Preparation method of composition containing ropinirole

A compound and mixture technology, applied in the field of preparation of pharmaceutical compositions, can solve the problems of complex preparation process and poor content uniformity of ropinirole preparations

Active Publication Date: 2014-01-08
XIAN LIBANG PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0011] The invention provides a preparation method of a ropinirole oral solid pharmaceutical composition, which can not only ensure the rapid dissolution of ropinirole, but also effectively solve the problems of complex preparation process and poor content uniformity of ropinirole preparations. problem without compromising its stability

Method used

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  • Preparation method of composition containing ropinirole
  • Preparation method of composition containing ropinirole
  • Preparation method of composition containing ropinirole

Examples

Experimental program
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Effect test

Embodiment 1

[0070] Embodiment 1: Preparation of ropinirole hydrochloride tablets by ropinirole hydrochloride-microcrystalline cellulose mixing-powder direct compression process

[0071] Take an appropriate amount of ropinirole hydrochloride, add 90% ethanol solution to dissolve, pour the solution into an appropriate amount of microcrystalline cellulose, stir and mix, and dry at 40°C for 4 hours; the dried powder is cross-linked with carboxymethyl cellulose with other auxiliary materials Sodium sodium, lactose and magnesium stearate were mixed, and the proportions of ropinirole hydrochloride, microcrystalline cellulose, croscarmellose sodium, lactose and magnesium stearate in the prescription were kept at 0.38%, 46.56%, 46.56%, 6% and 0.5%, compressed into tablets, and then coated with Opadry II 85G coating material, controlling the coating weight gain between 2% and 3%.

Embodiment 2

[0072] Embodiment 2: Preparation of ropinirole hydrochloride tablets by ropinirole hydrochloride-microcrystalline cellulose mixing-powder direct compression process

[0073] Take an appropriate amount of ropinirole hydrochloride, add 75% ethanol solution to dissolve, pour the solution into an appropriate amount of microcrystalline cellulose, stir and mix, and after mixing, place it in a hot air circulation drying oven for 2 hours at room temperature; the dried powder and prescription Other excipients in croscarmellose sodium, lactose and magnesium stearate are mixed to keep ropinirole hydrochloride, microcrystalline cellulose, croscarmellose sodium, lactose and magnesium stearate in the prescription The proportions in the prescription are 0.76%, 61.16%, 30.58%, 7% and 0.5% respectively, compressed into tablets, and then coated with Opadry II 85G coating material, controlling the weight gain of the coating at 2%-3% between.

Embodiment 3

[0074] Embodiment 3: Preparation of ropinirole hydrochloride tablets by ropinirole hydrochloride-silicon dioxide mixing-powder direct compression process

[0075] Take an appropriate amount of ropinirole hydrochloride, add an appropriate amount of water to dissolve, pour the solution into an appropriate amount of silicon dioxide, stir and mix, and dry at 40°C after mixing; the dried powder is cross-linked with other excipients in the prescription. Sodium cellulose, lactose and magnesium stearate are mixed, except that the microcrystalline cellulose in the embodiment 1 is replaced by silicon dioxide, keep the composition of the prescription and the composition of the prescription in the embodiment 2 the same, compress tablets, then use European Coating with Badai II 85G coating material, control the weight gain of the coating between 2% and 3%.

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Abstract

The invention discloses a preparation method of a solid pharmaceutical composition containing ropinirole or derivatives of ropinirole. The preparation method is characterized by comprising the following steps: firstly, dissolving the ropinirole or derivatives of ropinirole into a proper solvent, then adding the solution to a pharmaceutically acceptable carrier; evenly mixing, drying and then mixing with other materials, and finally preparing into an oral solid preparation. By adopting the method, ropinirole can be rapidly dissolved out, the problems of complicated preparation process and poor content uniformity in the preparation process of the ropinirole preparation can be effectively solved; meanwhile, the stability of ropinirole is not affected.

Description

technical field [0001] The invention relates to a preparation method of a pharmaceutical composition, in particular to a preparation method of a pharmaceutical composition containing ropinirole. Background technique [0002] Ropinirole hydrochloride, chemical name: 4-2-di-n-propylaminoethyl-1,3-dihydro-2H-indol-2-one hydrochloride, the structural formula is as follows: [0003] [0004] The drug is a selective non-ergoline dopamine D2 receptor agonist developed by Smithkline Beecham Company. It was first launched in the UK in 1996 and is clinically used to treat Parkinson's disease. Soon, France and the United States were also approved to go on the market under the trade name Requip. This product is clinically used to treat Parkinson's disease and restless legs syndrome, etc. It can be used alone or in combination with levodopa. It is one of the few effective drugs for early Parkinson's disease and restless legs syndrome one. Ropinirole hydrochloride has been disclosed...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/4045A61P25/16A61P25/14
Inventor 梅兴国李志平狄忠刘燕赵希青余维平陈涛
Owner XIAN LIBANG PHARMA
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