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Pentoxifylline injection composition and preparation method thereof

A technology of theobromine injections and compositions, which is applied in the direction of drug combinations, active ingredients of heterocyclic compounds, anti-inflammatory agents, etc., can solve problems such as poor stability, adverse reactions, and increased content of related substances, and achieve good quality stability and process Simple and easy to implement, enhanced stability effect

Active Publication Date: 2017-01-11
CSPC OUYI PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] The existing pentoxifylline injection product, the prescription consists of pentoxifylline, disodium edetate, sodium dihydrogen phosphate, disodium hydrogen phosphate and water for injection, which has the disadvantage of poor stability, and related substances are prone to appear during long-term storage Increased content, darkened color, and large changes in PH value lead to some adverse reactions in patients after taking it, which seriously restricts the wide application of this product in clinical practice.

Method used

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  • Pentoxifylline injection composition and preparation method thereof
  • Pentoxifylline injection composition and preparation method thereof
  • Pentoxifylline injection composition and preparation method thereof

Examples

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Embodiment 1

[0029] Embodiment 1 Pentoxifylline injection composition of the present invention

[0030] prescription:

[0031]

[0032] Preparation Process:

[0033] Take 70% of the total amount of water for injection at 75°C, add sodium dihydrogen phosphate, taurine, and vitamin B6 to dissolve, then add disodium edetate, add pentoxifylline, stir to dissolve, and then add 2% phosphoric acid Adjust the pH value of the disodium hydrogen solution to 5.0, add activated carbon for needles with a total volume of 0.1% (g / mL), stir and adsorb at 50-60°C for 20 minutes, filter and decarburize with a titanium filter stick, add water for injection to 1L, and stir Evenly, after coarse filtration and fine filtration with a 0.22um filter, filled with nitrogen, potted and sealed, sterilized with damp heat at 100°C for 30 minutes to obtain the product.

Embodiment 2

[0034] Embodiment 2 Pentoxifylline injection composition of the present invention

[0035] prescription:

[0036]

[0037] Preparation Process:

[0038] Take 80% of the total amount of water for injection at 80°C, add sodium dihydrogen phosphate, taurine, and vitamin B6 to dissolve, then add disodium edetate, add pentoxifylline, stir to dissolve, and then add 2% phosphoric acid Adjust the pH value of the disodium hydrogen solution to 5.5, add activated carbon for needles with 0.1% (g / mL) of the total volume of the solution, stir and absorb at 50-60°C for 20 minutes, filter and decarburize with a titanium filter stick, add water for injection to 1L, and stir Evenly, after coarse filtration and fine filtration with a 0.22um filter, filled with nitrogen, potted and sealed, sterilized with damp heat at 100°C for 30 minutes to obtain the product.

Embodiment 3

[0039] Embodiment 3 Pentoxifylline injection composition of the present invention

[0040] prescription:

[0041]

[0042]

[0043] Preparation Process:

[0044] Take 75% of the total amount of water for injection at 80°C, add sodium dihydrogen phosphate, taurine, and vitamin B6 to dissolve, then add disodium edetate, add pentoxifylline, stir to dissolve, and then add 2% phosphoric acid Adjust the pH value of the disodium hydrogen solution to 5.6, add activated carbon for needles with a total volume of 0.1% (g / mL), stir and adsorb at 50-60°C for 20 minutes, filter and decarburize with a titanium filter stick, add water for injection to 1L, and stir Evenly, after coarse filtration and fine filtration with a 0.22um filter, filled with nitrogen, potted and sealed, sterilized with damp heat at 100°C for 30 minutes to obtain the product.

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Abstract

The invention relates to a pentoxifylline injection composition and a preparation method thereof, belonging to the technical field of medical preparations. The injection composition is prepared from pentoxifylline, sodium dihydrogen phosphate, taurate, vitamin B6, disodium edetate and the like. The pentoxifylline injection composition is simple and feasible in technique. After the pentoxifylline injection composition is placed under accelerated test conditions for 6 months, the solution is still colorless, the pH value is basically unchanged, the increase of related substances is not obvious, the pentoxifylline content decrease is not obvious, and the product has obviously higher quality and stability than the control product.

Description

technical field [0001] The invention relates to an injection composition and a preparation method thereof, in particular to a pentoxifylline injection composition and a preparation method thereof, and belongs to the technical field of pharmaceutical preparations. Background technique [0002] Pentoxifylline is a methylxanthine derivative. It is an alkaloid obtained from theobromine extracted from cocoa beans and then introduced into a pentanone group. It is a white powder or granule; it has a slight odor and a bitter taste; Soluble in chloroform, soluble in water or ethanol, slightly soluble in ether. Molecular formula is C 13 h 18 N 4 o 3 , the chemical name is 3,7-dihydro-3,7-dimethyl-1-(5-oxohexyl)-1H-purine-2,6-dione, and the structural formula is as follows: [0003] [0004] Pentoxifylline is a non-selective phosphodiesterase inhibitor. By inhibiting phosphodiesterase, it increases intracellular adenosine triphosphate, improves the deformability of red blood ce...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K31/522A61K47/22A61K47/20A61P9/10A61P9/14A61P3/10A61P13/12A61P25/02A61P1/16A61P29/00
CPCA61K9/0019A61K9/08A61K31/522A61K47/20A61K47/22
Inventor 孙成勇郭倩胡瑞娟刘光苹马园园
Owner CSPC OUYI PHARM CO LTD
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