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Fasudil hydrochloride pharmaceutical composition and preparation method thereof

A technology of fasudil hydrochloride and its composition, which is applied in the field of medicine and can solve the problems of less attention to insoluble particles

Inactive Publication Date: 2019-03-26
九瑞健康股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] The insoluble particles of injection preparations, especially intravenous injection preparations, have been considered to be an important reason for the side effects of many drugs in clinical practice. Fasudil hydrochloride injection is usually diluted with an appropriate amount of electrolyte solution for intravenous drip injection in clinical practice. Currently, for Little attention has been paid to the change of insoluble particles after fasudil hydrochloride dilution

Method used

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  • Fasudil hydrochloride pharmaceutical composition and preparation method thereof
  • Fasudil hydrochloride pharmaceutical composition and preparation method thereof
  • Fasudil hydrochloride pharmaceutical composition and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0016]

[0017] Preparation:

[0018] Add 80% of the prescribed amount of water for injection into the liquid preparation tank, then add the prescribed amount of fasudil hydrochloride, sodium citrate and sodium chloride, stir to dissolve, add 0.05% of activated carbon for needles, stir evenly, and let it stand Adsorb for 10 minutes, add water for injection to nearly full amount, stir evenly, adjust the pH value to 6.0 with 0.1mol / L hydrochloric acid solution or 0.1mol / L sodium hydroxide solution, and filter to remove carbon for 5-10 minutes. Filter at 0.45 μm, fine filter with a 0.22 μm filter element, light check until there is no visible foreign matter, potting, sterilize in a water bath at 121°C for 15 minutes, light check, and pack.

Embodiment 2

[0020]

[0021] The preparation method is the same as in Example 1.

Embodiment 3

[0023]

[0024] The preparation method is the same as in Example 1.

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PUM

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Abstract

The invention belongs to the technical field of pharmaceutical preparations and in particular relates to a hydroxyfasudil pharmaceutical composition. The hydroxyfasudil pharmaceutical composition has a dosage form of an injection and is characterized by comprising sodium citrate which is capable of preventing change of insoluble particles in the process of preparation placement and guaranteeing the stability and the safety of a preparation.

Description

technical field [0001] The invention belongs to the technical field of medicines, and in particular relates to a pharmaceutical composition of fasudil hydrochloride and a preparation method thereof. The composition is an injection. Background technique [0002] The chemical name of Fasudil hydrochloride is: Hexahydro-1-(5-sulfonylisoquinoline)-1(H)-1,4-diazepine hydrochloride. Fasudil hydrochloride is a new type of drug with a wide range of pharmacological effects. As an RHO kinase inhibitor, it expands blood vessels by increasing the activity of myosin light chain phosphatase, reduces the tension of endothelial cells, improves the microcirculation of brain tissue, and does not produce And aggravate blood stealing in the brain, at the same time, it can antagonize inflammatory factors, protect nerves against apoptosis, and promote nerve regeneration. It is clinically used to prevent and improve vasospasm caused by various reasons, selectively expand the spasmed blood vessels...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/08A61K31/551A61K47/12A61P9/10A61P25/00
Inventor 安东
Owner 九瑞健康股份有限公司