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Childhood cefodizime sodium and low-sodium carrier pharmaceutical composition

A technology for cefodizime sodium and a composition, which is applied in the field of medicinal chemistry, can solve problems such as unsatisfactory substance indicators, increase the risk of using preparations, etc., so as to improve product stability and drug safety, improve clinical application quality, The effect of improving extraction efficiency

Inactive Publication Date: 2015-09-30
ZHEJIANG CHANGDIAN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Although this method controls the water content in the product well, the applicant found during the research process that the relevant substance indicators of this method are not ideal, which increases the risk of using the preparation

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0035] (1) Weigh 100 g of the crude product of cefodizime sodium, add 1000 ml of water, heat up to 30° C. to completely dissolve, add 10 g of activated carbon, stir for decolorization, and filter;

[0036] (2) Add 10ml of ethyl acetate under stirring, transfer to a 1000ml pressure-resistant container, make sure it is full and air bubbles are removed, seal the container, oscillate, and freeze at -18°C for 8 hours before taking it out;

[0037] (3) Remove the organic phase. After the ice melts, control the temperature at 10-15°C, slowly add 3000ml of ethanol dropwise for about 1 hour under the protection of nitrogen, cool down to 0-5°C and continue growing crystals for 1h, filter with suction, and wash with ethanol for 40 ℃ vacuum drying.

Embodiment 2

[0039] (1) Weigh 200 g of the crude product of cefodizime sodium, add 1000 ml of water, heat up to 30° C. until completely dissolved, add 10 g of activated carbon, stir for decolorization, and filter;

[0040] (2) Add 10ml of chloroform under stirring, transfer to a 1000ml pressure-resistant container, make sure it is full and the air bubbles are removed, seal the container, oscillate, and freeze at -18°C for 3 hours before taking it out;

[0041] (3) Remove the organic phase. After the ice melts, control the temperature at 10-15°C, slowly add 3000ml of ethanol dropwise for about 1 hour under the protection of nitrogen, cool down to 0-5°C and continue growing crystals for 1h, filter with suction, and wash with ethanol for 40 ℃ vacuum drying.

Embodiment 3

[0043] (1) Weigh 100 g of the crude product of cefodizime sodium, add 1000 ml of water, heat up to 30° C. to completely dissolve, add 10 g of activated carbon, stir for decolorization, and filter;

[0044] (2) Add 7ml of ethyl acetate under stirring, transfer to a 1000ml pressure-resistant container, make sure it is full and air bubbles are removed, seal the container, oscillate, freeze at -18°C for 8 hours, and then take it out;

[0045] (3) Remove the organic phase. After the ice melts, control the temperature at 10-15°C, slowly add 3000ml of ethanol dropwise for about 1 hour under the protection of nitrogen, cool down to 0-5°C and continue growing crystals for 1h, filter with suction, and wash with ethanol for 40 ℃ vacuum drying.

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Abstract

The invention relates to a childhood cefodizime sodium pharmaceutical composition, namely a pharmaceutical composition preparation of cefodizime sodium and low-sodium carrier transfusion, and in particular relates to a combined application package. The pharmaceutical composition comprises cefodizime sodium for injection and low-sodium carrier transfusion; the low-sodium carrier transfusion comprises a sodium chloride and dextrose injection ((15-200) to 1), a glucose and sodium chloride potassium chloride injection ((15-200) to 1 to (0-1)) and the like. Compared with combined and mixed application of the cefodizime sodium for injection and the low-sodium carrier transfusion, the clinical application steps are simplified; the clinical risk caused by immature development of kidneys of children and no metabolic capability on excessive sodium in blood is reduced; and the clinical application quality and safety of medicines for children are improved.

Description

technical field [0001] The invention relates to a pharmaceutical composition of children's type cefodizime and a low-sodium carrier, belonging to the field of medicinal chemistry. Background technique [0002] Cefodizime, original product name: Modi, chemical name: (6R,7R)-7-[(2-amino-4-thiazolyl)(methoxyimino)acetamido]-3-[[(5 -Carboxymethyl-4-methyl-2-thiazolyl)thio]methyl]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid disodium salt. It is a semi-synthetic third-generation cephalosporin broad-spectrum antibacterial drug, which has antibacterial activity against Gram-positive bacteria and negative bacteria, is stable to β-lactamase, and is extremely stable to cephalosporinase and penicillinase. Clinically, it is mainly used for pneumonia, bronchitis, pharyngitis, tonsillitis, pyelonephritis, urinary tract infection, gonococcal urethritis, cholecystitis, cholangitis, gynecological infection, sepsis and Otitis media etc. [0003] What affect the quality of c...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K47/02A61K47/26A61K31/546A61K9/08A61P31/04
Inventor 陈宇东厉达中
Owner ZHEJIANG CHANGDIAN PHARMA
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