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Ceftazidime crystal compound, preparation method of compound and pharmaceutical composition of compound in sterile mixed powder form

A crystalline compound, ceftazidime technology, applied in the field of medicine, can solve the problems of increased risk of allergic reactions, increased polymer content, etc., to achieve the effect of improving drug safety and effectiveness, reducing incidence, and good stability

Active Publication Date: 2013-02-13
HAINAN HERUI PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0010] Though above-mentioned purification method has solved its purity problem to a certain extent, find through further research, because ceftazidime is in storage process, especially under the condition of high temperature (> 50 ℃), degradation and polymerization often take place, along with The prolongation of storage time will increase the content of high polymers, which will increase the risk of allergic reactions in the human body

Method used

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  • Ceftazidime crystal compound, preparation method of compound and pharmaceutical composition of compound in sterile mixed powder form
  • Ceftazidime crystal compound, preparation method of compound and pharmaceutical composition of compound in sterile mixed powder form
  • Ceftazidime crystal compound, preparation method of compound and pharmaceutical composition of compound in sterile mixed powder form

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0043] [Example 1] Preparation of Ceftazidime Crystalline Compound

[0044] 1) Prepare the crude product solution: add 200 g of the crude product of ceftazidime into 1500 ml of a mixed solvent prepared by dimethyl sulfoxide and tetrahydrofuran in a volume ratio of 5:1, stir to dissolve, add activated carbon for decolorization, and filter to obtain the crude product solution. spare;

[0045] 2) Preparation of a crystallization solvent: prepare a crystallization solvent with acetone and ethyl acetate at a ratio of 2:10 by volume, and the volume of the crystallization solvent is 12 times the weight of the crude ceftazidime;

[0046] 3) Crystallization: under stirring, add the crystallization solvent obtained in step 2) to the crude product solution obtained in step 1), and solids are precipitated; after the addition is completed, continue to add ethanol dropwise under stirring until crystals are precipitated; stand for 5h, Filter, wash with dimethyl sulfoxide, and dry to obtain ...

Embodiment 2～9

[0048] [Example 2~9] Preparation of Ceftazidime Crystal Compound

[0049] The following are Examples 2-9 of the present invention, the steps are the same as Example 1, and the specific process parameters are shown in Table 1:

Embodiment 2-9

[0051]

[0052] The ceftazidime crystalline compound obtained in Examples 2-9 was measured by powder X-ray diffraction measurement method, and the X-ray powder diffraction pattern represented by 2θ±0.2° diffraction angle was the same as that in Example 1.

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Abstract

The invention relates to a ceftazidime crystal compound, a preparation method of the compound and a pharmaceutical composition of the compound in a sterile mixed powder form. The structural formula of the ceftazidime crystal compound is as shown in a formula (I); and the crystal compound is measured by using a powder X-ray diffraction measurement method, and an X-ray powder diffraction map expressed by a 2theta+ / -0.2-degree diffraction angle shows characteristic diffraction peaks at 5.7 degrees, 7.6 degrees, 9.1 degrees, 11.8 degrees, 12.2 degrees, 12.6 degrees, 13.3 degrees, 15.5 degrees, 16.7 degrees, 18.4 degrees, 20.5 degrees, 25.8 degrees, 26.3 degrees and 31.8 degrees. The crystal compound is high in purity and stability, and almost does not absorb moisture.

Description

technical field [0001] The invention belongs to the field of medicine, and in particular relates to a ceftazidime crystal compound, a preparation method thereof and a pharmaceutical composition in the form of aseptic mixed powder. Background technique [0002] Ceftazidime, the chemical name is (6R,7R)-7-[[(2-amino-4-thiazolyl)-[(1-hydroxy-1-methylethoxy)imino]acetyl]amino]-2 -Carboxy-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-3-methylpyridinium inner salt pentahydrate, a cephalosporin widely used in clinical element, its structural formula is: [0003] [0004] In order to ensure the safety of human medicine, the National Pharmacopoeia stipulates that for ceftazidime antibiotics, the content of ceftazidime pentahydrate is not less than 95%, the content of polymer is not more than 0.3%, and its color is not higher than No. 6 color. During storage, ceftazidime antibiotics tend to degrade and polymerize, especially when subjected to high temperature (>50°C), to form poly...

Claims

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Application Information

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IPC IPC(8): C07D501/46C07D501/12A61K31/546A61K9/14A61P31/04
Inventor 钟正明
Owner HAINAN HERUI PHARMA
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