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A kind of pentoxifylline injection and preparation method thereof

A technology for theobromine injection and pentoxifylline, which is applied in the fields of blood diseases, pharmaceutical formulations, extracellular fluid diseases, etc., can solve the problems of large excipients, pH value changes, increase in impurities, etc., to improve stability and reduce impurities. The effect of increasing content and broad application prospects

Active Publication Date: 2022-08-09
SHIJIAZHUANG NO 4 PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] Aiming at the problems of the existing pentoxifylline injections in the long-term storage process, the impurities increase, the pH value changes greatly, and more excipients are contained, the invention provides a pentoxifylline injection and a preparation method thereof

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  • A kind of pentoxifylline injection and preparation method thereof
  • A kind of pentoxifylline injection and preparation method thereof
  • A kind of pentoxifylline injection and preparation method thereof

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Embodiment 1

[0027] The present embodiment provides a kind of pentoxifylline injection, and the dosage of the prescription is shown in the following table:

[0028]

[0029] The preparation method of above-mentioned pentoxifylline injection is as follows:

[0030] Step a, take 500 mL of water for injection at 70°C, add sodium chloride, stir and dissolve, add 0.1 mol / L sodium hydroxide solution to adjust pH to 7.0, add pentoxifylline, stir and dissolve to obtain pentoxifylline medicinal solution;

[0031] Step b, add the remaining water for injection to 1L, and then add 0.1mol / L sodium hydroxide solution to adjust the pH to 7.0, filter through polyethersulfone filter cartridges with pore diameters of 1.0 μm, 0.45 μm and 0.2 μm in turn, and fill with polyethersulfone. The propylene ampoule was sterilized at 121° C. for 12 minutes to obtain the pentoxifylline injection.

Embodiment 2

[0033] The present embodiment provides a kind of pentoxifylline injection, and the dosage of the prescription is shown in the following table:

[0034]

[0035]

[0036] The preparation method of above-mentioned pentoxifylline injection is as follows:

[0037] Step a, take 600 mL of water for injection at 65°C, add sodium chloride, stir and dissolve, add 0.1 mol / L sodium hydroxide solution to adjust pH to 7.5, add pentoxifylline, stir and dissolve to obtain pentoxifylline medicinal solution;

[0038] Step b, add the remaining water for injection to 1L, then add 0.1mol / L hydrochloric acid solution to adjust the pH to 6.6, filter through polyethersulfone filter elements with pore diameters of 1.0 μm, 0.45 μm and 0.2 μm in turn, and fill polypropylene ampoules , sterilized at a constant temperature of 121° C. for 15 minutes to obtain the pentoxifylline injection.

Embodiment 3

[0040] The present embodiment provides a kind of pentoxifylline injection, and the dosage of the prescription is shown in the following table:

[0041]

[0042] The preparation method of above-mentioned pentoxifylline injection is as follows:

[0043] Step a, take 400 mL of water for injection at 75°C, add sodium chloride, stir and dissolve, add 0.1 mol / L sodium hydroxide solution to adjust pH to 6.8, add pentoxifylline, stir and dissolve to obtain pentoxifylline medicinal solution;

[0044] Step b, add the remaining water for injection to 1L, then add 0.1mol / L sodium hydroxide solution to adjust the pH to 7.3, filter through polyethersulfone filter cartridges with pore diameters of 1.0 μm, 0.45 μm and 0.2 μm in turn, and fill with polyethersulfone. The propylene ampoule was sterilized at 121° C. for 12 minutes to obtain the pentoxifylline injection.

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Abstract

The invention relates to the technical field of pharmaceutical preparations, and specifically discloses a pentoxifylline injection and a preparation method thereof. The preparation method is as follows: adding the osmotic pressure regulator in the recipe amount to the water for injection with a total volume of 40-60%, stirring and dissolving, adjusting the pH to 6.5-7.5, then adding the pentoxifylline in the recipe amount, stirring and dissolving, Add water for injection to make up the total amount, adjust the pH to 6.5-7.5, filter through the multi-stage polyethersulfone filter element with decreasing pore size in turn, fill and sterilize to obtain pentoxifylline injection. Compared with the prior art, the present invention achieves the purpose of ensuring product quality stability without adding a stabilizer, and the prescription is simpler. It does not increase, the pH value is stable, the color of the solution is always a colorless and clear solution, and the production cost is also reduced, which is convenient for industrialized production and has high promotion value.

Description

technical field [0001] The invention relates to the technical field of pharmaceutical preparations, in particular to a pentoxifylline injection and a preparation method thereof. Background technique [0002] Pentoxifylline, chemical name is 3,7-dihydro-3,7-dimethyl-1-(5-oxohexyl)-1H-purine-2,6-dione, molecular formula C 13 H 18 N 4 O 3 , is a methylxanthine derivative, an alkaloid obtained by introducing a hexanone group into the cocoa alkaloid extracted from cocoa beans. It is a white powder or granule, slightly odorous, slightly bitter, Soluble in methyl chloride, soluble in water or ethanol, slightly soluble in ether. Pentoxifylline can reduce blood viscosity, thereby improving blood fluidity, promoting the microcirculation of ischemic tissue, increasing the oxygen supply to special organs, and can also increase intracellular adenosine triphosphate content by inhibiting phosphodiesterase, thereby improving red blood cells. In addition, it also has the ability to redu...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/00A61K9/08A61K31/522A61K47/02A61K47/04A61P7/02A61J3/00
CPCA61K31/522A61K9/08A61K9/0019A61K47/02A61P7/02A61J3/00Y02A50/30
Inventor 王立江焦翠欢王恰茹李鑫王晖赵辉吴雷殷合闯
Owner SHIJIAZHUANG NO 4 PHARMA
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