Hemolysis refers to the rupture of red blood cells and the escape of hemoglobin into plasma or serum, which can occur in vivo and in vitro. The factors affecting hemolysis are also very complicated. After hemolysis of plasma and serum, many physiological components such as hemoglobin, bilirubin, phospholipids, etc. increase significantly. These components may affect the detection of drugs in hemolyzed samples. The samples for biopharmaceutical analysis are generally plasma or serum samples, and there are problems such as fewer samples to be tested, complex samples, and many interfering substances. In the actual analysis of biological samples, the collected plasma or serum samples often show hemolysis.
In the analysis of biopharmaceuticals, the occurrence of hemolysis will affect the chromatographic separation of the analyte. There may be some unique endogenous interferences in the hemolytic matrix that co-elute with the analyte; it may also affect the analyte in the mass spectrometer. The matrix effect in the detection, and even the enzymes released from red blood cells may affect the stability of the analyte. The inaccurate measurement data of samples caused by hemolysis will directly affect the pharmacokinetic research of drugs. Biological sample analysis is often included in the services provided by some pharmacokinetic outsourcing agencies.
The application of LC-MS/MS technology can obtain abundant and effective compound structure information and establish a fast and efficient analysis and research system. It has become an important method for in vivo biopharmaceutical analysis. The pharmacokinetics and human bioequivalence studies of prototype drugs and metabolites in plasma samples and their pharmacokinetics and human bioequivalence studies are very important in drug development. The application of pharmacokinetics in different aspects is conducive to providing relevant evidence for clinical safe drug use, and it also allows researchers to better understand drug properties.
Medicilon provides outsourcing services for pharmacokinetics. The pharmacokinetic laboratory has passed CFDA’s GLP certification. Experimental research follows the guidelines of ICH, CFDA and FDA. In vivo and in vitro pharmacokinetics can be designed and carried out according to customer needs. Test, provide customers with a complete set of pharmacokinetic evaluation and optimization services.
When analyzing biological samples, avoid hemolysis in serum or plasma samples. Hemolysis generally occurs for the following reasons:
(1) The occurrence of hemolysis may be caused by internal factors such as disease state and physiological condition.
(2) The occurrence of hemolysis is directly related to the sample collection process, such as the diameter of the blood sampling needle is too small, the blood sampling speed is too fast, the blood sampling point is improperly selected, the tourniquet is used for a long time, the blood sampling tube is not full, and the blood sampling is too mixed. Excessive vibration during transportation will cause hemolysis.
(3) Improper operation during the transfer and storage process, such as severe vibration during the transfer; long transfer time; excessively high temperature of the transfer vehicle, severe vibration, etc. will also cause hemolysis.
Among them, external factors are the main cause of hemolysis. Plasma or serum samples are generally collected at different time points, which involve a long period and many influencing factors. The production of hemolytic samples is difficult to avoid. Therefore, researchers need to conduct personnel training in advance and pay close attention to the whole process of blood sample collection to reduce collection and Hemolysis may occur in any link of centrifugation, cryopreservation and transfer.
According to online reports, after hemolysis occurs, the analysis of biological samples will cause the following consequences:
(1) Affect the stability of the drug. The enzyme released by the rupture of red blood cells may cause the drug to be unstable in hemolyzed plasma. Studies have shown that the stability of hormones, vitamins, morphine, etc. in hemolyzed plasma is affected.
(2) Influencing drugs with high affinity with red blood cells, making the measured concentration higher than the actual concentration, and the drug concentration can be hundreds of times higher. For example, slight hemolysis can significantly increase the concentration of methazolamide.
(3) For drugs that affect the high plasma binding rate, the intracellular fluid causes the drug to be diluted, and the measured concentration is lower than the actual concentration.
(4) Hemolysis increases the physiological components of cells, causing ion suppression or enhancement, and the matrix effect is significant, which affects the determination of the target analyte.
For biochemical testing, the occurrence of hemolysis will cause detection errors and cause problems such as degradation of test quality. In order to improve the accuracy of biopharmaceutical analysis, it is necessary to conduct an in-depth analysis of the causes of hemolysis and find out and solve the problems.
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