抗感泡腾片生产过程中酚酸类成分的质量控制方法研究  

Quality control of phenolic acids in preparation of Kanggan Effervescent Tablet

作　　者：张媛媛[1] 张加晏[1] 迟玉明[1] 杨光[1] 

机构地区：[1]中药复方新药开发国家工程研究中心,北京100075

出　　处：《现代药物与临床》2011年第4期307-309,共3页Drugs & Clinic

基　　金：北京市科技计划项目(D0205004040331)

摘　　要：目的建立抗感泡腾片提取液中酚酸类成分的测定方法,为抗感泡腾片生产过程的在线质量控制提供参考。方法以抗感泡腾片生产工艺为基础,在线收集样品。通过亚硝酸钠显色反应,采用分光光度法以绿原酸为对照品对样品进行分析。结果绿原酸在0.083～0.332mg呈线性关系,平均回收率为101.91%,RSD为1.65%。结论该方法有利于生产过程中的质量控制,且简便、准确、可靠,可作为抗感泡腾片的质量控制方法。Objective To establish a method for the determination of phenolic acids in extract solution of Kanggan Effervescent Tablet, and provide reference for Kanggan Effervescent Tablet quality control of the production process. Method Based on the production process of Kanggan Effervescent Tablet, collection of samples was online carried out. The chlorogenic acid were determined with the chlorogenic acid as a control standard by spectrophotometry through the color reaction of sodium nitrite. Results Good linearity of chlorogenic acid was obtained within the range of 0.083-0.332 mg . The recovery was 101.91%, and RSD was 1.65%. Conclusion The method is simple, accurate , reliable, and conducive to the quality control in the production process, and it can be used as a method for Kanggan Effervescent Tablet quality.

关 键 词：抗感泡腾片 酚酸类成分 绿原酸 分光光度法 质量控制 

分 类 号：R282.71[医药卫生—中药学]