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Method for testing bacterial endotoxin of ferric citrate pyrophosphate raw material

A technology of pyrophosphate citric acid and bacterial endotoxin, which is applied in the direction of analyzing materials, measuring devices, instruments, etc., can solve problems such as the difficulty in designing bacterial endotoxin inspection methods, and achieve scientific test methods, broad application prospects, and accurate test results Effect

Inactive Publication Date: 2019-04-12
CHINA OTSUKA PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] Since ferric pyrophosphate citrate raw material is rarely listed in China, and the Chinese Pharmacopoeia 2015 Pharmacopoeia does not include this raw material, it is very difficult to design a method for bacterial endotoxin detection. Therefore, a pyrophosphate is proposed It is very necessary to check the bacterial endotoxin of ferric citrate raw material

Method used

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  • Method for testing bacterial endotoxin of ferric citrate pyrophosphate raw material
  • Method for testing bacterial endotoxin of ferric citrate pyrophosphate raw material
  • Method for testing bacterial endotoxin of ferric citrate pyrophosphate raw material

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Embodiment Construction

[0030] The present invention will be further described below in conjunction with embodiments.

[0031] 1. Test preparation

[0032] 1. Test product: raw material of pyrophosphate iron citrate

[0033] 2. Limulus reagent: Sensitivity: 0.06EU / ml (purchased from Zhanjiang Andus Biological Co., Ltd.)

[0034] 3. Bacterial endotoxin standard product: potency: 10EU / piece (purchased from Zhanjiang Andus Biological Co., Ltd.)

[0035] 4. Bacterial endotoxin test water (purchased from Zhanjiang Andus Biological Co., Ltd.)

[0036] 5. Test equipment (see Table 1 for details)

[0037] Table 1 Test equipment

[0038] equipment name

factory

Lot number / model

Test tube thermostat

Zhanjiang Andus

TAL-40C

Vortex mixer

Shanghai Medical University

XW-80A

High temperature oven

YAMATO

DKN612C

Precision pipette

Shanghai refinement

Specification: 50μl~250μl

Electronic balance

METTLER

PR502

[0039] 2. Establishment of test method

[0040] 1. Preparation of solution series

[0041] 1.1 Pre...

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Abstract

The invention discloses a method for testing bacterial endotoxin of a ferric citrate pyrophosphate raw material, comprising the following steps of: preparing the ferric citrate pyrophosphate raw material into a sample solution S having a concentration of 0.6 g / 10 ml by using bacterial endotoxin test water; diluting the sample solution S 40 times with the bacterial endotoxin test water, that is, solution A (S40); performing a bacterial endotoxin test with a TAL (Tachypleus Amebocyte Lysate) having sensitivity of 0.06 EU / ml; keeping warm for 60+ / -2 minutes in a 37+ / -1 DEG C tube thermostat; andgently removing a test tube from the thermostat and slowly reversing by 180 degree. If an in-tube gel does not deform and slip off a tube wall, it is positive. If the in-tube gel does not remain intact and slips off the wall, it is negative. The test method of the invention is scientific, has an accurate test result, fills the blank of the method for testing bacterial endotoxin of the ferric citrate pyrophosphate raw material, and has broad application prospect.

Description

Technical field [0001] The invention relates to a biological substance of the limulus lysate, in particular to a method for checking bacterial endotoxins as a raw material of iron pyrophosphate citrate. Background technique [0002] Ferric citrate pyrophosphate is used as an iron replacement product to help maintain hemoglobin in patients with chronic kidney disease who are dependent on dialysis. In November 2014, the FDA Oncology Drug Advisory Committee voted that the benefits of ferric citrate pyrophosphate outweighed its risks and recommended full approval of this drug, which is designed to deliver iron to the bone marrow of dialysis patients non-invasively. [0003] With the development of the pharmaceutical industry and the advancement of science and technology, people have discovered a complex of lipopolysaccharide and protein on the cell wall of gram-negative bacteria-bacterial endotoxin. Its particularity is not bacteria. Or a metabolite of bacteria, but a substance with e...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N33/579
CPCG01N33/579
Inventor 孙毅
Owner CHINA OTSUKA PHARM CO LTD
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