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Stable sodium nitroprusside crystal compound, pharmaceutical composition and preparation method thereof

A crystalline compound, sodium nitroprusside technology, applied in the field of medicine, can solve problems such as unstable aqueous solution, and achieve stable product quality, mild reaction, and good stability

Inactive Publication Date: 2014-11-05
TIANJIN SONGRUI MEDICAL TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The aqueous solution is unstable, easy to decompose from brown to blue

Method used

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  • Stable sodium nitroprusside crystal compound, pharmaceutical composition and preparation method thereof
  • Stable sodium nitroprusside crystal compound, pharmaceutical composition and preparation method thereof
  • Stable sodium nitroprusside crystal compound, pharmaceutical composition and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0088] Dissolve the sodium nitroprusside solid in distilled water first, adjust the temperature of the solution to drop anhydrous cyclohexanol, a mixed solvent of absolute ethanol and anhydrous isopropanol under the condition of 50°C, the anhydrous cyclohexanol, The volume ratio of absolute ethanol and absolute isopropanol is 1:1.5:1.25, and the feeding speed of described anhydrous cyclohexanol, absolute ethanol and absolute isopropanol is 2ml / min; For anhydrous cyclohexanol, absolute ethanol and anhydrous isopropanol, the stirring speed is 30 rpm. After the mixed solvent is added dropwise, continue to keep stirring for 30 minutes, lower the temperature to 30°C, keep stirring for 30 minutes, and obtain crystals: After filtering, the filter cake was washed with 90% ethanol, and vacuum-dried for 2 hours to obtain the sodium nitroprusside crystalline compound.

[0089] X-ray powder diffraction obtained by using Cu-Kα ray measurement shows characteristic peaks at 2θ of 18.6°, 19.9...

Embodiment 2

[0091] Dissolve the sodium nitroprusside solid in distilled water first, adjust the temperature of the solution to drop anhydrous cyclohexanol, a mixed solvent of absolute ethanol and anhydrous isopropanol under the condition of 55°C, the anhydrous cyclohexanol, Dehydrated alcohol, the volume ratio with dehydrated isopropanol is 1:1.75:1.75, and the feeding speed of described anhydrous cyclohexanol, dehydrated alcohol and dehydrated isopropanol is 5ml / min; For anhydrous cyclohexanol, absolute ethanol and anhydrous isopropanol, the stirring speed is 30 rpm. After the mixed solvent is added dropwise, continue to keep stirring for 30 minutes, lower the temperature to 32°C, and keep stirring for 30 minutes to obtain crystals: After filtering, the filter cake was washed with 90% ethanol, and vacuum-dried for 4 hours to obtain a crystal compound of sodium nitroprusside.

[0092] X-ray powder diffraction obtained by using Cu-Kα ray measurement shows characteristic peaks at 2θ of 18.6...

Embodiment 3

[0094] Dissolve the sodium nitroprusside solid in distilled water first, adjust the temperature of the solution to 50-55°C and add dropwise anhydrous cyclohexanol, a mixed solvent of absolute ethanol and anhydrous isopropanol, the anhydrous cyclohexyl alcohol The volume ratio of alcohol, absolute ethanol, and anhydrous isopropanol is 1:1:1, and the feeding speed of described anhydrous cyclohexanol, absolute ethanol and anhydrous isopropanol is 7ml / min; When adding anhydrous cyclohexanol, absolute ethanol and anhydrous isopropanol, the stirring speed is 20 rpm. After the mixed solvent is added dropwise, continue to keep stirring for 30 minutes, cool down to 30°C, and keep stirring for 30 minutes to obtain Crystals: filtered, the filter cake was washed with ethanol, and dried in vacuum for 2 hours to obtain the crystalline compound of sodium nitroprusside.

[0095]X-ray powder diffraction obtained by using Cu-Kα ray measurement shows characteristic peaks at 2θ of 18.6°, 19.9°, 2...

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Abstract

The invention belongs to the technical field of medicines and provides a stable sodium nitroprusside crystal compound, a pharmaceutical composition and a preparation method thereof. The preparation method of the compound comprises the following steps: dissolving a sodium nitroprusside solid in water, dropwise adding a mixed solvent of anhydrous cyclohexanol, absolute ethanol and anhydrous isopropanol, performing insulated stirring, cooling, performing insulated stirring, filtering, washing, and drying in vacuum to obtain the sodium nitroprusside crystal compound, wherein the sodium nitroprusside crystal compound is high in yield and purity and stable in quality. The invention also provides a sodium nitroprusside pharmaceutical composition for injection and a preparation method thereof. The sodium nitroprusside pharmaceutical composition for injection, prepared by adopting a preparation formula and a preparation process, is stable in quality and easy to industrialize.

Description

technical field [0001] The invention relates to the field of medicine, in particular to a stable sodium nitroprusside crystal compound, a pharmaceutical composition and a preparation method thereof. Background technique [0002] Sodium nitroprusside [0003] Chemical name: sodium nitroferricyanide monohydrate; [0004] Molecular formula: Na 2 Fe(CN) 5 NO2H 2 O; [0005] Molecular weight: 279.93; [0006] Structural formula: [0007] Properties: reddish-brown crystal or powder; odorless or almost odorless. Soluble in water, slightly soluble in ethanol. [0008] Sodium nitroprusside is generally sold in the form of dihydrate, which is a bright red, odorless, tasteless solid or crystal, easily soluble in water, slightly soluble in alcohol, which contains [Fe(CN) 5 NO] 2- Anion, that is, an octahedral complex ion formed by the coordination of an iron atom with five cyano groups and a linear nitroso group. It belongs to [Fe(CN) 5 L] 2- type, is ferrocyanide ([Fe(CN...

Claims

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Application Information

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IPC IPC(8): C01C3/12A61K33/26A61K47/12A61P9/12A61P9/04
Inventor 张昊
Owner TIANJIN SONGRUI MEDICAL TECH
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