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Analysis method for colistimethate sodium

A sodium methanesulfonate and analysis method technology, applied in the field of analysis of the content of each component of polymyxin E sodium methanesulfonate, can solve the problem of unproven colistin, etc., to facilitate standardized operation, and the results are true and effective Effect

Active Publication Date: 2013-07-10
SHANGHAI INST OF PHARMA IND CO LTD +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

(See Li J, MilneRW, Nation RL, et al.Simple Method for Assaying ColistinMethanesulfonate in Plasma and Urine Using High-Performance Liquid Chromatography.ANTIMICROBIAL AGENTS AND CHEMOTHERAPY; 2002,46(10):3304-3307) This method is limited to Lower concentrations of colistin sodium methanesulfonate (0.025 mg / ml) require the presence of plasma for conversion, and complete conversion to colistin has not been demonstrated

Method used

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  • Analysis method for colistimethate sodium
  • Analysis method for colistimethate sodium
  • Analysis method for colistimethate sodium

Examples

Experimental program
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Effect test

Embodiment 1

[0032] Embodiment 1: the preparation of polymyxin E sulfate

[0033] Weigh an appropriate amount of industrial-grade polymyxin E sulfate, add water to dissolve, and make a solution containing 100 mg per 1 ml, and separate it on a chromatographic column. The chromatographic conditions are as follows:

[0034] Chromatography packing: polystyrene / divinylbenzene as the skeleton and bonded phenyl, model NM-100, produced by Suzhou Nano Microbe Technology Co., Ltd.

[0035] Column specification: 45×400mm,

[0036] Column volume (CV): 635.9ml

[0037] Flow rate: 30.0ml / min

[0038] Sample volume: 500ml

[0039] Elution conditions:

[0040] Wash the mobile phase: first wash 10CV with a dilute sulfuric acid solution containing 8% ethanol (adjust the pH of the solution to 2.4 with 0.05mol / L sulfuric acid).

[0041]Eluent: then use 30% ethanol dilute sulfuric acid solution (use 0.05mol / L sulfuric acid to adjust the pH value of the solution to 2.4.) to elute 10CV. The eluate was coll...

Embodiment 2

[0042] Embodiment 2: polymyxin E sulfate 1 and E 2 preparation of

[0043] Weigh an appropriate amount of industrial-grade polymyxin E sulfate, add water to dissolve, and make a solution containing 100 mg per 1 ml, and separate it on a chromatographic column. The chromatographic conditions are as follows:

[0044] Column: C 18 SunFire Prep OBD (10μm); 19×150mm, purchased from WATERS, USA

[0045] Column volume (CV): 42.5ml

[0046] Flow rate: 10.0ml / min

[0047] Elution conditions: 30CV isocratic elution with dilute sulfuric acid solution containing 30% ethanol (use 0.05mol / L sulfuric acid to adjust the pH value of the solution to 2.3.).

[0048] Sample volume: 50ml

[0049] Collection: 10ml / tube

[0050] Analysis and processing of collected samples: analyzed by analytical HPLC (chromatographic conditions refer to the purity determination of polymyxin E in European Pharmacopoeia 5.0), and the combined purity of polymyxin E is above 95%. 1 and E 2 The components are t...

Embodiment 3

[0052] Embodiment 3: the preparation of polymyxin E sodium methanesulfonate

[0053] Weigh 10.0 g of the polymyxin E sulfate prepared by the method in Example 1, add water to dissolve and set the volume to 50 ml, then add 6.2 ml of formaldehyde solution, stir and adjust the pH to 7.0 with 10 mol / L NaOH solution, after maintaining the reaction for 30 min, 28 ml of 40% sodium bisulfite solution was added thereto, and then the pH was adjusted to 7 with NaOH solution, and the reaction was stopped after stirring for 10 h. Get this reaction solution, ultrafiltration to about 20ml with a molecular weight cut-off of 3000 ultrafiltration membrane (the product of U.S. MILLIPORE company, is a cellulose acetate membrane), then add water to about 100ml, then ultrafiltration and concentration to 20ml, so repeated for 5 times, about 15ml of ultrafiltration retentate was obtained. The temperature was controlled at 20-25°C throughout the reaction and ultrafiltration period. The ultrafiltrati...

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Abstract

Belonging to the technical field of pharmaceutical analysis, the invention specifically relates to an analysis method for colistimethate sodium. With simple operation, good reproducibility, high sensitivity and accuracy, as well as easy standardized operation, an analysis method for components of colistimethate sodium, or in other words, a composition analysis method for components of colistimethate sodium is provided. The analysis method is characterized in that: a colistimethate sodium solution is converted to a colistin solution by means of pyrohydrolysis after acidification, and then components of colistin are employed to represent components of colistimethate sodium.

Description

technical field [0001] The invention belongs to the technical field of drug analysis, and in particular relates to an analysis method for the content of each component of polymyxin E sodium methanesulfonate. Background technique [0002] Polymyxin E (colistin) is a polypeptide antibiotic composed of multiple components, mainly composed of E 1 and E 2 Composition (or called A or B). In the 1950s, polymyxin E was used clinically, mainly for infections caused by Gram-negative bacteria, especially multidrug-resistant Pseudomonas aeruginosa (P. aeruginosa), Acinetobacter baumannii (Acinetobacter baumannii) and other infection-causing treatment. There are two types of colistin used clinically, one is polymyxin E sulfate (also known as colistin sulfate) for oral or topical use, and the other is polymyxin E methyl sulfide for injection Sodium (ColistimethateSodium). Both of these drugs are multi-component drugs. In polymyxin E sulfate, it contains E 1 ,E 2 ,E 3 Wait for at l...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N30/06
Inventor 冯军张喜全薛春佳赵伟徐宏江吴勇马宇旋路建光
Owner SHANGHAI INST OF PHARMA IND CO LTD
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