仿制药一致性评价大背景下医药产业计量需求研究

Research on Metrological Demand of Pharmaceutical Industry Under the Background of Conformity Evaluation of Generic Drugs

仿制药是我国公共卫生事业的重要支撑,加快推进仿制药质量一致性评价已上升为国家战略。体外溶出曲线测试已成为固体制剂的一致性评价关键指标。本文探讨了药物溶出度仪机械性能验证方法及实际测试情况,以此为例,强调用于仿制药质量一致性评价的仪器需要更高可靠性、准确性对仪器计量要求远高于普通计量检测,对医药产业计量工作提出严峻的挑战更是难得的发展机遇。

Generic drugs are an important support for China’s public health undertakings.Accelerating the quality consistency evaluation of generic drugs has become a national strategy.In vitro dissolution curve test has become a key indicator for consistency evaluation of solid preparations.Mechanical properties,this paper discusses the drug dissolution instrument verification method and actual test,for example,emphasize for generic drugs quality consistency evaluation instrument need higher reliability and accuracy of the instrument measurement requirements is far higher than common measurement test,put forward sever challenges of metrological work for the pharmaceutical industry is a rare development opportunity.