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Palonosetron lyophilized formulation and its preparation method

A technology for palonosetron and freeze-dried preparations is applied in the field of freeze-dried preparations of palonosetron hydrochloride and its preparation, which can solve the problems such as no literature reports of palonosetron powder injection, and achieve the storage of medicines. The effect of extended period, good stability and product quality assurance

Inactive Publication Date: 2006-05-10
CHONGQING PHARMA RES INST
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0006] There is no literature report on palonosetron powder injection at home and abroad

Method used

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  • Palonosetron lyophilized formulation and its preparation method

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Embodiment 1

[0028] Dissolve the prescribed amount of glucose in an appropriate amount of water for injection, add an appropriate amount of activated carbon for needles, heat and stir, filter and decarbonize, and add accurately weighed 0.25 g of palonosetron hydrochloride (calculated in bases) to the fine filtrate cooled to room temperature , dissolve, adjust the pH to 3.70-3.99 with 0.1M HCL, add water to the prepared volume of 1000ml, that is, the concentration of palonosetron is 0.25mg / ml, filter and sterilize with a 0.22u mixed cellulose ester microporous membrane, press each bottle 1ml is divided into vials, freeze-dried to powder injection, corked under vacuum, sealed with an aluminum cap, and labeled.

[0029] The advantage of the present invention is that palonosetron hydrochloride adopts the freeze-dried preparation form and has better stability than the aqueous injection form. The palonosetron hydrochloride powder injection of the present invention is investigated for stability. ...

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PUM

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Abstract

The invention relates to the freeze-dried preparation of Palonosetron or its medicinal salts, in particular Palonosetron hydrochloride freeze-dried preparation and its preparing process, which can improve the preparation stability.

Description

Technical field: [0001] The invention relates to a new dosage form of a freeze-dried preparation of palonosetron or a pharmaceutically acceptable salt thereof, in particular to a freeze-dried preparation of palonosetron hydrochloride and a preparation method thereof. Background technique: [0002] The chemical name of Palonosetron Hydrochloride is 2-[(S)-1-azabicyclo[2,2,2]octane-3-yl]-2,3,3a(S),4 , 5,6-Hexahydro-1H-benzisoquinolin-1-one hydrochloride. The chemical structure is: [0003] [0004] Palonosetron hydrochloride is a 5-hydroxytryptamine 3 receptor antagonist developed by Helsinn Healthcare company in Switzerland. Its injection (water injection) was listed in the U.S. in September 2003. The trade name is Aloxi TM Clinically, it is mainly used to treat vomiting reactions during cancer chemotherapy and radiotherapy. Palonosetron hydrochloride is a potent and highly selective serotonin 3 Receptor antagonists characterized by the para-serotonin 3 High receptor ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/473A61K9/19A61P1/08
Inventor 杨翼翔牟才华
Owner CHONGQING PHARMA RES INST
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