A kind of polymyxin e sodium methanesulfonate freeze-dried preparation and preparation method thereof

A technology of sodium methanesulfonate and polymyxin, which is applied in the field of medicine, can solve the problems of large particle size, collapsed appearance of polymyxin E sodium methanesulfonate freeze-dried preparation, and many insoluble particles, and achieves uniform crystal form. , The appearance is full, the effect of easy rehydration

Active Publication Date: 2015-08-05
JIANGSU AOSAIKANG PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The polymyxin E sodium methanesulfonate freeze-dried preparation obtained by the preparation method provided by the invention solves the problems of collapsed appearance, uneven internal structure, more insoluble particles after rehydration and larger particle size

Method used

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  • A kind of polymyxin e sodium methanesulfonate freeze-dried preparation and preparation method thereof
  • A kind of polymyxin e sodium methanesulfonate freeze-dried preparation and preparation method thereof
  • A kind of polymyxin e sodium methanesulfonate freeze-dried preparation and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0037] Sodium polymyxin E methanesulfonate 0.077g

[0038] Add water for injection to make 2ml solution

[0039] Add the prescribed amount of polymyxin E sodium methanesulfonate into the water for injection, stir and dissolve, pass through a 0.22 μm microporous filter membrane for sterile filtration, and fill the filtrate into 10ml vials with 2ml each aseptically, and half-tighten the stopper to the freeze dryer. Control the temperature of the front box of the freeze dryer at -30°C to -35°C, pre-freeze the product to this temperature and maintain it for 2 hours, and at the same time the temperature of the cold trap drops to -60°C; adjust the temperature of the partition to -15°C, when the product rises to this temperature Maintain the temperature for 2 hours; adjust the temperature of the partition to -30°C ~ -35°C again, and maintain it for 1 hour after the product drops to this temperature; turn on the vacuum pump, and then adjust the temperature of the partition to 0°C, wh...

Embodiment 2

[0041] Sodium polymyxin E methanesulfonate 0.155g

[0042] Add water for injection to make 2ml solution

[0043] Add the prescribed amount of polymyxin E sodium methanesulfonate into the water for injection, stir and dissolve, pass through a 0.22 μm microporous filter membrane for sterile filtration, and fill the filtrate into 10ml vials with 2ml each aseptically, and half-tighten the stopper to the freeze dryer. Control the temperature of the front box of the freeze dryer at -40°C to -45°C, pre-freeze the product to this temperature and maintain it for 3 hours, and at the same time the temperature of the cold trap drops to -60°C; adjust the temperature of the partition to -15°C, when the product rises to this temperature Maintain the temperature for 3 hours; adjust the temperature of the partition to -40°C ~ -45°C again, and maintain it for 1 hour after the product drops to this temperature; turn on the vacuum pump, and then adjust the temperature of the partition to 0°C, wh...

Embodiment 3

[0045] Sodium polymyxin E methanesulfonate 0.310g

[0046] Add water for injection to make 2ml solution

[0047] Add the prescribed amount of polymyxin E sodium methanesulfonate into the water for injection, stir and dissolve, pass through a 0.22 μm microporous filter membrane for sterilizing filtration, and the filtrate is aseptically filled in 10ml vials with 2ml each, and half-tightened to the freeze dryer. Control the temperature of the front box of the freeze dryer at -40°C to -45°C, pre-freeze the product to this temperature and maintain it for 3 hours, and at the same time the temperature of the cold trap drops to -60°C; adjust the temperature of the partition to -15°C, when the product rises to this temperature Maintain the temperature for 3 hours; adjust the temperature of the partition to -40°C ~ -45°C again, and maintain it for 2 hours after the product drops to this temperature; turn on the vacuum pump, and then adjust the temperature of the partition to 0°C, when...

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Abstract

The invention provides a freeze-dried preparation employing polymyxin E methanesulfinic acid sodium salt as an active component and a preparation method thereof. The preparation method of the polymyxin E methanesulfinic acid sodium salt includes following steps: adding polymyxin E methanesulfinic acid sodium salt to water, carrying out a stirring and dissolving process to obtain a polymyxin E methanesulfinic acid sodium salt solution, filtering the solution through a microporous filtration membrane to obtain a filtrate, and carrying out a freeze-drying process to obtain the freeze-dried preparation. The polymyxin E methanesulfinic acid sodium salt preparation is plump in appearance, is uniform in crystallization form and is easy to rehydrate. When a bottle of the preparation is rehydrated, the number of insoluble particles, which are not less than 10 [mu]m in particle sizes, is not more than 200.

Description

technical field [0001] The invention belongs to the technical field of medicine, and more specifically relates to a freeze-dried preparation with polymyxin E sodium methanesulfonate as an active ingredient and a preparation method thereof. Background technique [0002] Polymyxin E (polymyxin E) is a basic polypeptide antibiotic produced by the metabolism of Bacillus polymyxin var.colistinus, which has a strong antibacterial effect on Gram-negative bacilli. Polymyxin E, also known as colistin, colistin, Christine, anti-enemy, etc., is a white crystal or crystalline powder mixture containing at least more than 30 different components, the main component of which is polymyxin Mycocin E 1 and polymyxin E 2 , its structure is a decapeptide consisting of a seven-ring and a tripeptide at the end, the fatty acid at the tail is connected to the tripeptide at the end through an amide bond, the seven-ring has a hydrophilic end and a hydrophobic end, and the tripeptide has only a hydr...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K38/12A61K9/19A61P31/04
Inventor 赵小伟王孝雯金雪锋宗在伟
Owner JIANGSU AOSAIKANG PHARMA CO LTD
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