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Fasudil hydrochloride injection composition and its preparation method

A technology for fasudil hydrochloride and injection, which is applied in the field of medicine, can solve the problems of cysteine ​​hydrochloride having a peculiar smell, influence on the quality of preparations, complicated prescriptions, etc. The effect of simple prescription

Active Publication Date: 2013-07-31
CHENGDU EASTON BIOPHARMACEUTICALS CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Although the cysteine ​​hydrochloride added in the prescription has improved the instability of this product to light to a certain extent, the prescription is relatively complicated, and the cysteine ​​hydrochloride has a peculiar smell and has an antioxidant effect. Destroyed by oxidation, and can form salt when encountering strong acid and strong alkali, which will have a certain impact on the quality of the preparation

Method used

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  • Fasudil hydrochloride injection composition and its preparation method
  • Fasudil hydrochloride injection composition and its preparation method
  • Fasudil hydrochloride injection composition and its preparation method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0058] Weigh 30g of Fasudil hydrochloride and 0.2g of calcium sodium edetate, add 1800ml of water for injection, stir for 15 minutes, dissolve and stir evenly; measure the pH value of the solution, adjust the pH value with 0.1mol / L hydrochloric acid solution 4.5, add water to 2000ml, stir to mix evenly, check the pH value of the solution, if necessary, adjust the pH value to 4.5 with 0.1mol / L hydrochloric acid solution; add 0.1% (W / V) medicinal charcoal, absorb for 20 minutes, and decarbonize; Fine filter with "0.45μm+0.22μm" sterilizing filter in series, fill the filtrate into 2ml colorless and transparent low borosilicate glass ampoule bottle under the condition of nitrogen filling, melt and seal, and extinguish with 115℃ damp heat steam Bacteria for 30 minutes, lamp inspection, to obtain Fasudil Hydrochloride Injection.

Embodiment 2

[0060] Weigh 30g of Fasudil hydrochloride and 0.2g of calcium sodium edetate, add 1600ml of water for injection, stir for 10 minutes, dissolve and stir evenly; measure the pH value of the solution, adjust the pH value with 0.1mol / L hydrochloric acid solution 4.0, add water to 2000ml, stir to mix evenly, check the pH value of the solution, adjust the pH value to 4.0 with 0.1mol / L hydrochloric acid solution if necessary; add 0.1% (W / V) medicinal charcoal, absorb for 20 minutes, and decarbonize; Fine filter with "0.45μm+0.22μm" sterilizing filter in series, fill the filtrate into 2ml colorless and transparent low borosilicate glass ampoule bottle under the condition of nitrogen filling, melt and seal, and extinguish with 115℃ damp heat steam Bacteria for 30 minutes, lamp inspection, to obtain Fasudil Hydrochloride Injection.

Embodiment 3

[0062] Weigh 30g of Fasudil hydrochloride and 0.2g of calcium sodium edetate, add 1700ml of water for injection, stir for 12 minutes, dissolve and stir evenly; measure the pH value of the solution, adjust the pH value with 0.1mol / L hydrochloric acid solution 4.2, add water to 2000ml, stir to mix evenly, check the pH value of the solution, adjust the pH value to 4.2 with 0.1mol / L hydrochloric acid solution if necessary; add 0.1% (W / V) medicinal charcoal, absorb for 20 minutes, and decarbonize; Fine filter with "0.45μm+0.22μm" sterilizing filter in series, fill the filtrate into 2ml colorless and transparent low borosilicate glass ampoule bottle under the condition of nitrogen filling, melt and seal, and extinguish with 115℃ damp heat steam Bacteria for 30 minutes, lamp inspection, to obtain Fasudil Hydrochloride Injection.

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Abstract

The invention provides a novel Fasudil hydrochloride injection composition and its preparation method. A prescription and a preparation technology are simple. As a metal ion chelating agent, sodium calcium edetate in the prescription can be used to reduce degradation of the product under a high-light condition. In addition, the preparation technology provided by the invention is easy to operate. The quality of the prepared product is controllable, and the product has good stability and meets regulations of SFDA (State Food and Drug Administration).

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, chemical name is hexahydro-1-(5-sulfonylisoquinoline)-1H-1,4-diazepine hydrochloride, molecular formula is C 14 h 17 N 3 o 2 S HCl, the molecular weight is 327.83, and the structural formula is: [0003] [0004] Fasudil hydrochloride is a new and highly effective vasodilator, which can effectively relieve cerebral vasospasm and improve the prognosis of patients with subarachnoid hemorrhage. The product was jointly developed by Asahi Kasei Pharmaceutical Co., Ltd. and the Pharmacology Laboratory of Nagoya University. It was officially approved for clinical use in Japan in 1995, and was later approved for marketing in China and other places for the prevention and treatment of chronic ischemic cerebral vasospasm. . [0005] Chinese Patent Application No...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K31/551A61K47/18A61P9/08
Inventor 王颖
Owner CHENGDU EASTON BIOPHARMACEUTICALS CO LTD
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