Method for detecting endotoxin content

Abstract

The invention discloses a method for detecting endotoxin content. The method comprises the following steps: S1. preparing at least five endotoxin standard solutions containing different concentrations; S2. respectively mixing a tachypleus amebocyte lysate diluent with each endotoxin standard solution at the ratio; S3. respectively detecting the time required when the elasticity of each mixed liquid reaches 0.1 amplitude by virtue of a thrombelastogram instrument, and drawing a bilogarithmic graph of time-endotoxin concentration to obtain a standard curve graph; and S4. mixing the tachypleus amebocyte lysate diluent with a to-be-detected sample liquid according to a specific ratio, detecting the time required when the elasticity reaches 0.1 amplitude by virtue of the thrombelastogram instrument, and comparing with the standard curve graph, so as to obtain the endotoxin content in the to-be-detected sample liquid. Compared with traditional nephelometry and electrochemical biosensor, relatively comprehensive detection can be carried out on the overall process; research on the special physiological process is facilitated; the detection time is greatly shortened; and the detection sensitivity and accuracy are synchronously improved.

Description

technical field [0001] The invention relates to the technical field of endotoxin detection, in particular to a method for analyzing endotoxin content by elastic method. Background technique [0002] A series of symptoms such as fever, cold sensation, chills, nausea, vomiting, headache, waist and limb joint pain, pale complexion, leukopenia, increased vascular permeability, coma, shock, death, etc. called pyrogenic reaction. Bacterial endotoxin is one of the most widespread pyrogens. It is clinically very important to prevent pyrogen contamination of drugs and devices for infusion. 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 endoto...

AI Technical Summary

Problems solved by technology

The bacterial endotoxin determination methods stipulated in the Pharmacopoeia of my country are turbidimetric technique and chromogenic technique (Chromogenic Technique), and also include some electrochemical methods, but these methods are end-point methods and cannot be used for the process of endotoxin coagulation. Monitor, if fibrinolysis cannot be observed after reaching peak coagulation

In addition, the traditional turbidity method and electrochemical method take a long time to detect, which can no longer meet the current high-throughput and high-efficiency monitoring requirements.

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