根痛合剂和凉血消疕合剂中重金属与砷盐的限量检查  

Limited Inspection of Heavy Metals and Arsenic Salts in Gentong Mixture and Liangxue Xiaobi Mixture

作　　者：刘文波 刘新国[1] 程璐[1] 张耕[1] 

机构地区：[1]武汉市第一医院,武汉430022

出　　处：《中国药师》2018年第9期1670-1672,共3页China Pharmacist

基　　金：湖北省卫生和计划生育委员会科研项目(编号:WJ2017M180)

摘　　要：目的:对两种新医疗机构制剂中重金属与砷盐进行限量检查。方法:重金属采用纳氏比色法,砷盐采用古蔡氏法测定限量。结果:所测样品的重金属含量全部低于百万分之十,所测样品的砷盐含量全部低于百万分之二,说明这两种新研制的医疗机构制剂符合中国药典2015年版对于重金属及有害残留物限量制定指导原则的要求。结论:随着医疗机构制剂的加速发展,对中药制剂产品标准与安全性要求越来越高,必须对重金属与砷盐超标问题进行严格控制,逐步制定和完善其限量标准,确保临床上广大患者的用药安全。Objective： To examine the contents of heavy metals and arsenic salts in two new preparations of medical institution. Methods： The contents of heavy metals were determined by colorimetry, and those of arsenic slats were determined by ancient Chua＇ s method. Results： The contents of heavy metals in the samples were all lower than 10 parts per million, the contents of arsenic salts in the samples were all lower than 2 parts per million, and both were in line with the requirements of the limits of heavy metals and harmful residues described in Chinese Pharmacopoeia （2015 edition）. Conclusion： With the acceleration of medical preparations, more and more attention has been paid to the factors affecting product quality and safety. Heavy metals and excessive arsenic salts in traditional Chinese medicines should be strictly controlled, and their limited standards should be gradually formulated and improved in order to ensure the safety of the majority of patients in clinical use.

关 键 词：医疗机构制剂 重金属 砷盐 限量检查 

分 类 号：R927.11[医药卫生—药学]