盐酸氯环利嗪质量标准研究  

Study on Quality Standard for Chlorcyclizine Hydrochloride

作　　者：杨本霞[1] 王焕锋[2] 陈杰[1] 袁利杰[1] 

机构地区：[1]河南省食品药品检验所,郑州450003 [2]中州大学,郑州450044

出　　处：《中国药品标准》2015年第6期432-434,共3页Drug Standards of China

摘　　要：目的：改进盐酸氯环利嗪含量测定方法，建立盐酸氯环利嗪残留溶剂测定法。方法：采用不使用汞盐的电位滴定法测定盐酸氯环利嗪的含量、气相色谱法测定盐酸氯环利嗪的残留溶剂。结果：含量测定中盐酸氯环利嗪在0．16—0．24g范围内线性关系良好（r=0．9999），平均回收率为99．7％，RSD为0．3％（n=9）；残留溶剂测定中乙醇与乙酸乙酯能得到有效分离，在所考察的浓度范围内线性关系良好（相关系数分别为0．9993，0．9998），平均回收率（n=9）分别为101．3％、100．9％。结论：所建方法专属性强，准确度高，可用于盐酸氯环利嗪的质量控制。Objective： To improve the determination method of Chlorcyclizine Hydrochloride and establish a method for the determination of residual solvents in Chlorcyclizine Hydrochloride. Methods： Potentiometric titration with no mercuric acetate was used to determine the content of Chlorcyclizine Hydrochloride and GC method to determine residual solvents in it. Results ： The contents of Chlorcyclizine Hydrochloride was linear in the ranges of 0. 16 - 0. 24 g（ r = 0. 999 9 ）, the average recovery was 99. 7% with RSD of 0. 3% （ n = 9）. Alcohol and ethyl acetate were separated completely, the calibration curves showed good linear relationships （ r = 0. 999 1, 0. 999 9）, the average recoveries were 101.3% and 100. 9% （n = 9）, respectively. Conclusion：The improved method is specific and accurate. It can be used to control the quality of Chloreyclizine Hydrochloride.

关 键 词：盐酸氯环利嗪 残留溶剂 含量测定 

分 类 号：R921.2[医药卫生—药学]