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Preparation method of cefotiam hydrochloride for injection

A cefotiam hydrochloride injection technology, applied in the field of medicine, can solve the problems of excessive acetone, insufficient tolerance of the human body, damage to the human body, etc., and achieve a high stability effect

Active Publication Date: 2015-02-11
SICHUAN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] The existing cefotiam hydrochloride for injection is not stable enough in the blood and also has the phenomenon that acetone exceeds the standard, which seriously affects its clinical application effect.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0018] The preparation method of cefotiam hydrochloride for injection comprises the following steps:

[0019] (1) Add the crude product of cefotiam hydrochloride into sterile water to dissolve completely, then add activated carbon for decolorization, perform vacuum filtration after decolorization, filter out the activated carbon with filter paper, and then use membrane filtration to remove impurities on the crude product of cefotiam hydrochloride , wash with ethanol aqueous solution to obtain cefotiam hydrochloride filtrate when filtering;

[0020] (2) Add an appropriate amount of acetone eluting agent dropwise to the filtered cefotiam hydrochloride filtrate while stirring, control the temperature at 18-25°C, and stir at 210-215r / min. -60min, then continue to stir, the stirring speed is 202-208r / min, when a large number of crystals appear, add butanol or propanol to soak completely, then vacuum filter the solution to obtain refined cefotiam hydrochloride;

[0021] (3) Mix anh...

Embodiment 2

[0025] Similar to Example 1, the difference is:

[0026] The volume of the added butanol or propanol is 45 times of the volume of the cefotiam hydrochloride filtrate. The purity of cefotiam hydrochloride is 88.0%, and the amount of acetone is 0.45%.

Embodiment 3

[0028] Similar to Example 1, the difference is:

[0029] The volume of the added butanol or propanol is 60 times of the volume of the cefotiam hydrochloride filtrate. The purity of cefotiam hydrochloride is 88.0%, and the amount of acetone is 0.50%.

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PUM

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Abstract

The invention discloses a preparation method of cefotiam hydrochloride for injection. A recrystallization method is adopted, an appropriate reagent is selected for carrying out soaking treatment, and high-purity cefotiam hydrochloride can be prepared. The preparation method of cefotiam hydrochloride for injection has the advantages that technology is simple and technological conditions are strictly controlled, so that a pharmaceutical preparation with high stability and good quality can be obtained.

Description

technical field [0001] The invention relates to the field of medicine, in particular to a preparation method of cefotiam hydrochloride for injection. Background technique [0002] Cefotiam Hydrochloride for Injection is mainly used for Staphylococcus, Streptococcus (except Enterococcus), Pneumococcus, Influenza Bacillus, Escherichia coli, Klebsiella, and Enterococcus that are sensitive to this product , Citrobacter, Proteus mirabilis, Proteus vulgaris, Proteus Rettgeri, Proteus morganii, etc. caused the following infections: sepsis, postoperative infection, burn infection, subcutaneous abscess, bloat, furuncle, furuncle , osteomyelitis, septic arthritis, tonsillitis (peritonsillitis, peritonsillar abscess), bronchitis, bronchiectasis with infection, pneumonia, pulmonary suppuration, empyema, cholangitis, cholecystitis, peritonitis, pyelonephritis, bladder inflammation, urethritis, prostatitis, meningitis, endometritis, pelvic inflammatory disease, parauterine tissue inflamm...

Claims

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Application Information

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IPC IPC(8): A61K9/14A61K31/546A61P31/04
Inventor 王强张静文刘萍
Owner SICHUAN PHARMA
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