Method for determination of concentration of 5, 6-dihydro-7,8-dimethyl-4,5-dioxy-4-H-pyranoquinoline-2-carboxylic acid in plasma

A pyranquinoline and dimethyl technology, which is applied in the field of drug analysis, can solve the problem that the determination method is not reported in literature and the like, and achieve the effects of simple pretreatment method, high sensitivity and rapid method.

Inactive Publication Date: 2017-02-15
THE SECOND HOSPITAL AFFILIATED TO SUZHOU UNIV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

At present, there is no literature report on the determination method of the active me

Method used

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  • Method for determination of concentration of 5, 6-dihydro-7,8-dimethyl-4,5-dioxy-4-H-pyranoquinoline-2-carboxylic acid in plasma
  • Method for determination of concentration of 5, 6-dihydro-7,8-dimethyl-4,5-dioxy-4-H-pyranoquinoline-2-carboxylic acid in plasma
  • Method for determination of concentration of 5, 6-dihydro-7,8-dimethyl-4,5-dioxy-4-H-pyranoquinoline-2-carboxylic acid in plasma

Examples

Experimental program
Comparison scheme
Effect test

Example Embodiment

[0027] Example 1: Determination of the concentration of MY-1250 in human plasma.

[0028] 1. Experimental materials and instruments

[0029] MY-1250 reference substance: provided by Henan Furentang Pharmaceutical Co., Ltd., batch number: 20140501D; levetiracetam reference substance: provided by Zhejiang Huahai Pharmaceutical Co., Ltd., batch number: 201308-2; test water: ultrapure water ; Methanol: Chromatographic Pure (Merck Company); Ammonia, Ammonium Acetate: Analytical Pure (Sinopharm Chemical Reagent Co., Ltd.); Hydrochloric acid: Analytical Pure (Shanghai Lingfeng Chemical Reagent Co., Ltd.).

[0030] API 4000 LC / MS / MS combination instrument (Applied Biosystems, USA), Chromatography Workstation: Analyst 1.6; Mettler XS 105DU Electronic Balance (Mettler, Switzerland); Eppendorf Centrifuge 5424R High Speed ​​Low Temperature Centrifuge (Eppendorf, Germany ); KDC-2042 low-speed refrigerated centrifuge (Anhui Zhongke Zhongjia Scientific Instrument Co., Ltd.); Millipore Drict-Q5 ult...

Example Embodiment

[0052] Example 2: Determination of the concentration of MY-1250 in human plasma

[0053] With reference to Example 1, 5 healthy female subjects took 150 mg of Repilast tablets on an empty stomach, and took it with 250 mL of warm water; 4 hours after the administration, 3 mL of peripheral venous blood was collected, injected into a heparin tube, and centrifuged (4000r·min -1 , 5min), draw 600μL of the subject’s plasma sample, add 12μL of hydrochloric acid solution (5mol·L -1 ), vortex and mix, prepare plasma. The treatment and determination conditions of the medicated plasma samples were the same. As a result, the levels of MY-1250 in the plasma of 5 healthy female subjects who took 150 mg of Repikast tablets on an empty stomach for 4 hours were 50.24, 52.71, 41.2, 26.12, 43.45 ng·mL, respectively -1 .

Example Embodiment

[0054] Example 3: Determination of the concentration of MY-1250 in human plasma

[0055] With reference to Example 1, 5 healthy male subjects took 50 mg of Repilast granules per bag × 3 bags on an empty stomach, and dispense with 250 mL warm water; 2 hours after the administration, 3 mL of peripheral venous blood was collected, injected into a heparin tube, and centrifuged (4000r ·Min -1 , 5min), draw 600μL of the subject’s plasma sample, add 12μL of hydrochloric acid solution (5mol·L -1 ), vortex and mix, prepare plasma. The treatment and determination conditions of the medicated plasma samples were the same. The results showed that the levels of MY-1250 in the plasma of 5 healthy male subjects who took 150 mg of Repikast Granules on an empty stomach were 49.26, 107.6, 56.76, 100.7, and 124.5 ng·mL, respectively. -1 .

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Abstract

The invention discloses a method for determination of concentration of 5, 6-dihydro-7,8-dimethyl-4,5-dioxy-4-H-pyranoquinoline-2-carboxylic acid in plasma, the method uses a liquid chromatography-mass spectrometry system for the determination, and the method is as follows: first taking a to-be-tested plasma sample, adding a certain amount of an inorganic acid for acidification, adding an organic solvent into the acidified plasma sample to precipitate proteins, centrifuging at a high speed, taking supernatant to add a certain amount of deionized water for even mixing, separating by a chromatographic column, and detecting with a mass spectrometry detector. The method is rapid, accurate, high-sensitivity, simple in operation, and suitable for the determination of the concentration of the 5, 6-dihydro-7,8-dimethyl-4,5-dioxy-4-H-pyranoquinoline-2-carboxylic acid in the plasma.

Description

technical field [0001] The invention belongs to the technical field of drug analysis, and relates to an analysis and determination method for drugs in vivo, in particular to a method for determining 5,6-dihydro-7,8-dimethyl-4,5-dioxo-4-hydro-pyridine in blood plasma Quinoline-2-carboxylic acid concentration method. Background technique [0002] Repimilast is an anti-allergic drug, which can be rapidly degreased into the active metabolite 5,6-dihydro-7,8-dimethyl-4,5-dioxo-4-hydro-pyranoquinoline in the body -2-Carboxylic acid (also known as MY-1250), exerts anti-asthma effect by inhibiting the release of chemical mediators such as histamine, allergic slow-response substances, and platelet activating factor through MY-1250. Oral administration of repimilast to patients with bronchial asthma can inhibit the decline in lung function and skin allergic reactions caused by antigens, and it is mainly used clinically for the prevention and treatment of bronchial asthma. At present...

Claims

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Application Information

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IPC IPC(8): G01N30/02
CPCG01N30/02
Inventor 王蒙张全英黄明宗顺麟周文佳
Owner THE SECOND HOSPITAL AFFILIATED TO SUZHOU UNIV
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