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Anti-infection micafungin freeze-drying composition and preparation method thereof

A technology of micafungin and its composition, which is applied in the field of micafungin freeze-dried composition and its preparation, can solve the problems of large photodegradation impurities, inconvenience, and increased risk of use for patients, and achieve convenient preparation and improved safety The effect of stability and quality

Inactive Publication Date: 2016-07-13
张光泉
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0011] The micafungin freeze-dried composition needs to be diluted with 0.9% sodium chloride solution or 5% glucose solution during clinical use, and its aqueous solution is prone to photodegradation reaction, and its photodegradation impurities become larger as the storage time prolongs, which is It brings inconvenience to the clinical drug preparation of medical staff, and also increases the risk of use of patients. The inventor found through the investigation of the prescription that the current technology cannot solve this problem

Method used

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  • Anti-infection micafungin freeze-drying composition and preparation method thereof
  • Anti-infection micafungin freeze-drying composition and preparation method thereof
  • Anti-infection micafungin freeze-drying composition and preparation method thereof

Examples

Experimental program
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Effect test

Embodiment 1

[0028] prescription

[0029]

[0030] Preparation Process

[0031] 1). Weigh the prescribed amount of micafungin sodium and meglumine and dissolve in an appropriate amount of water for injection, stir and mix to dissolve;

[0032] 2). Weigh the prescribed amount of mannitol and dissolve it in an appropriate amount of water for injection;

[0033] 3). Add the prepared solution 1) into the solution 2), stir and mix evenly, adjust the pH value with an appropriate amount of dilute hydrochloric acid or dilute sodium hydroxide solution, use water for injection to make up the volume to the total amount, stir and mix evenly, filter, Filling, freeze-drying, and visual inspection to get the finished product.

[0034] Freeze-drying curve:

[0035] 1). Pre-freezing stage: place the filled and semi-stoppered semi-finished product on the partition in the freeze-drying cabinet for pre-freezing, and make the semi-finished product reach the pre-freezing temperature in the shortest possib...

Embodiment 2

[0039] prescription

[0040]

[0041] Preparation process: with embodiment 1

Embodiment 3

[0043] prescription

[0044]

[0045] Preparation process: with embodiment 1

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Abstract

The invention belongs to the technical field of medicines, and in particular relates to an anti-infection micafungin freeze-drying composition and a preparation method thereof. The anti-infection micafungin freeze-drying composition mainly consists of active components micafungin, mannitol, meglumine and a pH adjusting agent. The anti-infection micafungin freeze-drying composition provided by the invention is stable in quality and free of conspicuous light degradation phenomenon after being diluted, so that convenience can be brought to clinical medical operators to prepare medicines, and use security to patients can be improved.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a micafungin freeze-dried composition and a preparation method thereof. Background technique [0002] Micafungin is a new type of water-soluble echinocandin lipopeptide developed by Fujisawa Company in Japan. It is a non-competitive inhibitor of the synthesis process of 1,3-8-n-glucan, the main component of fungal cell walls. It has a broad-spectrum antibacterial effect on deep fungal infections caused by Candida and Aspergillus, and has a strong in vitro antibacterial effect on fluconazole and itraconazole-resistant Candida, and has a strong antibacterial effect on Aspergillus spore germination and bacteria. It has inhibitory effect on silk growth and is currently mainly used for deep fungal infections caused by Candida and Aspergillus. [0003] Micafungin Sodium for Injection, whose trade name is Mikamin, was developed by Japan Astellas Pharmaceutical Co., Ltd. It...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K38/12A61K47/10A61K47/18A61P31/10F26B5/06
CPCA61K38/12A61K9/0019A61K9/19A61K47/10A61K47/18F26B5/06
Inventor 不公告发明人
Owner 张光泉
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