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Fasudil hydrochloride injection composition and preparation method thereof

A technology of fasudil hydrochloride and composition, which is applied in the field of medicine, can solve problems such as side effects, blood vessels, irritation, and complicated prescriptions, and achieve the effects of high product qualification rate, poor solution stability, and good long-term stability

Active Publication Date: 2015-08-19
SHANDONG NEWTIME PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The patented prescription is relatively complicated. Although adding benzyl alcohol to the prescription can relieve pain and inhibit microbial reproduction, and benzyl alcohol will be slowly oxidized into benzaldehyde and benzoic acid in the air, nitrogen should be filled before filling to prevent oxidation.
[0007] Judging from the prior art, the photostability of fasudil hydrochloride injection and the suppression of insoluble particles are difficult problems to be solved. Adding a water-soluble opacifying agent and lowering the pH range of the injection will solve the problem, but both will bring problems to clinical medication. Side effects and irritation to blood vessels when injected

Method used

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

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0025]

[0026] Preparation:

[0027] Degas the water for injection for 30 minutes, weigh the prescribed amount of fasudil hydrochloride, reduced glutathione, sodium chloride and poloxamer 188, add 80% of the total amount of water for injection and stir to dissolve, adjust the pH of the solution When the value is 5.0, add 0.05% (W / V) activated carbon for needles, stir for 30 minutes, filter the carbon with a 0.45 μm microporous membrane, add water for injection to the full amount, degas for 90 minutes, pass nitrogen for 30 minutes, and then Fine filter with 0.22μm microporous membrane, take samples for intermediate detection, fill after passing the test, extract air in a closed space, and then fill high Pure nitrogen, sterilized at 121°C for 15 minutes, inspected by light, and packaged to obtain finished products.

Embodiment 2

[0029]

[0030]

[0031] Preparation method: with embodiment 1.

Embodiment 3

[0033]

[0034] Preparation method: with embodiment 1.

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PUM

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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...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K31/551A61K47/34A61K47/18A61P9/10
Inventor 张贵民刘万路马永杰
Owner SHANDONG NEWTIME PHARMA
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