对《中国药典》双氯芬酸钠重金属检查的商榷  

Discussion on the heavy metalstest of diclofenac sodium in ChP 2015

作　　者：姚永青[1] 刘英[1] YAO Yongqing;LIU Ying(Henan Institute for Food and Drug Control,Zhengzhou 450003,China)

机构地区：[1]河南省食品药品检验所,郑州450003

出　　处：《中国药品标准》2019年第1期5-8,共4页Drug Standards of China

摘　　要：目的:对《中国药典》双氯芬酸钠重金属检查方法进行完善。方法:分别采用现行标准和优化方法检查双氯芬酸钠中的重金属并对结果进行分析。结果:依据现行标准检测,结果丙管颜色不浅于甲管,甲管和乙管颜色相近;对现行标准进行优化,分别在三管中加氨水使溶液对酚酞指示液显中性,再分别加醋酸盐缓冲液和硫代乙酰胺试液,摇匀,放置,结果丙管颜色不浅于甲管,乙管颜色不深于甲管。结论:依据重金属检查的原理,优化方法更为严谨,更具可操作性,能更好地对样品中的重金属进行控制。Objective:To improve the test method for heavy metals of diclofenac sodium in Chinese Pharmacopoeia 2015.Methods:The presentpharmacopeia methodand improved method wereused to determine heavy metals in diclofenac sodium,and the results were analyzed.Results:The color of tube C was no lighter than that of tube A,and the color of tube A is close to that of tube B as per the present Pharmacopeia method.The present pharmacopeia method was optimized.Ammonia was added into three tubes to obtain the neutral solu- tion indicated withphenolphthalein indicator solution.Acetate buffer and thioacetamide solution were added into three tubes,and the tubes were shaken well and placed.The color of tube C was no lighter than that of tube A,and the color of tube B was no darker than that of tube A.Conclusion:According to the principle of heavy metals test,the optimized method is more rigorous and practicable.It can be used for better control of heavy metals in the samples.

关 键 词：重金属 双氯芬酸钠 

分 类 号：R921.2[医药卫生—药学]