Xiong Fen, Jiang Kai-Yuan, Xiong Ai-Zhen, Ju Zheng-Cai, Yang Li, Wang Zheng-Tao
Key Laboratory for Standardization of Chinese Medicines under MOE, Institute of Chinese Materia Medica,Shanghai University of Traditional Chinese Medicine Shanghai 201203, China.
Key Laboratory for Standardization of Chinese Medicines under MOE, Institute of Chinese Materia Medica,Shanghai University of Traditional Chinese Medicine Shanghai 201203, China Shanghai R&D Center for Standardization of Traditional Chinese Medicines Shanghai 201203, China.
Zhongguo Zhong Yao Za Zhi. 2020 Jan;45(1):92-97. doi: 10.19540/j.cnki.cjcmm.20191001.301.
Pyrrolizidine alkaloids(PAs) are a kind of natural toxins, which can cause severe hepatotoxicity, pulmonary toxicity, genotoxicity, neurotoxicity, embryotoxicity and even death. Therefore, international organizations and countries such as World Health Organization have paid great attention to herbal medicines and preparations containing PAs. PAs are widely distributed in Chinese herb medicines and contained in hundreds of traditional Chinese medicine preparations. The content of adonifoline, the main PAs in Senecionis Scandentis Herba, shall be less than 0.004% in herbal medicines as described in Chinese pharmacopeia. However, there is no guidance in preparations which contain Senecionis Scandentis Herba. In this study, 14 preparations were analyzed by an UPLC-MS method. Among them, 8 preparations were found to contain adonifoline much higher than the content limits of such countries as Germany, Netherlands and New Zealand. And the highest contents of adonifoline were found in Qianbai Biyan Tablets and Qianbai Biyan Capsules, which are officially recorded in Chinese Pharmacopeia. The contents of adonifoline varied in different batches of the same preparations. The highest content was 156.10 μg·g~(-1) Qianbai Biyan Tablets, whose daily intake of adonifoline was up to 1 030.26 μg according to the recommended dosage of the preparation. Our results showed the potential risk of these preparations, and the content limit of adonifoline shall be inspected Chinese medicine preparations containing Senecionis Scandentis Herba.
吡咯里西啶生物碱（PAs）是一类天然毒素，可导致严重的肝毒性、肺毒性、遗传毒性、神经毒性、胚胎毒性甚至死亡。因此，世界卫生组织等国际组织和国家高度关注含有PAs的草药及制剂。PAs广泛分布于中药材中，数百种中药制剂中均含有PAs。《中国药典》规定，中药材中千里光所含主要PAs阿多尼弗林碱的含量应低于0.004%。然而，对于含有千里光的制剂却没有相关规定。本研究采用超高效液相色谱-质谱联用法对14种制剂进行了分析。结果发现，其中8种制剂中阿多尼弗林碱的含量远高于德国、荷兰和新西兰等国的限量标准。且《中国药典》收载的千柏鼻炎片和千柏鼻炎胶囊中阿多尼弗林碱含量最高。同一制剂不同批次的阿多尼弗林碱含量存在差异。千柏鼻炎片中阿多尼弗林碱含量最高达156.10μg·g-1，按照该制剂推荐用量计算，阿多尼弗林碱日摄入量高达1030.26μg。研究结果揭示了这些制剂存在的潜在风险，含有千里光的中药制剂应考察阿多尼弗林碱的含量限度。
