Process for producing ibuprofen microcrystal

A process and product technology, applied in the field of preparation technology of ibuprofen microcrystalline products, to achieve the effect of narrow particle size distribution

Active Publication Date: 2005-07-06
SHANDONG XINHUA PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0002] At present, there is no report on the preparation of microcrystalline products of ibuprofen, and the existing ones are all ibuprofen crystallization preparation processes, which utilize the solubility of ibuprofen in ethanol-water mixed solution or sherwood oil, hexane and other solvents to change with temperature The larger principle is to adopt the method of cooling crystallization to heat and dissolve the crude product of ibuprofen with about 60% (v / v) ethanol (or petroleum ether), decolorize it, then cool it down to about 0°C, and carry out recrystallization (see Chinese medicine "Technology of Organic Synthetic Drugs" by Industrial Corporation, 1981, October; "National Compilation of Raw Materials Technology" by the State Administration of Pharmaceutical Sciences, 1980)

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0013] Use a 250ml reaction bottle to add crude ibuprofen (reduced to pure 120g), then add 110ml85% (v / v) ethanol, stir and heat up to 60°C-70°C, make it dissolve, then add activated carbon for decolorization, filter; then use 30ml85% (v / v) wash with ethanol, combine the filtrate and washing solution, cool down to 30°C for later use.

[0014] Add 120ml of 40% (v / v) ethanol in another 250ml reaction bottle, cool down to -5°C, add a small amount of ibuprofen seed crystals, then quickly add the spare ibuprofen solution at 30°C, then stir for half an hour; Raise the temperature to about 25°C, keep it warm for 40 minutes, cool down to 0°C, filter and dry to obtain the finished product.

Embodiment 2

[0016] Use a 250ml reaction bottle to add crude ibuprofen (120g in pure form), then add 150ml of petroleum ether, heat to 50°C-60°C to make the solution transparent, cool down to 40°C for later use.

[0017] Add 120ml of petroleum ether into another 250ml reaction bottle, cool down to -3°C, add a small amount of ibuprofen seed crystals, then quickly add the spare ibuprofen solution at 40°C, then stir for half an hour; then raise the temperature to about 25°C , keep warm for 40 minutes, then cool down to 0°C, filter and dry to obtain the finished product.

Embodiment 3

[0019] Use a 250ml reaction bottle to add the ibuprofen crude product (reduced to pure 120g), then add 85ml85% (v / v) ethanol, stir and heat up to 60°C-70°C, make it dissolve, then add activated carbon for decolorization, filter; then use 23ml85% (v / v) wash with ethanol, combine the filtrate and washing solution, and keep warm at 60°C for later use.

[0020] Add 180ml of 40% (v / v) ethanol in another 250ml reaction flask, cool to 0°C, add a small amount of ibuprofen seed crystals, then quickly add the spare ibuprofen solution at 60°C, then stir for half an hour, and cool down to 0°C, filter and dry to obtain the finished product. ]

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PUM

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Abstract

The invention relates to a process for preparing microcrystalline medicine, especially preparation process of ibuprofen microcrystalline product. Solving the crude ibuprofen in solvent, such as alcohol solution, petroleum ether, hexane and so on, to produce solution with higher temperature; then putting the ibuprofen into the solvent with lower temperature for separating the small ibuprofen crystal by increasing the supersaturation degree of ibuprofen; finally, filtering drying and producing the buprofen microcrystalline product. The mixed solution of said higher temperature solution and lower temperature solvent can be resolved at some temperature after separation by crystallization, crystallized by decreasing temperature, filtered, and dried to produce ibuprofen microcrystalline product with different granularity and narrow particle size distribution.

Description

technical field [0001] The invention relates to a preparation process of microcrystals of medicines, in particular to a preparation process of ibuprofen microcrystals. Background technique [0002] At present, there is no report on the preparation of microcrystalline products of ibuprofen, and the existing ones are all ibuprofen crystallization preparation processes, which utilize the solubility of ibuprofen in ethanol-water mixed solution or sherwood oil, hexane and other solvents to change with temperature The larger principle is to adopt the method of cooling crystallization to heat and dissolve the crude product of ibuprofen with about 60% (v / v) ethanol (or petroleum ether), decolorize it, then cool it down to about 0°C, and carry out recrystallization (see Chinese medicine Industrial Corporation "Organic Synthetic Drug Technology" 1981, October; State Administration of Medicine "National Compilation of Raw Materials Technology" 1980). Contents of the invention [000...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/192A61P19/02A61P29/00C07C57/30
Inventor 张忠明刘增业舒瑞友张玲
Owner SHANDONG XINHUA PHARMA CO LTD
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