A method for measuring the concentration of sodium tanshinone IIA sulfonate 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 (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 plasma. So far, there is no lit...

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Problems solved by technology

There is a literature report on a method for measuring the concentration of STS in rat plasma by Ion-Pair Reversed-Phase HPLC-UV. The lowest limit of quantification of this method is 0.5 μg / mL, obviously its sensitivity is low It cannot meet the determination requirements of the low concentration point of STS in human plasma; another report uses liquid chromatography-tandem mass spectrometry (Liquid Chromatography Tandem Mass Spectrometry) to measure STS in rat plasma, and the quantitative linear range of this method is 1-500ng / mL, in fact, the highest blood concentration of rats after intravenous injection is as high as 10000ng / mL, which far exceeds the verification range of the methodology, and the measurement results are inaccurate; in addition, because the matrix of animal plasma is different from that of human plasma , and there are often drug combinations in human plasma. Therefore, the analytical method for determining animal plasma cannot meet the determination requirements of human plasma samples in terms of specificity; it is also disclosed that STS is unstable in plasma, which may be related to factors such as light, However, no methodological verification has been carried out for this, and ensuring the stability of STS during the analysis process is the key to ensuring the accuracy of its human plasma concentration determination method

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