Amisulpride oral-administration solution

An amisulpride and oral solution technology, which can be applied in the directions of inactive components of polymer compounds, nervous system diseases, and pharmaceutical formulations, etc., can solve problems such as bad taste and increase drug solubility.

Inactive Publication Date: 2020-05-05
BEIJING VENTUREPHARM BIOTECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

But amisulpride is an insoluble drug, and the difficulty of preparing amisulpride oral solution is to increase the solubility of the drug in the solvent system, while covering the bad taste of the drug and keeping a good mouthfeel

Method used

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  • Amisulpride oral-administration solution
  • Amisulpride oral-administration solution

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0017] Prepare 1000mL of amisulpride concentration of 5% (w / v) oral solution, which contains the following components: amisulpride 50g, hydroxypropyl-β-cyclodextrin 150g, propylene glycol 300ml, 70% sorbitol 200ml , 0.5g Tween 80, 0.1g ethylparaben, 0.5g sodium saccharin, appropriate amount of sodium hydroxide, add distilled water to 1000ml.

[0018] Preparation method: first add 0.5g Tween 80 to 200ml of distilled water, add 150g of hydroxypropyl-β cyclodextrin and stir, continue to add 300ml of propylene glycol and stir evenly; add 50g of amisulpride into hydroxypropyl-β under constant stirring In the cyclodextrin solution, the inclusion complex solution of amisulpride was obtained, and then 200ml of 70% sorbitol solution, 0.1g of ethylparaben, 0.5g of sodium saccharin were added, and the pH was adjusted to 3.5 with 1mol / L sodium hydroxide solution. The solution obtained was diluted to 1000ml with distilled water, filtered to obtain amisulpride oral solution.

Embodiment 2

[0020] Prepare 1000mL of amisulpride concentration of 8% (w / v) oral solution, which contains the following components: amisulpride 80g, hydroxypropyl-β-cyclodextrin 240g, propylene glycol 200ml, 70% sorbitol 200ml , 0.5g Tween 80, 0.1g benzoic acid, 0.5g sodium saccharin, appropriate amount of sodium hydroxide, add distilled water to 1000ml.

[0021] Preparation method: first add 0.5g Tween 80 to 200ml distilled water, add 240g hydroxypropyl-β cyclodextrin and stir, continue to add 200ml propylene glycol and stir evenly; add 80g amisulpride to hydroxypropyl-β under constant stirring In the cyclodextrin solution, the clathrate solution of amisulpride was obtained, and then 200ml of 70% sorbitol solution, 0.1g of benzoic acid, 0.5g of sodium saccharin were added, and the pH was adjusted to 3.5 with 1mol / L sodium hydroxide solution to obtain the The solution was diluted to 1000ml with distilled water, filtered to obtain amisulpride oral solution.

Embodiment 3

[0023] Prepare 1000mL of amisulpride concentration of 2% (w / v) oral solution, which contains the following components: amisulpride 20g, hydroxypropyl-β-cyclodextrin 100g, propylene glycol 400ml, 70% sorbitol 200ml , 0.5g Tween 80, 0.1g benzoic acid, 0.5g sodium saccharin, appropriate amount of sodium hydroxide, add distilled water to 1000ml.

[0024] Preparation method: first add 0.5g Tween 80 to 200ml of distilled water, add 100g of hydroxypropyl-β cyclodextrin and stir, continue to add 400ml of propylene glycol and stir evenly; add 20g of amisulpride into hydroxypropyl-β under constant stirring In the cyclodextrin solution, the clathrate solution of amisulpride was obtained, and then 200ml of 70% sorbitol solution, 0.1g of benzoic acid, 0.5g of sodium saccharin were added, and the pH was adjusted to 3.5 with 1mol / L sodium hydroxide solution to obtain the The solution was diluted to 1000ml with distilled water, filtered to obtain amisulpride oral solution.

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Abstract

The invention provides a drug solution applicable to oral dosing. The drug solution comprises Amisulpride, cyclodextrin or derivatives thereof, an appropriate medicinal solvent system and other adjuvants. The cyclodextrin or derivatives thereof and a drug cosolvent system can be used for remarkably improving the solubility of the Amisulpride in the solvent system, promoting drug absorption and enhancing a treatment effect. The Amisulpride oral liquid preparation provided by the invention is high in absorption rate, convenient to take and easy in divided dose, can rapidly exert a drug effect and can simultaneously meet various requirements such as clinical medication, sufferer compliance and industrialized mass production.

Description

technical field [0001] The invention relates to a drug solution of amisulpride suitable for oral administration. Background technique [0002] Amisulpride is an atypical antipsychotic drug indicated for the treatment of paranoid progressive schizophrenia, acute delusional psychosis, and also for the treatment of deficit states in schizophrenia, residual psychotic evolution, and accompanying There is a sluggish inhibition state. Early diagnosis and treatment of such diseases can significantly improve their recovery and outcome. In addition, early therapeutic intervention can avoid costly hospitalization. [0003] At present, the dosage form of amisulpride marketed at home and abroad is tablet. The oral solution of amisulpride of the present invention can meet the specific needs of patients with paranoid progressive schizophrenia and acute delusional psychosis, and these patients have difficulty in swallowing solid oral preparations. An oral solution could also give doctor...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K31/40A61K47/40A61P25/18
CPCA61K9/0053A61K9/08A61K31/40A61K47/40A61P25/18
Inventor 李春王宇杰
Owner BEIJING VENTUREPHARM BIOTECH
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