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Freeze dry formulation of fasudil hydrochloride and its preparation process

A technology for fasudil hydrochloride and freeze-dried preparations is applied in freeze-dried delivery, pharmaceutical formulations, medical preparations containing active ingredients, etc. Production, broad market scene, rapid and full effect of dissolution

Inactive Publication Date: 2006-02-08
吴良信
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] In order to solve the problems existing in the prior art, the object of the present invention is to provide a vasodilator preparation and a manufacturing method thereof which are convenient to use and transport and have stable performance, which solves the problems of using, storing and transporting existing vasodilators. Convenience and other issues, and stable performance

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1-4

[0033]Take an appropriate amount of Fasudil hydrochloride (produced in Tianjin), mannitol (Shandong Jiejing Group), and water for injection, and dissolve them completely. Use phosphoric acid-sodium dihydrogen phosphate buffer solution, hydrochloric acid, sodium gluconate, and appropriate amount of NaOH solution to adjust the pH value of the solution to about 4, 5.0, 6, and 6.5 to obtain a solution containing 15 mg of fasudil hydrochloride and 50 mg of mannitol per ml . Add activated carbon according to the dosage of 0.02, 0.5, 1, 3% (g / ml) respectively, stir at 25, 30, 35, 55°C for 30, 25, 20, 10 minutes respectively, decarbonize and filter, and the obtained filtrate is filtered with 0.22 μm Sterilization by microporous membrane fine filtration. Under aseptic conditions, the resulting solution is placed in a sterile vial, placed in a lyophilizer and freeze-dried according to the method of Example 10 for about 22, 25, 28, and 30 hours respectively, and aseptically sealed to ob...

Embodiment 5

[0035] Take an appropriate amount of Fasudil hydrochloride, sodium gluconate and lactose (imported), add an appropriate amount of water for injection, stir to make it dissolve completely, add sodium hydroxide solution to adjust the pH value of the solution to 7.5, and obtain 20 mg of Fasudil hydrochloride per milliliter , a solution of 19 mg of sodium gluconate and 60 mg of lactose. Add activated carbon according to the dosage of 1% (g / ml), stir at 30° C. for 30 minutes, decarbonize and filter, and the resulting filtrate is sterilized by fine filtration with a 0.22 μm microporous membrane. Under aseptic conditions, the resulting solution is placed in a sterile vial, freeze-dried in a freeze dryer for about 25 hours respectively, and aseptically sealed to obtain the Fasudil hydrochloride freeze-dried powder preparation E of the present invention.

Embodiment 6

[0037] Take an appropriate amount of fasudil hydrochloride and mannitol, add an appropriate amount of water for injection, and stir to dissolve completely. An appropriate amount of HCl solution was added to adjust the pH value of the solution to about 4.5 to obtain a solution containing 35 mg of fasudil hydrochloride and 200 mg of mannitol per milliliter. Activated carbon was added according to the amount of 2.0% solution, stirred at 25°C for 25 minutes, decarbonized and filtered, and the resulting filtrate was sterilized by fine filtration with a 0.22 μm microporous membrane. Under aseptic conditions, the resulting solution is placed in a sterile vial, and after being freeze-dried in a freeze dryer for 28 hours, it is aseptically sealed to obtain the Fasudil hydrochloride freeze-dried powder preparation F of the present invention.

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Abstract

The invention relates to a freeze dried powder injection of Fasudil hydrochloride and its preparation, which comprises (by weight percent) Fasudil hydrochloride 1-5%, excipient 4-40%. The excipient can be mannitol, lactose, sodium chloride, glucose, glycine, and / or other pharmaceutically acceptable excipient.

Description

technical field [0001] The invention relates to a vasodilator preparation with stable performance and convenient use and transportation and a manufacturing method thereof, in particular to a freeze-dried preparation of fasudil hydrochloride and a preparation method thereof. Background technique [0002] At present, the annual incidence of subarachnoid hemorrhage (SAH) in the world is 6 / 100,000, accounting for 5-10% of stroke incidence, of which 65-80% comes from intracranial aneurysm rupture. Delayed cerebral vasospasm is the most serious complication after SAH, often leading to death or disability of the patient. Nimodipine is a calcium antagonist widely used clinically in the treatment of cerebral vasospasm, and its effectiveness has been recognized. However, nimodipine has some disadvantages pharmacologically. First of all, it is soluble in alcohol-containing solvents, and whether repeated injections are harmful to humans remains to be studied. Secondly, nimodipine is ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/5513A61K9/19A61P9/00A61P43/00
Inventor 吴良信
Owner 吴良信
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