Method for optimizing freeze-drying curve of chorionic gonadotrophin freeze-drying preparation for injection

A technology of chorionic gonadotropin and freeze-dried preparations, 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

[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 ke...

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PUM

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Abstract

The invention discloses a method for optimizing a freeze-drying curve of a chorionic gonadotrophin freeze-drying preparation for injection. According to the technical scheme of the invention, reasonable pre-freezing and sublimation temperatures and reasonable vacuum degrees during drying are selected to improve the properties of freeze-dried products. The biological stability of chorionic gonadotrophin is ensured. The quality standard of freeze-dried products conforms to various indexes specified by the national drug standard. The method has the advantages that the freeze-dried products are stable in character, attractive in appearance, stable in biological activity 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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Patent Type & Authority Applications(China)
IPC IPC(8): F26B5/06F26B25/00A61K38/24A61K9/19
CPCA61K9/0019A61K9/19A61K38/24F26B5/06F26B25/00
Inventor 刘乃山董慧毅傅玉
Owner 青岛华迈士药业有限公司
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