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Method for checking bacterial endotoxin in Shenxiong glucose injection

A technology of ginseng glucose and bacterial endotoxin, which is applied in the field of bacterial endotoxin inspection, can solve the problems of cumbersome and time-consuming operation, cannot use quality monitoring, etc., and achieves the effects of reducing inspection cost, facilitating production process monitoring and inspection work, and detecting accurate detection.

Inactive Publication Date: 2012-10-10
GUIZHOU JINGFENG INJECTION
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  • Abstract
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  • Claims
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Problems solved by technology

[0003] Shenxiong Glucose Injection is included in the 12th volume of National Standards of National Drug Standards for Chemical Drugs. The original quality standard pyrogen test method is the rabbit method, and the accuracy and consistency of the test results of the rabbit method depend on the condition of the experimental animals, so There are strict requirements on the breeding environment, testing conditions and operators of raising rabbits. The operation is cumbersome and time-consuming, and it cannot be used for quality control in the production process.

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  • Method for checking bacterial endotoxin in Shenxiong glucose injection
  • Method for checking bacterial endotoxin in Shenxiong glucose injection
  • Method for checking bacterial endotoxin in Shenxiong glucose injection

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Embodiment Construction

[0016] 1. Experimental materials and instruments

[0017] Limulus reagent (TAL): Zhanjiang Bokang Marine Biological Co., Ltd., specification: 0.1mL, batch number: 1012020, sensitivity: 0.25EU·mL -1 ; Zhanjiang Andus Biological Co., Ltd., specification: 0.1mL, batch number: 1101181, sensitivity: 0.25EU·mL -1 .

[0018] Bacterial endotoxin working standard (WSE): China Institute for the Control of Pharmaceutical and Biological Products, potency: 120EU / bottle, batch number: 150601-201072.

[0019] Bacterial endotoxin test water (BET): China Institute for the Control of Pharmaceutical and Biological Products, specification: 10mL, batch number: 2008-04.

[0020] Shenxiong Glucose Injection: Guizhou Jingfeng Injection Co., Ltd., specification 100mL, batch number: 1, 2, 3.

[0021] Instruments: electric drying oven, ET-96 bacterial endotoxin gel tester, vortex mixer, micropipette, pyrogen-free tip, test tube, test tube rack, 75% alcohol cotton ball, parafilm, scissors, grinding wh...

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Abstract

The invention discloses a method for checking bacterial endotoxin in Shenxiong glucose injection, which comprises the following steps: (1) determining the limit value (L) of the bacterial endotoxin in the Shenxiong glucose injection; (2) rechecking the sensitivity of tachypleus amebocyte lysate; (3) carrying out preliminary test of an interference test, i.e. determining the minimum noninterference dilution factor of the Shenxiong glucose injection; (4) carrying out official interference test; and (5) detecting the bacterial endotoxin of a provided sample. When the method disclosed by the invention is utilized to check the bacterial endotoxin in the Shenxiong glucose injection, the method is rapid and sensitive, the detection time is greatly shortened, the detection cost is reduced and the method is particularly suitable to carry out detection work in a laboratory.

Description

Technical field: [0001] The invention relates to Shenxiong Glucose Injection, in particular to a bacterial endotoxin inspection method for Shenxiong Glucose Injection. Background technique: [0002] Shenxiong Glucose Injection has the effects of anti-platelet aggregation, dilating arteries, reducing blood viscosity, improving microcirculation, and improving myocardial blood supply and oxygen supply. It is a commonly used clinical drug. [0003] Shenxiong Glucose Injection is included in the 12th volume of National Standards of National Drug Standards for Chemical Drugs. The original quality standard pyrogen test method is the rabbit method, and the accuracy and consistency of the test results of the rabbit method depend on the condition of the experimental animals, so There are strict requirements on the breeding environment, testing conditions and operators for raising rabbits. The operation is cumbersome and time-consuming, and it cannot be used for quality control in the ...

Claims

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Application Information

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IPC IPC(8): G01N33/15
Inventor 叶湘武毕昌琼周光羽左红雨
Owner GUIZHOU JINGFENG INJECTION
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