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Pharmaceutical composition of naloxone hydrochloride injection and preparation method thereof

A technology of naloxone hydrochloride and a composition, applied in the field of medicine, can solve the problems of oxidation, discoloration of polyethylene glycol, affecting naloxone hydrochloride, etc., and achieve the effects of reducing degradation, simple prescription and improving stability

Active Publication Date: 2014-06-25
CHENGDU EASTON BIOPHARMACEUTICALS CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the formation of the above complexes will affect the efficacy of naloxone hydrochloride to a certain extent, and polyethylene glycol will change color when it encounters iron, and it will be oxidized when exposed to air for a long time at a temperature of 50 ° C.

Method used

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  • Pharmaceutical composition of naloxone hydrochloride injection and preparation method thereof
  • Pharmaceutical composition of naloxone hydrochloride injection and preparation method thereof
  • Pharmaceutical composition of naloxone hydrochloride injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0033] Example 1 Naloxone Hydrochloride Injection (in 1000 sticks, unit: g)

[0034] Naloxone Hydrochloride

[0035] Preparation process: Add 900ml of water for injection into the liquid mixing tank, add 0.2g of malic acid and 0.4g of naloxone hydrochloride, stir until dissolved; take an appropriate amount of 0.1mol / L hydrochloric acid to adjust the pH value to 3.4, add water for injection to the full amount, stir Mix well and set aside; filter, fill into 1ml ampoules; sterilize with circulating steam at 100°C for 30 minutes; pack.

Embodiment 2

[0036] Example 2 Naloxone Hydrochloride Injection (in 1000 sticks, unit: g)

[0037] Naloxone Hydrochloride

[0038] Preparation process: Add 900ml of water for injection into the liquid mixing tank, add 0.5g of malic acid and 0.4g of naloxone hydrochloride, stir until dissolved; take an appropriate amount of 0.1mol / L hydrochloric acid to adjust the pH value to 3.2, add water for injection to the full amount, stir Mix well and set aside; filter, fill into 1ml ampoules; sterilize with circulating steam at 100°C for 30 minutes; pack.

Embodiment 3

[0039] Example 3 Naloxone Hydrochloride Injection (in 1000 sticks, unit: g)

[0040] Naloxone Hydrochloride

[0041] malic acid

[0042] Preparation process: Add 900ml of water for injection into the liquid mixing tank, add 2.0g of malic acid and 0.4g of naloxone hydrochloride, stir until dissolved; take an appropriate amount of 0.1mol / L hydrochloric acid to adjust the pH value to 3.7, add water for injection to the full amount, stir Mix well and set aside; filter, fill into 1ml ampoules; sterilize with circulating steam at 100°C for 30 minutes; pack.

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PUM

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Abstract

The invention provides a novel pharmaceutical composition of a naloxone hydrochloride injection and a preparation method thereof. The prescription is simple, the stability of a naloxone hydrochloride water solution is obviously increased after a certain amount of malic acid is added to the prescription, and malic acid is free of poison or thrill, so that the pharmaceutical composition is better in safety; meanwhile, the preparation process disclosed by the invention is easy to operate, and the prepared product is controllable in quality.

Description

technical field [0001] The invention relates to the technical field of medicine, in particular to a pharmaceutical composition of naloxone hydrochloride injection and a preparation method thereof. Background technique [0002] Naloxone hydrochloride is a specific morphine receptor antagonist, which can competitively block and replace the combination of opioids and receptors, clear the symptoms of opioid drug intoxication, and rapidly induce the withdrawal symptoms of opioid addicts. Naloxone has a rapid onset of action, reliable curative effect, and few side effects. However, due to the large first-pass effect in the liver, oral administration is ineffective. [0003] The Chinese patent application No. 200510080479.5 discloses a new packaged naloxone hydrochloride injection and a production method thereof. The stability of the naloxone hydrochloride injection is improved by replacing the ampoule with a vial. Although this patent has changed the packaging method of the produ...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K31/485A61K47/12A61P25/36
Inventor 王颖
Owner CHENGDU EASTON BIOPHARMACEUTICALS CO LTD
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