Ceftriaxone sodium pharmaceutical composition and preparation method thereof

Abstract

The invention provides a ceftriaxone sodium pharmaceutical composition and a preparation method thereof, relating to the field of a medicinal preparation and a preparation method thereof. The invention mainly solves the problems of high dosage of single ceftriaxone sodium and metronidazole preparation, poor treatment effect after combination, and great side effect in the prior art. The pharmaceutical composition comprises ceftriaxone 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 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 ceftriaxone sodium pharmaceutical composition and a preparation method thereof. Background technique: [0002] The chemical name of ceftriaxone sodium is: [6R-[6alpha,7beta(Z)]]-3-[[(1,2,5,6-tetrahydro-2-methyl-5,6-dioxo- 1,2,4-Triazin-3-yl)thio]methyl]-7-[[(2-amino-4-thiazolyl](methoxyimino)acetyl]amino]-8-oxo- 5-Thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid sodium salt. Molecular formula: C 18 h 16 N 8 Na 2 o 7 S 3 ·3H 2 O, molecular weight: 661.59. Its chemical structural formula is: [0003] [0004] Ceftriaxone sodium is a third-generation cephalosporin antibiotic, used for lower respiratory tract infection, urinary tract, biliary tract infection caused by sensitive pathogenic bacteria, as well as abdominal infection, pelvic infection, skin and soft tissue infection, bone and joint infection, sepsis , Meningitis, etc. a...

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 ceftriaxone sodium and metronidazole is commonly used to prevent surgical infection and treat complex infections containing anaerobic bacteria, but both ceftriaxone 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

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