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A kind of preparation method of high bulk density ibuprofen spherical crystal and product thereof

A technology of spherical crystals and bulk density, which is applied in organic chemical methods, separation/purification of carboxylic acid compounds, organic chemistry, etc., can solve the problems of complex process control, high cost, and unfavorable industrial production, etc., and achieve simple process and reliable Good tabletability and high bulk density

Active Publication Date: 2022-04-22
ZHEJIANG NHU CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

This method uses a variety of solvents, the process control is complicated, the cost is high, and it is not conducive to industrial production

Method used

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  • A kind of preparation method of high bulk density ibuprofen spherical crystal and product thereof
  • A kind of preparation method of high bulk density ibuprofen spherical crystal and product thereof
  • A kind of preparation method of high bulk density ibuprofen spherical crystal and product thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0049] (1) First, 5kg of ibuprofen is put into a melting tank, heated to 77-85°C for melting;

[0050] (2) Add 10kg of purified water into the crystallizer, open the jacket of the crystallizer to cool with frozen brine, and cool the purified water to 5-10°C;

[0051] (3) Open the double-layer paddle stirrer in the crystallizer, and control the rotating speed to be 300-350rpm;

[0052] (4) Pressurize the melting tank of step (1) to 0.15-0.20MPa with nitrogen, then drop the ibuprofen molten liquid from the melting tank into the crystallizer through the rotating ball liquid distributor, and the rotating ball liquid distribution The diameter of the liquid hole of the device is 0.6mm, and the droplets evenly fall to the water surface after being sprayed by rotation, and the flow control valve is adjusted so that the whole batch of feed liquid is added in 1.5 to 2 hours;

[0053] (5) During the dropping process, the temperature in the crystallizer is controlled at 5-10°C, and cryst...

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Abstract

The invention discloses a method for preparing spherical ibuprofen crystals with high bulk density and its products. The preparation method comprises: (1) heating the ibuprofen to a molten state; (2) heating the ibuprofen in a molten state After pressurization, drop it into the crystallizer filled with water through the liquid distributor. Under the condition of stirring, crystallize while adding dropwise until the ibuprofen in the molten state is added dropwise, reduce the stirring speed, and carry out crystal growth. The crystal slurry is post-treated to obtain spherical ibuprofen crystals with a bulk density of 0.50-0.70 g / mL, a median particle size of 300-1000 μm, and an angle of repose of 22-29°. The preparation method is simple in process, does not use additives, and is suitable for industrial production. The prepared ibuprofen spherical crystals have regular crystal habit, smooth crystal surface, good fluidity, high bulk density, high product purity, and product quality conforms to CP2020 and EP9.8 , USP41 and other pharmacopoeia requirements.

Description

technical field [0001] The invention relates to the technical field of drug synthesis, in particular to a method for preparing spherical ibuprofen crystals with high bulk density and a product thereof. Background technique [0002] Ibuprofen (CAS: 15687-27-1), chemical name 2-methyl-4-(2-methylpropyl) phenylacetic acid, aliases, ibuprofen, ibuprofen. Ibuprofen is a non-steroidal anti-inflammatory drug widely used clinically, with a history of more than 50 years of use. English name is Ibuprofen, molecular formula C 13 h 18 o 2 , molecular weight 206.29, usually white crystalline powder, melting point is 75-77°C. Insoluble in water, easily soluble in ethanol, chloroform, ether, acetone and other solvents. It is mainly used for analgesic and anti-inflammatory effects such as sprains, strains, headaches, low back pain, and postoperative pain. Since the 1980s, the drug has been included in the pharmacopoeias of the United States, the United Kingdom, the European Union, and...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): C07C51/43C07C57/30
CPCC07C51/43C07B2200/13C07C57/30
Inventor 刘金龙吕叔敏胡瑞君何雪忠杜梦良王晓春汪紫玉梁兰英
Owner ZHEJIANG NHU CO LTD
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