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Polymyxin E2 composition, and preparation method and application thereof

A technology of colistin and composition, which is applied in the field of polymyxin E2 composition, and can solve the problems of unproven colistin, etc.

Inactive Publication Date: 2011-09-21
SHANGHAI INST OF PHARMA IND +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

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

Method used

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  • Polymyxin E2 composition, and preparation method and application thereof
  • Polymyxin E2 composition, and preparation method and application thereof
  • Polymyxin E2 composition, and preparation method and application thereof

Examples

Experimental program
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Embodiment 1

[0028] Embodiment 1: polymyxin E sulfate 2 Preparation of the composition

[0029] 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:

[0030] Column: C 18 SunFire Prep OBD (10μm); 19×150mm, purchased from WATERS, USA

[0031] Column volume (CV): 42.5ml

[0032] Flow rate: 10.0ml / min

[0033] Elution conditions: Use 30% ethanol-containing dilute sulfuric acid solution (use 0.05mol / L sulfuric acid to adjust the pH of the solution to 2.3.) Isocratic elution for 30CV.

[0034] Sample volume: 50ml

[0035] Collection: 10ml / tube

[0036] Analysis and processing of collected samples: analyzed by analytical HPLC (chromatographic conditions refer to the determination of the purity of polymyxin E in European Pharmacopoeia 5.0), and the combined polymyxin sulfate with a purity of more than 95% 2 The e...

Embodiment 2

[0038] Embodiment 2: polymyxin E sulfate 2 Preparation of the composition

[0039] Weigh an appropriate amount of industrial-grade polymyxin E sulfate, add water to dissolve, and make a solution containing 120 mg per 1 ml, and separate it on a chromatographic column. The chromatographic conditions are as follows:

[0040] Chromatography packing: polystyrene / divinylbenzene as the skeleton and bonded phenyl, model NM-100, produced by Suzhou Nano Microbe Technology Co., Ltd.

[0041] Column specification: 45×400mm,

[0042] Column volume (CV): 635.9ml

[0043] Flow rate: 30.0ml / min

[0044] Elution conditions: first use 25% ethanol sulfuric acid dilute solution (use 0.05mol / L sulfuric acid to adjust the pH value of the solution to 2.3.) to elute 20CV, and then use 30% ethanol sulfuric acid dilute solution (use 0.05mol / L sulfuric acid to Adjust the pH value of the solution to 2.5.) Elution 20CV.

[0045] Sample volume: 500ml

[0046] Collection: 100ml / tube

[0047] Analysis...

Embodiment 3

[0049] Embodiment 3: polymyxin E sulfate 2 Preparation of the composition

[0050] Weigh an appropriate amount of industrial-grade polymyxin E sulfate, add water to dissolve, and make a solution containing 120 mg per 1 ml, and separate it on a chromatographic column. The chromatographic conditions are as follows:

[0051] Chromatography packing: polystyrene / divinylbenzene as the skeleton and bonded phenyl, model NM-100, produced by Suzhou Nano Microbe Technology Co., Ltd.

[0052] Column specification: 25×200cm,

[0053] Column volume (CV): 98.13L

[0054] Flow rate: 200.0ml / min

[0055] Elution conditions: first use 23% ethanol sulfuric acid dilute solution (use 0.05mol / L sulfuric acid to adjust the pH value of the solution to 2.3.) to elute 26CV, and then use 30% ethanol sulfuric acid dilute solution (use 0.05mol / L sulfuric acid to Adjust the pH value of the solution to 2.5.) Elution 25CV.

[0056] Sample volume: 100L

[0057] Detection wavelength: 215nm

[0058] Coll...

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Abstract

The invention belongs to the technical field of medicine, and particularly relates to a polymyxin E2 composition, and a preparation method and application thereof. The composition mainly contains polymyxin E2, and also comprises E1, E3, E1-1, E1-7M0A and the like. The application provided by the invention is the application of the composition in preparation of medicaments for treating gram-negative bacterial infection.

Description

technical field [0001] The invention belongs to the technical field of medicine, in particular to polymyxin E 2 Compositions, and also their preparation methods and uses. 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 (Colistimethate Sodium). Both of these drugs are multi-component drugs. In polymyxin E sulfate, it contains E 1 ,E 2 ,E 3 Wait for at least 5 components (see European Pha...

Claims

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Application Information

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IPC IPC(8): C07K7/62C07K1/20C07K1/34C07K1/14A61K38/12A61P31/04
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
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