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Dexrazoxane freezing-dried powder injection and preparation method thereof

A technique for freeze-dried powder injection and dextropropyl imine, which is applied in the field of dextropropyl imine freeze-dried powder injection and its preparation, achieving the effect of less incompatibility, excellent stability, and stable transportation and storage

Inactive Publication Date: 2008-03-19
JIANGSU AOSAIKANG PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] In order to solve the stability problem of dextropropyl imine freeze-dried powder injection, it is necessary not only to set a reasonable prescription, but also to precisely control the process parameters of each stage of production in view of the multiple factors that cause the instability of dextropropyl imine

Method used

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

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0020] prescription

[0021] Dextropropyl imine 250g

[0022] Concentrated hydrochloric acid 37ml

[0023] Add water for injection to 10000ml

[0024]

[0025] A total of 1000 bottles were made

[0026] Take concentrated hydrochloric acid and put it in a sterile container, add water for injection to 80,000ml, cool down and keep warm at 4°C, add dextranimine, stir well, slowly add 1.0mol / L hydrochloric acid to dissolve under stirring, add water for injection to 10,000ml , add 30g activated carbon to adsorb for 30 minutes, decarbonize, after measuring the content of intermediates to pass, filter with 0.22μm microporous membrane, fill the filtrate in 25ml vials according to the filling capacity of 10ml per bottle, and partially plug the butadiene rubber stopper, Put it into a plate, put it into the freeze-drying box, insert the temperature probe, close the door, open the freeze-dryer in advance, use heat transfer oil to cool the plate layer, un...

Embodiment 2

[0028] prescription

[0029] Dextropropyl imine 250g

[0030] Concentrated hydrochloric acid 120ml

[0031] Add water for injection to 10000ml

[0032]

[0033] A total of 1000 bottles were made

[0034]Take concentrated hydrochloric acid and put it in a sterile container, add water for injection to 80,000ml, cool down and keep warm at 2°C, add dextropropyl imine, stir well, slowly add 1.0mol / L hydrochloric acid to dissolve under stirring, add water for injection to 10,000ml , add 30g activated carbon to adsorb for 30 minutes, decarbonize, after measuring the content of intermediates to pass, filter with 0.22μm microporous membrane, fill the filtrate in 25ml vials according to the filling capacity of 10ml per bottle, and partially plug the butadiene rubber stopper, Put it into a plate, put it into the freeze-drying box, insert the temperature probe, close the door, open the freeze-dryer in advance, use heat transfer oil to cool the plate lay...

Embodiment 3

[0036] prescription

[0037] Dextropropyl imine 250g

[0038] Concentrated hydrochloric acid 310ml

[0039] Add water for injection to 10000ml

[0040]

[0041] A total of 1000 bottles were made

[0042] Take concentrated hydrochloric acid and put it in a sterile container, add water for injection to 80,000ml, cool down and keep warm at 6°C, add dextropropylimine, stir well, slowly add 1.0mol / L hydrochloric acid until dissolved under stirring, add water for injection To 10000ml, add 30g activated carbon to absorb for 30 minutes, decarbonize, after the determination of intermediate content is qualified, filter with 0.22μm microporous membrane, fill the filtrate into 25ml vials with 10ml per bottle, and partially plug with butyl rubber Plug, put on a plate, send it into the freeze-drying box, insert the temperature probe, close the box door, open the freeze-dryer in advance, use heat transfer oil to cool the plate until the temperature of the ...

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Abstract

The invention relates to a dexrazoxane freeze-dried powder injection and the preparation method. The preparation is used for resisting the cardiac toxicity which is induced by the cumulate quantity of adriamycin. The dexrazoxane freeze-dried powder injection contains the active components of the dexrazoxane and hydrochloric acid, the weight proportion of which is 1 to 0.05 to 0.5, and the preferential proportion is 1 to 0.2 to 0.5. The preparation method is that the hydrochloric acid is put into an aseptic vessel; the water for injecting is added till 80 percent of the preparation quantity, and the temperature is reduced and kept at 2 to 6 DEG C; the dexrazoxane is added to be mixed, and the hydrochloric acid of 1.0mol / L is dripped slowly into the solution to be solved while mixing the solution; the water for injecting is added till the full quantity; active carbon of 0.3 percent is added for absorbing for thirty minutes, and then the solution is decarbonized; after the medium body content is mensurated as being eligible, the solution is filtered by a 0.22 micron-micropore filtering filer; the filtrate is filled into a 25ml cillin bottle according to the filling quantity of 10ml each bottle, and the bottles are partially plugged by buna plugs and filled onto a plate to be sent into a freeze-drying box; a temperature probe is inserted, and the box door is closed; the filtrate is warmed, sublimed and dried be stages; nitrogen is puffed; the plugs are pressed; the filtrate is taken out from the box for rolling the openings, detecting the quality and packaging and the preparation can be obtained.

Description

technical field [0001] The present invention relates to a dextropropyl imine freeze-dried powder injection and a preparation method thereof. The preparation is used to resist the cardiotoxicity induced by the accumulation of doxorubicin, and provides clinical application of relatively large doses of doxorubicin under better safety. and more treatment sessions. Background technique [0002] Anthracycline antibiotics are commonly used clinical antineoplastic drugs. Daunorubicin is the first generation, and doxorubicin is the second generation. Now there are many congeners such as epirubicin and 4'-deoxydoxorubicin, which are artificially semi-synthesized. Mitoxantrone is a synthetic anthracycline compound. Clinically, it is mainly used for acute and chronic leukemia, malignant lymphoma, and also for combined chemotherapy of gastric cancer, small cell lung cancer, ovarian cancer, breast cancer, etc. However, such drugs such as doxorubicin are highly toxic, and in addition to...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K31/496A61P35/00
Inventor 叶东王宏响戴艳
Owner JIANGSU AOSAIKANG PHARMA CO LTD
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