高效凝胶渗透色谱法测定邻苯二甲酸羟丙甲基纤维素酯的相对分子质量及其分布___

目的：建立一种邻苯二甲酸羟丙甲基纤维素酯的相对分子质量的质控方法。方法：采用高效凝胶渗透色谱法（HPGPC）,色谱柱为Styrage Waters-HR4（7.8 mm×300 mm），以已知分子量的聚苯乙烯为标样，四氢呋喃为流动相 柱温40 ℃ 流速1.0 mL•min-1 示差折光检测器。结果：利用GPC软件处理得到邻苯二甲酸羟丙甲基纤维素酯的重均分子量，分子量分布和分布系数。结论：本文所建立HPGPC方法简便快速，重复性好(RSD<2%)，适合于该类药物的质量控制。

Objective:To set up a method for the determination of related molecular mass and molecular weight distribution for the quality control of hypromellose phthalate.Methods:The average molecular weight (Mw)and molecular weight distribution of hypromellose phthalate were determined by high performance gel permeation chromatography (HPGPC)on StyrageWaters-HR4（7.8 mm×300 mm）column with tetrahydrofuran as mobile phase using polystyrol with known molecular weight as calibration standars.The flow rate was 1.0 mL•min-1.The column temperature was 40 ℃ and RI detector was used.Results:The Mw and molecular weight distribution were obtained by GPC software from the calibration curves which were made by standard polystyrol.Conclusion:The method is simple and quick with good reproducibility (RSD<2%)and suitable for the control of the medicine.

1LUO Ming-sheng(罗明生)，GAO Tian-hui（高天惠）.Pharmaceutical Excipients Daquan(药剂辅料大全).Chengdu(成都):Sichuan Publishing House of Sciense and Technology (四川科学技术出版社)，2006.835
2SHAO Zi-qiang(邵自强),XU Ya-qing(徐雅青).Preparation and properties determination of hydroxypropyl methylcellulose phthalate.(羟丙基甲基纤维素酞酸酯的制备与性能测定).West China J Pharm(华西药学杂志),2008,23(2):183
3Miyuki Fukasawa,Sakae′Obara.Molecular weight determination of hypromellose phthalate(HPMCP)using size exclusion chromatography with a multi-angle laser light scattering detector.J Chim Pharm Bull,2003,51(11):1304
4ChP（中国药典）.2005.Vol Ⅱ(二部):Appendix(附录)35
5WANG Zhen-guo(王振国)，WANG Zhong(王忠)，AN Jing-hua(安景华)，et al. The study of coating materials of celluloses used by drugs (纤维素类药用薄膜包衣材料研究).J New Chem Mater (化工新型材料)，1994，1：34