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Antitumor drug oxaliplatin composition

An anti-tumor drug, the technology of oxaliplatin, which is applied in the field of medicine, can solve the problems of poor fluidity, easy moisture absorption, poor quality, and difference in loading

Inactive Publication Date: 2016-01-20
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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  • Antitumor drug oxaliplatin composition
  • Antitumor drug oxaliplatin composition
  • Antitumor drug oxaliplatin composition

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0022] Example 1: Preparation of Oxaliplatin Crystals

[0023] Dissolve oxaliplatin in a mixed solvent of methanol and acetonitrile whose volume is 10 times the weight of oxaliplatin at 45°C. The volume ratio of methanol to acetonitrile is 3:2. After the dissolution is completed, add a volume of oxaliplatin 6 times the weight of platinum in ether solvent, lower the temperature to room temperature within 1-2 hours, keep at room temperature for 3 hours, then further lower the temperature to 0--5°C, and then place it at 0--5°C for 2- After 3 hours, crystals were precipitated to obtain oxaliplatin crystals.

[0024] 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

[0025] Example 2: Preparation of Oxaliplatin Compositions

[0026] The composition is: 1 part by weight of oxaliplatin crystal prepared by the present invention, and 0.01 part by weight of arginine.

[0027] The preparation method is:

[0028] (1) Weigh oxaliplatin crystals and arginine in proportion and mix them thoroughly;

[0029] (2) Dispense into sterilized vials and stopper them.

Embodiment 3

[0030] Example 3: Preparation of Oxaliplatin Compositions

[0031] The composition is: 1 part by weight of oxaliplatin crystal prepared by the present invention, and 0.02 part by weight of arginine.

[0032] The preparation method is:

[0033] (1) Weigh oxaliplatin crystals and arginine in proportion and mix them thoroughly;

[0034] (2) Dispense into sterilized vials and stopper them.

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Abstract

Belonging to the technical field of medicine, the invention relates to an antitumor drug oxaliplatin composition. The composition comprises: oxaliplatin and arginine. The oxaliplatin is crystal, and the X-ray powder diffraction pattern obtained by Cu-Kalpha ray measurement is shown as Figure 1. The new crystal form of oxaliplatin provided by the invention is different from the crystal structure of the prior art. Experimental verification finds that the new crystal form compound has the advantages of high purity, good fluidity, good stability, low impurity content, difficult absorption of moisture, and safe and reliable clinical application. The powder-injection obtained by the new crystal form compound has good stability, is stable after compatibility with a solvent, and has very low insoluble particle content, thus being very suitable for clinical application.

Description

technical field [0001] The invention belongs to the technical field of medicine and relates to an antitumor 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 various cell tumors, espe...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/555A61K47/18A61P35/00C07F15/00
Inventor 刘学键
Owner QINGDAO HUAZHICAO PHARMA CO LTD
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