Flunarizine hydrochloride lyophilized agent for injection and its preparing method

A technology of flunarizine hydrochloride and freeze-drying agent, which is applied in the directions of freeze-dried transportation, medical preparations without active ingredients, and medical preparations containing active ingredients, etc., can solve the problems of poor stability, inconvenient transportation and inconvenience. It is suitable for long-term storage and other problems, to achieve the effect of stable quality, convenient transportation and storage

Inactive Publication Date: 2006-10-25
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

Its stability is also poor, easy to degrade, not suitable for long-term storage, and transportation is extremely inconvenient,

Method used

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  • Flunarizine hydrochloride lyophilized agent for injection and its preparing method
  • Flunarizine hydrochloride lyophilized agent for injection and its preparing method
  • Flunarizine hydrochloride lyophilized agent for injection and its preparing method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0025] The ratio of raw and auxiliary materials is as follows: (2.5mg / bottle as an example)

[0026] Flunarizine Hydrochloride 9.9g

[0027] Mannitol 323g

[0028] Weigh flunarizine hydrochloride and mannitol according to the above dosage, mix thoroughly and evenly, put in a container, add medicine and water while stirring, adjust the pH to 2.8 with 10% potassium citrate solution, add 10000ml of water for injection, Shake well, add 1g of activated carbon and keep stirring at room temperature for 30 minutes, decarbonize and then filter and sterilize through a 0.22um microporous membrane, pack in aliquots, 3ml per bottle, use quick-freezing method, cool down to -40°C, and keep for 4 hours , evacuated, and freeze-dried. The first stage of sublimation, the temperature should be controlled at -20°C. The vacuum degree was controlled at 0.1 mbar for 30 hours. The second stage of sublimation. The temperature is 40°C, and the time is 4 hours. After freeze-drying, cover and seal. ...

Embodiment 2

[0030] The ratio of raw and auxiliary materials is as follows: (5mg / bottle as an example)

[0031] Flunarizine Hydrochloride 12.9g

[0032] Mannitol 390g

[0033] Weigh flunarizine hydrochloride and mannitol according to the above dosage, mix thoroughly and evenly, put in a container, add medicine and water while stirring, adjust the pH to 3.0 with 10% sodium citrate solution, add 10000ml of water for injection, Shake well, add 10g of needles and stir with activated carbon at room temperature for 30 minutes, decarbonize and then filter and sterilize through a 0.22um microporous membrane, pack in aliquots, 4.5ml per bottle, use quick-freezing method, cool to -50°C, and maintain for 6 hours , evacuated and freeze-dried. In the first stage of sublimation, the temperature should be controlled at -20°C. The vacuum was controlled at 0.1 mbar for 32 hours. The second stage of sublimation. The temperature is 40°C, and the time is 6 hours. After freeze-drying, cover and seal.

Embodiment 3

[0035] The ratio of raw and auxiliary materials is as follows: (2.5mg / bottle as an example)

[0036] Flunarizine Hydrochloride 9.9g

[0037] Mannitol 160g

[0038] Weigh flunarizine hydrochloride and mannitol according to the above dosage, mix well, put in a container, add medicine and water while stirring, adjust pH to 3.5 with 10% sodium hydroxide solution, add water for injection to 10000ml, Shake well, add 5g of activated carbon and keep stirring at room temperature for 30 minutes, decarbonize and then pass through a 0.22um microporous membrane to filter and sterilize, subpackage, 3ml per bottle, use quick-freezing method, cool down to -40°C, and maintain for 6 hours , evacuated, and freeze-dried. The first stage of sublimation, the temperature should be controlled at -20°C. The vacuum was controlled at 0.1 mbar for 28 hours. The second stage of sublimation. The temperature is 40°C, and the time is 3 hours. After freeze-drying, cover and seal.

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PUM

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Abstract

The present invention discloses a flunaizine hydrochloride freeze-dried preparation for injection. Its composition includes (by wt%) 1-50% of flunarizine hydrochloride and 50-99% of auxiliary material, said auxiliary material is mannitol or mannitol composite. Its preparation includes the following steps: a), uniformly mixing flunarizine hydrochloride and medicinal auxiliary material, using acid or alkali to regulate pH value to 2.0-3.5; b), adding 0.01%-0.1% of active carbon, stirring at room temperature, filtering, removing heat source, filtering and sterilizing; c), quickly cooling to-30-50 deg.C, retaining for 2-6 hr.; and d), vacuum freezing, drying and sealing.

Description

technical field [0001] The invention relates to a pharmaceutical preparation and a preparation method thereof, in particular to a lyophilized flunarizine hydrochloride for injection and a preparation method thereof. Background technique [0002] Flunarizine hydrochloride is a piperazine compound, which is a cerebral vasodilator and a selective calcium ion antagonist. Under various etiological stimuli, excessive calcium ion influx across the membrane causes cell damage or death without affecting normal calcium ion balance, and can pass through the blood-brain barrier. Flunarizine hydrochloride mainly acts on brain cells and cerebral blood vessels, and is used to treat cerebrovascular diseases. [0003] Flunarizine hydrochloride was developed by France in 1970, used clinically in 1977, and went on the market in China in the late 1980s. The currently marketed flunarizine hydrochloride only has an oral preparation, which has low bioavailability and slow absorption, and is not ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K31/495A61K47/10A61P9/10
Inventor 张凤侠周露谈学兵王姗姗
Owner 南京虹桥医药技术研究所有限公司
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