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Nedaplatin medical composition and application

A nedaplatin and composition technology, applied in the field of nedaplatin pharmaceutical composition, can solve the problems of high water content, poor clarity, difficult freeze-drying of nedaplatin, etc., to achieve improved curative effect, good clarity, and not easy to decompose Effect

Active Publication Date: 2011-06-08
QILU PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, nedaplatin using dextran 70 as the backbone agent is difficult to freeze-dry, and the moisture content of the sample is high and the clarity is not good

Method used

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  • Nedaplatin medical composition and application
  • Nedaplatin medical composition and application
  • Nedaplatin medical composition and application

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0049] Weigh 25g of hydroxypropyl-β-cyclodextrin, add 70 5g of dextran to 1800ml of sterile water for injection and stir to dissolve, add activated carbon to absorb to remove heat source, add nedaplatin to stir and dissolve, add to 2000ml, equipped with 0.22 micropore Membrane filtration, filling in sterile vials. Freeze in a freeze-drying cabinet at -45°C to -55°C for 2 hours, sublimate and dry at -10°C to 0°C for 12 hours, and then dry at 35°C for 10 hours, fill the box with nitrogen, seal it with a plug, and pack it.

Embodiment 2

[0051] Weigh 25g of hydroxypropyl-β-cyclodextrin, add 705g of dextran to 800ml of sterile water for injection and stir to dissolve, add activated carbon to absorb to remove the heat source, add nedaplatin to stir and dissolve, add to 1000ml, equipped with 0.22 micropore Membrane filtration, filling in sterile vials. Freeze in a freeze-drying cabinet at -45°C to -55°C for 2.5 hours, sublimate and dry at -10°C to 0°C for 15 hours, dry at 35°C for 8 hours, press the plug, take it out of the box, seal it with a cap, and pack it.

Embodiment 3

[0053] Weigh 25g of hydroxypropyl-β-cyclodextrin, add 705g of dextran to 800ml of sterile water for injection and stir to dissolve, add activated carbon to absorb to remove the heat source, add nedaplatin to stir and dissolve, add to 1000ml, equipped with 0.22 micropore Membrane filtration, filling in sterile vials. Place the sterile solution in a large plate and put it in a freeze-drying cabinet to freeze at -45°C to -55°C for 3 hours, sublimate and dry at -10°C to 0°C for 20 hours, and then dry at 35°C for 6 hours, then fill it with nitrogen gas out of the box, and pulverize . Determine the content of nedaplatin in the freeze-dried powder, divide and pack into vials according to the converted weight of nedaplatin, add stoppers, press caps and seal, and pack.

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Abstract

The present invention relates to a nedaplatin medical composition, particularly to a nedaplatin freeze-dried powder preparation made by mixing nedaplatin with cyclodextrin or cyclodextrin with dextranum. The present invention relates to a method for preparing the composition and an application of the medical composition to the cancer treating prospect as a non-gastrointestinal administration medical product.

Description

technical field [0001] The invention relates to a nedaplatin pharmaceutical composition and its application, in particular to a freeze-dried product for injection and a sterile subpackaged product for injection of the nedaplatin pharmaceutical composition. technical background [0002] Nedaplatin is an antineoplastic drug developed by Shionogi Company in Japan. Its freeze-dried powder injection was approved for marketing for the first time in June 1995. Esophageal cancer, bladder cancer, testicular cancer, ovarian cancer, cervical cancer. The toxicity spectrum of nedaplatin is different from that of cisplatin, and its dose-limiting toxicity is thrombocytopenia caused by myelosuppression. However, the nephrotoxicity and gastrointestinal side effects are reduced compared with cisplatin, and it has no cross-resistance, good solubility and other advantages. [0003] Nedaplatin is slightly soluble in water and almost insoluble in most organic solvents such as methanol and ethan...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/282A61K47/40A61P35/00
Inventor 徐先艳杨清敏邱丽明张明会王晶翼
Owner QILU PHARMA CO LTD
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