 30-55% of microcrystalline cellulose, 1-5% of sodium carboxymethyl starch, 26.9-30% of starch, 0.1-1% of surfactant and 2-4% of adhesive; and the coatings are at least prepared from the following components in percentage by mass: 78.9-90.9% of I acrylic resin emulsion, 2.3-7.9% of triethyl citrate and 6.8-13.2% of talcum powder. The coatings are coated outside the tilmicosin phosphate elemental granules, so that the tilmicosin phosphate enteric granules are basically not released in the livestock or fowl stomach, but are gradually and completely released in the livestock or fowl intestinal tract, thereby obviously enhancing the treatment effect of the tilmicosin phosphate.

Description

technical field [0001] The invention relates to a tilmicosin phosphate enteric-coated granule and a preparation method thereof, belonging to the technical field of veterinary medicine. Background technique [0002] Tilmicosin Phosphate is a semi-synthetic macrocyclic lipid antibiotic tilmicosin phosphate, which has strong antibacterial activity and broad antibacterial spectrum. It is effective against all Gram-positive bacteria and some Gram-positive bacteria. Negative bacteria, mycoplasma, spirochetes, mycoplasma, etc. are all inhibited. Especially for Actinobacillus pleuropneumoniae, Pasteurella, Staphylococcus aureus, Streptococcus pyogenes, Corynebacterium pyogenes and Mycoplasma of livestock and poultry, the activity is stronger than Tylosin. The drug has been approved for clinical use in Australia, Brazil, France, Malaysia, Spain, the United States and other countries for the treatment of infectious diseases in cattle, goats, dairy cows, pigs, chickens and other anima...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/16A61K31/706A61K47/20A61K47/26A61K47/38A61K47/32A61P31/04A61P31/00
Inventor 陈清平汪敦辉王铭宏
Owner HUBEI LONGXIANG PHARMA TECH CO LTD
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