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Flunarizine hydrochloride injection and its preparing method

A technology of flunarizine hydrochloride and injection, which is applied in the fields of blood diseases, medical formulas, extracellular fluid diseases, etc. It can solve the problems of not containing solubilizers and analgesics, etc., and achieve remarkable curative effect and convenient use

Inactive Publication Date: 2005-05-18
南京虹桥医药技术研究所有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] The technical problem to be solved by the present invention is to overcome the defects in the prior art, provide a kind of flunarizine hydrochloride injection and preparation method thereof, because adopt preparation technology to solve the dissolving problem of flunarizine hydrochloride, so no Contains solubilizers and pain relievers

Method used

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  • Flunarizine hydrochloride injection and its preparing method

Examples

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Comparison scheme
Effect test

Embodiment 1

[0026] Accurately weigh 0.5 g of flunarizine hydrochloride, add 500 ml of water for injection at 10 degrees Celsius, and stir to disperse evenly. Heat to 100 degrees Celsius, add 0.1‰ activated carbon and keep it warm for 15 minutes, filter while it is hot, dilute the filtrate with water for injection to 1000ml, fine filter until clear, add appropriate amount of sodium hydroxide to adjust the pH to 3.5, after the semi-finished product is qualified, potting, 5ml per bottle, sterilized by circulating steam at 100°C for 30 minutes. Specifications: 5ml: 2.5mg. It can be added to 5% or 10% glucose injection for intravenous infusion.

Embodiment 2

[0028] Accurately weigh 0.25 g of flunarizine hydrochloride, add 500 ml of 5% glucose aqueous solution at 20 degrees Celsius, and stir to disperse evenly. Heat to 80 degrees Celsius, add 0.1‰ activated carbon to keep warm for 15 minutes, filter while it is hot, directly add 5% glucose aqueous solution to the filtrate to dilute to 1000ml, fine filter until clear, add appropriate amount of sodium hydroxide to adjust the pH to 3.5, after the semi-finished product is qualified, pour Sealed, 5ml per bottle, sterilized by circulating steam at 100°C for 30 minutes. Specifications: 5ml: 1.25mg. It can be added to 5% or 10% glucose injection for intravenous infusion.

Embodiment 3

[0030] Accurately weigh 0.5 g of flunarizine hydrochloride, add 500 ml of water for injection at 40 degrees Celsius, and stir to disperse evenly. Heat to 60 degrees Celsius, add 0.1‰ activated carbon to keep warm for 15 minutes, filter while it is hot, dilute the filtrate with water for injection to 1000ml, fine filter until clear, add an appropriate amount of sodium hydroxide solution to adjust the pH to 3.0, after the semi-finished product is tested, pour Sealed, 5ml per bottle, sterilized by circulating steam at 100°C for 30 minutes. Specifications: 5ml: 2.5mg. It can be added to 5% or 10% glucose injection for intravenous infusion.

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Abstract

The flunarizine hydrochloride injection consists of flunarizine hydrochloride 1-5 g, 0.1 mol / L sodium hydroxide solution 0-250 ml and water for injection or 5 % or 10 % glucose solution 50,000 ml; or flunarizine hydrochloride 1-5 g, and 0.1 mol / L hydrochloric acid solution 0-600 ml or 10 % glucose solution 1,000,000 ml. The preparation process makes flunarizine hydrochloride dissolved fully through adding flunarizine hydrochloride into solution at low temperature to disperse flunarizine hydrochloride through stirring, and heating to relatively high temperature to dissolve flunarizine hydrochloride fully. The injection contains no solabilizer and analgetic, thus has no bad irritation to blood vessel and muscle, and is convenient in use, safe and obvious in curative effect.

Description

technical field [0001] The invention relates to a flunarizine hydrochloride injection and a preparation method thereof. The flunarizine hydrochloride injection has expansion effect on vascular smooth muscle and is used for cerebral thrombosis, cerebral embolism, cerebral arteriosclerosis and other diseases. Background technique [0002] The currently marketed flunarizine hydrochloride only has an oral preparation, which has low bioavailability and slow absorption, and is not suitable for critically ill patients. Disclosed a kind of flunarizine hydrochloride injection and preparation method in Chinese patent " flunarizine hydrochloride injection and preparation technology " (application number: 01142869.4), when preparing flunarizine hydrochloride injection with its method, It is an injection prepared by processing flunarizine hydrochloride, benzyl alcohol solution, propylene glycol solution, activated carbon and water for injection in a certain proportion. The injection tha...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K31/495A61P7/02A61P9/10
Inventor 张凤侠谈学兵周露
Owner 南京虹桥医药技术研究所有限公司
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