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Opicapone compound

A technology of Opica and composition, applied in the field of medicine, can solve problems such as unfavorable drug quality control

Inactive Publication Date: 2018-03-09
TIANJIN HANKANG PHARMA BIOTECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0006] The preparation method of Opicapone was first recorded in CN101248064. During the research process, the method of the above-mentioned patent documents was repeated, and the obtained Opicapone all had greater hygroscopicity, which was not conducive to the quality control of medicines; in addition, the obtained Opicapone often contains more impurities. For the quality of the drug, it must be purified, but removing these impurities is challenging

Method used

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Examples

Experimental program
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Effect test

Embodiment 1

[0030] In the reaction bottle, add 10 grams of opicapone and 110ml of methane-ethanol-water (8:2:0.2) mixture, heat to 61°C-64°C, stir for 20 minutes, filter while hot, 38°C- 40°C, heat preservation for 3 hours, then lower the temperature, heat preservation at 17°C-21°C for 9 hours, filter, and dry to obtain the above-mentioned opimcapone crystals with a purity of 99.94%.

Embodiment 2

[0032] In the reaction bottle, add 10 grams of opicapone and 100ml of methane-ethanol-water (9:1:0.1) mixture, heat to 61°C-64°C, stir for 20 minutes, filter while hot, 38°C- 40°C, heat preservation for 3 hours, then lower the temperature, heat preservation at 17°C-21°C for 9 hours, filter, and dry to obtain the above-mentioned opimcapone crystals with a purity of 99.96%.

Embodiment 3

[0034] Tablets containing Opicapone

[0035] Prescription: 4.41 grams of opicapone crystals, 195 grams of lactose, 45 grams of PEG-4000, 18 grams of magnesium stearate, 48 grams of croscarmellose sodium, appropriate amount of distilled water, made into 1000 tablets.

[0036] Process: Grind PEG-4000 and Opicapone crystals together, pass through 80-mesh sieve, mix with other materials, use distilled water to make soft material, 16-mesh sieve to make granules, dry in a drying oven at 40-45°C, 16 mesh Sieve the granules, add magnesium stearate to the dry granules, mix well, and press into tablets.

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Abstract

The invention belongs to the technical field of medicines, and in particular relates to a crystal form of opicapone and a preparation method thereof. The crystal form of opicapone obtained by the invention has high purity and good stability, and the weight gain is not obvious even under high humidity conditions.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a crystal form of opicapone and a preparation method thereof. The invention also relates to treating Parkinson's disease with the composition of the crystal form of opicapone. Background technique [0002] Opicapone, 5-[3-(2,5-dichloro-4,6-dimethyl-1-oxo-pyridin-3-yl)-[1,2,4]oxadi [0003] Azol-5-yl]-3-nitrobenzene-1,2-diol, which has the following formula (I) structure: [0004] [0005] (I) [0006] The preparation method of Opicapone was first recorded in CN101248064. In the research process, the method of the above-mentioned patent documents was repeated, and the obtained Opicapone had a large hygroscopicity, which was not conducive to the quality control of medicines; in addition, the obtained Opicapone often contains more impurities. For the quality of the drug, it must be purified, but removing these impurities is challenging. [0007] The crystal form o...

Claims

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Application Information

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IPC IPC(8): C07D413/04A61K31/4439A61P25/16
CPCC07D413/04C07B2200/13
Inventor 严洁王志凤
Owner TIANJIN HANKANG PHARMA BIOTECH
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