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Freeze-dried composition containing micafungin and preparation method of freeze-dried composition

A technology of micafungin and a composition, applied in the field of pharmaceutical preparations, can solve the problems of increasing the difficulty of quality control, the risk of medication, and the types of excipients.

Inactive Publication Date: 2015-12-02
JIANGSU AOSAIKANG PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Due to the increase in the types of excipients, the above combined stabilizers also increase the difficulty of quality control and the risk of medication

Method used

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  • Freeze-dried composition containing micafungin and preparation method of freeze-dried composition
  • Freeze-dried composition containing micafungin and preparation method of freeze-dried composition
  • Freeze-dried composition containing micafungin and preparation method of freeze-dried composition

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0040]

[0041]Preparation method: Dissolve sucrose in 100ml of cooled water for injection at room temperature, add about 0.1g of citric acid and an appropriate amount of 0.1M sodium hydroxide solution to adjust the pH of the solution to 5-6, add micafungin sodium and stir until Dissolve, add water for injection to 125ml; filter the obtained medicinal solution through a 0.20μm sterile filter membrane, pack into 50 10ml vials, each 2.5ml, and half stopper. Place the vial containing the medicinal liquid in a tray in the cold trap of an ordinary lyophilizer for cooling. The freezing liquid in the tray is 60% ethylene glycol solution, and the liquid level of the freezing liquid is flush with the medicinal liquid level in the vial. When the medicinal liquid When the temperature is cooled to about 0°C, start the multi-frequency ultrasonic cell disruptor to perform pulse ultrasonic treatment on the frozen liquid. The ultrasonic frequency is 25kHz, the electric power is 150W, and th...

Embodiment 2

[0043]

[0044]

[0045] Preparation method: Dissolve sucrose in 100ml of cooled water for injection at room temperature, add about 0.1g of citric acid and an appropriate amount of 0.1M sodium hydroxide solution to adjust the pH of the solution to 5-6, add micafungin sodium and stir until Dissolve, add water for injection to 125ml; filter the obtained medicinal solution through a 0.20μm sterile filter membrane, pack into 50 10ml vials, each 2.5ml, and half stopper. Place the vials containing the medicinal solution in a tray in the cold trap of an ordinary lyophilizer to freeze. The freezing liquid in the tray is 60% ethylene glycol solution. When the temperature is cooled to about -2°C, start the multi-frequency ultrasonic cell disruptor to perform pulse ultrasonic treatment on the frozen liquid, with an ultrasonic frequency of 30 kHz, an electric power of 100 W, and a duty ratio of 4:1 until the liquid freezes. Then, put the vial into a freeze-drying box, lower the temp...

Embodiment 3

[0047]

[0048] Preparation method: Dissolve sucrose in 100ml of cooled water for injection at room temperature, add about 0.1g of citric acid and an appropriate amount of 0.1M sodium hydroxide solution to adjust the pH of the solution to 5-6, add micafungin sodium and stir until Dissolve, add water for injection to 125ml; filter the obtained medicinal solution through a 0.20μm sterile filter membrane, pack into 50 10ml vials, each 2.5ml, and half stopper. Place the vials containing the medicinal solution in a tray in the cold trap of an ordinary lyophilizer to freeze. The freezing liquid in the tray is 60% ethylene glycol solution. When the temperature is cooled to about -5°C, start the multi-frequency ultrasonic cell disruptor to perform pulse ultrasonic treatment on the frozen liquid, with an ultrasonic frequency of 40kHz, an electric power of 80W, and a duty ratio of 5:1 until the liquid freezes. Then, put the vial into a freeze-drying box, lower the temperature of the ...

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Abstract

The invention provides a freeze-dried composition containing micafungin and a preparation method of the freeze-dried composition. The preparation method includes dissolving the micafungin or pharmaceutically acceptable salt thereof, excipient and optional pH modifier in injection water and freezing the mixed liquor to obtain a solution, starting pulse ultrasonic treatment until freezing of the solution after the solution is frozen to the temperature ranging from 0 DEG C to -5 DEG C, and performing normal freeze-drying. The freeze-dried composition has the advantages that cane sugar, lactose and the like can serve as stabilizer, freeze-dried products are low and uniform in moisture content, the content of related substances is low and stability is high.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, in particular to a freeze-dried composition containing micafungin and a preparation method thereof. Background technique [0002] Micafungin sodium (Micafunginsodium, trade name: ) is an echinocandin antifungal drug developed by Astellas. It was first launched in Japan in 2002, and was approved by the FDA in May 2005 in the United States. The indications are fungal blood caused by Aspergillus and Candida. Syndrome, Respiratory Mycosis, Gastrointestinal Mycosis. The structural formula is as follows: [0003] [0004] Micafungin sodium is a white or off-white amorphous powder compound, sensitive to light, hygroscopic, soluble in water, isotonic sodium chloride solution, N,N-dimethylformamide and dimethylformamide Sulfoxide, slightly soluble in methanol, almost insoluble in acetonitrile, ethanol (95%), acetone, ether and n-hexane. This compound exhibits poor fluidity and thus does ...

Claims

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Application Information

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IPC IPC(8): A61K38/12A61K9/19A61K47/26A61P31/10
Inventor 陈庆财陈祥峰杨奇珍郦江平
Owner JIANGSU AOSAIKANG PHARMA CO LTD
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