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Method for optimizing freeze-drying curve of torasemide freeze-drying preparation for injection

A technology for torasemide and injection, which is applied in the field of pharmaceutical preparations, can solve problems such as rising, softening and collapsing of drugs, and achieve the effects of optimizing the freeze-drying curve, being easy to grasp, and improving product properties

Inactive Publication Date: 2017-05-24
青岛华迈士药业有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0009] Choosing a reasonable pre-freezing and sublimation temperature to improve product properties is the purpose of our research. After hard work, we finally found a reasonable pre-freezing time, temperature and drying temperature and time. Carefully increasing the temperature is an important part of the production process. Once the heat is provided too much and too fast, excess water vapor will evaporate into the freeze-drying chamber, and if the refrigeration system cannot condense the water vapor in time, the excess water vapor will increase the air pressure in the chamber and reduce the vacuum state, which will The drug will soften and collapse

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0031] (1), torasemide 10g

[0032] Mannitol 20g

[0033] Water for injection 2000ml

[0034] Make 1000 bottles

[0035] (2), filter the solution in step (1) and fill it into a 10ml controlled injection bottle;

[0036] (3), put the semi-finished product filled in step (1) into the freeze dryer;

[0037] (4) Set the freeze-drying curve as follows:

[0038] Pre-freezing: reach -40°C for 2 hours;

[0039] One sublimation: reach -30℃, keep for 30 minutes;

[0040] Reach -15°C for 4 hours;

[0041] Reach -5°C for 2 hours;

[0042] Reach 10°C, hold for 1 hour

[0043] Analysis and drying: The temperature of the heat transfer oil reaches 40 °C and is maintained for 2 hours;

[0044] Pressure rise test: set the pressure rise to 10Pa / 3 minutes. The pressure rise is qualified, and the freeze-drying is completed.

Embodiment 2

[0046] (1), torasemide 10g

[0047] Mannitol 20g

[0048] Water for injection 2000ml

[0049] Make 1000 bottles

[0050] (2), filter the solution in step (1) and fill it into a 10ml controlled injection bottle;

[0051] (3), put the semi-finished product filled in step (1) into the freeze dryer;

[0052] (4) Set the freeze-drying curve as follows:

[0053] Pre-freezing: reach -40°C for 2.5 hours;

[0054] One sublimation: reach -30℃, keep for 60 minutes;

[0055] Reach -15°C for 3.5 hours;

[0056] Reach -5°C for 1.5 hours;

[0057] Reach 10°C, hold for 1 hour

[0058] Analysis and drying: The temperature of the heat transfer oil reaches 40 °C and is maintained for 2 hours;

[0059] Pressure rise test: set the pressure rise to 10Pa / 3 minutes. The pressure rise is qualified, and the freeze-drying is completed.

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PUM

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Abstract

The invention discloses a method for optimizing a freeze-drying curve of a torasemide freeze-drying preparation for injection. According to the technical scheme, the characters of dried frozen aquatic products are improved by selecting reasonable pre-freezing and sublimating temperatures. The quality standards meet various indexes specified in National Drug Standards. The method disclosed by the invention has the advantages of stable characters of the dried frozen aquatic products, small auxiliary material addition amount, short freeze-drying time and the like.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, and relates to a method for selecting reasonable pre-freezing and sublimation temperatures and optimizing freeze-drying curves. Background technique [0002] The vacuum freeze-drying technology is to make the moisture in the sample sublime directly from ice at a relatively low temperature (-10℃~-50℃) to achieve the purpose of drying. During the drying process, it is not affected by surface tension and the sample is not deformed. , the drying technology that finally dehydrates the material. [0003] China is a big country in the production of APIs, so the application of this technology is very promising. However, it should be noted that the vacuum freeze-drying technology has been promoted very rapidly in my country. In contrast, its basic theoretical research is relatively lag and weak, and there are not many professional and technical personnel. Moreover, compared with other drying t...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K47/26A61K31/44
CPCA61K9/19A61K9/0019A61K31/44A61K47/26
Inventor 刘乃山付玉黄晓燕季维尚
Owner 青岛华迈士药业有限公司
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