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Method for detecting bacterial endotoxin of xylitol injection

A technology of bacterial endotoxin and xylitol, which is applied in the direction of material analysis by observing the impact on chemical indicators, and analysis by making materials undergo chemical reactions, etc., can solve the problem that the test results take a long time, are easily contaminated, Problems such as adverse effects of test results

Inactive Publication Date: 2010-06-02
蚌埠丰原涂山制药有限公司
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Problems solved by technology

The gel method is also a method stipulated in the Pharmacopoeia, and the requirements for experimental equipment are low, but this method is a limit determination method, which can only judge whether it is qualified, and whether the bacterial endotoxin in the qualified liquid medicine is at the upper limit level or an extremely low level cannot be determined. Give a judgment; and since the sensitivity review and interference test need to be done newly, it will take a long time to get the test results of the product, and it is easy to be contaminated during the process, which will have a negative impact on the test results

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  • Method for detecting bacterial endotoxin of xylitol injection

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Embodiment 1

[0013] 1 Materials and Instruments

[0014] Bacterial endotoxin national standard product (batch number 200707, specification: 140EU / cart. National Institute for the Control of Pharmaceutical and Biological Products); dynamic turbidity Limulus reagent (batch number: 0807302, produced by Zhanjiang Andus Biological Co., Ltd., specification: λ=0.5EU / bottle; batch number: 08120512, produced by Fuzhou Xinbei Biochemical Industry Co., Ltd.; specification: λ=0.5EU / box); bacterial endotoxin test water (lot number: 0807100, specification: 5mL / box, Zhanjiang Andus Biological Co., Ltd.); 木糖醇注射液(规格:250ml:12.5g,批号:09030161、09030162、09030163,09030191,09030192,09030193;规格:500ml:25g,批号:09030151,09030152,09030153,09030194,09030195,09030196.安徽丰原 Pharmaceutical production); BET-32B Bacterial Endotoxin Tester (Tianjin University Radio Factory).

[0015] 2 Methods and results

[0016] 2.1 Determination of bacterial endotoxin limit according to the formula L=K / M, K is the prescribed route of admi...

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Abstract

The invention relates to a method for detecting bacterial endotoxin of a xylitol injection, which comprises the step of detecting the xylitol injection by using a tal reagent through a dynamic nephelometry, wherein the xylitol injection to be detected is diluted for 2 to 4 times, the pH of the xylitol injection to be detected is adjusted to be between 6.2 and 7.2, and the detection temperature is controlled to be 37.2+ / -0.2 DEG C. The method can overcome the defects of an animal pyrogen test, is time-saving and economical for detecting the bacterial endotoxin, can more quickly and more clearly obtain the actual content of the bacterial endotoxin in the xylitol injection, and has a positive significance for discharging a finished product.

Description

technical field [0001] The invention relates to a method for detecting injection, in particular to a method for detecting bacterial endotoxin in xylitol injection. Background technique [0002] During the production of xylitol injection, according to the provisions of the 2005 edition of the "Chinese Pharmacopoeia", it is necessary to use the rabbit heating method for pyrogen inspection. This method is to inject a certain dose of the test product intravenously into the rabbit body, observe and record the temperature rise of the rabbit within the specified time, so as to determine whether the limit of the pyrogen contained in the test product meets the regulations. The accuracy and consistency of the inspection results depend on the condition of the experimental animals, laboratory conditions and standardization of operations. The sensitivity of the rabbit method to detect endotoxin is 0.001 μg / ml, and the test result is close to the real situation of the human body. It is r...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N21/82
Inventor 张爱文汪君
Owner 蚌埠丰原涂山制药有限公司
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