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Bortezomib freeze-dried composition and preparation method thereof

A kind of technology of bortezomib and composition, applied in the field of medicine

Inactive Publication Date: 2013-12-18
JIANGSU AOSAIKANG PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0012] In order to overcome the problem that the main drug is difficult to dissolve and the main drug is sensitive to the oxygen environment, the present invention adopts a specific preparation process to obtain boron for injection with high quality and good stability Tezomib freeze-dried composition

Method used

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  • Bortezomib freeze-dried composition and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0043] prescription

[0044] Bortezomib 100mg Mannitol 1000mg tert-butanol 20g Water for Injection Dilute to 100ml

[0045] Preparation Process:

[0046]Weigh 20 g of tert-butanol at 40°C that meets the requirements of injection grade, add 100 mg of bortezomib, stir to mix the two evenly, and obtain a tert-butanol solution containing bortezomib, add 1000 mg of mannitol to the above solution, stir and mix Evenly, to obtain a mixed suspension; spray the mixed suspension into liquid nitrogen to form frozen particles, add water for injection to the frozen particles to 90ml, stir at 5°C for about 10 minutes, the main drug is completely dissolved, add water to the full amount, Sampling and detection of intermediates. After the intermediates are qualified, fill them. Cool the filled samples to -40°C for pre-freezing and keep them for 1 hour; raise the temperature to -20°C, keep them warm for 2 hours, then cool them down to -45°C and keep them war...

Embodiment 2

[0049] prescription

[0050] Bortezomib 200mg Mannitol 2000mg tert-butanol 40g Water for Injection Dilute to 100ml

[0051] Preparation Process:

[0052] Weigh 42g of tert-butanol at 25°C that meets the requirements of injection grade, add bortezomib 200mg, stir to mix the two evenly, and obtain a tert-butanol solution containing bortezomib, add 2000mg of mannitol to the above solution, stir and mix Evenly, a mixed suspension is obtained; spray the mixed suspension into liquid nitrogen to form frozen particles, add water for injection to the frozen particles to 90ml, stir at 25°C for about 8 minutes, the main drug is completely dissolved, add water to the full amount, Sampling and detection of intermediates. After the intermediates are qualified, fill them. Cool the filled samples to -45°C for pre-freezing and keep them for 3 hours; heat them up to -25°C, keep them warm for 3 hours, then cool them down to -40°C and keep them warm for 3 hou...

Embodiment 3

[0056] prescription

[0057] Bortezomib 175mg Mannitol 1750mg tert-butanol 33g Water for Injection Dilute to 100ml

[0058] Preparation Process:

[0059] Weigh 33g of tert-butanol that meets the requirements of injection grade at 30°C, add 175mg of bortezomib, and mix well to obtain a tert-butanol solution containing bortezomib, add 150mgg mannitol to the above solution, stir and mix evenly to obtain a mixed Suspension: Spray the mixed suspension into liquid nitrogen to form frozen particles, add water for injection to 90ml of frozen particles, stir at 25°C for about 10 minutes, the main drug is completely dissolved, add water to the full amount, and take a sample to detect the intermediate , after the intermediate is qualified, it is filled, the filled sample is cooled to -50°C for pre-freezing, and kept for 2 hours; the temperature is raised to -20°C, kept for 3 hours, and then cooled to -50°C for 2 hours; open the cold trap, open Vacuu...

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Abstract

The invention belongs to the field of medicine and provides a bortezomib freeze-dried composition and a preparation method thereof. The bortezomib freeze-dried composition is a freeze-dried composition which is obtained through the steps of spraying the mixed solution of bortezomib, mannitol and tertiary butanol into liquid nitrogen to form frozen microparticles, dissolving the microparticles in water for injection, and finally, performing freeze-drying. The bortezomib freeze-dried composition provided by the invention is better in quality and higher in stability.

Description

[0001] technical field [0002] The invention belongs to the field of medicine, in particular relates to the field of preparation of bortezomib, and more specifically relates to a bortezomib freeze-dried composition and a preparation method thereof. Background technique [0003] Bortezomib (bortezomib) belongs to the dipeptidyl boronic acid compound and is a new type of highly efficient and specific protease inhibitor. It was first developed by Millennium Pharmaceuticals in the United States and was approved by the FDA on May 19, 2003. It is named as Velcade? It is marketed as an injection. The structural formula of Bortezomib is as follows: [0004] [0005] This product was approved for marketing in the UK in May 2004 for the treatment of multiple myeloma who have previously received at least two therapies and have progressed after the last treatment. The preparation of this product has been imported and listed in China. It was first approved for listing in 2005. The...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K31/69A61K38/05A61K47/26A61K47/10A61P35/00
Inventor 赵俊蔡继兰宗在伟吉同琴贾元超
Owner JIANGSU AOSAIKANG PHARMA CO LTD
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