低分子量羟丙甲纤维素的分子量及其分布的测定  

Determination of the Molecular Weight and Its Distribution of Low Molecular Weight Hypromellose

作　　者：刘广桢 沈永[2] 彭健 杨蕙如 凌霄 孙会敏[3] 赵寅恒 LIU Guangzhen;SHEN Yong;PENG Jian;YANG Huiru;LING Xiao;SUN Huimin;ZHAO Yinheng(Shandong Institute for Food and Drug Control,Jinan 250101,China;Shandong Quality Inspection Center for Medical Device,Jinan 250101,China;National Institute for Food and Drug Control,Beijing 102629,China;America Wyatt Co.,Ltd.,Beijing 100082,China)

机构地区：[1]山东省食品药品检验研究院,济南250101 [2]山东省医疗器械产品质量检验中心,济南250101 [3]中国食品药品检定研究院,北京102629 [4]美国怀雅特技术公司,北京100082

出　　处：《中国现代应用药学》2020年第5期569-571,共3页Chinese Journal of Modern Applied Pharmacy

基　　金：“重大新药创制”国家科技重大专项(2017ZX09101001)。

摘　　要：目的测定低分子量羟丙甲纤维素的分子量及其分布。方法利用高效体积排阻色谱-示差折光检测器-多角激光光散射检测器(HPSEC-RID-MALLS)技术,以0.1mol·L-1硝酸钠-甲醇(95∶5)为流动相,采用Shodex OHpak SB-804 HQ(8.0 mm×300mm)凝胶柱进行检测。结果低分子量羟丙甲纤维素的重均分子量测定误差≤2%,数均分子量和分子量分布误差均≤5%,结果准确可靠。结论利用HPSEC-RID-MALLS技术可测定低分子量羟丙甲纤维素的分子量及其分布。OBJECTIVE To determine the molecular weight and its distribution of low molecular weight hypromellose. METHODS High performance size exclusion chromatograghy in conjunction with refractive index detector and eighteen-angle laser light scatter detector(HPSEC-RID-MALLS), was performed on the Shodex OHpak SB-804 HQ(8.0 mm×300 mm) column, using 0.1 mol·L-1 sodium nitrate-methanol(95∶5) as mobile phase. RESULTS The error of the weight-average molecular weight of low molecular weight hypromellose was ≤2%, and the error of number-average molecular weight and molecular weight distribution of low molecular weight hypromellose were ≤5%. The results were accurate and reliable. CONCLUSION It can be used to determine the molecular weight and its distribution of low molecular weight hypromellose by HPSEC-RID-MALLS.

关 键 词：低分子量羟丙甲纤维素 高效凝胶色谱法 多角度激光光散射 分子量 分子量分布 

分 类 号：R917[医药卫生—药物分析学]