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Anti-inflammatory and antiallergic medicine solid dispersoid composition and preparation method thereof

A technology of solid dispersion and composition, which is applied in the direction of drug combinations, anti-inflammatory agents, and pharmaceutical formulations. The effect of utilization

Inactive Publication Date: 2018-08-10
孙金霞
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the melting point of deflazacort is 255-256.5°C. For such a drug with a relatively high melting point, the hot-melt extrusion method will easily lead to thermal decomposition of the drug carrier, thus limiting the wide application of this method.

Method used

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  • Anti-inflammatory and antiallergic medicine solid dispersoid composition and preparation method thereof
  • Anti-inflammatory and antiallergic medicine solid dispersoid composition and preparation method thereof
  • Anti-inflammatory and antiallergic medicine solid dispersoid composition and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0034] A Defucot hot melt extruded solid dispersion was prepared consisting of the following formulation:

[0035]

[0036] Weigh according to the recipe quantity, mix the weighed deflucolate, monoglyceride, magnesium lauryl sulfate, polylactic acid-carboxyacetic acid copolymer with a mixer for 15 minutes, and pass the mixed material through a 50-mesh sieve twice . Set the extrusion temperature of the twin-screw extruder to 100 °C, start the screw after the temperature rises to the set value, add the mixed sieved material to the extruder, raise the temperature to 125 °C to completely melt, and extrude to obtain a strip. thing. The strips are cooled at 25°C, and after cooling, they are subjected to 80-mesh pulverization to obtain drug solid dispersion granules or powders.

Embodiment 2

[0038]

[0039] Weigh according to the recipe quantity, mix the weighed deflucolate, monoglyceride, magnesium lauryl sulfate, polylactic acid-carboxyacetic acid copolymer with a mixer for 15 minutes, and pass the mixed material through a 50-mesh sieve twice . Set the extrusion temperature of the twin-screw extruder to 100 °C, start the screw after the temperature rises to the set value, add the mixed sieved material to the extruder, heat up to 135 °C to completely melt, and extrude to obtain a strip. thing. The strips are cooled at 25°C, and after cooling, they are subjected to 80-mesh pulverization to obtain drug solid dispersion granules or powders.

Embodiment 3

[0041]

[0042] Weigh according to the recipe quantity, mix the weighed deflucolate, monoglyceride, magnesium lauryl sulfate, polylactic acid-carboxyacetic acid copolymer with a mixer for 15 minutes, and pass the mixed material through a 50-mesh sieve twice . Set the extrusion temperature of the twin-screw extruder to 100 °C, start the screw after the temperature rises to the set value, add the mixed sieved material to the extruder, heat up to 130 °C to completely melt, and extrude to obtain a strip. thing. The strips are cooled at 25°C, and after cooling, they are subjected to 80-mesh pulverization to obtain drug solid dispersion granules or powders.

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PUM

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Abstract

The invention relates to the field of pharmaceutical preparations, and particularly discloses an anti-inflammatory and antiallergic medicine solid dispersoid composition and a preparation method of the composition. A solid dispersoid comprises deflazacort, monoglyceride, magnesium laurylsulfate and a polylactic acid-carboxyl acetic acid copolymer. With the adoption of the auxiliary materials, a hot melt extrusion temperature is lowered; an extrusion technology is facilitated; a threaded rod shearing effect with enough intensity can be obtained; in addition, a solubilization effect can be exerted; the hot melt temperature can be reduced to 125-135 DEG C; the energy consumption is reduced; the medicine stability is ensured; a dissolution rate is increased. A preparation technology is simple,low in energy consumption, free from solvent residue and easy for continuous massive production.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to an anti-inflammatory and anti-allergic pharmaceutical solid dispersion composition and a preparation method thereof. Background technique [0002] Deflazacort, the English name is Deflazacort. For a white crystalline powder. Molecular formula: C25H31NO6, the structural formula is as follows: [0003] [0004] Defecort is a corticosteroid and adrenocorticotropic hormone drug. This product has anti-inflammatory and anti-allergic effects, and its effect is 10-20 times that of prednisolone. It is suitable for adrenal insufficiency, autoimmune diseases, allergic diseases and blood system diseases. [0005] Defluke is often administered as an oral preparation. For oral administration, the crystal form and particle size of the drug in the preparation are important factors that affect the bioavailability of the drug, which directly affects the efficacy of the drug. Defl...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/14A61K9/16A61K31/58A61K47/20A61K47/34A61K47/14A61P29/00A61P37/08
CPCA61K9/145A61K9/146A61K9/1617A61K9/1647A61K31/58A61P29/00A61P37/08
Inventor 孙金霞陈莉莉刘志强齐坤坤
Owner 孙金霞
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