关于中药新药毒理研究用样品的思考与讨论

Consideration and discussion on samples for toxicology research of new traditional Chinese medicines

毒理研究用样品是药物非临床安全性评价的关键所在,对于保障毒理学试验结果的科学性具有重要意义。与成分明确的化学药不同,中药的组成及成分复杂、剂型多样,因此应根据品种特点对中药新药毒理研究用样品开展针对性研究,规范毒理研究用样品的制备、配制,加强研究过程的质量控制,建立完善的样品档案。本文对中药新药毒理研究用样品的研究内容和需重点关注的问题进行了讨论,以期为研发提供参考。

Samples for toxicology research are important to the non-clinical safety evaluation of drugs,and of great significance for ensuring the scientificity of toxicology tests.Different from chemical drugs with clear ingredients,traditional Chinese medicines have complex compositions and various dosage forms.Therefore,targeted research should be carried out on samples according to the characteristics of the drugs,such as standardized preparation of samples,strict control of the quality for the research process,and complete sample files.In this paper,the key issues of samples for toxicology research of new traditional Chinese medicines were discussed,in order to provide useful references for researchers.