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Method adopting supercritical CO2 fluid technology to produce water-soluble medicine controlled-release particles

A technology of water-soluble drugs and fluid technology, which is applied in the field of preparation of drug dosage forms, can solve the problems of inability to prepare water-soluble drug sustained-release particles, and achieve the effects of high drug activity retention, low toxicity, and no solvent residue

Inactive Publication Date: 2012-01-25
SICHUAN UNIV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] The purpose of the present invention is to provide a new method for preparing pharmaceutical preparations, which solves the disadvantage that traditional supercritical fluid technology cannot prepare water-soluble drug sustained-release particles

Method used

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  • Method adopting supercritical CO2 fluid technology to produce water-soluble medicine controlled-release particles
  • Method adopting supercritical CO2 fluid technology to produce water-soluble medicine controlled-release particles
  • Method adopting supercritical CO2 fluid technology to produce water-soluble medicine controlled-release particles

Examples

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Effect test

example 1

[0015] Example 1 Preparation of morphine-polylactic acid drug-loaded microspheres

[0016] (1) Take 4ml of Morphine Hydrochloride Injection 10mg / ml, dilute to 24ml with distilled water, and put it in a brown bottle for later use. Weigh 300 mg of poly-L-lactic acid with a molecular weight of 100 KDa, add 60 ml of organic solvent into the reaction flask, and stir to dissolve at room temperature. Prepare pure ethanol for analysis.

[0017] (2) Assemble the high-pressure reactor, turn on the supercritical fine particle device, start the refrigeration system, set the reaction temperature to 33°C, the pressure to 12MPa, CO 2 The pump flow rate is 300ml / min. Turn on the high-pressure plunger pump, constant temperature water bath box and blast drying oven to increase the pressure and temperature of the reaction kettle. Adjust the vent valve and the temperature control switch to keep the temperature and pressure of the reactor constant at the set value.

[0018] (3) Turn on the eth...

example 2

[0023] Example 2 Preparation of bovine serum albumin polylactic acid drug-loaded microspheres

[0024] (1) Weigh 20mg of bovine serum albumin (BSA) and dissolve it in 12ml of distilled water. Weigh 300mg of poly-L-lactic acid (PLLA) with a molecular weight of 10KDa, add 60ml of organic solvent into the reaction flask, and stir to dissolve at room temperature. Prepare pure ethanol for analysis.

[0025] (2) Assemble the high-pressure reactor, turn on the supercritical fine particle device, start the refrigeration system, set the reaction temperature to 33°C, the pressure to 12MPa, CO 2 The pump flow rate is 300ml / min. Turn on the high-pressure plunger pump, constant temperature water bath box and blast drying oven to increase the pressure and temperature of the reaction kettle. Adjust the vent valve and the temperature control switch to keep the temperature and pressure of the reactor constant at the set value.

[0026] (3) Turn on the ethanol pump, set the flow rate to 1ml...

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Abstract

The invention relates to a method adopting a supercritical CO2 fluid technology to produce water-soluble medicine controlled-release particles, which belongs to the technical field of the novel preparation method and application of pharmaceutical dosage form variation. The traditional microsphere preparation method cannot keep the bioactivity of medicine, the supercritical anti-solvent technique is mild and safe, but is limited because the supercritical CO2 is difficult to be mixed with the polar solvent. In the invention, a mixer which is specially designed is adopted to mix the supercritical CO2 and ethanol, so the water blending performance is increased; and a triple-channel coaxial nozzle is adopted, the medicine aqueous solution, macromolecule carrier organic solution and ethanol are mixed with the supercritical CO2 to be simultaneously sprayed into a reactor through the inner layer of channel, the intermediate layer of channel and the outer layer of channel of the nozzle, extraction and separation are completed in one step, so medicine controlled-release particles are prepared. The method has mild conditions, the retentivity degree of the medicine activity is high, the residual amount of the organic solvent is low, and the operation is simple. The produced microspheres are smooth and spherical, have the particle size of 1-5mum, and the particle size distribution is narrow. The invention has application prospect in preparing water-soluble controlled-release microspheres.

Description

technical field [0001] The invention belongs to the field of new preparation method and application technology for changing pharmaceutical dosage forms, and in particular relates to improving the traditional supercritical fluid technology and adopting new technologies and methods to change the dosage forms of existing medicines. Background technique [0002] Due to the high development of biotechnology, water-soluble drugs such as proteins and polypeptides have been successfully applied to the field where the curative effect of chemical drugs is not significant due to their strong biological activity, relatively low cost, and specific action targets. Research hotspots. However, most protein and polypeptide drugs have shortcomings such as short half-life, certain immunogenicity, and large toxic and side effects. The drug controlled release system can reduce the toxic and side effects of drugs and improve the bioavailability of drugs by maintaining the blood drug concentratio...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61J3/02
Inventor 尹光福张严之廖晓明
Owner SICHUAN UNIV
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