Doxofylline lyophilized powder injection

A technology of freeze-dried powder injection and doxofylline, which is applied in the field of freeze-dried powder injection, can solve the problems of slowing down the sublimation speed of water, without coordinated control, and increasing energy consumption, so as to reduce the energy consumption of freeze-drying evaporation and reduce production cost effect

Inactive Publication Date: 2016-07-06
QINGDAO HUANGDAO HOSPITAL OF TRADITIONAL CHINESE MEDICINE
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  • Abstract
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  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0002] In the current preparation process of doxofylline freeze-dried powder injection, due to the poor water solubility of doxofylline, the original configuration process does not coordinate the dissolution temperature and dissolution pH, and can only combine doxofylline and doxofylline at most. The concentration of its excipients is prepared at 0.038-0.042g / ml, which increases the filling volume, slows down the sublimation rate of water in the freeze-drying process, and increases energy consumption

Method used

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  • Doxofylline lyophilized powder injection
  • Doxofylline lyophilized powder injection

Examples

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Embodiment 1

[0042] According to the following preparation method, add 200g doxofylline and 150g mannitol into a graduated container, add water for injection to 4800ml, stir while adding, add 6g of activated carbon, stir and absorb for 30 minutes, decarbonize, use 0.01 mol / L hydrochloric acid solution to adjust the pH value to 5.5, then add water for injection to 6000ml, sterilize and filter, and then fill it into a 20ml vial with a filling volume of 5.8-6.3ml / bottle, totaling 1000 bottles. Finally, the filled injection is put into a freeze dryer for freeze drying, and after the freeze drying is finished, it is plugged and capped to obtain the product.

[0043] Wherein, freeze-drying comprises following three steps:

[0044] (1) Pre-freezing: the pre-freezing temperature is controlled at -40°C, and the time is 1.5 to 3 hours;

[0045] (2) Sublimation: Vacuum control 10-30Pa, take 20 hours to raise the product temperature to 0°C;

[0046] (3) Analytical drying: take 8 hours to raise the ...

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Abstract

The invention relates to a freeze-dried powder injection, in particular to a freeze-dried powder injection of doxofylline, which is characterized in that it is obtained according to the following preparation method, adding 200g of doxofylline and 150g of mannitol into a graduated container, Add water for injection to 4800ml, stir while adding, add 4.8g of activated carbon according to the standard of 1mg / ml with the solution, stir and absorb for 30 minutes, decarbonize, adjust the pH value to 4.5-6.5 with 0.01mol / L hydrochloric acid solution, and then add Water for injection is sterilized and filtered to 6000ml, and then filled with a filling volume of 5.8-6.3ml / bottle. Finally, the filled injection is placed in a freeze dryer for freeze-drying. Cover and serve. The invention has the advantage of adjusting the process scientifically and rationally, so that the amount of the vial before freeze-drying is only about 6ml, thereby reducing the energy consumption of freeze-drying and evaporation, and reducing the production cost.

Description

technical field [0001] The invention relates to a freeze-dried powder injection, in particular to a doxofylline freeze-dried powder injection. Background technique [0002] In the current preparation process of doxofylline freeze-dried powder injection, due to the poor water solubility of doxofylline, the original configuration process does not coordinate the dissolution temperature and dissolution pH, and can only combine doxofylline and doxofylline at most. The concentration of the auxiliary material is prepared at 0.038-0.042g / ml, which increases the filling volume, slows down the sublimation speed of water in the freeze-drying process, and increases energy consumption. Contents of the invention [0003] The object of the present invention is to provide a doxofylline freeze-dried powder injection, which can increase the concentration of doxofylline and its auxiliary materials and reduce the filling volume, thereby accelerating the sublimation speed of water in the freez...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K31/522A61K47/10
Inventor 卢彦敏
Owner QINGDAO HUANGDAO HOSPITAL OF TRADITIONAL CHINESE MEDICINE
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