医院制剂二元化发展的探讨

摘要

Hospital medicinal preparations have been playing an complementary but important and effective role in clinical practice. None￣theless,due to state regulations and introduction of imported drugs under the provisions of WTO,the business of hospital preparations has been,as a whole,shrinking. To bring hospital preparations into full play and take their advantages and to preserve and further develop the traditional Chinese medicine (TCM),hospitals should develop hospital preparations on a dualistic basis,i.e., the traditional self-sustaining mode and the new-drug research mode ( development of new medicines on the basis of traditional preparations) . This study analyzed the problems in the busi￣ness of hospital preparations,proposed some suggestions to resolve the problems and specifically designed some feasible solutions or modes from the perspectives of law-making,policy support,establishment of supervising system,and disentanglement of complicated and unclear ownership.%医院制剂在配合临床用药中功效显著，但由于国家管制标准的提升以及WTO背景下外来药品涌入，医院制剂行业呈现出整体萎靡的态势。以发挥医院制剂功能优势、延续和发展传统中医药文化为目标，应该首先确定医院制剂未来发展的两种模式，即传统的存续性发展模式以及向新药转化的二次研发模式，并在此基础上通过分析现阶段我国医院制剂行业存在的问题，从法律法规的制定与完善、政策性支持、监管体系的建立以及疑难权属关系的梳理等方面，提出摆脱困境的建议和具体设计。