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Cefquinome medicinal composition for injection capable of being stored stably and dissolved easily in water

A technology of cefquinome and composition, which is applied in the field of cefquinome pharmaceutical composition for injection, which can be stored stably and is easily soluble in water, can solve the problems of slow absorption speed, inconvenient use, high preparation process requirements, etc. The effect of rapid dissolution and stable quality

Inactive Publication Date: 2007-08-01
QILU ANIMAL HEALTH PROD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the preparation process of emulsion or suspension is relatively high, the absorption speed is slow, and it is inconvenient to use

Method used

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  • Cefquinome medicinal composition for injection capable of being stored stably and dissolved easily in water
  • Cefquinome medicinal composition for injection capable of being stored stably and dissolved easily in water

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0032] Take 10g of cefquinome sulfate, add 100ml of freshly prepared cold water for injection, add 4g of L-arginine and 0.6g of mannitol under stirring, adjust the pH to 6.5 with 0.1N aqueous sodium hydroxide solution or 0.1N hydrochloric acid aqueous solution, add 0.1 g activated carbon and stirred for 20 minutes to decarbonize. Under aseptic conditions, after coarse filtration, use a 0.22-micron microporous membrane filter to filter and sterilize. The filtrate is divided into vials and freeze-dried to obtain a freeze-dried powder for injection, which is made into cefquinome-containing 0.1g / bottle specification.

[0033] The test sample of Example 1 was stored at 4°C ± 2°C for 6 months, and the solubility was detected by the same method before and after storage. The results showed that 0.2g of the sample before and after storage could be dissolved in 3ml of normal temperature injection within 10 seconds In water, without leaving any water-insoluble solid matter, to meet the ...

Embodiment 2

[0040] Under sterile environment, mix 100g cefquinome sulfate sterile powder and 24gNa 2 CO 3 The aseptic powder is mixed evenly, ground through a No. 6 sieve, and then aseptically divided into bottles to obtain cefquinome powder for injection, which is made into a specification containing 1 g of cefquinome per bottle.

[0041] The test sample of Example 2 was stored at 4°C ± 2°C for 6 months, and the solubility was detected by the same method before and after storage. The results showed that 0.2g of the sample before and after storage could be dissolved in 3ml of normal temperature injection within 20 seconds In water, without leaving any water-insoluble solid matter, to meet the needs of injection medicine.

[0042] The test samples of Example 2 were stored at 4°C±2°C for 6 months, and the relevant physical and chemical properties were measured at 0 month, 3 months, and 6 months respectively, as shown in Table 2.

[0043] Table 2. Stability data of cefquinome sulfate powde...

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Abstract

The invention relates to the water soluble Cefquinome compounds which are used for injection. The compounds include Cefquinome (the active ingredient) and / or added salt with acid, one kind or many kinds of auxiliary solvent which can be used in medicine, and one kind or many kinds of additives commonly used for injections. The preparing method of the compounds is also mentioned in the invention. The product in the invention has a steady quality and can be dissolved in water easily.

Description

technical field [0001] The invention relates to a pharmaceutical composition of cefquinome and / or a pharmaceutically acceptable salt thereof for injection and a preparation method thereof. Background technique [0002] Cefquinome (cefquinome) is the fourth-generation animal-specific cephalosporin antibiotic, its structure is shown in the following formula (I), and its chemical name is (6R, 7R)-7-[(2Z)-(2-aminothiazol-4-yl )-2-methoxyiminoacetamido]-3-(5,6,7,8-tetrahydroquinolinium-1-ylmethyl)-8-oxo-5-thia-1-aza Bicyclo[4.2.0]oct-2-ene-2-carboxy inner salt. [0003] [0004] Cefquinome overcomes the shortcomings of the previous three generations of cephalosporin antibiotics, which are highly effective against Gram-positive bacteria and relatively weak against Gram-negative bacteria, and have a strong killing effect on both Gram-negative and positive bacteria. At a lower concentration, it can have a strong inhibitory effect on Staphylococcus aureus, Streptococcus, Pasteur...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/546A61K9/19A61K9/14A61P31/04
Inventor 孔梅刘红娟吴连勇禚宝山
Owner QILU ANIMAL HEALTH PROD
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