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Medigoxin liquid preparation, its preparation method and use

A technology for medigoxin and liquid preparations, which is applied in pharmaceutical formulations, medical preparations with inactive ingredients, and medical preparations containing active ingredients, etc., can solve the problems of easy hydrolysis and oxidation, difficult to stabilize, and low content.

Active Publication Date: 2020-02-11
SHANDONG DYNE MARINE BIOTECHCAL PHARM HLDG CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] The liquid preparation of medigoxin is easy to hydrolyze and oxidize, and it is not easy to be stable. During the preparation process and storage process, the content will become lower and the related substances will increase.

Method used

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  • Medigoxin liquid preparation, its preparation method and use
  • Medigoxin liquid preparation, its preparation method and use
  • Medigoxin liquid preparation, its preparation method and use

Examples

Experimental program
Comparison scheme
Effect test

example 1

[0035] Preparation of medigoxin oral drops

[0036] Composition of medigoxin oral drops

[0037]

[0038] Add water to make up to 1000ml to make 100 sticks. The concentration of arginine is 35mg / ml.

[0039] The medigoxin raw material was added to ethanol, stirred to dissolve, and the prescribed amount of glycerin, propylene glycol and water were sequentially added, and the resulting solution was heated to 60°C, stirred for 1 hour, and filtered. The prescription amount of arginine is added to the above solution, and the pH of the drug solution is adjusted to 7.0-8.0 with a 0.1 mol / L sodium hydroxide solution. The liquid medicine is filtered and filled.

example 2

[0041] Preparation of medigoxin oral drops

[0042] Composition of medigoxin oral drops

[0043]

[0044] Add water to make up to 1000ml to make 100 sticks. The concentration of arginine is 50 mg / ml.

[0045] The medigoxin raw material was added to ethanol, stirred to dissolve, and the prescribed amount of glycerin, propylene glycol and water were sequentially added, and the resulting solution was heated to 60°C, stirred for 1 hour, and filtered. The prescription amount of arginine is added to the above solution, and the pH of the drug solution is adjusted to 7.0-8.0 with a 0.1 mol / L sodium hydroxide solution. The liquid medicine is filtered and filled.

example 3

[0047] Preparation of medigoxin oral drops

[0048] Composition of medigoxin oral drops

[0049]

[0050] Add water to make up to 1000ml to make 100 sticks. The concentration of arginine is 20 mg / ml, the concentration of histidine is 40 mg / ml, and the concentration of the two is 60 mg / ml when used in combination.

[0051] The medigoxin raw material was added to ethanol, stirred to dissolve, and the prescribed amount of glycerin, propylene glycol and water were sequentially added, and the resulting solution was heated to 60°C, stirred for 1 hour, and filtered. The prescription amount of arginine and histidine are added to the above solution, and the pH of the drug solution is adjusted to 6.0-8.0 with 0.1 mol / L sodium hydroxide solution. The liquid medicine is filtered and filled.

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Abstract

The invention relates to a medigoxin liquid preparation, which includes medigoxin as an active component and arginine and / or histidine or salts thereof as a stabilizer. The invention also relates to a preparation method and applications of the medigoxin liquid preparation.

Description

Technical field [0001] The present invention relates to a liquid preparation containing medigoxin for treating heart failure and arrhythmia, especially including medigoxin injection and oral solution, as well as a preparation method and application thereof. Background technique [0002] In 1542, German scholar Fuchsius created the general term digitalis to name digitalis plants. In 1785, William Withering published the first book on the pharmacological effects of digitalis. After that, physicians began to use digoxin preparations to treat edema, arrhythmia and chronic heart failure (CHF). The famous DIG test results published in 1997 once again established the status of digoxin in the treatment of CHF. Today, digoxin is not only one of the most commonly used drugs necessary to relieve the symptoms of CHF patients, but also a commonly used drug to control the resting ventricular rate of patients with atrial fibrillation (AF). [0003] Digoxin, as a drug for the treatment of heart...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/08A61K47/18A61K47/22A61K31/7048A61P9/06A61P9/04
CPCA61K9/0019A61K9/0053A61K9/08A61K31/7048A61K47/18A61K47/22
Inventor 杨杰何淑旺张自强姚静景亚军胡醒陶元景
Owner SHANDONG DYNE MARINE BIOTECHCAL PHARM HLDG CO LTD