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Pharmaceutical fasudil hydrochloride composition capsule for angiectasis

A technology of fasudil hydrochloride and vasodilation, which is applied in the field of medicine, can solve the problems of the solubility difference of crystalline drugs, the surface between particles is easy to hydrate, and the free energy per unit surface is large, so as to achieve good fluidity and safe and reliable clinical application , high dissolution effect

Inactive Publication Date: 2015-12-23
QINGDAO LANSHENGYANG PHARMA & BIOTECH 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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  • Pharmaceutical fasudil hydrochloride composition capsule for angiectasis
  • Pharmaceutical fasudil hydrochloride composition capsule for angiectasis
  • Pharmaceutical fasudil hydrochloride composition capsule for angiectasis

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0028] Example 1: Preparation of Fasudil Hydrochloride Crystals

[0029] Take the bulk drug of fasudil hydrochloride, add the mixed solvent A of water, acetone and N-methylacetamide with a volume of 8 times the weight of fasudil hydrochloride at 30°C, water, acetone, N-methylacetamide The volume ratio is 4:1:0.5, and a solution is obtained; then a constant magnetic field with a magnetic field strength of 0.6T is applied in the horizontal direction of the liquid level of the obtained solution, and under the condition of the constant magnetic field, a volume of hydrochloric acid is added dropwise to the solution. Mixed solvent B of ethanol, isobutanol and diethyl ether is 5 times the weight of Sudil, and the volume ratio of ethanol, isobutanol and diethyl ether is 2:3:4; , filtered, washed, and dried in vacuo to obtain the fasudil hydrochloride crystals.

[0030] The X-ray powder diffraction pattern of the prepared fasudil hydrochloride crystal using Cu-Kα ray measurement is ...

Embodiment 2

[0031] Example 2: Preparation of Fasudil Hydrochloride Capsules

[0032] Recipe: in parts by weight as shown in Table 1

[0033] Table 1 fasudil hydrochloride composition prescription

[0034]

[0035] Preparation:

[0036] 1) Weigh according to the process prescription;

[0037] 2) Processing of raw and auxiliary materials: pass fasudil hydrochloride through a 100-mesh sieve;

[0038] 3) Pre-mixing: Mix the prescribed amount of fasudil hydrochloride raw material and lactose in an equal increment method;

[0039] 4) Preparation of povidone K30 ethanol solution: place the 95% ethanol of the prescription in a stainless steel bucket, add the povidone K30 of the prescription while stirring, and stir until it is completely dissolved for later use;

[0040] 5) Mixing and granulation: Add the pre-mixed fasudil hydrochloride, lactose, microcrystalline cellulose and sodium alginate in the prescribed amount to the wet mixing granulator, turn on the stirring motor for dry mixing...

Embodiment 3

[0045] Example 3:Preparation of Fasudil Hydrochloride Capsules

[0046] Recipe: in parts by weight as shown in Table 2

[0047] Table 2 Fasudil hydrochloride composition prescription

[0048]

[0049] Preparation:

[0050] 1) Weigh according to the process prescription;

[0051] 2) Processing of raw and auxiliary materials: pass fasudil hydrochloride through a 100-mesh sieve;

[0052] 3) Pre-mixing: Mix the prescribed amount of fasudil hydrochloride raw material and lactose in an equal increment method;

[0053] 4) Preparation of povidone K30 ethanol solution: place the 95% ethanol of the prescription in a stainless steel bucket, add the povidone K30 of the prescription while stirring, and stir until it is completely dissolved for later use;

[0054] 5) Mixing and granulation: Add the pre-mixed fasudil hydrochloride, lactose, microcrystalline cellulose and sodium alginate in the prescribed amount to the wet mixing granulator, turn on the stirring motor for dry mixing ...

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Abstract

The invention discloses a pharmaceutical fasudil hydrochloride composition capsule for angiectasis, and belongs to the technical field of a medicine. The composition is prepared from fasudil hydrochloride, lactose, microcrystalline cellulose, sodium alginate, povidone K30, ethanol with the concentration of 95%, glycerin monostearate and talcum powder. The fasudil hydrochloride, different from fasudil hydrochloride reported in the prior art, is a novel crystalline compound, and an X-ray powder diffraction pattern measured through Cu-K alpha ray is as shown in Figure 1; upon tests, the novel crystalline compound is high in purity, good in fluidity, good in stability, low in impurity content, not easy in moisture absorption, safe and reliable in clinical application; and a capsule prepared from the novel crystalline compound is high in dissolution degree, good in stability and high in bioavailability, and the capsule is quite suitable for clinical application.

Description

technical field [0001] The invention belongs to the technical field of medicine, and relates to a combination capsule of a vasodil drug fasudil hydrochloride. 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 Asahi Kasei Corporation of Japan, and it was listed in China in 2004. It is mainly used to improve the symptoms of ischemic cerebrovascular diseases caused by cerebral vasospasm after subarachnoid ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/48A61K31/551C07D401/12A61P9/10
Inventor 刘学键
Owner QINGDAO LANSHENGYANG PHARMA & BIOTECH CO LTD
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