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A kind of impurity compound of oteracil potassium and its preparation method and use

A technology of oteracil potassium and compound, which is applied in the field of pharmaceutical analytical chemistry, can solve problems such as toxic and side effects, affect the efficacy of drugs, etc., and achieve the effect of quality control

Active Publication Date: 2016-03-02
鲁南新时代生物技术有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] The content of the active ingredient of a drug is an important indicator of the purity of the drug, and the impurities in the drug directly affect the efficacy of the drug and may cause toxic and side effects

Method used

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  • A kind of impurity compound of oteracil potassium and its preparation method and use
  • A kind of impurity compound of oteracil potassium and its preparation method and use
  • A kind of impurity compound of oteracil potassium and its preparation method and use

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0052] The preparation of embodiment 1 oteracil potassium impurity compound

[0053] (1) Accurately weigh 1.0 g of the crude product of Otiraci potassium, dissolve it in 100 ml of purified water, and prepare a 10 mg / ml sample solution for primary preparation, mix well, ultrasonicate, and set aside.

[0054] (2) Primary preparation conditions are: mobile phase: KH 2 PO 4 Aqueous solution (concentration: 5.0g / L, adjusted pH to 2.0 by phosphoric acid): ethanol=96:4, flow rate: 30ml / min, detection wavelength: 220nm, column temperature: room temperature, preparation model: innovative Tongheng semi-preparative liquid phase system, Packing: octadecylsilane bonded silica gel, injection volume: 5ml.

[0055] Experimental steps: a. Turn on the machine and equilibrate the system with mobile phase.

[0056] b. Inject 5ml of sample, start the pump, and start elution.

[0057] c. The retention time of the target peak is about 8.9 minutes, and the target peak is collected.

[0058] d. C...

Embodiment 2

[0068] Embodiment 2 The purposes of oteracil potassium impurity compound as impurity reference substance

[0069] Chromatographic conditions: Chromatographic column: InertsilODS-3V-C18 column (4.6×150mm, 5μm), detection wavelength 220nm, column temperature 35°C, flow rate 1.0ml / min, mobile phase: aqueous phase: organic phase = 900: 100 (of which water The phase is: add 0.65gKH to 900ml purified water 2 PO 4 , after dissolving, add 2ml of 10% tetrabutylammonium hydroxide solution, mix well and adjust the pH to 3.2 with dilute phosphoric acid; the organic phase is methanol).

[0070] Experimental procedure: dissolve oteracil potassium with mobile phase and quantitatively dilute to make a solution containing about 1.0 mg of oteracil potassium in every 1 ml, as the test solution; impurity compounds are dissolved with mobile phase and quantitatively diluted to prepare A solution containing about 5 μg in every 1 ml was used as a contrast solution; each 10 μl of the test solution a...

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Abstract

The invention discloses a compound shown as a formula I, and also discloses a preparation method of the compound and application of the compound as an impurity reference substance in check of potassium oxonate related substances. Due to the implementation of the compound, the quality of the potassium oxonate is effectively controlled, thus having significance to safe medication of the masses.

Description

technical field [0001] The invention relates to the field of pharmaceutical analytical chemistry, in particular to an impurity compound of oteracil potassium, a preparation method and application thereof. Background technique [0002] Oteracil potassium, the English name is Potassiumoxonate, also known as potassium oxonate, chemical name: 1,4,5,6-tetrahydro-4,6-dihydro-1,3,5-triazine-2- potassium carboxylate. Oteracil potassium is one of the main components of the anti-cancer compound drug S-1, which was first developed by Japan Dapeng Pharmaceutical Co., Ltd., and has been approved for gastric cancer, non-small cell cancer, colon cancer and other cancers The treatment mainly consists of the active ingredient tegafur and two biochemical regulators gimeracil and oteracil potassium. [0003] Oteracil potassium itself has no anti-tumor activity. After taking it, the drug stays in the gastrointestinal tract and selectively acts on orotate phosphoribosyltransferase to block the...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): C07D233/96G01N30/02G01N30/06
CPCC07D233/96G01N30/02G01N30/06
Inventor 李铁健张建峰
Owner 鲁南新时代生物技术有限公司
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