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Oily injection containing valnemulin hydrochloride/poloxamer 407

A technology of warnemulin hydrochloride and poloxamer, which is applied in the field of preparation of veterinary long-acting injections containing warnemulin hydrochloride, which can solve problems such as difficulty in injection and increased viscosity of preparations

Active Publication Date: 2014-04-09
河北威远药业有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The in situ gelling injection containing P407 disclosed in the literature and patents uses water as the main solvent, and the concentration of P407 in the preparation must reach more than 20% to have a better sustained release effect; a certain amount of methyl alcohol is added to the preparation Blocking agents such as cellulose, sodium carboxymethylcellulose, highly substituted hydroxypropylcellulose (H-HPC) or hydroxypropylmethylcellulose (HPMC) can enhance the sustained release effect, but will cause the viscosity of the formulation to increase high, making injections more difficult

Method used

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  • Oily injection containing valnemulin hydrochloride/poloxamer 407
  • Oily injection containing valnemulin hydrochloride/poloxamer 407

Examples

Experimental program
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Effect test

Embodiment 1

[0024] Embodiment 1, preparation 15% warnemulin hydrochloride injection

[0025] Preparation composition: 150 g of warnemulin hydrochloride, 100 g of P407, and soybean oil for injection are added to 1 liter.

[0026] Preparation method: (1) Melt P407 at 65-75°C, then add warnemulin hydrochloride and methanol equivalent to 2-3 times the amount of warnemulin hydrochloride, stir well, cool and reduce pressure, remove methanol, and prepare To obtain a solid solution, crush the solid solution and pass through a 40-mesh sieve to obtain warnemulin hydrochloride / P407 drug-loaded particles. (2) Disperse the drug-loaded particles in an appropriate amount of soybean oil, grind them to a particle size of about 100 μm with a colloid mill, and further grind them to a particle size of less than 10 μm with a sand mill, then add the remaining soybean oil, and use a high-shear homogenizer The 15% warnemulin hydrochloride injection was prepared by the homogenizer several times under the conditi...

Embodiment 2

[0027] Embodiment 2, preparation 10% warnemulin hydrochloride injection

[0028] Preparation composition: every liter contains 100 g of warnemulin hydrochloride, 60 g of P40760 g, 30 g of HPMC, and IPM added to the final volume.

[0029] Preparation method: (1) Melt P407 at 65-75°C, then add warnemulin hydrochloride and HPMC, mix well, add methanol equivalent to 2-3 times the amount of warnemulin hydrochloride, stir well, cool and Under reduced pressure, methanol was removed to obtain a solid solution, which was pulverized and passed through a 40-mesh sieve to obtain drug-loaded particles containing warnemulin hydrochloride. (2) Disperse the drug-loaded particles in an appropriate amount of IPM, grind them to a particle size of about 100 μm with a colloid mill, and then grind them further to a particle size of less than 8 μm with a sand mill, then add the remaining IPM, and use a high-shear homogenizer to After repeated homogenization under the condition of 5000rpm, 10% warne...

Embodiment 3

[0030] Embodiment 3, preparation 13% warnemulin hydrochloride injection

[0031] Preparation composition: Each liter contains 130 g of warnemulin hydrochloride, 65 g of P4076, and 40 g of H-HPC, and IPM is added to the final volume.

[0032] Preparation method: (1) Melt P407 at 65-75°C, then add warnemulin hydrochloride and H-HPC, mix well, add methanol equivalent to 2-3 times the amount of warnemulin hydrochloride, stir well, Cool and depressurize, remove methanol to obtain a solid solution, crush the solid solution, and pass through a 40-mesh sieve to obtain drug-loaded particles containing warnemulin hydrochloride. (2) Disperse the drug-loaded particles in an appropriate amount of IPM, grind them to a particle size of about 100 μm with a colloid mill, and then grind them further to a particle size of less than 8 μm with a sand mill, then add the remaining IPM, and use a high-shear homogenizer to After repeated homogenization under the condition of 5000rpm, 6.5% warnemulin hy...

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Abstract

The invention discloses an oily long-acting injection containing valnemulin hydrochloride / poloxamer 407 drug-loading particles, which is prepared by combining the valnemulin hydrochloride with poloxamer 407 into drug-loading particles and further dispersing the drug-loading particles into an oily medium and grinding. Hydroxypropyl methyl cellulose or high-substituted hydroxypropyl cellulose also can be added into the drug-loading particles, and the sustained-release effect of the preparation is obviously enhanced. The preparation process of the injection is simple, the drug release is uniform, the biocompatibility is good, irreversible damage to the tissue of the injection part is avoided, and the adopted sustained-release carrier can be degraded and excreted.

Description

technical field [0001] The invention belongs to the preparation technology of veterinary drug preparations, and in particular relates to the preparation of veterinary long-acting injections containing warnemulin hydrochloride by using poloxamer 407 and oily medium as carriers. Background technique [0002] Wernemulin hydrochloride is a semi-synthetic antibacterial drug specially used for animals. It has the characteristics of broad antibacterial spectrum, high activity, low toxicity and side effects, not easy to produce drug resistance, and low residue. It is mainly used to prevent and treat pigs, cattle, sheep and poultry. Mycoplasmosis and infection with Gram-positive bacteria. At present, the commercially available products include a premix that is added to the feed to feed animals and warnemulin hydrochloride injection. [0003] Patent CN102119919B discloses a kind of oil-based injection of vonemulin, which is a solution-type oily injection prepared with ethanol or glyc...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/10A61K47/34A61K31/22A61K47/38A61P31/04
Inventor 王玉万戴晓曦潘贞德任雅楠翁志飞沈力
Owner 河北威远药业有限公司
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