Cefotetan disodium compound as well as preparation method and medicinal composition thereof

A technology of cefotetan disodium and compounds, applied in organic chemistry, antibacterial drugs, pharmaceutical formulations, etc., can solve problems such as difficulties in production, storage and use, instability of cefotetan disodium, and unqualified products, and achieve Stable product quality, avoiding potential safety hazards, and good stability

Active Publication Date: 2012-10-17
永春县产品质量检验所福建省香产品质量检验中心国家燃香类产品质量监督检验中心福建
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] Although the curative effect of cefotetan disodium is clinically recognized, because cefotetan disodium is very unstable, it is easy to degrade when it encounters water during production, storage and use, and related substances will increase rapidly, resulting in unqualified products. There is no way to use it, which brings great difficulties to production, storage and use

Method used

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  • Cefotetan disodium compound as well as preparation method and medicinal composition thereof
  • Cefotetan disodium compound as well as preparation method and medicinal composition thereof
  • Cefotetan disodium compound as well as preparation method and medicinal composition thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0067] [Example 1] Preparation of Cefotetan Disodium Compound

[0068] 1) Dissolve cefotetan disodium in a mixed solvent of tetrahydrofuran and methanol to obtain a tetrahydrofuran / methanol solution of cefotetan disodium;

[0069] 2) Add chloroform dropwise to the tetrahydrofuran / methanol solution of cefotetan disodium obtained in step 1) under an ultrasonic field until crystals are precipitated;

[0070] 3) Turn off the ultrasonic field, stand still, filter, wash the filter cake with methanol, and dry to obtain the cefotetan disodium compound.

[0071] The characteristic peaks in the X-ray powder diffraction pattern of the obtained cefotetan disodium compound measured using Cu-Kα rays are 8.0°, 12.1°, 15.4°, 17.0°, 19.8°, 21.6°, 23.0°, 2θ. 24.3°, 25.7°, 27.4°, 30.7° and 33.5° display.

[0072] The following are Examples 2-9, the preparation method is the same as that of Example 1, and the specific process parameters are shown in Table 1:

[0073] Table 1

[0074]

[0075] The characteri...

preparation Embodiment 1

[0076] [Formulation Example 1] Cefotetan disodium freeze-dried powder injection

[0077]

[0078] Preparation Process:

[0079] (1) Weigh the prescription amount of the cefotetan disodium compound prepared in Example 1 and add it to 80% of the total volume of water for injection, and stir to obtain a solution;

[0080] (2) Determine the pH of the solution (range from 4.5 to 5.5), adjust the pH with 0.1 mol / L dilute hydrochloric acid if necessary;

[0081] (3) Add water for injection to 100%;

[0082] (4) Add 0.1% activated carbon, stir, let stand for 20 minutes, filter and decarbonize, filter with 0.22μm filter membrane;

[0083] (5) Intermediate testing;

[0084] (6) Fill the above-mentioned solution according to the volume of 4ml / piece (specification: 1g), stopper half, freeze-dry, stopper and cap.

[0085] (7) Fully inspect the above-mentioned freeze-dried products and obtain them after they are qualified.

preparation Embodiment 2

[0086] [Formulation Example 2] Cefotetan disodium freeze-dried powder injection

[0087]

[0088] Preparation process: the same as in Example 1, except that the cefotetan disodium compound used was prepared in Example 2. In step (6), it was filled with 8ml / piece (specification: 2g).

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Abstract

The invention relates to a preparation method and a medicinal composition of a cefotetan disodium compound. The cefotetan disodium compound is crystal, wherein characteristic peak of the crystal in an X-ray powder diffraction pattern measured by using Cu-Ka ray is indicated in 2 theta of 8.0 degrees, 12.1 degrees, 15.4 degrees, 17.0 degrees, 19.8 degrees, 21.6 degrees, 23.0 degrees, 24.3 degrees, 25.7 degrees, 27.4 degrees, 30.7 degrees and 33.5 degrees. The compound crystal has good stability and hygroscopicity, and can be well stored and saved, so that the stability of cefotetan disodium is improved to a certain degree.

Description

Technical field [0001] The invention belongs to the field of pharmaceutical preparations, and in particular relates to a new cefotetan disodium compound, its preparation method and its pharmaceutical composition. Background technique [0002] Cefotetan disodium is traded as Cefotan. It is a second-generation cephalosporin antibiotic developed by Japan's Yamanouchi Pharmaceuticals and was launched in Japan in March 1984. The structural formula is as follows: [0003] [0004] Cefotetan Disodium [0005] This product is a derivative of cephalosporin, which has strong binding to penicillin binding protein, thereby blocking the synthesis of bacterial cell wall and exerting strong bactericidal power in a short time. It is extremely stable to the lactamase produced by various bacteria, and it also has a strong antibacterial effect on the β-lactamase producing seedlings. It has good antibacterial effect on gram-negative bacteria and anaerobic bacteria. Especially for coliform, Serratia,...

Claims

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Application Information

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IPC IPC(8): C07D501/57C07D501/12A61K31/546A61K9/19A61P31/04
Inventor 张金花黄兹河
Owner 永春县产品质量检验所福建省香产品质量检验中心国家燃香类产品质量监督检验中心福建
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