摘要
目的:基于"质量源于设计"(QbD)理念设计并优化对乙酰氨基酚双释双层片(简称为"双层片")的制备工艺。方法:采用Plackett-Burman考察法确定双层片制备工艺的关键工艺参数(CPPs);采用Box-Behnken响应面设计,以缓释层的释放度、速释层的溶出度作为关键质量属性(CQAs),优化双层片的最佳处方、工艺参数;在二次多项式回归模型的基础上建立双层片工艺设计空间,并加以验证。结果:对乙酰氨基酚双层片最佳工艺为:崩解剂量所占比例为9.5%,制粒目数为22目,缓材比例为5∶1;设计空间以Overlay plot方式展示,并加入95%置信区间,设计空间工艺稳定可靠。结论:所制定的工艺对乙酰氨基酚双释双层片制备工艺简单,制剂稳定,适合大工业生产。
OBJECTIVE To design and optimize the preparation process of paracetamol bilayer tablets(abbreviated as"bilayer tablets") based on the concept of "quality by design"(QbD) METHODS Plackett-Burman method was used to determine the key process parameters(CPPs) of bilayer tablet preparation process;Box-Behnken response surface design was used to optimize the optimal formulation and process parameters of bilayer tablets using the release rate of sustained-release layer and the dissolution rate of immediate-release layer as the key quality attributes(CQAs);the process design space of bilayer tablets was established and validated on the basis of quadratic polynomial regression model RESULTS The optimum process of paracetamol bilayer tablets was as follows:the proportion of disintegration dose was 9.5%,the number of granulation items was 22,and the proportion of buffer materials was 5∶1;the design space was displayed in Overlayplot mode,and 95% confidence interval was added,and the design space process was stable and reliable.CONCLUSION Paracetamol double-release bilayer tablets have simple preparation process with stable characterization and are suitable for large-scale industrial production.
作者
卢美彤
孙敬蒙
房辰晨
张炜煜
LU Mei-tong;SUN Jing-meng;FANG Chen-chen;ZHANG Wei-yu(College of Pharmacy,Changchun University of Traditional Chinese Medicine,Jilin Changchun 130117,China;Department of Pharmacy,Bethune First Hospital,Jilin University,Changchun 130021,China)
出处
《中国医院药学杂志》
CAS
北大核心
2020年第24期2535-2539,共5页
Chinese Journal of Hospital Pharmacy
基金
吉林省教育科学“十三五”规划项目(编号:GH19135)。
关键词
对乙酰氨基酚
双层片
质量源于设计
制备工艺
优化
paracetamol
bilayer tablet
quality by design
preparation process
optimization
