ZHOU Hao, WANG Ya-jing, TIAN Qian-yu, et al. Identification of Critical Quality Attributes and Ranges of Particle Affecting Tensile Strength of Sanye Tablets Based on Quality by Design[J]. Chinese journal of experimental traditional medical formulae, 2018, 24(2): 9-13.
ZHOU Hao, WANG Ya-jing, TIAN Qian-yu, et al. Identification of Critical Quality Attributes and Ranges of Particle Affecting Tensile Strength of Sanye Tablets Based on Quality by Design[J]. Chinese journal of experimental traditional medical formulae, 2018, 24(2): 9-13. DOI: 10.13422/j.cnki.syfjx.2018020009.
which prepared by changing fluidized bed process conditions
were taken as the research objects
and tensile strength is the main quality attribute of products to identify critical quality attributes and establish the design space(DS). Method:Orthogonal test was carried out to prepare different kinds of Sanye particles and their powder properties of the particles were determined.Orthogonal partial least square(OPLS) was used to establish the relational model between the powder properties and tensile strength.According to the characteristics of comprehensive variables extracted by OPLS
then independent variables were to find out
which had the strongest explanatory effect on the tensile strength
then we drew contour maps between independent variables and tensile strength to find the DS. Result:The median particle size(D50) and the porosity(ε) were identified as critical quality attributes.Relational models between D50 and ε with tensile strength were established
in the case of tensile strength range being fixed
the appropriate DS was found as 75.7% < ε < 78.2%
0.390 mm < D50 < 0.582 mm. Conclusion:The established OPLS can determine the influence of various factors on tensile strength
and the fitting effect is good.The established DS is clear
which can provide basis for establishing the technological parameters of fluidized bed granulation.