Method for measuring concentration of Sodium Tanshinone IIA Sulfonate (STS) in human plasma

Abstract

The invention belongs to the field of medical examination, and relates to the analysis and measurement method of in vivo drugs, particularly to a method capable of measuring the concentration of Sodium Tanshinone IIA Sulfonate (STS) in human plasma. The method uses deuterium 5-dehydroepiandrosteronesulfate (DHEAS-D5) as an interior label, and the condition of a yellow light safety lamp without UV (light at the wavelength of 420 nm or below is removed) is adopted to control STS degradation during the blood sample treatment process, so that the accuracy of the method is ensured; after the blood sample is acidized using formic acid, a certain amount of organic solvent methyl alcohol and acetonitrile mixed liquor is added to enable protein to precipitate; a tandem mass spectrometry is used to measure the concentration of STS and the interior label; the quantitative linear range is 2-1000 ng / mL, the requirements of human pharmacokinetic studies are met. The method has the advantages that the less sample is required, the pretreatment is simple, quick, and sensitive, only general-type equipment and reagents are required, the analysis period is short, and the cost is low; the method is applicable to the detection of clinical blood routine STS concentration.

Description

technical field [0001] The invention belongs to the field of medical examination and relates to an analysis and determination method of drugs in vivo, in particular to a method for determining the concentration of sodium tanshinone IIA sulfonate (STS) in human blood plasma. Background technique [0002] The prior art discloses that Sodium Tanshinone IIA Sulfonate (Sodium TanshinoneIIASulfonate, STS) is clinically used to treat cardiovascular diseases such as coronary heart disease, angina pectoris, and myocardial infarction. Although sodium tanshinone IIA sulfonate (STS) has been used clinically for more than 30 years, practice shows that its clinical drug reference materials are still insufficient, such as human pharmacokinetic parameters have not been reported, which limits its safe and effective clinical application . One of the important reasons for the lack of STS human pharmacokinetic parameters is the lack of methods for determining the concentration of STS in human ...

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Problems solved by technology

A method for measuring the concentration of STS in rat plasma by Ion-PairReversed-PhaseHPLC-UV has been reported in the literature. The minimum quantification limit of this method is 0.5 μg / mL. Obviously, its low sensitivity cannot meet The determination requirement of STS low concentration point in human plasma; Another report adopts liquid chromatography-tandem mass spectrometry (Liquid Chromatography Tandem Mass Spectrometry) to measure the method for STS in rat plasma, the quantitative linear range of this method is 1-500ng / mL, in fact, Among them, the highest blood drug concentration after intravenous injection in rats was as high as 10000ng / mL, which far exceeded the verification range of the methodology, and the measurement results were inaccurate; in addition, because the matrix of animal plasma is different from that of human plasma, and there are often Therefore, the analytical method for determining animal plasma cannot meet the requirements for the determination of human plasma samples in terms of specificity; research has also revealed that STS is unstable in plasma, which may be related to factors such as light, but no method has been conducted for this To ensure the stability of STS in the analysis process is the key to ensure the accuracy of its human plasma concentration determination method

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