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Pramipexole dihydrochloride sustained release tablet and preparation method thereof

A technology of pramipexole hydrochloride and sustained-release tablets, which is applied in the field of pharmaceutical preparations, can solve problems such as burst release effects, and achieve the effects of easy administration, small side effects, and great clinical application value

Inactive Publication Date: 2014-11-19
SHANGHAI SUNTECH PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

But the dissolution rate of the pramipexole hydrochloride sustained-release tablet prepared by this method has just reached 25% in the first hour, and there is a burst effect

Method used

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  • Pramipexole dihydrochloride sustained release tablet and preparation method thereof
  • Pramipexole dihydrochloride sustained release tablet and preparation method thereof
  • Pramipexole dihydrochloride sustained release tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0042] Embodiment 1: Pramipexole Hydrochloride Sustained Release Tablets

[0043]

[0044] *Removed during coating process

[0045] preparation:

[0046] (1) Mix 22.5g of pramipexole hydrochloride and 22.5g of the same amount of lactose to obtain mixture a, then add 45g of lactose equal to the amount of mixture a and mix to obtain mixture b, until the amount of the mixture is close to the amount of remaining lactose, add The remaining 193.8 g of lactose and 30 g of copolymer of butyl methacrylate, dimethylaminoethyl methacrylate and methyl methacrylate (1:2:1) were mixed.

[0047] (2) Dissolve 12 g of hydroxypropyl cellulose in 228 g of water to form a binder solution, and add the binder solution to the mixture in step (1) for granulation.

[0048] (3) Dry at 50°C in a blast drying oven DHG-9620A.

[0049] (4) Add 1.2 g of silicon dioxide to the dry granules obtained in step (3) and mix.

[0050] (5) Add 3 g of magnesium stearate to step (4) and mix to lubricate the mix...

Embodiment 2

[0055] Embodiment 2: Pramipexole Hydrochloride Sustained Release Tablets

[0056]

[0057] *Removed during coating process

[0058] (1) Mix 1.875g of pramipexole hydrochloride and 1.875g of the same amount of lactose to obtain mixture a, then add 3.75g of lactose equivalent to mixture a and mix to obtain mixture b, until the amount of the mixture is close to the amount of remaining lactose, Add remaining lactose and mix.

[0059] (2) Dissolve 12 g of hydroxypropyl cellulose in 228 g of water to form a binder solution, and add the binder solution to the mixture in step (1) for granulation.

[0060] (3) Dry the wet granules at 50°C in a blast drying oven DHG-9620A.

[0061] (4) Add 1.2 g of silicon dioxide to the dry granules obtained in step (3) and mix.

[0062] (5) Add 3 g of magnesium stearate to step (4) and mix to lubricate the mixture in step (4).

[0063] (6) Put the final mixture in step (5) into a tablet press and press to make 5000 tablet cores.

[0064] (7) D...

Embodiment 3

[0067] Embodiment 3: Pramipexole Hydrochloride Sustained Release Tablets

[0068]

[0069]

[0070] *Removed during coating process

[0071] The preparation of the tablet core is basically the same as in Example 2, except that the coating formulation is different and the prepared coated tablet is not perforated.

[0072] The amount of pramipexole hydrochloride in each tablet was measured to be 0.360mg, equivalent to 96.0% of the theoretical content.

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Abstract

The invention provides a pramipexole dihydrochloride sustained release tablet and a preparation method thereof. The pramipexole dihydrochloride sustained release tablet comprises a pramipexole dihydrochloride tablet core and a coating, and one side or two sides of the tablet are provided with holes. The tablet core comprises at least a water-soluble filler, or comprises at least one cationic polymer, which is not dissolved in almost neutral (pH 5-7) environment and is rapidly dissolved in a medium with the pH less than 5. Due to the cationic polymer, the final tablet can release in the medium with the pH less than 5 faster than in the medium with the pH of 5-7. The pramipexole dihydrochloride sustained release tablet can constantly and stably release in a body, is not affected by the change of pH of the gastrointestinal tract, only needs to be taken once a day, is easy to take, has small side effects, stable curative effect and good tolerance and compliance, is beneficial to treatment of patients of Parkinsonism, can be used for maintaining the blood concentration in effective therapeutic concentration range for long and reducing the dosing frequency, and has greater clinical application value. The preparation method is simple and is applicable to industrial production.

Description

technical field [0001] The invention relates to a pharmaceutical preparation, in particular to a drug sustained-release preparation and a preparation method thereof, in particular to a pramipexole hydrochloride sustained-release tablet and a preparation method thereof. Background technique [0002] Pramipexole hydrochloride refers to the monohydrate of pramipexole containing two hydrochloric acid molecules, the chemical formula is C 10 h 17 N 3 S·2HCL·H 2 O, with a molecular weight of 211.32, is usually used to treat Parkinson's disease. Parkinson's disease is a deforming disease of the central nervous system, and most patients develop after the age of 60. The main manifestations are slow movements of patients, tremors in hands, feet or other parts of the body, which make the body lose flexibility and coordination. At present, there is no complete cure for the disease, and long-term and continuous drug treatment is needed to inhibit the progression of the disease. Ther...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/30A61K9/44A61K31/428A61P25/16
Inventor 何平谭萍莉
Owner SHANGHAI SUNTECH PHARMA
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