Identification of Critical Quality Attributes and Ranges of Particle Affecting Tensile Strength of Sanye Tablets Based on Quality by Design

ZHOU Hao; WANG Ya-jing; TIAN Qian-yu; ZHANG Zhe; SHI Hui-shu; WANG Ya-nan; LI Jin-ling

doi:10.13422/j.cnki.syfjx.2018020009

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Identification of Critical Quality Attributes and Ranges of Particle Affecting Tensile Strength of Sanye Tablets Based on Quality by Design

更新时间：2024-01-04

- Identification of Critical Quality Attributes and Ranges of Particle Affecting Tensile Strength of Sanye Tablets Based on Quality by Design
- Chinese Journal of Experimental Traditional Medical Formulae Vol. 24, Issue 2, Pages: 9-13(2018)
- 作者机构：
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- DOI：10.13422/j.cnki.syfjx.2018020009
  CLC： R283.6
- Published：2018
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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：

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.

摘要

目的：以改变流化床工艺条件制备的9批三叶片颗粒为研究对象，抗张强度为产品主要质量属性，辨识颗粒粉体学性质中影响抗张强度的关键质量属性（CQA），并确立设计空间（design space，DS）。方法：采用正交试验制备不同性质的三叶片颗粒，测定颗粒的粉体学性质。采用正交偏最小二乘法（OPLS）建立颗粒粉体学性质与抗张强度间关系模型。根据OPLS提取综合变量的特性，找出对抗张强度解释作用最强的自变量，再绘制抗张强度与自变量的等高线图，求得设计空间。结果：确定关键质量属性为中值粒径（D50）和颗粒孔隙率（ε）。建立D50，ε与抗张强度间的关系模型，在抗张强度范围固定的情况下，找到合适的设计空间，75.7% < ε < 78.2%，0.390 mm < D50 < 0.582 mm。结论：建立的OPLS可明确各因素对抗张强度的影响程度大小，拟合效果良好。设计空间范围明确，可为确立三叶片流化床制粒的工艺参数提供实验依据。

Abstract

Objective:Nine batches of Sanye particles

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.

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Related Institution

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