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Dispersing compound for detecting bacterial endotoxin

A technology of bacterial endotoxin and composition, which is applied in the field of dispersed composition for bacterial endotoxin detection, can solve problems such as secondary pollution, difficulty in effective detection, complicated operation of centrifugation methods, etc., to improve accuracy, eliminate interference, simplify internal Effect of Toxin Detection Step

Active Publication Date: 2014-12-17
SICHUAN KELUN PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] For non-water-soluble test products, because they are not miscible with water for bacterial endotoxin detection, they will be separated after mixing for a period of time, making it difficult to effectively detect
At present, the commonly used method is to take the mixture of the test product and the water for bacterial endotoxin detection before stratification, or take the water phase part by centrifugation for interference experiments, but it is necessary to take the mixture of the test product and water for bacterial endotoxin detection for interference experiments. Only by diluting a larger multiple can the interference be eliminated or even the interference cannot be eliminated; the centrifugation method has complex operations, is prone to secondary pollution, and has false positives. At the same time, it cannot ensure that the bacterial endotoxin in the oil phase is completely dissolved in the water phase. False negatives and other shortcomings are prone to occur in toxin detection
For drugs containing such non-water-soluble raw materials, although they can be miscible with water, when they are diluted with water for bacterial endotoxin detection, there are still cases where bacterial endotoxins are not uniformly dispersed in the test product and the interference cannot be established.
[0005] Shang Jun et al., "Research on Bacterial Endotoxin Test Method for Oil Agent Procaine Penicillin Injection", Chinese Journal of Veterinary Medicine 2000, 34 (1): 20-22, using appropriate amount of sterile and qualified endotoxin in the sample 0.1mol / L sodium hydroxide, 1% Tween-80 solution, and adjust the pH value of sample solution with 0.1mol / L hydrochloric acid, solved the dissolving problem of oil agent procaine penicillin injection, but this method is complicated to operate, And after research, it cannot be widely used in commonly used water-insoluble drugs

Method used

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  • Dispersing compound for detecting bacterial endotoxin
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  • Dispersing compound for detecting bacterial endotoxin

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0023] The preparation and application of embodiment 1 dispersion liquid of the present invention

[0024] 1. Preparation method

[0025] (1) Reagent selection

[0026] The anionic surfactant is sodium oleate, whose HBL value is 18; the nonionic surfactant is polysorbate-80, whose HBL value is 15.

[0027] (2) Removal of experimental equipment and reagent pyrogens

[0028] All the experimental equipment used, including iodine flask, volumetric flask, medicine spoon and beaker, should be dry-baked at 250°C for 2 hours to remove the pyrogen; sodium oleate should be placed in the iodine flask to remove pyrogen, and dried at 150°C Dry roast for 2h.

[0029] (3) Preparation of dispersion

[0030] Weigh 0.1 g of sodium oleate that has been dry-baked at 150°C for 2 hours, and dissolve 1% glycerin solution prepared with bacterial endotoxin testing water in a beaker that has been depyrogenated to prepare a 0.1% sodium oleate solution. Then add 1% polysorbate-80, so that the ratio ...

Embodiment 2

[0152] Embodiment 2 Preparation and application of the dispersion liquid of the present invention

[0153] 1. Preparation method

[0154] (1) Reagent selection

[0155] The anionic surfactant is sodium oleate, whose HBL value is 18; the nonionic surfactant is polysorbate-80, whose HBL value is 15.

[0156] (2) Removal of experimental equipment and reagent pyrogens

[0157] All the experimental equipment used, including iodine flask, volumetric flask, medicine spoon, and beaker, should be dried at 250°C for 2 hours to remove the pyrogen; sodium oleate should be placed in the iodine flask to remove pyrogen, and dried at 150°C. Bake for 2 hours.

[0158] (3) Preparation of dispersion

[0159] Weigh 0.2 g of sodium oleate that has been dry-baked at 150°C for 2 hours, and dissolve the 2% glycerin solution prepared with bacterial endotoxin testing water in a beaker that has been depyrogenated to prepare a 0.2% sodium oleate solution. Then add 0.5% polysorbate-80, so that the ra...

Embodiment 3

[0175] Embodiment 3 The preparation and application of dispersion liquid of the present invention

[0176] 1. Preparation method

[0177] (1) Reagent selection

[0178] Sodium oleate and oleic acid were selected as anionic surfactants, and their HBL values ​​were 18 and 1, respectively; polysorbate-21 was selected as a nonionic surfactant, and their HBL values ​​were 13.3.

[0179] (2) Removal of experimental equipment and reagent pyrogens

[0180] All the experimental equipment used, including iodine flask, volumetric flask, medicine spoon, and beaker, should be dried at 250°C for 2 hours to remove the pyrogen; sodium oleate should be placed in the iodine flask to remove pyrogen, and dried at 150°C. Bake for 2h.

[0181] (3) Preparation of dispersion:

[0182] Weigh 0.4g of sodium oleate that has been dry-baked at 150°C for 2 hours, and dissolve the 0.1% glycerin solution prepared with bacterial endotoxin testing water in a beaker that has been depyrogenated to prepare a ...

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Abstract

The invention discloses a dispersing compound for detecting a bacterial endotoxin. The dispersing compound contains the components of: 1 to 20 volume parts of glycerol, 0.5 to 5 weight parts of an anionic surfactant, and 1 to 10 volume parts of a nonionic surfactant. The invention also discloses a dispersing solution for detecting the bacterial endotoxin and a preparation method of the dispersing solution. The dispersing compound for detecting the bacterial endotoxin can effectively improve the accuracy of the bacterial endotoxin detection method and simplify endotoxin detection steps, and has good economic benefits.

Description

technical field [0001] The invention belongs to the field of medicines, in particular to a dispersion composition for bacterial endotoxin detection. Background technique [0002] Bacterial endotoxin is G - The unique structure on the bacterial cell wall, its main component is lipopolysaccharide, which has strong pyrogenic activity. When bacterial endotoxin enters the human body through the digestive tract, it does not cause harm, but when endotoxin enters the blood through injection or other means, it can lead to different degrees of endotoxemia. Therefore, bacterial endotoxin control should be carried out for injections and the raw materials used in their production to ensure product quality and drug safety. [0003] The common methods for detection of bacterial endotoxin are rabbit pyrogen method and limulus reagent method, and the limulus reagent method is more widely used at present. Before using this method for bacterial endotoxin detection, an interference experimen...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N33/579
Inventor 杨秋艳朱雪梅杨军王利春王晶翼梁隆沈鑫程志鹏
Owner SICHUAN KELUN PHARMA CO LTD