background overview | trimetazidine is a piperazine derivative, which is a new type of anti-myocardial ischemia drug, mainly by inhibiting 3-ketoacyl coenzyme A thiolase to inhibit myocardial fatty acid beta oxidation, increase glucose oxidation, and improve glycolysis and glycolysis Coupling with glycolysis, optimizing myocardial cell energy metabolism. A large number of basic studies have confirmed that trimetazidine hydrochloride can reduce the overload of H, Na and Ca2 in cells, inhibit the generation of oxygen free radicals, stabilize the functional state of mitochondrial membrane, and has various cytoprotective effects such as anti-oxidation and anti-apoptosis, and does not affect hemodynamics. Its good pharmacological effect is increasingly favored by clinicians. Trimetazidine hydrochloride, as a new drug to improve myocardial energy metabolism, has been confirmed in the treatment of heart failure, has no obvious toxic and side effects, is well tolerated, safe and reliable, and is worthy of clinical application. However, for the treatment of arrhythmia in patients, improve the mortality of patients and long-term application of adverse reactions and other clinical data are less, and further research is needed. At present, there are mainly 8 kinds of trimetazidine impurities detected, including trimetazidine impurity A, mestazine impurity B, mestazine impurity C, mestazine impurity D, mestazine impurity E, mestazine impurity F, mestazine impurity G, mestazine impurity H, it may come from process impurities, reaction by-products and unreacted starting materials, intermediates and reagents in the API. With the improvement of the quality of life, people pay more and more attention to drug safety, and impurities in drugs are directly related to the quality of drugs. The Technical Guidelines for Chemical Drug Impurities Research systematically stipulate the analysis of impurities, and the rapid characterization of impurities has good guiding significance for quality control and process optimization in the research and development process. |