The MOE Key Laboratory of Standardization of Chinese Medicines and the SATCM Key Laboratory of New Resources and Quality Evaluation of Chinese Medicines, Institute of Chinese Materia Medica, Shanghai University of Traditional Chinese Medicine, Shanghai 201203, China.
The MOE Key Laboratory of Standardization of Chinese Medicines and the SATCM Key Laboratory of New Resources and Quality Evaluation of Chinese Medicines, Institute of Chinese Materia Medica, Shanghai University of Traditional Chinese Medicine, Shanghai 201203, China; Shanghai R&D Center for Standardization of Chinese Medicines, Shanghai 201203, China.
J Pharm Biomed Anal. 2021 Nov 30;206:114353. doi: 10.1016/j.jpba.2021.114353. Epub 2021 Sep 1.
Traditional Chinese medicine injections (TCMIs) are a new pharmaceutical form in the modernization of traditional Chinese medicines (TCMs). Its efficacy is rapid, the curative effect is improved, and is widely used in critical and acute diseases, complicated and severe diseases, and other treatment. However, with the broad applications of TCMIs, clinical adverse reactions frequently occur, and safety problems become more prominent. Therefore, the quality control of TCMIs is essential. Chemical analysis methods and biological analysis methods are widely used in the quality control of TCMIs. This article describes the current status of TCMIs, the analytical techniques, and methods currently used, and the quality control of TCMIs. A summary of the advantages and disadvantages of the current analysis methods is presented. An overview of the quality control of TCMIs is introduced. In addition, emerging techniques of the quality control of TCMIs are introduced.
中药注射剂是中药现代化的一种新剂型。其疗效迅速，疗效提高，广泛应用于危急重症、复杂重症及其他治疗中。然而，随着中药注射剂的广泛应用，临床不良反应频繁发生，安全性问题更加突出。因此，中药注射剂的质量控制至关重要。化学分析方法和生物分析方法广泛应用于中药注射剂的质量控制中。本文介绍了中药注射剂的现状、目前使用的分析技术和方法以及中药注射剂的质量控制。对当前分析方法的优缺点进行了总结。对中药注射剂的质量控制进行了概述。此外，还介绍了中药注射剂质量控制的新兴技术。
