羟丙甲纤维素的来源差异对其性质及功能性的影响  

Effect of Different Sources on Properties and Functions of HPMC

作　　者：宫艳畅 杨白雪 孙瑞濛 孙会敏[2] 李三鸣[1] GONG Yanchang;YANG Baixue;SUN Ruimeng;SUN Huimin;LI Sanming(Shenyang Pharmaceutical University,Shenyang 110016;China Institute of Food and Drug Control,Beijing 100050)

机构地区：[1]沈阳药科大学,辽宁沈阳110016 [2]中国食品药品检定研究院,北京100050

出　　处：《中国医药工业杂志》2020年第9期1178-1183,1188,共7页Chinese Journal of Pharmaceuticals

基　　金：国家“重大新药创制”科技重大专项(2017ZX0901001-006-012)。

摘　　要：分别测定了不同来源羟丙甲纤维素(HPMC)的粒径及粒度分布、润湿性、流动性和压缩性,并采用热重分析和差示扫描量热法进行表征。进一步将不同来源的HPMC制成空白骨架片,通过称重法比较了片剂吸水膨胀以及溶蚀等性质的异同。结果表明,不同来源HPMC的粒度分布、润湿性、流动性和压缩性,及用其制备的骨架片的吸水速率常数、膨胀指数、溶蚀速率常数等均存在差异。同一黏度规格、不同来源的HPMC的性质差异较大,对后续制得片剂的溶蚀及膨胀等性质均有影响。因此,考察不同来源HPMC的性质差异对药物制剂质量的影响甚至对仿制药的研发有重要意义。The particle size and size distribution,wettability,flowability and compressibility of different sources of hydroxypropyl methyl cellulose(HPMC) were measured,and thermogravimetric analysis and differential scanning calorimetry were also conducted.Further,blank matrix tablets were prepared with HPMC from different sources,and their differences in the properties of water absorption,swelling and erosion were compared by weighing method.The results showed that there were certain differences in particle size and size distribution,wettability,flowability and compressibility among the HPMC products from different sources.Correspondingly,the water absorption rate constant,expansion index and erosion rate constant of their matrix tablets were different.The properties of HPMC with same viscosity but different sources were quite different,which subsequently affected the erosion and swelling properties of the matrix tablets.Therefore,it is of great significance to investigate the impact of the differences in the properties of HPMC from different sources on the quality of pharmaceutical preparations and even the development of generic drugs.

关 键 词：羟丙甲纤维素 粒径 流动性 压缩性 吸水性 溶蚀性 膨胀性 

分 类 号：R944.4[医药卫生—药剂学]