The correlation between material attributes of hydroxypropyl methylcellulose type 2208 and skeleton performance
10.19778/j.chp.2025.02.009
- VernacularTitle:2208型羟丙甲纤维素物料属性与骨架性能相关性研究
- Author:
Naicong CAI
1
;
Bobo LIU
;
Hongyan LI
;
Zhengyu LIU
;
Yong BI
;
Jiasheng TU
;
Chunmeng SUN
Author Information
1. 中国药科大学药学院药用辅料及仿创药物研发评价中心,南京 210009;国家药品监督管理局药物制剂及辅料研究与评价重点实验室,南京 210009
- Publication Type:Journal Article
- Keywords:
2208 hydroxypropyl methylcellulose;
material properties;
skeleton performance;
principal component analysis;
orthogonal partial least-squares discrimination analysis
- From:
Drug Standards of China
2025;26(2):167-178
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To establish a method for evaluating the material attributes and skeletal performance of 2208 hydroxypropyl methylcellulose(HPMC),to clarify the influence of different material attributes on the skeletal per-formance of HPMC,to compare the differences between the products of different manufacturers,and to analyze the factors affecting the process.Methods:In this study,the material attributes such as powder chemical properties,viscosity,gelation temperature,thermodynamic properties,weight-average molecular weight,methoxy and hydroxypropoxy contents of different manufacturers were firstly investigated.Then,the water absorption,swelling,and dissolution properties of HPMC blank skeleton tablets were determined using the weighing method.Finally,Principal Component Analysis(PCA)and Orthogonal Partial Least-Squares Discrimination Analysis(OPLS-DA)were used to systematically evaluate the material attributes and skeleton performance of HPMC.The systematic evaluation of each material attribute and skeleton performance of HPMC was carried out to elucidate the intrinsic relationship between each material attribute and skeleton performance of HPMC.Results:The results showed that there were obvious differences in the material attributes of HPMC from different manufacturers,such as the proper-ties of powder,viscosity,and weight-average molecular weight,and that there were differences in the corrosion performance,water absorption,and swelling performance of the skeleton tablets prepared from different manufactur-ers,with the most obvious differences between K4Mand K100M.The results of the PCA and OPLS-DA analyses indicated that these 19 variables showed some correlation with each other.Both mathematical models showed better differentiation and classification effects on HPMC samples,and the OPLS-DA model had better classification effects than the PCA model.Conclusion:Based on the PCA and OPLS-DA models,this study conducted systematical research on HPMC,clarified the degree of influence of different material attributes on the skeletal performance of HPMC,and suggested the addition of HPMC particle size and size distribution,and weight-average molecular weight as the quality standards,which provide a basis for the quality control of the related excipients,the screening of formulation prescriptions,and the improvement of performance.
