A kind of ceftiofur crystal suspension injection and preparation method thereof

A technology of ceftiofur crystals and suspension injection, which is applied in liquid delivery, pharmaceutical formula, emulsion delivery, etc. It can solve the problems of waste of human and financial resources in farms, animal stress response, short action time, etc., and achieve improved mixing. Suspension adhesion effect, uniform mixing, long half-life effect

Active Publication Date: 2018-05-22
SICHUAN HENGTONG ANIMAL PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] According to the "Compilation of Veterinary Drug Quality Standards 2006-2011", ceftiofur mainly includes ceftiofur sodium freeze-dried powder injection, ceftiofur hydrochloride and other dosage forms. The disadvantage of these dosage forms is that the action time is short. For 3 to 5 days, this kind of frequent injections will cause a waste of manpower and financial resources in the farm, and will also cause stress reactions in animals

Method used

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  • A kind of ceftiofur crystal suspension injection and preparation method thereof
  • A kind of ceftiofur crystal suspension injection and preparation method thereof
  • A kind of ceftiofur crystal suspension injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0029] 10% ceftiofur crystal suspension injection formula 1:

[0030] raw material

Feeding

content

Ceftiofur crystals

537.6g

10% (W / V)

Povidone K-17

250g

2% (W / V)

polyethylene glycol 400

1.5L

30% (V / V)

Benzyl alcohol

50mL

1% (V / V)

Soybean oil

3.06L

[0031] Preparation:

[0032] 1) dissolving povidone K-17 in polyethylene glycol 400, adding soybean oil to obtain an injection vehicle;

[0033] 2) adding benzyl alcohol to the injection solvent in step 1;

[0034] 3) Under nitrogen protection, sterilize the mixed solvent in step 2 at 135° C. for 5 hours, and place it at room temperature for later use;

[0035] 4) Under the protection of nitrogen, add ceftiofur crystals to the mixed solvent, and use a high-speed shear disperser to stir for 30 minutes under the condition of 1200r / min, and mix well;

[0036] 5) Go through a colloid mill to obtain ceftiofur crystal suspension injection.

...

Embodiment 2

[0057] 10% Ceftiofur Crystalline Suspension Injection Formula II:

[0058] raw material

Feeding

proportion

Ceftiofur crystals

537.6g

10% (W / V)

Povidone K-12

250g

2% (W / V)

polyethylene glycol 300

0.5L

10% (V / V)

Chlorobutanol

25mL

0.5% (V / V)

olive oil

4.08L

[0059] Preparation:

[0060] 1) Dissolving povidone K-12 in polyethylene glycol 300, adding olive oil, to obtain an injection vehicle;

[0061] 2) Add chlorobutanol to the injection vehicle in step 1;

[0062] 3) Under argon protection, sterilize the mixed solvent in step 2 at 140° C. for 3 hours, and place it at room temperature for later use;

[0063] 4) Under the protection of argon, add ceftiofur crystals to the mixed solvent, and use a high-speed shear disperser to stir for 15 minutes under the condition of 2000r / min, and mix well;

[0064] 5) Obtaining ceftiofur crystal suspension injection through colloid milling.

Embodiment 3

[0066] 15% Ceftiofur Crystalline Suspension Injection Formula:

[0067] raw material

Feeding

proportion

Ceftiofur crystals

805.4g

15% (W / V)

Povidone K-17

625g

5% (W / V)

polyethylene glycol 400

0.5L

10% (V / V)

Chlorobutanol

50mL

1% (V / V)

ethyl oleate

4.74L

[0068] Preparation:

[0069] 1) Dissolving povidone K-17 in polyethylene glycol 400, adding ethyl oleate to obtain an injection vehicle;

[0070] 2) Add chlorobutanol to the injection vehicle in step 1;

[0071] 3) Under nitrogen protection, sterilize the mixed solvent in step 2 at 135° C. for 5 hours, and place it at room temperature for later use;

[0072] 4) Under the protection of nitrogen, add ceftiofur crystals to the mixed solvent, and use a high-speed shear disperser to stir for 15 minutes under the condition of 1500r / min, and mix well;

[0073] 5) Obtaining ceftiofur crystal suspension injection through colloid milling.

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Abstract

The invention provides a ceftiofur crystal suspension injection, which is prepared by the following method: adding povidone and polyethylene glycol into oil for injection to obtain an injection vehicle; adding a bacteriostatic agent to the injection vehicle; inert Under gas protection, sterilize the above mixed solvent at high temperature, cool to room temperature, add ceftiofur crystals, stir and mix evenly with high-speed shearing; pass through a colloid mill to obtain a long-acting ceftiofur crystal suspension injection. The ceftiofur crystal suspension injection of the present invention has the characteristics of good redispersibility, good fluidity, slow sedimentation, and low incidence of adverse reactions, and its quality conforms to the relevant regulations of the Chinese Veterinary Pharmacopoeia; Efficiency; at the same time, the preparation process is simple, the equipment requirements are low, and it is suitable for industrialized large-scale production, so its application prospect is very broad.

Description

technical field [0001] The invention relates to a cephalosporin drug injection and a preparation method thereof, in particular to a ceftiofur crystal suspension injection and a preparation method thereof, belonging to the field of animal medicine. Background technique [0002] Ceftiofur, chemical name (6R,7R)-7-[2-(2-aminothiazol-4-yl)(methoxyimino)acetamido]-3-[(2-furylcarbonyl) Thiomethyl]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid, the third generation semi-synthetic cephalosporin for animals. Ceftiofur (ceftiofur) was first synthesized by Bernard Labeeuw et al. in 1984. It has a lactam ring and a furan chain in its structure, and it has a strong killing effect on Gram-positive bacteria and negative bacteria. After entering the body, the furan The chain is first degraded to produce a metabolite - desfuroseftiofur, which still has a strong bactericidal effect due to the integrity of the lactam ring. [0003] According to the "Compilation of Veterinary Dr...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/10A61K31/546A61K47/32A61K47/10A61P31/04
Inventor 郭亮刘起军
Owner SICHUAN HENGTONG ANIMAL PHARMA
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