国产羟丙基纤维素 L-11批间重现性及其在一致性评价中的意义  

Reproducibility of domestic HPC L-11 with different batches and its significance to consistency evaluation

作　　者：刘威 李三鸣[1] 杨白雪[1] 孙微 吴路路 金丹妮 杨馥骏 LIU Wei;LI Sanming;YANG Baixue;SUN Wei;WU Lulu;JIN Danni;YANG Fujun(School of Pharmacy,Shenyang Pharmaceutical University,Shenyang 110016,China)

机构地区：[1]沈阳药科大学药学院,辽宁沈阳110016

出　　处：《沈阳药科大学学报》2020年第9期778-781,788,共5页Journal of Shenyang Pharmaceutical University

基　　金：国家自然科学基金资助项目(81473161);国家科技重大专项-重大新药创制“药物一致性评价关键技术与标准研究”课题(2017ZX09101001-006-012)。

摘　　要：目的对比某国内企业生产的三批羟丙基纤维素L-11(hydroxypropyl cellulose L-11,HPC L-11)表面形貌、粉体学性质和部分功能性指标,分析和研究辅料HPC L-11的批间重现性及其可能对制剂性质的影响。方法采用扫描电子显微镜、差示扫描量热法、热重分析法、比表面积法、静态液滴法等测定HPC L-11的表面形貌、粉体学性质等。结果在各研究项目中三批次辅料的结果是一致的。结论提示国产辅料的质量及批间重现性有所提升。该研究方法及结果对辅料和制剂生产工艺及质量平行稳定有重要意义,对制剂性质、质量和疗效的一致性评价工作具有参考价值。Objective To compare the surface morphology,micromeritic properties and some functionality-related characteristics of domestic HPC L-11 with three batches and then analyze their probable effects on the pharmacy characters.Methods Scanning electron microscope,differential scanning calorimetry,specific surface area measurement,and contact angle measurement and so on.Results All the results showed similar respectively among these batches.Conclusion The results implied the quality and reproducibility promotion of domestic excipients.On one hand,the methods and results obtained in the study were beneficial to the improvement of stability of excipients and the production process of preparations.On the hand,it provided useful values for the consistency evaluation of quality,property and therapeutic effect of preparations.

关 键 词：药用辅料 批间重现性 粉体性质 辅料功能性 一致性评价 

分 类 号：R94[医药卫生—药剂学]