Doxofylline freeze-dried powder injection

A technology of freeze-dried powder for injection and doxofylline, which is applied in the field of freeze-dried powder for injection, can solve the problems of uncoordinated control, slowing down the water sublimation speed, and increasing the filling amount, so as to reduce production costs and reduce freeze-drying evaporation. The effect of energy consumption

Inactive Publication Date: 2012-06-27
REYOUNG PHARMA
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  • Abstract
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  • Claims
  • Application Information

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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 freeze-dried powder injection
  • Doxofylline freeze-dried 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 doxofylline freeze-dried powder injection. The injection is characterized by being prepared according to the following preparation method: adding 200 g of doxofylline and 150 g of mannitol into a container with scales; adding injection water to 4,800 ml; stirring while adding; adding 4.8 g of active carbon according to a standard that 1 mg of active carbon is added per 1 ml of solution; stirring and adsorbing for 30 minutes; decarburizing; adjusting pH value to be 4.5-6.5 by using 0.01 mol / L hydrochloric acid solution; adding injection water to 6,000 ml; removing bacteria and filtering; then filling in the amount of 5.8-6.3 ml per bottle; and finally, placing the filled injection into a freeze-dryer to freeze-dry, pressing a plug after the freeze-drying is finished, and capping to obtain the freeze-dried powder injection. The freeze-dried powder injection has the advantages that: the process is adjusted scientifically and rationally, so that the allocation quantity filled in a penicillin bottle before freeze-drying is about 6 ml; and therefore, the freeze-dry evaporation energy consumption is reduced, and the production cost is reduced.

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): A61K9/19A61K31/522A61K47/26
Inventor 王可成王连彦
Owner REYOUNG PHARMA
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