| 引用本文: | 刘广桢,沈永,彭健,杨蕙如,凌霄,孙会敏,赵寅恒.低分子量羟丙甲纤维素的分子量及其分布的测定[J].中国现代应用药学,2020,37(5):569-571. |
| LIU Guangzhen,SHEN Yong,PENG Jian,YANG Huiru,LING Xiao,SUN Huimin,ZHAO Yinheng.Determination of the Molecular Weight and Its Distribution of Low Molecular Weight Hypromellose[J].Chin J Mod Appl Pharm(中国现代应用药学),2020,37(5):569-571. |
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| 低分子量羟丙甲纤维素的分子量及其分布的测定 |
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刘广桢1, 沈永2, 彭健2, 杨蕙如1, 凌霄1, 孙会敏3, 赵寅恒4
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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
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| 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0.1 mol·L-1硝酸钠-甲醇（95：5）为流动相，采用Shodex OHpak SB-804 HQ（8.0 mm×300 mm）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。 |
| 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 |
| DOI：10.13748/j.cnki.issn1007-7693.2020.05.010 |
| 分类号:R917 |
| 基金项目:“重大新药创制”国家科技重大专项（2017ZX09101001） |
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| Determination of the Molecular Weight and Its Distribution of Low Molecular Weight Hypromellose |
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LIU Guangzhen1, SHEN Yong2, PENG Jian2, YANG Huiru1, LING Xiao1, SUN Huimin3, ZHAO Yinheng4
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1.Shandong Institute for Food and Drug Control, Jinan 250101, China;2.Shandong Quality Inspection Center for Medical Device, Jinan 250101, China;3.National Institute for Food and Drug Control, Beijing 102629, China;4.America Wyatt Co., Ltd., Beijing 100082, China
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| Abstract: |
| 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-804HQ(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． |
| Key words: low molecular weight hypromellose HPSEC MALLS molecular weight molecular weight distribution |
