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Crystal form of (s)-ornidazole phosphate disodium and preparation method thereof, and application of pharmaceutical compositions

A technology of levonidazole phosphate disodium crystal and levonidazole phosphate disodium crystal, which is applied in the field of chemical drug crystallization, can solve problems affecting the stability, solubility, and clinical efficacy of pharmaceutical preparations, and achieve easy industrial Simple application and preparation method, good reproducible effect

Inactive Publication Date: 2017-03-01
HC SYNTHETIC PHARMA CO LTD
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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 disodium phosphate. For medicines, different crystal forms may have different physical and chemical properties, such as solubility, melting point, stability, etc., and these properties will directly affect the pharmaceutical preparation. Stability, solubility, and even affect the most serious clinical efficacy

Method used

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  • Crystal form of (s)-ornidazole phosphate disodium and preparation method thereof, and application of pharmaceutical compositions
  • Crystal form of (s)-ornidazole phosphate disodium and preparation method thereof, and application of pharmaceutical compositions
  • Crystal form of (s)-ornidazole phosphate disodium and preparation method thereof, and application of pharmaceutical compositions

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0049] Example 1: Preparation of Levonidazole Phosphate Disodium Crystal Form 1

[0050] Take 10g of levornidazole disodium phosphate, add 60ml of water, stir until dissolved, then add 0.6g of activated carbon, stir for 30 minutes and filter, put the filtrate at 10°C, stir and slowly add 180ml of ethanol dropwise until the solid precipitates, filter, 30°C After drying, 8.9 g of levonidazole phosphate disodium crystal form 1 was obtained, with a yield of 89.0%.

Embodiment 2

[0051] Example 2: Preparation of Levonidazole Phosphate Disodium Crystal Form 2

[0052] Take 10g of levonidazole phosphate disodium, add 50ml of 90% methanol to dissolve, then add 1.0 g of activated carbon for decolorization, stir for 60 minutes and filter, put the filtrate at 20°C, stir and slowly add 500ml of ethanol dropwise until the solid precipitates, filter, 30°C After drying, 8.1 g of levonidazole phosphate disodium crystal form 2 was obtained, with a yield of 81.0%.

Embodiment 3

[0053] Example 3: Preparation of Levonidazole Phosphate Disodium Form 3

[0054] Take 10g of levonidazole disodium phosphate, add 200ml of 90% ethanol water, heat and stir at 60°C until dissolved, then add 0.5g of activated carbon, stir for 20 minutes and filter. Set aside for 12 hours, filter, and dry to obtain 8.8 g of levonidazole phosphate disodium crystal form 3, with a yield of 88.0%.

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Abstract

The invention provides a crystal form of (s)-ornidazole phosphate disodium, and a preparation method for the crystal form of the (s)-ornidazole phosphate disodium. In addition, pharmaceutical compositions containing the crystal form of the (s)-ornidazole phosphate disodium are applied in treatment of a plurality of infectious diseases caused by sensitive anaerobic bacteria like bacteroides fragilis, bacteroides distasonis, bacteroides ovatus, bacteroides thetaiotaomicron, bacteroides vulgatus, clostridium colinum, eubacterium, peptococcus and peptostreptococcus, helicobacter pylori, bacteroides melaninogenicus, fusobacterium, capnocytophaga and bacteroides gingivalis.

Description

technical field [0001] The invention belongs to the technical field of crystallization of chemical medicines, and in particular relates to a crystal form of levonidazole phosphate disodium and a preparation method thereof. The present invention also relates to the application of a crystal form of levonidazole disodium phosphate in a pharmaceutical composition and the application of the crystal form and the composition in treating anaerobic infection, protozoan infection and various other diseases. 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 or...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C07F9/6506A61K31/675A61P31/04
Inventor 张起愿张学超
Owner HC SYNTHETIC PHARMA CO LTD
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