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Polymyxin E liposome as well as preparation method and application thereof

A technology of polymyxin and polymyxin sulfate, which is applied in the field of biomedicine, can solve the problems of long half-life, unstable polymyxin E nano dosage form, no good slow and controlled release property, etc., and achieves good structural stability. long-lasting effect

Pending Publication Date: 2020-04-10
SHANGHAI JINGFENG PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] However, the existing polymyxin E nano dosage forms are unstable, and do not have good sustained and controlled release and long half-life. Therefore, a new type of polymyxin E with better structural stability, sustained release and Longer half-life liposomes of colistin are of great interest

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0049] The present embodiment provides a polymyxin E liposome, the components of the polymyxin E liposome include 2 parts of polymyxin sulfate, 10 parts of DSPG, and 5 parts of HSPC in parts by weight , 10 parts of cholesterol, 0.1 part of antioxidant (tocopherol), 30 parts of sucrose, 20 parts of mannitol and 10 parts of disodium succinate.

[0050] Its preparation method is:

[0051] (1) Mix and dissolve HSPC, cholesterol, antioxidant and chloroform at 40°C according to the formula to obtain the first mixed solution;

[0052] (2) Mix and dissolve DSPG, polymyxin E sulfate and chloroform at 40°C according to the formula to obtain the second mixed solution;

[0053] (3) mixing the first mixed solution and the second mixed solution obtained in step (1) and step (2), performing ultrasonic emulsification, and removing the solvent by vacuum evaporation to form a lipid film;

[0054] (4) hydrating the lipid film obtained in step (3) at 60° C. with an aqueous solution containing h...

Embodiment 2

[0058] The present embodiment provides a kind of polymyxin E liposome, and the component of described polymyxin E liposome comprises polymyxin E sulfate 3 parts, DPPC 15 parts, DSPC 10 parts by weight , 5 parts of cholesterol, 0.2 parts of antioxidant (tocopherol), 100 parts of trehalose, 50 parts of lactose and 5 parts of sodium dihydrogen phosphate.

[0059] Its preparation method is:

[0060] (1) Mix and dissolve DSPC, cholesterol, antioxidants and solvents (miscible with ethanol and chloroform) at 60°C according to the formula to obtain the first mixed solution;

[0061] (2) Mix and dissolve DPPC, polymyxin E sulfate and solvent (miscible with ethanol and chloroform) at 60°C according to the formula to obtain the second mixed solution;

[0062] (3) mixing the first mixed solution and the second mixed solution obtained in step (1) and step (2), emulsifying with a high-speed shear, removing the solvent by rotary evaporation, and forming a lipid film;

[0063] (4) hydrating...

Embodiment 3

[0067] The present embodiment provides a kind of polymyxin E liposome, and the component of described polymyxin E liposome comprises 1 part of polymyxin sulfate E, 5 parts of DPPC, 5 parts of EPC, 5 parts of cholesterol, 0.5 parts of antioxidant (tocopherol), 50 parts of trehalose, 20 parts of mannitol and 5 parts of disodium succinate.

[0068] Its preparation method is:

[0069] (1) Mix and dissolve EPC, cholesterol, antioxidant and solvent (miscible with methanol and chloroform) at 50°C according to the formula to obtain the first mixed solution;

[0070] (2) Mix and dissolve DPPC, polymyxin sulfate and solvent (miscible with methanol and chloroform) at 50°C according to the formula to obtain the second mixed solution;

[0071] (3) mixing the first mixed solution and the second mixed solution obtained in step (1) and step (2), emulsifying with a high-speed shear machine, and removing the solvent by spray drying to form a lipid powder;

[0072] (4) hydrating the lipid powd...

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PUM

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Abstract

The invention relates to a polymyxin E liposome. The polymyxin E liposome comprises the following components: polymyxin E sulfate, first-class phospholipid, second-class phospholipid, cholesterol, anantioxidant, an excipient and a buffer agent. Different from other phospholipid complex products, the polymyxin E liposome provided by the invention has the following advantages: the microstructure ofthe polymyxin E liposome is that a drug is embedded into a phospholipid bilayer of the liposome and the drug and phospholipid are not simply compounded, so the polymyxin E liposome has better structural stability, slow release property and a longer half-life period.

Description

technical field [0001] The invention belongs to the technical field of biomedicine, and in particular relates to a polymyxin E liposome and a preparation method and application thereof. Background technique [0002] Polymyxin E is a group of polypeptide antibiotics produced by Bacillus polymyxa. Its sulfate salt is commonly used. It is a white crystalline powder, easily soluble in water, hygroscopic, stable in acidic solution, and its neutral solution is at room temperature. Standing for a week does not affect the potency, and the alkaline solution is unstable. It has antibacterial effect on Gram-negative bacteria such as Pseudomonas aeruginosa, Escherichia coli, Klebsiella pneumoniae, Haemophilus, Enterobacter, Salmonella, Shigella, pertussis, Pasteurella and Vibrio. Proteus, Neisseria, Serratia, Providencia, Gram-negative bacteria and obligate anaerobic bacteria are not sensitive to this class of drugs. Bacteria have cross-resistance to this product and polymyxin E, but ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K38/12A61K9/127A61K47/24A61P31/04
CPCA61K38/12A61K9/1277A61K47/24A61P31/04
Inventor 吴柯棣刘君梁艳平徐阳
Owner SHANGHAI JINGFENG PHARMA
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