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Fasudil hydrochloride injection and preparation method thereof

A technology of fasudil hydrochloride and injection, which is applied in the field of medicine and can solve the problems of deepening color and reducing light transmittance

Inactive Publication Date: 2016-02-03
BEIJING LANDAN PHARMA TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] In addition to the above problems, fasudil hydrochloride also has stability problems in the clinical compatibility process. For example, after it is compatible with cefpirome sulfate, the color will deepen during placement and the light transmittance will decrease.

Method used

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

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0020] prescription:

[0021]

[0022] Process:

[0023] (1) Take water for injection, add fasudil hydrochloride and citric acid, stir and dissolve;

[0024] (2) adopt disodium hydrogen phosphate to regulate the pH value of solution to be 6.5;

[0025] (3) Filtration through a 0.22 μm filter membrane;

[0026] (4) Potting, sterilized at 122±1°C (F 0 >12), get it.

Embodiment 2

[0028] prescription:

[0029]

[0030] Process:

[0031] (1) Take water for injection, add fasudil hydrochloride and citric acid, stir and dissolve;

[0032] (2) adopt disodium hydrogen phosphate to regulate the pH value of solution to be 4.0;

[0033] (3) Filtration through a 0.22 μm filter membrane;

[0034] (4) Potting, sterilized at 122±1°C (F 0 >12), get it.

Embodiment 3

[0036] prescription:

[0037]

[0038] Process:

[0039] (1) Take water for injection, add fasudil hydrochloride and citric acid, stir and dissolve;

[0040] (2) The pH value of the solution adjusted by disodium hydrogen phosphate is 6.3;

[0041] (3) Filtration through a 0.22 μm filter membrane;

[0042] (4) Potting, sterilized at 122±1°C (F 0 >12), get it.

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Abstract

The invention provides a fasuadil hydrochloride injection and a preparation method thereof. The fasuadil hydrochloride injection is prepared from fasuadil hydrochloride with the concentration of 15mg / mL, citric acid with the concentration of 1 to 10mg / mL, and disodium hydrogen phosphate; the disodium hydrogen phosphate is adopted to adjust a solution pH value to be 4.0 to 6.5. Preferably, the concentration of the citric acid is 3 to 7mg / mL, and the pH value is 5.5 to 6.5. More preferably, the concentration of the citric acid is 5mg / mL, and the pH value is 5.7 to 6.3. By adopting the fasuadil hydrochloride injection prepared by the method, visible foreign matters meet quality standard provisions in a freezing and thawing test, and the compatible stability with cefpirome sulfate is improved.

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 is a new type of vasodilator, which can effectively relieve cerebral vasospasm and improve the prognosis of patients with subarachnoid hemorrhage. The product was developed by Asahi Kasei Pharmaceutical Co., Ltd., and was launched in Japan in 1995. [0003] Fasudil hydrochloride, its structural formula is: [0004] [0005] Fasudil hydrochloride has poor photostability. Patent CN200580008301 controls its pH below 5.5 to increase its photostability. Patent CN201310159617 increases photostability by adding calcium sodium edetate. The listed products are packaged in brown bottles to solve the problem of light stability. [0006] Secondly, patent CN201110165243 adds sodium chloride to the formula, and controls the pH at 3.6-3.9, which solves the precipitation...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K31/551A61K47/12A61K47/04A61P9/08A61P9/10
Inventor 不公告发明人
Owner BEIJING LANDAN PHARMA TECH
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