药学学报, 2019, 54(12): 2189-2194
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.
YAN Liang-chun, HUA Hua, LUO Xi, ZHAO Jun-ning. Quality evaluation and toxicity assay for injectable traditional Chinese medicine using Microtox technology[J]. Acta Pharmaceutica Sinica, 2019, 54(12): 2189-2194.

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
鄢良春, 华桦, 罗茜, 赵军宁
四川省中医药科学院, 四川省中医药转化医学中心, 国家中医药管理局中药质量生物评价重点研究室, 四川省道地药材系统开发工程技术研究中心, 中药品质评价与创新中药研究四川省重点实验室, 四川省中医药管理局中药毒性快速检测实验室, 四川 成都 610041
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。
关键词:    中药注射剂      微小毒性      Microtox技术      质量波动      风险预警     
Quality evaluation and toxicity assay for injectable traditional Chinese medicine using Microtox technology
YAN Liang-chun, HUA Hua, LUO Xi, ZHAO Jun-ning
Sichuan Academy of Chinese Medicine Sciences, Sichuan Center for Translational Medicine of Traditional Chinese Medicine, Key Laboratory of Biological Evaluation of Traditional Chinese Medicine Quality of the State Administration of Traditional Chinese Medicine, Sichuan Engineering Technology Research Center of Genuine Regional Drug, Sichuan Provincial Key Laboratory of Quality Evaluation and New Drug Creation of Traditional Chinese Medicine, Laboratory for Rapid Detection of Toxicity of Traditional Chinese Medicine in Sichuan Provincial Administration of Chinese Medicine, Chengdu 610041, China
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.
Key words:    traditional Chinese medicine injection    microtoxicity    Microtox technology    quality fluctuation    risk early warning   
收稿日期: 2019-06-21
DOI: 10.16438/j.0513-4870.2019-0503
基金项目: 四川省科技厅科技创新团队项目(2017TD0003);“重大新药创制”科技重大专项资助项目(2015ZX09501004-001-005);四川省重大科技专项课题(2018SZDZX0004).
通讯作者: 赵军宁,Tel:86-28-85231378,E-mail:zarmy@189.cn
Email: zarmy@189.cn
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