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Detection method of bacterial endotoxins in pharmaceutical raw materials

A technology of bacterial endotoxin and detection method, applied in the field of microbial inspection, can solve the problems of being insoluble in water and unable to be directly inspected, and achieve the effect of ensuring safety

Inactive Publication Date: 2012-07-11
YICHANG HUMANWELL PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

However, volatile raw materials such as isoflurane, enflurane, and sevoflurane are insoluble in water, and bacterial endotoxins in samples cannot be directly detected by known methods

Method used

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  • Detection method of bacterial endotoxins in pharmaceutical raw materials
  • Detection method of bacterial endotoxins in pharmaceutical raw materials
  • Detection method of bacterial endotoxins in pharmaceutical raw materials

Examples

Experimental program
Comparison scheme
Effect test

preparation example Construction

[0019] 2) Preparation of the test solution: Weigh the selected drug raw material, heat it to the boiling point to make it volatilize, and use an equal amount of bacterial endotoxin test water (BET) to supplement the quality of the original drug to obtain the test solution;

[0020] 3) Use the test solution obtained in step 2) to detect bacterial endotoxin in the drug raw material by conventional methods.

[0021] 1. Experiment preparation

[0022] 1. Experimental equipment:

[0023] 1) Digital display constant temperature water bath, model: HH-2, Jintan Ronghua Instrument Manufacturing Co., Ltd.

[0024] 2) VORTEX-2 vortex mixer.

[0025] 3) Other glass test instruments were ultrasonically washed with purified water three times, and then dry-baked at 250°C for more than 2 hours.

[0026] ,experiment material:

[0027] Limulus Reagent: The specification is 0.1ml / cartridge, and the sensitivity mark value of Limulus Reagent is λ=0.5EU / ml;

[0028] Bacterial endotoxin wo...

Embodiment

[0047] Calculate L=0.045EU / mg (K=5EU / kg·hr, M=110mg / kg·hr) according to the limit value, and determine the bacterial endotoxin limit of isoflurane raw material L<0.045EU / mg.

[0048] , Preparation of test samples

[0049] Take 2g of isoflurane, heat it at 55°C to make it evaporate completely, and then add bacterial endotoxin test water to 2g as the test solution.

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Abstract

The invention relates to a detection method of bacterial endotoxins in pharmaceutical raw materials. The detection method comprises the following steps: selecting the pharmaceutical raw materials: selecting the pharmaceutical raw materials which are easy to volatilize and difficult to dissolve in water; preparing a test liquid: weighing and metering the selected pharmaceutical raw materials, heating to volatilize the pharmaceutical raw materials, and supplementing the equal quantity of water for testing the bacterial endotoxins till the original pharmaceutical mass to get the test liquid; and detecting the bacterial endotoxins in the pharmaceutical raw materials in the test liquid through a conventional method. According to the detection method, the bacterial endotoxins that are difficult to dissolve in the water and easy to volatilize, and can not be directly determined through a known method in the pharmaceutical raw materials, such as isoflurane, enflurane, sevoflurane and the like, can be determined, and the quality of sterile products can be controlled from a source, so that the detection method is highly significant in ensuring the safety of preparation productions. The addition of other reagents is not required during the detection process, and the existence of the bacterial endotoxins in samples can be simply, conveniently and reliably detected.

Description

technical field [0001] The invention belongs to the field of microbiology testing, and in particular relates to a method for measuring bacterial endotoxin in volatile and water-insoluble pharmaceutical raw materials. Background technique [0002] Sterile drugs refer to preparations and raw materials that have sterility inspection items listed in the statutory drug standards, including sterile preparations and sterile raw materials. "The sterility or other quality characteristics of the product must not rely solely on any form of final processing or finished product inspection (including sterility inspection)." It is one of the basic principles of sterile drug management in the 2010 version of the Good Manufacturing Practice for Drugs. [0003] Bacterial endotoxin is the main pollutant in injection medicine. Bacterial endotoxin is a complex of lipopolysaccharide and trace protein on the cell wall of Gram-negative bacteria. Toxin Biologically active substance. Endotoxin has...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N33/15
Inventor 刘峰赵蔓菁李莉娥徐华斌钟丽君
Owner YICHANG HUMANWELL PHARMA
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