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Sodium valproate oral preparation slow-release preparation and preparation method thereof

A technology of sodium valproate and oral preparations, which is applied in the direction of pharmaceutical formulas, medical preparations of non-active ingredients, anhydride/acid/halide active ingredients, etc., which can solve the problems of poor taste and difficulty in taking it by patients, and achieve the preparation method Simple, convenient medication, and the effect of reducing the number of medications

Active Publication Date: 2016-06-01
北京达因高科儿童药物研究院有限公司 +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] In order to overcome the technical problems of the prior art that the time for maintaining the drug effect is short, the medicine with bad smell has poor taste after being made into liquid preparation, and the patient is difficult to take it, the present invention provides a medicine that can improve the compliance of the patient to take it (suitable for taking it) , easy to divide doses, etc.), long-lasting drug effect, good mouthfeel sodium valproate oral preparation body slow-release preparation and preparation method thereof

Method used

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  • Sodium valproate oral preparation slow-release preparation and preparation method thereof
  • Sodium valproate oral preparation slow-release preparation and preparation method thereof
  • Sodium valproate oral preparation slow-release preparation and preparation method thereof

Examples

Experimental program
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Effect test

Embodiment 1

[0023] formula:

[0024]

[0025] Preparation Process:

[0026] 1) Preparation of drug-containing resin: add ion-exchange resin to 700 mg / ml sodium valproate aqueous solution at room temperature, stir at constant temperature, take samples regularly, and measure the concentration of drug in the solution. After reaching equilibrium, wash off the unbound drug on the surface of the resin with deionized water, and dry at 40-60°C to obtain the drug-loaded resin;

[0027] 2) Preparation of drug-containing microcapsules: use fluidized bed bottom spray coating, put the drug resin into the fluidization chamber, adjust the air volume to make the particles in an ideal fluidization state in the fluidization chamber, control the temperature at 20°C, and keep The flow pump pumps the coating solution containing plasticizer and microcapsule material at a constant speed, so that the coating solution has a good atomization effect, and there is no intermittent drying time for continuous coati...

Embodiment 2

[0030] formula:

[0031]

[0032] Preparation Process:

[0033] 1) Preparation of drug-containing resin: add ion-exchange resin to 800 mg / ml sodium valproate aqueous solution at room temperature, stir at constant temperature, take samples regularly, and measure the concentration of drug in the solution. After reaching equilibrium, wash off the unbound drug on the surface of the resin with deionized water, and dry at 40-60°C to obtain the drug-loaded resin;

[0034] 2) Preparation of drug-containing microcapsules: use fluidized bed bottom spray coating, put the drug resin into the fluidization chamber, adjust the air volume to make the particles in an ideal fluidization state in the fluidization chamber, control the temperature at 35°C, and keep The flow pump pumps the coating solution containing plasticizer and microcapsule material at a constant speed, so that the coating solution has a good atomization effect, and there is no intermittent drying time for continuous coating...

Embodiment 3

[0037] formula:

[0038]

[0039] Preparation Process:

[0040] 1) Preparation of drug-containing resin: add ion-exchange resin to 900 mg / ml sodium valproate aqueous solution at room temperature, stir at constant temperature, take samples regularly, and measure the concentration of drug in the solution. After reaching equilibrium, wash off the unbound drug on the surface of the resin with deionized water, and dry at 40-60°C to obtain the drug-loaded resin;

[0041] 2) Preparation of drug-containing microcapsules: spray coating at the bottom of the fluidized bed, put the drug resin into the fluidization chamber, adjust the air volume to make the particles in an ideal fluidization state in the fluidization chamber, control the temperature at 40°C, and keep The flow pump pumps the coating solution containing plasticizer and microcapsule material at a constant speed, so that the coating solution has a good atomization effect, and there is no intermittent drying time for contin...

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Abstract

The invention relates to a sodium valproate oral preparation slow-release preparation and a preparation method thereof and solves the technical problem of short efficacy maintaining time and the technical problems of poor taste and difficulty in administration by patients after medicine with undesirable peculiar smell is prepared into liquid preparations. The slow-release preparation contains sodium valproate and further contains ion exchange resin, microcapsule material, suspending agent and purified water, sodium valproate is adsorbed on the ion exchange resin to form microparticles which are wrapped by a coating material to form microcapsules, and the microcapsules are uniformly distributed in a liquid medium of the suspending agent and the purified water. The invention further provides a preparation method. The preparation method can be used for preparing the sodium valproate oral preparation slow-release preparation.

Description

technical field [0001] The invention relates to a pharmaceutical composition containing sodium valproate and a preparation method thereof, in particular to a sodium valproate oral preparation sustained-release preparation and a preparation method thereof. Background technique [0002] Valproic acid was first synthesized by Burton in 1882, but until 1962 when Pierre Eymard stumbled upon its anti-epileptic effect in G.Carraz's laboratory, there was no record of its clinical application. The clinical trial of sodium valproate was reported for the first time, and then in 1967, sodium valproate was first launched in France by Sanofi. [0003] Valproic acid has been used as an antiepileptic drug for nearly 48 years, and it is currently on the market in more than 100 countries around the world. Since valproic acid was introduced into the clinic, as the main antiepileptic drug, because of its multiple activities, it is used to treat many different types of epileptic seizures, and i...

Claims

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Application Information

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IPC IPC(8): A61K9/00A61K31/19A61K47/46A61P25/08
CPCA61K9/0002A61K31/19A61K47/46
Inventor 王凤英何淑旺景亚军
Owner 北京达因高科儿童药物研究院有限公司
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