Pharmaceutical composition containing active component, namely nalmefene hydrochloride

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...

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 changes (increased to 1.4% by 0.7%), and the pH value changes also more obviously ( increased from 3.9 to about 5.3), there is a certain risk to the safety and effectiveness of the drug

However, the test results of influencing factors carried out according to the prescription in the instruction manual show that adding the above weak salts to the prescription can stabilize the pH value of the solution, but it is not satisfied with the effect of reducing the content of related substances in the sample.

Images