Method for detecting endotoxin

Abstract

The invention discloses a method for detecting endotoxin. The method includes a material with oxidation reduction activity is added in tachypleus amebocyte lysate, a sample to be tested is added in the tachypleus amebocyte lysate, the sample to be tested may comprise the endotoxin, an oxidation reduction potential corresponding to the material with the oxidation reduction activity is exerted on the tachypleus amebocyte lysate, size of current passing through the tachypleus amebocyte lysate is monitored in real time simultaneously, and concentration of the endotoxin in the sample to be tested is obtained. Logarithm linear relationship exists between the concentration of the endotoxin added in the tachypleus amebocyte lysate and a time dropping point of the current passing through the tachypleus amebocyte lysate. Viscosity change in a tachypleus amebocyte lysate solidification process is shown through an electrochemical process directly, interference of sample colors is avoided, detection of the endotoxin can be achieved rapidly and accurately, and the method for detecting the endotoxin can be widely applied to the field of drug quality control, medical equipment pyrogen monitoring and the like.

Description

technical field [0001] The invention relates to a detection method of endotoxin, in particular to an electrochemical detection method of endotoxin. Background technique [0002] All substances that can cause pyrogen reactions are called pyrogens, and the pyrogens in medicines are mainly bacterial endotoxins. For more than half a century, the pyrogen inspection method has played an important role in ensuring the safety of injectable drugs. However, with the development of the pharmaceutical industry, this method is not completely suitable for the inspection of many varieties of pyrogens. To this end, people have studied a method to replace the pyrogen inspection method, which is the bacterial endotoxin inspection method that we are studying and expanding application today. Bacterial endotoxin inspection is an important index in the quality control of infused drugs and devices. Endotoxin is one of the main components of the cell wall of Gram-negative bacteria. After Gram-ne...

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Problems solved by technology

Both the chromogenic method and the turbidimetric method require a spectrophotometer, which takes 1-2 hours, and the detection is easily interfered by the chromogenic substances in the sample, and the coagulation process of the Limulus reagent interferes with the optical measurement to a certain extent, so it is difficult to achieve accurate detection. Accurate detection of endotoxin

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