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Medicine crystal, preparation method and purpose thereof

A technology for crystals and compounds, applied in the field of new drug crystal forms and their preparation, can solve problems such as not very ideal

Inactive Publication Date: 2012-01-04
北京福瑞康正医药技术研究所
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Chinese patents 98800011.3 (disclosure date is May 26, 1999), 98805675.5 (disclosure date is July 5, 2000), 200410047367.5 (disclosure date is February 7, 2007), four different crystal forms of the drug According to the research, the dissolution rate of the three crystal forms A, B, and C is better than that of the A' crystal form, but it is still not ideal, especially the dissolution rate in 0-15 minutes. Therefore, it is necessary to study a crystal form with good dissolution rate. imperative

Method used

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  • Medicine crystal, preparation method and purpose thereof
  • Medicine crystal, preparation method and purpose thereof
  • Medicine crystal, preparation method and purpose thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0037] The new crystal of the present invention

[0038] The 2θ angle measured by X-ray powder atlas method is: 8.17, 13.16, 15.20, 16.09, 18.13, 19.12, 20.880, 21.07, 23.50, 25.01, 27.64, 28.30, 29.79, 31.92, 35.23, 35.37, 39.30 degrees;

[0039] KBr tablet-transmission method has the following absorptions in the infrared spectrum: 3409, 3172, 3081, 1637, 1566, 1464, 1396, 1318, 1280, 1238, 1124, 1071, 1062, 1035, 1011, 889, 851, 793, 789 , 761, 723, 686cm -1 ;

[0040] In the thermal analysis diagram of differential scanning calorimetry, there is an endothermic signal in the range of 230°C-252°C, and the peak temperature is 243-247°C.

[0041] The above-mentioned crystals have a purity greater than or equal to 95% and less than 100%.

[0042] A pharmaceutical preparation prepared from the above crystals.

[0043] The pharmaceutical preparations of the present invention include, but are not limited to, conventional oral preparations such as tablets, capsules, micropills, ...

Embodiment 2

[0046] The new crystal of the present invention

[0047] The 2θ angle measured by X-ray powder atlas method is: 8.21, 13.19, 15.47, 16.15, 18.07, 19.10, 20.89, 21.04, 23.52, 25.11, 27.72, 28.35, 29.75, 32.04, 35.19, 35.04, 39.37 degrees;

[0048] KBr tablet-transmission method has the following absorptions in the infrared spectrum: 3404, 3179, 3085, 1630, 1561, 1468, 1399, 1321, 1283, 1234, 1128, 1074, 1059, 1038, 1015, 881, 849, 794, 782 , 765, 721, 685cm -1 ;

[0049] In the thermal analysis diagram of differential scanning calorimetry, there is an endothermic signal in the range of 231°C-249°C, and the peak temperature is 241-246°C.

[0050]The above-mentioned crystals have a purity greater than or equal to 95% and less than 100%.

[0051] A pharmaceutical preparation prepared from the above crystals.

[0052] The pharmaceutical preparations of the present invention include, but are not limited to, conventional oral preparations such as tablets, capsules, micropills, gr...

Embodiment 3

[0054] The new crystal of the present invention

[0055] The 2θ angle measured by X-ray powder atlas method is: 8.28, 13.32, 15.56, 16.82, 18.14, 19.30, 20.30, 21.70, 24.06, 25.30, 27.32, 27.78, 28.94, 31.66, 34.24, 35.90, 39.56 degrees;

[0056] KBr tablet-transmission method has the following absorptions in the infrared spectrum: 3411, 3189, 3093, 1634, 1560, 1474, 1398, 1325, 1285, 1236, 1126, 1081, 1052, 1037, 1014, 886, 840, 799, 780 , 769, 723, 687cm -1 ;

[0057] In the thermal analysis chart of differential scanning calorimetry, there is an endothermic signal in the range of 230°C-250°C, and the peak temperature is 240-246°C.

[0058] The above-mentioned crystals have a purity greater than or equal to 95% and less than 100%.

[0059] A pharmaceutical preparation prepared from the above crystals.

[0060] The pharmaceutical preparations of the present invention include, but are not limited to, conventional oral preparations such as tablets, capsules, micropills, gra...

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Abstract

The invention discloses a new rufinamide crystal and a preparation method thereof. An infrared spectrum is determined by an X-ray powder map method and a KBr sheeting-transmission method, and thermal analysis determination is carried out by a differential scanning magnitude method. A preparation prepared by the new crystal has good dissolution degree and is more suitable for being used by a patient suffering from epilepsy at the stage of attack.

Description

technical field [0001] The invention relates to the technical field of medicines, in particular to a new crystal form of medicines and its preparation method and application. Background technique [0002] During the crystallization of drugs, due to the influence of various factors, the intramolecular or intermolecular bonding mode changes, resulting in different arrangements of molecules or atoms in the lattice space, forming different crystal structures. , melting point, dissolution rate, bioavailability, etc. may be significantly different, thus affecting the stability, bioavailability and curative effect of the drug. This phenomenon is particularly obvious in oral solid preparations. The phenomenon of different crystal forms of drugs is It is one of the important factors affecting drug quality and clinical efficacy. Therefore, the research on the crystal form of drugs is the top priority in the process of drug research. [0003] 1-(2,6-difluorobenzyl)-1H-1,2,3-triazole-...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): C07D249/04A61K31/4192A61P25/08
Inventor 顾群孙学伟徐春霞米长江阮爱华李志刚李学敏孙德杰
Owner 北京福瑞康正医药技术研究所