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Fasudil hydrochloride injection and preparing method thereof

A technology of fasudil hydrochloride and injection, which is applied in the direction of medical formulas, medical preparations with non-active ingredients, medical preparations containing active ingredients, etc., can solve the problems of complicated preparation process, inconvenient industrial production, and high cost. Achieve the effect of simple preparation process, stable quality and low cost

Active Publication Date: 2015-12-23
CISEN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

There are also such stability problems in the above-mentioned statements.
In addition, the current prior art still has defects such as complex preparation process, high cost, and inconvenient industrial production.

Method used

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  • Fasudil hydrochloride injection and preparing method thereof
  • Fasudil hydrochloride injection and preparing method thereof
  • Fasudil hydrochloride injection and preparing method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0015] Raw materials and consumables: Fasudil hydrochloride 30g, sodium citrate 10g, disodium edetate 0.01g, activated carbon for needles 0.5g, water for injection to 2000ml, made into 1000 sticks.

[0016] Preparation method: 1) Measure 80% of the total amount of water for injection, put into the prescribed amount of fasudil hydrochloride, sodium citrate, and disodium edetate, and stir to make them completely dissolve; 2) adjust with 1mol / L NaOH solution pH to 5.81; 3) Add the prescribed amount of activated carbon for needles, stir and absorb for 20 minutes, decarbonize and filter; 4) Add water for injection to the full amount, stir for 10 minutes, mix well and fine filter with a 0.22 μm filter; 5) Filter the filtrate Fill in 2ml brown ampoules and seal; 6) Sterilize the sealed ampoules at 121°C for 15 minutes, inspect the sterilized ampoules with light, and pack.

Embodiment 2

[0018] Raw materials and consumables: Fasudil hydrochloride 30g, sodium citrate 10g, edetate disodium 0.01g, dihydroconiferyl alcohol γ-O-α-L-rhamnoside 0.02g, activated carbon for needles 0.5g , Water for injection to 2000ml, made into 1000 sticks.

[0019] Preparation method: 1) Measure 80% of the total amount of water for injection, and drop into prescribed amounts of fasudil hydrochloride, sodium citrate, disodium edetate, dihydroconiferyl alcohol γ-O-α-L-ratamine 2) Use 1mol / L NaOH solution to adjust the pH to 5.81; 3) Add the prescribed amount of activated carbon for needles, stir and adsorb for 20 minutes, and decarbonize and filter; 4) Supplement water for injection to the full amount, stir for 10 5) Fill the filtrate into a 2ml brown ampoule and seal it; 6) Sterilize the sealed ampoule at 121°C for 15 minutes, inspect the sterilized ampoule with light, Package.

Embodiment 3

[0021] Raw materials and consumables: Fasudil hydrochloride 30g, sodium citrate 10g, disodium edetate 0.025g, activated carbon for needles 0.5g, water for injection to 2000ml, made into 1000 sticks.

[0022] Preparation method: 1) Measure 80% of the total amount of water for injection, put into the prescribed amount of fasudil hydrochloride, sodium citrate, and disodium edetate, and stir to make them completely dissolve; 2) adjust with 1mol / L NaOH solution pH to 5.99; 3) Add the prescribed amount of activated carbon for needles, stir and absorb for 20 minutes, decarbonize and filter; 4) Add water for injection to the full amount, stir for 10 minutes, mix well and fine filter with a 0.22 μm filter; 5) Filter the filtrate Fill in 2ml brown ampoules and seal; 6) Sterilize the sealed ampoules at 121°C for 15 minutes, inspect the sterilized ampoules with light, and pack.

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Abstract

The invention belongs to the technical field of drug preparation, and particularly relates to fasudil hydrochloride injection and a preparing method thereof. The fasudil hydrochloride injection is prepared from, by mass, 30 parts of fasudil hydrochloride, 5-15 parts of sodium citrate, 0.1-0.4 part of ethylenediamine tetraacetic acid disodium, and 1500-2500 parts of injection water. Compared with the prior art, the fasudil hydrochloride injection has the advantages that the ph value, content and related material results of every embodiment are still qualified after the fasudil hydrochloride injection is exposed to high temperature, illumination and acceleration for 6 months and 24 months, and therefore the quality of the whole product is stable; furthermore, the preparing process is simple, cost is quite low, and industrialized production is facilitated.

Description

technical field [0001] The invention belongs to the technical field of medicine preparation, and in particular relates to a fasudil hydrochloride injection and a preparation method thereof. Background technique [0002] Fasudil hydrochloride is hexahydro-1-(5-sulfonylisoquinoline)-1(H)-1,4-diazepine hydrochloride, which is a new type of highly effective vasodilator. The product was jointly developed by Asahi Kasei Pharmaceutical Co., Ltd. and the Pharmacology Laboratory of Nagoya University. It was approved for clinical use in Japan in 1995 and is used to prevent chronic ischemic cerebral vasospasm. [0003] The Chinese patent application number 201010617277.0 discloses a fasudil hydrochloride injection and its preparation method, which adopts 0.1-1.0 mol / L sodium hydroxide and hydrochloric acid to adjust the pH between 5.5-7.0, and potting in in a brown container. The Chinese patent application number 201210111795.4 discloses fasudil hydrochloride injection and its prepar...

Claims

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Application Information

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IPC IPC(8): A61K31/551A61K9/08A61K47/16A61K47/12A61P9/10
Inventor 成瑞明卢秀莲杜振新冉茂翔董江涛王绍同石井岗
Owner CISEN PHARMA
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