Pramipexole tablet preparation method, tablet prepared therethrough, and application of tablet

A technology for a cable tablet and a solvent, which is applied in the field of pharmaceutical preparations, can solve the problems of many types of substances and a large total impurity content in the pramipexole tablet, and achieves the effects of a simple and reasonable preparation method, a reduction in the content of related substances, and a low cost.

Active Publication Date: 2014-08-06
NANJING SANHOME PHARM RES & DEV CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

According to the method described in the patent application, during trial production of samples, it was found that the obtained pramipexole tablets had many types of related substances and a large content of total impurities
[0006] At the same time, the inventors of the present invention have also found that there are many related substances in these pramipexole tablets and the problem that the total impurity content is large

Method used

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  • Pramipexole tablet preparation method, tablet prepared therethrough, and application of tablet
  • Pramipexole tablet preparation method, tablet prepared therethrough, and application of tablet
  • Pramipexole tablet preparation method, tablet prepared therethrough, and application of tablet

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0049] Example 1 Pramipexole Hydrochloride Tablets (0.125g)

[0050] Prescription, each 1000 tablets contains the following components:

[0051] Pramipexole dihydrochloride monohydrate

125mg

starch

43g

Mannitol

43g

Magnesium stearate

0.45g

silica

0.45g

Polyvinylpyrrolidone

1.5g

[0052] The preparation method of pramipexole hydrochloride sheet described in the present embodiment, comprises the following steps:

[0053] 1) Suspend 100g of medicinal starch in 100g of 10% (weight) ethanol-water solution, fully swell, disperse, stir for 20min, filter and dry.

[0054] 2) Repeat step 1) 5 times;

[0055] 3) Pass pramipexole hydrochloride, starch, mannitol, and silicon dioxide obtained in step 2) through a 100-mesh sieve, and pass magnesium stearate through a 60-mesh sieve for later use;

[0056] 4) Weigh pramipexole dihydrochloride monohydrate and the starch in step 3) according to the component conten...

Embodiment 3

[0076] Example 3 Pramipexole Hydrochloride Tablets (1g)

[0077] Prescription, each 1000 tablets contains the following components:

[0078] Pramipexole dihydrochloride monohydrate

1g

starch

100g

Mannitol

100g

Magnesium stearate

1.0g

silica

1.0g

Polyvinylpyrrolidone

6.3g

[0079] 1) Suspend 200g of medicinal starch in 600g of 20% by weight ethanol-water solution, fully swell, disperse, and stir for 20min, then filter and dry;

[0080] 2) Repeat step 1) 5 times;

[0081] 3) Pass pramipexole hydrochloride, starch, mannitol, and silicon dioxide obtained in step 2) through a 100-mesh sieve, and pass magnesium stearate through a 60-mesh sieve for later use;

[0082] 4) Weigh pramipexole dihydrochloride monohydrate and the starch in step 3) according to the component content of 1000 tablets, and fully mix them uniformly by the method of equal increments to obtain a mixed powder;

[0083] 5) Weigh the ma...

Embodiment 4

[0090] Example 4 Pramipexole Hydrochloride Tablets (0.125g)

[0091] Prescription, each 1000 tablets contains the following components:

[0092] Pramipexole dihydrochloride monohydrate

125mg

starch

43g

Mannitol

43g

Magnesium stearate

0.45g

silica

0.45g

Polyvinylpyrrolidone

4.58g

[0093] 1) Suspend 100g of medicinal starch in 900g of 60% by weight ethanol-water solution, fully swell, disperse, stir for 40min, filter and dry;

[0094] 2) Repeat step 1) once;

[0095] 3) Pass pramipexole hydrochloride, starch, mannitol, and silicon dioxide obtained in step 2) through a 100-mesh sieve, and pass magnesium stearate through a 60-mesh sieve for later use;

[0096] 4) Weigh pramipexole dihydrochloride monohydrate and the starch in step 3) according to the component content of 1000 tablets, and fully mix them uniformly by the method of equal increments to obtain a mixed powder;

[0097] 5) Weigh the mannit...

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PUM

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Abstract

The invention provides a pramipexole tablet preparation method. The method comprises the following steps: suspending starch in a solvent, fully swelling, dispersing and stirring, filtering, and drying; sieving pramipexole, starch, mannitol, silica and magnesium stearate, fully mixing pramipexole with starch according to an equivalent progressive maximum process; and sequentially adding mannitol and an ethanol solution of polyvinylpyrrolidone, granulating, drying, and adding magnesium stearate and silica. The invention also provides a pramipexole tablet prepared through the preparation method, and an application of the pramipexole tablet in the preparation of medicines for treating the Parkinson's disease and restless legs syndrome. The content of related substances in the pramipexole tablet is less than 0.5%. The pramipexole tablet prepared through the method contains few types of the related substances, and has an obviously reduced content of total impurities.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and in particular relates to a new preparation method of pramipexole tablets, the pramipexole tablets obtained by the method of the invention and the application of the pramipexole tablets of the invention. Background technique [0002] Pramipexole hydrochloride is a dopamine D2 receptor agonist approved by the US FDA in 1997 for the treatment of Parkinson's disease and restless legs syndrome. At present, the marketed dosage forms include ordinary tablets and sustained-release tablets, and the market specifications of ordinary tablets include 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg. [0003] The chemical name of pramipexole is S-(-)-2-amino-6-n-propylamino-4,5,6,7-tetrahydrobenzothiazole, and the molecular formula is C 10 h 17 N 3 S, the relative molecular mass is 211.33. The marketed form is pramipexole dihydrochloride monohydrate, which has the following chemical structure: [00...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K31/428A61K47/32A61P25/16A61P43/00
Inventor 王勇陈跃坚王俊生赵静张仓藤再进张迪
Owner NANJING SANHOME PHARM RES & DEV CO LTD
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