基于质量源于设计理念优化布洛芬双释双层片的处方工艺  

Study of Ibuprofen Biphase-release Bilayer Tablets Based on Quality by Design(QbD)Theory

作　　者：房辰晨 孙敬蒙 卢美彤 张炜煜[1] FANG Chenchen;SUN Jingmeng;LU Meitong;ZHANG Weiyu(School of Pharmaceutical,Changchun University of Chinese Medicine,Changchun 130117,China;Department of Pharmacy, the First Hospital of Jilin University,Changchun 130021,China)

机构地区：[1]长春中医药大学药学院,长春130117 [2]吉林大学白求恩第一医院药学部,长春130021

出　　处：《医药导报》2021年第9期1237-1242,共6页Herald of Medicine

基　　金：吉林省教育科学“十三五”规划项目(GH19135)。

摘　　要：目的基于质量源于设计(QbD)的理念与方法,优化布洛芬双释双层片的处方及工艺参数。方法在风险评估的基础上结合单因素考察结果和鱼骨分析法确定关键工艺参数,采用Plackett-Burman设计筛选出显著影响因素,然后再采用Box-Behnken设计优化关键工艺参数,建立设计空间,并加入95%置信区间使设计空间更加稳定可靠,对其进行验证。结果通过筛选和优化关键工艺参数,确定设计空间为崩解剂用量6%~7%,缓释材料用量15%~18%,致孔剂用量5.5%~6.5%。结论设计空间的建立降低了生产过程中的风险,使布洛芬双释双层片的制备工艺简单稳定可行,适合大工业生产。Objective To optimize the formulation and process parameters of ibuprofen double-release bilayer tablets based on the concept and method of quality derived design(QbD).Methods The critical process parameter(CPP)was determined based on the risk assessment and fishbone analysis.The Plackett-Burman design(PBD)was used to screen out significant influencing factors,and then Box-Behnken design(BBD)was used to optimize CPPs.The design space was established and 95%confidence interval was added,which make the design space more stable and reliable.And then the design was verified.Results By screening and optimizing CPPs,the design space was determined to be 6%-7%disintegrating agent,15%-18%sustained-release material,and 5.5%-6.5%pore-making agent.Conclusion The establishment of design space reduces the risk in the production process,and makes the preparation process of ibuprofen double-release double-layer tablets simple,stable and feasible.It is suitable for large industrial production.

关 键 词：布洛芬 质量源于设计 双层片 双相释放 PLACKETT-BURMAN设计 BOX-BEHNKEN设计 

分 类 号：R971.1[医药卫生—药品] R944.4[医药卫生—药学]