Pentoxifylline injection and preparation method thereof

A technology of theobromine injection and pentoxifylline, which can be used in blood diseases, medical formulas, extracellular fluid diseases, etc., and can solve problems such as changes in pH, increased impurities, and large excipients

Active Publication Date: 2021-07-06
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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  • Pentoxifylline injection and preparation method thereof
  • Pentoxifylline injection and preparation method thereof
  • Pentoxifylline injection and preparation method thereof

Examples

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Embodiment 1

[0027] The present embodiment provides a kind of pentoxifylline injection, and the prescription dosage 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 to dissolve, add 0.1 mol / L sodium hydroxide solution to adjust the pH to 7.0, add pentoxifylline, stir and dissolve to obtain pentoxifylline liquid medicine;

[0031] Step b, add the remaining water for injection to 1L, then add 0.1mol / L sodium hydroxide solution to adjust the pH to 7.0, filter through polyethersulfone filter elements with pore sizes of 1.0 μm, 0.45 μm and 0.2 μm in turn, and fill the polyethersulfone Propylene ampoules were sterilized at a constant temperature of 121° C. for 12 minutes to obtain the pentoxifylline injection.

Embodiment 2

[0033] The present embodiment provides a kind of pentoxifylline injection, and the prescription dosage 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 to dissolve, add 0.1 mol / L sodium hydroxide solution to adjust the pH to 7.5, add pentoxifylline, stir and dissolve to obtain pentoxifylline liquid medicine;

[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 sizes of 1.0μm, 0.45μm and 0.2μm in turn, and fill polypropylene ampoules , 121 ° C constant temperature sterilization for 15 minutes to obtain the pentoxifylline injection.

Embodiment 3

[0040] The present embodiment provides a kind of pentoxifylline injection, and the prescription dosage 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 to dissolve, add 0.1 mol / L sodium hydroxide solution to adjust the pH to 6.8, add pentoxifylline, stir and dissolve to obtain pentoxifylline liquid medicine;

[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 elements with pore sizes of 1.0 μm, 0.45 μm and 0.2 μm in turn, and fill the polyethersulfone Propylene ampoules were sterilized at a constant temperature of 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 particularly discloses a pentoxifylline injection and a preparation method thereof. The preparation method comprises the following steps of adding the osmotic pressure regulator of the prescription dosage into the water for injection which is 40-60% of the total preparation volume, stirring and dissolving, adjusting the pH value to 6.5-7.5, then adding the pentoxifylline of the prescription dosage, stirring and dissolving, supplementing the water for injection to the total preparation volume, adjusting the pH value to 6.5-7.5, filtering through a multi-stage polyether sulfone filter element of which the pore diameter is sequentially reduced, filling, and sterilizing to obtain the pentoxifylline injection. Compared with the prior art, the preparation method realizes the purpose of ensuring the product quality stability under the condition of not adding a stabilizer, the prescription is simpler, the total impurity content is less than or equal to 0.05%, the impurity content is basically not increased, the pH value is stable, the solution is always a colorless and clear solution in an accelerated six-month test process, the production cost is also reduced, the industrial production is convenient to realize, and the popularization value is relatively high.

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 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 theobromine extracted from the cocoa bean. It is a white powder or granule, slightly smelly, slightly bitter, and in Soluble in methyl chloride, soluble in water or ethanol, slightly soluble in ether. Pentoxifylline can reduce blood viscosity, thereby improving blood fluidity, promoting microcirculation of ischemic tissue, increasing oxygen supply of special organs, and increasing intracellular adenosine triphosphate content by inhibiting phosphodiesterase, thus improving red blood cell In addition, it also has the ability to reduce fibrinogen and inh...

Claims

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Application Information

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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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