A kind of preparation method of ceftizoxime sodium for injection

Abstract

The invention relates to a preparation method of ceftizoxime sodium for injection, which belongs to the technical field of medicine. The method comprises the following steps: (a) reducing the temperature of the purified water to 0‑5°C; adding ceftizoxime acid to the purified water, and adding a buffer solution; (b) adding a salt-forming agent to the solution obtained in step (a), controlling The temperature is 0-5°C, stir until it dissolves; (c) add sodium chloride to the solution obtained in step (b), and stir until it dissolves; (d) add activated carbon to the filtrate obtained in step (c) for decolorization, decolorization Then filter; (e) Control the temperature of the solution obtained in step (d) to 13-15°C, add ethanol for the first time, then add ceftizoxime sodium seed crystals, and grow crystals. After a large amount of crystals are produced, add ethanol again, cool down and continue to grow crystals , filtered, washed, and dried to obtain ceftizoxime sodium powder; (f) aseptically subpackaging the ceftizoxime sodium powder obtained in step (e) to obtain ceftizoxime sodium powder for injection. The product is easy to pack for powder injection preparations.

Description

technical field [0001] The invention relates to the technical field of medicine, in particular to a preparation method of ceftizoxime sodium for injection. Background technique [0002] Ceftizoxime sodium is the third-generation cephalosporin antibiotic first developed by Fujisawa Pharmaceutical Co., Ltd. in Japan. It was first listed in Japan in 1982 under the trade name Ceftizox. This product is commonly used as a third-generation cephalosporin antibiotic. It is clinically used to treat lower respiratory tract infection, urinary tract infection, abdominal infection, pelvic infection, sepsis, skin and soft tissue infection, bone and joint infection, meningitis caused by Streptococcus pneumoniae or Haemophilus influenzae and simple gonorrhea. Its chemical name is: (6R,7R)-7-[[2,3-dihydro-2-imino-4-thiazolyl)(methoxyimino)acetyl]amino]-8-oxo-5 - Thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid sodium salt. The structural formula is as follows: [0003] [0004] The...

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Problems solved by technology

[0005] The patent "A Refining Method of Ceftizoxime Sodium" (CN109553626A) provides a ceftizoxime sodium prepared by adding concentrated hydrochloric acid and sodium bicarbonate to ceftizoxime acid. The color grade of the product is not good, and various solvents are used in the crystallization process It is not conducive to the recycling of solvents; the patent "A New Crystal Form of Ceftizoxime Sodium and Its Preparation for Reducing Allergic Reaction" (CN105622635A) also has the problem that various solvent crystals are difficult to recycle

[0006] The ceftizoxime sodium product prepared by the patent "A Preparation and Refining Method of Ceftizoxime Sodium" (CN102911186A) and "A Preparation Method of Ceftizoxime Sodium" (CN102807573A) also has the problem of color difference; at the same time, the product has low purity, Affect drug safety

[0007] The patent "A Ceftizoxime Sodium Compound and New Method" (CN102079750A) provides a method for converting ceftizoxime sodium into ceftizoxime acid and then into ceftizoxime sodium. The process is complicated and the production cost is high

The same patent "high-purity ceftizoxime sodium and its preparation method" (CN101348492A) also has the problem of complex process

[0008] "A preparation method of ceftizoxime sodium" (CN102603771A) uses sodium hydroxide as a salt-forming agent under high pH value conditions, and the dissolution process will cause damage to the product structure and affect product quality, resulting in high impurity content in the product. Low, resulting in high production costs, not suitable for industrial production

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