Continuous ban on injections of traditional Chinese medicines
Journal Title: Traditional Medicine Research - Year 2018, Vol 3, Issue 4
Abstract
Recently, the State Drug Administration of the People's Republic of China issued a series of notifications to ban certain herbal injections or modify the instructions for their use： May 29, 2018: A contraindication was added in the Caihu injection manual: forbidden for use in children! June 11, 2018: A contraindication was added in the Shuanghuanglian injection manual: forbidden for use in children aged 4 years and under and pregnant women! June 12, 2018: A contraindication was added in the Danseng injection manual: forbidden for use in newborns, infants, and pregnant women! In addition to the inclusion of prohibition of use by children, allergic reactions were clearly emphasized in the adverse reactions. Besides the abovementioned injections, there are also a few other commonly used traditional Chinese medicine (TCM) injections that need attention: Yinzhihuang injection, Xiyanping injection, Chuanhuning injection, Yanhuning injection, Shengmai injection, Lianbizhi injection, Qingkailing injection, Yuxingcao injection, Honghua injection, Compound Pugongying injection, etc. Since 2005, restrictions have been imposed on the clinical use of at least 45 kinds of TCM injections, or orders have been issued for modifications in their contraindications and matters needing attention. Therefore, according to the “Opinions on Deepening the Reform of Examination and Approval system and Encouraging the Innovation of Drug and Medical Devices" issued by the General Office of the Communist Party of China Central Committee and the General Office of the State Council, the re-evaluation of TCM injections in the market needs to be carried out to ensure their safety and efficacy. Since TCM injections contain many biological macromolecules and impurities as well as several unidentified components, new impurities or insoluble granules are easily generated during their storage. This makes them prone to becoming potential allergens that result in allergic reactions and even lead to shock, especially in children. The present special issue on the modern Chinese herbs will focus on the latest research on the efficacy and mechanism of TCM.
Authors and Affiliations
Editor Group of TMR
Keywords
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