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Medicament oxaliplatin composition for treating cancers

A technology of oxaliplatin and composition, which is applied in the field of oxaliplatin composition for the treatment of cancer, can solve the problems of easy moisture absorption, change in quality, capacity, fluidity, and difference, etc.

Inactive Publication Date: 2015-12-09
QINGDAO HUAZHICAO PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] At the same time, oxaliplatin has a strong hygroscopic ability, especially after the powder injection is prepared, the hygroscopic ability becomes stronger, the fluidity becomes worse, it is easy to absorb moisture and deteriorate, and there is a difference in filling capacity

Method used

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  • Medicament oxaliplatin composition for treating cancers
  • Medicament oxaliplatin composition for treating cancers
  • Medicament oxaliplatin composition for treating cancers

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0023] Example 1: Preparation of Oxaliplatin Crystals

[0024] Dissolve oxaliplatin in a mixed solvent of methanol and N-methylacetamide whose volume is 6 times the weight of oxaliplatin at 35°C, and the volume ratio of methanol to N-methylacetamide is 1.5:5; Add a mixed solvent of ethanol and ether whose volume is 9 times the weight of oxaliplatin at a rate of 40ml / min, the volume ratio of ethanol and ether is 1:3, stir while adding, control the temperature at 35°C, and grow crystals for 3h; Then add chloroform whose total volume is 7 times the weight of oxaliplatin at a speed of 20ml / min, after growing the crystal for 1 hour, cool down to -5°C at a speed of 10°C / h, and then keep stirring at a stirring speed of 90r / min Crystallization and crystal growth for 3 hours; filtration, washing, and drying under reduced pressure to obtain oxaliplatin crystal compound.

[0025] The X-ray powder diffraction pattern obtained by the Cu-Kα ray measurement of the prepared oxaliplatin cry...

Embodiment 2

[0026] Example 2: Preparation of Oxaliplatin Compositions

[0027] The composition is: 1 part by weight of the oxaliplatin crystal prepared by the present invention, and 0.1 part by weight of anhydrous sodium carbonate.

[0028] The preparation method is:

[0029] (1) Weigh oxaliplatin crystals and anhydrous sodium carbonate in proportion and mix them thoroughly;

[0030] (2) Dispense into sterilized vials and stopper them.

Embodiment 3

[0031] Example 3: Preparation of Oxaliplatin Compositions

[0032] The composition is: 1 part by weight of oxaliplatin crystal prepared by the present invention, and 0.15 part by weight of anhydrous sodium carbonate.

[0033] The preparation method is:

[0034] (1) Weigh oxaliplatin crystals and anhydrous sodium carbonate in proportion and mix them thoroughly;

[0035] (2) Dispense into sterilized vials and stopper them.

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PUM

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Abstract

The invention relates to a medicament oxaliplatin composition for treating cancers, belonging to the technical field of medicaments. The composition is prepared from oxaliplatin and anhydrous sodium carbonate; the oxaliplatin is crystals, and an X-ray powder diffraction pattern obtained by measurement with Cu-Ka rays is as shown in Figure 1. The novel crystal form of the oxaliplatin provided by the invention is different from a crystal form structure of the prior art. Experiments prove and find that the novel crystal form compound is high in purity, good in flowability, good in stability, low in impurity content, unlikely to absorb moisture, and safe and reliable in clinical application; a powder injection prepared from the novel crystal form compound is good in stability after matching with a solvent, extremely low in content of insoluble particles and very suitable for clinical application.

Description

technical field [0001] The invention belongs to the technical field of medicine and relates to a drug oxaliplatin composition for treating cancer. Background technique [0002] Oxaliplatin is the third-generation platinum anticancer drug after cisplatin and carboplatin. It has broad-spectrum antitumor activity both in vivo and in vitro, and is also cytotoxic to cisplatin-resistant tumor cells. A synergistic cytotoxic effect of the combination of oxaliplatin and 5-fluorouracil was observed in both in vivo and in vitro studies. Oxaliplatin has few adverse reactions, no renal toxicity of cisplatin, and no myelosuppression of carboplatin. Its main site of action is DNA. By forming a conjugate with DNA, preventing its replication and transcription, it achieves the effect of killing tumor cells. Purpose, and the spectrum of anti-tumor activity has a significant inhibitory effect on colorectal cancer, non-small cell lung cancer, gastric cancer, ovarian cancer, and a variety of cel...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/282A61K9/14C07F15/00A61P35/00
Inventor 卢德国
Owner QINGDAO HUAZHICAO PHARMA CO LTD
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