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Asepsis inspection method of cefotiam hydrochloride for injection

A technology for cefotiam hydrochloride and sterility inspection, which is applied in the field of medicine and can solve the problems of not establishing a sterility inspection method and the like

Inactive Publication Date: 2015-02-25
SICHUAN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] There will be strict control of the number of bacteria in clinical medicine, so in the production process, there is an actual production demand for strict control and inspection of the number of bacteria. A simple and effective sterility inspection method has not yet been established.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0016] A method for sterility testing of cefotiam hydrochloride for injection. Take a fully-enclosed triple bacterium collector, wet the membrane of the fully-closed triple bacterium collector with an appropriate amount of 0.9% sterile sodium chloride solution, and then take a sample to be tested and inject Then inject 0.9% sterile sodium chloride solution into the fully enclosed triple bacteria collection device, filter after dissolving, and then rinse with sodium chloride-peptone buffer solution with a pH of 7.0. Before washing, add the bacteria to be tested, and then filter Add a medium suitable for the growth of the bacteria to be tested for culture and measure the number of colonies, and simultaneously conduct positive control tests and negative control tests.

[0017] The bacteria to be tested are Staphylococcus aureus, Escherichia coli, Bacillus subtilis, Candida albicans or Aspergillus niger.

[0018] The preparation method of the positive control group is to take a fu...

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PUM

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Abstract

The invention discloses an asepsis inspection method of cefotiam hydrochloride for injection. The method comprises the following steps: taking a fully closed triple bacterium collector, wetting the film of the fully closed triple bacterium collector with a proper amount of a 0.9% sterile sodium chloride solution, injecting a sample to be tested into the fully closed triple bacterium collector, injecting the 0.9% sterile sodium chloride solution to dissolve the sample, filtering, flushing by using a sodium chloride-peptone buffer solution with the pH value of 7.0, adding a bacterium to be inspected before the end of the flushing, filtering, adding a medium suitable for the growth of the bacterium to be inspected, culturing, determining the colony count, and simultaneously carrying out positive control test and negative control test. The method can be used to simply, effectively and accurately inspect the quantity of bacteria in the cefotiam hydrochloride for injection, and provides the basis for the product quality control and inspection of the qualified rate.

Description

technical field [0001] The invention relates to the field of medicine, in particular to a method for sterility testing 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 tiss...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C12Q1/14C12Q1/04C12R1/445C12R1/19C12R1/125C12R1/725C12R1/685
Inventor 沈千万周璇刘萍
Owner SICHUAN PHARMA