Mezlocillin sodium pharmaceutical composition for injection and preparation method thereof

Abstract

The invention provides a mezlocillin sodium pharmaceutical composition for injection 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 mezlocillin sodium and metronidazole preparation, poor treatment effect after combination, and great side effect in the prior art. The pharmaceutical composition comprises mezlocillin 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 freeze-dried powder injection, the pH value of the water solution of the pharmaceutical composition is 6.5-7.0. The pharmaceutical composition freeze-dried 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 mezlocillin sodium pharmaceutical composition for injection and a preparation method thereof. Background technique: [0002] Mezlocillin Sodium (Mezlocillin Sodium) was discovered in 1968 by the Bayer Company of the Federal Republic of Germany in the study of ampicillin α-amino acylated derivatives. In 1977, the Federal Republic of Germany was the first to go on the market. In 1981, the US FDA officially approved the drug to be launched in the United States. Since the 1980s, it has been listed in the United States, Japan, Italy, the Netherlands, and Switzerland. This product has been widely used abroad as the third-generation semi-synthetic penicillin. Mezlocillin has a spectrum antibacterial effect on Gram-positive and negative bacteria, has superior antibacterial activity on Pseudomonas aeruginosa and most anaerobic bacteria, and has certai...

AI Technical Summary

Problems solved by technology

[0006] 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, mezlocillin sodium and metronidazole are commonly used in combination to prevent surgical infection and treat complex infections containing anaerobic bacteria. However, both mezlocillin sodium for injection and metronidazole for injection are used as single products. 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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