Dexrazoxane-containing composition and preparation method thereof, and dexrazoxane freeze-drying preparation and redissolving solvent thereof

A technology of dextropropylimine and freeze-dried preparation, applied in the field of medicine, can solve the problems of purification process and purification process burden, high production cost, influence on production process and the like, achieves good clinical reconstitution effect, fast dissolution speed, and finished product related problems. Substance small effect

Inactive Publication Date: 2013-11-20
JIANGSU AOSAIKANG PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

We know that the more excipients involved, it will bring a burden to the purification process and purification process, so this solution not only brings about higher production costs, but also affects the entire production process

Method used

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  • Dexrazoxane-containing composition and preparation method thereof, and dexrazoxane freeze-drying preparation and redissolving solvent thereof
  • Dexrazoxane-containing composition and preparation method thereof, and dexrazoxane freeze-drying preparation and redissolving solvent thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0052] Add 8L of water for injection and 0.5L of tert-butanol to the mixing tank, cool down the water for injection in the mixing tank to 4°C~8°C, add the calculated amount of hydrochloric acid to make a 0.1mol / L hydrochloric acid solution. Slowly put 250g of dextropropylimine into the batching tank, adjust the pH value of the liquid to 1.8-2.0 with 1mol / L hydrochloric acid solution under stirring, after the raw materials are dissolved, add wetted activated carbon, add Water for injection to 10L, stirred for 20 minutes, decarbonized and sterilized by filtration; the filtrate was evenly distributed in 1000 vials and freeze-dried.

[0053] Freeze-drying curve: lower the temperature of the product to -45~-35°C and keep it warm for 2 hours. When the cold trap is cooled below -40°C, turn on the vacuum pump. When the vacuum degree drops below 20Pa, start to heat up; set the heat conduction oil to heat up to 25°C within 5 minutes, and keep it warm for about 30 hours. Shut down, pre...

Embodiment 2

[0056] Add 7L of water for injection and 0.8L of tert-butanol into the mixing tank, cool down the water for injection in the mixing tank to about 4°C, add the calculated amount of hydrochloric acid to form a 0.15mol / L hydrochloric acid solution. Slowly put 250g of dextropropylimine into the batching tank, adjust the pH value of the liquid to 1.5-1.8 with 1mol / L hydrochloric acid solution under stirring, after the raw materials are dissolved, add wetted activated carbon, and add water for injection below 10°C to 10L, stirred for 20 minutes, decarbonized and sterilized by filtration; the filtrate was evenly distributed in 1000 vials and freeze-dried.

[0057] Freeze-drying curve: lower the temperature of the product to -40~-30°C and keep it warm for 3 hours. When the cold trap is cooled below -40°C, turn on the vacuum pump. When the vacuum degree drops below 25Pa, start to heat up; set the heat transfer oil to 20°C within 10 minutes, and keep it warm for about 35 hours. Shut d...

Embodiment 3

[0060] Add 8L of water for injection and 0.8L of tert-butanol to the mixing tank, cool down the water for injection in the mixing tank to about 4°C, add the calculated amount of hydrochloric acid to form a 0.05mol / L hydrochloric acid solution. Slowly put 250g of dextropropylimine into the batching tank, adjust the pH value of the liquid to 1.8-2.0 with 1mol / L hydrochloric acid solution under stirring, after the raw materials are dissolved, add wetted activated carbon, and add water for injection at about 6°C to 10L, stirred for 20 minutes, decarbonized and sterilized by filtration; the filtrate was evenly distributed in 500 vials and freeze-dried.

[0061] Freeze-drying curve: lower the temperature of the product to -45~-35°C and keep it warm for 3 hours. When the cold trap is cooled below -40°C, turn on the vacuum pump. When the vacuum degree drops below 30Pa, start to heat up; set the heat conduction oil to heat up to 30°C within 10 minutes, and keep it warm for about 30 ho...

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Abstract

The invention relates to the field of medicine, in particular relates to the fields of preparation and application of dexrazoxane, and more particularly relates to a dexrazoxane-containing composition and a preparation method thereof, and a dexrazoxane freeze-drying preparation and a redissolving solvent thereof. The dexrazoxane-containing composition is a solution consisting of dexrazoxane, hydrochloric acid, water and tertiary butanol, wherein the dexrazoxane concentration of the composition is 20 to 30 mg/mL. The dexrazoxane freeze-drying preparation provided by the invention has excellent stability and the preparation method is easy to industrialize.

Description

[0001] technical field [0002] The present invention belongs to the field of medicine, especially relates to the field of preparation and application of dextropropylimine, more specifically relates to a composition containing dextropropylimine and its preparation method, lyophilized preparation of dextropropylimine and its compound Solvent. [0003] Background technique [0004] Anthracyclines are commonly used antineoplastic drugs in clinical practice. Daunorubicin is the first generation, and doxorubicin is the second generation, and many congeners such as epirubicin and 4'-deoxydoxorubicin have been artificially 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 side effects such as na...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K9/08A61K31/496A61P9/00A61P35/00A61K31/704
Inventor 陈庆财陈祥峰赵霞
Owner JIANGSU AOSAIKANG PHARMA CO LTD
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