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Nalmefene hydrochloride pharmaceutical composition for injection

A technology of nalmefene and composition, which is applied in the field of nalmefene hydrochloride pharmaceutical composition and its preparation, can solve the problems of increasing curative effect, etc., and achieve the effect of simple method, good stability and good clarity

Inactive Publication Date: 2014-03-26
TIANJIN SONGRUI MEDICAL TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Cumulative doses greater than 1.0 μg / kg do not increase efficacy

Method used

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  • Nalmefene hydrochloride pharmaceutical composition for injection
  • Nalmefene hydrochloride pharmaceutical composition for injection
  • Nalmefene hydrochloride pharmaceutical composition for injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0049] Every 1000 described nalmefene hydrochloride injection pharmaceutical compositions, its formula consists of:

[0050] Nalmefene hydrochloride as nalmefene 0.1g

[0051] Edetate Calcium Sodium 0.2g

[0052] Add water for injection to 1L.

[0053] Preparation process: Take 70% of the prescribed amount of water for injection, at a temperature of 30-40°C, add the prescribed amount of edetate calcium sodium, stir to dissolve; add the prescribed amount of nalmefene hydrochloride, stir until completely dissolved; measure the initial pH Value, according to the initial pH value, use 4% sodium hydroxide solution and 10% hydrochloric acid solution to adjust the pH value range to 3.0-5.0; add 0.05% medicinal charcoal to the liquid medicine, stir for 15 minutes; suction filter, add water for injection to Full dose, mixed evenly; fine filtration; filling; autoclaving at 121°C for 20 minutes; lamp inspection; storage; to obtain Nalmefene Hydrochloride Injection.

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PUM

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Abstract

The invention relates to a medicine in the field of medicine, and particularly relates to a nalmefene hydrochloride pharmaceutical composition for injection with good stability and a preparation method thereof. As a new generation of opioid receptor antagonist, the composition is used for completely or partially reversing the effects of opioids, including respiratory depression caused by natural or synthetic opioids; moreover, the composition is applied to the treatment of known or suspected overdose of opioids.

Description

technical field [0001] The invention relates to medicines in the medical field, in particular to a nalmefene hydrochloride pharmaceutical composition with good stability for injection and a preparation method thereof. Background technique [0002] This product is a new opioid receptor antagonist developed and produced by American Omeda Pharmaceutical Company, which was approved by the US FDA in 1995. [0003] Nalmefene Hydrochloride [0004] [0005] Relative molecular mass: 375.889; [0006] Molecular formula: C 21 h 25 NO 3 HCl; [0007] Chemical name: 17-cyclopropylmethyl-6-methylene-4,5α-epoxymorphinan-3,14-diol hydrochloride; [0008] Indications: Nalmefene is used to completely or partially reverse the effects of opioids, including respiratory depression caused by natural or synthetic opioids. [0009] Mechanism of action: The chemical structure is a derivative of naltrexone, the effect is similar to that of naloxone, but the effect lasts much longer. [001...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K31/485A61K47/18A61P11/00A61P39/02
Inventor 张昊
Owner TIANJIN SONGRUI MEDICAL TECH
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