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Method for preparing cefuroxime sodium

A technology of cefuroxime sodium and cefuroxime acid, which is applied in the field of drug synthesis, can solve problems such as visible foreign matter and difficulty in aseptic control, prolonged post-processing steps, and increased product exposure opportunities, so as to reduce material powder exposure and human contact opportunity, short dissolution time, and easy-to-control effects

Active Publication Date: 2010-12-08
LIVZON PHARM GRP INC +1
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  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0003] However, in the existing cefuroxime sodium preparation process, sodium isooctanoate or sodium lactate is used as a raw material to form sodium salt in the product refining process, and the product has crystal stickiness during the salt formation process, resulting in difficulty in solid-liquid separation and difficult washing of the product. Dry, poorly soluble and poor crystal fluidity, and prolongs post-processing steps, increasing product exposure, making visible foreign matter and aseptic control difficult in products

Method used

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  • Method for preparing cefuroxime sodium

Examples

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Effect test

Embodiment 1

[0020] Example 1: Preparation of Cefuroxime Sodium

[0021] Add 200ml of acetone and 30ml of purified water to a 500ml three-necked bottle, put in 40g of cefuroxime acid, stir at a temperature of 25°C until it is completely dissolved, add 4g of activated carbon, filter with suction, and add a completely dissolved solution to the filtrate at a temperature of 25~-30°C. The mixed solution of sodium isooctanoate, sodium acetate and sodium lactate was added and stirred for 15 minutes, 600ml of acetone was added dropwise to crystallize, slowly stirred for 30 minutes to grow the crystals, suction filtered, washed with acetone and dried for 2 hours to obtain the finished product of cefuroxime sodium. The content is 94.8%, and the maximum impurity is 0.2%.

Embodiment 2

[0022] Example 2: Detection of Cefuroxime Sodium Product Properties

[0023] Five batches of cefuroxime sodium products were prepared according to the preparation method in Example 1, and the batch numbers were Y0810001, Y0810002, Y0810003, Y0810004 and Y0810005, and the following items were tested for these five batches of cefuroxime sodium products. The results are shown in Table 1

[0024] Table 1 Test results of cefuroxime sodium product properties

[0025]

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Abstract

The invention provides a method for preparing cefuroxime sodium. The method comprises a step of reacting cefuroxime acid with mixed sodium salt to produce the cefuroxime sodium, wherein the mixed sodium salt comprises two or three of sodium acetate, sodium lactate and sodium iso-octoate. The product prepared by the method has the advantages of uniform crystal dispersion, greatly improved fluidity and easy packaging; the solubility of the product is greatly improved, and compared with similar products prepared by the conventional methods, the dissolution time is the shortest; the method greatly shortens the time for washing, filtering and drying the product, reduces the opportunities of powder exposure and human contact, more easily controls visible foreign matters in the product and effectively reduces the number of insoluble particles in the product; because the method improves the crystal form of the product, the crystal is easy to wash and dry, the time of the product at a high temperature is shortened and the stability of the product is improved effectively. The color grade of the product is further reduced, and the product is more stable and uniform and has better performance on indexes such as the color grade, content, impurities and the like.

Description

technical field [0001] The invention belongs to the technical field of drug synthesis, relates to a preparation method of cephalosporin antibiotics, in particular to a preparation method of cefuroxime sodium. Background technique [0002] Cefuroxime sodium is the sodium salt of cefuroxime, which belongs to the second generation of cephalosporin antibiotics. It has a broad antibacterial spectrum and is effective against most Gram-negative bacteria, including Haemophilus influenzae, Neisseria gonorrhoeae, Meningococcus, Escherichia coli, Klebsiella, Proteus mirabilis, Enterobacter, Citrobacter, Salmonella bacteria, Shigella, and some indole-positive mutated bacilli, etc. The antibacterial spectrum against Gram-positive bacteria is similar to that of cephalexin, mainly including Staphylococcus and Streptococcus. This product is relatively stable to β-lactamase, and its stability is no less than that of the third-generation cephalosporins. It is stable to almost all standard e...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C07D501/34C07D501/02
Inventor 符国庆周自金董曲波龙伟刚
Owner LIVZON PHARM GRP INC
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