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Pregabalin sustained release pellets and preparation method thereof

A technology of pregabalin and sustained-release pellets, which is applied in the direction of pharmaceutical formulations, medical preparations containing active ingredients, organic active ingredients, etc., and can solve problems such as unstable drug treatment effects, greater kidney damage, and human health damage , to improve bioavailability, stabilize therapeutic effect and reduce irritation

Inactive Publication Date: 2015-04-01
HEILONGJIANG ZHICHENG MEDICAL TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] At present, there are many drugs for the treatment of postherpetic neuralgia in the market, but most of the drugs have relatively large side effects, which will cause harm to human health, especially for The damage to the kidneys is greater, and the therapeutic effect of most drugs is not stable and the bioavailability is low

Method used

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  • Pregabalin sustained release pellets and preparation method thereof

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Embodiment 1

[0032] A kind of pregabalin 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: 50mg pregabalin, 70mg blank core, 100-200mg filler, 25-125mg lubricant, 5-50mg binder, the coating layer includes: 35-175mg Eudragit NE30D, 5-52mg talcum powder.

[0033] The optimal mass ratio of raw materials in the drug-containing pellets is: 50mg pregabalin, 70mg blank ball core, 190mg filler, 25mg lubricant, 10mg binder.

[0034] The optimal mass ratio of raw materials in the coating layer is: 35mg Eudragit NE30D, 7mg talcum powder.

[0035] The filler is microcrystalline cellulose.

[0036] Described lubricant is talcum powder.

[0037] The binder is hypromellose.

[0038] The coating layer also includes traces of sodium lauryl sulfate or polyethylene glycol.

Embodiment 2

[0040] A preparation method of pregabalin sustained-release pellets, characterized in that: comprising the following steps:

[0041] Step 1: Prepare materials: according to the above mass ratio, pregabalin is pulverized with a pulverizer, and passed through a 100-mesh sieve;

[0042] Step 2: Mixing: Weigh the pregabalin and microcrystalline cellulose according to the above mass ratio, put them into a three-dimensional mixer and mix for 30 minutes to make a fine drug powder, take it out for later use;

[0043] 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;

[0044] 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, a...

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Abstract

The invention provides pregabalin sustained release pellets. The pregabalin 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 50mg of pregabalin, 70mg of hollow pellet cores, 100-200mg of a filling agent, 25-125mg of a lubricating agent and 5-50mg of an adhesive; the coating layers comprise 35-175mg of Eudragit NE30D and 5-52mg of talcum powder. A preparation method of the pregabalin 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 pregabalin sustained release pellets provided by the invention have the beneficial effects that the pregabalin sustained release pellets have good stability, high bioavailability and small side effects; as the two kinds of advanced technologies, namely novel sustained release preparations and pellet preparations, are adopted, the pregabalin 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 of the pregabalin sustained release pellets is simple and practicable and is suitable for industrial production.

Description

technical field [0001] The invention belongs to the technical field of chemical medicine sustained-release preparations, and in particular relates to a pregabalin sustained-release pellet and a preparation method thereof. Background technique [0002] The root cause of postherpetic neuralgia is the exposure of the nerve axons (inner core) of the damaged skin, which is caused by the herpes zoster virus eating the thick fibers in the nerve sheath, resulting in the loss of myelin sheath, the inner core is exposed, and the appearance of The short circuit of the biological current causes the patient to experience severe pain like an electric shock, which is extremely painful. [0003] Shingles is caused by the varicella-zoster virus, which normally resides dormant in the dorsal root neurons of the spinal cord. But the body's resistance is low or fatigue, infection, cold and fever, anger, etc., the virus can grow and multiply again, and move to the skin along the nerve fibers, ca...

Claims

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Application Information

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IPC IPC(8): A61K9/58A61K9/16A61K31/197A61P25/00A61P31/22A61P25/28
Inventor 张昕
Owner HEILONGJIANG ZHICHENG MEDICAL TECH
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