Method for detecting bacterial endotoxin in citric acid raw material

A bacterial endotoxin and detection method technology, applied in the field of microbial detection, can solve the problems of inaccurate detection of bacterial endotoxin content, etc., and achieve the effects of high specificity, strong reproducibility, accuracy and sensitivity

Inactive Publication Date: 2014-12-24
CHINA OTSUKA PHARM CO LTD
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Problems solved by technology

[0005] As a new pharmaceutical raw material, citric acid cannot accurately detec

Method used

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  • Method for detecting bacterial endotoxin in citric acid raw material
  • Method for detecting bacterial endotoxin in citric acid raw material

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Experimental program
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preparation example Construction

[0027] Step 1, preparation of test solution

[0028] Take 50 mg of citric acid raw material and add it to a test tube, add 10 ml of water for bacterial endotoxin testing, and oscillate until the raw material is fully dissolved, which is the sample solution; dilute the sample solution 10 times with water for bacterial endotoxin testing to generate S 10 solution; then use Na 2 HPO 4 solution will be S 10 The solution is diluted 2 times to generate S 20 solution; diluted S 20 Solution is as need testing solution, i.e. solution A;

[0029] Step 2, preparation of three groups of control solutions

[0030] Prepare the test solution and the bacterial endotoxin standard product into endotoxin solutions containing bacterial endotoxin concentrations of 2.0λ, 1.0λ, 0.5λ, and 0.25λ, respectively, as solution B; each concentration is prepared in parallel with 4 tubes;

[0031] Prepare endotoxin solutions containing bacterial endotoxin concentrations of 2.0λ, 1.0λ, 0.5λ, and 0.25λ wit...

Embodiment 1

[0038] At present, the bacterial endotoxin inspection of raw materials is mainly carried out with reference to the standards of the "Chinese Pharmacopoeia". The raw materials of citric acid are not recorded in the Chinese Pharmacopoeia. The bacterial endotoxin limit value of citric acid raw material in "British Pharmacopoeia": L<0.5EU / mg. Establish internal control standards for citric acid raw materials, set the bacterial endotoxin limits as L<0.25EU / mg and L<0.125EU / mg respectively, and compare the test results.

[0039] Because citric acid is slightly acidic, it is necessary to use pyrogen-free sodium carbonate to weaken its acidity so that the pH value of the test solution is between 6.0-8.0 to meet the requirements of the bacterial endotoxin test method. Considering that pyrogen-free sodium carbonate may affect the test results, NA2HPO4 and pyrogen-free sodium carbonate were selected for the test at the same time, and the test results were compared. Na 2 HPO 4 The sol...

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Abstract

The invention discloses a method for detecting bacterial endotoxin in a citric acid raw material. The method comprises the following steps of firstly carrying out interference test to determine the sensitivity of tachypleus amebocyte lysate selected to detect the bacterial endotoxin in the citric acid raw material; and then diluting the to-be-detected citric acid raw material to prepare a to-be-detected solution, adding the tachypleus amebocyte lysate determined in the interference test and detecting the bacterial endotoxin. By virtue of the method for detecting bacterial endotoxin in the citric acid raw material, which is disclosed by the invention, the problem of detection of the bacterial endotoxin in the citric acid raw material for a newly developed injection product is solved; the quality of a sterile product is controlled at the source and the method is of great significance for ensuring the safety of the injection product. Since the method has a theoretical basis of biochemistry, the method is more scientific; molecular and biochemical reactions of an enzyme are applied and the method has the advantages of high specificity, strong reproducibility, high accuracy and sensitivity, no need of special instrument and equipment and strong practicability and is simple and quick to operate.

Description

technical field [0001] The invention belongs to the technical field of microorganism detection, and relates to a method for detecting bacterial endotoxin in citric acid raw materials. Background technique [0002] Infusion products are necessary basic medicines for daily use in hospitals. At present, the domestic infusion solution market is in a price war, and product upgrading is the key. The raw materials used in product upgrading must be strictly controlled to ensure product quality. Bacterial endotoxin is one of the control items. [0003] Bacterial endotoxin is the main representative substance of pyrogen. Pyrogen reaction occurs when pyrogen is injected into the human body. Pyrogen reaction brings great harm to clinical treatment. Generally, within a few minutes to one hour after pyrogen enters the human body, high fever symptoms will appear, and severe reactions may cause death, so it must be strictly controlled. [0004] The traditional pyrogen inspection is usua...

Claims

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Application Information

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IPC IPC(8): C12Q1/56
Inventor 陈莹孙毅金丽武晓飞
Owner CHINA OTSUKA PHARM CO LTD
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