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Small-size sodium ozagrel freeze-dried powder needle as well as preparation method and production device thereof

A technology for sodium ozagrel and freeze-dried powder injection, which is applied in the field of small-volume sodium ozagrel freeze-dried powder injection and its preparation, can solve the problems of poor stability of ozagrel, shortened product validity period, poor product reconstitution, and the like, Achieve the effect of reducing packaging and transportation costs, reducing volume, and optimizing product processes

Inactive Publication Date: 2013-09-04
REYOUNG PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Ozagrel is insoluble in water, and Ozagrel itself has poor stability and is easy to precipitate in aqueous solution, resulting in poor resolubility of the product. The longer the storage time, the deeper the turbidity, and the shorter the validity period of the product

Method used

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  • Small-size sodium ozagrel freeze-dried powder needle as well as preparation method and production device thereof
  • Small-size sodium ozagrel freeze-dried powder needle as well as preparation method and production device thereof
  • Small-size sodium ozagrel freeze-dried powder needle as well as preparation method and production device thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0030] The preparation method of 20mg small volume ozagrel sodium freeze-dried powder injection:

[0031] The formula is as follows:

[0032]

[0033] Before production, flush the device with edetate disodium with a concentration of 0.018%, complex for 0.8h, rinse with water for injection after the complexation is completed, and then prepare the nitrogen gas through the nitrogen sterilization filter to replace the feed liquid with air, which is called Take the prescribed amount of sodium citrate and edetate disodium, add them into the container and start stirring, take the prescribed amount of ozagrel and sodium hydroxide, the salt formation reaction is complete, adjust the pH to 8.0, and control the temperature at 18°C. After the preparation is completed, weigh 1.28g of activated carbon and add it, stir and absorb for 25 minutes, turn on the first Grundfos pump and use a titanium rod filter to decarbonize and filter, and the feed liquid is sterilized by the first sterilizi...

Embodiment 2

[0037] The preparation method of 40mg small volume ozagrel sodium freeze-dried powder injection:

[0038]

[0039] Before production, flush the device with edetate disodium with a concentration of 0.02%, complex for 1 hour, rinse with water for injection after the complexation is completed, and then prepare it. Nitrogen passes through the nitrogen sterilization filter to replace the feed liquid with air, and weighs Add the prescribed amount of sodium citrate and edetate disodium into the container and start stirring, take the prescribed amount of ozagrel and sodium hydroxide, the salt formation reaction is complete, adjust the pH to 9.3, and control the temperature at 20°C, the preparation is completed Finally, weigh 2g of activated carbon and add it, stir and absorb for 30min, turn on the first Grundfos pump and use a titanium rod filter to decarbonize and filter, and pass the feed liquid through the first sterilizing filter element to sterilize and transport it to the asep...

Embodiment 3

[0042] The preparation method of 80mg small volume ozagrel sodium freeze-dried powder injection:

[0043]

[0044] Before production, flush the device with edetate disodium with a concentration of 0.022%, complex for 1.2 hours, rinse with water for injection after the complexation is completed, and then prepare the nitrogen gas through the nitrogen sterilization filter to replace the feed liquid with air, which is called Take the prescribed amount of sodium citrate and edetate disodium, add them into the container and start stirring, take the prescribed amount of ozagrel and sodium hydroxide, the salt formation reaction is complete, adjust the pH to 9.5, and control the temperature at 19°C to prepare After completion, weigh 2.46g of activated carbon and add it, stir and absorb for 28 minutes, turn on the first Grundfos pump and use a titanium rod filter to decarbonize and filter, and the feed liquid is sterilized by the first sterilizing filter element and transported to the...

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Abstract

The invention belongs to the technical field of freeze-dried powder needle preparation and relates to a small-size sodium ozagrel freeze-dried powder needle as well as a preparation method and a production device thereof. The small-size sodium ozagrel freeze-dried powder needle is characterized in that sodium ozagrel freeze-dried powder is filled into a 7ml pipe penicillin bottle; and the content of sodium ozagrel in the sodium ozagrel freeze-dried powder needle is 20mg, 40mg or 80mg. The preparation method comprises the following steps of: before preparation, washing the device by a metal complexing agent firstly and then by injection water, and meanwhile, introducing nitrogen; reacting the sodium ozagrel, sodium hydroxide and an auxiliary material; after reaction, adding active carbon; decarbonizing and filtering by a titanium rod, and then carrying out fine filtering; and then filling the powder into the 7ml pipe penicillin bottle, and carrying out freeze-drying, pressing and blocking, as well as cover rolling to obtain the product. According to the small-size sodium ozagrel freeze-dried powder needle as well as the preparation method and the production device thereof disclosed by the invention, a product process is optimized so that the size of the sodium ozagrel freeze-dried powder needle is reduced, the yield of the product is improved, and the packaging and transporting cost is reduced; and as the device is washed by the metal complexing agent, the quality of the product is improved and the medication safety is guaranteed.

Description

technical field [0001] The invention belongs to the technical field of preparation of freeze-dried powder injection, and relates to a small-volume sodium ozagrel freeze-dried powder injection, a preparation method and a production device thereof. Background technique [0002] The specifications of the currently commercially available ozagrel sodium freeze-dried powder injections are 20mg, 40mg, and 80mg, respectively filled with 15ml, 10ml, and 10ml molded vials. The occupied area is just large, causing the shortcoming of low yield of products produced in each batch; and the volume of the products is large, and the cost of packaging and transportation will increase. [0003] The commercially available ozagrel sodium freeze-dried powder injection has poor stability and immature preparation process, which shortens the validity period of the product. Since Ozagrel sodium is obtained from the salt formation of Ozagrel and sodium hydroxide, this product is easily soluble in wate...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K31/4174A61J3/02C23G5/036
Inventor 何茂群苗得足张光明白先杰司吉晖张国明
Owner REYOUNG PHARMA
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