Drug composition of micafungin or salt thereof

A technology of micafungin and a composition is applied in the field of stable pharmaceutical compositions of the cyclic polypeptide compound micafungin, and can solve the problems of unsuitability for use as pharmaceutical excipients, inability to use excipients, gastrointestinal discomfort, and the like, and achieves the Low requirements, stable appearance, and the effect of reducing production costs

Active Publication Date: 2013-10-02
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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  • Drug composition of micafungin or salt thereof
  • Drug composition of micafungin or salt thereof
  • Drug composition of micafungin or salt thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0031]

[0032] Dissolve dextran 70 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. Using a conventional lyophilizer, freeze-dry using a conventional method to obtain freeze-dried compositions each containing 50 mg of micafungin.

Embodiment 2

[0034]

[0035] Dissolve dextran 20 and glucose 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. Using a conventional lyophilizer, freeze-dry using a conventional method to obtain freeze-dried compositions each containing 50 mg of micafungin.

Embodiment 3

[0037]

[0038] Dissolve dextran 40 and glucose 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 invention discloses a drug composition of micafungin or a salt thereof, wherein a polysaccharide or a monosaccharide or a mixture of a polysaccharide and a monosaccharide is adopted as an excipient, and the drug composition can contain a suitable amount of a pH value regulation agent. In addition, stability and potential safety of the drug composition of the present invention are superior to stability and potential safety of the existing preparation.

Description

technical field [0001] The present invention relates to a stable pharmaceutical composition of 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 monosaccharides or their mixtures 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 whic...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K38/12A61K47/26A61K47/36A61K47/38A61P31/10
CPCA61K9/19A61K38/12A61K47/26A61K47/36A61P31/10
Inventor 项文娟孙长安王小雷孙运栋
Owner JIANGSU HANSOH PHARMA CO LTD
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