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Process for reifining Nedaplatin

A technology for nedaplatin and refined products, applied in the field of refining nedaplatin, can solve the problems of low purity and low yield in high performance liquid chromatography analysis

Active Publication Date: 2007-11-14
SIMCERE ZAIMING PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0007] The process involves raw materials containing metallic silver, and the metallic silver will be brought into the product. In the Pharmacopoeia, the silver ion is required to be controlled below 5ppm, but the refined nedaplatin with the current process cannot make the silver content reach the standard, and the yield is low , high performance liquid chromatography analysis purity is not high

Method used

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  • Process for reifining Nedaplatin
  • Process for reifining Nedaplatin

Examples

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example 1

[0018] Dissolve 10 g of nedaplatin containing 150 ppm of silver in 800 ml of hot water at 60°C, add about 1.5 mg of KI, stir for 10 min, and filter with a 0.22 μm filter membrane. After stirring, add 1200ml of ethanol next time, cool to -18°C and crystallize for 15 hours, filter the precipitated solid, and vacuum dry at 50°C for 6 hours to obtain the refined product of Nida Platinum 8.2, yield: 82%; no flame atomic absorption spectrometry analysis, silver The content is less than 5ppm, and the high performance liquid chromatography analysis shows that the content is greater than 99%.

example 2

[0020] Dissolve 10 g of nedaplatin containing 150 ppm of silver in 500 ml of hot water at 70°C, add about 1.5 mg of KI, stir for 10 min, and filter with a 0.22 μm filter membrane. After stirring, add 1000ml of ethanol next time, cool to -18°C to crystallize for 15 hours, filter the precipitated solid, and dry it in vacuum at 50°C for 6 hours to obtain the refined product of Nida Platinum 8.6, yield: 86%; no flame atomic absorption spectrometry analysis, silver The content is less than 5ppm, and the high performance liquid chromatography analysis shows that the content is greater than 99%.

example 3

[0022] Dissolve 10 g of nedaplatin containing 150 ppm of silver in 500 ml of hot water at 45°C, add about 1.5 mg of KI, stir for 10 min, and filter with a 0.22 μm filter membrane. After stirring, add 1000ml of ethanol next time, cool to -18°C for crystallization for 15 hours, filter the precipitated solid, and vacuum dry at 50°C for 6 hours to obtain the refined product of Nida Platinum 8.3, yield: 83%; no flame atomic absorption spectrometry analysis, silver The content is less than 5ppm, and the high performance liquid chromatography analysis shows that the content is greater than 99%.

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Abstract

This invention relates purifing method a refined Nedaplatin. By weight proportion of 1:15 to 80, dissolve Nedaplatin crude product in water of 25 to 70 deg, after completeness dissolving add KI, by filtration, remove excessive Ag+, add 1 to 5 times volume C1 to C2 alkyl alcoho filtrate, through crystallization, cooling, filtration, dryness, gain Nedaplatin refiend product; the cooling crystallization temperature is -25 to 25deg, time for 5 to 30h,drying temperature is 40 to 70deg, and drying time is 4 to 15h. The Ag content of this refined Nedaplatin is very low.

Description

technical field [0001] A method for refining nedaplatin according to the invention relates to a method for refining and purifying nedaplatin. Background technique [0002] Nedaplatin is called cis-glycolic acid-diammine platinum (II), the English name is Nedaplatin, and the trade names are Nedaplait and Aqupla. [0003] The structural formula is: [0004] [0005] Nedaplatin is a platinum-based antitumor drug developed by Shionogi Pharmaceutical Co., Ltd. in Japan. It was approved for marketing in Japan in 1995 and is used for the treatment of head and neck tumors, small cell and non-small cell lung cancer, esophageal cancer, bladder cancer, testicular cancer, Cervical cancer, etc. Nedaplatin has an effective rate of more than 40% for head and neck tumors, which is better than cisplatin; the efficacy for lung cancer is equivalent to that of cisplatin; the effective rate for esophageal cancer is more than 50%, which is about 20% higher than cisplatin; The effective rate...

Claims

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Application Information

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IPC IPC(8): C07F15/00
Inventor 肖中伟鲍威罗丰茂
Owner SIMCERE ZAIMING PHARM CO LTD
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