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Drug fasudil hydrochloride combination for treating cerebrovascular diseases

A technology for fasudil hydrochloride and cerebrovascular diseases, applied in the field of medicine, can solve problems such as low binding strength, difference in solubility of crystalline drugs, and easy hydration of the surface between particles

Inactive Publication Date: 2016-01-06
QINGDAO HUAZHICAO PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Compounds with different crystal structures are in different energy states due to the difference in molecular arrangement order. Generally, amorphous drugs have greater potential energy, and the bonding strength between particles is smaller than that of crystal forms. The total unit surface free The energy is large, and the surface between the particles is easy to hydrate, resulting in a difference in solubility from that of crystalline drugs

Method used

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  • Drug fasudil hydrochloride combination for treating cerebrovascular diseases
  • Drug fasudil hydrochloride combination for treating cerebrovascular diseases
  • Drug fasudil hydrochloride combination for treating cerebrovascular diseases

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0023] Example 1: Preparation of Fasudil Hydrochloride Crystals

[0024] (1) Dissolve fasudil hydrochloride in a mixed solvent of acetone, methyl ethyl ketone and water. The amount of solvent required per gram of fasudil hydrochloride is 50ml, and the volume ratio of acetone, methyl ethyl ketone and water is 1:1: 3.5;

[0025] (2) After heating to 30℃ to dissolve, add seed crystal after cooling to room temperature;

[0026] (3) Cool to below 0°C, stir to crystallize, the temperature of crystallization is -15°C, filter, dry, collect the crystals to obtain fasudil hydrochloride crystals.

[0027] The prepared fasudil hydrochloride crystals used Cu-Kα rays to measure the X-ray powder diffraction pattern as shown in figure 1 As shown, the purity determined by high performance liquid chromatography is 99.9%.

Embodiment 2

[0028] Example 2: Preparation of fasudil hydrochloride composition

[0029] The composition is: 1 part by weight of fasudil hydrochloride crystal prepared by the present invention and 0.04 part by weight of sodium chloride.

[0030] The preparation method is:

[0031] (1) Weigh fasudil hydrochloride crystals and sodium chloride in proportion and mix them thoroughly;

[0032] (2) Dispense into sterilized vials and stopper.

Embodiment 3

[0033] Example 3: Preparation of fasudil hydrochloride composition

[0034] The composition is: 1 part by weight of fasudil hydrochloride crystal prepared by the present invention and 0.05 part by weight of sodium chloride.

[0035] The preparation method is:

[0036] (1) Weigh fasudil hydrochloride crystals and sodium chloride in proportion and mix them thoroughly;

[0037] (2) Dispense into sterilized vials and stopper.

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Abstract

The invention relates to a drug fasudil hydrochloride combination for treating cerebrovascular diseases and belongs to the technical field of pharmaceuticals. The combination is composed of fasudil hydrochloride and sodium chloride, the fasudil hydrochloride is crystal, and an X-ray powder diffraction diagram acquired by using Cu-Ka ray for measurement is shown as a figure 1. Novel crystal form of the fasudil hydrochloride is different from crystal form structure of the prior art, and experimental verification finds in surprise that the novel-crystal-form compound is high in purity, fluidity and stability, low in impurity content, less prone to moisture absorption and safe and reliable in clinical application; a powder injection prepared by utilizing the novel-crystal-form compound is high in stability after being combined with a solvent, extremely low in insoluble particle content and quite suitable for clinical application.

Description

technical field [0001] The invention belongs to the technical field of medicine, and relates to a drug composition of fasudil hydrochloride for treating cerebrovascular diseases. Background technique [0002] Fasudil hydrochloride (fasudilhydrochloride, 1) is a new type of isoquinoline sulfonamide derivatives jointly developed by Asahi Kasei Co., Ltd. and Nagoya University. As a RHO kinase inhibitor and novel intracellular Ca 2+ Antagonist, the drug can dilate blood vessels by increasing the activity of myosin light chain phosphatase, reduce the tension of endothelial cells, improve the microcirculation of brain tissue, protect ischemic brain tissue, and at the same time antagonize inflammatory factors and protect nerves against apoptosis , promote nerve regeneration. In June 1995, it was listed by Japan Asahi Kasei Co., Ltd. and in China in 2004. It is mainly used for the improvement of symptoms of ischemic cerebrovascular diseases caused by cerebral vasospasm after subar...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/551A61P9/10C07D401/12
Inventor 刘学键
Owner QINGDAO HUAZHICAO PHARMA CO LTD
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