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Polymyxin E composition and preparation method and application thereof

A kind of technology of polymyxin and composition, applied in the field of polymyxin E composition and preparation thereof

Inactive Publication Date: 2011-09-21
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

Unfortunately, although polymyxin E sodium methanesulfonate is also included in these pharmacopoeias, there is no corresponding HPLC method to analyze the composition of the components in the product, and only the silicotungstic acid color method is used to control Colistin E sodium mesylate does not contain polymyxin E

Method used

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  • Polymyxin E composition and preparation method and application thereof
  • Polymyxin E composition and preparation method and application thereof
  • Polymyxin E composition and preparation method and application thereof

Examples

Experimental program
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Effect test

Embodiment 1

[0033] Embodiment 1: the preparation of polymyxin E sulfate

[0034] 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:

[0035] Chromatography packing: polystyrene / divinylbenzene as the skeleton and bonded phenyl, model NM-100, produced by Suzhou Nano Microbe Technology Co., Ltd.

[0036] Column specification: 45×400mm,

[0037] Column volume (CV): 635.9ml

[0038] Flow rate: 30.0ml / min

[0039] Sample volume: 500ml

[0040] Elution conditions:

[0041] Wash the mobile phase: first wash 5CV with dilute sulfuric acid solution containing 8% ethanol (use 0.05mol / L sulfuric acid to adjust the pH value of the solution to 2.4.).

[0042] Eluent: Then use 30% ethanol-containing 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...

Embodiment 2

[0043] Embodiment 2: the preparation of polymyxin E sulfate

[0044] Weigh an appropriate amount of industrial-grade polymyxin E sulfate, add water to dissolve, and make a solution containing 150 mg per 1 ml, and separate it on a chromatographic column. The chromatographic conditions are as follows:

[0045] Column: C 18 SunFire Prep OBD (10μm); 19×150mm, purchased from WATERS, USA

[0046] Column volume (CV): 42.5ml

[0047] Flow rate: 10.0ml / min

[0048] Sample volume: 50ml

[0049] Elution condition:

[0050] Wash the mobile phase: first wash 12CV with dilute sulfuric acid solution containing 6% ethanol (use 0.05mol / L sulfuric acid to adjust the pH value of the solution to 2.0.).

[0051] Eluent: Then use 20% ethanol-containing sulfuric acid dilute solution (use 0.05mol / L sulfuric acid to adjust the pH value of the solution to 2.0.) to elute 12cv. The eluate was collected, and after the ethanol was distilled off under reduced pressure, 2.8 g of polymyxin E sulfate wa...

Embodiment 3

[0052] Embodiment 3: the preparation of polymyxin E sulfate

[0053] 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:

[0054] Chromatography packing: polystyrene / divinylbenzene as the skeleton and bonded phenyl, model NM-100, produced by Suzhou Nano Microbe Technology Co., Ltd.

[0055] Column specification: 25×200cm,

[0056] Column volume (CV): 98.13L

[0057] Flow rate: 200.0ml / min

[0058] Sample volume: 100L

[0059] Elution condition:

[0060] Washing mobile phase: first wash 15CV with dilute sulfuric acid solution containing 5% ethanol (use 0.05mol / L sulfuric acid to adjust the pH value of the solution to 3.0.).

[0061] Eluent: Then use 40% ethanol-containing sulfuric acid dilute solution (use 0.05mol / L sulfuric acid to adjust the pH value of the solution to 3.0.) to elute 15cv. The...

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Abstract

The invention belongs to the technical field of medicines, and in particular relates to a polymyxin E composition and a preparation method and application thereof. In the composition, total content of polymyxins E1, E2, E3, E1-1 and E1-7MOA is more than or equal to 80 percent, wherein the polymyxin E is preferably polymyxin E sulfate or polymyxin E sodium mesylate, and is particularly preferably polymyxin E sodium mesylate. The polymyxin E composition can be used for preparing medicines for treating Gram-negative bacterial infections.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a polymyxin E composition and a preparation method and application thereof. 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 (se...

Claims

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Application Information

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Patent Type & Authority Applications(China)
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 CO LTD
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