Fasudil hydrochloride injection composition and preparation method thereof

Abstract

The invention provides a fasudil hydrochloride injection composition and a preparation method thereof. According to the fasudil hydrochloride injection composition, fasudil hydrochloride, reduced glutathione, poloxamer 188, sodium chloride and water for injection are mixed, and the pH of the mixture is adjusted to 4.5-5.5 by using a pH adjusting agent. The fasudil hydrochloride injection composition is high in product percent of pass and steady in the presence of light, cannot generate insoluble particles and has good long-term stability; and therefore, the safety of drug application is improved, and the fasudil hydrochloride injection composition is suitable for industrial production.

Description

technical field

[0001] The invention relates to the technical field of medicine, in particular to a fasudil hydrochloride injection and a preparation method thereof. Background technique

[0002] Fasudil hydrochloride, the chemical name is hexahydro-1-(5-sulfonylisoquinoline)-1H-1,4-diazepine hydrochloride, and the molecular formula is C 14 h 17 N 3 o 2 S HCl, the molecular weight is 327.83, and the structural formula is

[0003] Fasudil hydrochloride is a new type of isoquinoline sulfonamide derivatives jointly developed by Asahi Kasei Pharmaceutical Co., Ltd. and the Pharmacology Laboratory of Nagoya University. It was officially approved for clinical use in Japan in 1995, and it was also used in China and other places later. Approved for marketing, for the prevention and treatment of chronic ischemic cerebral vasospasm.

[0004] Chinese Patent Application No. 201010617277.0 discloses a fasudil hydrochloride injection and its preparation method, which contains fasudil...

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