中药注射剂大分子物质是活性成分还是杂质?

Are macromolecules in traditional Chinese medicine injections active components or impurities?

中药注射剂的有效性得到了临床的广泛认可,但安全性依然是当下面临的主要问题,受到业界和公众的广泛关注,提高内在质量是目前紧迫的产业问题。根据中药注射剂的不良反应特点、现有质量标准和生产流程,本文从技术层面分析得出,大分子物质是导致安全性问题的主要物质基础。随后对大分子杂质的种类、危害、来源进行分析,并较系统地提出去除大分子物质的策略,希望为提高中药注射剂的安全性提供较系统的参考思路。

The efficacy of traditional Chinese medicine injections （TCMIs） has been proved by massive clinical data.However, their safety problems draw many people’s eyes both in pharmaceutical industry and in general public. Therefore,the enhancement of their inner quality is an urgent problem that should be solved as soon as possible. According to thefeatures of TCMIs’ adverse reactions, the present quality standards, and the approved production process, this articletechnologically deduced that macromolecules are the important substances causing the adverse reactions. Then, the kinds,hazards and sources of the macromolecules were systematically analyzed to put forward the technologic strategy ofremoving the macromolecular substances and give a suggestion for improving the quality of TCMIs.