医院制剂复方甘草口服溶液质量回顾分析  

Process quality review analysis in hospital preparation compound glycyrrhiza oral solution

作　　者：柯月娇 张勇 蔡斌 宋洪涛 张晶 KE Yuejiao;ZHANG Yong;CAI Bin;SONG Hongtao;ZHANG Jing(Pharmacy Department,900 Hospital of the Joint Logistics Team,Fuzhou,Fujian 350025,China)

机构地区：[1]中国人民解放军联勤保障部队第九〇〇医院药剂科,福建福州350025

出　　处：《安徽医药》2022年第1期205-208,共4页Anhui Medical and Pharmaceutical Journal

摘　　要：目的对医院制剂复方甘草口服溶液进行质量回顾分析,及时发现并纠正生产过程的不良趋势,保证制剂质量。方法采用单值-移动极差控制图法和风险级别判断矩阵对中国人民解放军联勤保障部队第九〇〇医院近五年生产的复方甘草口服溶液质量进行分析。结果2014年6月至2019年6月,该院生产的30批次复方甘草口服溶液质量符合法定标准,控制图显示该品种生产工艺较稳定,针对复方甘草口服溶液中愈创木酚甘油醚含量波动较大的问题进行风险分析并采取了有效措施控制风险。结论控制图分析结合风险管理,更有利于我院持续、稳定地生产出质量优异的复方甘草口服溶液。Objective To retrospectively analyze the quality of Compound Glycyrrhiza Oral Solution of hospital preparation,find and correct the bad trend in production process to ensure the quality of preparation.Methods Using a I-MR control char and risk level classification matrix method,the quality of Compound Glycyrrhiza Oral Solution produced in the 900 Hospital of the Joint Logistics Team in recent five years was analyzed.Results From June 2014 to June 2019,a total of 30 batch of Compound Glycyrrhiza Oral Solution manufactured by our hospital met the statutory standards.The control chart showed that the preparation process was basically stable.Risk analysis was carried out to solve the problem of large fluctuation of guaifenesin content in the Compound Glycyrrhiza Oral Solution,and effective measures were taken to control the risk.Conclusion The combination of control chart analysis and risk management is more conducive to the continuous and stable production of Compound Glycyrrhiza Oral Solution with excellent quality in our hospital.

关 键 词：中草药 质量控制 复方甘草口服溶液 危害分析和关键控制点 控制图 风险管理 

分 类 号：R286.0[医药卫生—中药学]