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Method for optimizing freeze-drying curve of freeze-dried adenosine triphosphate preparation for injection

A technology of adenosine triphosphate and freeze-dried preparations, which is applied in the field of pharmaceutical preparations, can solve the problems of reduced productivity, reduced sublimation speed, drug shrinkage and foaming, etc., and achieve the effect of improving product properties and optimizing freeze-drying curves

Inactive Publication Date: 2019-07-02
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

If the medicine is not heated or the heat is insufficient, the water will absorb the heat of the medicine itself during sublimation and the temperature of the medicine will drop, resulting in a decrease in the vapor pressure of the medicine, which will cause a decrease in the sublimation speed and prolong the entire drying time. Productivity decreases; if the drug is heated too much, the sublimation rate of the drug will increase, but after offsetting the heat absorbed by the sublimation of the drug, the excess heat will increase the temperature of the frozen drug itself, which may cause partial or even complete melting of the drug , cause shrinkage and foaming of the medicine, and the entire drying will fail

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0029] (1), pre-freezing:

[0030] The temperature of the heat transfer oil reaches -40°C in 60 minutes and is maintained for 2 hours;

[0031] (2), a sublimation:

[0032] In the first stage, the temperature of the heat transfer oil reaches -20°C in 2 hours, and the vacuum degree is about 50 Pa, and it is kept for 6 hours;

[0033] In the second stage, the temperature of the heat transfer oil reaches -10°C in 1.5 hours, and the vacuum degree is about 30 Pa, and it is kept for 6 hours;

[0034] In the third stage, the temperature of the heat transfer oil reaches -5°C in 1 hour, and the vacuum degree is about 30 Pa, and it is kept for 6 hours;

[0035] In the fourth stage, the temperature of the heat transfer oil reaches 5°C in 1.5 hours, and the vacuum degree is about 30 Pa, and it is kept for 2 hours;

[0036] (3), analytical drying:

[0037] In the first stage, the temperature of the heat transfer oil reaches 15°C in 1.5 hours, and the vacuum degree is about 30 Pa, and i...

Embodiment 2

[0042] (1), pre-freezing:

[0043] The temperature of the heat transfer oil reaches -40°C in 40 minutes and is maintained for 2 hours;

[0044] (2), a sublimation:

[0045] In the first stage, the temperature of the heat transfer oil reaches -20°C in 1 hour, and the vacuum degree is about 40 Pa, and it is kept for 6 hours;

[0046] In the second stage, the temperature of the heat transfer oil reaches -15°C in 1.5 hours, and the vacuum degree is about 30 Pa, and it is kept for 6 hours;

[0047] In the third stage, the temperature of the heat transfer oil reaches -5°C in 1 hour, and the vacuum degree is about 30 Pa, and it is kept for 6 hours;

[0048] In the fourth stage, the temperature of the heat transfer oil reaches 5°C in 1.5 hours, and the vacuum degree is about 30 Pa, and it is kept for 2 hours;

[0049] (3), analytical drying:

[0050] In the first stage, the temperature of the heat transfer oil reaches 15°C in 1 hour, and the vacuum degree is about 30 Pa, and it is...

Embodiment 3

[0055] (1), pre-freezing:

[0056] The temperature of the heat transfer oil reaches -40°C in 30 minutes and is maintained for 2 hours;

[0057] (2), a sublimation:

[0058] In the first stage, the temperature of the heat transfer oil reaches -20°C in 1.5 hours, and the vacuum degree is about 50 Pa, and it is kept for 6 hours;

[0059] In the second stage, the temperature of the heat transfer oil reaches -8°C in 1 hour, and the vacuum degree is about 30 Pa, and it is kept for 6 hours;

[0060] In the third stage, the temperature of the heat transfer oil reaches -5°C in 1 hour, and the vacuum degree is about 30 Pa, and it is kept for 6 hours;

[0061] In the fourth stage, the temperature of the heat transfer oil reaches 3°C in 1 hour, and the vacuum degree is about 30 Pa, and it is kept for 2 hours;

[0062] (3), analytical drying:

[0063] In the first stage, the temperature of the heat transfer oil reaches 10°C in 1 hour, and the vacuum degree is about 30 Pa, and it is kep...

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Abstract

The invention discloses a method for optimizing a freeze-drying curve of a freeze-dried adenosine triphosphate preparation for injection. The technical solution of the invention comprises the steps ofselecting reasonable pre-freezing temperature, sublimation temperature and vacuum degree during drying to improve characters of the freeze-dried product. The quality standard of the preparation conforms to various indexes specified by the National Drug Standards. The method of the invention has the advantages of stable characters and attractive appearance of the freeze-dried product.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, a method for selecting reasonable prefreezing and sublimation temperatures and vacuum degree during drying, and optimizing the freeze-drying curve. Background technique [0002] Vacuum freeze-drying technology is to directly sublimate the moisture in the sample from ice at a lower temperature (-10°C to -50°C) to achieve the purpose of drying. During the drying process, the sample is not affected by surface tension and does not deform. , the drying technology that finally dehydrates the material. [0003] China is a big country in the production of raw materials, so the application prospect of this technology is very broad. 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 lagging and weak, and there are not many professional and technical personnel. Moreover, comp...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K31/7076
CPCA61K9/0019A61K9/19A61K31/7076
Inventor 刘乃山董慧毅付玉
Owner 青岛华迈士药业有限公司
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