A kind of Ⅲ crystal form pramipexole hydrochloride tablet and preparation method thereof

A technology for pramipexole hydrochloride and pramipexole hydrochloride tablets, which is applied in the field of III crystal pramipexole hydrochloride tablets and its preparation, and can solve the problems of increasing the load of tableting equipment, poor material fluidity, affecting tablet weight differences, tablet hardness, etc. , to achieve the effect of ensuring stability and avoiding the degradation of impurities

Active Publication Date: 2014-10-08
CHENGDU XINJIE HIGH TECH DEV CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

This method adopts the method of all-powder tableting. Due to the poor material fluidity of all-powder materials, the difference in tablet weight and tablet hardness will be affected during the tableting process, and the load on the tableting equipment will be increased at the same time.

Method used

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  • A kind of Ⅲ crystal form pramipexole hydrochloride tablet and preparation method thereof
  • A kind of Ⅲ crystal form pramipexole hydrochloride tablet and preparation method thereof
  • A kind of Ⅲ crystal form pramipexole hydrochloride tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0041] 1. According to prescription 1, pass mannitol, corn starch, magnesium stearate, and silicon dioxide through a 100-mesh sieve; and pass through a 200-mesh sieve for pramipexole hydrochloride monohydrate in the third form.

[0042] 2. According to the designed prescription, take 50,000 pieces of auxiliary materials that have passed through a 100-mesh sieve. Preliminarily mixed the weighed III crystal form pramipexole hydrochloride monohydrate raw materials, corn starch, and D-mannitol by the method of doubling increments, then put them in a high-efficiency mixer, mixed for 45 minutes, and tested the content uniformity, qualified Then proceed to the next step.

[0043] 3. After the mixing is completed, put the mixed material into a dry extrusion granulator for dry granulation. (Pre-pressing wheel: 15-20Hz, pressing material: 30-50Hz, feeding material: 10-15Hz, hydraulic pressure: 6-7Mpa). During the granulation process, add material in the hopper at any time. Adjust the...

Embodiment 2

[0048] According to the ratio of prescription 2-8 to make tablets, refer to Example 1 for specific operations.

Embodiment 3

[0050] Pramipexole hydrochloride is easily soluble in water. In the import quality standard (JX20070241), 500ml of citrate / phosphate buffer (PH6.8) is used as the solvent. The paddle method is used at a speed of 50 rpm. This method is consistent with the FDA dissolution database The conditions of the published dissolution method for pramipexole hydrochloride tablets are consistent. The present invention adopts four kinds of solvents (see Table 1) conditions to investigate the similarity (50≤f 2 ≤100) meet the requirements.

[0051] Table 1 Four kinds of solvent conditions

[0052]

[0053] Pramipexole hydrochloride tablets (batch number: 100602, specification: 0.25mg; batch number: 100601, specification: 1.0mg) and pramipexole hydrochloride tablets commercially available in the examples (Senfulol; batch number: 002448; specification: 1.0mg ; Batch number: 004381; Specification: 0.25mg) Carry out dissolution curve research in four kinds of dissolution media and draw dissol...

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PUM

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Abstract

The invention discloses a III crystal form pramipexole hydrochloride tablet and a preparation method thereof, comprising the following steps: crushing, mixing, dry granulation, total mixing and tabletting. The third crystal form announced by the brand drug is used for feeding to ensure the stability of the crystal form of the product, and there is no crystal form conversion; and the dry granulation can avoid the solid state of pramipexole hydrochloride monohydrate under other wet production processes. Stability, to avoid degradation of impurities caused by photosensitivity. Guarantee the stability of the product during the shelf life and the effectiveness and safety of clinical medication. The dissolution behavior of the product produced by the dry granulation process of the present invention is similar to that of the brand name drug.

Description

Technical field [0001] The present invention involves a Ⅲ crystal -type Plackhlonicine and its preparation method, which belongs to the field of drug preparations. Background technique [0002] The structural formula is shown below: [0003] [0004] Generally, Parkinson is used to treat Parkinson, which is commonly used for the elderly.Parkinson's disease belongs to the central nervous system transgender disease, and patients are mostly on the age of 60.The main manifestations are the tremor of the patient's movement slowly, the tremor of the hands and feet or the other part of the body, and the body loses its softness and coordination. [0005] Due to the very stable solids of Pralshochloride, existing technology (such as US20080254118A1; US20100252949A1; CN101505734A) uses solvents to ensure the uniform content of Plax hydrochloride in the product., Resulting in a rise in impurities, so use wet preparation to use solvents, such as solvents, such as water needed to dissolve t...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/20A61K31/428A61K47/36A61P25/16
Inventor 蒲洪林树李长生欧世荣张西彪
Owner CHENGDU XINJIE HIGH TECH DEV CO LTD
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