肠必清肠溶颗粒剂的质量控制  

Quality Control of Chang Bi Qing Enteric-coated Granules

作　　者：田莉[1] 陈象青[1] 刘圣[1] 黄守正[2] 陈礼明[1] 

机构地区：[1]安徽省立医院,合肥市230001 [2]安徽中医学院,合肥市230001

出　　处：《中国药房》2000年第1期11-12,共2页China Pharmacy

基　　金：安徽省科委"九五"科技攻关项目!;项目编号:9613010- 3

摘　　要：目的：建立肠必清肠溶颗粒剂的质量控制方法。方法：参照《中国药典》类似制剂的质量要求，对本品的质量进行了全面检测，并用薄层色谱法对本品的番泻苷Ａ 和橙皮苷进行定性鉴别，用比色法对总番泻苷进行含量测定。结果：本品的粒度、水分、释放度等均符合规定。薄层定性方法斑点清晰， 分离完全， 易于区别。含量测定方法精密度 ＜ １－６ ％ ， 平均回收率为９７－４０ ％ （ＲＳＤ ＝１－０６ ％ ，ｎ ＝ ５） 。结论：本文所建立的定性及定量方法准确、可靠，重现性好，可作为该制剂的质量控制方法。OBJECTIVE:To establish the quality control method for Chang Bi Qing enteric-coated granules.METHODS:The preparation was monitored according to the quality requirements of similar preparations in the Chinese pharmacopoeia.Its ingredients,sennoside A and hesperidin,were identified by TLC.The total sennosides in the preparation was quantitatively detected by colorimetry.RESULTS:The granularity,water content and release rate met the requirements.The spots were clear and separated completely in the TLC methods.The average recovery of the determining method was 97 40% with a RSD of 1 06% and its repeatability was good(standard derivations<1 6%).CONCLUSION:The quality standard of the preparation was provided.The methods of identification and determination were accurate and reproducible.It can be used for quality control of the preparation.

关 键 词：肠必清 肠溶颗粒剂 番泻苷 橙皮苷 质量控制 

分 类 号：R975[医药卫生—药品]