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A kind of preparation method of tigecycline freeze-dried powder injection

A technology of freeze-dried powder injection and tigecycline, which is applied in the field of preparation of tigecycline freeze-dried powder injection, and can solve problems such as unfavorable human health

Active Publication Date: 2017-09-12
SHANDONG NEWTIME PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

Antioxidants are bad for human health

Method used

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  • A kind of preparation method of tigecycline freeze-dried powder injection
  • A kind of preparation method of tigecycline freeze-dried powder injection
  • A kind of preparation method of tigecycline freeze-dried powder injection

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Effect test

Embodiment 1

[0019] The preparation process is as follows: water for injection is ultrasonically treated for more than 15 minutes, the temperature is kept at 10°C, 100g of lactose monohydrate is weighed, added with water for injection to 95% of the total amount, stirred and dissolved, cooled to 10°C, and 50g of tegecycline is slowly added Add water for injection to 3L, add 0.05% (g / v) activated carbon for needles, stir for 15 minutes, circulate, decarburize and filter, continue filtrate Transfer to the dilute preparation tank, circulate and filter, the medicinal liquid is sterilized and filtered through a 0.22 μm microporous membrane, and fill each vial with a medicinal liquid containing about 50 mg of tigecycline according to the intermediate detection data, freeze-dried, pressed Plugging, capping, visual inspection, packaging, and made into 1000 pieces.

Embodiment 2

[0021] The preparation process is: the water for injection is ultrasonically treated for more than 15 minutes, the temperature is kept at 15°C, and 100g of anhydrous lactose is weighed, and the water for injection is added to 95% of the total amount, stirred and dissolved, cooled to 15°C, and 50g of tegecycline is slowly added Add 0.05% (g / v) activated carbon for needles, stir for 15 minutes, circulate, decarburize and filter, continue filtrate Transfer to the dilute preparation tank, circulate and filter, the medicinal liquid is sterilized and filtered through a 0.22 μm microporous membrane, and fill each vial with a medicinal liquid containing about 50 mg of tigecycline according to the intermediate detection data, freeze-dried, pressed Plugging, capping, visual inspection, packaging, and made into 1000 pieces.

Embodiment 3

[0023] The preparation process is as follows: water for injection is ultrasonically treated for more than 15 minutes, the temperature is kept at 10°C, 100g of lactose monohydrate is weighed, added with water for injection to 95% of the total amount, stirred and dissolved, cooled to 10°C, and 50g of tegecycline is slowly added Add 0.05% (g / v) activated carbon for needles, stir for 15 minutes, circulate, decarburize and filter, continue filtrate Transfer to the dilute preparation tank, circulate and filter, the medicinal liquid is sterilized and filtered through a 0.22 μm microporous membrane, and fill each vial with a medicinal liquid containing about 50 mg of tigecycline according to the intermediate detection data, freeze-dried, pressed Plugging, capping, visual inspection, packaging, and made into 1000 pieces.

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Abstract

The application provides a preparation method of tigecycline freeze-dried powder injection. The method overcomes the shortcomings of tigecycline instability and easy oxidative deterioration, and provides a tigecycline jelly for injection with stable quality, total degradation products controlled within 0.2%, pollution-free, easy to operate, store and transport. Dry powder injection.

Description

technical field [0001] The invention relates to a preparation method of tigecycline freeze-dried powder injection. Background technique [0002] Tigecycline, the English name is Tigecycline; chemical 4S, 4aS, 5aR, 12As)-9-[2-(tert-butylamino) acetamido]-4,7-bis(dimethylamino)-1,4,4a, 5,5a6,11,12,12a-octahydro-3,10,12,12a-tetrahydroxy-1,11-dioxo-2-tetracenecarboxamide, the chemical structure is as follows: [0003] [0004] Tigecycline (Wyeth) was approved by the US Food and Drug Administration in June 2005 for bacterial infections. It is a glycylcycline class, the first new generation derivative of the tetracycline class, which has solved the problem of drug resistance of the previous tetracycline class. [0005] During the research and development process of the product, it was found that tigecycline is extremely unstable when exposed to heat, humidity and air, and the product is easily oxidized and hydrolyzed to deteriorate. At room temperature, the aqueous solution ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/19A61K31/65A61K47/26A61P31/04
Inventor 赵志全崔祥祯吕永超
Owner SHANDONG NEWTIME PHARMA