[关键词]
[摘要]
中药注射剂作为我国独创的新剂型,具有生物利用度高、起效快等特点,在对急重症的治疗上起到重要作用。但是,随着中药注射剂在临床上的广泛应用及品种的日益增多,不良反应的报道逐渐增加。临床应用过程中常发现同一品种的注射剂存在明显的色泽差异现象,这是否与安全性有关联,已引起研究者的关注。中药注射剂的安全性问题越来越突出,这极大限制了中药注射剂的应用和发展。因此,对影响中药注射剂色差和安全性的因素进行综述,并分析了二者之间的关系,以期为寻找影响中药注射剂安全性的因素提供思路,且通过工艺改进提高中药注射剂的质量,为临床安全合理应用中药注射剂提供一定的指导。
[Key word]
[Abstract]
As a unique innovative dosage form of China, traditional Chinese medicine injection (TCMI) has the characteristics of high bioavailability and rapid onset, therefore it plays an important role in the treatment of acute and severe diseases. However, more adverse reactions of TCMI have been reported along with its wide application in clinic and the increasing varieties. In the clinical application process, there are obvious color differences between the same kind of injection, which has attracted the attention of researchers whether this phenomenon is related to safety. The safety issue of TCMI has become more and more prominent, which greatly limits the application and development of TCMI. In this article, we summarized the reasons that influenced the chromatic aberration and safety of the TCMI, and analyzed the relationships between them. It is expected to provide some new ideas for exploring the reasons that affect the safety of TCMI and improving TCMI quality by technical improvement. This article provided a reference for rational application of TCMI in clinical practice.
[中图分类号]
R283
[基金项目]
山西大学引进人才事业发展经费(226545008);山西大学引进人才事业发展经费(226545003);山西省科技创新重点团队(201605D131045-18);地产中药功效物质研究与利用山西省重点实验室项目(201605D111004)