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Fosaprepitant dimeglumine freeze-dried powder and preparation method thereof

A technology of fosaprepitant dimeglumine and freeze-dried powder, which is applied in the field of medicine and can solve problems such as insufficient treatment, insufficient attention, and overtreatment

Inactive Publication Date: 2014-02-12
NANJING CORE TECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0002] More than 75% of chemotherapy drugs can cause nausea and vomiting in varying degrees. Since the advent of highly selective 5-hydroxytryptamine 3 receptor antagonists in 1987, it has opened a new chapter in antiemetic treatment. A number of derivatives have been used in Clinically, the nausea and vomiting caused by chemotherapy has been relieved to a large extent, but due to insufficient attention to it clinically, there are often cases of undertreatment or overtreatment

Method used

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  • Fosaprepitant dimeglumine freeze-dried powder and preparation method thereof
  • Fosaprepitant dimeglumine freeze-dried powder and preparation method thereof

Examples

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example 1

[0017] Example 1, the preparation of fosaprepitant dimeglumine freeze-dried powder, in 1000 pieces.

[0018] 1. Prescription

[0019]

[0020] 2. Preparation process

[0021] a): adding fosaprepitant dimeglumine, lactose, and polysorbate into an aqueous ethanol solution to dissolve, and stirring evenly;

[0022] b): above-mentioned solution adjusts PH value with sodium hydroxide solution, adds 0.05% gac, stirs 15-30min; Filter gac, medicinal liquid passes through 0.45um and 0.22um microporous membrane filtration again, detects intermediate content, according to each The bottle contains 115mg of fosaprepitant dimeglumine for filling.

[0023] c): Filling is completed, half stoppered, put into a freeze-drying box, pre-frozen at -45°C, and kept warm for 1.5 hours. Slowly raise the temperature to 0°C, then raise the temperature to 30°C, and keep it warm for 2h. After the freeze-drying process is over, it is out of the box.

example 2

[0024] Example two, the preparation of fosaprepitant dimeglumine freeze-dried powder, in 1000 pieces.

[0025] 1. Prescription

[0026]

[0027] 2. Preparation process

[0028] a): adding fosaprepitant dimeglumine, lactose, and polysorbate into an aqueous ethanol solution to dissolve, and stirring evenly;

[0029] b): above-mentioned solution adjusts PH value with sodium hydroxide solution, adds 0.05% gac, stirs 15-30min; Filter gac, medicinal liquid passes through 0.45um and 0.22um microporous membrane filtration again, detects intermediate content, according to each The bottle contains 115mg of fosaprepitant dimeglumine for filling.

[0030] c): Filling is completed, half stoppered, put into a freeze-drying box, pre-frozen at -45°C, and kept warm for 1.5 hours. Slowly raise the temperature to 0°C, then raise the temperature to 30°C, and keep it warm for 2h. After the freeze-drying process is over, it is out of the box.

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Abstract

The invention discloses fosaprepitant dimeglumine freeze-dried powder and a preparation method thereof, and relates to the technical field of drugs and drug production. The freeze-dried powder injection contains fosaprepitant dimeglumine, lactose, polysorbate 80 and ethanol water solution. The freeze-dried powder adopts the ethanol water solution as freeze-dried preparation solvent, so that the freeze-dried time is largely shortened, the energy consumption is decreased, and the production cost is reduced.

Description

[0001] Technical field: the present invention belongs to the field of medical technology, and relates to fosaprepitant dimeglumine freeze-dried powder and its preparation method, especially a preparation method using ethanol aqueous solution as a solvent, which greatly shortens the freeze-drying time. Background technique: [0002] More than 75% of chemotherapy drugs can cause nausea and vomiting in varying degrees. Since the advent of highly selective 5-hydroxytryptamine 3 receptor antagonists in 1987, it has opened a new chapter in antiemetic treatment. A number of derivatives have been used in Clinically, chemotherapy-induced nausea and vomiting have been alleviated to a large extent, but due to insufficient attention to it in clinical practice, there are often cases of undertreatment or overtreatment. Fear of nausea and vomiting caused by drugs is still one of the important factors for patients to refuse chemotherapy. Severe nausea and vomiting will not only lead to poor c...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K31/675A61K47/26A61K47/10A61P1/08
Inventor 王雪根何凌云张用杰田春梅杨振伟
Owner NANJING CORE TECH CO LTD
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