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Pharmaceutical naloxone hydrochloride composition for injection and preparation method of pharmaceutical naloxone hydrochloride composition

A technology of naloxone hydrochloride and its composition, which is applied in the field of medicine, can solve problems such as accumulation and subcutaneous granuloma, and achieve the effects of reducing production costs, improving product stability, and avoiding degradation

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, adding polyvinylpyrrolidone to the injection can easily form subcutaneous granulomas at the injection site, and may accumulate in body organs

Method used

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  • Pharmaceutical naloxone hydrochloride composition for injection and preparation method of pharmaceutical naloxone hydrochloride composition
  • Pharmaceutical naloxone hydrochloride composition for injection and preparation method of pharmaceutical naloxone hydrochloride composition
  • Pharmaceutical naloxone hydrochloride composition for injection and preparation method of pharmaceutical naloxone hydrochloride composition

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0041] Example 1 Naloxone hydrochloride for injection (based on 1000 bottles, unit: g)

[0042] Naloxone Hydrochloride

[0043] Preparation process: Inject 1000ml of water for injection into the liquid mixing tank, add 10g trehalose and 0.1g fumaric acid in turn, stir until dissolved, then add 0.4g naloxone hydrochloride and stir until dissolved; use a 0.22μm microporous membrane Finely filter until clear, carry out semi-finished product inspection, and measure the pH value to be 5.32; fill and seal in vials, carry out freeze-drying; crimp the cap, seal, pack.

Embodiment 2

[0044] Example 2 Naloxone hydrochloride for injection (based on 1000 bottles, unit: g)

[0045] Naloxone Hydrochloride

[0046] Preparation process: Inject 1000ml of water for injection into the liquid mixing tank, add 10g of trehalose and 1.0g of fumaric acid in turn, stir until dissolved, then add 0.4g of naloxone hydrochloride and stir until dissolved; use a 0.22μm microporous membrane Finely filter until clear, carry out inspection of semi-finished products, and measure the pH value to be 4.43; fill and seal in vials, and carry out freeze-drying; capping, sealing, and packaging.

Embodiment 3

[0047] Example 3 Naloxone Hydrochloride for Injection (based on 1000 bottles, unit: g)

[0048] Naloxone Hydrochloride

[0049] Preparation process: Inject 1000ml of water for injection into the liquid mixing tank, add 30g of trehalose and 0.5g of fumaric acid in turn, stir until dissolved, then add 0.4g of naloxone hydrochloride and stir until dissolved; use a 0.22μm microporous membrane Finely filter until clear, carry out inspection of semi-finished products, and measure the pH value to be 4.85; fill and seal in vials, and carry out freeze-drying; capping, sealing, and packaging.

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Abstract

The invention provides a pharmaceutical naloxone hydrochloride composition for injection and a preparation method of the pharmaceutical naloxone hydrochloride composition. In the prescription, trehalose is used as an excipient, and a certain quantity of fumaric acid is added, so that the pH value of a product can be controlled within a reasonable range, meanwhile, the degradation of naloxone hydrochloride in a storage process can also be avoided, and the stability of the product is greatly improved; in addition, the process is easy to operate, and the prepared product is full in appearance, stable in quality and relatively good in dissolvability and compatible stability.

Description

technical field [0001] The invention relates to a pharmaceutical composition for injection and a preparation process thereof, in particular to a pharmaceutical composition of naloxone hydrochloride for injection and a preparation method thereof, belonging to the technical field of medicine. Background technique [0002] The English name of Naloxone Hydrochloride is Naloxone Hydrochloride, and its molecular formula is C 19 h 21 NO 4 ·HCl·2H 2 O, the structural formula is: [0003] [0004] Naloxone hydrochloride is an opioid receptor antagonist, which can competitively antagonize various opioid receptors with rapid effect and strong antagonism. The formulations of naloxone hydrochloride preparations currently on the market are mainly injections and freeze-dried powder injections. Long-term storage of injections will reduce the quality of the drug and increase related substances, leaving hidden dangers for clinical use; while freeze-dried preparations still have many d...

Claims

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Application Information

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IPC IPC(8): A61K47/26A61K47/12A61K31/485
Inventor 王颖
Owner CHENGDU EASTON BIOPHARMACEUTICALS CO LTD
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