Post-treatment method of GnRH antagonist

An antagonist and nanofiltration technology, applied in the field of post-processing of GnRH antagonists, can solve the problems of sample loss, increase the use of organic solvents, long concentration time, etc., achieve high efficiency and productivity, prevent self-polymerization reaction, and shorten concentration time. Effect

Active Publication Date: 2020-04-21
SHENZHEN JYMED TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] Although the patent CN201380028448 mentioned three concentration methods, when the sample is concentrated by vacuum rotary evaporation, the concentration speed is slow, the efficiency is low, the concentration time is long, and the relatively high temperature of the rotary evaporation may cause the degradation of the sample, so it does not It is not suitable for large-scale industrial production; using freeze-drying to concentrate samples is not only time-consuming, but also has high requirements on the performance of the freeze dryer, and is also not suitable for industrial production; although the method of column concentration is limited to a certain extent In fact, the purpose of concentration can be achieved, but the disadvantages are also obvious. The use of organic solvents is involved in the process of column concentration, which will cause harm to human h

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0030] (1) Prepare before nanofiltration, clean the nanofiltration machine with purified water, the nanofiltration membrane is made of polyamide nanofiltration membrane, and prepare for nanofiltration;

[0031] (2) Take 20 L of degarelix sample solution, add 10.7 L of acetic acid to make the content of acetic acid in the sample solution 35%, and start nanofiltration;

[0032] (3) discharge nanofiltration liquid after nanofiltration finishes, clean nanofiltration machine with 35% acetic acid aqueous solution, mix nanofiltration liquid and cleaning solution, then dilute with 35% acetic acid aqueous solution, sample concentration after dilution is 15g / L, and acetic acid content is 35% %, the duration of nanofiltration is 4h;

[0033] (4) Pour the diluted sample into a freeze-drying tray, the thickness of the sample solution is 0.65cm, and then pre-freeze, and the pre-freeze temperature is -35°C;

[0034] (5) Sublimation drying, the sublimation drying temperature is -10°C, and th...

Embodiment 2

[0039] (1) Prepare before nanofiltration, clean the nanofiltration machine with purified water, the nanofiltration membrane is made of polyethersulfone nanofiltration membrane, and prepare for nanofiltration;

[0040] (2) 30 L of degarelix sample solution, add 3.3 L of acetic acid to make the content of acetic acid in the sample solution 10%, and start nanofiltration;

[0041] (3) discharge nanofiltrate after nanofiltration 6h, clean nanofiltration machine with 10% acetic acid aqueous solution, mix nanofiltrate and cleaning liquid, then dilute with 10% acetic acid aqueous solution, sample concentration after dilution is 15g / L, and acetic acid content is 10 %;

[0042] (4) Pour the diluted sample into a freeze-drying tray, the thickness of the sample solution is 0.65cm, and then pre-freeze, and the pre-freeze temperature is -35°C;

[0043] (5) Sublimation drying, the sublimation drying temperature is 0°C, and the sublimation drying time is 15 hours;

[0044] (6) Analytical dr...

Embodiment 3

[0048] (1) Prepare before nanofiltration, clean the nanofiltration machine with purified water, the nanofiltration membrane is made of polyamide nanofiltration membrane, and prepare for nanofiltration;

[0049] (2) The volume of the Ganirelix sample solution is 30 L, 3.3 L of acetic acid is added to make the content of acetic acid in the sample solution 10%, and nanofiltration is started. When the volume of the sample solution is 15L by nanofiltration, add 3L of acetic acid to control the content of acetic acid in the sample solution to be 25%, and then continue the nanofiltration;

[0050] (3) discharge nanofiltrate after nanofiltration 6.5h, clean nanofiltration machine with 25% acetic acid aqueous solution, mix nanofiltrate and cleaning solution, then dilute with 25% acetic acid aqueous solution, sample concentration after dilution is 26g / L, and acetic acid content is 25%.

[0051] (4) Pour the diluted sample into a freeze-drying tray, the thickness of the sample solution ...

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Abstract

The invention discloses a post-treatment method of a GnRH antagonist. The GnRH antagonist is subjected to concentration treatment by combining a nanofiltration process with a subsequent freeze-dryingprocess. The method can improve the purity and yield of the product, simplify the steps, reduce the cost, obtain a stable product with controllable moisture, acetic acid and optical density, and is more suitable for large-scale industrial production.

Description

technical field [0001] The invention relates to a post-treatment method of GnRH antagonists. It belongs to the technical field of biomedicine. Background technique [0002] GnRH antagonists are synthetic gonadotropin-releasing hormone analogs that inhibit the proliferation and metastasis of prostate cancer by inhibiting testosterone. GnRH antagonists mainly include abarelix, cetrorelix, Nal-Glu, ganirelix, and degarelix. The post-processing method involved in the present invention mainly refers to the concentration method and freeze-drying process of the purified sample solution. The post-processing method is a very important link in the process of preparing the GnRH antagonist raw material drug, which will directly affect the quality of the active ingredient of the drug. [0003] In the prior art, the patent CN102428097 uses column concentration + vacuum rotary evaporation to concentrate the purified sample of degarelix, and then lyophilizes it. The patent CN201380028448 ...

Claims

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Application Information

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IPC IPC(8): B01D61/02B01D65/02B01F3/08B01D7/00
CPCB01D61/027B01D65/02B01D7/00B01F23/405B01D61/02F26B5/06C07K1/34B01F23/40
Inventor 付玉清张利香李世东舒遂智王宏欣
Owner SHENZHEN JYMED TECH
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