A kind of ceftriaxone sodium powder injection preparation and preparation method thereof

Abstract

The invention relates to a ceftriaxone sodium injection preparation for injection and a preparation method of the ceftriaxone sodium injection preparation, and belongs to the technical field of medicine. The preparation is composed of ceftriaxone sodium and sodium hyaluronate, wherein the sodium hyaluronate is a sodium hyaluronate solution obtained through special treatment of ultrasonic concussion. The sterile ceftriaxone sodium powder for injection is flocculent, the solubleness of the powder injection during fluid preparation is good; the quality of the product is greatly improved, and indexes such as content, single impurity, total impurity and polymer are much higher than the Pharmacopoeia standard and superior to that of the products in the prior art; the stability is significantly improved, through an accelerated test in 6 months, the content is only reduced by 0.1%-0.2%, the single impurity is only reduced by 0.05%-0.06 %, the total impurity is only reduced by 0.10%-0.11%, thepolymer is only reduced by 0.02%, and the stability is obviously superior to that of the products in the prior art.

Description

technical field [0001] The invention relates to a powder preparation for injection, in particular to a ceftriaxone sodium powder preparation for injection and a preparation method thereof, belonging to the technical field of medicine. Background technique [0002] Ceftriaxone sodium, also known as ceftriaxone or ceftriaxone, is a ceftriaxone derivative. The original manufacturer is Roche in Switzerland, which was first launched in Switzerland in 1982 under the product name "Rocephin". It was launched in the U.S. in December 1984 after FDA review, and in Japan in 1986. It was registered in 28 countries and regions around the world in the early 1990s. It is a "milestone" drug in the development history of cephalosporin antibiotics. In 1995, CFDA approved the production of ceftriaxone sodium produced by Shanghai Roche Company. [0003] Ceftriaxone sodium is a third-generation cephalosporin antibiotic, which has strong activity against Enterobacteriaceae bacteria; The MIC90 o...

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Problems solved by technology

[0004] Ceftriaxone sodium has poor stability and is unstable to heat, acidic environment, and alkaline environment, and problems such as content reduction and impurity increase will occur

Patent CN201510104263.1 discloses a ceftriaxone sodium powder injection for injection and its preparation method. The ceftriaxone sodium powder for injection obtained by adopting the key production technology of new coupled crystallization has excellent hydrodynamic properties and perfect crystal shape. The particle size distribution is uniform, and the color grade, clarity, purity and stability have been improved, but it is not ideal, and when the injection product is configured into a solution, the dissolution rate is slow, which is not conducive to clinical application

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