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Rasagiline tablet

A technology of rasagiline tablet and rasagiline mesylate, applied in the field of pharmaceutical preparations, can solve the problems of many production processes, high cost, complicated prescription and the like, and achieve the effects of good stability and good long-term stability

Active Publication Date: 2016-04-20
CHONGQING PHARSCIN PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0010] Among the various prior art solutions disclosed, some have complicated prescriptions, some have many production processes, some have strict process control, and some have high costs. It is necessary to further improve the prescription process of this product to make it more suitable for industrialized large-scale production

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0030] Embodiment 1: tablet weight 100mg

[0031] prescription:

[0032] Name of raw material

% by weight

Rasagiline mesylate

1.56

hypromellose

2

sodium starch glycolate

8

EDTA-2Na

0.1

microcrystalline cellulose

50

starch

37.54

stearic acid

0.4

Micropowder silica gel

0.4

total

100

[0033] Process:

[0034] 1. Preparation of binder solution: prepare 5% hypromellose solution, take about 30% of it, add EDTA-2Na and rasagiline mesylate, and stir to dissolve. Take 5% of the prescription amount of microcrystalline fiber and disperse it with water. Mix the binder solution added with the main ingredient and EDTA-2Na with the microcrystalline cellulose suspension, control the temperature of the mixed solution at 30°C to 40°C, stir and disperse for 30 minutes.

[0035] 2. Mix the remaining microcrystalline cellulose, carboxymethyl starch sodium and starch evenly, f...

Embodiment 2

[0037] Embodiment 2: tablet weight 156mg

[0038] (difference from comparative example 1 is that the addition form of microcrystalline fiber of 3% prescription amount is different)

[0039] prescription:

[0040] Name of raw material

percentage%

Rasagiline mesylate

1

hypromellose

2.5

Crospovidone

2

EDTA-2Na

0.5

microcrystalline cellulose

60

precrossified starch

32

stearic acid

1

Talc powder

1

total

100

[0041] Process:

[0042] 1. Preparation of binder solution: prepare 8% hypromellose solution, take about 35% of it, add EDTA-2Na and rasagiline mesylate, and stir to dissolve. Take 3% of the prescription amount of microcrystalline fiber and disperse it with water. Mix the binder solution added with the main ingredient and EDTA-2Na with the microcrystalline cellulose suspension, control the temperature of the mixed solution at 30°C to 40°C, stir and disperse...

Embodiment 3

[0045] Embodiment 3: tablet weight 78mg

[0046] prescription:

[0047] Name of raw material

percentage%

Rasagiline mesylate

2

hypromellose

1.5

Croscarmellose Sodium

3

EDTA-2Na

1.5

microcrystalline cellulose

65

lactose

25.2

Talc powder

1

Micropowder silica gel

0.8

total

100

[0048] Process:

[0049] 1. Preparation of binder solution: prepare 10% hypromellose solution, take about 25% of it, add EDTA-2Na and rasagiline mesylate, and stir to dissolve. Get 7% microcrystalline fiber of the prescribed amount and disperse it with water. Mix the binder solution added with the main ingredient and EDTA-2Na with the microcrystalline cellulose suspension, control the temperature of the mixed solution at 30°C to 40°C, stir and disperse for 40 minutes.

[0050] 2. Mix the remaining amount of microcrystalline cellulose, croscarmellose sodium, and lactose evenly, first us...

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PUM

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Abstract

The invention discloses a rasagiline tablet. The rasagiline tablet comprises 1-3% of rasagiline mesylate, 1.5-3% of hydroxypropyl methylcellulose, 0.3-3% of EDTA (ethylenediaminetetraacetic acid)-2Na and 50-75% of microcrystalline cellulose by weight. The tablet is prepared by adopting wet granulation and is obtained by dissolving the main drug and EDTA-2Na in part of a hydroxypropyl methylcellulose solution, stirring and mixing suspension formed by the solution and part of microcrystalline cellulose, then mixing the suspension with the remaining microcrystalline cellulose and the residual hydroxypropyl methylcellulose solution to carry out wet granulation and carrying out tabletting. The rasagiline tablet has the advantages of simple prescription, easiness in operation of each process, low production cost and suitability for large-scale industrial production. The obtained product has good long-term stability.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, in particular to a rasagiline tablet. Background technique [0002] Parkinson's disease (PD), also known as Parkinson's disease, is the second most common neurodegenerative disease after Alzheimer's disease. The onset of Parkinson's disease is mainly due to the progressive degeneration of dopaminergic neurons in the substantia nigra-striatum system of the brain, resulting in the depletion of the neurotransmitter dopamine in the main motor area of ​​the striatum. Its two characteristic pathological signs-the selective death of a large number of dopaminergic neurons in the substantia nigra compact part of the midbrain and the existence of Lewy bodies in the remaining neurons, are the root of the clinical symptoms, and its important physiological basis is due to the decrease of dopamine The imbalance between central neurotransmitters caused by the relative increase of acetylcholine. The ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K31/135A61K47/38A61K47/18A61P25/16
CPCA61K9/2013A61K9/2054A61K9/2059A61K31/135
Inventor 张壹沈浩王茂游洪涛刘小英王道权魏洪刚吴科
Owner CHONGQING PHARSCIN PHARM CO LTD
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