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Phenytoin sodium sustained-release suspension and preparation method thereof

A slow-release suspension and phenytoin sodium technology, which is applied in the direction of pharmaceutical formulas, medical preparations with no active ingredients, medical preparations containing active ingredients, etc. To solve the problems such as large fluctuations in blood drug concentration, to achieve the effect of stable drug release, good stability and long duration of drug effect

Inactive Publication Date: 2020-09-22
JIANGSU SIHUAN BIOENGINEERING PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] Phenytoin sodium is widely used clinically, but the common preparation needs to be taken three times a day, the blood concentration fluctuates greatly, and the patient's compliance is poor, which is prone to wrong and missed doses
At present, there is no sustained-release dosage form on the market in China, and the dosage of the drug needs to be adjusted in time according to the condition to prepare a sustained-release preparation

Method used

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  • Phenytoin sodium sustained-release suspension and preparation method thereof
  • Phenytoin sodium sustained-release suspension and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

preparation example Construction

[0021] (1) Preparation of drug resin

[0022] Add the anion exchange resin to deionized water, add the drug under stirring and mix evenly, take samples regularly, and measure the concentration of the drug in the solution; when the drug concentration no longer changes with time, it will reach equilibrium, and wash off the resin surface with deionized water. Unbound drug, dried at 40°C-60°C to obtain drug-loaded resin;

[0023] (2) Impregnation of drug resin

[0024] Take the drug-loaded resin, add it to 20% polyethylene glycol 4000 aqueous solution, stir for 0.5 hours, dry and sieve to obtain the impregnated drug resin;

[0025] (3) Preparation of drug resin microcapsules

[0026] Prepare phenytoin sodium resin microcapsules by emulsification-solvent evaporation method, weigh the coating capsule material and plasticizer, add them to the acetone liquid, stir and dissolve as the dispersed phase; slowly add the impregnated phenytoin sodium resin into the dispersed phase , and s...

Embodiment 1

[0031] Prepare phenytoin sustained-release suspension according to the following formula.

[0032] Phenytoin 50mg

[0033] Anion resin 100mg

[0034] Propylene glycol 10mL

[0035] Macrogol 400 5mg

[0036] Macrogol 4000 50mg

[0037] Acrylic resin (Eudragit RS100, Eudragit RS100) 100mg

[0038] Xanthan Gum 50mg

[0039] Sucrose 10mg

[0040] Propylparaben 3mg

[0041] Banana flavor 15mg.

Embodiment 2

[0043] Prepare phenytoin sustained-release suspension according to the following formula.

[0044] Phenytoin 80mg

[0045] Anion resin 55mg

[0046] Propylene glycol 8mL

[0047] Macrogol 400 1.5mg

[0048] Macrogol 4000: 40mg

[0049] Acrylic resin (Eudragit RS100, Eudragit RS100) 55mg

[0050] Xanthan Gum 40mg

[0051] Povidone (K30) 15mg

[0052] Propylparaben 3mg

[0053] Banana flavor 15mg.

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Abstract

The present invention discloses a phenytoin sodium sustained-release suspension and a preparation method thereof, and belongs to the technical field of sustained-release preparations. The phenytoin sodium sustained-release suspension comprises phenytoin sodium, sustained-release auxiliary materials, impregnating agents, plasticizers, suspending agents, and wetting agents; and mass ratios of the phenytoin sodium, sustained-release auxiliary materials, impregnating agents, plasticizers and suspending agents are 10:(10-60):(0.1-10):(0.01-2):(0.1-2). The provided phenytoin sodium sustained-releasesuspension has good stability, an in vitro release rate of 75%-85% in 5 hours, a stable in vivo drug release, a long duration of drug effects and broad prospects in clinical applications.

Description

technical field [0001] The invention relates to an antiepileptic drug phenytoin sustained-release suspension and a preparation method thereof, belonging to the technical field of pharmaceutical preparations. Background technique [0002] Phenytoin sodium (Phenytoinum Natricum, PN) is a broad-spectrum antiepileptic drug, which can effectively prevent the abnormal discharge of brain neurons and its spread to surrounding tissues, and play a therapeutic role in epilepsy. In the treatment of epileptic seizures, it has strong effects, high curative effect, and small side effects, and is widely used clinically. It is the drug of choice for grand mal seizures. Oral medication is mainly absorbed through the small intestine, and the absorption rate varies greatly among individuals. The effective blood drug concentration is 10-20 mg / L. When the blood drug concentration exceeds 20 mg / L, it is easy to produce toxic reactions; when it exceeds 40 mg / L, severe toxic effects will occur. The...

Claims

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Application Information

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IPC IPC(8): A61K9/10A61K47/38A61K47/32A61K9/50A61K31/4166A61P25/08A61P25/12
CPCA61K9/10A61K47/38A61K47/32A61K9/5005A61K31/4166A61P25/08A61P25/12
Inventor 丁月萍江永红徐益明陶冬梅袁菊凤
Owner JIANGSU SIHUAN BIOENGINEERING PHARM CO LTD
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