摘要
目的对复方间苯二酚洗剂处方、配制、检验、使用环节存在的风险进行分析并提出控制办法,为洗剂的风险控制及质量标准的修正提供参考。方法依据中国知网(CNKI)收录的文献,分析指出《中国医院制剂规范》中复方间苯二酚洗剂存在的风险之处。结果复方间苯二酚洗剂存在处方中有毒物质含量过高、配制过程中可通过皮肤和呼吸道吸收、检验时没有对毒性物质的浓度严格控制、使用时间较长可累积的安全风险。结论复方间苯二酚洗剂应做风险评估,质量标准应完善和提高。
Objective To provide the reference for amending the risk control and quality standards of lotion by analyzing the risk of compound resorcinol lotion, including prescription, preparation, test and use. Methods Based on searching literatures from CNKI, the analysis showed that compound resorcinol lotion in China Hospital Preparations Specifcations carried risk. Results The compound resorcinol lotion formula has excessive amounts of toxic substance. During its preparation, toxic substance can be absorbed by skin and respiratory tract. Toxic substance concentration can not be strictly controlled when testing compound resorcinol lotion. The risk can be added up when using this lotion for a long time. Conclusion It is necessary to evaluate the risk of compound resorcinol lotion and improve its quality standards.
出处
《中国药物警戒》
2016年第12期733-736,共4页
Chinese Journal of Pharmacovigilance
关键词
苯酚
间苯二酚
风险
再评价
复方间苯二酚洗剂
phenol
m-dihydroxybenzene
risk
revaluation
compound resorcinol lotion
作者简介
王莉,女,本科,主管药师,医院制剂及医院药学
通讯作者：马佩杰,女,本科,副主任药师,医院制剂及医院药学.E-mail：ZXYYMPJ@163.com
