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Azlocillin sodium drug composition and preparation method thereof

A technology of azlocillin sodium and composition, applied in the field of azlocillin sodium pharmaceutical composition and preparation thereof, can solve the problems of large dosage of metronidazole, strong toxic and side effects of metronidazole, etc., and achieves simple preparation process and guaranteed stability sexual effect

Inactive Publication Date: 2013-05-22
HAINAN WEI KANG PHARMA QIANSHAN
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0009] Infections in clinical operations are often accompanied by mixed infections containing anaerobic bacteria and aerobic bacteria, rather than a single anaerobic or aerobic bacterial infection, because metronidazole is the clinical first choice for the treatment of anaerobic infection, Clinically, azlocillin sodium and metronidazole are commonly used in combination to prevent surgical infection and treat complex infections containing anaerobic bacteria. , the dosage of metronidazole is very large, and the toxic and side effects of metronidazole are very strong. Normal therapeutic doses of metronidazole can cause gastrointestinal reactions, the most common of which include nausea, vomiting, loss of appetite, abdominal cramps and high neurotoxicity

Method used

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  • Azlocillin sodium drug composition and preparation method thereof
  • Azlocillin sodium drug composition and preparation method thereof
  • Azlocillin sodium drug composition and preparation method thereof

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Embodiment 1

[0035] Embodiment 1, azlocillin sodium composition powder for injection, in 1000 pieces

[0036] Prescription (specification: 1.0g / bottle):

[0037]

[0038] Preparation Process:

[0039] Add the prescribed amount of metronidazole lipid microspheres (calculated as metronidazole) directly to an appropriate amount of water for injection; stir and dissolve, then add a pH regulator to adjust the pH of the solution so that it is in the range of 6.5-6.8; 0.45μm and 0.22μm filter membranes are used for sterilization cycle filtration for 30 minutes; after the sampling inspection meets the requirements, the solution is divided into stainless steel trays, put into a freeze-drying box, and freeze-dried to obtain sterile freeze-dried metronidazole powder, pulverized and sieved; after mixing the pulverized and sieved metronidazole freeze-dried powder and azlocillin sodium sterile powder, after the sampling inspection meets the requirements, subpackage according to the marked amount to ...

Embodiment 2

[0040] Embodiment two, azlocillin sodium composition powder for injection, in 1000 pieces

[0041] Prescription (specification: 2.0g):

[0042]

[0043] Preparation Process:

[0044] Add the prescribed amount of metronidazole lipid microspheres (calculated as metronidazole) directly to an appropriate amount of water for injection; stir and dissolve, then add a pH regulator to adjust the pH of the solution so that it is in the range of 6.5-6.8; 0.45μm and 0.22μm filter membranes are used for sterilization cycle filtration for 30 minutes; after the sampling inspection meets the requirements, the solution is divided into stainless steel trays, put into a freeze-drying box, and freeze-dried to obtain sterile freeze-dried metronidazole powder, pulverized and sieved; after mixing the pulverized and sieved metronidazole freeze-dried powder and azlocillin sodium sterile powder, after the sampling inspection meets the requirements, subpackage according to the marked amount to obtai...

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Abstract

The invention provides an azlocillin sodium drug composition and a preparation method thereof, relating to the fields of pharmaceutical preparations and preparation methods and mainly solving the problems that single preparations of azlocillin sodium and metronidazole in the prior art have great dosages, poor treatment effects after being combined and big side effects. The drug composition comprises azlocillin sodium and metronidazole lipid microspheres in a weight ratio of (100:3)-(100:10), wherein the weight of the metronidazole lipid microspheres is based on metronidazole. The drug composition is prepared into powder injection. The pH value of water solution of the drug composition is 6.5-7.0. The powder injection of the drug composition provided by the invention not only has high curative effect but also can reduce the dosage of metronidazole by over 80%, thus greatly reducing or avoiding the toxic and side effects, especially gastrointestinal reactions including nausea, emesis, anorexia, abdominal cramp and neurotoxicity, of metronidazole and further reducing the occurrence rate of adverse reactions.

Description

Technical field: [0001] The invention relates to the field of pharmaceutical preparations and preparation methods, in particular to an azlocillin sodium pharmaceutical composition and a preparation method thereof. Background technique: [0002] The chemical name of azlocillin sodium is: (2S,5R,6R)-3,3-dimethyl-6-[[[[(2-oxo-1-imidazolidinyl)carbonyl]amino]phenylacetyl Base]amino]-7-oxo-4-thia-1-azabicyclo[3,2,0]heptane-2-carboxylic acid sodium salt. Molecular formula: C 20 h 22 N 5 NaO 6 S, molecular weight: 483.47. Its chemical structural formula is: [0003] [0004] Azlocillin Sodium [0005] Azlocillin sodium is a penicillin antibiotic, the third-generation broad-spectrum semi-synthetic penicillin, effective against G+ bacteria, G- bacteria and anaerobic bacteria, and can strongly fight against Pseudomonas aeruginosa. It is suitable for infections caused by Gram + bacteria, Gram - bacteria and anaerobic bacteria. Various infections caused by sensitive Gram-neg...

Claims

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Application Information

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IPC IPC(8): A61K31/431A61K31/4164A61K9/14A61P31/04
Inventor 汪六一
Owner HAINAN WEI KANG PHARMA QIANSHAN
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