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
CN112891332AInactive Publication Date: 2021-06-04海南卓华制药有限公司
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Patent Information

Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
海南卓华制药有限公司
Publication Date
2021-06-04
Estimated Expiration
Not applicable · inactive patent

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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.
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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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