Method for measuring bacterial endotoxin content in injection grade granulesten by developing substrate method

A technology of bacterial endotoxin and soybean phospholipids, which is applied in the measurement of color/spectral characteristics and the preparation of test samples, etc., to achieve the effect of reducing detection costs

Inactive Publication Date: 2011-04-27
JIANGNAN UNIV
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  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

There is currently no documented method for the determinat

Method used

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  • Method for measuring bacterial endotoxin content in injection grade granulesten by developing substrate method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0024] Example 1. Determination of Bacterial Endotoxin Limit (L)

[0025] Referring to the import registration standard, the endotoxin content of lecithin for injection should be ≤6EU / g, that is, 0.006EU / mg.

Embodiment 2

[0026] Embodiment 2. the determination of the preparation of need testing solution and maximum dilutable factor (MVD)

[0027] The sample was accurately weighed under sterile conditions, and the phospholipids were dissolved into an initial solution of 10 mg / mL with bacterial endotoxin test water (BET water) (the concentration of the initial solution of 1 mg / mL was too small and exceeded the detection limit; the initial solution of 100 mg / mL A standard curve with a higher concentration is required, but the solution is turbid and the interference is enhanced). The limit L is 0.006EU / mg, the lowest concentration of the standard curve is 0.01EU / mL, and the maximum dilution factor of the test sample

Embodiment 3

[0028] Embodiment 3. standard curve reliability test

[0029] The establishment of the standard curve was carried out according to the operation steps of bacterial endotoxin inspection. Dilute the 0.1EU / mL endotoxin solution into a 0.01-0.1EU / mL bacterial endotoxin standard solution. Draw a standard curve with the absorbance value as the ordinate and the endotoxin concentration as the abscissa. The concentration is regressed with the absorbance value, and the regression equation is y=24.514x-0.0242, R 2 =0.9908, |r|≥0.980, so the standard curve is established.

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Abstract

The invention relates to a sensitive and accurate method for measuring the bacterial endotoxin content in injection grade granulesten, belonging to the field for detecting the bacterial endotoxin as an auxiliary material for a drug. In the method, the bacterial endotoxin content in the injection grade granulesten is measured by utilizing the developing substrate method of TAL (Tachypleus Amebocyte Lysate); the granulesten is accurately weighed; a 10mg/ml granulesten solution is prepared by utilizing the water for inspecting the bacterial endotoxin and is diluted to each dilution grade not exceeding the maximum effective dilution factor; the result of an interference test indicates that the 10mg/ml granulesten solution which is diluted by more than three times has no interference action on the measurement for the quantitive endotoxin of the developing substrate TAL; and the value of the bacterial endotoxin in the granulesten can be calculated by utilizing the dilution grade. The method provides a method for controlling and measuring the bacterial endotoxin for the production and scientific research of the injection grade granulesten.

Description

technical field [0001] The invention belongs to the field of bacterial endotoxin detection of pharmaceutical auxiliary materials, and relates to a method for detecting bacterial endotoxin in soybean lecithin, a medical auxiliary material. Background technique [0002] Soy lecithin is a plant-derived phospholipid, which has the advantages of low fat and cholesterol content, good emulsification stability, and low cost. In the pharmaceutical industry, refined natural phospholipids are often used as emulsifiers and excipients for preparing various pharmaceutical preparations. Among them, phospholipids are one of the most commonly used medical applications as emulsifiers for intravenous fat emulsion injections. As its emulsifier, phospholipids can withstand autoclaving without being destroyed, have little toxicity to organisms, high energy, good emulsification effect, and form oil particles that are highly dispersed and uniform, and their performance is superior to other emulsifi...

Claims

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Application Information

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IPC IPC(8): G01N21/31G01N1/38
Inventor 黄健花吕名蕊王兴国
Owner JIANGNAN UNIV
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