甲基纤维素粒度与粒度分布测定法研究

目的：建立甲基纤维素粒度与粒度分布测定方法。方法：使用马尔文2000激光粒度分析仪，干法测定甲基纤维素的粒度与粒度分布。光学参数为蓝光折射率1.336，遮光度范围1.5%~4.5%。结果：3个厂家的10批样品粒径分布特征值d_0.1在23.161~37.371 μm范围，d_0.5在66.709~111.511 μm范围，d_0.9在197.314~236.666 μm范围，平均残差在0.161%~0.366%之间。结论：本方法适用于甲基纤维素粒度与粒度分布测定。

Objective:To establish a method for determination of the particle size distribution of methylcellulose.Methods:The Malvern 2000 laser size analyzer was used to test particle size distribution of methylcellulose by the dry measurement. The condition of determination was as follows:the refractive index of the optical parameters of the blue light was 1.336;laser obscuration was 1.5%-4.5%. Results:The d_0.1 range of 10 batches of methylcellulose from 3 manufacturers was 23.161-37.371 μm, the d_0.5 range was 66.709-111.511 μm and the d_0.9 range was 197.314-236.666 μm. The mean residual was between 0.161%-0.366%. Conclusion:The method is suitable for the particle size control of methylcellulose.

[1] 罗RC,舍斯基PJ,韦乐PJ.药用辅料手册[M].第四版.郑俊民译.北京:化学工业出版社,2005:446 ROWE RC,SHESKEY PJ,WEILE PJ.Handbook of Pharmaceutical Excipients[M].4th Ed.Translated by ZHENG JM.Beijing:Chemical Industry Press,2005:446
[2] 陈燕平,王林波,邵泓,等.甲基纤维素动力黏度测定方法的研究[J].中国药学杂志,2013,48(5):385 CHEN YP,WANG LB,SHAO H,et al.Determination method of dynamic viscosity of methylcellulose[J].Chin Pharm J,2013,48(5):385
[3] 章斌,姚永秀.口腔崩解膜研究进展[J].中南药学,2015,13(7):749 ZHANG B,YAO YX.Research progress of orally disintegrating films[J].Cent South Pharm,2015,13(7):749
[4] 郭玲玲,沙娜,樊冬丽.盐酸文拉法辛缓释片的制备[J].上海师范大学学报(自然科学版),2013,42(4):368 GUO LL,SHA N,FAN DL.Preparation of venlafaxine hydrochloride sustained-release tablets[J].J Shanghai Norm Univ(Nat Sci),2013,42(4):368
[5] 中华人民共和国药典2015年版.四部[S].2015:500 ChP 2015.Vol Ⅳ[S].2015:500
[6] USP 40-NF 35[S].2016:5097
[7] BP 2017.Volume Ⅱ[S].2017:256
[8] 刘晓莉,马飞.硝苯地平原料药的粒度及粒度分布研究[J].广州化工,2016,44(7):99 LIU XL,MA F.Study on particle size and particle size distribution of nifedipine[J].Guangzhou Chem Ind,2016,44(7):99
[9] 狄天云,高原雨,朱捷,等.激光粒度仪测定醋酸肤轻松乳膏粒度的方法学研究[J].药物分析杂志,2016,36(1):181 DI TY,GAO YY,ZHU J,et al.Methodological study of particle size of fluocinonide cream by laser particle analyzer[J].Chin J Pharm Anal,2016,36(1):181
[10] 郑敏侠,辛芳,刘晓峰.Mastersizer 2000型激光粒度仪技术参数对粒度分布的影响[J].中国粉体技术,2013,19(1):76 ZHENG MX,XIN F,LIU XF.Influence of Mastersizer 2000 type laser particle analyzer technical parameters on particle size distribution[J].China Powder Sci Technol,2013,19(1):76
[11] 陈祝康,陈桂良,李慧义.药物及其制剂粒度测定法探讨[J].中国药品标准,2012,13(6):405 CHEN ZK,CHEN GL,LI HY.Discussion about particle size analysis for drug and pharmaceuticals[J].Drug Stand China,2012,13(6):405
[12] 王颖,韩鹏,张象麟.药用辅料标准和技术体系建设对我国辅料监管改革的重要作用[J].中国药师,2016,19(9):1726 WANG Y,HAN P,ZHANG XL.Important roles of pharmaceutical excipients standards and guidelines system construction in excipients regulatory reform in China[J].China Pharm,2016,19(9):1726
[13] 孙会敏,杨锐,张朝阳,等.2015年版《中国药典》提升药用辅料科学标准体系强化我国药品质量[J].中国药学杂志,2015,50(15):1353 SUN HM,YANG R,ZHANG ZY,et al.Improving the drug quality in China via the development of the standard system of pharmaceutical excipient of the 2015 Edition of Chinese Pharmacopeia[J].Chin Pharm J,2015,50(15):1353
[14] 冯巧巧,谢纪珍,孙利民,等.药用辅料行业发展现状分析与思考[J].中国药事,2018,32(1):54 FENG QQ,XIE JZ,SUN LM,et al.Analysis and thoughts on the current status of pharmaceutical excipient industry[J].Chin Pharm Aff,2018,32(1):54