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Oil injection containing tulathromycin/poloxamer 407

A technology of tebramycin and poloxamer, applied in the field of long-acting injections, can solve the problems of easy blocking of needles, difficulty in preparing high-concentration tebramycin injections, large volume, etc.

Inactive Publication Date: 2014-05-07
王玉万
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Due to the poor water solubility of telamycin, improper formulation of the suspension will cause defects such as low bioavailability and easy plugging of needles; preparing telamycin into nanoemulsions can overcome the shortcomings of large irritation, but it is difficult Prepare high-concentration telamycin injection (generally only can prepare the nanoemulsion of maximum no more than 7% concentration), can bring the shortcoming that administration volume is big like this, especially be used for large animal (as cattle), need more Point injection, very inconvenient

Method used

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  • Oil injection containing tulathromycin/poloxamer 407

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0016] Embodiment 1, preparation 10% telamycin injection

[0017] Preparation composition: telamycin 100g, P407 100g, BHT0.2g, BHA0.1g, IPM added to 1 liter.

[0018] Preparation method: (1) Melt P407 at 65-75°C, then add telamycin and an equal amount of ethyl acetate, mix well, and after the telamycin is completely dissolved, remove the solvent to obtain a solid solution. Pulverize and pass through a 40-mesh sieve to obtain telamycin / P407 drug-loaded particles. (2) Disperse the drug-loaded particles in an appropriate amount of IPM, shear them to a particle size of about 200 μm with a high-shear homogenizer, and further grind them to a particle size of less than 10 μm with a sand mill, then add the remaining ingredients, and use a high-shear homogenizer to The 10% telamycin injection was prepared after several times of homogenization by the cutting homogenizer under the condition of 5000 rpm.

Embodiment 2

[0019] Embodiment 2, preparation 14% telamycin injection

[0020] Preparation composition: each liter contains 140g of telamycin, 70g of P407, 8ml of Span-80, 0.7g of lecithin, 0.2g of BHT, 0.1g of BHA, 0.1g of PG, and soybean oil for injection is added to the final volume.

[0021] Preparation method: mix Tyramycin and P407 with soybean oil, homogenize with a high-shear homogenizer, and further grind with a sand mill until the particle size is less than 5 μm, then add the remaining ingredients, and homogenize with a high-shear homogenizer The 14% telamycin injection was prepared after several times of homogenization by the machine under the condition of 5000rpm.

Embodiment 3

[0022] Embodiment 3, preparation 18% telamycin injection

[0023] Preparation composition: telamycin 180g, P407 80g, BHT0.2g, BHA0.1g, PG0.1g, sesame oil for injection is added to 1 liter.

[0024] Preparation method: (1) P407, Tyramycin and acetone equivalent to 2 times the amount of Tyramycin are refluxed and dissolved at 60-70 ° C, mixed thoroughly, cooled and reduced pressure, and acetone is removed to obtain a solid solution. The solid solution was pulverized and passed through a 30-mesh sieve to obtain telamycin / P407 drug-loaded microparticles. (2) Disperse the drug-loaded particles in sesame oil, grind to a particle size of about 100 μm with a colloid mill, and further grind to a particle size of less than 10 μm with a sand mill, then add the remaining ingredients, and use a high-shear homogenizer at 5000 rpm After several times of homogenization, 18% telamycin injection was prepared.

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Abstract

The invention discloses combination of tulathromycin and poloxamer 407. The technology comprises the following steps: preparing medicine-carrying micro-particles; further dispersing the medicine-carrying micro-particles into oil medium; and preparing a long-acting oil injection containing tulathromycin and poloxamer 407 medicine-carrying micro-particles in a grinding manner. The injection is simple in preparation technology, good in slow-release effect, good in biocompatibility, and free of an irreversible damage to the tissue of the injection part.

Description

technical field [0001] The invention belongs to the preparation technology of veterinary drug preparations, and specifically relates to preparing telamycin and poloxamer 407 into drug-loaded microparticles, suspending the drug-loaded microparticles in an oily medium, and preparing long-acting injections containing telamycin drug-loaded microparticles. Background technique [0002] Tulathromycin (Tulathromycin) is a macrolide semi-synthetic antibiotic for animals. It is mainly used in veterinary clinics for respiratory diseases in pigs and cattle caused by actinomycetes, mycoplasma, Pasteurella, and Haemophilus para It has the advantages of high efficiency, broad spectrum, one-time administration, and low residue. Tyramycin has low bioavailability when administered orally, and the commercially available products are mainly injections. Although the currently commercially available Tyramycin injections have high bioavailability, they are more irritating, and "often cause short-...

Claims

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Application Information

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IPC IPC(8): A61K9/10A61K31/7052A61K47/34A61P31/04
Inventor 王玉万潘贞德戴晓曦翁志飞任雅楠沈力
Owner 王玉万
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