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Antibacterial agent cefazedone sodium composition

A technology of cefoxidone sodium and antibacterial drugs, applied in the field of medicine, can solve the problems of affecting drug safety, high content of related substances and high content of substances, and achieve the effects of improved stability, good fluidity and good safety

Inactive Publication Date: 2015-11-18
QINGDAO LANSHENGYANG PHARMA & BIOTECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Although the stability of the obtained cefazedone sodium powder injection of the present invention is relatively good, the content of related substances is still relatively high, and needs to be further reduced.
[0006] Patent CN101584671A discloses a cefzidone sodium powder injection, which is prepared by crushing and bottling the single main drug cefzidone sodium. The content is high, and the change is obvious after long-term storage, which affects the safety of the drug

Method used

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  • Antibacterial agent cefazedone sodium composition
  • Antibacterial agent cefazedone sodium composition
  • Antibacterial agent cefazedone sodium composition

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0026] Example 1: Preparation of Cefoxizone Sodium Crystals

[0027] (1) Grind the crude product of cefazedone sodium, pass through a 100-mesh sieve, then add it into deionized water whose volume is 6 times the weight of cefazedone sodium, and stir at 100 rpm for 10 minutes;

[0028] (2) Add methanol with a volume 4 times the weight of cefazedone sodium under stirring at 80 rpm, and raise the temperature to 30°C at the same time;

[0029] (3) After adding the solution, let it stand for 3 hours, and add dropwise chloroform at 0°C under the condition of stirring at 150 rpm. The volume of chloroform is 8 times the weight of cefazedone sodium, and add dropwise at a uniform speed within 2 hours. complete;

[0030] (4) After the dropwise addition, cool down to -3°C, continue to stir at a stirring rate of 75 rpm for 2 h, let stand for 1 h to precipitate crystals, filter, wash, and dry in vacuo to obtain crystals of cefazedone sodium.

[0031] The X-ray powder diffraction pattern ...

Embodiment 2

[0032] Example 2: Preparation of Cefazedone Sodium Composition

[0033] The composition comprises: 1 part by weight of cefazedone sodium crystal prepared by the present invention, and 0.01 part by weight of arginine.

[0034] The preparation method is:

[0035] (1) Weigh cefazedone sodium crystals and arginine in proportion and mix them thoroughly;

[0036] (2) Dispense into sterilized vials and stopper them.

Embodiment 3

[0037] Example 3: Preparation of Cefazedone Sodium Composition

[0038] The composition comprises: 1 part by weight of cefazedone sodium crystal prepared by the present invention, and 0.03 part by weight of arginine.

[0039] The preparation method is:

[0040] (1) Weigh cefazedone sodium crystals and arginine in proportion and mix them thoroughly;

[0041] (2) Dispense into sterilized vials and stopper them.

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Abstract

The invention discloses an antibacterial agent cefazedone sodium composition and belongs to the technical field of medicines. The composition comprises cefazedone sodium and arginine. Cefazedone sodium is crystal, an X-ray powder diffraction diagram obtained by measurement through Cu-Kalpha rays is as shown in . 1, the main particle size of the cefazedone sodium crystal is 200-300 [mu]m, and the distribution width is 185-315 [mu]m. The new crystal form of cefazedone sodium is different from a crystal structure in the prior art. Through test verification, it is found surprisingly pleasantly that compared with the prior art, powder injections prepared by utilizing the new crystal form composition are good in mobility, the content of impurities and moisture is effectively reduced, the product safety is good, and the stability is high.

Description

technical field [0001] The invention belongs to the technical field of medicine, and relates to an antibacterial drug cefazedone sodium composition. Background technique [0002] Infectious diseases are a common and frequently-occurring disease in clinical practice. According to the World Health Organization (WHO) report, the number of deaths from infectious diseases is as high as 33.3% of the total number of deaths from various causes. Cephalosporins are the most widely used first-line drugs in clinical practice. In recent years, due to the abuse of antibiotics, many "super bacteria" have emerged, and the problem of bacterial drug resistance has become increasingly serious. The "Administrative Measures for the Clinical Application of Antibacterial Drugs" officially implemented by the state restricts the clinical application of the third-generation and fourth-generation cephalosporins with strong alternatives. Therefore, there is an urgent need for clinically effective an...

Claims

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Application Information

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IPC IPC(8): A61K31/546A61K9/14A61P31/04C07D501/36C07D501/12
Inventor 何福云
Owner QINGDAO LANSHENGYANG PHARMA & BIOTECH CO LTD
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