Levetiracetam sustained release pellets and preparation method thereof

A technology for slow-release pellets and pellets, which is used in pharmaceutical formulations, medical preparations containing active ingredients, and bulk delivery, etc., can solve problems such as low bioavailability, large drug side effects, human nerve damage, etc. Good stability, convenient storage, and the effect of improving bioavailability

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

[0010] There are many drugs for the treatment of epilepsy 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 drugs are relatively large, which will cause damage to human nerves

Method used

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  • Levetiracetam sustained release pellets and preparation method thereof

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Comparison scheme
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Embodiment 1

[0034] A kind of levetiracetam sustained-release pellets, comprising drug-containing pellets and a coating layer, the coating layer wraps the drug-containing pellets, and the drug-containing pellets include: 250mg levetiracetam, 70mg Blank pellet core, 60-110mg filler, 18-68mg lubricant, 2-10mg binder, and the coating layer includes: 45-225mg Eudragit NE30D, 7-68mg talcum powder.

[0035] The optimal mass ratio of the raw materials in the drug-containing pellets is: 250mg levetiracetam, 70mg blank pellet core, 70mg filler, 20mg lubricant and 10mg binder.

[0036] The optimal mass ratio of raw materials in the coating layer is: 45mg Eudragit NE30D, 7mg talcum powder.

[0037] The filler is microcrystalline cellulose.

[0038] Described lubricant is talcum powder.

[0039] The binder is hypromellose.

[0040] The coating layer also includes traces of sodium lauryl sulfate or polyethylene glycol.

Embodiment 2

[0042] A preparation method of levetiracetam sustained-release pellets, comprising the following steps:

[0043] Step 1: material preparation: according to the above mass ratio, levetiracetam is pulverized with a pulverizer, and passed through a 100-mesh sieve;

[0044] Step 2: Mixing: Weigh levetiracetam and microcrystalline cellulose according to the above mass ratio, put them into a three-dimensional mixer and mix for 30 minutes to make a drug fine powder, take it out for later use;

[0045] 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;

[0046] 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, and start sprayi...

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Abstract

The invention provides levetiracetam sustained release pellets. The levetiracetam 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 levetiracetam, 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 levetiracetam 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 levetiracetam sustained release pellets used for treating epilepsy 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 levetiracetam 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, in particular to a levetiracetam sustained-release pellet 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 pupils are dilat...

Claims

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Application Information

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IPC IPC(8): A61K9/16A61K31/4015A61P25/08
Inventor 马玉国
Owner HARBIN SHENGJI PHARMA
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