液体注射剂拉曼无损筛查数据库的建立

Establishment of a Raman database for non-invasive and rapid screening of liquid injectables

目的:建立拉曼光谱快速无损筛查液体注射液和大输液的数据库。方法:对拉曼无损检测液体的方法制定规范化操作规程(SOP),对每个注射液品种建立拉曼模型,根据动态验证的结果调节每个品种的个体化阈值,最终形成数据库用于液体注射剂的快速无损筛查。结果:建立了114个拉曼液体注射剂品种的拉曼无损筛查数据库。结论:随着液体注射剂拉曼光谱的不断累积,数据库将进一步步完善,实现现场液体注射液和大输液的快速无损检测。

Objective ：To establish a Raman database for rapid and non-invasive screening of liquid injectable and intravenous （IV） drugs. Methods： Standard operation procedure （SOP） was formulated for the non-invasive method to determine liquid injectable by Raman spectroscopy, and models for liquid injections were built. With the adjust- ment of the individual threshold of each injection according to the dynamic verification results, the database for the rapid screening of injectable drugs was finally established. Results：A Raman non-invasive and rapid screening da- tabase including overall 114 liquid injactables was established. Conclusion：With the gradual supplement of Raman spectra of liquid injectables, the established database could be further improved, which will be finally applied for the on-site determination of liquid injectable and IV drugs in a fast and non-invasive way.