S-(-)-ornidazol disodium phosphate hexahydrate crystal form and preparation method thereof

A technology of levonidazole phosphate and hexahydrate, which is applied in the field of crystal form of levonidazole phosphate disodium hexahydrate and its preparation, and can solve the problem of affecting the stability, solubility, and clinical efficacy of pharmaceutical preparations, etc. question

Inactive Publication Date: 2017-09-12
HC SYNTHETIC PHARMA CO LTD +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

There is no relevant literature report on the crystal form of levonidazole phosphate disodium hexahydrate. For drugs, different crystal forms may have different physical and chemical properties, such as solubility, melting point, stability, etc. These properties will directly affect the drug. The stability and solubility of the preparation even affect the most important clinical efficacy

Method used

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  • S-(-)-ornidazol disodium phosphate hexahydrate crystal form and preparation method thereof
  • S-(-)-ornidazol disodium phosphate hexahydrate crystal form and preparation method thereof
  • S-(-)-ornidazol disodium phosphate hexahydrate crystal form and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0025] Example 1: Preparation of Levonidazole Phosphate Disodium Hexahydrate Crystal Form

[0026] Take 20g of levonidazole disodium phosphate, add 120ml of water, stir until dissolved, then add 1.2g of activated carbon, stir for 30 minutes and filter, put the filtrate at 10°C, stir and slowly add 360ml of ethanol dropwise until the solid precipitates, filter, 30°C After drying, 17.7 g of levonidazole phosphate disodium hexahydrate was obtained, with a yield of 88.5%.

Embodiment 2

[0027] Example 2: Preparation of Levonidazole Phosphate Disodium Hexahydrate Crystal Form

[0028] Take 20g of disodium levonidazole phosphate, add 60ml of water, stir until dissolved, then add 0.6g of activated carbon, stir for 10 minutes and filter, put the filtrate at 15°C, stir and slowly add 280ml of methanol dropwise until the solid precipitates, filter, 30°C After drying, 17.4 g of levonidazole phosphate disodium hexahydrate was obtained, with a yield of 87.0%.

Embodiment 3

[0029] Example 3: Preparation of Levonidazole Phosphate Disodium Hexahydrate Crystal Form

[0030] Take 20g of levonidazole disodium phosphate, add 100ml of 60% methanol to dissolve, then add 1g of activated carbon for decolorization, stir for 40 minutes and filter, put the filtrate at -5°C, stir and slowly add 300ml of ethanol dropwise until the solid precipitates, filter, 30 After drying at °C, 16.2 g of levonidazole phosphate disodium hexahydrate was obtained, with a yield of 81.0%.

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Abstract

The invention provides a crystal form of S-(-)-ornidazol disodium phosphate hexahydrate. A preparation method of the crystal form of S-(-)-ornidazol disodium phosphate hexahydrate is simple, and is suitable for industrial production. The crystal form of S-(-)-ornidazol disodium phosphate hexahydrate has high purity and good stability.

Description

technical field [0001] The invention belongs to the technical field of crystallization of chemical medicines, in particular to a crystal form of levonidazole phosphate disodium hexahydrate and a preparation method thereof. Background technique [0002] Ornidazole is a nitroimidazole derivative, which is a powerful drug against anaerobic bacteria and antiprotozoal infection. Broader third-generation nitroimidazole derivatives. [0003] In the further research on ornidazole, it was found that after the use of ornidazole, it will produce a certain degree of central toxicity, and the central toxicity of its single left-handed enantiomer is much lower than that of its racemate, which is the reason for ornidazole. Nitazole research has directed a new direction. The research on L-ornidazole and its derivatives has become a new hotspot. [0004] Levo-ornidazole disodium phosphate is the prodrug of levo-ornidazole, after administration, it can be degraded into levo-ornidazole unde...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C07F9/6506
CPCC07B2200/13C07F9/6506
Inventor 刘晓鹏张起愿陆华龙
Owner HC SYNTHETIC PHARMA CO LTD
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