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Method for stable light focusing of fasudil hydrochloride and composition obtained using same

A technology of fasudil hydrochloride and a composition, which is applied in the directions of drug combination, pharmaceutical formula, drug delivery, etc., can solve the problems of inconvenient preparation process and safety inspection, hidden danger of safe medication, low permeability and the like

Active Publication Date: 2013-04-03
通辽市华邦药业有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Such results have the following disadvantages: (1) when the pH value was below 5, fasudil hydrochloride would undergo photodecomposition and have a color reaction, and become yellow, which is one of the reasons for the low transmittance. Can be judged
[0007] The above three deficiencies not only bring a lot of inconvenience to the preparation process and safety inspection, but also bring many hidden dangers to safe drug use.

Method used

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  • Method for stable light focusing of fasudil hydrochloride and composition obtained using same
  • Method for stable light focusing of fasudil hydrochloride and composition obtained using same
  • Method for stable light focusing of fasudil hydrochloride and composition obtained using same

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0019] Embodiment 1 adds 0.05% photostabilizer methyl paraben on the basis of comparative example

[0020]

[0021] Detection method is equal to comparative example, and the obtained results are shown in Table 3

[0022] The various test results of the obtained composition of table 3 embodiment 1

[0023]

[0024] It can be seen from Table 3 that the total impurity content has no significant change, and the transmittance has no significant change, which shows that the composition is stable to light and does not need to be stored in the dark.

Embodiment 2

[0025] Embodiment 2 adds 0.15% light stabilizer on the basis of comparative example

[0026]

[0027] Detection method is equal to comparative example, and the obtained results are shown in Table 4:

[0028] The various detection results of the composition obtained in table 4 embodiment 2

[0029]

[0030] It can be seen from Table 4 that the total impurity content has no significant change, and the transmittance has no significant change, which shows that the composition is stable to light and does not need to be stored in the dark.

Embodiment 3

[0031] Embodiment 3 adds 0.25% photostabilizer methyl paraben on the basis of comparative example

[0032]

[0033] Detection method is equal to comparative example, and the obtained results are shown in Table 5

[0034] The various detection results of table 5 embodiment 3 gained compositions

[0035]

[0036] It can be seen from Table 5 that the total impurity content has no obvious change, and the transmittance has no obvious change, which shows that the composition is stable to light and does not need to be stored in the dark.

[0037] We have also investigated the stability under each pH value (regulating with hydrochloric acid or sodium hydroxide) when the content of sodium methylparaben (in methylparaben) is from 0.05% to 0.25%, the results show that it is all stable, and there is no Significant difference, enumerated again below the methyl paraben content is respectively 0.05, 0.15 and 0.25, and each inspection result that pH is measured when being 1 and 9 respe...

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Abstract

The invention deeply and thoroughly researches the light focusing stability of the fasudil water solution so as to take the methylparaben as a stabilizing agent. The fasudil hydrochloride water solution is stable by adjusting the content of the methylparaben, so that the invention is suitable for preparing not only the oral solution but also the injection with higher requirement.

Description

technical field [0001] A method for light-stabilizing fasudil hydrochloride and a composition obtained by the method. Background technique [0002] Fasudil hydrochloride, chemical name is hexahydro-1-(5-isoquinolinesulfonyl)-1H-1,4-diazepine hydrochloride. Fasudil hydrochloride is a new type of intracellular calcium ion antagonist and protein kinase inhibitor, which can dilate blood vessels by blocking the phosphorylation of myosin light chain in the final stage of vasoconstriction, inhibit vasospasm, and protect ischemic brain tissue. Thereby preventing and treating CVS, effectively treating various ischemic encephalopathy caused by CVS, protecting brain nerve cells, improving prognosis and reducing mortality. Fasudil hydrochloride injection has quick onset and definite curative effect on the treatment of CVS after SAH, can prevent and alleviate CVS, and reduce the mortality and disability rate of CVS. The results of the study showed that both fasudil hydrochloride and ni...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/551A61K31/235A61K9/08A61P9/10A61P25/00
Inventor 闫志刚杨秀伟曹建英黄牧童
Owner 通辽市华邦药业有限公司
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