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Method for detecting endotoxin in quaternary ammonium salt and biguanide solution

A technology for quaternary ammonium salts and endotoxins, which is applied in the field of detection of endotoxins in quaternary ammonium salts and biguanide solutions. It can solve problems such as unqualified products, endotoxin contamination, and impact on corporate reputation and image, so as to reduce impact and improve accuracy. , the effect of avoiding false negative results

Pending Publication Date: 2020-11-03
斯坦利思生物科技(杭州)有限公司
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Problems solved by technology

[0003] Every link in biopharmaceuticals may contaminate endotoxin and make the product unqualified, which not only causes great economic losses to the manufacturer, but also directly affects the reputation and image of the company

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  • Method for detecting endotoxin in quaternary ammonium salt and biguanide solution

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Embodiment Construction

[0027] The following will clearly and completely describe the technical solutions in the embodiments of the present invention with reference to the accompanying drawings in the embodiments of the present invention. Obviously, the described embodiments are only some, not all, embodiments of the present invention. Based on the embodiments of the present invention, all other embodiments obtained by persons of ordinary skill in the art without making creative efforts belong to the protection scope of the present invention.

[0028] A method for detecting endotoxin in quaternary ammonium salt and biguanide solution, comprising the steps:

[0029] Step 1. Prepare the stock solution for detection: prepare the quaternary ammonium salt solution or biguanide solution or the mixed solution of quaternary ammonium salt and biguanide used in the detection, the content of quaternary ammonium salt in the solution is <50%; the content of biguanide in the solution is <20%. ; and the detection s...

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Abstract

The invention discloses a method for detecting endotoxin in a quaternary ammonium salt and biguanide solution, which neutralizes quaternary ammonium salt or biguanide by adding a neutralizer into thesolution, and only neutralizes the quaternary ammonium salt and biguanide components in the solution on the premise of ensuring no endotoxin contained in the solution. The problem that in the prior art, in the detection process of a quaternary ammonium salt solution, a biguanide solution or a quaternary ammonium salt and biguanide mixed solution, a tachypleus amebocyte lysate and endotoxin cannotbe condensed after making contact with each other due to quaternary ammonium salt and biguanide is solved, a false negative result is avoided, and therefore the accuracy of a detection result is improved; on the basis of a tachypleus amebocyte lysate method, a neutralizing agent is added into a quaternary ammonium salt or biguanide solution to be used as pretreatment, so that a neutralizing effectis achieved, the influence of inspection or biguanide content on tachypleus amebocyte lysate testing is reduced, and the detection accuracy is improved.

Description

technical field [0001] The invention relates to the technical field of endotoxin detection methods in quaternary ammonium salt and biguanide solutions, in particular to a method for detecting endotoxins in quaternary ammonium salt and biguanide solutions. Background technique [0002] Bacterial endotoxin is a complex of lipopolysaccharide and trace protein on the cell wall of Gram-negative bacteria. Toxin Biologically active substance. The harm of endotoxin is very serious, it will cause: 1. Fever reaction: The human body is extremely sensitive to bacterial endotoxin. A very small amount (1-5ng / kg) of endotoxin can cause body temperature to rise; 2. Leukocyte reaction: After bacterial endotoxin enters the host body, due to the movement of cells and adhesion to tissue capillaries, the blood stream accounts for 60% of the total number of white blood cells ~70% of the neutrophils decrease rapidly; 3. Endotoxin shock: a large amount of endotoxin acts on the body's macrophages,...

Claims

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Application Information

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IPC IPC(8): G01N33/579G01N1/28
CPCG01N1/28G01N33/579
Inventor 毛斌杰褚培忠陈杭
Owner 斯坦利思生物科技(杭州)有限公司
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