摘要
目的测定7个厂家布洛芬混悬液中防腐剂苯甲酸钠的含量,考察儿童服药时药用辅料的安全性问题,为安全用药提供参考。方法高效液相色谱法测定布洛芬混悬液中苯甲酸钠的含量,判断其是否超出FDA辅料数据库中苯甲酸钠使用限量;评价儿童按药品说明书规定用量服药时,药品中苯甲酸钠是否超出以WHO推荐的苯甲酸钠日最高摄入量(ADI)。结果7个厂家布洛芬混悬液中,苯甲酸钠含量(以苯甲酸计)为0.97~3.86 mg/ml,均未超出FDA辅料数据库中使用限量(7.58 mg/ml);按药品说明书最大用量用药,1~3岁、7~9岁、10~12岁儿童在服用药品E时,摄入的苯甲酸钠均超过WHO规定的ADI。结论应在《中国药典》混悬液通则项下,增加苯甲酸钠用量限值;在药品标准中增加苯甲酸钠的法定检验方法;在布洛芬混悬液药品标准中,设定防腐剂限量并增加防腐剂含量测定。
Objective To determine the content of preservative-sodium benzoate-in ibuprofen suspension from 7 factories,and to investigate the safety of pharmaceutical excipients in children′s medication,so as to provide reference for safe drug use.Methods The content of sodium benzoate in ibuprofen suspension was determined by high performance liquid chromatography to determine whether it exceeded the use limit of sodium benzoate in FDA auxiliary materials database;evaluate whether the sodium benzoate in the drug exceeded the maximum daily intake of sodium benzoate(ADI)recommended by WHO when children took the drug according to the dosage specified in the drug manual.Results The content of sodium benzoate(calculated by benzoic acid)in the suspension of ibuprofen from seven manufacturers was 0.97~3.86 mg/ml,which did not exceed the use limit(7.58 mg/ml)in the database of FDA excipients.According to the maximum dosage in the drug manual,the intake of sodium benzoate in drug E by children aged 1~3,7~9 and 10~12 exceeded the ADI specified.Conclusion The limit of sodium benzoate should be increased under the general principles of suspension in Pharmacopoeia of China;the legal test method of sodium benzoate should be added to the drug standard;the limit of preservative should be set and the content of preservative should be determined in the drug standard of ibuprofen suspension.
作者
张志超
韩慧丽
苏莎莎
ZHANG Zhi-chao;HAN Hui-li;SU Sha-sha(Luoyang Institute for Food and Drug Control,Luoyang 471000,China;The First Affiliated Hospital of Henan University of Science and Technology,Luoyang 471000,China;Luoyang Central Hospital Affiliated to Zhengzhou University,Luoyang 471000,China)
出处
《实用药物与临床》
CAS
2020年第9期842-844,共3页
Practical Pharmacy and Clinical Remedies
关键词
布洛芬混悬液
儿童用药
苯甲酸钠
药用辅料安全性
Ibuprofen suspension
Pediatric drug
Sodium benzoate
Safety of pharmaceutical excipients
