新药通过大量的实验工作,经过毒理学和临床药理学研究,证实为安全有效后,还要进行质量标准的研究。本文从实用角度出发,并结合中国药典1977年版二部(以下简称新版药典),讨论关于质量控制所选用的检验方法。检验方法的选择,应根据准确、灵敏、简便,快速和节约的原则,既要考虑实际情况(例如国内多数地区、单位的实验设备和技术条件),又要能反映新技术的应用和发展,注意引进国外的先进技术为我所 New drugs through a large number of experimental work, after toxicology and clinical pharmacology studies, confirmed as safe and effective, but also to conduct quality standards. This article from a practical point of view, combined with the Chinese Pharmacopoeia 1977 edition two (hereinafter referred to as the new Pharmacopoeia) to discuss the quality control of the selected test methods. The choice of test methods should be based on the principle of accuracy, sensitivity, simplicity, speediness and economy, taking into account the actual situation (for example, the experimental equipment and technical conditions in most parts of China) and the application and development of new technologies. Attention to the introduction of foreign advanced technology for our