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Bumetanide injection and preparation method thereof

A technology of bumetanide and bumetanide ≤ is applied in the field of medicine, which can solve problems such as uncontrollable quality defects and cumbersome operations, and achieve the effects of high stability, simplified process and high stability

Inactive Publication Date: 2021-06-04
海南卓华制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In the preparation of bumetanide injection, since bumetanide is insoluble in water, in order to fully dissolve the original bumetanide in water for injection, an alkaline solution is usually used to dissolve the bumetanide powder, and then Add buffer salt to adjust the pH value of the solution to 6.5-8.5; at the same time, the subsequent preparation process also includes operations such as activated carbon decolorization, detoxification, and fine filtration; these preparation processes are cumbersome to operate, and the addition of buffer solution and excess alkaline solution will cause The resulting bumetanide injection still has uncontrollable quality defects in subsequent clinical applications

Method used

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  • Bumetanide injection and preparation method thereof
  • Bumetanide injection and preparation method thereof
  • Bumetanide injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0031] (1) Accurately weigh 0.25g of bumetanide;

[0032] (2) Add water for injection at 8°C to bumetanide, the amount of water for injection is 90% of the total amount prepared; under stirring state, according to the molar ratio of bumetanide to sodium hydroxide 1:1.04, accurately add 0.95ml of 3% sodium hydroxide solution, and ultrasonically treat the mixed drug solution for 15 minutes. After the treatment is completed, continue to stir the mixed drug solution for 20 minutes; observe the dissolution state of bumetanide, and monitor the solution just after adding 3% sodium hydroxide solution and stirring The pH value after completion is recorded in Table 1;

[0033] (3) Add the remaining water for injection to make up to 1000ml;

[0034] (4) Use two 0.22 μm, PES material sterilization filters to carry out redundant filtration on the above solution, and the filtrate is used for standby;

[0035] (5) Divide the above-mentioned filtered solution into 2ml: 0.5mg and store it fo...

Embodiment 2

[0037] (1) Accurately weigh 0.25g of bumetanide;

[0038] (2) Add water for injection at 6°C to bumetanide, the amount of water for injection is 90% of the total amount prepared; under stirring state, according to the molar ratio of bumetanide to sodium hydroxide 1:1.05, accurately add 0.96ml of 3% sodium hydroxide solution, and sonicate the mixed drug solution for 13 minutes. After the treatment is completed, continue to stir the mixed drug solution for 20 minutes; observe the dissolution state of bumetanide, and monitor the drug solution just after adding 3% sodium hydroxide solution and stirring The pH value after completion is recorded in Table 1;

[0039] (3) Add the remaining water for injection to make up to 1000ml;

[0040] (4) Use two 0.22 μm, PES material sterilization filters to carry out redundant filtration on the above solution, and the filtrate is used for standby;

[0041] (5) Divide the above-mentioned filtered solution into 2ml: 0.5mg and store it for later...

Embodiment 3

[0043] (1) Accurately weigh 0.25g of bumetanide;

[0044] (2) Add water for injection at 2°C to bumetanide, the amount of water for injection is 90% of the total amount prepared; under stirring state, according to the molar ratio of bumetanide to sodium hydroxide 1:1.10, accurately add 1.005ml of 3% sodium hydroxide solution, and ultrasonically treat the mixed drug solution for 10 minutes. After the treatment is completed, continue to stir the mixed drug solution for 20 minutes; observe the dissolution state of bumetanide, and monitor the solution just after adding 3% sodium hydroxide solution and stirring The pH value after completion is recorded in Table 1;

[0045] (3) Add the remaining water for injection to make up to 1000ml;

[0046] (4) Use two 0.22 μm, PES material sterilization filters to carry out redundant filtration on the above solution, and the filtrate is used for standby;

[0047] (5) Divide the above-mentioned filtered solution into 2ml: 0.5mg and store it f...

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Abstract

The invention relates to the technical field of medical technology, and in particular relates to bumetanide injection, which is composed of the following components: bumetanide; sodium hydroxide; and water for injection. According to the bumetanide injection disclosed by the invention, other substances are not introduced while stable dissolution of bumetanide is ensured, so that sensitization is low, and clinical application is relatively safe. The invention also relates to a preparation method of the bumetanide injection. The preparation method specifically comprises the following steps of: (1) weighing bumetanide; (2) adding water for injection accounting for 90% of the total preparation amount into bumetanide, adding a sodium hydroxide solution in a stirring state, and enabling the pH value of the mixed solution to be 7.0-8.0 after the addition is completed; (3) supplementing the residual water for injection; (4) performing refined filtration to obtain filtrate for later use; and (5) filling the filtrate, and capping. The preparation method disclosed by the invention is simple to operate; operations of activated carbon filtration and the like are not set; the content of a main drug is ensured; furthermore, the stability of the bumetanide is high in the process; and the prepared bumetanide injection has relatively excellent comprehensive performance.

Description

technical field [0001] The invention relates to the technical field of medical technology, in particular to a bumetanide injection and a preparation method thereof. Background technique [0002] Bumetanide is a derivative of m-aminobenzenesulfonamide, which is a powerful diuretic. Clinically, its site of action, mechanism of action and features of action are similar to those of furosemide and ethacrynic acid. It is mainly used for the treatment of liver diseases, Heart failure, kidney disease, etc., with the characteristics of high efficiency, quick action, short action and low toxicity. The diuretic mechanism of bumetanide is related to the inhibition of Na-K-ATPase activity, which is mainly through the inhibition of the thick segment of the ascending branch of the loop of Henle against Cl - Active reabsorption and Na + The passive reabsorption of bumetanide affects the process of concentration and dilution of urine, and plays a diuretic effect. Bumetanide can also act on...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/196A61K9/08A61K47/02A61P1/16A61P13/12A61P9/04
CPCA61K9/0019A61K9/08A61K31/196A61K47/02A61P1/16A61P9/04A61P13/12
Inventor 魏雪纹戴宏旭苏凌彭琪
Owner 海南卓华制药有限公司
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