Tachypleus amebocytes lysate quality monitoring method

A technology for the quality of LAL, which is applied in the field of monitoring the quality of LAL, can solve problems affecting production and verification work, the content of effective substances in LAL or the lack of detection and control of the concentration, and the quality difference of LAL, etc., so as to achieve work efficiency High, reduce error, improve the effect of accuracy

Inactive Publication Date: 2006-04-26
DALIAN INST OF CHEM PHYSICS CHINESE ACAD OF SCI
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Sensitivity is an important indicator of Limulus reagent, but there is no method to detect and control the quality indicators such as the content of effective substances or concentration of Limulus reagent
This will cause differences in the quality of Limulus reagent, affecting its production and testing work

Method used

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  • Tachypleus amebocytes lysate quality monitoring method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0020] Take the dry powder sample of LAL with a sensitivity of 0.125EU / ml and a marked dissolution volume of 0.5ml, add 0.5ml of pyrogen-free water to dissolve, mix the standard endotoxin solution and the dissolved LAL in equal proportions in a 7mm inner diameter flat-bottomed test tube, place in In the detection hole of the endotoxin analyzer, the reaction temperature is 37.1°C, the total reaction volume is 0.3ml, the concentration of the standard endotoxin solution is 0.133EU / ml, and the detection time is 60 minutes. After the reaction, the equilibrium turbidity value of the reaction was 0.20, and the result of the gel was positive. The characteristic reaction time when the turbidity value reaches 0.02 is 1260 seconds, and the characteristic reaction time when the turbidity value reaches 0.077 is 2120 seconds.

Embodiment 2

[0022] Take the dry powder sample of LAL with a sensitivity of 0.125EU / ml and a marked dissolution volume of 0.5ml, add 1.5ml of pyrogen-free water to dissolve, mix the standard endotoxin solution and the dissolved LAL in equal proportions in a 7mm inner diameter flat-bottomed test tube, place in In the detection hole of the endotoxin analyzer, the reaction temperature is 37.1°C, the total reaction volume is 0.3ml, the standard endotoxin solution concentration is 0.133EU / ml, and the detection time is 140 minutes. After the reaction, the equilibrium turbidity value of the reaction was 0.08, and the result of the gel was positive. The characteristic reaction time when the turbidity value reaches 0.02 is 1120 seconds, and the characteristic reaction time when the turbidity value reaches 0.077 is 3070 seconds.

Embodiment 3

[0024] Take the dry powder sample of LAL with a sensitivity of 0.125EU / ml and a marked dissolution volume of 0.5ml, add 0.15ml of pyrogen-free water to dissolve, mix the standard endotoxin solution and the dissolved LAL in equal proportions in a 7mm inner diameter flat-bottomed test tube, place in In the detection hole of the endotoxin analyzer, the reaction temperature is 37.1°C, the total reaction volume is 0.3ml, the standard endotoxin solution concentration is 0.133EU / ml, and the detection time is 140 minutes. After the reaction, the equilibrium turbidity value of the reaction was 0.26, and the result of the gel was positive. The characteristic reaction time when the turbidity value reaches 0.077 is 4190 seconds.

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Abstract

The invention discloses an observation method of limulus reagent quality, which is characterized by the following: putting the same bulk limulus mixture of reagent and standard endotoxin solution in the detection hole of endotoxin determinator to detect turbidity value; defining the turbidity value ranged from 0.08 to 0.27 as on-spec product; recording reaction time of multiple experiment samples and reading turbidity value automatically; judging the experiment result according to the turbidity value.

Description

Technical field: [0001] The invention relates to a detection method of a limulus reagent used for detecting bacterial endotoxin, and in particular provides a monitoring standard for the quality of the limulus reagent. Background technique: [0002] Bacterial endotoxin is a macromolecular substance with different biological activities produced by Gram-negative bacteria, and its main chemical component is lipopolysaccharide (LPS). Endotoxin is the main pollutant in injection drugs (raw materials, etc.). [0003] The detection methods of bacterial endotoxin include rabbit test method and limulus test method. Limulus Amebocyte Lysate (LAL) is an in vitro detection method that uses the principle of agglutination reaction between Limulus Amebocyte Lysate and endotoxin to qualitatively or quantitatively detect the degree of bacterial endotoxin infection in drugs or body fluids. The specific method is divided into gel method and quantitative method. [0004] The gel method is a m...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N33/579G01N21/00
Inventor 李京华邵英光岳丽娜王俊德
Owner DALIAN INST OF CHEM PHYSICS CHINESE ACAD OF SCI
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