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Tedizolid phosphate freeze-dried powder injection

A technology of tedizolid phosphate and freeze-dried powder injection, which is applied in the field of medicine, can solve problems such as the decrease of the clarity of the reconstitution solution, the impact on product quality, and the increase of related substances, so as to achieve high safety in clinical use, stable product quality, The effect of reducing the generation of impurities

Inactive Publication Date: 2017-01-25
TIANJIN CHASE SUN PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Residual water will affect the stability of this product, and will lead to a series of problems such as the decrease of the clarity of the reconstitution solution and the increase of related substances in the product, which will ultimately affect the product quality and the safety of the drug.

Method used

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  • Tedizolid phosphate freeze-dried powder injection
  • Tedizolid phosphate freeze-dried powder injection
  • Tedizolid phosphate freeze-dried powder injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0040] prescription

[0041] tedizolid phosphate 200mg Mannitol 105mg sodium hydroxide solution 1mol / L Hydrochloric acid solution 1mol / L activated carbon 0.1％ Water for Injection 2ml

[0042] craft

[0043] a) Inject 50% of the prescribed amount of water for injection into the liquid preparation tank, cool down to room temperature, add the prescribed amount of tedizolid phosphate to disperse for 5 minutes, add sodium hydroxide solution until the pH of the liquid is 7.50-7.70, and continue stirring for 30 minutes, Add mannitol to dissolve, and adjust the pH value to 7.70-7.80 with 1mol / L sodium hydroxide solution or 1mol / L hydrochloric acid solution.

[0044] b) Add 0.1% activated carbon to the medicinal solution in step a), stir and absorb for 20 minutes, and filter with 0.45 titanium rod.

[0045] c) After decarburization, water for injection is added to the medicinal solution to 100% of the prescription volume, mixed evenly, ...

Embodiment 2

[0053] prescription

[0054]

[0055] craft

[0056] a) Inject 50% of the prescribed amount of water for injection into the liquid preparation tank, cool down to room temperature, add the prescribed amount of tedizolid phosphate to disperse for 5 minutes, add 3mol / L sodium hydroxide solution until the pH of the liquid is 7.50-7.70, and continue stirring After 30 minutes, add mannitol to dissolve, and adjust the pH value to 7.70-7.80 with 3mol / L sodium hydroxide solution or 3mol / L hydrochloric acid solution.

[0057] b) Add 0.2% activated carbon to the medicinal solution in step a), stir and absorb for 20 minutes, and filter with 0.45 titanium rod.

[0058] c) After decarburization, water for injection is added to the medicinal solution to 100% of the prescription volume, mixed evenly, and the medicinal solution is filtered through a 0.22um+0.22um microporous membrane.

[0059] d) Intermediate test, after the test is qualified, it will be filled with 2ml / cartridge.

[006...

Embodiment 3

[0065] prescription

[0066]

[0067] craft

[0068] a) Inject 50% of the prescribed amount of water for injection into the liquid preparation tank, cool down to room temperature, add the prescribed amount of tedizolid phosphate to disperse for 5 minutes, add 5 mol / L sodium hydroxide solution until the pH of the liquid is 7.50-7.70, and continue stirring After 30 minutes, add mannitol to dissolve, and adjust the pH value to 7.70-7.80 with 5mol / L sodium hydroxide solution or 5mol / L hydrochloric acid solution.

[0069] b) Add 0.5% activated carbon to the medicinal solution in step a), stir and absorb for 20 minutes, and filter with 0.45 titanium rod.

[0070] c) After decarburization, water for injection is added to the medicinal solution to 100% of the prescription amount, mixed evenly, and the medicinal solution is filtered twice through a 0.22um microporous membrane.

[0071] d) Intermediate test, after the test is qualified, it will be filled with 2ml / cartridge.

[007...

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Abstract

The invention discloses a tedizolid phosphate freeze-dried powder injection preparation and a preparation method thereof, belonging to the technical field of pharmaceutical preparations. Every tedizolid phosphate freeze-dried powder injection solution contains 200mg of tedizolid phosphate, 105mg of mannitol and 2ml of water for injection. The invention aims to solve the following technical problems: the tedizolid phosphate is insoluble in water, and the preparation needs to be prepared into the freeze-dried powder injection preparation.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a freeze-dried powder injection of tedizolid phosphate and a preparation method thereof. Background technique [0002] Tedizolid Phosphate is a drug for the treatment of acute bacterial skin diseases and skin structure infections developed by Cubist Corporation of the United States (now acquired by Merck). It is an oxazolidinone antibacterial drug. The drug was approved by the FDA in June 2014 and launched in the United States under the trade name SIVEXTRO, which is a 200mg tablet and lyophilized powder for injection. The administration method is 200 mg orally or intravenously (1 hour) per day for 6 days. [0003] This drug is indicated for the infection of Staphylococcus aureus, (Methicillin-resistant Staphylococcus aureus, Methicillin-susceptible Staphylococcus aureus), Streptococcus pyogenes, Streptococcus, Streptococcus angina group (including angina chain Acut...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K31/675A61K47/26A61P31/04A61P17/00
CPCA61K9/19A61K9/0019A61K31/675A61K47/26
Inventor 郑玲玲吴玉珠王桂霞苗玉梅董凯
Owner TIANJIN CHASE SUN PHARM CO LTD
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