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Method for freeze-drying curve optimization of defibrase freeze-drying preparation for injection

A technology of freeze-dried preparations and defibrase, which is applied in the field of pharmaceutical preparations, can solve problems such as decreased productivity, reduced sublimation speed, failure, etc., and achieves the effect of improving product properties and optimizing the freeze-drying curve

Inactive Publication Date: 2019-06-18
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

[0027] (1), pre-freezing:

[0028] The temperature of the heat transfer oil reaches -40°C in 30 minutes and is maintained for 2 hours;

[0029] (2), a sublimation:

[0030] In the first stage, the temperature of the heat transfer oil reaches -20°C in 1.5 hours, and the vacuum degree is about 30 Pa, and it is kept for 6 hours;

[0031] 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 1 hour;

[0032] In the third stage, the temperature of the heat transfer oil reaches 0°C in 1.5 hours, and the vacuum degree is about 30 Pa, and it is kept for 0.5 hours;

[0033] (3), analytical drying:

[0034] In the first stage, the temperature of the heat transfer oil reaches 30°C in 2 hours, and the vacuum degree is about 30 Pa, and it is kept for 1 hour;

[0035] In the second stage, the temperature of the heat transfer oil reaches 30°C in 1 minute, and the vacuum degree is about 10 Pa, and...

Embodiment 2

[0038] (1), pre-freezing:

[0039] The temperature of the heat transfer oil reaches -40°C in 40 minutes and keeps for 2 hours;

[0040] (2), a sublimation:

[0041] In the first stage, the temperature of the heat transfer oil reaches -25°C in 1.5 hours, and the vacuum degree is about 35 Pa, and it is kept for 6 hours;

[0042] In the second stage, the temperature of the heat transfer oil reaches -15°C in 1.5 hours, and the vacuum degree is about 35 Pa, and it is kept for 1 hour;

[0043] In the third stage, the temperature of the heat transfer oil reaches -5°C in 1.5 hours, and the vacuum degree is about 35 Pa, and it is kept for 1 hour;

[0044] (3), analytical drying:

[0045] In the first stage, the temperature of the heat transfer oil reaches 30°C in 2 hours, and the vacuum degree is about 35 Pa, and it is kept for 1 hour;

[0046] In the second stage, the temperature of the heat transfer oil reaches 30°C in 2 minutes, and the vacuum degree is about 15 Pa, and it is ke...

Embodiment 3

[0049] (1), pre-freezing:

[0050] The temperature of the heat transfer oil reaches -40°C in 60 minutes and is maintained for 2 hours;

[0051] (2), a sublimation:

[0052] 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;

[0053] In the second stage, the temperature of the heat transfer oil reaches -8°C in 1 hour, and the vacuum degree is about 40 Pa, and it is kept for 1.5 hours;

[0054] In the third stage, the temperature of the heat transfer oil reaches 0°C in 1 hour, and the vacuum degree is about 40 Pa, and it is kept for 1 hour;

[0055] (3), analytical drying:

[0056] In the first stage, the temperature of the heat transfer oil reaches 35°C in 1 hour, and the vacuum degree is about 40 Pa, and it is kept for 1.5 hours;

[0057] In the second stage, the temperature of the heat transfer oil reaches 35°C in 1 minute, and the vacuum degree is about 15 Pa, and it is kep...

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Abstract

The invention discloses a method for freeze-drying curve optimization of a defibrase freeze-drying preparation for injection. According to the technical scheme, characters of a freeze-dried product are improved by selecting reasonable pre-freezing and sublimation temperatures and the vacuum degree during drying, so that the biological stability of defibrase is guaranteed. The quality standard of the preparation meets various indexes specified in national medicine standards, and the method has the advantages that the freeze-dried product is stable in character, attractive in appearance, stablein bioactivity and the like.

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): A61K9/19A61K38/48
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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