Levosimendan-containing medicine composition

A technology of levosimendan and pharmaceutical preparations, applied in the field of pharmaceutical preparations, can solve the problems of blocking blood vessels and danger, and achieve the effects of reducing hemolysis, good stability and strong stability

Inactive Publication Date: 2015-03-18
迈洋致达(北京)科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Precipitation of intravenous solutions is very dangerous because particulate matter can block blood vessels

Method used

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  • Levosimendan-containing medicine composition
  • Levosimendan-containing medicine composition
  • Levosimendan-containing medicine composition

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0026] Example 1 Levosimendan Injection

[0027]

[0028] Anhydrous citric acid, povidone K17 and levosimendan were dissolved in absolute ethanol in a sterile formulation container to prepare a concentrated solution. The resulting bulk solution was filtered through a sterile filter (0.22 μm). The sterilization method of this product is sterile filtration, because ethanol solution has the risk of explosion and cannot be sterilized by autoclaving. The sterile-filtered bulk solution was aseptically filled into 10ml injection vials, 5ml per vial, and sealed with a rubber stopper. The storage period of this product is 2 years at 2-8°C.

Embodiment 2

[0029] Example 2 Levosimendan infusion

[0030]

[0031]

[0032] The above-mentioned aqueous infusion solution was prepared by diluting the infusion concentrate solution of Example 1 with isotonic (0.9%) sodium chloride solution, and the resulting aqueous solution was clear without precipitation.

Embodiment 3

[0033] Embodiment 3 Levosimendan oral liquid

[0034]

[0035] The levosimendan composition is mixed with the corn oil, and stirred evenly under the condition of stirring to obtain a clear oily liquid, which can be used as an oral liquid, or as the content of the soft capsule to make a soft capsule.

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Abstract

The invention relates to a medicine composition containing levosimendan or the pharmaceutically acceptable salts thereof as active ingredients. The composition comprises the following ingredients: (1) 5-50mg of levosimendan or the pharmaceutically acceptable salts per dose; (2) 10-500mg of povidone K17 per dose; (3) 0.1-100ml of medicinal solvent per dose.

Description

technical field [0001] The invention relates to a pharmaceutical preparation, in particular to a solution preparation of the anti-heart failure drug levosimendan, which solves the problems of safety and stability of intravenous administration. Background technique [0002] Levosimendan (Levosimendan) is a new type of drug for the treatment of heart failure --- cardiomyopathy inotropic drugs, also known as calcium sensitizers. It was researched and developed by Orion Corporation of Finland and first launched in Switzerland in October 2000. It is suitable for short-term intravenous injection treatment of acute decompensated severe chronic heart failure after hospitalization. When conventional drugs alone are not effective enough, it is used as an additional drug. treat. The marketed dosage form is injection, the trade name is Simdax, and the specifications are 5ml:12.5mg and 10ml:25mg. It was launched in Norway, Peru, Portugal, Austria, and Finland in 2001, in Spain, Brazil,...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/00A61K31/50A61K47/32A61K47/12A61P9/04
Inventor 颜文革漆新国王红艳刘念
Owner 迈洋致达(北京)科技有限公司
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