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Medicine composition containing pramipexole dihydrochloride and preparation method thereof

A technology of pramipexole hydrochloride and its composition, which is applied in the field of pharmaceutical preparations, and can solve the problems of inability to meet the requirements of preparations, poor compatibility of pramipexole hydrochloride, etc.

Active Publication Date: 2015-12-16
TIANJIN CHASE SUN PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0009] At present, there is no public information about pramipexole hydrochloride orally disintegrating tablets. The inventors tried to prepare pramipexole hydrochloride into orally disintegrating tablets, but found during the preparation process that many excipients had poor compatibility with pramipexole hydrochloride. Unable to meet formulation requirements

Method used

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  • Medicine composition containing pramipexole dihydrochloride and preparation method thereof
  • Medicine composition containing pramipexole dihydrochloride and preparation method thereof
  • Medicine composition containing pramipexole dihydrochloride and preparation method thereof

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0102] The preparation of embodiment 1 pramipexole hydrochloride orally disintegrating tablets

[0103] Based on 1000 dosage units, and each dosage unit contains 0.125mg of pramipexole hydrochloride, its prescription is

[0104] ingredient name

Dosage (g)

pramipexole hydrochloride

0.125

lactose

50

microcrystalline cellulose

35

Croscarmellose Sodium

10

Magnesium stearate

1.5

Micropowder silica gel

1.5

aspartame

1

Co-made

1000 pieces

[0105] Preparation Process:

[0106] (1) Pass lactose, microcrystalline cellulose, croscarmellose sodium, magnesium stearate, micronized silica gel and aspartame through an 80-mesh sieve, and pramipexole hydrochloride through a 200-mesh sieve;

[0107] (2) Mix all materials evenly. When mixing, pramipexole hydrochloride and lactose are mixed in equal increments;

[0108] (3) Microcrystalline cellulose, croscarmellose sodium, micropowder...

Embodiment 2

[0110] The preparation of embodiment 2 pramipexole hydrochloride orally disintegrating tablets

[0111] Based on 1000 dosage units, and each dosage unit contains 0.25mg of pramipexole hydrochloride, its prescription is as follows:

[0112] ingredient name

Dosage (g)

pramipexole hydrochloride

0.25

Mannitol

50

microcrystalline cellulose

30

[0113] Croscarmellose Sodium

5

Low-substituted hydroxypropyl cellulose

10

Magnesium stearate

1.5

Micropowder silica gel

1.5

aspartame

1

Co-made

1000 pieces

[0114] Preparation Process:

[0115] (1) Pass mannitol, microcrystalline cellulose, croscarmellose sodium, low-substituted hydroxypropyl cellulose, magnesium stearate, micronized silica gel and aspartame through an 80-mesh sieve, and pramipexole hydrochloride Pass through 200 mesh sieve;

[0116] (2) Mix all materials evenly. When mixing, pramipexole hydr...

Embodiment 3

[0119] The preparation of embodiment 3 pramipexole hydrochloride orally disintegrating tablets

[0120] Based on 1000 dosage units, and each dosage unit contains 0.5mg of pramipexole hydrochloride, its prescription is as follows:

[0121] ingredient name

Dosage (g)

pramipexole hydrochloride

0.5

Mannitol

50

microcrystalline cellulose

30

Crospovidone

5

Low-substituted hydroxypropyl cellulose

10

Magnesium stearate

1.5

Micropowder silica gel

1.5

stevia

1

Co-made

1000 pieces

[0122] Preparation Process:

[0123] (1) respectively passing mannitol, microcrystalline cellulose, crospovidone, low-substituted hydroxypropyl cellulose, magnesium stearate, micronized silica gel and stevioside through a 80-mesh sieve, and pramipexole hydrochloride through a 200-mesh sieve;

[0124] (2) Mix all materials evenly. When mixing, pramipexole hydrochloride and mannitol are mixe...

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PUM

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Abstract

The invention relates to medicine composition containing pramipexole dihydrochloride and a preparation method thereof. The composition is orally disintegrating tablets and comprises components in percentage by weight in the specification. The preparation process of the pramipexole dihydrochloride orally disintegrating tablets is simple, and the pramipexole dihydrochloride orally disintegrating tablets taste good, have better compliance for medicine taking by comparison with products on the current market and are especially suitable for the special population such as the old, people who have difficulty in swallowing and the like.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, in particular to a pharmaceutical composition containing pramipexole hydrochloride and a preparation method thereof. Background technique [0002] Pramipexole hydrochloride is a dopamine receptor agonist. [0003] The chemical formula is as follows: [0004] [0005] (s)-2-Amino-4,5,6,7-tetrahydro-6-propylamine-benzothiazole, molecular formula C 10 h 19 C l2 N 3 S.H 2 O, the molecular weight is 302.27. [0006] Pramipexole hydrochloride monohydrate dihydrochloride is commonly used in preparations. [0007] Pramipexole hydrochloride is pharmacologically a full agonist and has receptor selectivity for the dopamine D2 family of dopamine receptors. It is used to treat conditions such as Parkinson's disease and restless legs syndrome. At present, the marketed dosage forms include ordinary tablets and sustained-release tablets. mg, 0.75mg, 1.5mg, 2.25mg, 3mg, 3.75mg and 4.5mg and...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K31/428A61P25/16A61P25/14
Inventor 魏征郭嘉林董凯孙长海姚小青
Owner TIANJIN CHASE SUN PHARM CO LTD
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