富马酸氯马斯汀搽剂的制备与质量控制  

Preparation and quality control of Clemastine Fumarate Liniment

作　　者：焦守宗 

机构地区：[1]山东博山制药有限公司,山东淄博255215

出　　处：《药学研究》2013年第11期655-656,共2页Journal of Pharmaceutical Research

摘　　要：目的制备富马酸氯马斯汀搽剂,并制定质量控制标准。方法以富马酸氯马斯汀为主药制成富马酸氯马斯汀搽剂,用高效液相色谱法进行质量控制。结果所制备的搽剂质量稳定、操作方法简便,质量控制准确、可靠。富马酸氯马斯汀的平均回收率为99.63%,RSD为0.83%(n=9)。结论该制剂制备工艺简单,含量测定方法操作简便、结果准确,适用于富马酸氯马斯汀搽剂的制备和质量控制。Objective To prepare Clemastion Fumarate Liniment and formulate quality control standards. Methods With clemastine fumarate as the main drug, Clemastine Fumarate Liniments was prepared. Quality control carried out by hight performance liquid chromatography （ HPLC ）. Results The quality of prepared liniment was stable, operation method was simple and quality control was accurate and reliable. The average recovery of clemastine fumarate was 99. 63% , RSD was 0. 83 % （ n = 9 ）. Conclusion The preparation process was simple, determination method was simple, accurate, and it was suitable for the preparation and quality control of Clemastine Fumarate Liniment.

关 键 词：富马酸氯马斯汀 搽剂 质量控制 

分 类 号：R927.1[医药卫生—药学]