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Method for determining concentrations of valsartan and sacubitril in human plasma and application of valsartan and sacubitril

A sacubitril and determination method technology, applied in the directions of measuring devices, instruments, scientific instruments, etc., can solve the problem that valsartan and sacubitril are not suitable for clinical pharmacokinetic detection, and achieve good reproducibility, The effect of avoiding dilution and reducing workload

Inactive Publication Date: 2021-02-26
方达医药技术(上海)有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0011] The existing methods for detecting the concentration of valsartan and sacubitril in rat plasma are not suitable for large-scale sample detection in clinical pharmacokinetic studies

Method used

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  • Method for determining concentrations of valsartan and sacubitril in human plasma and application of valsartan and sacubitril
  • Method for determining concentrations of valsartan and sacubitril in human plasma and application of valsartan and sacubitril
  • Method for determining concentrations of valsartan and sacubitril in human plasma and application of valsartan and sacubitril

Examples

Experimental program
Comparison scheme
Effect test

preparation example Construction

[0097] Preparation of control group (SET1) samples: Add 380µL of diluent 2 (methanol / water, 1 / 1, volume ratio) to a 1.5mL centrifuge tube, add 20µL of quality control mixed working solution (low concentration quality control working solution / medium concentration quality control working solution / high concentration quality control working solution) to obtain sample solutions with valsartan and sacubitril concentrations of 22.5 / 15ng / mL, 600 / 400ng / mL, and 5700 / 3800ng / mL, respectively, in a 96-well plate Add 50µL sample solution and 50µL internal standard solution, add 500µL 30% acetonitrile aqueous solution precisely, vortex mix, centrifuge at 6000g for 10min, draw 100µL supernatant into a new 96-well plate, add 200µL 30% acetonitrile water to dilute , after vortex mixing, centrifuge at 6000g, 5°C for 5min, and take 5µL for HPLC-MS / MS analysis. Prepare 3 samples for each concentration, record the chromatogram, record the peak area of ​​valsartan (A), calculate its average value As...

Embodiment

[0156] Example: Human Bioequivalence Study of Sacubitril-Valsartan Sodium Tablets

[0157] Taking Chinese healthy volunteers as subjects, evaluate sacubitril valsartan calcium sodium tablets (100mg: 1 tablet, test preparation) developed and produced by a certain company orally on an empty stomach and sacubitril valsartan produced by Novartis The relative bioavailability of sodium tablets, trade name Nuoxintuo® (100mg: 1 tablet, reference preparation), evaluates whether the test preparation and the reference preparation are or may be bioequivalent. This study is a single-center, randomized, open-label, two-drug, single-administration, three-cycle partially repeated crossover, fasting, and postprandial bioequivalence experiment in healthy subjects.

[0158] Design blood collection points: 0 hours after administration (within 60 minutes before administration) and 0.167 (10min), 0.333 (20min), 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5 after administration , 6, 8, 12, 24, 36, 48, an...

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Abstract

The invention relates to a method for determining the concentrations of valsartan and sacubitril in human plasma and application of valsartan and sacubitril. Provided is a method for measuring the concentrations of valsartan and sacubitril in human plasma, the method comprises the following steps: a step for preparing a plasma sample, and a step for high performance liquid chromatography-tandem mass spectrometry in which a mixed solution of water containing 0.1% formic acid and acetonitrile containing 10% methanol at a volume ratio of 90 / 10 is used as a mobile phase, and gradient elution is performed by adopting a chromatographic column with the particle size of 3.5 micronmeters.

Description

technical field [0001] The invention relates to a method for detecting drug concentration in human blood plasma. Specifically, the present invention relates to a method for determining the concentrations of valsartan and sacubitril in human plasma by high performance liquid chromatography-tandem mass spectrometry (high performance liquid chromatography-tandem massspectrometry, HPLC-MS / MS). Background technique [0002] Angiotensin II (Ang II) is a polypeptide substance produced by the hydrolysis of angiotensin I under the action of angiotensin converting enzyme. Angiotensin receptors are present on the smooth muscle of blood vessels, zona glomerular cells of the adrenal cortex, and cells of some parts of the brain, heart, and kidney organs. Angiotensin Ⅱ binds to angiotensin receptors, causing corresponding physiological effects, including ①constrict arterioles and veins throughout the body, increase blood pressure, and increase blood return to the heart; ②increase the rele...

Claims

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Application Information

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IPC IPC(8): G01N30/02G01N30/06G01N30/14G01N30/34G01N30/72
CPCG01N30/02G01N30/06G01N30/14G01N30/34G01N30/72
Inventor 余珊曹媛媛古珑房成伟
Owner 方达医药技术(上海)有限公司
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