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Preparation of superfine prednisolone powder

A technology of prednisolone and powder, which is applied in the field of drug micronization, can solve the problems of complex and unstable operating equipment, and achieve the effects of reducing settling time, increasing driving force and reducing requirements

Inactive Publication Date: 2007-08-15
BEIJING UNIV OF CHEM TECH +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Although this method can control the size of the particles very well, the size of the obtained particles is 1-5 μm, but the operating equipment is relatively complicated, and the product is unstable in water

Method used

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  • Preparation of superfine prednisolone powder
  • Preparation of superfine prednisolone powder
  • Preparation of superfine prednisolone powder

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0033] Take prednisolone crude drug 5.2g, dissolve and prepare clear prednisolone solution with 5ml N-methylpyrrolidone. Prepare 500ml of deionized water in a 1000ml beaker. Place the beaker containing the 500ml anti-solvent solution under the emulsifier at a speed of 10000rpm, then inject the above-mentioned solution containing 5.2g of prednisolone into the stirring anti-solvent, and the two solutions are mixed very quickly and efficiently to produce Precipitation and crystallization generate white prednisolone precipitates, and the obtained slurry is filtered, washed, and dried to obtain prednisolone granules. In operation, the volume ratio of prednisolone drug solution to aqueous solution is about 1:100, and when the precipitation temperature is 2 or 30°C, the morphology and particle size obtained by the two temperatures are basically the same, that is, the length is 5-20 μm, and the width is 2- 3μm rod-shaped particles, as shown in Figure 3.

Embodiment 2

[0035] Take prednisolone crude drug 5.2g, dissolve and prepare clear prednisolone solution with 5ml N-methylpyrrolidone. Prepare 500ml of 0.2wt% hydroxypropyl methylcellulose aqueous solution in a 1000ml beaker. Place the beaker containing the 500ml anti-solvent solution under the emulsifier at a speed of 10000rpm, then inject the above-mentioned solution containing 5.2g of prednisolone into the stirring anti-solvent, and the two solutions are mixed very quickly and efficiently to produce Precipitation and crystallization generate white prednisolone precipitates, and the obtained slurry is filtered, washed, and dried to obtain prednisolone granules. In operation, the volume ratio of prednisolone drug solution and 0.2wt% hydroxypropyl methylcellulose aqueous solution is about 1: 100, and when precipitation temperature is 14 ℃, what obtain is approximate hexagonal flake particle; At 4°C, approximately quadrilateral particles are obtained. Its average particle size is about 2 μ...

Embodiment 3

[0037] Take prednisolone crude drug 2g, dissolve and prepare clear prednisolone solution with 5ml dimethyl sulfoxide. Prepare 200ml of 0.25wt% hydroxypropylcellulose aqueous solution in a 500ml beaker. Place the beaker containing the 500ml anti-solvent solution under the emulsifier at a speed of 10000rpm, then inject the above solution containing 2g of prednisolone into the stirring anti-solvent, the two solutions are mixed very quickly and efficiently and precipitate Crystallization produces white prednisolone precipitates, and the resulting slurry is filtered, washed, and dried to obtain prednisolone granules. In operation, the volume ratio of prednisolone drug solution and 0.25wt% hydroxypropyl cellulose aqueous solution is about 1: 40, and when precipitation temperature is 14 ℃, what obtain is hexagonal sheet-shaped particle; Precipitation temperature is 4 ℃ When , quadrilateral particles are obtained. Its average particle size is about 3 μm, and at least 90% of the part...

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Abstract

This invention relates to a method for preparing superfine prednisolone powder, and belongs to the field of micronization. Open question at present: particle diameter of prednisolone is small but can not obtain dry powder, or the dry powder has wide size distribution, bad redispersibility, and instability in water. The invention is to realize the preparation of prednisolone granule with controllable particle diameter, narrow particle size distribution, and superfine or nano-graded quadrilate and hexagon through inverse solvent recrystallization.the prednisolone of the invention has the advantages of controllable particle diameter, narrow particle size distribution, good redispersibility, stable micropowder, and good dissolving effect; and has prodigious dominance in the development of drug effect and new medicament form.

Description

technical field [0001] The invention relates to a method for preparing prednisolone from a prednisolone-containing crude drug solution, in particular using its filtrate as an anti-solvent to prepare two kinds of quadrilateral flakes and hexagonal flakes with narrow particle size distribution and controllable average particle diameter. The invention relates to a method for superfine prednisolone powders with different shapes, belonging to the field of medicine micronization. Background technique [0002] Prednisolone, namely 11β, 17α, 21-trihydroxypregna-1,4-diene-3,20-dione, has the following structural formula: [0003] [0004] Prednisolone is a very slightly water-soluble adrenal cortex hormone. Due to its good anti-inflammatory effect, it is widely used for arthritis, colitis, asthma, bronchitis, skin rashes, and inflammation and allergies of the nose and eyes In the disease, the main dosage forms are tablet and suspension (the main ingredient of commercially availab...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/57A61K9/14A61K47/38A61P1/00A61P11/00A61P11/02A61P11/06A61P17/00A61P27/02A61P29/00A61P37/08C07J7/00B01D9/02
Inventor 陈建峰李湘山王洁欣沈志刚甄崇礼
Owner BEIJING UNIV OF CHEM TECH
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