Medicine cefotiam hydrochloride composition for treating bacterial infection

A technology for cefotiam hydrochloride and bacterial infection, applied in the field of medicine, can solve the problems of loss of antibacterial activity, structural damage, poor mixing uniformity and the like

Inactive Publication Date: 2015-12-30
QINGDAO HUAZHICAO PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] However, the structure of cefotiam hydrochloride contains an unstable β-lactam ring, which is prone to hydrolysis and rearrangement reactions, resulting in the destruction of the structure and the loss of antibacterial activity. Some degradation products may cause allergic reactions. The stability in the
[0005] However, the literature "Study on the Compatibility Stability of Cefotiam Hydrochloride for Injection and Three Kinds of Infusions" [Luo Xiaoru, Wei Liping, et al. Study on the Compatibility Stability of Cefotiam Hydrochloride for Injection and Three Kinds of Infusions, Journal of Pharmaceutical Sciences of P...

Method used

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  • Medicine cefotiam hydrochloride composition for treating bacterial infection
  • Medicine cefotiam hydrochloride composition for treating bacterial infection
  • Medicine cefotiam hydrochloride composition for treating bacterial infection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0028] Example 1: Preparation of Cefotiam Hydrochloride Crystals

[0029] (1) Get cefotiam hydrochloride crude drug, add deionized water, the volume dosage of deionized water is 5 times of the mass of cefotiam hydrochloride;

[0030] (2) Stir until completely dissolved, and adjust the pH to 6-9;

[0031] (3) Add activated carbon for decolorization and filter to obtain a clear solution;

[0032] (4) Move the clarified solution into a pressure vessel, add dropwise a mixed solution of isopropanol and acetone at 2°C under the condition that the pressure in the pressure vessel is controlled at 2.0Mpa and stirred, the stirring speed is controlled at 35rmp, isopropanol 1. The volume consumption of the mixed solution of acetone is 3 times of the volume of deionized water, and the volume ratio of isopropanol and acetone is 1:1;

[0033] (5) Release the pressure after the dropwise addition, cool the solution to -5°C at a rate of 10°C / min, let it stand for 2 hours, filter, wash with ...

Embodiment 2

[0035] Example 2: The preparation method of cefotiam hydrochloride composition

[0036] The composition comprises: 1 part by weight of cefotiam hydrochloride crystal prepared by the present invention, and 0.03 part by weight of sodium dihydrogen phosphate.

[0037] The preparation method is:

[0038] (1) Weigh cefotiam hydrochloride crystals and sodium dihydrogen phosphate in proportion, and mix them thoroughly;

[0039] (2) Dispense into sterilized vials and stopper them.

Embodiment 3

[0040] Example 3: Preparation of cefotiam hydrochloride composition

[0041] The composition comprises: 1 part by weight of cefotiam hydrochloride crystal prepared by the present invention, and 0.04 part by weight of sodium dihydrogen phosphate.

[0042] The preparation method is:

[0043] (1) Weigh cefotiam hydrochloride crystals and sodium dihydrogen phosphate in proportion, and mix them thoroughly;

[0044] (2) Dispense into sterilized vials and stopper them.

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PUM

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Abstract

The invention relates to a medicine cefotiam hydrochloride composition for treating the bacterial infection, and belongs to the technical field of medicines. The composition is composed of cefotiam hydrochloride and sodium dihydrogen phosphate. The cefotiam hydrochloride is a crystal. An X-ray powder diffraction pattern obtained through measurement by means of Cu-K alpha ray is shown in a figure 1. The novel crystal form of the hydroxyfasudil is different from a crystal form structure in the prior art. According to experimental verification, surprisingly, it is found that the novel crystal-form compound is high in purity, good in mobility and stability, low in polymer content and not prone to moisture absorption, the obtained powder injection is matched with a 0.9% sodium chloride injection, 5% glucose injection and 5% sodium chloride and dextrose injection and the stability of the solution is good after the solution is placed at the room temperature for 4 h.

Description

technical field [0001] The invention belongs to the technical field of medicine, and relates to a cefotiam hydrochloride composition for treating bacterial infection. Background technique [0002] Cefotiam hydrochloride is a widely used cephalosporin in clinical practice. During storage, especially at high temperature (>50°C), it often undergoes degradation and polymerization reactions, resulting in a decrease in the content of active ingredients in the drug. The color is enhanced and the content of polymer impurities is increased. In addition, cefotiam hydrochloride that has expired, due to long storage time, often reduces the content of active ingredients of the drug, darkens the color, and has a particularly high polymer content. When the polymer content is high, it is easy to cause allergic reactions in the human body. [0003] Although the prior art has solved its purity problem to a certain extent, it has been found through further research that degradation and pol...

Claims

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Application Information

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IPC IPC(8): A61K31/546A61P31/04C07D501/12C07D501/36
Inventor 刘学键
Owner QINGDAO HUAZHICAO PHARMA CO LTD
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