Divalproex sodium sustained release pellets and preparation method thereof

A technology of sodium divalproex and sustained-release pellets, applied in the direction of anhydride/acid/halide active ingredients, bulk delivery, nervous system diseases, etc. It can improve the bioavailability, easy storage and good drug stability.

Inactive Publication Date: 2015-02-18
HARBIN SHENGJI PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0011] At present, there are many drugs for the treatment of epilepsy and mania on the market, most of which are sedatives with unstable efficacy and low bioavailability, and only provide temporary relief It cannot be cured fundamentally, and the side effects of the drug are relatively large, which will cause damage to the human nerves.

Method used

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  • Divalproex sodium sustained release pellets and preparation method thereof

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Comparison scheme
Effect test

Embodiment 1

[0035] A divalproex sodium sustained-release pellet, comprising drug-containing pellets and a coating layer, the coating layer wraps the drug-containing pellets, and the drug-containing pellets include: 250mg divalproex sodium, 70mg Blank pellet core, 60-110mg filler, 18-68mg lubricant, 2-10mg binder, the coating layer includes: 45-225mg Eudragit NE30D, 7-68mg talcum powder.

[0036] A divalproex sodium sustained-release pellet according to claim 1, characterized in that: the optimal mass ratio of raw materials in the drug-containing pellet is: 250 mg divalproex sodium, 70 mg blank core , 100mg filler, 20mg lubricant, 7mg binder.

[0037] The optimal mass ratio of raw materials in the coating layer is: 45mg Eudragit NE30D, 7mg talcum powder.

[0038] The filler is microcrystalline cellulose.

[0039] Described lubricant is talcum powder.

[0040] The binder is hypromellose.

[0041] The coating layer also includes traces of sodium lauryl sulfate or polyethyle...

Embodiment 2

[0043] A preparation method of divalproex sodium sustained-release pellets, comprising the following steps:

[0044] Step 1: Prepare materials: according to the above mass ratio, divalproex sodium is pulverized with a pulverizer, and passed through a 100-mesh sieve;

[0045] Step 2: Mixing: Weigh the divalproex sodium and microcrystalline cellulose according to the above mass ratio, put them into a three-dimensional mixer and mix them for 30 minutes to make drug fine powder, take them out for later use;

[0046] Step 3: Preparation of adhesive: Weigh an appropriate amount of hypromellose according to the above mass ratio, add an appropriate amount of hot water to prepare an adhesive with a concentration of 2%, and set aside;

[0047] Step 4: Pill making: put the mixed drug fine powder into the feeding tank of the centrifugal pellet machine, put the adhesive into the liquid supply tank, put the blank pellet core into the pot, turn on the machine, adjust the parameters...

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Abstract

The invention provides divalproex sodium sustained release pellets. The divalproex sodium sustained release pellets comprise medicine-containing pellets and coating layers, wherein the medicine-containing pellets are coated by the coating layers; the medicine-containing pellets comprise 250mg of divalproex sodium, 70mg of hollow pellet cores, 60-110mg of filling agent, 18-68mg of lubricating agent and 2-10mg of adhesive; the coating layers comprise 45-225mg of Eudragit NE30D and 7-68mg of talcum powder. A preparation method of the divalproex sodium sustained release pellets comprises the following processes: 1. material preparation; 2. mixing; 3. preparation of the adhesive; 4. preparation of the pellets; 5. preparation of a coating agent; 6. coating; 7. filling; 8. aluminium-plastic packaging and preparation of finished products. The divalproex sodium sustained release pellets used for treating epilepsy and mania and the preparation method have the beneficial effects that as the two kinds of advanced technologies, namely novel sustained release preparations and pellet preparations, are adopted, the divalproex sodium sustained release pellets have stable treatment effects and higher bioavailability and have the advantages of good medicine stability, convenience in packaging, transportation and storage, and the like; the preparation method is simple and practicable and is suitable for industrial production.

Description

technical field [0001] The invention belongs to the field of chemical drug sustained-release preparations, and in particular relates to divalproex sodium sustained-release pellets and a preparation method thereof. Background technique [0002] Epilepsy, commonly known as "shorn wind" or "epilepsy", is a chronic disease in which the sudden abnormal discharge of brain neurons leads to transient brain dysfunction. According to the latest epidemiological data in China, the overall prevalence rate of epilepsy in China is 7.0‰, the annual incidence rate is 28.8 / 100,000, and the prevalence rate of active epilepsy with seizures within one year is 4.6‰. [0003] According to the type of clinical attack is divided into: [0004] 1. Generalized tonic-clonic seizures (major seizures): sudden loss of consciousness, followed by tonic and then clonic convulsions, often accompanied by screaming, blue complexion, urinary incontinence, tongue biting, white or bloody foam at the mouth, The p...

Claims

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Application Information

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IPC IPC(8): A61K9/16A61K31/20A61P25/08A61P25/18
Inventor 马玉国
Owner HARBIN SHENGJI PHARMA
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