Method for preparing ibuprofen with large crystal form

A technology of crystal form and seed crystal, which is applied in the field of large crystal form preparation of ibuprofen, can solve problems such as no method for preparing large particle size crystal form, and achieve the effect of simple processing method, good fluidity and uniform particles

Active Publication Date: 2012-01-18
HUBEI BIOCAUSE HEILEN PHARM CO LTD
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AI Technical Summary

Problems solved by technology

Existing existing reports are most all the recrystallization process in the preparation process of ibuprofen, promptly utilize the principle that the solubility of ibuprofen in solvents such as ethanol aqueous solution or acetic acid aqueous solution or sherwood oil, n-hexane changes greatly with temperature, adopts The method of direct cooling crystallization, for example, the ibuprofen crude product is heated and dissolved with about 70% ethanol aqueous solution (or sherwood oil), activated carbon decolorizes, then cools down to about 0 ℃ and crystallizes, filters, and obtains the ibuprofen product (see CN92106667. 8; State Administration of Medicine "National Material Drug Technology Compilation" 1980); In CN200310114695.8, the preparation technology of ibuprofen microcrystalline product has been introduced, and its crystallization process is that the higher ibuprofen solution of temperature is added to t

Method used

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Examples

Experimental program
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Effect test

Example Embodiment

[0011] In a 2000L stainless steel crystallization kettle, add 400kg of ibuprofen, add 800kg of 65% ethanol, heat to 65℃, stir to dissolve, clarify, filter, slowly lower the temperature to 38℃, and put 8kg of ibuprofen seed crystal with a particle size of 60-90μm , Stir well, keep it warm for 40 minutes, then under slow stirring, cool down every 30 minutes, each time the temperature is 1-2℃, after cooling to 30℃, fully open the ice salt water in the jacket of the crystallization kettle, cooling to 5℃ Following centrifugal filtration and drying at 60-65°C, a large crystalline ibuprofen product with a crystal particle size of 250-450 μm and an intermediate particle size of about 300 μm is obtained.

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Abstract

A method for preparing ibuprofen with a large crystal form comprises the following steps: dissolving ibuprofen in an organic solvent, heating to 60-70 DEG C, stirring for dissolution, filtering, slowly cooling the filtrate to 36-39 DEG C, adding crystal seed, performing heat preservation for 30-50 min, slowing cooling to 30 DEG C with a program, cooling to -5 DEG C-5 DEG C, performing centrifugalfiltration, drying at 60-65 DEG C to obtain an ibuprofen product with a large particle size. The invention has the following advantages: the processing method is simple; large crystals with an average particle size of 250-450 microns can be obtained by dissolving ibuprofen in a solvent and controlling the crystallization conditions; the product has high purity, good fluidity, and uniform particles.

Description

technical field [0001] The invention relates to the field of pharmaceutical processing methods, in particular to a method for preparing a large crystal form of ibuprofen. Background technique [0002] Ibuprofen, whose chemical name is 2-(4-isobutylphenyl) propionic acid, is a non-steroidal antipyretic analgesic of aryl propionic acid, which has been clinically used for many years at home and abroad, and is widely used in the treatment of Rheumatoid arthritis, osteoarthritis, gouty arthritis, rheumatoid arthritis and other chronic arthritis, as well as the treatment of non-articular pain, fever, etc. It has the advantages of definite curative effect and low toxic and side effects. Since the 1980s, the drug has been included in the pharmacopoeias of the United States, the United Kingdom, the European Union, and Japan, and has been accepted by doctors and patients internationally. Various preparations of ibuprofen have entered the OTC drug range in almost all countries in the w...

Claims

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Application Information

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IPC IPC(8): C07C57/30C07C51/43
Inventor 雷小刚李立威关宏录徐吉会曹晓燕
Owner HUBEI BIOCAUSE HEILEN PHARM CO LTD
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