Looking for breakthrough ideas for innovation challenges? Try Patsnap Eureka!

Children type cefoxitin sodium and low-sodium carrier pharmaceutical composition

A technology of cefoxitin sodium and composition, which is applied in the field of children's cefoxitin sodium and low-sodium carrier pharmaceutical composition, can solve the problems of inability to effectively solve cefoxitin sodium, increase the safety of clinical use, and high impurity index , to achieve the effect of improving the quality of clinical application, reducing impurities and reducing the content of impurities

Inactive Publication Date: 2015-09-30
ZHEJIANG CHANGDIAN PHARMA
View PDF2 Cites 0 Cited by
  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] The applicant found in actual production that although the above-mentioned process adopts sodium acetate trihydrate as a salt-forming agent and acetone and methanol as solvents through the improved new process, the prepared cefoxitin sodium is not stable in terms of quality and stability, crystal form and product particle size. Compared with the original process in all aspects, it has obvious advantages, simple operation, low cost, and is more suitable for industrial production. However, it cannot effectively solve the problem of cefoxitin sodium fat-soluble related substances, and the impurity index is still high, which increases the safety of clinical use. sex

Method used

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
View more

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0035] (1) Weigh 100 g of crude cefoxitin sodium, add 1000 ml of water, heat up to 30-40 ° C and stir until completely dissolved, add 10 g of activated carbon, stir for decolorization, and filter;

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

[0037] (3) Remove the organic phase, transfer to the crystallization tank after the ice melts, add 5000ml of acetone dropwise for about 1 hour at 0-5°C, stir at a slow speed for 30 minutes, continue to grow crystals for 1 hour, filter with suction, wash with ethanol, and dry in vacuum , to obtain the finished product of cefoxitin sodium. The maximum impurity is 0.13%, and the total impurity is 0.33%.

Embodiment 2

[0039] (1) Weigh 100 g of crude cefoxitin sodium, add 1000 ml of water, heat up to 30-40 ° C and stir until completely dissolved, add 10 g of activated carbon, stir for decolorization, and filter;

[0040] (2) Add 5ml of chloroform to the above filtrate under stirring, transfer it to a 1000ml pressure-resistant container, make sure it is full and the air bubbles are removed, seal the container, oscillate, freeze at -18°C for 3 hours, and then take it out;

[0041] (3) Remove the organic phase, transfer to the crystallization tank after the ice melts, add 5000ml of acetone dropwise for about 1 hour at 0-5°C, stir at a slow speed for 30 minutes, continue to grow crystals for 1 hour, filter with suction, wash with ethanol, and dry in vacuum , to obtain the finished product of cefoxitin sodium. The maximum impurity is 0.21%, and the total impurity is 0.40%.

Embodiment 3

[0043] (1) Weigh 100 g of crude cefoxitin sodium, add 1000 ml of water, heat up to 30-40 ° C and stir until completely dissolved, add 10 g of activated carbon, stir for decolorization, and filter;

[0044] (2) Add 10ml of diethyl ether to the above filtrate under stirring, transfer it to a 1000ml pressure-resistant container, ensure that it is full and remove air bubbles, seal the container, oscillate, freeze at -18°C for 8 hours, and then take it out;

[0045] (3) Remove the organic phase, transfer to the crystallization tank after the ice melts, add 5000ml of acetone dropwise for about 1 hour at 0-5°C, stir at a slow speed for 30 minutes, continue to grow crystals for 1 hour, filter with suction, wash with ethanol, and dry in vacuum , to obtain the finished product of cefoxitin sodium. The maximum impurity is 0.17%, and the total impurity is 0.40%.

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
Login to View More

PUM

No PUM Login to View More

Abstract

The present invention relates to a children type cefoxitin sodium pharmaceutical composition, especially to a combination application package, wherein the composition is a cefoxitin sodium and low-sodium carrier infusion pharmaceutical combination preparation, which comprises cefoxitin sodium for injection and a low-sodium carrier infusion, wherein the low-sodium carrier infusion contains a glucose and sodium chloride injection (15-200:1), a glucose, sodium chloride and potassium chloride injection (15-200:1:0-1) and the like. According to the present invention, the clinical application steps are simplified compared with the compatible mixing use of the cefoxitin sodium and the low-sodium carrier infusion; and the clinical risk caused by the excessive sodium positioned in the blood and incapable of being metabolized due to the children kidney achieving the immature development state is reduced so as to improve the clinical application quality and the safety of the children medication are improved.

Description

technical field [0001] The invention relates to a pharmaceutical composition of children's cefoxitin sodium and a low-sodium carrier, belonging to the field of medicinal chemistry. Background technique [0002] Cefoxitin sodium, the chemical name is: 3-carbamoyloxymethyl-7-methoxy-8-oxo-7-(2-thiopheneacetamido)-5-thio-1-azabicyclo( 4.2.0) Oct-2-ene-2-carboxylic acid sodium salt, Chinese alias: Meifuxian. [0003] Cefoxitin Sodium is a cefoxitin antibiotic. The effect is similar to the second-generation cephalosporins, so it is used to be included in the second-generation cephalosporins. Cefoxitin is weak against Gram-positive bacteria and strong against Gram-negative bacteria. It has antibacterial effect on Escherichia coli, Klebsiella, Haemophilus influenzae, Neisseria gonorrhoeae, Proteus mirabilis, and indole-positive Proteus. It also has a good effect on anaerobic bacteria. Such as Peptococcus, Peptostreptococcus, Clostridium, Bacteroides (including Bacteroides frag...

Claims

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
Login to View More

Application Information

Patent Timeline
no application Login to View More
Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/546A61K9/08A61K47/26A61K47/02A61P31/04B65D81/32
Inventor 陈宇东厉达中
Owner ZHEJIANG CHANGDIAN PHARMA
Who we serve
  • R&D Engineer
  • R&D Manager
  • IP Professional
Why Patsnap Eureka
  • Industry Leading Data Capabilities
  • Powerful AI technology
  • Patent DNA Extraction
Social media
Patsnap Eureka Blog
Learn More
PatSnap group products

Browse by: Latest US Patents, China's latest patents, Technical Efficacy Thesaurus, Application Domain, Technology Topic, Popular Technical Reports.

© 2024 PatSnap. All rights reserved.Legal|Privacy policy|Modern Slavery Act Transparency Statement|Sitemap|About US| Contact US: help@patsnap.com