Method for detecting bacterial endotoxin in egg yolk lecithin by gel method

A technology of bacterial endotoxin and egg yolk lecithin, which is applied in measurement devices, biological tests, material inspection products, etc., can solve the problems of high detection cost, complicated operation, and the solution of the test sample is not clear and transparent, and achieves the effect of effective detection.

Pending Publication Date: 2021-08-06
CISEN PHARMA
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  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

Currently on the market, the turbidimetric method is used for testing (the concentration of ethanol in the test product should be less than 20%), but the solution of the test product is not clear and transparent, and the detection result of the photometric method is not accurate and reliable, and the operation is complicated and the detection cost is high.

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  • Method for detecting bacterial endotoxin in egg yolk lecithin by gel method
  • Method for detecting bacterial endotoxin in egg yolk lecithin by gel method
  • Method for detecting bacterial endotoxin in egg yolk lecithin by gel method

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Embodiment

[0027] Absolute ethanol interference test: the first step of verification, the operation steps are: dissolve a bacterial endotoxin standard in BET water, mix continuously for 15 minutes with a vortex mixer, dilute with BET water, and mix for at least 30 seconds in each step. Diluted to 4EU / ml (128λ) standard solution. Measure 0.5 ml of absolute ethanol, add 0.5 ml of 128λ standard solution, and gradually dilute with BET water to the test solution containing bacterial endotoxin standard 2λ of 15.625 μl / ml in absolute ethanol concentration.

[0028] Absolute ethanol interference test: the second step of verification, the operation steps are: dissolve a bacterial endotoxin standard in BET water, mix continuously for 15 minutes with a vortex mixer, dilute with BET water, and mix for at least 30 seconds in each step. Diluted successively to 0.125EU / ml (4λ), 0.06EU / ml (2λ), 0.03EU / ml (λ), 0.015EU / ml (0.5λ) standard solution. Dilute absolute ethanol to a concentration of 31.25 μl / ml...

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Abstract

The invention discloses a method for detecting bacterial endotoxin in egg yolk lecithin by a gel method. The method comprises the following steps: determining a bacterial endotoxin limit value L and a minimum effective dilution concentration c in egg yolk lecithin; rechecking sensitivity of the tachypleus amebocyte lysate; carrying out interference pre-test on the test sample solutions with different dilution ratios, finding out the maximum non-interference concentration under the non-interference condition, and carrying out interference test on the test sample solution with the maximum non-interference concentration; performing absolute ethyl alcohol interference test; and carrying out egg yolk lecithin interference test. According to the method for detecting the bacterial endotoxin in the egg yolk lecithin through the gel method, the bacterial endotoxin in the egg yolk lecithin is accurately detected through a simple method, and interference can be effectively eliminated through detection of the test solution.

Description

technical field [0001] The invention relates to the field of drug analysis, in particular to a gel method for detecting bacterial endotoxin in egg yolk lecithin. Background technique [0002] Bacterial endotoxins are cell wall components of Gram-negative bacteria that are released when the bacteria die or autolyse. Therefore, bacterial endotoxins widely exist in nature. When endotoxin enters the human body through the digestive tract, it does not cause harm, but when endotoxin enters the blood through injection or other means, it will cause different diseases. After a small amount of endotoxin enters the blood, it will be inactivated by liver cells without causing damage to the body. A large amount of endotoxin entering the blood will cause pyrogen reaction, resulting in fever, leukocyte reaction, endotoxin shock and diffuse intravascular coagulation. Therefore, preparations such as biological products, injections, chemicals, radiopharmaceuticals, antibiotics, vaccines, di...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N33/579G01N33/92
CPCG01N33/579G01N33/92
Inventor 吴艳党祥玉孙彦凤
Owner CISEN PHARMA
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