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Pramipexole dihydrochloride sustained release pellets

A technology of pramipexole hydrochloride and sustained-release pellets, which is applied in the fields of organic active ingredients, nervous system diseases, and pharmaceutical formulations, can solve unproven problems, achieve the effects of reducing irritation, uniform absorption, and enhancing technical advantages

Inactive Publication Date: 2015-02-25
HARBIN SHENGJI PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Genetic susceptibility. In recent years, the Alα53THr mutation of a common nuclide gene has been found in patients with familial Parkinson's disease, but it has not been confirmed many times later

Method used

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  • Pramipexole dihydrochloride sustained release pellets

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0030] A kind of pramipexole hydrochloride sustained-release pellets, comprising drug-containing pellets and an enteric coating layer, the enteric coating layer wraps the drug-containing pellets, and the drug-containing pellets include: 0.1mg pramipexole hydrochloride Cable, 180mg blank ball core, 10mg binder, the enteric coating layer includes: 32-96mg Eudragit NE30D, 5-29mg talcum powder.

[0031] The optimal mass ratio of the raw materials in the enteric coating layer is: 45mg Eudragit NE30D, 7mg talcum powder.

[0032] The binder is hypromellose.

[0033] The enteric coating layer also includes traces of sodium lauryl sulfate or polyethylene glycol.

Embodiment 2

[0035] A preparation method of pramipexole hydrochloride sustained-release pellets, comprising the following steps:

[0036] Step 1: Prepare materials: take pramipexole hydrochloride and hypromellose according to the above mass ratio, and dissolve them with purified water;

[0037] Step 2: Pill making: take the blank pellet core, place it in the fluidized bed coating agent, put the dissolved raw material into the liquid supply tank, stir it from time to time, turn on the machine, adjust the parameters, and start coating. After the raw materials are used up, start to heat up to keep the material temperature above 40 degrees, dry for 30 minutes, cool down, discharge, and turn off the machine;

[0038] Step 3: Preparation of enteric coating agent: weigh Eudragit NE30D, talcum powder, sodium lauryl sulfate, and purified water according to the above mass ratio, first add sodium lauryl sulfate into the purified water and stir to dissolve , then add Eudragit NE30D and stir w...

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Abstract

The invention provides pramipexole dihydrochloride sustained release pellets. The pramipexole dihydrochloride sustained release pellets comprise medicine-containing pellets and enteric coating layers, wherein the medicine-containing pellets are coated by the enteric coating layers; the medicine-containing pellets comprise 0.1mg of pramipexole dihydrochloride, 180mg of hollow pellet cores and 10mg of adhesive; the enteric coating layers comprise 32-96mg of Eudragit NE30D and 5-29mg of talcum powder. A preparation method of the pramipexole dihydrochloride sustained release pellets comprises the following processes: 1. material preparation; 2. pellet preparation; 3. preparation of an enteric coating agent; 4. coating; 5. filling; 6. aluminium-plastic packaging and preparation of finished products. The pramipexole dihydrochloride sustained release pellets used for treating idiopathic Parkinson's diseases have the beneficial effects that as the two kinds of advanced technologies, namely novel sustained release preparations and pellet preparations, are adopted, the pramipexole dihydrochloride 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 pramipexole dihydrochloride sustained release pellets 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 pramipexole hydrochloride sustained-release pellets and a preparation method thereof. Background technique [0002] Parkinson's disease, also known as idiopathic Parkinson's disease (PD), referred to as Parkinson's disease, also known as paralysis agitans (shaking palsy), is a common neurodegenerative disease in middle-aged and elderly people. The most common extrapyramidal system disease in humans, the main lesions are in the substantia nigra and striatum pathways, and the production of dopamine is reduced. The prevalence rate of people over 65 years old is 1000 / 100,000, increasing with age, and slightly more in men than women. [0003] Cause: [0004] Aging (25%): [0005] Parkinson's mainly occurs in the middle-aged and elderly people, and the onset is rare before the age of 40, suggesting that aging is related to the onset. Studies ha...

Claims

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Application Information

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IPC IPC(8): A61K9/58A61K9/16A61K31/428A61P25/16
Inventor 马玉国
Owner HARBIN SHENGJI PHARMA
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