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Method for detecting fleroxacin bacterial endotoxin used for injection

A technology of bacterial endotoxin and fleroxacin, which is applied in the direction of measuring devices, instruments, scientific instruments, etc., can solve the problems that samples cannot be accurately detected and interference cannot be eliminated, and achieve the effect of improving quality standards, easy operation, and eliminating interference

Inactive Publication Date: 2012-12-26
LIAONING THINKING DECKER MEDICAL TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, when this method is used for the detection of bacterial endotoxin of fleroxacin for injection, there is interference, and the sample cannot be detected accurately. Even if the sample dilution concentration, the sensitivity of the limulus reagent and the pH value of the sample are changed, the interference cannot be eliminated.

Method used

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  • Method for detecting fleroxacin bacterial endotoxin used for injection
  • Method for detecting fleroxacin bacterial endotoxin used for injection
  • Method for detecting fleroxacin bacterial endotoxin used for injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0011] 1. Experimental materials:

[0012] 1.1 Test product: fleroxacin for injection

[0013] Production unit: Shenyang Xinma Pharmaceutical Co., Ltd.

[0014] Specification: 0.1g Batch number: 20100703, 20100704, 20100705;

[0015] Specification: 0.2g Batch number: 20101221, 20101222, 20101223;

[0016] 1.2 Limulus reagent

[0017]

[0018] 1.3 Bacterial endotoxin working standard (CSE)

[0019] Production unit: China Institute for the Control of Pharmaceutical and Biological Products, batch number 150601-201065, potency 180 EU / bottle.

[0020] 1.4 Bacterial endotoxin test water (BET water)

[0021] Production unit: Zhanjiang Andus Biological Co., Ltd., specification: 5ml, batch number: 1002050.

[0022] 1.5 Special diluent for blood preservation solution

[0023] Production unit: Zhanjiang Andus Biological Co., Ltd., specification: 5ml, batch number 1008310.

[0024] 2. Determination of limit value

[0025] Clinical usage and dosage of this product: 0.2-0.4g (ca...

Embodiment 2

[0055] Dilute the bacterial endotoxin working standard to 0.25 EU / ml with bacterial endotoxin test water; dilute fleroxacin for injection to 0.667 mg / ml with a special diluent for blood preservation solution to make NPC, and use 1.333 mg / ml for the test solution Dilute it with 0.50 EU / ml endotoxin solution to make PPC. Results: NPC and NC were negative reactions, PPC and PC were positive reactions, and the bacterial endotoxin test results met the requirements.

Embodiment 3

[0057] Dilute the bacterial endotoxin working standard to 0.5EU / ml with bacterial endotoxin test water; dilute fleroxacin for injection with a special diluent for blood preservation solution to a 20mg / ml solution, and then prepare the dilution with bacterial endotoxin test water To 0.08mg / ml to make NPC, use 0.16mg / ml test solution and 1.0 EU / ml endotoxin solution to dilute in equal amount to make PPC. Results: NPC and NC were negative reactions, PPC and PC were positive reactions, and the bacterial endotoxin test results met the requirements.

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Abstract

The invention relates to a method for detecting fleroxacin bacterial endotoxin used for injection, comprising the steps of detecting fleroxacin used for injection by adopting a gel method or a luminous intensity determination method by utilizing tachypleus amebocyte lysate, diluting the fleroxacin used for injection with a bivalent cation solution and then detecting. The method disclosed by the invention is simple to operate, is sensitive and accurate, can eliminate interference and can avoid defects of a pyrogen inspection method, thus the method disclosed by the invention has positive significance to improvement of quality standard, delivery of finished product and safety of clinical use.

Description

technical field [0001] The invention relates to a method for detecting bacterial endotoxin, in particular to a method for detecting bacterial endotoxin of fleroxacin for injection. Background technique [0002] Fleroxacin for injection is an antibacterial drug, and its clinical usage is intravenous infusion. The national standard stipulates that the rabbit method should be used for pyrogen inspection to control its limit, and this variety is not recorded in foreign pharmacopoeias. Rabbit method for checking pyrogens is to inject a certain dose of the test product intravenously into the rabbit body, and observe the temperature rise of the rabbit within a specified period of time to determine whether the limit of pyrogen contained in the test product meets the regulations. Because the pyrogen reaction of rabbits is the same as that of humans, this method is a relatively recognized pyrogen determination method. However, this method is time-consuming and complicated to operate,...

Claims

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Application Information

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IPC IPC(8): G01N33/579
Inventor 王勇刘彤关玉晶王淑君
Owner LIAONING THINKING DECKER MEDICAL TECH
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