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Fasudil hydrochloride injection and its preparation process

A technology of fasudil hydrochloride and injection, which is applied in pharmaceutical formulations, medical preparations containing active ingredients, drug delivery, etc., can solve problems such as singleness, and achieves the advantages of avoiding trouble, convenient and fast clinical use, and great practical value. Effect

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

[0005] In order to solve the problems existing in the prior art, the present invention provides a kind of Fasudil hydrochloride injection, which can overcome the single problem of existing similar products, and is convenient and safe to use

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1-6

[0026] Take an appropriate amount of Fasudil hydrochloride (manufactured by Tianjin Xuanhong Pharmaceutical Technology Co., Ltd.) and sodium chloride, add water for injection with 70% of the prescription amount of water for injection, stir to make it completely dissolve, and add water for injection to the full amount. Use appropriate amount of phosphoric acid-sodium dihydrogen phosphate buffer solution, sodium gluconate, phosphoric acid-sodium dihydrogen phosphate buffer solution, NaOH solution, NaOH solution, and NaOH solution to adjust the pH value of the solution to 4, 5.5, 6, 6.5, 7, Around 7.5, a solution containing 0.3 mg of fasudil hydrochloride and 9 mg of sodium chloride per milliliter was obtained. Add activated carbon according to the dosage of 0.06, 0.5, 1, 2, 3, 4% (g / ml) respectively, stir at 55, 45, 40, 35, 30, 25°C for 15, 25, 20, 20, 30, After 10 minutes, decarbonize and filter, and the resulting filtrate is sterilized by fine filtration with a 0.22 μm micropo...

Embodiment 7

[0028] Take an appropriate amount of fasudil hydrochloride and glucose, add an appropriate amount of water for injection, and stir to completely dissolve it. Add an appropriate amount of HCl solution to adjust the pH value of the solution to about 4.5 to obtain a solution containing 0.6 mg of fasudil hydrochloride and 200 mg of glucose per milliliter. Add activated carbon according to the dosage of 1.0 g / ml solution, stir at 25°C for 30 minutes, decarbonize and filter, and the obtained filtrate is sterilized by fine filtration with a 0.22 μm microporous membrane. After the semi-finished product passes the inspection, it is potted in a qualified infusion bottle, sealed and capped, and sterilized at 120°C for 20 minutes to obtain Fasudil Hydrochloride Injection G of the present invention.

Embodiment 8-10

[0030]Take an appropriate amount of Fasudil hydrochloride and amino acids, add an appropriate amount of water for injection, and stir to completely dissolve it. Add appropriate amount of NaOH solution, HCl solution, and NaOH solution to adjust the pH value of the solution to about 7.0, 5.5, and 6.5, respectively, to obtain a solution containing 0.8 mg of Fasudil hydrochloride and 100 mg of amino acid per milliliter, and Fasudil hydrochloride per milliliter A solution of 0.3 mg and 200 mg of amino acid, and a solution containing 0.3 mg of fasudil hydrochloride and 300 mg of amino acid per milliliter. Add activated carbon according to the dosage of 1.0 g / ml solution, stir at 25°C for 20 minutes, decarbonize and filter, and the obtained filtrate is sterilized by fine filtration with a 0.22 μm microporous membrane. After semi-finished product inspection is qualified, potting is in the transfusion bottle that handles qualified, and sealing gland, after 115 ℃ of sterilizations 30 mi...

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Abstract

The invention provides a Fasudil hydrochloride injection, which comprises Fasudil hydrochloride, sodium chloride, glucose, amino acid, and the aqueous solution of other pharmaceutically acceptable thinning agent, wherein the content of Fasudil hydrochloride is 0.01-0.2 wt%, the content of the aqueous solution of other pharmaceutically acceptable thinning agent is 0.5-50 wt%, the content of sodium chloride is 0.9-5 wt%, the content of glucose is 5-20%, the content of amino acid is 0.5-30 wt%.

Description

technical field [0001] The invention relates to a vasodilator and a manufacturing method thereof, in particular to fasudil hydrochloride injection and a manufacturing 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 solvents containing alcohol, and whether repeated injections are harmful to the human body remains to be studied. Secondly, nimodipine is sensitive to light and needs to be protected from light when dripping. Moreover, it...

Claims

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Application Information

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IPC IPC(8): A61K31/5513A61K9/08A61P9/00A61P9/10
Inventor 吴良信
Owner 吴良信
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