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Injection containing nalmefene hydrochloride

A technology of injection and nalmefene, applied in the field of injection containing nalmefene hydrochloride and its preparation, can solve the problems of poor stability and many additives

Inactive Publication Date: 2017-03-08
CHENGDU GUOHONG PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] In order to overcome the existing technology of nalmefene hydrochloride injection, there are many additives added and problems such as poor stability, the present invention provides the following technical solutions:

Method used

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  • Injection containing nalmefene hydrochloride
  • Injection containing nalmefene hydrochloride
  • Injection containing nalmefene hydrochloride

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0090]

[0091] Nitrogen flushing process is used in the whole preparation process. Take 80% of the prescribed amount of water for injection, add the full amount of sodium chloride in the prescription, stir to dissolve, then adjust the dissolved pH to 3.9 with hydrochloric acid, then add the full amount of nalmefene hydrochloride in the prescription, stir to dissolve, and add the remaining water for injection To the full amount, filter with a 0.22um microporous membrane, fill it into a container for injection, seal it, and steam sterilize it at 115°C for 30 minutes.

Embodiment 2

[0093]

[0094] Nalmefene hydrochloride injection was prepared according to the preparation method described in Example 1.

Embodiment 3

[0096]

[0097] Nalmefene hydrochloride injection was prepared according to the preparation method described in Example 1.

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Abstract

The invention relates to an injection containing nalmefene hydrochloride and a preparation method thereof. The nalmefene hydrochloride injection is a unit dosage form. Each unit dosage form of the injection comprises 0.35 to 0.75 mg of nalmefene hydrochloride (calculated by nalmefene), preferably 0.5 mg of nalmefene hydrochloride (calculated by nalmefene). The injection can maximally reduce the degradation reactions during the storage process. After long term storage, the content of bis-nalmefene impurity is extremely low, the product stability is better, the shelf life is longer, and the safety is higher.

Description

technical field [0001] The invention relates to pharmaceutical preparations, in particular to an injection containing nalmefene hydrochloride and a preparation method thereof. Background technique [0002] Nalmefene hydrochloride is a new generation of pure opioid receptor antagonist synthesized after naloxone and naltrexone. It was developed by Ivax / Ohmeda company in the United States and was first approved by the FDA in 1995. The marketed dosage form is injection. At present, nalmefene hydrochloride has become a substitute for naloxone. Compared with naloxone and naltrexone, it has the advantages of long action time, high oral bioavailability, small dosage, and wide safety range. Nalmefene hydrochloride has a wide range of clinical uses, and has been used to antagonize the symptoms of respiratory depression, sedation and hypotension caused by narcotic analgesics, and is also used in the treatment of alcoholism and heroin dependence. [0003] So far, the nalmefene hydrochl...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K31/485A61K47/04A61P25/36
Inventor 汪飞郭礼新郭晖
Owner CHENGDU GUOHONG PHARMA
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