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Method for detecting bacterial endotoxin of sodium metabisulfite

A technology of sodium metabisulfite and bacterial endotoxin, which is applied in the directions of measuring devices, instruments, scientific instruments, etc., can solve the problems of inability to obtain quantitative results, and achieve the effect of high specificity, strong practicability, and guaranteeing safety.

Active Publication Date: 2016-03-30
CHINA OTSUKA PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0009] In order to solve the problem that the traditional gel method can only analyze whether the endotoxin content in the product exceeds the standard, but cannot obtain exact quantitative results, the present invention proposes a detection method for sodium pyrosulfite bacterial endotoxin

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  • Method for detecting bacterial endotoxin of sodium metabisulfite
  • Method for detecting bacterial endotoxin of sodium metabisulfite
  • Method for detecting bacterial endotoxin of sodium metabisulfite

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Embodiment Construction

[0024] Below in conjunction with embodiment the present invention will be further described.

[0025] 1. Experimental materials

[0026] 1.1 Test product

[0027]

[0028] 1.2 Reagents and instruments

[0029]

[0030] 2. Selection of standard curve and determination of minimum effective concentration

[0031] 2.1 Selection of standard curve

[0032] Based on the maximum filling volume of each injection being 20mL, the maximum concentration of sodium metabisulfite being used at 0.2%, and the clinical safety factor being 10 times, the amount of antioxidant used in one clinical application is 400mg. Endotoxin limit L=K / M=5EU / kg÷(400mg÷60kg)=0.75EU / mg.

[0033] In this test, 0.8mg / ml, 0.4mg / ml, and 0.2mg / ml were selected for the preliminary interference screening test. Therefore, according to the limit value of endotoxin, the maximum amount of endotoxin that may be contained in the series of reaction solutions is 0.75EU / mg×0.8mg / ml=0.6EU / ml, and the highest sensitivit...

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Abstract

The invention discloses a method for detecting bacterial endotoxin of sodium metabisulfite and relates to the field of biological substances of limulus dissolving agents. The detection method comprises steps as follows: a, reaction solution preparation: (I), sodium metabisulfite is weighed and added to water for bacterial endotoxin test, and the concentration of a test article sodium metabisulfite is 100 mg / ml; (II), the test article sodium metabisulfite is diluted to 0.1 mg / ml-0.6 mg / ml by the water for the bacterial endotoxin test; b, a dynamic development limulus reagent is taken and opened to be added to the water for bacterial endotoxin test for redissolving; c, 0.1 mg / ml-0.6 mg / ml of the test article sodium metabisulfite is mixed with the redissolved limulus reagent in the step b with the same volume, the mixture is added to a reaction test tube, the reaction test tube is inserted into a dynamic test tube detection instrument, and the endotoxin content is calculated. The method overcomes defects of an animal pyrogen detection method, and is high in repeatability and sensitivity and simple and convenient to operate.

Description

technical field [0001] The invention relates to a biological substance of a limulus lysate, in particular to a detection method for sodium metabisulfite bacterial endotoxin. Background technique [0002] Sodium metabisulfite is a commonly used antioxidant, widely used in the production of pharmaceuticals, food and other industries. Sodium pyrosulfite is easily oxidized. Substances with strong reducing properties have a lower oxidation potential than drugs. ) exists at the same time, it can first act with it to keep the main drug in a stable state. [0003] Infusion products are necessary basic medicines for daily use in hospitals. At present, the domestic infusion solution market is in a price war, and product upgrading is the key. The raw materials used in product upgrading must be strictly controlled to ensure product quality. Pyrogen or bacterial endotoxin is one of the key quality control items for injections. [0004] According to the provisions of the 2015 edition ...

Claims

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Application Information

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IPC IPC(8): G01N33/579
CPCG01N33/579
Inventor 于玥
Owner CHINA OTSUKA PHARM CO LTD
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