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Solid oral prepn. of leishajilan

A solid preparation and tablet technology, applied in the field of rasagiline pharmaceuticals, can solve the problems of difficult operation, low mechanical strength, high energy consumption, etc., and achieve the effect of low cost, high price and high energy consumption

Inactive Publication Date: 2007-02-14
CHONGQING PHARMA RES INST +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, due to the preparation by solvent sublimation technology (freeze drying), not only the energy consumption is high, the operation is difficult, but also the mechanical strength is low, fragile, and easy to be damaged in the process of production, storage and transportation.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0025] Embodiment 1: Rasagiline mesylate oral solid preparation (orally disintegrating tablet)

[0026] Rasagiline mesylate 1.56g, mannitol 200g, microcrystalline cellulose 50g, low-substituted hydroxypropyl cellulose 17.5g, talcum powder 7g, micropowder silica gel 1g, aspartame 1g, and appropriate amount of spices. Become 1000 solid preparations of the present invention.

[0027] The preparation process is as follows: the above-mentioned amount of mannitol, microcrystalline cellulose, low-substituted hydroxypropyl cellulose, aspartame and spices are crushed through a 100-mesh sieve, mixed evenly, and then mixed with rasagiline mesylate in the same amount Add and mix evenly, add talcum powder and micropowder silica gel to mix evenly, and use a rotary tablet press to directly compress tablets.

[0028] The above-mentioned oral solid preparation made is a kind of orally disintegrating tablet. According to the relevant requirements of the Chinese Pharmacopoeia 2000 edition appen...

Embodiment 2

[0029] Embodiment 2: Rasagiline mesylate oral solid preparation (orally disintegrating tablet)

[0030] Rasagiline mesylate 1.56g, mannitol 76g, microcrystalline cellulose 2g, cross-linked PVP 6g, low-substituted hydroxypropyl cellulose 10g, talc 1g, aspartame 3g, these are made into 1000 tablets Invention of the solid formulation.

[0031] The preparation process is as follows: the above-mentioned amount of mannitol, microcrystalline cellulose, cross-linked PVP, low-substituted hydroxypropyl cellulose, and aspartame are pulverized through a 100-mesh sieve, mixed evenly, and then mixed with rasagiline mesylate Add equal amounts and mix evenly, add talcum powder and mix evenly, and use a rotary tablet press to directly compress tablets.

[0032] The solid preparation prepared in this example is an orally disintegrating tablet. According to the relevant requirements of the appendix of the Chinese Pharmacopoeia 2000, the measured results are: its hardness is 4.0 kg, its friabili...

Embodiment 3

[0033] Embodiment 3: Rasagiline mesylate oral solid preparation (orally disintegrating tablet)

[0034] Rasagiline Mesylate 1.56g, Lactose 20.4g, Mannitol 16g, Croscarmellose Sodium Starch 2.5g, Povidone 3.5g, Magnesium Stearate 1g, Aspartame 1.5g, Peppermint Flavor 3g , gelatin 1.1g, these are made into 1000 solid preparations of the present invention.

[0035] Preparation process: add the above amount of rasagiline mesylate into the aqueous solution of gelatin, stir for 1 hour, dry at 40°C for 12 hours, until completely dry, crush and pass through a 100-mesh sieve, the obtained powder is mixed with lactose and mannitol Mix evenly, use 75% ethanol solution of povidone as a binder to make a soft material, pass through a 40-mesh sieve to granulate, dry at 60°C, and granulate until the water content is below 2%. Add cross-linked sodium carboxymethyl starch, aspartame, and mint essence, put it into a V-shaped mixer and mix for half an hour, then add magnesium stearate and contin...

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Abstract

An orally taken solid of rasagiline with high disintegrating speed in oral cavity is proportionally prepared from rasagiline or its pharmacologic salt, filler and disintegrant.

Description

technical field [0001] The invention relates to a rasagiline medicament, in particular to a rasagiline oral various solid preparations for treating Parkinson's disease. Background technique [0002] Parkinson's disease (Parkinsonism'disease, hereinafter referred to as PD) is a common progressive central nervous system degenerative disease, which occurs frequently in middle-aged and elderly people. With the advent of an aging society, the number of PD patients tends to increase. Statistics show that currently about 300,000 people in Germany are suffering from PD, while the number of patients in the United States is as high as 1 million. At present, the total number of people suffering from PD in my country has reached 1.7 million, and the prevalence of PD among people over 55 years old is nearly 1%. PD is a movement disorder. The main clinical symptoms are static tremor, stiffness, slow movement, and difficulty walking. [0003] The chemical name of rasagiline (rasagiline)...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K9/14A61K31/13A61P25/16
Inventor 宗太丽牟才华
Owner CHONGQING PHARMA RES INST
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