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Production technology and detection method of cefoxitin sodium preparation

A technology of cefoxitin sodium and its production process, which is applied in the field of medicine and can solve the problems of cefoxitin sodium oral instability, damp-heat instability, and low bioavailability

Inactive Publication Date: 2011-12-21
SUZHOU ERYE PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] Because cefoxitin sodium is very unstable when taken orally, its bioavailability is extremely low, and it is also very unstable to damp heat, so it can only be processed into powder injection (sterile powder) by aseptic technology for clinical use in the selection of dosage forms.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0021] Prescription: cefoxitin sodium (in C 16 h 17 N 3 o 7 S 2 Count) 500g

[0022] Packing 1000 bottles

[0023] Preparation method: After sorting and splitting the vials, wash them in a washing machine with purified water and water for injection respectively, put them in a tunnel oven to sterilize at 350°C for 5 minutes, and cool them for later use; use purified water and water for injection respectively for butyl rubber stoppers. After washing with water for injection, first use compressed air to stir, vacuum sterilize for 90 minutes, then use 121°C steam sterilization for 30 minutes, and then dry heat sterilization at 120°C in an oven for 2 hours, and cool it for later use; the aluminum-plastic cover is placed in the oven Sterilize at 120°C for 2 hours and cool down for later use. Take sterile cefoxitin sodium powder (in the form of C 16 h 17 N 3 o 7 S 2 Total) 500g in Class 10000 clean area, local Class 100 clean area, temperature 20°C, relative humidity 45%, ...

Embodiment 2

[0025] Prescription: cefoxitin sodium (in C 16 h 17 N 3 o 7 S 2 Count) 2000g

[0026] Packing 1000 bottles

[0027] Preparation method: After sorting and splitting the vials, wash them in a washing machine with purified water and water for injection respectively, put them in a tunnel oven to sterilize at 350°C for 5 minutes, and cool them for later use; use purified water and water for injection respectively for butyl rubber stoppers. After washing with water for injection, first use compressed air to stir, vacuum sterilize for 90 minutes, then use 121°C steam sterilization for 30 minutes, and then dry heat sterilization at 120°C in an oven for 2 hours, and cool it for later use; the aluminum-plastic cover is placed in the oven Sterilize at 120°C for 2 hours and cool down for later use. Take sterile cefoxitin sodium powder (in the form of C 16 h 17 N 3 o 7 S 2 Total) 2000g in 10000-level clean area, local 100-level clean area, temperature 22 ℃, relative humidity 50%...

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PUM

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Abstract

The invention provides a production process of cefoxitin sodium for injection with simple production process, stable and reliable quality, and a method for determining related substances in cefoxitin sodium by high performance liquid chromatography. The method adopts a chromatographic column with phenylsilane-bonded silica gel as the filler, the mobile phase A is water (adjusted to pH 2.7 with formic acid), and the mobile phase B is acetonitrile; linear gradient elution, high performance liquid chromatography for the determination of cefoxitin related substances in sodium. The specificity of this law is good, and the relevant substances are basically completely detected.

Description

technical field [0001] The invention belongs to the field of medicine, and relates to a production process and detection of cefoxitin sodium powder injection. Background technique [0002] Cefoxitin sodium is a cephamycin antibiotic, produced by Streptomyces slactamdurans, cephamycin C (Cephamycin C), a new type of antibiotic produced by semi-synthesis, its mother nucleus is similar to cephalosporin, and has antibacterial properties Similarly, it is customarily included in the second-generation cephalosporins. It is characterized by its strong antibacterial effect on Gram-negative bacteria and its high resistance to β-lactamase. The antibacterial spectrum includes Escherichia coli, Klebsiella pneumoniae, indole-positive Proteus and Serratia, Klebsiella, influenza bacillus, Salmonella, Shigella, etc. It also has a good effect on staphylococcus and various streptococci. Clinically, it is mainly used for respiratory tract infection, endocarditis, peritonitis, pyelonephri...

Claims

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Application Information

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IPC IPC(8): A61K9/14A61K31/546G01N30/02A61P31/04
Inventor 徐立伽颜彦隋巍峰陈洋洋
Owner SUZHOU ERYE PHARMA CO LTD
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