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Cefquinome powder injection

A technology of cefquinome and powder injection, which is applied in the field of powder injection and can solve the problems of decreased water solubility and unstable crystal form, etc.

Active Publication Date: 2018-10-23
RINGPU TIANJIN BIOLOGICAL PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] In order to solve the problem of water-solubility decline caused by the unstable crystal form of the cefquinome crystal form powder injection based on the Chinese patent document CN 105646543A during storage, the technical solution adopted in the present invention is:

Method used

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  • Cefquinome powder injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0020] Prescription: crystalline cefquinome: 10g; polyethylene glycol 4000: 5g; N-acyl sarcosine: 0.5g.

[0021] Production process: (1) Melting: Heat polyethylene glycol 4000 to 55 degrees to melt, add crystalline cefquinome and amino acid surfactant, mix and stir for 15 minutes. Get liquid A.

[0022] (2) Cooling: Rapidly cool liquid A to below 15 degrees to obtain solid mixture B.

[0023] (3) Pulverization: Ultrafine pulverization of the solid mixture B.

[0024] (4) Mixing: The pulverized material was mixed for 30 minutes.

[0025] (5) Subpackage: Subpackage in a sterile room, the specification of subpackage is 1g / cartridge (calculated as cefquinome).

Embodiment 2

[0027] Prescription: Crystalline cefquinome: 10g; polyethylene glycol 4000: 10g; N-acyl sarcosine: 0.8g

[0028] Production process: (1) Melting: Heat polyethylene glycol 4000 to 55 degrees to melt, add crystalline cefquinome and amino acid surfactant, mix and stir for 15 minutes. Get liquid A.

[0029] (2) Cooling: Rapidly cool liquid A to below 15 degrees to obtain solid mixture B.

[0030] (3) Pulverization: The solid mixture B is mechanically pulverized.

[0031] (4) Mixing: The pulverized material was mixed for 15 minutes.

[0032] (5) Subpackage: Subpackage in a sterile room, the specification of subpackage is 1g / cartridge (calculated as cefquinome).

Embodiment 3

[0034] Composition: crystalline cefquinome: 10g; polyethylene glycol 4000: 10g; N-acyl sarcosine: 1.2g

[0035] Production process: (1) Melting: Heat polyethylene glycol 4000 to 55 degrees to melt, add crystalline cefquinome and amino acid surfactant, mix and stir for 15 minutes. Get liquid A.

[0036] (2) Cooling: Rapidly cool liquid A to below 15 degrees to obtain solid mixture B.

[0037] (3) Pulverization: The solid mixture B is mechanically pulverized.

[0038] (4) Mixing: The pulverized material was mixed for 15 minutes.

[0039] (5) Subpackage: Subpackage in a sterile room, the specification of subpackage is 1g / cartridge (calculated as cefquinome).

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Abstract

Cefquinome powder injection is characterized by comprising crystalline cefquinome, and polyethylene glycol and amino acid surfactant acting as crystal transition inhibitory auxiliaries; the mass ratioof the polyethylene glycol to the amino acid surfactant is 10:(0.5-2). A preparation method of the cefquinome powder injection includes the steps of (1) melting, to be specific, heating the polyethylene glycol to 50-65 DEG C for melting, adding the crystalline cefquinome and the amino acid surfactant, and mixing to obtain melt A; (2) cooling, to be specific, quickly cooling the melt A to solid state to obtain solid mixture B; (3) crushing the solid mixture B.

Description

technical field [0001] The invention relates to a powder injection containing cefquinome. Background technique [0002] Cefquinome (Cefquinome CAS::84957-30-2) is a fourth-generation cephalosporin antibiotic for animals developed and developed by Hoechst Animal Health in Germany in the 1980s. It was first approved for marketing in 1993. Cefquinome has broad-spectrum antibacterial activity and strong antibacterial activity. It is mainly used in the clinical treatment of respiratory infections in pigs and cattle caused by sensitive bacteria, mastitis in dairy cows, and agalactia syndrome in sows. The raw materials used in the current commercially available cefquinome preparations are all cefquinome sulfates - cefquinome sulfate (Cefquinome Sulfate, CAS: 118443-89-3), and the raw material properties of cefquinome sulfate are white, off-white or Light yellow crystalline powder, slightly soluble in water, insoluble in ethanol, melting point 179.9°C. Molecular formula is C 23 h...

Claims

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Application Information

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IPC IPC(8): A61K9/14A61K47/10A61K47/18A61K31/546A61P31/04
CPCA61K9/145A61K9/146A61K31/546A61P31/04
Inventor 聂丽娜夏雪林刘爱玲李旭东
Owner RINGPU TIANJIN BIOLOGICAL PHARMA