替格瑞洛片有关物质的毒理评价及含量分析

Toxicology Evaluation and Content Analysis of Related-substances in Ticagrelor Tablets

目的:研究替格瑞洛片中相关杂质的毒理性质和质量。方法:通过毒理分析软件对该系列杂质进行评价,并按药品标准检验分析其含量。结果:经软件分析预测,部分杂质具有特定毒性,各杂质的含量均符合规定。结论:替格瑞洛部分杂质预测有特定毒性,有必要进行相关毒理学实验研究,为科学的制定各杂质的限度、统一和完善替格瑞洛片的质量标准提供依据。

Objective:To evaluate the toxic completely and assay the contents of related-substances in Ticagrelor tablets.Methods A toxicity prediction software was used to predict the toxic of relate-substances in Ticagrelor tablets completely and analysis the contents of these relate-substances in routine test.Results:According to the toxicity prediction software analysis and evaluation,some of these relate-substances in Ticagrelor tablets have specific toxic.The study of that content of each impurities in ticagrelor tablets are in accordance with the drug standards.Conclusions:Some of relate-substances in Ticagrelor tablets have specific toxic,It is necessary to carry out relevant toxicological experiments to provide a basis for the scientific formulation of the control items and limits of impurities,and for the unification and improvement of the quality standards of Ticagrelor tablets.