Injection-use pharmaceutical composition comprising cefmetazole sodium and clavulanate potassium

A technology of azolium sodium clavulanate potassium and cefmetazole sodium, which is applied in the field of pharmaceutical compositions of cefmetazole sodium and clavulanate potassium for injection, which can solve the problem that the antibacterial activity is greatly affected and the optimization degree of antibacterial activity cannot be expected , Inhibition enzyme spectrum and stability differences, etc., to achieve high antibacterial activity, improve drug stability, and excellent stability

Active Publication Date: 2013-09-04
FUAN PHARM (GRP) CO LTD +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] The pharmaceutical composition of some β-lactam antibiotics and β-lactamase inhibitors has been disclosed in the prior art, but because different β-lactam antibiotics have specific antibacterial spectrum, different β-lactamase The inhibitory spectrum and stability of the inhibitors are also different, resulting in the pharmaceutical composition includi...

Method used

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  • Injection-use pharmaceutical composition comprising cefmetazole sodium and clavulanate potassium
  • Injection-use pharmaceutical composition comprising cefmetazole sodium and clavulanate potassium
  • Injection-use pharmaceutical composition comprising cefmetazole sodium and clavulanate potassium

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0029] Cefmetazole Sodium 100g

[0030] Potassium clavulanate 100g

[0031] L-Arginine 20g

[0032] n-Butyl cyanoacrylate 200g

[0033] Tween 80 100g

[0034] PVP 60g

[0035] Mannitol 50g

[0036] Glycine 50g

[0037] A total of 500 sticks were prepared

[0038] Add cefmetazole sodium, L-arginine and potassium clavulanate to 2.5L water for injection in turn, stir and dissolve at room temperature, add alkyl cyanoacrylate monomer, Tween and PVP, continue stirring for 3 hours, add mannitol and glycine , add 0.5L of water for injection, stir until completely dissolved, adjust the pH to 5-7, filter aseptically with a 0.22 μm filter membrane; divide the filtrate into sterilized vials, pre-freeze at -45°C for 2 hours, Freeze-dried with a freeze dryer, sealed with a sterile rubber stopper, and then sealed with a sterile aluminum cap. Example 2

Embodiment 2

[0039] Cefmetazole Sodium 150g

[0040] Potassium clavulanate 100g

[0041] L-Arginine 20g

[0042] n-Butyl cyanoacrylate 300g

[0043] Tween 80 100g

[0044] PVP 50g

[0045] Mannitol 50g

[0046] Glycine 50g

[0047] A total of 500 sticks were prepared

[0048] Add cefmetazole sodium, L-arginine and potassium clavulanate to 2.5L water for injection in turn, stir and dissolve at room temperature, add alkyl cyanoacrylate monomer, Tween and PVP, continue stirring for 3 hours, add mannitol and glycine , add 0.5L of water for injection, stir until completely dissolved, adjust the pH to 5-7, filter aseptically with a 0.22 μm filter membrane; divide the filtrate into sterilized vials, pre-freeze at -45°C for 2 hours, Freeze-dried with a freeze dryer, sealed with a sterile rubber stopper, and then sealed with a sterile aluminum cap. Example 3

Embodiment 3

[0049] Cefmetazole Sodium 200g

[0050] Potassium clavulanate 100g

[0051] L-Arginine 40g

[0052] Isobutyl cyanoacrylate 400g

[0053] Tween 20 100g

[0054] PVP 60g

[0055] Mannitol 55g

[0056] Glycine 55g

[0057] A total of 500 sticks were prepared

[0058] Add cefmetazole sodium, L-arginine and potassium clavulanate to 2.5L water for injection in turn, stir and dissolve at room temperature, add alkyl cyanoacrylate monomer, Tween and PVP, continue stirring for 3 hours, add mannitol and glycine , add 1L of water for injection, stir until completely dissolved, adjust the pH to 5-7, filter aseptically with a 0.22μm filter membrane; divide the filtrate into sterilized vials, pre-freeze at -45°C for 2 hours, and use Freeze-dried in a freeze dryer, sealed with a sterile rubber stopper, and then sealed with a sterile aluminum cap. Example 4

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Abstract

The invention provides an injection-use pharmaceutical composition comprising cefmetazole sodium and clavulanate potassium, and the pharmaceutical composition has a cooperatively antibacterial effect. The pharmaceutical composition comprises the following ingredients: in parts by weight, 1-4 parts of the cefmetazole sodium; 1-2 parts of the clavulanate potassium; 2-6 parts of polyalkylcyanoacrylate; 0.2-0.5 parts of L-arginine; 0.5-1 parts of PVP; 0.5-1 parts of mannitol; 0.5-1 parts of glycine; 1-2 parts of a tween. The pharmaceutical composition has the advantages of high stability, good redissolubility, simple preparation processes, a good inhibitory effect on ESBLs-producing escherichiacoli, klebsiellapeumoniae, and proteusmirabilis, and a definite curative effect, can reduce the dosage of a single prescription preparation and shorten the treatment cycle, and has broad market prospects.

Description

technical field [0001] The invention relates to a compound preparation of β-lactam antibiotics and β-lactamase inhibitors, in particular to a pharmaceutical composition of cefmetazole sodium and clavulanate potassium for injection. Background technique [0002] β-lactam antibiotics (β-lactams) refer to a large class of antibiotics with a β-lactam ring in their chemical structure, including the most commonly used penicillins and cephalosporins in clinical practice, as well as the newly developed cephamycins and thiomycetes. Other atypical β-lactam antibiotics such as steroids and monocyclic β-lactams. Such antibiotics have the advantages of strong bactericidal activity, low toxicity, wide indications and good clinical curative effect. The chemical structure of this class of drugs, especially the change of the side chain, has formed many antibiotics with different antibacterial spectrum and antibacterial effect and various clinical pharmacological properties. [0003] Cefmet...

Claims

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Application Information

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IPC IPC(8): A61K31/546A61K9/19A61P31/04A61K31/424
CPCY02A50/30
Inventor 周旭东杜江徐霞陈小勇
Owner FUAN PHARM (GRP) CO LTD
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