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Quantitative detection method of trospium chloride in plasma

A quantitative detection method, the technology of trospium chloride, is applied in measurement devices, instruments, scientific instruments, etc., and can solve the problems of inability to meet the requirements of biological sample determination, low dosage and bioavailability, and the need to improve detection sensitivity. , to achieve efficient, rigorous, convenient and accurate sample analysis, shorten the research cycle, and introduce small errors.

Inactive Publication Date: 2019-06-14
康诚科瑞医药研发(武汉)有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

The lower dosage and bioavailability lead to low blood concentration of this product, and conventional analysis methods cannot meet the determination requirements of biological samples
At present, the established methods for the determination of trospium chloride in biological samples include pre-column derivatization HPLC combined with fluorescence detection, radioimmunoassay and GC-MS, but the detection sensitivity of these methods still needs to be improved

Method used

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  • Quantitative detection method of trospium chloride in plasma
  • Quantitative detection method of trospium chloride in plasma
  • Quantitative detection method of trospium chloride in plasma

Examples

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Embodiment 1

[0040]The present embodiment provides a kind of method for the quantitative detection of trospium chloride in the plasma of an embodiment comprising the following steps:

[0041] (1) Preparation of standard working solution: Weigh a certain amount of trospium chloride into a glass bottle, add methanol, and prepare a concentration of 1 mg·mL -1 The trospium chloride stock solution is marked as S01-1, and the trospium chloride stock solution is diluted into eight trospium chloride working solutions (concentration is 1~400ng ·mL -1 ), the concentrations of the eight trospium chloride working solutions were different, and the concentrations of the eight trospium chloride working solutions were 400, 360, 250, 100, 25.0, 5, 2 and 1ng·mL -1 ; Weigh a certain amount of trospium chloride-d8 into a glass bottle, add methanol to prepare a concentration of 1mg mL -1 internal standard stock solution, diluted to a concentration of 10 ng·mL with methanol aqueous solution at a volume ratio ...

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Abstract

The invention belongs to the field of detection technology of trospium chloride, and discloses a quantitative detection method of trospium chloride in plasma. The method comprises the following steps:(1) preparation of a standard working solution: respectively diluting a trospium chloride stock solution with a methanol aqueous solution with a volume ratio of 1:1 to obtain a plurality of trospiumchloride working solutions; diluting an internal standard stock solution with the methanol aqueous solution with the volume ratio of 1:1 to obtain an internal standard working solution with a concentration of 10-20 ng.mL-1; (2) pretreatment process of a plasma sample to be tested; (3) preparation of a standard curve: using a chromatographic peak area ratio of trospium chloride and trospium chloride-d8 as a vertical coordinate, using a ratio of the plasma concentration of the trospium chloride to the plasma concentration of the trospium chloride-d8 as an abscissa, performing linear regression by using the weighted least square method to prepare the standard curve so as to obtain a regression equation Y=a+bX; and (4) calculating the plasma concentration of the trospium chloride in the plasmasample to be tested according to the regression equation. According to the quantitative detection method provided by the invention, the liquid chromatography-mass spectrometry / mass spectrometry is adopted to perform measurement, and the sensitivity is high.

Description

technical field [0001] The invention belongs to the technical field of trospium chloride detection, and in particular relates to a quantitative detection method for trospium chloride in blood plasma. Background technique [0002] Trospium chloride (trospium chloride) is a synthetic tropic acid derivative with 4 ammonium groups. It belongs to the parasympathetic blocker. It works by competitively binding to the post-synaptic membrane M-receptors. It can reduce the tension of parasympathetic nerves and remove the smooth muscle spasm caused by parasympathetic nerves on organs innervated by parasympathetic nerves. It also has certain effects on gastrointestinal tract, biliary tract and urinary tract. effect. This product has low fat solubility and is not easy to pass through the blood-brain barrier, and will not produce central nervous system side effects. Trospium chloride is clinically used for the treatment of the following symptoms: frequent urination, nocturia, bladder dy...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02G01N30/06
Inventor 李高张媛
Owner 康诚科瑞医药研发(武汉)有限公司
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