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Rivastigmine-hydrogentartrate-containing pharmaceutical composition and preparation method

A technology of rivastigmine bitartrate and its composition, which is applied in the field of pharmaceutical compositions containing rivastigmine bitartrate and its preparation, and can solve problems such as the impact of fillers on the stability of active pharmaceutical ingredients.

Inactive Publication Date: 2010-09-22
万全万特制药江苏有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

There is no report on the influence of fillers on the stability of active pharmaceutical ingredients in domestic and foreign literature

Method used

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  • Rivastigmine-hydrogentartrate-containing pharmaceutical composition and preparation method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0018] components

[0019] Preparation process: crush rivastigmine bitartrate through a 140-mesh sieve, and set aside. Weigh rivastigmine heavy tartrate and lactose according to the prescription amount, mix according to the equal amount incremental method, add the microcrystalline cellulose of the prescription amount, mix evenly, and granulate with 10% starch slurry. Dry at 50°C, add croscarmellose sodium and magnesium stearate, mix evenly, and compress into tablets.

Embodiment 2

[0021] components

[0022] components

[0023] Preparation process: crush rivastigmine bitartrate through a 140-mesh sieve, and set aside. Weigh rivastigmine heavy tartrate and lactose according to the prescription amount, mix according to the equal amount incremental method, add the microcrystalline cellulose of the prescription amount, mix evenly, and granulate with 10% starch slurry. Dry at 50°C, add croscarmellose sodium, anhydrous colloidal silicon dioxide and magnesium stearate, mix evenly, and press into tablets.

Embodiment 3

[0025] components

[0026] Preparation process: crush rivastigmine bitartrate through a 140-mesh sieve, and set aside. Weigh rivastigmine heavy tartrate and lactose according to the prescription amount, mix according to the equal amount incremental method, add the microcrystalline cellulose of the prescription amount, mix evenly, and granulate with 10% starch slurry. Dry at 50°C, add croscarmellose sodium, silicon dioxide and magnesium stearate, mix well, and press into tablets.

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PUM

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Abstract

The invention discloses a pharmaceutical composition containing an active ingredient rivastigmine hydrogentartrate. The pharmaceutical composition comprises the rivastigmine hydrogentartrate and microcrystalline cellulose with weight percent of more than 50 percent, and then other excipients are added to be made into a corresponding formulation. The invention effectively solves the problem of hygroscopicity.

Description

technical field [0001] The invention discloses a pharmaceutical composition for treating senile dementia caused by Alzheimer's disease and Parkinson's syndrome, in particular to a pharmaceutical composition containing rivastigmine bitartrate and a preparation method thereof. Background technique [0002] Alzheimer's disease (Alzheimer's Disease, AD)) is a primary gray matter encephalopathy, often occurs in the elderly. At present, cholinesterase inhibitors (ChEI) are a class of important drugs as alternative therapy in the treatment of AD, wherein tacrine and donepezil have been put into clinical application, and rivastigmine hydrogen tartrate, whose trade name is Exelon, is It is the third cholinesterase inhibitor approved by FDA in April 2000. In July 2006, the U.S. FDA approved another indication of rivastigmine bitartrate for the treatment of Parkinson's disease-related mild and moderate dementia, which is the first FDA-approved treatment for Parkinson's disease-induced...

Claims

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Application Information

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IPC IPC(8): A61K31/27A61K47/38A61P25/28A61P25/16
Inventor 蔡巍刘海丽郭夏
Owner 万全万特制药江苏有限公司
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