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A kind of crystalline form b of sodium salt of oxazolidinone antibacterial drugs and its preparation method and application

A technology of antibacterial drugs and oxazolidinone, which is applied in the field of medicine, can solve the problems of increasing the difficulty of the preparation manufacturing process, and achieve the effects of easy storage and transportation, good fluidity and good stability

Inactive Publication Date: 2018-10-09
SHANGHAI INST OF MATERIA MEDICA CHINESE ACAD OF SCI
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  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

However, further studies have found that both the amorphous product and the crystal form A product of the sodium salt of formula 2 are very hygroscopic (according to the standards in the 2015 edition of the Chinese Pharmacopoeia Part Four "9103 Drug Hygroscopicity Test Guidelines", the weight gain of the hygroscopic greater than 15%), which increases the difficulty of the manufacturing process of the preparation

Method used

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  • A kind of crystalline form b of sodium salt of oxazolidinone antibacterial drugs and its preparation method and application
  • A kind of crystalline form b of sodium salt of oxazolidinone antibacterial drugs and its preparation method and application
  • A kind of crystalline form b of sodium salt of oxazolidinone antibacterial drugs and its preparation method and application

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Experimental program
Comparison scheme
Effect test

Embodiment 4

[0039] The X-ray powder diffraction spectrum of embodiment 4 crystal form B:

[0040] Measuring instrument: EMPYREAN diffractometer, PANALYTICAL

[0041] Determination conditions:

[0042]

[0043] figure 1 It is the X-ray diffraction pattern of the crystal form B prepared in Example 1, and the measured data are listed in Table 1.

[0044] The X-diffraction measurement data of table 1 oxazolidinone antibiotic sodium salt crystal form B

[0045]

[0046] The X-ray diffraction spectrum and figure 1 same.

Embodiment 5

[0047] The quality comparison of embodiment 5 crystal form B and amorphous and crystal form A product

[0048] According to the relevant provisions of the Chinese Pharmacopoeia 2015 edition of the four general rules , the guidelines and , the compound patent EP2940024A1 was used to prepare the compound without After finalizing the shape, the crystal form A prepared according to the crystal form patent CN105949241A and the crystal form B prepared by the method of the present application were subjected to solvent residue detection, accelerated test and hygroscopicity test. The results are as follows:

[0049]

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Abstract

The invention discloses an oxazolidinone type antibacterial medicine sodium salt crystal form B, and a preparation method and application thereof, and belongs to the field of medicine chemical industry. The crystal form B comprises the following 2 theta reflection angle measuring characteristic peaks in an X-ray powder diffraction spectrum: 11.4+ / -0.2 degrees, 15.3+ / -0.2 degrees, 16.6+ / -0.2 degrees, 17.9+ / -0.2 degrees, 20.7+ / -0.2 degrees and 24.4+ / -0.2 degrees. The crystal form has the advantages that better stability is realized; the organic solvent residue is lower; the moisture absorption is avoided; better flowability and preparation processing performance are realized; important application significance is realized in the antibiotic medicine preparation.

Description

technical field [0001] The invention belongs to the field of medicine, and in particular relates to a crystal form B of sodium salt of oxazolidinone antibacterial drugs, a preparation method and application thereof. Background technique [0002] Bacterial drug resistance has become an increasingly serious global public health crisis, posing a huge threat to human health and affecting social stability. For this reason, the World Organization warns that the world is facing the danger of returning to the "post-antibiotic era", that is, the dark age when there is no way to deal with bacterial infections. In 2015, the Sixty-eighth World Health Assembly approved a global action plan, one of its five strategic goals is to increase investment in interventions such as research and development of new antibacterial drugs. In 2016, 14 ministries and commissions including the National Health and Family Planning Commission jointly issued the "Notice on Printing and Distributing the Nation...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): C07D498/04A61P31/04
CPCC07B2200/13C07D498/04
Inventor 赵胜贤叶素斌祝方猛赵能选储结根苏利民付凌燕曹俊哲
Owner SHANGHAI INST OF MATERIA MEDICA CHINESE ACAD OF SCI
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