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Frusemide oral solution and preparation method thereof

An oral solution, the technology of furosemide, applied in the field of furosemide oral solution, can solve the problems that the safety and effectiveness cannot be guaranteed, the number of other impurities increases, and furosemide cannot be prepared, so as to improve the light stability , Convenient access at will, high safety effect

Inactive Publication Date: 2019-02-05
南京泽恒医药技术开发有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Through the stability experiment, it can be known that the furosemide oral solution that has been marketed at home and abroad is placed in the original packaging material, and after being placed for 3 months under the long-term test conditions of 25°C and 60%RH, the increase of its impurity C has been far greater than that of According to the pharmacopoeia standards of various countries, the number of other impurities has also increased greatly, and the safety and effectiveness of the product cannot be guaranteed
[0005] In summary, the prior art cannot prepare a furosemide oral solution that can ensure complete dissolution of furosemide and ensure its stability

Method used

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  • Frusemide oral solution and preparation method thereof
  • Frusemide oral solution and preparation method thereof
  • Frusemide oral solution and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0037] furosemide

[0038] Preparation method: dissolve meglumine in 40g of purified water, stir to dissolve, add furosemide, stir to dissolve, add sweet orange essence and sunset yellow, stir to dissolve, dilute to 100mL with purified water, filter with 0.45μm polyethersulfone filter element After that, filling.

Embodiment 2

[0040] furosemide

[0041] Preparation method: Dissolve meglumine in 20g of purified water in advance, add furosemide into 40g of purified water, stir evenly, then add meglumine solution, heat up to 60°C, stir to dissolve, cool to room temperature, add sweet orange essence, Stir to dissolve the sunset yellow, dilute to 100mL with purified water, filter through a 0.22μm polyethersulfone filter, and fill.

Embodiment 3

[0043] furosemide

[0044] Preparation method: Boil 50g of purified water for 30min, add meglumine and stir to dissolve, cool to 60°C, add furosemide and stir to dissolve, cool to room temperature, dilute to 100mL with purified water, filter with a 0.45μm polyethersulfone filter element, filling.

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PUM

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Abstract

The invention discloses a frusemide oral solution and a preparation method thereof. The oral solution is prepared from frusemide, meglumine, a corrigent, an aromatic agent, a coloring agent and purified water, wherein the meglumine is a co-solvent as well as a stabilizer. The oral solution disclosed by the invention has good stability under high temperature conditions, convenient storage, convenient administration, excellent mouthfeel and high compliance.

Description

technical field [0001] The invention relates to a diuretic oral solution, in particular to a furosemide oral solution. Background technique [0002] Furosemide is a rapid and highly potent diuretic commonly used clinically to treat edema associated with heart failure, including pulmonary edema and associated renal and hepatic disease, and may be effective in patients unresponsive to thiazide diuretics; it is also available For the treatment of oliguria caused by renal failure or insufficiency, used alone or in combination with other antihypertensive drugs to treat hypertension. [0003] The diuretic mechanism of furosemide is to inhibit the reabsorption of electrolytes in the medulla and cortex of the thick ascending limb of the loop of Henle and the distal renal tubules, and inhibit the proximal renal tubules from reabsorbing Na + , Cl - reabsorption, leading to a decrease in the concentration function of the renal tubules, resulting in water, Na + , Cl - Increased excr...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K47/26A61K31/341A61P7/10A61P9/12
CPCA61K9/0095A61K31/341A61K47/26A61P7/10A61P9/12
Inventor 赵佳谢晓燕
Owner 南京泽恒医药技术开发有限公司
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