“齐二药”亮菌甲素注射液毒性物质筛查研究  

Screening of Toxic Substance from Armillarisin A Injection in "Qieryao" Adverse Drug Events

作　　者：李瑾翡[1] 梁祈[1] 黎旸[1] 

机构地区：[1]广东省药品检验所,广州市510180

出　　处：《中国药房》2011年第5期437-439,共3页China Pharmacy

基　　金：广东省科技厅2008年资助项目(2008A060202003)

摘　　要：目的:对"齐二药"事件中亮菌甲素注射液进行毒性物质筛查研究,寻找发生原因及建立相关的应急检验方法。方法:对"齐二药"与大理药业有限公司生产的亮菌甲素注射液进行小鼠急性毒性试验(半数致死量LD50)比较;对亮菌甲素注射液中辅料聚乙二醇400进行小鼠急性毒性实验,筛查正常的辅料是否含有毒性物质;用气相色谱法测定2个厂家产品中二甘醇的含量,并用气-质联用色谱法对"齐二药"亮菌甲素注射液中二甘醇进行成分确证。结果:2个厂家的亮菌甲素注射液LD50分别为17.72、21.06mL·kg-1,二甘醇含量分别为293mg·mL-1、未检出;聚乙二醇400小鼠组均存活,并表现正常;气-质联用色谱法证实"齐二药"亮菌甲素注射液中含有二甘醇。结论:确认"齐二药"亮菌甲素注射液毒性增大是由二甘醇引起的;利用动物实验对毒性物质进行筛查可用于药品质量的应急检验。OBJECTIVE： To detect the toxic substance from Armillarisin A injection in ＂Qieryao＂ adverse drug events, and to find out the cause and establish emergency laboratory method. METHODS： Mice acute toxicity test was conducted to compare the toxicity （LD50） between Armillarisin A injection produced by Qiqihar Second Pharmaceutical Company and Dali Pharmaceutical Limited Company. The toxicity of PEG400 in Armillarisin A injection was determined to confirm whether general excipients contained toxic substance. The contents of diethylene-glycol in Armillarisin A injection from 2 companies were determined by GC; the diethylene-glycol component of Armillarisin A injection produced by Qiqihar Second Pharmaceutical Company was confirmed by GC-MS spectrometry. RESULTS： The LD50 of Armillarisin A injection from 2 companies were 17.72 mL·kg-1 and 21.06 mL·kg-1; the content of diethylene-glycol was 293 mg·mL-1 in Armillarisin A injection produced by Qiqihar Second Pharmaceutical Company while hadn’t been detected in the other one. Mice used PEG400 survived and grew normally. GC-MS spectrometry confirmed that Armillarisin A injection produced by Qiqihar Second Pharmaceutical Company contained diethylene-glycol. CONCLUSION： It has been confirmed that the increasing toxicity of Armillarisin A injection produced by Qiqihar second pharmaceutical company is induced by diethylene-glycol. The screening of toxic substance by animal experiment can be used for emergency laboratory method.

关 键 词：“齐二药”事件 亮菌甲素注射液 毒性物质 二甘醇 应急检验 

分 类 号：R927.1[医药卫生—药学] R975.5