Sterility test method for gentamicin sulphate injection

A gentamicin sulfate, sterility inspection technology, applied in biochemical equipment and methods, microbial determination/inspection, etc., can solve problems such as excessive flushing fluid volume, false negatives, inaccurate inspection, etc., to achieve accurate Reliable sterility check, reduced bacteriostatic effect

Active Publication Date: 2019-11-22
甘肃省药品检验研究院
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

For injections with antibacterial properties, the membrane filtration method is generally used for sterility inspection, and multiple methodological applicability tests are carried out to eliminate antibacterial properties by diluting the drug and rinsing the film to determine the final sterility inspection method. However, the amount of flushing liquid in the determined sterility test method should not be too large. A large amount of flushing liquid will flush the film, which may cause false negative results and inaccurate testing.

Method used

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  • Sterility test method for gentamicin sulphate injection
  • Sterility test method for gentamicin sulphate injection
  • Sterility test method for gentamicin sulphate injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0060] 1. A method for sterility inspection of gentamicin sulfate injection, the steps are as follows:

[0061] 1.1 Preparation of culture medium, bacterial liquid, diluent, and buffer: prepare thioglycolate fluid medium and tryptone soya peptone liquid medium; prepare Escherichia coli suspension with bacterial count less than 100 cfu / mL; prepare buffer Sodium chloride-peptone buffer at pH 7.0.

[0062] 1.2 Preparation of experimental group: After a group of double closed membrane filters were wetted with buffer, 10 bottles of gentamicin sulfate injection samples were filtered through, and each membrane was washed with 800 mL of buffer, 100 mL each time, to obtain 2 samples containing the sample. Filter cartridges; 100 mL of thioglycolate fluid medium and 100 mL of tryptone soy medium were added to the two filter cartridges, respectively, and cultured and observed daily.

[0063] 1.3 Preparation of positive control: After a set of double closed membrane filters were wetted wi...

Embodiment 2

[0078] The sterile inspection method and method applicability verification test of gentamicin sulfate injection are all referring to Example 1, the difference is: diluent 0.9% sterile sodium chloride solution is also prepared; gentamicin sulfate injection sample is filtered Add 100 mL of diluent to each 10 bottles before dilution; rinse each membrane with 500 mL of buffer, 100 mL each time.

[0079] The method applicability verification test results of the present embodiment are as follows:

[0080] Table 2

[0081]

[0082] Note: + means the liquid is cloudy; - means the liquid is clear

[0083] The results in Table 2 show that 6 kinds of experimental bacteria all grow after culturing for 72 hours, indicating that the inspection method of Example 2 is suitable for sterility inspection of gentamicin sulfate injection.

Embodiment 3

[0085] The sterility inspection method of gentamicin sulfate injection and the verification test of method applicability are all referring to Example 1, the difference is: 200 mL of buffer solution is added to each 10 bottles of gentamicin sulfate injection as a diluent to dilute before filtration; Rinse each membrane with 300 mL of buffer, 100 mL each time.

[0086] The method applicability verification test results of the present embodiment are as follows:

[0087] table 3

[0088]

[0089] Note: + means the liquid is cloudy; - means the liquid is clear

[0090] The results in Table 3 show that 6 kinds of experimental bacteria all grow after culturing for 48 hours, indicating that the inspection method of Example 3 is suitable for sterility inspection of gentamicin sulfate injection.

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Abstract

The invention discloses a sterility test method for a gentamicin sulphate injection. A membrane filtration method is adopted, and the preparation step of a culture involves that a bigeminy closed membrane filter is used for membrane filtration, wherein the flushing amount of a buffer solution is 100-800 mL per membrane, and the addition amount of a culture medium is 100 mL per membrane; the preparation step of a test group involves that the gentamicin sulphate injection is added into a diluent to be diluted, wherein the volume of the diluent is 0-10 times of the volume of the injection; the filtration amount of the injection is 0.8 million of filtering titers per membrane; the preparation step of a positive control group involves that escherichia coli is adopted as positive contrast bacteria, and the positive contrast bacteria are added after the culture medium is added. According to the provided sterility test method for the gentamicin sulphate injection, according to the bacteriostatic characteristic of gentamicin sulphate, the sterility test process, the culture medium, the buffer solution and other elements are adjusted, and the sterility test can be conducted accurately and reliably on the gentamicin sulphate injection.

Description

technical field [0001] The invention relates to the field of drug detection, in particular to a method for sterility inspection of gentamicin sulfate injection. Background technique [0002] Gentamicin sulfate is an aminoglycoside antibiotic, which has a good antibacterial effect on various gram-negative bacteria and gram-positive bacteria. Its mechanism of action is to combine with bacterial ribosomal subunits to inhibit bacterial protein synthesis. Gentamicin sulfate is suitable for the treatment of serious infections caused by Gram-negative bacteria, such as sepsis, lower respiratory tract infections, and intestinal infections. The hygienic index of gentamicin sulfate injection requires sterility. During the production process, although sterilized, there may be some low-living or dormant microorganisms that have not been killed or removed. [0003] Sterility inspection method is an inspection method established for the sterility reliability of sterile drugs, etc. The acc...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C12Q1/22
CPCC12Q1/22Y02A50/30
Inventor 何小英郭朝晖
Owner 甘肃省药品检验研究院
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