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Pramipexole dihydrochloride slow-release tablets and preparation method thereof

A technology of pramipexole hydrochloride and sustained-release tablets, which is applied in the field of pramipexole hydrochloride sustained-release tablets and its preparation, can solve problems such as drug dumping, and achieve the effects of good content uniformity and strong skeleton strength

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

AI Technical Summary

Problems solved by technology

The tablets described in the above two patents all use water-swellable materials as the sustained-release matrix, such as hypromellose, hypromellose, ethyl cellulose, and pregelatinized starch, which also have the risk of drug dumping

Method used

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  • Pramipexole dihydrochloride slow-release tablets and preparation method thereof
  • Pramipexole dihydrochloride slow-release tablets and preparation method thereof
  • Pramipexole dihydrochloride slow-release tablets and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0046] Embodiment 1: Pramipexole Hydrochloride Sustained Release Tablets

[0047]

[0048] Preparation:

[0049] (1) Pass 3.75g of pramipexole hydrochloride through a 100-mesh sieve, mix well with 18g of colloidal silicon dioxide and 147g of glyceryl behenate.

[0050] (2) Add 1319.25g of glyceryl behenate and 1494g of anhydrous calcium hydrogen phosphate to the above mixture and mix evenly. After passing through a 40-mesh sieve twice, after mixing evenly, add 18g of magnesium stearate and mix evenly to obtain Total blend prior to compression.

[0051] (3) Put the total mixture into a tablet machine and press into tablets to obtain pramipexole hydrochloride sustained-release tablets (10,000 tablets).

Embodiment 2

[0052] Embodiment 2: Pramipexole Hydrochloride Sustained Release Tablets

[0053]

[0054] Preparation:

[0055] (1) Pass 3.75g of pramipexole hydrochloride through a 100-mesh sieve, mix well with 18.75g of colloidal silicon dioxide and 150g of glyceryl behenate.

[0056] (2) Add 1,350g of glyceryl behenate, 1,908.75g of anhydrous calcium hydrogen phosphate, and 300g of hypromellose K4M to the above mixture and mix evenly. After passing through a 40-mesh sieve twice and mixing evenly, add stearic acid 18.75 g of magnesium was mixed uniformly to obtain the total mixture before tableting.

[0057] (3) Put the total mixture into a tablet machine and press into tablets to obtain pramipexole hydrochloride sustained-release tablets (10,000 tablets).

Embodiment 3

[0058] Embodiment 3: Pramipexole Hydrochloride Sustained Release Tablets

[0059]

[0060] Preparation:

[0061] (1) Pass 7.5g of pramipexole hydrochloride through a 100-mesh sieve, and mix well with 90g of colloidal silicon dioxide and 210g of glyceryl behenate.

[0062] (2) Add 1,890g of glyceryl behenate and 712.5g of lactose to the above mixture and mix evenly. After passing through a 40-mesh sieve twice, after mixing evenly, add 90g of magnesium stearate and mix evenly to obtain the total volume before tableting. mixture.

[0063] (3) Put the total mixture into a tablet machine and press into tablets to obtain pramipexole hydrochloride sustained-release tablets (10,000 tablets).

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Abstract

The present invention provides pramipexole dihydrochloride slow-release tablets and a preparation method thereof. The pramipexole dihydrochloride slow-release tablets comprise, by weight, 0.1-1.5% of a pramipexole dihydrochloride dihydrate, 40.0-75.0% of a matrix material with no swelling in water, 0.5-3.0% of a glidant, 0.5-3.0% of a lubricant, and 20.0-58.9% of other pharmaceutically acceptable carriers. According to the present invention, the pharmaceutically acceptable carrier with no swelling in water is provided, wherein swelling and deformation can not be produced when the formed matrix tablet contacts the aqueous medium so as to maintain the strong matrix strength in the body and not to cause dose burst release due to the food influence; and the preparation method of the present invention adopts the direct powder tableting process, the produced pramipexole dihydrochloride slow-release tablets have the good content uniformity, and the method of the present invention is simple, is suitable for industrial production, and has the great application value.

Description

technical field [0001] The pharmaceutical preparation of the invention specifically relates to a pramipexole hydrochloride sustained-release tablet and a preparation method thereof. Background technique [0002] Pramipexole hydrochloride is the monohydrate of pramipexole containing two hydrochloric acid molecules with the chemical formula C 10 h 17 N 3 S·2HCL·H 2 O, with a molecular weight of 302.26, is used to treat Parkinson's disease. Parkinson's disease is a degenerative 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. The common preparation of pramipexole hydrochloride currently on the market needs to be taken 3 times a...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/22A61K31/428A61K47/14A61K47/10A61K47/44A61P25/16
Inventor 何平顾宙辉黄献华
Owner SHANGHAI SUNTECH PHARMA
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