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Liposome preparation device and method for preparing liposome by using same

A system and lipid technology, which is applied in the direction of liposome delivery, making drugs into special physical or taking forms, etc., can solve the difficulty of drug dispersion speed reaching the ideal level, the influence of liposome particle size, lipid Problems such as uneven particle size of plastids, to achieve the effect of excellent preparation reproducibility, narrow particle size distribution, and short production cycle

Inactive Publication Date: 2013-01-23
ARMY MEDICAL UNIV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

When using this method to prepare liposome medicine, if the reaction device is not well controlled to the stirring rate and the drug drop rate, it will cause the dispersion speed of the medicine to be difficult to reach the ideal level, and then the formed liposome particle size is uneven. During clinical treatment, it is difficult for drugs to penetrate tissues through capillaries, and they are only absorbed by the mononuclear phagocyte system in large quantities; at the same time, due to the low solubility of lipids in solvents during the preparation process, the particle size of liposomes is also limited. Influence, when using this method to prepare liposomes on a large scale, the preparation effect is often not good

Method used

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  • Liposome preparation device and method for preparing liposome by using same

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Effect test

Embodiment 1

[0029]With the concentration of ethanol as solvent, lecithin and 100mg / ml cholesterol are mixed with a molar ratio of 1:1, and 500ml is dissolved in 1000ml of ethanol at 46°C to form an organic phase solution, and the organic phase solution Inject into the emulsification bottle 3; 2.5g of the polypeptide drug hepatitis B core antigen HBcAg18-27 is dissolved in 500ml of 50% ethanol at 46°C to form a drug solution with a concentration of 5mg / ml, and the organic The phase solution and the drug solution are mixed in the emulsification bottle 3. While mixing, nitrogen gas with a pressure of 1mpa is passed into the emulsification bottle, and the emulsion is kept at a constant temperature of 46°C for 20mins through the thermostat 4; after 20mins, the nitrogen gas is increased. Pressure, according to the speed of 1ml / s, the emulsification is hydraulically injected into the reactor 6, and 10L of sterilized pharmaceutical water with a temperature of 46°C is added to the reactor 6 in adva...

Embodiment 2

[0032] Mix lecithin with a concentration of 100mg / ml and 100mg / ml cholesterol with ethanol as a solvent in a molar ratio of 1:1, take 500ml and dissolve it in 1000ml of ethanol at 40°C to form an organic phase solution, and dissolve the organic phase solution Inject into emulsifying bottle 3; vitamin B 12 5g is dissolved in 500ml of 50% ethanol at 25°C to form a drug solution with a concentration of 5mg / ml, then the organic phase solution and the drug solution are mixed in the emulsification bottle 3 according to the volume ratio of 2:1, and when mixing, add Inject nitrogen gas with a pressure of 1mpa into the emulsification bottle, and maintain the temperature of the emulsion at 46°C for 20mins through the thermostat 4; after 20mins, increase the nitrogen pressure, and pump the emulsion into the reactor 6 at a speed of 1ml / s. 10L of sterilized pharmaceutical water with a temperature of 46°C was added to the reactor 6 in advance. During the process of injecting the emulsion in...

Embodiment 3

[0035] Mix lecithin with a concentration of 100mg / ml and 100mg / ml cholesterol with ethanol as a solvent in a molar ratio of 1:1, take 500ml and dissolve it in 1000ml of ethanol at 40°C to form an organic phase solution, and dissolve the organic phase solution Inject into the emulsification bottle 3; 2g of insulin is dissolved in 500ml of 50% ethanol at 25°C to form a drug solution with a concentration of 5mg / ml, and then the organic phase solution and the drug solution are mixed in the emulsification bottle according to the volume ratio of 2:1. 3. Mix in 3. While mixing, feed nitrogen gas with a pressure of 1mpa into the emulsification bottle, and keep the emulsified liquid at a constant temperature of 46°C for 20mins through a thermostat; after 20mins, increase the nitrogen pressure at a speed of 1ml / s Put the emulsified fluid into the reactor 6, and add 10L of sterilized pharmaceutical water at a temperature of 46°C to the reactor 6 in advance. During the process of injecting...

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Abstract

The invention discloses a liposome preparation device and a method for preparing a liposome by using the same. The device comprises a nitrogen bottle, an emulsion bottle with a thermostatic device, a reactor, a cyclic heating device for heating the reactor and an ultrafiltration device, wherein the top end of the emulsion bottle is sealed and is provided with a sampling hole; the top end of the reactor is sealed and is provided with an ultrafiltration hole; the nitrogen bottle is communicated with the emulsion bottle; the reactor is communicated with the emulsion bottle through a sampling tube; the sampling tube is positioned in the reactor, and a spray head for laser boring is arranged at the end part at one end of the reactor; an agitating paddle and a numerically controlled speed regulating motor are correspondingly arranged at the top end of the reactor; and an output shaft of the numerically controlled speed regulating motor is fixedly connected with the agitating paddle. The device leads the dispersion speed of lipoid materials to be controlled within the ideal level through controlling the reacted agitating speed and the medicament adding speed, so that the liposome has high medicament encapsulation efficiency, narrow grain size distribution and good clinical application. The method for the preparing the liposome by using the device has the advantages of controllable process and excellent reproducibility.

Description

technical field [0001] The invention relates to the field of liposome preparation, in particular to a liposome preparation device and a liposome preparation method using the device. Background technique [0002] Liposomes are phospholipids and other amphiphilic substances dispersed in water, forming one or more concentric lipid bimolecular membranes and encapsulating them into concentric hollow spherical structures. Liposomes can absorb and carry both water-soluble substances and fat-soluble substances, so both water-soluble drugs and fat-soluble drugs can be used as carriers. Liposomes are non-toxic, and their bilayers have greater similarity and tissue compatibility with biological membranes. Therefore, when they enter the blood circulation through various channels, and then are swallowed by the reticulated intradermal system, the drugs carried That is, it accumulates in tissues and organs rich in phagocytes such as liver, spleen, lung and bone marrow. [0003] Targeting...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61J3/00A61K9/127
Inventor 周伟杨曌吴玉章
Owner ARMY MEDICAL UNIV
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