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Small-size doxofylline freeze-dried powder injection and preparation method and production device thereof

A technology of doxofylline and freeze-dried powder injection, which is applied in the direction of freeze-drying transportation, making medicines into special physical or taking forms, powder transportation, etc., which can solve the problems of increasing filling volume, low product output, Increased energy consumption and other issues, to achieve the effect of reducing packaging volume, reducing costs, and reducing energy consumption

Active Publication Date: 2012-10-24
REYOUNG PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0002] The currently commercially available 0.2g doxofylline freeze-dried powder injection is filled with 20ml molded vials, so there is a large volume of the inner packaging container, and the area occupied by each bottle in the freeze-drying box is large, causing each batch of production The shortcoming of the low yield of the product, because the water solubility of doxofylline itself is not good, so it needs to use a large amount of solvent to dissolve in the preparation process, so as to make doxofylline freeze-dried powder injection
The original preparation process did not control the preparation temperature, and the temperature is generally 20°C to 25°C during concentrated preparation. Therefore, it is necessary to add 60 times the water of the main drug to dissolve it, thereby increasing the filling volume. In order to ensure freeze-drying The sublimation speed of water in the process is filled with 20ml molded vials, resulting in a decrease in the output of each batch, an increase in the energy consumption of more water in freeze-drying, and an increase in packaging and transportation costs

Method used

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  • Small-size doxofylline freeze-dried powder injection and preparation method and production device thereof
  • Small-size doxofylline freeze-dried powder injection and preparation method and production device thereof
  • Small-size doxofylline freeze-dried powder injection and preparation method and production device thereof

Examples

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Embodiment 1

[0023]

[0024] The preparation method of small-volume doxofylline freeze-dried powder injection is to lower the temperature below 50°C, add mannitol, stir and dissolve, keep the solution temperature between 40°C and 45°C, then add doxofylline, and keep the temperature of the liquid at Between 40°C and 45°C. After the feed liquid is dissolved, take a sample to test the pH value of the feed liquid, which is required to be controlled between 4.5-6.5, and add 0.1% (W / V) activated carbon for decolorization for 30 minutes.

[0025] Turn on the second Grundfos pump 9 and use the titanium rod filter 2 for decarburization and filtration, pass the feed liquid through the second sterilizing filter element 8 to sterilize, and transport it to the aseptic insulation solution storage tank 3 for storage. After sterilizing and filtering, add the remaining amount of water for injection at 40-45°C to the heat-preserving dispensing tank 1, transport it to the titanium rod filter 2 through the...

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PUM

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Abstract

The invention belongs to the technical field of freeze-dried powder injection preparation, and relates to a small-size doxofylline freeze-dried powder injection, a preparation method and a production device thereof. The doxofylline freeze-dried powder injection is filled in a 15-ml tubular penicillin bottle, and the doxofylline content in the doxofylline freeze-dried powder injection is 0.2 g. Compared with the prior art, the invention has the beneficial effects of effectively increased yield, reduced energy consumption, reduced package size, and thus reduced packaging and transport cost; the filling amount is reduced to be only 6-6.2 ml; the freeze-drying and evaporation energy consumption is greatly reduced; and the cost is further reduced.

Description

technical field [0001] The invention belongs to the technical field of freeze-dried powder injection preparation, and relates to a small-volume doxofylline freeze-dried powder injection, a preparation method and a production device thereof. Background technique [0002] The currently commercially available 0.2g doxofylline freeze-dried powder injection is filled with 20ml molded vials, so there is a large volume of the inner packaging container, and the area occupied by each bottle in the freeze-drying box is large, causing each batch of production The shortcoming of low product yield, because the water solubility of doxofylline itself is not good, thus needs to be dissolved with a large amount of solvents in the preparation process, so that make doxofylline freeze-dried powder injection. The original preparation process did not control the preparation temperature, and the temperature is generally 20°C to 25°C during concentrated preparation. Therefore, it is necessary to ad...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K31/522A61J3/02
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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