鄢良春, 华桦, 罗茜, 赵军宁. 基于微小毒性检测的中药注射剂质量波动及安全风险预警研究进展J. 药学学报, 2019,54(12): 2189-2194. doi: 10.16438/j.0513-4870.2019-0503
引用本文: 鄢良春, 华桦, 罗茜, 赵军宁. 基于微小毒性检测的中药注射剂质量波动及安全风险预警研究进展J. 药学学报, 2019,54(12): 2189-2194. doi: 10.16438/j.0513-4870.2019-0503
YAN Liang-chun, HUA Hua, LUO Xi, ZHAO Jun-ning. Quality evaluation and toxicity assay for injectable traditional Chinese medicine using Microtox technologyJ. Acta Pharmaceutica Sinica, 2019,54(12): 2189-2194. doi: 10.16438/j.0513-4870.2019-0503
Citation: YAN Liang-chun, HUA Hua, LUO Xi, ZHAO Jun-ning. Quality evaluation and toxicity assay for injectable traditional Chinese medicine using Microtox technologyJ. Acta Pharmaceutica Sinica, 2019,54(12): 2189-2194. doi: 10.16438/j.0513-4870.2019-0503

基于微小毒性检测的中药注射剂质量波动及安全风险预警研究进展

Quality evaluation and toxicity assay for injectable traditional Chinese medicine using Microtox technology

  • 摘要: 中药注射剂具有成分复杂、批间变异度大以及综合毒性、微小毒性、毒性物质及机制尚不完全清楚等特点,急需在现行的中药注射剂质量控制方法基础上进一步提升对其质量一致性和临床应用风险的防控水平。Microtox(微毒)技术是以一种非致病的发光细菌为指示生物,以其发光强度的变化为指标,测定环境中有害有毒物质的一种简单、快速的生物毒性检测手段。基于生物检定原理和原则,本文对Microtox技术应用于中药注射剂微小毒性检测的原则、内容、应用等进行了系统研究和综述,以期作为一种新的生物活性检定方法用于中药注射剂的质量波动检测及安全风险预警,提高中药注射剂质量控制的可靠性。

     

    Abstract: Injectable traditional Chinese medicine often contains multiple components including undefined toxic substances, can have high variability between batches, with undefined mechanisms of action. It is urgent to improve the quality and consistency and reduce the toxicity risk of traditional Chinese medicine. The Microtox technology is a simple, rapid method for the detection of toxic substances in the environment that uses non-pathogenic luminescent bacteria as an indicator, and the change in luminosity as an index. Using this bioassay we have systematically applied Microtox technology for the detection of microtoxicity in injectable traditional Chinese medicine. As a new method of bioactivity characterization, Microtox technology is expected to be used in the detection of quality fluctuations and toxicity risks at an early stage in the preparation of injectable traditional Chinese medicines and to improve the quality of injectable traditional Chinese medicine.

     

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