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Bortezomib-containing medicinal composition and preparation method thereof

The technology of bortezomib and composition is applied in the field of bortezomib-containing composition and preparation thereof, which can solve the problems of easy-to-oxidize freeze-dried powder injection, difficulty in dissolving bortezomib and high water content, and achieve low cost and stable quality , The effect of simple operation of the production process

Inactive Publication Date: 2015-11-18
HANGZHOU HUADONG MEDICINE GRP PHARMA RES INST +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0011] The purpose of the present invention is to provide a preparation method of bortezomib freeze-dried powder injection, which adopts the method of adding tert-butanol and effectively controlling the freeze-drying curve, so as to solve the problem of bortezomib being difficult to dissolve, easy to oxidize and spray bottle of freeze-dried powder injection , high moisture problems

Method used

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  • Bortezomib-containing medicinal composition and preparation method thereof
  • Bortezomib-containing medicinal composition and preparation method thereof
  • Bortezomib-containing medicinal composition and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0037] prescription:

[0038]

[0039]

[0040] Process:

[0041] (1) Add mannitol to 700ml water for injection, stir until completely dissolved;

[0042] (2) Bortezomib is added to 160ml of tert-butanol solution and stirred until completely dissolved;

[0043] (3) Mix the above two solutions evenly, filter and fill the medicinal solution with a 0.22 μm filter;

[0044] (4) Pre-freezing: Pre-freezing at -45°C for 4 hours;

[0045] (5) Sublimation drying 1: heat up to -35°C in 1h, keep for 10h, vacuum degree 0.06mbar;

[0046] (6) Sublimation drying 2: heat up to 0°C in 20 hours, vacuum degree 0.12mbar;

[0047] (7) Analytical drying: heat up to 40°C in 2 hours, keep for 4 hours, and vacuum degree 0.01mbar;

[0048] (8) Full pressure plug, rolled aluminum plastic cover.

Embodiment 2

[0050] prescription:

[0051]

[0052] Process:

[0053] (1) Add mannitol to 300ml water for injection, stir until completely dissolved;

[0054] (2) Add bortezomib to 87.5ml tert-butanol solution, stir until completely dissolved;

[0055] (3) Mix the above two solutions evenly, filter and fill the medicinal solution with a 0.22 μm filter;

[0056] (4) Pre-freezing: Pre-freezing at -50°C for 3 hours;

[0057] (5) Sublimation drying 1: heat up to -30°C in 1h, keep for 5h, vacuum degree 0.12mbar;

[0058] (6) Sublimation drying 2: heat up to 0°C in 4 hours, vacuum 0.06mbar;

[0059] (7) Analytical drying: heat up to 20°C in 1h, keep for 8h, vacuum degree 0.001mbar;

[0060] (8) Full pressure plug, rolled aluminum plastic cover.

Embodiment 3

[0062] prescription:

[0063]

[0064] Process:

[0065] (1) Add mannitol to 420ml water for injection, stir until completely dissolved;

[0066] (2) Bortezomib is added to 280ml of tert-butanol solution and stirred until completely dissolved;

[0067] (3) Mix the above two solutions evenly, filter and fill the medicinal solution with a 0.22 μm filter;

[0068] (4) Pre-freezing: Pre-freezing at -50°C for 5 hours;

[0069] (5) Sublimation drying 1: raise the temperature to -33°C in 2 hours, keep it for 8 hours, and vacuum degree 0.10mbar;

[0070] (6) Sublimation drying 2: heat up to 0°C for 8 hours, vacuum 0.10mbar;

[0071] (7) Analytical drying: heat up to 45°C for 6 hours, keep for 6 hours, and vacuum degree 0.004mbar;

[0072] (8) Full pressure plug, rolled aluminum plastic cover.

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Abstract

The invention discloses a bortezomib-containing medicinal composition, and especially relates to a freeze-dried powder injection. The invention also discloses a preparation method of the bortezomib-containing medicinal composition. Addition of tert-butyl alcohol in a prescription and effective control of a freeze-drying curve solve the technical defects of difficult dissolving of bortezomib, and spray bottle and high water content of freeze-dried powder injections. The bortezomib-containing medicinal composition disclosed in the invention has high and stable quality, and the preparation method has the advantages of simple operation, short freeze-drying cycle and low cost, and is very suitable for industrial production.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a composition containing bortezomib and a preparation method thereof. Background technique [0002] Bortezomib (PS-341), trade name Velcade, clinical dosage form is powder injection, is a new type of anti-tumor drug developed by Millennium Pharmaceutical Company of the United States. Bortezomib has already been imported in China, and Xi'an Janssen Pharmaceutical Co., Ltd. was also approved for marketing in 2005, with two specifications of 1 mg and 3.5 mg. [0003] Bortezomib leads to tumor cell death by blocking the degradation of various intracellular proteins that regulate apoptosis and signal transduction. A large number of studies have found that bortezomib has strong anti-tumor activity against a variety of tumors, especially multiple myeloma, mantle cell lymphoma, other B-cell lymphomas, and Hodgkin's lymphoma in hematological tumors. The drug is a proteasome in...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K38/05A61K9/19A61K31/69A61K47/10A61P35/00
Inventor 姚忠立罗艳华鄢丰张洪记车宝军
Owner HANGZHOU HUADONG MEDICINE GRP PHARMA RES INST
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