Microtox(微毒)技术应用于参附注射液综合毒性检测  

Microtox-based Fast Testing Method of Comprehensive Toxicity of Shen-Fu Injection

作　　者：罗荔敏 鄢良春[2] 侯新莲 华桦[2] 干建伟 赵军宁[2] 

机构地区：[1]华润三九(雅安)药业有限公司,雅安625000 [2]四川省中医药科学院,成都610041

出　　处：《世界科学技术-中医药现代化》2017年第3期491-496,共6页Modernization of Traditional Chinese Medicine and Materia Medica-World Science and Technology

基　　金：科学技术部"重大新药创制"科技重大专项(2015ZX09501004-001-005):基于Microtox(微毒)测试的中药安全性快速检测;质量控制与风险预警新技术研究;负责人:赵军宁;四川省科技厅科技创新团队项目(2017TD0003):中药毒性生物评价研究四川省青年科技创新研究团队-中药毒性生物评价研究;负责人:鄢良春;四川省科技厅重大科技成果转化项目(2012SC0015):中药大品种参附注射液技术成果转化;负责人:郝莉;国家自然科学基金委面上项目(81470180):基于Microtox技术的中药毒性分级原理与标准研究;负责人:赵军宁

摘　　要：目的:探索Microtox技术应用于独家品种-参附注射液综合毒性检测。方法:以费氏弧菌为测试菌种,通过方法学考察确定最优检测体系及方法学可靠性;在最优检测体系条件下,首次以费氏弧菌对某药厂独家品种参附注射液进行发光菌综合毒性检测。结果:2 mL反应体系下,最优复苏液体积0.9 mL/支菌,每个待测样品加入最优菌液体积50μL,最优检测时间为10 min,pH为5-10,且10 min发光强度80-120万;重复性试验、中间精密度试验的RSD,均符合测定要求。9批次待测参附注射液EC50值无显著性差异(41.07%,RSD<5%)。结论:参附注射液对费氏弧菌的毒性存在显著的浓度-效应关系,且不同批次之间成品EC50值无显著性差异,说明参附注射液不同批次之间质量波动性较小,生产工艺控制力较强。In this research, Microtox technology was used to evaluate the comprehensive toxicity of Shen-Fu injection, which was an exclusive product of the pharmaceutical company. Firstly, vibrio fischeri was used as test strain. The best test system and methodology were identified. Under the best test conditions, vibrio fischeri was firstly used in the luminescent bacteria comprehensive toxicity of the exclusive product Shen-Fu injection. The results showed that in the 2 mL reaction system, the best recovery liquid volume was 0.9 mL/ freeze-dried vial, 50 p,L bacterial suspensions/ sample, the detection time was 10 min after adding bacterial suspensions, the pH was 5-10, the luminous intensity was 800 000- 12 000 000 for 10 min. The RSD of replication experiment and intermediate precision test was ？ and ？, respectively, which fitted to the requirements. There was no significant difference on EC50 values among 9 batches of tested Shen-Fu injection （41.07%, RSD 〈 5% ）. It was concluded that there was significant concentration-effect relationship between Shen-Fu injection and the toxicity of vibrio fischeri. There was no significant difference on EC50 values among different batches. It indicated that there was small quality volatility among different batches of Shen-Fu injection. The control on product manufacturing was strong.

关 键 词：Microtox技术 发光细菌 参附注射液 综合毒性 

分 类 号：R285[医药卫生—中药学]