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Antibacterial drug injection containing poloxamer 407 and oily medium

An antibacterial drug, oily medium technology, applied in antibacterial drugs, medical preparations containing active ingredients, pharmaceutical formulations, etc.

Active Publication Date: 2014-04-09
荷本(北京)大药厂有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, oily long-acting injections containing antibacterial drugs / P407 drug-loaded particles have not been reported

Method used

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  • Antibacterial drug injection containing poloxamer 407 and oily medium
  • Antibacterial drug injection containing poloxamer 407 and oily medium
  • Antibacterial drug injection containing poloxamer 407 and oily medium

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0027] Example 1. Preparation of 10% Ceftiofur Hydrochloride Injection

[0028] Preparation composition: 90% ceftiofur hydrochloride 110g, P407 60g, H-HPC 30g, and soybean oil for injection to 1 liter.

[0029] Preparation method: (1) Melt P407 at 60-70°C, add H-HPC and mix well, add methanol equivalent to 2 times the amount of ceftiofur hydrochloride, wait until H-HPC is dissolved and cool to room temperature, add ceftiofur hydrochloride , Fully mix, remove methanol under reduced pressure, cool, solidify, pulverize, and pass through a 40-mesh sieve to obtain drug-loaded particles containing ceftiofur hydrochloride. (2) Disperse the drug-carrying particles in part of soybean oil, grind it with a colloid mill to a particle size of less than 50μm, and then grind it with a sand mill until the particle size is less than 10μm, add the remaining medium, and use a high-shear homogenizer to Under the condition of about 5000 rpm, after repeated homogenization, ceftiofur hydrochloride injec...

Embodiment 2

[0030] Example 2. Preparation of 8% Ceftiofur Hydrochloride Injection

[0031] Preparation composition: 90% ceftiofur hydrochloride 90g, P407 80g, IPM added to 1 liter.

[0032] Preparation method: (1) Melt P407 at 60-70°C, add ceftiofur hydrochloride superfine powder, mix well, cool, pulverize after solidification, and pass through a 40-mesh sieve to obtain drug-loaded particles containing ceftiofur hydrochloride. (2) Disperse the drug-loaded particles in a part of the IPM, grind it with a colloid mill to a particle size of less than 100μm, then grind it with a sand mill until the particle size is less than 20μm, add the remaining medium, and use a high-shear homogenizer to After repeated homogenization under the condition of 5000 rpm, ceftiofur hydrochloride injection with a particle size of less than 20 μm was prepared.

Embodiment 3

[0033] Example 3. Blood drug concentration detection

[0034] Control preparation: 9g of ceftiofur hydrochloride superfine powder, 8g of P407, sterile water added to 100ml, ready to use.

[0035] Select 6 healthy pigs weighing about 30 kg, and randomly divide them into two groups A and B, each with 3 pigs. The control preparation and the preparation of Example 2 were injected intramuscularly at a dose of 8 mg / kg bw. The crossover test method was adopted. The test interval is 20 days, the blood is collected on time, the plasma is separated by centrifugation, the plasma samples of the same group at the same time are mixed in equal amounts, and the test samples are obtained through the processes of extraction, purification, and concentration. High pressure liquid chromatography (C 18 Column) Determine the concentration of ceftiofur in plasma. The experimental results are shown in Table 1 and Table 2.

[0036] Table 1. Results of the first test

[0037]

[0038] ※The value in the table i...

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Abstract

The invention discloses an oily long-acting injection containing antibacterial drug / poloxamer 407 drug-loading particles, which is prepared by combining the antibacterial drug 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 specifically relates to the preparation of long-acting veterinary injections containing antibacterial drugs by using poloxamer 407 and an oily medium as carriers. Background technique [0002] Poloxamer is a polyoxyethylene-polyoxypropylene ether copolymer. This type of polymer has a variety of specifications. Among them, the aqueous solution of poloxamer 407 (hereinafter referred to as P407) has the characteristic of "from sol to gel with increasing temperature" "Transformation characteristics", a certain concentration of P407 aqueous solution generally gels above 28°C. Based on this characteristic, P407 is used in the preparation of sustained-release injections, which are called in-situ gelling preparations. After the in-situ gel injection containing P407 is injected into the body, under the effect of body temperature, it usually changes from a sol to a gel (semi-soli...

Claims

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Application Information

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IPC IPC(8): A61K9/10A61K45/00A61K47/44A61K47/12A61K47/38A61K47/34A61P31/04
Inventor 王玉万戴晓曦潘贞德任雅楠翁志飞沈力
Owner 荷本(北京)大药厂有限公司
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