对乙基纤维素质量标准的探讨及修订意见  

Exploration and suggestion on monograph of ethylcellulose in Chinese Pharmacopoeia 2015

作　　者：石颖 章娟[1] SHI Ying;ZHANG Juan(Guangzhou Institute for Drug Control, Guangzhou 510160, China)

机构地区：[1]广州市药品检验所

出　　处：《中国药品标准》2019年第3期218-223,共6页Drug Standards of China

基　　金：2017年药品医疗器械审评审批制度改革专项课题药用辅料相关通用性技术要求研究——药用辅料品种制修订(乙基纤维素标准修订)课题编号:ZG2017-05-03

摘　　要：目的:针对《中国药典》2015年版乙基纤维素质量标准中黏度和含量测定项前处理方法的可完善之处,提出修订意见。方法:比较不同前处理方法下黏度测定和含量测定的结果,优化实验方案。结果:黏度项选择甲苯∶乙醇(4∶1,w/w)为溶剂及5%供试品质量浓度使黏度测定方法与国际接轨;含量测定项减少供试品取样量并明确加热温度为140℃可有效提高实验安全性和结果准确性。结论:本改进后的方法消除了国产乙基纤维素黏度测定结果与国际不接轨的现象;提高了含量测定方法操作的安全性,实验结果准确、可靠。为2020年版《中国药典》乙基纤维素质量标准修订提供了参考。Objective:To put forward some revision suggestions on pretreatment methods for viscosity and assay in monograph of ethylcellulose in Chinese Pharmacopoeia 2015. Methods:The test methods were optimized by comparison of the test results of viscosity and assay obtained with different pretreatment methods. Results:The mixture of toluene and ethanol (4 ∶ 1,w/w) as the solvent and 5% mass concentration of test sample were chosen to harmonize the viscosity method to global standard. The reduced sampling amount and the heat temperature set at 140℃can improve the test safety and accuracy of results effectively. Conclusion:The improved method removes the differences of labeling viscosity between domestic ethylcellulose and foreign products, and it also improves the operation safety and accuracy on assay. It provides a reference for revision of monograph of ethylcellulose in Chinese Pharmacopoeia 2020.

关 键 词：乙基纤维素 中国药典 质量标准修订 黏度 含量测定 

分 类 号：R921.2[医药卫生—药学]