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Nalmefene hydrochloride injection medicinal composition and preparation method thereof

A technology of nalmefene hydrochloride and nalmefene, which is applied in the field of medicine, can solve problems such as high production equipment requirements, decreased blood calcium concentration, and existing clinical risks, and achieve product quality improvement, simple prescription, and simple and controllable production process Effect

Active Publication Date: 2015-10-28
CHENGDU EASTON BIOPHARMACEUTICALS CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Since tryptophan is an amino acid antioxidant, it is easy to interact with the main drug; disodium edetate can combine with calcium ions to form a soluble complex to cause a decrease in calcium, and its use in intravenous preparations can lead to Decreased blood calcium concentration, thereby presenting a clinical risk
In addition, the nalmefene hydrochloride injection disclosed in this patent needs to be prepared by a nitrogen filling process, which is relatively complicated, requires high production equipment, and will increase production costs

Method used

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  • Nalmefene hydrochloride injection medicinal composition and preparation method thereof
  • Nalmefene hydrochloride injection medicinal composition and preparation method thereof
  • Nalmefene hydrochloride injection medicinal composition and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1～4

[0053] Embodiment 1~4 preparation method:

[0054] Take 90% of the prescribed amount of water for injection, add the prescribed amount of sodium chloride and seaweed polysaccharide in turn, stir until completely dissolved, adjust the pH value to 3.6 with 0.2mol / L hydrochloric acid solution or 0.1mol / L sodium hydroxide solution, add the prescription Amount of nalmefene hydrochloride, stir to dissolve, and then add water for injection to the full amount; sterilize and filter with a 0.22μm PES filter cartridge, and fill according to 1ml / cartridge; sterilize at 121°C for 15 Minutes and it's ready.

Embodiment 5～7

[0055] Embodiment 5~7 preparation method:

[0056] The preparation method is the same as that in Examples 1-4, the pH value is adjusted to 3.4, and the filling volume is 1ml / cartridge.

Embodiment 8～9

[0057] Embodiment 8~9 preparation method:

[0058] The preparation method is the same as that in Examples 1-4, the pH value is adjusted to 3.8, and the filling volume is 1ml / cartridge.

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Abstract

The invention relates to a nalmefene hydrochloride injection medicinal composition and a preparation method thereof. The nalmefene hydrochloride injection medicinal composition is composed of nalmefene hydrochloride, sodium chloride, alga polysaccharides and injection water. The above prescription is simple, and an antioxidant used in the prior art is not used in the method, so untoward effects induced by the antioxidant are avoided, and the safety is guaranteed; a small amount of the alga polysaccharides is added to the prescription, so degradation of nalmefene hydrochloride injection in the storage process is effectively prevented, and the stability of products is obviously enhanced; and a nitrogen introduction loading technology is not needed, so the production steps are simplified, and the cost is reduced.

Description

technical field [0001] The invention relates to the technical field of medicine, in particular to a nalmefene hydrochloride injection pharmaceutical composition and a preparation method thereof. Background technique [0002] Nalmefene hydrochloride, the English name is nalmefene hydrochloride, and its structural formula is: [0003] [0004] Nalmefene hydrochloride is a μ, κ, α opioid receptor blocker, which can competitively antagonize various opioid receptors, especially has a strong affinity for μ receptors. After nalmefene binds to peripheral opioid receptors, it can also bind to opioid receptors in the brainstem and other parts, thereby blocking the production of central nervous system respiratory and circulatory systems caused by endogenous opioids under physical stress. a series of symptoms. The currently marketed dosage form is an injection, which is mainly used to completely or partially reverse the effects of opioids, including respiratory depression caused by...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K31/485A61K47/36A61P25/36
Inventor 王颖
Owner CHENGDU EASTON BIOPHARMACEUTICALS CO LTD
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