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

A technology of cefotetan disodium and compound, applied in the directions of organic chemistry, antibacterial drugs, pharmaceutical formulations, etc., can solve the problems of difficulty in production, storage and use, instability of cefotetan disodium, unqualified products, etc. Stable product quality, avoiding potential safety hazards, and good stability

Active Publication Date: 2014-02-26
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) dissolving 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, let stand, filter, wash the filter cake with methanol, and dry to obtain the cefotetan disodium compound.

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

[0072] Below is embodiment 2-9, and preparation method is with embodiment 1, and its concrete process parameter is shown in Table 1:

[0073] Table 1

[0074]

[0075] Th...

preparation Embodiment 1

[0076] [Preparation Example 1] Cefotetan Disodium Freeze-Dried Powder Injection

[0077]

[0078] Preparation Process:

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

[0080] (2) Measure the pH of the solution (the range is 4.5-5.5), and adjust the pH with 0.1mol / 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, and filter with a 0.22μm filter membrane;

[0083] (5) Intermediate detection;

[0084] (6) Fill the above solution at a volume of 4ml / bottle (specification: 1g), stopper halfway, freeze-dry, and stopper and cap.

[0085] (7) Fully inspect the above-mentioned freeze-dried products, and obtain them after passing the test.

preparation Embodiment 2

[0086] [Preparation Example 2] Cefotetan Disodium Freeze-Dried Powder Injection

[0087]

[0088] Preparation process: same as Example 1, except that the cefotetan disodium compound used is prepared in Example 2, and filled in step (6) with a volume of 8ml / bottle (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, in particular to a new cefotetan disodium compound, a preparation method and a pharmaceutical composition thereof. Background technique [0002] The trade name of cefotetan disodium is Cefotan, which is a second-generation cephalosporin antibiotic developed by Japan's Yamanouchi Pharmaceutical Co., Ltd. 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 cephamycin, which has a strong binding property with penicillin-binding protein, thereby blocking the synthesis of bacterial cell walls and exerting a strong bactericidal effect in a short time. It is extremely stable to the lactamase produced by various bacteria, and has a strong antibacterial effect on the seedlings produced by β-lactamase. It has good antibacterial effect on Gram-negative bacteria and anaerobic bacteria. Es...

Claims

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Application Information

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Patent Type & Authority Patents(China)
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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