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Dexrazoxane freeze-dried powder injection and preparation method thereof

A kind of technology of freeze-dried powder injection and dextrin, which is applied in the field of dextrin lyophilized powder for injection and preparation thereof, and can solve problems such as inconvenience

Inactive Publication Date: 2014-12-03
BEIJING SUNHO PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0013] Because the existing dextromethyridine freeze-dried powder injection needs to be diluted with a specific diluent before use, and then intravenously infused with normal saline, it is inconvenient in practical application

Method used

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  • Dexrazoxane freeze-dried powder injection and preparation method thereof
  • Dexrazoxane freeze-dried powder injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0039] Composition of dextromethyridine freeze-dried powder injection:

[0040] 29.45g of dextranimine hydrochloride (equivalent to 25g of dextranimine);

[0041] Sodium acetate 35g;

[0042] Mannitol 20g.

[0043] Follow the steps below to prepare dextranimine freeze-dried powder injection:

[0044] (1) Dissolve sodium acetate in 400mL water for injection and stir until completely dissolved;

[0045] (2) Add mannitol into the solution prepared in (1), and stir until completely dissolved;

[0046] (3) Add dextranimine hydrochloride into the solution prepared in (2), and stir until completely dissolved;

[0047] (4) Adjust the pH to 2.5 with 0.1mol / L hydrochloric acid, and add water for injection to 500ml;

[0048] (5) Use 0.1% (W / V) activated carbon and stir for 15 minutes to absorb pyrogen;

[0049] (6) Rapidly filter with 0.45 μm and 0.22 μm microporous membranes, dispense into freeze-dried vials, 5 mL per vial, freeze-dry, stopper, and crimp the cap.

[0050] Freeze-...

Embodiment 2

[0053] Composition of dextromethyridine freeze-dried powder injection:

[0054] 29.45g of dextranimine hydrochloride (equivalent to 25g of dextranimine);

[0055] Sodium acetate 45g;

[0056] Mannitol 35g.

[0057] Follow the steps below to prepare dextranimine freeze-dried powder injection:

[0058] (1) Dissolve sodium acetate in 400ml water for injection and stir until completely dissolved;

[0059] (2) Add mannitol into the solution prepared in (1), and stir until completely dissolved;

[0060] (3) Add dextranimine hydrochloride into the solution prepared in (2), and stir until completely dissolved;

[0061] (4) Adjust the pH to 4.5 with 0.1mol / L hydrochloric acid, and add water for injection to the full amount;

[0062] (5) Use 0.1% (W / V) activated carbon and stir for 15 minutes to absorb pyrogen;

[0063](6) Rapidly filter with 0.45μm and 0.22βm microporous membranes, dispense into lyophilized vials, 5mL per vial, lyophilize, stopper, and crimp the cap.

[0064] Fr...

Embodiment 3

[0067] 29.45g of dextranimine hydrochloride (equivalent to 25g of dextranimine);

[0068] Sodium acetate 50g;

[0069] Mannitol 40g.

[0070] The specific operation process is the same as in Embodiment 1.

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Abstract

The invention relates to a dexrazoxane freeze-dried powder injection and a preparation method thereof. The dexrazoxane freeze-dried powder injection consists of a dexrazoxane salt, sodium acetate and mannitol, the above compositions are used to prepare a solution, the solution is processed according to the following conditions: pre-freezing at -40 DEG C to -45 DEG C for 4 h, vacuumizing, keeping the vacuum degree at 20 pa, slowly heating to -20 DEG C to -25 DEG C, and keeping the temperature for 10 h, slowing heating to 25 DEG C to 30 DEG C and keeping the temperature for 5 h, so that the powder injection is obtained. The powder injection is diluted with common injection water for intravenous injection without being diluted by using a specific diluent, and application is convenient.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a dextromethanimine freeze-dried powder injection and a preparation method thereof. Background technique [0002] Dexrazoxane, chemical name: (S)-4,4'-(1-methyl-1,2-ethylenediyl)bis-2,6-piperazinedione. [0003] [0004] Dextropropanimine hydrochloride was developed by Chiron Corporation of the United States. It was first marketed in Italy in the form of injection in 1992. It is used to reduce the cardiotoxicity caused by doxorubicin treatment in breast cancer patients. It was approved by FDA in July 1995. Listed in the United States, and then successively listed in many countries. Now the main manufacturer is Pfizer. [0005] Dextropropanimine hydrochloride is made into powder injection. When in use, use 0.167mol / L sodium lactate injection to prepare a 10mg / ml concentration solution, and inject slowly intravenously or dilute with 0.9% sodium chloride or 5% glucose...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K31/496A61K47/26A61P9/00
Inventor 林晓洁颜克序张裴修勇
Owner BEIJING SUNHO PHARMA
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