Analysis on Safety of Polysorbate 80 as a Solubilizing Excipient in Traditional Chinese Medicine Injections / 中国实验方剂学杂志

ABSTRACT

There are safety problems in traditional Chinese medicine(TCM) injections. Most of the adverse reactions of TCM injections are very similar to those of hypersensitivity reactions. The hypersensitivity reaction of macromolecular substances in TCM injections has also been confirmed by experiments. Polysorbate 80 (trade name of tween-80) is a solubilizing excipient commonly used in TCM injections. Polysorbate 80 contains macromolecular impurities and the material basic research is not clear enough, and its quality problems need to be solved urgently. Based on this, the authors concluded that the macromolecular impurities in polysorbate 80 were the important material basis for the safety of TCM injections contained polysorbate 80. In this paper, the research progress of application of polysorbate 80 as a solubilizing excipient in TCM injections was reviewed and analyzed, so as to provide ideas for improving the safety of TCM injections contained polysorbate 80 and to promote the healthy development of TCM injections.