Ceftazidime combined powder injection and preparation method and product specification thereof

Abstract

The invention discloses a ceftazidime combined powder injection and a preparation method and a product specification thereof. The ceftazidime combined powder injection is prepared from the following components in parts by mass: 8.7 parts of ceftazidime nanoparticles, 6.4 parts of chitosan nanoparticles, 22 to 28 parts of liposome vesicles and 1.64 to 6.87 parts of a cosolvent. According to the preparation method, ceftazidime and chitosan are prepared into nanoparticles, the ceftazidime nanoparticles and the chitosan liposome nanoparticles are respectively coated with vesicles to obtain liposomes, and then the liposomes are coated together to form liposome mixed nanoparticles so that the product obtained by the preparation method is stable in quality and good in drug effect; the product purity is high, the use specification is 0.25 g, the selection range is enlarged, the side effect is small, and the safety is high.

Description

technical field [0001] The invention relates to the field of medicine, in particular to a ceftazidime combined powder injection, a preparation method and product specifications thereof. Background technique [0002] Ceftazidime is an antibiotic with outstanding efficacy against Pseudomonas aeruginosa. It is one of the important third-generation semi-synthetic cephalosporin antibiotics and has a wide range of responses against Gram-positive and Gram-negative bacteria. It is suitable for sepsis caused by sensitive Gram-negative bacilli, lower respiratory system infection, abdominal cavity biliary system infection, complicated urinary tract infection and severe skin and soft tissue infection. [0003] The ceftazidime raw materials or injections currently on the market have problems such as high impurity content and stability deviation. During the storage process, the impurities change rapidly, especially when the storage conditions are exceeded, the impurity content often excee...

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Problems solved by technology

[0003] The ceftazidime raw materials or injections currently on the market have problems such as high impurity content and stability deviation. During the storage process, the impurities change rapidly, especially when the storage conditions are exceeded, the impurity content often exceeds the limit requirements, such as ceftazidime. The polymer reaches more than 0.3wt%, the impurity pyridine exceeds 0.12wt%, and the total amount of other impurities exceeds 2.0wt%. These ceftazidime containing more impurities have a greater impact on the curative effect and safety of the drug, such as prone to allergic reactions, Decreased efficacy and reduced safety

[0004] In order to solve this problem in the market, every effort is made to purify before use, or add activated carbon to the powder injection to improve the purity, but not only the steps are cumbersome, but the cost is also increased, and the purification effect is not good, and the impurities are still uncontrollable If the purity is low, the dosage must be large. The general dosage is above 1g, and the lowest dosage is 0.5g. If the dosage is large, the burden on the human body will increase, and the possibility of adverse reactions will increase. The market needs a The ceftazidime powder injection that can make the purity of ceftazidime stable, not affected by environmental changes, stable product quality, good drug efficacy, small side effects, and high safety, the present invention solves such problems

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