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Fasudil hydrochloride injection composition and preparation method thereof

A technology for fasudil hydrochloride and a composition, which is applied in the directions of drug delivery, pharmaceutical formulations, and medical preparations containing active ingredients, can solve problems such as poor stability, quality defects, and difficulty in reaching the expiration date.

Inactive Publication Date: 2012-10-10
HAINAN XIANTONG PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The Fasudil Hydrochloride Injection prepared from the above-mentioned existing preparations has quality defects of poor stability, and it is difficult to meet the standard requirements of the validity period.

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

experiment example 1

[0025] Experimental example one: measure the millimolar osmotic pressure experiment of pharmaceutical composition of the present invention (prepared in embodiment one)

[0026] The formula consists of:

[0027]

[0028] Note: * is the pharmaceutical composition of the present invention prepared in Example 1.

[0029] Each formulation uses the same preparation method: add fasudil hydrochloride and solid excipients to an appropriate amount of water for injection, shake to dissolve, use 0.1mol / L hydrochloric acid solution to adjust the pH of the drug solution to 3.6-3.9, and accurately transfer the drug solution into 250ml In the measuring bottle, add water for injection to the mark, shake well, transfer the solution into a beaker, use a filter with a pore size of 0.22 μm to filter and fill, the volume of each bottle is 1.80 ~ 2.20ml (the ampoule has been cleaned and sterilized), melt and seal, Autoclaving at 121°C for 15 minutes, and light inspection. Check the prope...

experiment example 2

[0032] Experimental example 2: freeze-thaw test

[0033] The formula consists of:

[0034]

[0035] Each formulation uses the same preparation method: add fasudil hydrochloride and solid excipients to an appropriate amount of water for injection, shake to dissolve, use 0.1mol / L hydrochloric acid solution to adjust the pH of the drug solution to 3.6-3.9, and accurately transfer the drug solution into 250ml In the measuring bottle, add water for injection to the mark, shake well, transfer the solution into a beaker, use a filter with a pore size of 0.22 μm to filter and fill, the volume of each bottle is 1.80 ~ 2.20ml (the ampoule has been cleaned and sterilized), melt and seal, Samples were autoclaved at 121°C for 15 minutes and inspected by light.

[0036] Place the samples according to the freeze-thaw test conditions, the specific method is as follows:

[0037] The freeze-thaw test should include three cycles, each cycle should be under the condition of -10~-20°C for 2 d...

experiment example 3

[0042] The experiment was done in 2 groups, and its samples were respectively the pharmaceutical composition of the present invention (same as experimental example 2) and domestic marketed preparations (same as experimental example 2).

[0043] Each group takes 3 rabbits that are healthy and qualified and have no damage to the ear margins, administer the drug according to body weight, and inject 5ml / kg of this product into the left ear margin vein with an aseptic method [During the test, take 5 bottles of this product, add Dilute and dissolve N.S to 50ml to 0.6mg / ml for testing], inject the same volume of N.S on the right side in the same way, and the injection speed is about 2ml / min. 1 time per day for a total of 3 days. Every day before administration and 48-96 hours after the last administration and on the 14th day after the end of the observation period, observe whether there is congestion, erythema, and edema in the tissues and blood vessels below the proximal end of the ...

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Abstract

The invention relates to a Fasudil hydrochloride injection composition and a preparation method thereof. The composition comprises Fasudil hydrochloride serving as a main medicine and 0.7-percent sodium chloride serving as an auxiliary material, wherein the pH value of the composition is 3.6 to 3.9. The preparation method of the composition comprises: adding water for injection into Fasudil hydrochloride and sodium chloride, regulating pH value by using hydrochloric acid, adding active carbon into the solution, adding water, stirring, filtering, filling and performing lamp detection to obtainthe medicinal composition of the invention. The medicinal composition is less irritant, very stable and easy for storage and transport.

Description

technical field [0001] The invention relates to a pharmaceutical composition and a preparation method thereof, in particular to a fasudil hydrochloride composition and a preparation method thereof. Background technique [0002] Fasudil hydrochloride, chemical name is hexahydro-1-(5-isoquinolinesulfonyl)-1H-1,4-diazepine hydrochloride, molecular formula C14H17N3O2S HCl, molecular weight 327.83, structural formula: [0003] [0004] Is a protein kinase inhibitor that is intracellular calcium antagonists. Chinese patent CN1729985A discloses a preparation method of fasudil hydrochloride injection, preparing a solution containing fasudil hydrochloride, sodium chloride, glucose, amino acid or other pharmaceutically acceptable diluents, and adjusting the pH value 4.0-7.5, decolorized, sterilized. Chinese patent CN1729984A discloses a preparation method of a fasudil hydrochloride freeze-dried preparation, which consists of pharmaceutically acceptable excipients such as fasudil ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/551A61K47/02A61K9/08
Inventor 齐慧
Owner HAINAN XIANTONG PHARMA CO LTD
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