Pharmaceutical composition containing micafungin or its salt

A composition and drug technology, which is applied in the field of stable pharmaceutical compositions of the cyclic polypeptide compound micafungin, can solve problems such as unsuitability for use as pharmaceutical excipients, unsuitable excipients, potential safety hazards, etc., and achieves stability and safety. Excellent performance, less adverse reactions, and energy saving effects

Active Publication Date: 2015-08-05
JIANGSU HANSOH PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

It can be seen that trehalose has not been approved by any country for its use in medicines, and it is not suitable for use in pharmaceutical excipients, let alone as excipients for lyophilized powder for intravenous infusion
In addition, the high osmotic activity of trehalose in visceral organs can cause adverse reactions such as gastrointestinal discomfort in patients.
Therefore, using trehalose as an excipient for micafungin sodium freeze-dried powder injection has a greater potential safety hazard

Method used

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  • Pharmaceutical composition containing micafungin or its salt
  • Pharmaceutical composition containing micafungin or its salt
  • Pharmaceutical composition containing micafungin or its salt

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0031]

[0032] Dissolve dextran 70 in pure water (750ml) at room temperature, add micafungin sodium, and let stand or stir gently until the raw drug is completely dissolved. Add an appropriate amount of 0.1 mol / L citric acid aqueous solution and / or 0.1 mol / L sodium hydroxide aqueous solution to the solution to adjust the pH value of the solution to 5.5. Then dilute to 1250ml with pure water. The resulting solution was dispensed into 500 10ml control antibiotic bottles, 2.5ml in each bottle. Freeze-drying was performed by a conventional method to obtain freeze-dried compositions each containing 50 mg of micafungin.

Embodiment 2

[0034]

[0035] Dissolve dextran 20 and sucrose in 750ml of pure water at room temperature, then add micafungin sodium, and let stand or stir gently until the raw drug is completely dissolved. An appropriate amount of 0.1 mol / L hydrochloric acid solution and / or 0.1 mol / L aqueous sodium hydroxide solution was added to the solution to adjust the pH value of the solution to 5.5. Then dilute to 1250ml with pure water. The resulting solution was dispensed into 500 10ml control antibiotic bottles, 2.5ml in each bottle. Freeze-drying was performed by a conventional method to obtain freeze-dried compositions each containing 50 mg of micafungin.

Embodiment 3

[0037]

[0038] Dissolve dextran 40 and sucrose in 750ml of pure water at room temperature, then add micafungin sodium, and let stand or stir gently until the raw drug is completely dissolved. Add an appropriate amount of 0.1 mol / L citric acid aqueous solution and / or 0.1 mol / L sodium hydroxide aqueous solution to the solution to adjust the pH value of the solution to 5.5. Then dilute to 1250ml with pure water. The resulting solution was dispensed into 500 10ml control antibiotic bottles, 2.5ml in each bottle. Freeze-drying was performed by a conventional method to obtain freeze-dried compositions each containing 50 mg of micafungin.

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PUM

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Abstract

The present invention provides a pharmaceutical composition containing micafungin or a salt thereof. In the pharmaceutical composition, polysaccharide or disaccharide or a mixture of polysaccharide and disaccharide is used as an excipient, and the pharmaceutical composition may contain an appropriate amount of pH regulation agent.

Description

technical field [0001] The invention relates to a stable pharmaceutical composition of the cyclic polypeptide compound micafungin. Specifically, the present invention relates to a stable pharmaceutical composition with micafungin and pharmaceutically acceptable salts thereof as active ingredients and polysaccharides or disaccharides or mixtures thereof as excipients. Background technique [0002] Micafungin is the second echinocandin antifungal drug approved by the FDA after caspofungin. Micafungin Sodium for Injection, whose trade name is Mikamin, was developed by Japan Astellas Pharmaceutical Co., Ltd. It was first launched in Japan in 2002, approved by FDA in 2005, and entered my country in 2006. Its clinical trials have shown that compared with caspofungin, micafungin has stronger antibacterial activity, lower minimum effective concentration, and lower incidence of adverse reactions. [0003] Patent CN1179748C is a patent for micafungin sodium preparations, in which la...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K38/12A61K47/26A61K47/36A61P31/10
CPCA61K38/12A61K9/0014A61P31/10
Inventor 项文娟孙长安王小雷孙运栋
Owner JIANGSU HANSOH PHARMA CO LTD
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