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Cefuroxime sodium pharmaceutical composition and preparation method thereof

A technology of cefuroxime sodium and its composition, which is applied in the field of pharmaceutical preparations and preparations, can solve the problems of large dosage of metronidazole, strong toxic and side effects of metronidazole, etc., and achieve the effect of simple preparation process and guaranteed stability

Inactive Publication Date: 2013-06-05
HAINAN WEI KANG PHARMA QIANSHAN
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  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] 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, the combination of cefuroxime sodium and metronidazole is commonly used to prevent surgical infection and treat complex infections containing anaerobic bacteria, but both cefuroxime sodium for injection and metronidazole for injection are , 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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  • Cefuroxime sodium pharmaceutical composition and preparation method thereof
  • Cefuroxime sodium pharmaceutical composition and preparation method thereof
  • Cefuroxime sodium pharmaceutical composition and preparation method thereof

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Embodiment 1

[0033] Embodiment 1, cefuroxime sodium composition powder for injection, in 1000 pieces

[0034] Prescription (specification: 0.75g):

[0035]

[0036] Preparation Process:

[0037] 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; mix the pulverized and sieved freeze-dried metronidazole powder and cefuroxime sodium sterile powder, and after sampling and testing meet the requirements, subpackage according to the marked amount to obtain the requ...

Embodiment 2

[0038] Embodiment two, cefuroxime sodium composition powder injection for injection, in 1000 pieces

[0039] Prescription (specification: 1.5g):

[0040]

[0041] Preparation Process:

[0042] 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; mix the pulverized and sieved freeze-dried metronidazole powder and cefuroxime sodium sterile powder, and after sampling and testing meet the requirements, subpackage according to the marked amount to obta...

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Abstract

The invention provides a cefuroxime sodium pharmaceutical composition and a preparation method thereof, relating to the field of a pharmaceutical preparation and a preparation method thereof. The invention mainly solves the problems of high dosage of single cefuroxime sodium and metronidazole preparation, poor treatment effect after combination, and great side effect in the prior art. The pharmaceutical composition comprises cefuroxime sodium and metronidazole lipid microspheres in a weight ratio of 100:3-100:10, wherein the weight of the metronidazole lipid microspheres is metered on the basis of on metronidazole; and when the pharmaceutical composition is prepared into a powder injection, the pH value of the water solution of the pharmaceutical composition is 6.5-7.0. The pharmaceutical composition powder injection provided by the invention has high curative effect, and can reduce the consumption of the metronidazole by more than 80%, thereby greatly relieving or avoiding the toxic and side effects of the metronidazole, especially digestive tract reactions, including nausea, vomit, inappetence, abdominal colic and neurotoxicity, and lowering the incidence rate of adverse reactions.

Description

Technical field: [0001] The invention relates to the field of pharmaceutical preparations and preparation methods, in particular to a cefuroxime sodium pharmaceutical composition and a preparation method thereof. Background technique: [0002] The chemical name of cefuroxime sodium is: (6R,7R)-7-[2-furyl(methoxyimino)acetamido]-3-carbamoyloxymethyl-8-oxo-5-thia- 1-Azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid sodium salt. Molecular formula: C 16 h 15 N 4 NaO 8 S, molecular weight: 446.37. Its chemical structural formula is: [0003] [0004] Cefuroxime sodium is a second-generation cephalosporin with broad antibacterial spectrum and strong antibacterial activity. It has good antibacterial activity against both Gram-positive and Gram-negative microorganisms. It is highly stable against β-lactamase and has no side effects. small. [0005] [0006] In 1972, Tally first discovered that metronidazole has a systemic anti-anaerobic effect, and was identified by the Wor...

Claims

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Application Information

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IPC IPC(8): A61K31/546A61K31/4164A61K9/19A61P31/04
Inventor 汪金灿汪六一
Owner HAINAN WEI KANG PHARMA QIANSHAN
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