Pharmaceutical composition containing active component, namely nalmefene hydrochloride

A technology of nalmefene hydrochloride and active ingredients, which is applied in the field of medicine and can solve problems such as dissatisfaction, drug safety, effectiveness risk, failure to achieve the stable effect of the instructions, etc.

Active Publication Date: 2014-08-27
西藏易明西雅医药科技股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] Disclosed in Chinese patent CN1895251 is a kind of stable nalmefene hydrochloride injection and its preparation method. The core of its preparation is to add antioxidant sodium bisulfite and chelating agent disodium edetate in the prescription, but according to the prescription The stability test result that carries out shows, can't reach the stabilizing effect of its instructions, and in the long-term 12-month stability investigation period, related substances have more obvious change

Method used

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  • Pharmaceutical composition containing active component, namely nalmefene hydrochloride
  • Pharmaceutical composition containing active component, namely nalmefene hydrochloride
  • Pharmaceutical composition containing active component, namely nalmefene hydrochloride

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0054] Under clean conditions, take 7000ml of water for injection at a temperature of 30-40℃, add 0.4g polyethylene glycol 300 to the water for injection, stir to dissolve, add 0.3g L-glutamic acid, stir evenly, add 0.05% (g / ml) activated carbon, stirred and adsorbed for 15 minutes, filtered to remove the carbon, added 1.108g of nalmefene hydrochloride, added 9g of sodium chloride, added water for injection to 10000ml, filtered through a 0.22μm microporous membrane, filled; heated at 121℃ Autoclave for 20 minutes; light inspection; put in storage; get nalmefene hydrochloride injection

Embodiment 2

[0056] Under clean conditions, take 7000ml of water for injection at a temperature of 30-40℃, add 0.5g of polyethylene glycol 300 to the water for injection, stir to dissolve, add 0.35g of L-glutamic acid, stir evenly, add 0.05% (g / ml) activated carbon, stirred and adsorbed for 15 minutes, filtered to remove the carbon, added 1.108g of nalmefene hydrochloride, added 9g of sodium chloride, added water for injection to 10000ml, filtered through a 0.22μm microporous membrane, filled; heated at 121℃ Autoclave for 20 minutes; light inspection; put in storage; then nalmefene hydrochloride injection is obtained.

Embodiment 3

[0058] Under clean conditions, take 7000ml of water for injection at a temperature of 30-40℃, add 0.55g polyethylene glycol 300 to the water for injection, stir to dissolve, add 0.6g L-glutamic acid, stir evenly, add 0.05% (g / ml) activated carbon, stirred and adsorbed for 15 minutes, filtered to remove the carbon, added 1.108g of nalmefene hydrochloride, added 9g of sodium chloride, added water for injection to 10000ml, filtered through a 0.22μm microporous membrane, filled; heated at 121℃ Autoclave for 20 minutes; light inspection; put in storage; then nalmefene hydrochloride injection is obtained.

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PUM

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Abstract

The invention belongs to the technical field of medicines, and in particular relates to a pharmaceutical composition containing an active component nalmefene hydrochloride. The pharmaceutical composition disclosed by the invention contains nalmefene hydrochloride, polyethylene glycol 300 and L-glutamic acid. Injection prepared from the pharmaceutical composition disclosed by the invention is good in stability; after placing for 24 months, the content of bis-nalmefene is less than 0.1%; furthermore, the content of naloxone hydrochloride is less than 0.01%; the injection prepared from the pharmaceutical composition disclosed by the invention is convenient to use and beneficial to storing and transporting; the pharmaceutical composition disclosed by the invention is simple in preparation method, easy for industrialization production and low in production cost.

Description

Technical field [0001] The invention belongs to the technical field of medicine, and specifically relates to a pharmaceutical composition containing the active ingredient nalmefene hydrochloride. Background technique [0002] Nalmefene hydrochloride is a derivative of water-soluble naltrexone and a pure opioid receptor antagonist. It can bind to the opioid receptors μ, K, and δ, and the binding effect to the μ receptor is the strongest. The chemical structure of nalmefene hydrochloride and its 6-methylene group make it have the characteristics of long action time, multiple drug routes, high bioavailability, fewer side effects, stronger physiological activity, and easier penetration of biofilms. It is effective in maintaining breathing and circulation. , Digestion, endocrine and normal functions of the nervous system have varying degrees of action. It has been used in the antagonism of narcotic analgesics, the treatment of heart failure and shock, the treatment of alcoholism and a...

Claims

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Application Information

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IPC IPC(8): A61K31/485A61K9/08A61K47/34A61K47/18A61P9/00A61P25/00A61P39/02
Inventor 曹捷高帆周战尚磊
Owner 西藏易明西雅医药科技股份有限公司
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