对2004—2007年申请注册中药有效部位新药的申请数量、剂型、适应型、结构类型、纯化工艺、涉及药材、临床试验周期、处理结论等基本信息进行了统计分析。2004—2007年申请临床试验的中药有效部位新药共202个,申请生产的23个,从申请数量看,有效部位新药自2005年后明显下降。有效部位的剂型、适应症、纯化工艺等均呈现出相对集中的趋势。从阶段性处理结论看,申请临床试验有效部位新药的不批准率约48.0%,申请生产新药的不批准率约8.7%。中药有效部位新药在剂型选择、适应症定位、纯化工艺研究等方面还需进一步加强研究。

The basic information,including the number of applications,dosage forms,indications,structure types,purification processes,medicinal materials,period of clinical trials,and dealing conclusions for registration of active fractions in Chinese materia medica(CMM) during 2004-2007,was analyzed.The numbers of registration for clinical trials and applications for production during 2004-2007 were 202 and 23,respectively.It could be found that the numbers of registrations of active fractions in CMM declined obviously since 2005 and the dosage form,indication,and purification process of those applications showed a trend of the relative concentration.From aspect of the stage conclusions,the rate of "not to approve" of applications for clinical trials and production were 48.0% and 8.7%,respectively.So,it could be concluded that the studies on the selection of dosage form,indication,and purification process of active fractions in CMM should be further strengthened.