摘要
目的对市售喘嗽宁片中重金属及有机氯类农药残留量进行分析,以期为喘嗽宁片用药安全评估提供参考。方法采用微波消解-电感耦合等离子体质谱法,测定样品中铅、镉、砷、汞、铜的含量。工作条件为射频功率1.2 kW,雾化流速0.9 L/min,蠕动泵吸液流速0.3 ml/min。采用气相色谱法测定样品中17种有机氯农药残,色谱条件为DB-1701毛细管柱(30 m×0.25 mm),63Ni-ECD电子捕获检测器,进样口温度:230℃,检测器温度:300℃,不分流进样,程序升温:初始100℃,每分钟10℃升至220℃,每分钟8℃升至250℃,保持10 min。结果三个厂家的样品五种重金属均有检出,且各个厂家间存在差异,变化范围为铅0.66~2.26 mg/kg、镉0.02~0.12 mg/kg、砷0.28~1.72 mg/kg、汞0.05~0.18 mg/kg、铜0.42~2.38 mg/kg,都在质控限度范围内,铅≤5 mg/kg、镉≤1 mg/kg、砷≤2 mg/kg、汞≤0.2 mg/kg、铜≤20 mg/kg;三个厂家样品中均未检出有机氯农药残留。结论本文建立的重金属及有害元素分析及17种有机氯农药残留量测定方法为喘嗽宁片的用药安全评估提供参考。
Objective To investigate the pollution of heavy metals and pesticides in Chuansouning Tablets,in order to provide reference for drug safety assessment of Chuansouning Tablets.Methods The plumbum,cadmium,arsenic,hydrargyrum and cuprum in the samples were determined by inductively coupled plasma-mass spectrometry.Residues of 17 organochlorine pesticides were determined by gas chromatography.The working conditions were RF power 1.2 kW,atomization flow rate 0.9 L/min,peristaltic pump suction flow rate 0.3 ml/min.The chromatographic conditions were DB-1701 capillary column(30 m×0.25 mm),63Ni-ECD electron capture detector,inlet temperature 230℃,63Ni-ECD detector temperature 300℃,splitless injection,temperature program:initial 100℃,10℃per minute to 220℃,8℃per minute to 250℃,hold for 10 minutes.Results All the five kinds of heavy metals were detected in the samples from three manufacturers,and there were differences among different manufacturers,the range of plumbum 0.66-2.26 mg/kg,cadmium 0.02-0.12 mg/kg,arsenic 0.28-1.72 mg/kg,hydrargyrum 0.05-0.18 mg/kg,cuprum 0.42-2.38 mg/kg,and within the limits of quality control,plumbum≤5 mg/kg,cadmium≤1 mg/kg,arsenic≤2 mg/kg,hydrargyrum≤0.2 mg/kg,cuprum≤20 mg/kg.Pesticide residues were not detected in the samples of the three manufacturers.Conclusion The established methods for the analysis of heavy metals and pesticides can provide reference for the safety assessment of Chuansouning Tablets.
作者
李岩
马晓静
LI Yan;MA Xiaojing(Pharmaceutical Factory,Jilin Provincial Brain Hospital,Jilin Province,Siping 136000,China;Chinese Medicine Room Siping City Institute for Food and Drug Control,Jilin Province,Siping 136000,China)
出处
《中国当代医药》
CAS
2023年第6期21-24,共4页
China Modern Medicine
关键词
喘嗽宁片
重金属
有机氯农药残留
Chuansouning Tablets
Heavy metals
Pesticide residues
