Cefradine injection packed by double-cavity bag and preparation method thereof

Abstract

The invention discloses cefradine injection packed by a double-cavity bag. A bulk drug of a medicinal compound of the injection comprises components: 0.1-2 part(s) by weight of cefradine in a powder cavity, and glucose injection or sodium chloride injection in a liquid cavity, wherein 100 parts by volume of the glucose injection comprise 4-11 parts by weight of glucose, and 100 parts by volume of the sodium chloride injection comprise 0.8-1 part by weight of sodium chloride. The cefradine injection provided by the invention is packed by adopting the double-cavity bag; through respectively filling cefradine sterile medicinal powder and a solvent (the sodium chloride injection or the glucose injection) in two chambers partitioned and separated by virtual welding; and when the cefradine injection is in use, a medicine bag is only necessary to be extruded, so that a virtual welding isolating strip can be opened, so that the cefradine sterile medicinal powder and the solvent can be quickly dissolved and mixed under a closed sterile condition and form totally medicinal treating mixed liquid which is directly used for a patient.

Description

technical field [0001] The invention relates to a pharmaceutical composition and a preparation method thereof, in particular to a double-cavity bag-packed cephradine injection and a preparation method thereof. Background technique [0002] The chemical name of cephradine is: (6R,7R)-7[(R)-2-amino-2-(1,4-cyclohexenyl)acetamido]-3-methyl-8-oxo-5-sulfur Hetero-1-azabicyclo[4,2,0]oct-2-ene-2-carboxylic acid, a first-generation cephalosporin, is effective against non-penicillinase-producing and penicillinase-producing Staphylococcus aureus, coagulase-negative grape Some strains of gram-positive cocci such as cocci, group A hemolytic streptococcus, pneumococcus pneumoniae and viridans streptococcus have good antibacterial effect. Anaerobic Gram-positive bacteria are more sensitive to this product, and Bacteroides fragilis are resistant to this product. Methicillin-resistant Staphylococcus and Enterococcus are resistant to this product. Cephradine is similar to cephalexin in its...

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Problems solved by technology

[0003] At present, the main preparation forms of this product at home and abroad are: freeze-dried powder injection, aseptic subpackage powder injection, small-volume injection, etc., and the above-mentioned preparations must use appropriate solvents (such as 0.9% chlorine dioxide) before infusion into the patient's body. Sodium chloride injection or 5% glucose injection) can be dissolved or diluted into a solution with a concentration lower than 2mg / ml before intravenous infusion, and the process of dissolving and diluting is relatively time-consuming. Due to the cumbersome dispensing process, rapid intravenous administration is often not possible under certain conditions; the site area of ​​ambulance equipment is narrow and the movement is bumpy, making it difficult to perform dispensing operations or medical errors or accidents such as dispensing errors; air and particle pollution in the ambulance site can easily cause secondary accidents. secondary pollution; therapeutic drugs are packaged in glass bottles, which are easily broken and cannot be airdropped; there are problems such as the matching of therapeutic drugs and carrier infusion quantities and expiration dates in war storage, resulting in the environment and time of the rescue site not reaching the standard for conventional infusion preparation. needs

[0004] Freeze-dried powder injections and sterile subpackaged powder injections sold in the market are all packaged in vials and sealed with butyl rubber stoppers. During the storage and transportation of drugs, when the drug powder comes into contact with the rubber stoppers, the additives in the rubber stoppers may be precipitated or A physical or chemical reaction with the drug powder will lead to unqualified test results of solution clarity and affect the safety of product use

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