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Preparation method of beclometasone dipropionate transparent aqueous phase nano dispersion

A technology of beclomethasone dipropionate and nano-dispersion, which is applied in the direction of non-active ingredient medical preparations, medical preparations containing active ingredients, pharmaceutical formulas, etc. Large diameter and other problems, to achieve the effect of good human body and environment, improved dissolution rate, and simple composition

Inactive Publication Date: 2016-11-02
BEIJING UNIV OF CHEM TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

These methods can nanometerize the drug and increase its dissolution rate, but they also have limitations in their application, such as complex preparation process, large particle size, uneven distribution, containing chemical reagents, causing harm to the human body and the environment, etc.

Method used

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  • Preparation method of beclometasone dipropionate transparent aqueous phase nano dispersion
  • Preparation method of beclometasone dipropionate transparent aqueous phase nano dispersion
  • Preparation method of beclometasone dipropionate transparent aqueous phase nano dispersion

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0036] 1) Weigh 50mg of beclomethasone dipropionate and 50ml of deionized water, and add them to the reaction kettle at the same time;

[0037] 2) Weigh 7.5 mg of polyethylene glycol and dissolve it in 5 ml of deionized water, pour it into a collection beaker, place the beaker containing the aqueous solution in an ice-water bath, control the temperature of the water bath to 18° C., and the stirring rate to 800 rpm.

[0038] 3) After the air tightness test of the experimental device, the temperature of the system is controlled by the heater to rise to 120 ° C, N 2 Through the high-pressure pump into the reaction device and within 5 minutes to raise the pressure of the entire experimental device to 6MPa, adjust the high-pressure pump to keep the pressure of the entire experimental device constant, after the system is stable, turn on the stirring device in the reactor, and adjust the stirring speed to 160r / min, stirring for 20min to make the system reach the dissolution equilibri...

Embodiment 2

[0041] 1) Weigh 50mg of beclomethasone dipropionate and 50ml of deionized water, and add them to the reaction kettle at the same time;

[0042] 2) Weigh 7.5 mg of polyethylene glycol and dissolve it in 5 ml of deionized water, pour it into a collection beaker, place the beaker containing the aqueous solution in an ice-water bath, control the temperature of the water bath to 18° C., and the stirring rate to 800 rpm.

[0043] 3) After the airtightness test of the experimental device, the temperature of the system is controlled by the heater to rise to 140 ° C, N 2 Through the high-pressure pump into the reaction device and within 5 minutes to raise the pressure of the entire experimental device to 6MPa, adjust the high-pressure pump to keep the pressure of the entire experimental device constant, after the system is stable, turn on the stirring device in the reactor, and adjust the stirring speed to 160r / min, stirring for 20min to make the system reach the dissolution equilibriu...

Embodiment 3

[0046] 1) Weigh 50mg of beclomethasone dipropionate and 40ml of deionized water, and add them to the reaction kettle at the same time;

[0047] 2) Weigh 7.5 mg of polyethylene glycol and dissolve it in 5 ml of deionized water, pour it into a collection beaker, place the beaker containing the aqueous solution in an ice-water bath, control the temperature of the water bath to 0° C., and the stirring rate to 800 rpm.

[0048] 3) After the airtightness test of the experimental device, the temperature of the system is controlled by the heater to rise to 140 ° C, N 2 Through the high-pressure pump into the reaction device and within 5 minutes to raise the pressure of the entire experimental device to 6MPa, adjust the high-pressure pump to keep the pressure of the entire experimental device constant, after the system is stable, turn on the stirring device in the reactor, and adjust the stirring speed to 160r / min, stirring for 20min to make the system reach the dissolution equilibrium...

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Abstract

The invention discloses a preparation method of a beclometasone dipropionate transparent aqueous phase nano dispersion. The method comprises the steps of: 1) adding beclometasone dipropionate and water into a reaction kettle simultaneously; 2) dissolving a dispersant into water to prepare an accessory aqueous solution, and controlling the temperature of the aqueous solution at 0-20DEG C; 3) introducing N2 gas into the reaction kettle, adjusting a system temperature value preset temperature, and adjusting the reaction system pressure to a preset pressure; and 4) ejecting the liquid in the reaction kettle rapidly into the accessory aqueous solution to precipitate out beclometasone dipropionate nano particles, thus obtaining the transparent aqueous phase nano dispersion. The invention also discloses a preparation method of the beclometasone dipropionate aqueous phase nano dispersion. The method uses subcritical water anti-solvent technology to prepare the beclometasone dipropionate nano particles, reduces organic solvent consumption, makes the whole process non-toxic and pollution-free, the product has no solvent residue, and the production cost is low, thus achieving good protective effect on the human body and environment.

Description

technical field [0001] The invention relates to the field of medicine and health food preparation, in particular to a method for preparing a transparent aqueous nano-dispersion of beclomethasone dipropionate. Background technique [0002] Beclomethasone dipropionate is a corticosteroid drug with anti-inflammatory effect, and has multiple pharmacological effects such as anti-inflammatory, anti-allergic, and immunosuppressive. In clinical use, beclomethasone dipropionate delivers the active ingredient of the drug to the lungs of patients in the form of aerosol, but beclomethasone dipropionate is a poorly water-soluble compound, which hinders the ability of such compounds to be released in the lungs of patients. Therefore, improving the solubility and bioavailability of beclomethasone dipropionate has always been a hot spot in drug research. [0003] Studies have shown that the change of dissolution rate is a key factor to improve the bioavailability of poorly water-soluble dr...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/00A61K9/14A61K31/573A61K47/34A61K47/40A61K47/32A61K47/38
Inventor 浦源李银华杨晓晨
Owner BEIJING UNIV OF CHEM TECH