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Pramipexole dihydrochloride solution prepared from pramipexole dihydrochloride solid preparation and determination method thereof

A technology of pramipexole hydrochloride and solid preparations, which is applied in the field of pramipexole hydrochloride solution and its determination, which can solve the problems of unavailable, expensive enzyme solution, and difficult disintegration of tablets, and achieve high accuracy

Active Publication Date: 2020-08-04
珠海润都制药股份有限公司
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  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The pramipexole hydrochloride preparation contains two excipients, HPMC and carbomer, which make it difficult to disintegrate the tablet and extract the main component.
In the "Standards for Registration of Imported Drugs of the State Food and Drug Administration", the powdered pramipexole hydrochloride sustained-release tablets are added with methanol-acetonitrile-phosphoric acid solvent, after shaking, phosphate buffer and enzyme solution are added, and after shaking, phosphate buffer diluted with liquid, and then filtered with a filter membrane, the enzyme solution used in this method is relatively expensive and not easy to obtain
[0005] In the "European Pharmacopoeia", the powdered pramipexole hydrochloride sustained-release tablets are mixed and shaken with solution A. Solution A is a mixture of methanol and mobile phase A. Mobile phase A is potassium dihydrogen phosphate and octane Sodium sulfonate is adjusted to the mixed solution of pH3.0 by phosphoric acid, the shortcoming of this method is that pramipexole hydrochloride sustained-release tablet can not be directly dissolved in the solution A, must grind pramipexole hydrochloride sustained-release tablet into powder in advance, And the detection accuracy is not high

Method used

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  • Pramipexole dihydrochloride solution prepared from pramipexole dihydrochloride solid preparation and determination method thereof
  • Pramipexole dihydrochloride solution prepared from pramipexole dihydrochloride solid preparation and determination method thereof
  • Pramipexole dihydrochloride solution prepared from pramipexole dihydrochloride solid preparation and determination method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0026] Preparation of pramipexole hydrochloride solution of the present invention (sample specification: API: 0.26 mg): Take 5 pramipexole sustained-release tablets, weigh them precisely, place them in a 500ml measuring bottle, add 25ml of isopropanol, and let stand for 5 minutes. Add 25ml of dimethyl sulfoxide, stir magnetically for 20min, and rotate at 1000rpm; add 350ml of diluent, sonicate for 60min, shake occasionally during sonication, take out the stirring bar, and dilute to the mark with diluent; centrifuge at 9000rpm for 20min. After filtering with a 0.45 μm filter membrane, 3 ml of the initial filtrate was discarded, and the filtrate obtained pramipexole hydrochloride solution.

Embodiment 2

[0032] 1. Experimental materials and instrument conditions

[0033] Experimental materials: acetonitrile, manufacturer: Rankem; phosphoric acid, manufacturer: Merck; potassium dihydrogen phosphate, manufacturer: Merck; anhydrous 1-octanesulfonic acid sodium salt, manufacturer: Rankem; dimethyl sulfoxide, manufacturer Manufacturer: Rankem; isopropanol, manufacturer: Merck; ultrapure water, manufacturer: Zhuhai Rundu Pharmaceutical Co., Ltd.; pramipexole hydrochloride sustained-release tablets, manufacturer: Zhuhai Rundu Pharmaceutical Co., Ltd., specification: 0.26 mg, 0.58mg, 1.05mg.

[0034] Instrument: high performance liquid chromatography: Agilent 1260; ultrasonic instrument: pH meter: Lab India-PICO+; semi-micro balance: Radwag-XA 82 / 220 / 2X; ultrasonic instrument: PCI analytics; constant temperature oscillator: Glass co; centrifuge : Eltek; electronic analytical balance: XSE205DU, GR-200; chromatographic column: Inertsil ODS-3V (150×4.6mm), 5 μm.

[0035] Detection meth...

Embodiment 3

[0048] Embodiment 3 Detection method specificity test of the present invention

[0049] Specificity is to examine the identification and selectivity of the components to be tested. It is required that the blank solution and blank excipients do not interfere with the detection of pramipexole hydrochloride; in the system adaptability solution, all impurity peaks are well separated from the chromatographic peaks of pramipexole hydrochloride .

[0050] Interference assessment of blank solution and blank excipient solution: Analyze the blank solution (diluent), reference solution and blank excipient solution according to the assay method.

[0051] Conclusion: The number of theoretical plates is not less than 2000, the tailing factor is not more than 2.0, the blank solution has no interference at the retention time of pramipexole, the blank excipient solution has no interference at the retention time of pramipexole hydrochloride, and all impurity peaks in the sample solution are It...

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Abstract

The invention aims at providing a pramipexole dihydrochloride solution prepared from a pramipexole dihydrochloride solid preparation and a determination method thereof. The invention provides a methodfor preparing a pramipexole dihydrochloride solution by adopting a pramipexole dihydrochloride sustained-release tablet, wherein the method is short in detection time, high in efficiency, easy in rawmaterial obtaining and low in cost; and the pramipexole dihydrochloride sustained-release tablets are directly dissolved in the organic solvent to prepare the pramipexole dihydrochloride solution, and the preparation method is simple and convenient. The pramipexole dihydrochloride solution prepared by the method disclosed by the invention is used for detecting pramipexole dihydrochloride in pramipexole dihydrochloride sustained-release tablets; according to the present invention, the method conforms to the guidance principle of the verification of the Chinese pharmacopoeia method in terms ofthe system applicability, the specificity, the precision, the detection limit, the quantification limit and the like; and the unexpected results show that the accuracy of the detection method of the present invention is significantly high by being compared with the existing method, such that the method has important significance for the production manufacturers of pramipexole dihydrochloride preparations.

Description

technical field [0001] The invention belongs to the technical field of drug analysis, in particular to a pramipexole hydrochloride solution prepared from a pramipexole hydrochloride solid preparation and a determination method thereof. Background technique [0002] Pramipexole was developed by Boehringer-Ingelheim (Boehringer-Ingelheim), Germany, and pramipexole hydrochloride immediate release tablets (pramipexoledihydrochloride immediate release tablets) were first listed in the United States in 1997; ) listed in China. After more than 20 years of clinical application of pramipexole hydrochloride tablets, its efficacy and safety have been unanimously recognized by doctors and patients. [0003] Pramipexole is a non-ergot dopamine receptor agonist that acts highly selectively on D2 and D3 receptors, and has significantly higher affinity for D3 receptors than D2 receptors. Improve the motor symptoms of PD patients by selectively exciting striatal post-synaptic membrane D2 a...

Claims

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Application Information

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IPC IPC(8): G01N30/02G01N30/06G01N30/86
CPCG01N30/02G01N30/06G01N30/8679G01N2030/065Y02A50/30
Inventor 刘彦杉吴晓斐姚文娟李中辉伍小云谢斌刘杰王晴晴
Owner 珠海润都制药股份有限公司
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