Ceftazidime injectable powder for injection and preparation method of ceftazidime injectable powder for injection

Abstract

The invention discloses ceftazidime injectable powder for injection and a preparation method of the ceftazidime injectable powder for injection. The ceftazidime injectable powder for injection comprises the following raw materials in parts by weight of 8.26-12.31 parts of ceftazidime, 6.45-9.22 parts of chitosan nanoparticles, 0.06-3.8 parts of arginine, 0.06-3.8 parts of lysine, 0.82-5.3 parts ofsuperfine bacteria-free sodium carbonate and 0.00005-0.0019 part of sodium bisulfite. The ceftazidime injectable powder for injection disclosed by the invention is high in purity, particularly low inimpurity content, good and stable in quality, better in clarity and wide in in vitro antibacterial activity spectrum, the antibacterial activity of the ceftazidime on Gram-negative bacteria can be significantly strengthened, the content of polymers is low, drug allergy reactions are reduced, the dissolving speed is high, the ceftazidime injectable powder for injection can quickly dissolve even atlow temperature of 10 DEG C, and the ceftazidime injectable powder for injection is convenient in clinical use. The preparation method of the ceftazidime injectable powder for injection disclosed bythe invention is simple and convenient to operate, low in cost, good in safety and suitable for industrial production.

Description

technical field [0001] The invention relates to the technical field of pharmaceutical preparations, in particular to a ceftazidime powder for injection and a preparation method thereof. Background technique [0002] Ceftazidime belongs to the third-generation cephalosporin antibiotic, which has bactericidal effect on Pseudomonas aeruginosa, Enterobacter, anaerobic bacteria, fragilis bacilli, etc.; at the same time, it has great antibacterial activity against various Gram-positive and negative bacteria; it is very stable to enzymes , safety, small side effects and broad antibacterial spectrum, so it is considered to be an ideal substitute for aminoglycoside antibiotics. In 1985, it was rated as a Class 1A drug by the US FDA. Ceftazidime is clinically applicable to severe negative bacillary infection, prevention of infection in complex or contaminated surgery, and severe infection of various body systems. [0003] The existing ceftazidime powder for injection on the market m...

AI Technical Summary

Problems solved by technology

[0003] The existing ceftazidime powder for injection on the market mainly has the following problems: 1. Arginine is added as a cosolvent in the ceftazidime powder for injection currently on the market, but excessive intake of arginine may bring certain side effects, such as Cause shortness of breath, itching, eczema, nausea and stomach pain, allergic reactions such as changes in blood chemicals, etc. In addition, people with liver and kidney diseases are also prone to adverse reactions; It is difficult to dissolve in use, and it is inconvenient to use clinically at low temperatures; 3. Because ceftazidime is unstable when exposed to light and heat, it is easy to produce degradation products, especially when subjected to high temperatures (> 50°C), it is often prone to degradation and polymerization reactions , to generate polymers such as ceftazidime dimers, trimers and polymers, which will lead to a decrease in the content of active ingredients in the drug, a stronger color, and an increase in the content of polymer impurities; The content of ingredients decreases, the color becomes darker, and the content of polymers increases; when the content of polymers is high, it is easy to cause allergic reactions in the human body

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