药品的质量稳定、有效、安全是药品上市的前提,药品质量是保障药品稳定、安全、有效的基础。由于我国药品研发行业起步比较晚,与西方国家还存在较大差距,不同药品生产企业对于药品质量的认知存在差异,甚至同一药品的执行标准也各不相同。接下来,本文将浅要论述基于QbD理念的药品质量分析研究。 The quality of medicines is stable, effective and safe. It is the precondition of listing medicines. The quality of medicines is the basis for the stable, safe and effective medicines. Due to the relatively late start of the drug research and development industry in our country, there is still a long way to go to the western countries. Different pharmaceutical manufacturers have different understandings on the quality of medicines and even the implementation standards of the same medicines vary. Next, this article will briefly discuss QbD-based drug quality analysis.