“质量源于设计”在阿法骨化醇软胶囊处方开发中的应用  

Application of“Quality by Design”in Formulation Development of Alfacalcidol Soft Capsules

作　　者：路婷婷 张鑫 杨昊 刘博铭 刘清梁 LU Tingting;ZHANG Xin;YANG Hao;LIU Boming;LIU Qingliang(China Resources Double-Crane Pharmaceutical Co.,Ltd.,Beijing 100111)

机构地区：[1]华润双鹤药业股份有限公司,北京100111

出　　处：《中国医药工业杂志》2023年第4期591-594,共4页Chinese Journal of Pharmaceuticals

摘　　要：应用“质量源于设计”理念,对影响阿法骨化醇软胶囊崩解时间的处方因素进行初始风险评估,确定了具有潜在影响的高风险处方变量,即明胶型号,明胶、甘油、水的比例以及遮光剂二氧化钛用量。以市售阿法骨化醇软胶囊为对照制剂,对这些处方变量进行单因素试验。所得优化软胶囊采用型号为180LB8的明胶,明胶、甘油和水的质量比为1∶0.30∶1,每粒软胶囊胶皮中含二氧化钛2.5 mg。该自制软胶囊在加速条件下放置1个月,崩解时间未见明显变化,且与对照制剂接近。Applying the concept of“quality by design”,an initial risk assessment of various formulation variables of alfacalcidol soft capsules affecting disintegration time was conducted.The potential high-risk variables,including gelatin type,the mass ratio of gelatin to glycerol to water,and the amount of titanium dioxide used as opacifier,were obtained from the risk analysis.Single factor tests were carried out to optimize these variables with commercially available alfacalcidol soft capsules as the control.The optimal soft capsules were prepared with gelatin(180LB8)in a 1∶0.30∶1 mass ratio of gelatin to glycerol to water,and each soft capsule shell contained 2.5 mg of titanium dioxide.The disintegration time of the self-made soft capsules stored under accelerated conditions for 1 month did not significantly change,which was close to the control soft capsules stored at the same condition.

关 键 词：阿法骨化醇 软胶囊 质量源于设计 风险评估 崩解时间 

分 类 号：R944.5[医药卫生—药剂学]