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Anticancer oxaliplatin composition

A technology of oxaliplatin and anti-cancer drugs, applied in the field of medicine, can solve the problems of poor fluidity, difference, easy moisture absorption and quality change, etc.

Inactive Publication Date: 2015-11-25
杨献美
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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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  • Anticancer oxaliplatin composition
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  • Anticancer oxaliplatin composition

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0023] Example 1: Preparation of Oxaliplatin Crystals

[0024] Prepare oxaliplatin crude product saturated methanol solution at 40°C, then add a mixed solvent of ether and 2-picoline whose volume is 8 times the volume of the saturated methanol solution, and the volume ratio of said ether and 2-picoline is 4:1.5, after stirring evenly, stir while cooling down, the cooling rate is 15°C / hour, the stirring speed is 100 rpm, stop stirring after cooling down to -5°C, let the crystal grow for 2 hours, filter, and dry under reduced pressure Finally, the oxaliplatin crystal compound is obtained.

[0025] The X-ray powder diffraction pattern obtained by the Cu-Kα ray measurement of the prepared oxaliplatin crystal is as follows: figure 1 Shown, its purity as determined by high performance liquid chromatography is 99.9%.

Embodiment 2

[0026] Example 2: Preparation of Oxaliplatin Compositions

[0027] The composition is: 1 part by weight of oxaliplatin crystal prepared by the present invention, and 0.4 part by weight of sodium chloride.

[0028] The preparation method is:

[0029] (1) Weigh oxaliplatin crystals and sodium chloride 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 0.5 part by weight of sodium chloride.

[0033] The preparation method is:

[0034] (1) Weigh oxaliplatin crystals and sodium chloride 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 an anticancer oxaliplatin composition, and belongs to the technical field of medicine. The composition comprises oxaliplatin and sodium chloride, wherein oxaliplatin is crystal; the X-ray powder diffraction pattern, obtained through Cu-K[alpha] of oxaliplatin is shown in the figure 1. The novel crystal form of oxaliplatin is different from the conventional crystal form of oxaliplatin; tests show that the novel crystal form compound is high in purity, flowability and stability, and low in impurity content and hygroscopicity; the clinical application is safe and reliable; powder injection prepared from the novel crystal form compound is high in stability; the mixture of the powder injection and a solvent is high in stability and quite low in insoluble particle content. Therefore, the oxaliplatin composition is highly suitable for clinical application.

Description

technical field [0001] The invention belongs to the technical field of medicine and relates to an anticancer drug oxaliplatin composition. 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 cell tumors...

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 杨献美
Owner 杨献美
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