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Process for preparing pramipexole dihydrochloride tablets

A preparation process, the technology of pramipexole tablet, which is applied in the direction of pill delivery, medical preparations containing active ingredients, organic active ingredients, etc., can solve the complex process, demanding process conditions, pramipexole dihydrochloride monohydrate Unstable tablet storage and other problems, to achieve the effect of low quality, high quality and good storage stability

Active Publication Date: 2013-07-03
重庆瑞泊莱医药科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] The pramipexole dihydrochloride monohydrate tablet listed in the USA in 2005 has the problem of unstable storage. After 18 months of storage, there is only about 95% of the active ingredient in the average labeled amount in the tablet, which affects the The efficacy of the drug and increase the cost and safety of manufacturing and patient administration
Those skilled in the art know that the above-mentioned patented technology has complex processes, harsh process conditions (such as: dark operation, strict control of the moisture content of the product), special equipment (fluidized bed granulator), and final product The stability is still not ideal and other defects, it does not meet the requirements and needs of industrial mass production

Method used

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  • Process for preparing pramipexole dihydrochloride tablets
  • Process for preparing pramipexole dihydrochloride tablets
  • Process for preparing pramipexole dihydrochloride tablets

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0031] a) Ingredients

[0032] On the basis of 1000 dosage units, and each dosage unit contains 0.125 mg of pramipexole dihydrochloride monohydrate, weigh:

[0033]

[0034] b) Prepare the total mixture

[0035] ① Add pramipexole dihydrochloride monohydrate into a micronizer and pulverize until the particle size is not greater than 50 μm;

[0036] ②Put the pulverized pramipexole dihydrochloride monohydrate, binder (microcrystalline cellulose), and glidant (micropowder silica gel) into the mixer, mix for 5 minutes, and take a sample to detect its RSD≈8.5%; Mix for another 5 minutes, take a sample to detect its RSD ≈ 4%, release the material, and obtain material A;

[0037] ③ Add material A, filler (lactose) and disintegrant (sodium starch glycolate) into the mixer, mix for 5 minutes, release the material, and obtain material B;

[0038] ④ Add material B and lubricant (magnesium stearate) into the mixer and mix for 10 minutes to obtain the total mixed material;

[0039] c...

Embodiment 2

[0041] a) Ingredients

[0042] On the basis of 1000 dosage units, and each dosage unit contains 0.25 mg of pramipexole dihydrochloride monohydrate, weigh:

[0043]

[0044] For the rest of the content, refer to the description in Example 1.

Embodiment 3

[0046] a) Ingredients

[0047] On the basis of 1000 dosage units, and each dosage unit contains 0.5 mg of pramipexole dihydrochloride monohydrate, weigh:

[0048]

[0049] For the rest of the content, refer to the description in Example 1.

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Abstract

The invention discloses a process for preparing pramipexole dihydrochloride tablets. The process is a dry-method preparation process of performing dry-method direct tablet compression on the prepared mixed material of a main medicine, namely, pramipexole dihydrochloride, and pharmaceutically acceptable tablet auxiliary materials. With the adoption of the process for preparing pramipexole dihydrochloride tablets provided by the invention, a series of problems and defects of complex process, harsh requirements on process conditions, need of special equipment, instable quality and short storage life of finally-finished products, and the like caused by that pramipexole dihydrochloride is easily photodegrade in a solution state are effectively solved; preparation for the pramipexole dihydrochloride tablets which are stable in quality, excellent in quality, and good in storage stability by a simple, practicable and low-cost process is realized; and the requirements of industrialized batch production for the pramipexole dihydrochloride tablets in quality and economy can be met. Therefore, the process has an industrialized application value.

Description

technical field [0001] The invention relates to a preparation process of pramipexole hydrochloride tablets, in particular to a process for preparing pramipexole hydrochloride tablets by a dry method, and belongs to the technical field of preparation of pharmaceutical preparations. Background technique [0002] Pramipexole is a dopamine receptor agonist. dopamine receptor D 2 Subfamily binding is highly selective and specific, and has full intrinsic activity, for which D 3 Receptors have preferential affinity. [0003] Usually the pharmaceutically used solvent and drug form are pramipexole dihydrochloride monohydrate (molecular formula is C 10 h 17 N 3 S 2HCl H 2 O). Pramipexole dihydrochloride monohydrate is a highly soluble compound with a water solubility greater than 20 mg / ml, and a solubility in a buffer medium with a pH between 2 and 7.4 generally above 10 mg / ml. Pramipexole dihydrochloride monohydrate has extremely low hygroscopicity and is highly crystalline, ...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K31/428A61P25/16
Inventor 李锋邹玉珠
Owner 重庆瑞泊莱医药科技有限公司
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