结肠宁灌肠剂质量标准研究  

Study on Quality Standard for Jiechangning Enema

作　　者：丁野[1] 孙辉[1] 李文莉[1] 

机构地区：[1]湖南省药品检验所,长沙410001

出　　处：《中国药师》2011年第6期778-780,共3页China Pharmacist

基　　金：国家药典委员会国家药品标准提高行动计划项目(编号:355)

摘　　要：目的:建立结肠宁灌肠剂质量标准。方法:采用TLC法对蒲黄、丁香蓼进行鉴别;用HPLC法测定没食子酸的含量,色谱柱为Agilent TC-C_(18)(250mm×4.6mm,5μm),流动相为甲醇-0.1%磷酸溶液(5:95),柱温:35℃,流速:0.8ml·min^(-1),检测波长为273nm。结果:TLC色谱斑点清晰;没食子酸在4.985～1994.0ng范围内线性关系良好(r=0.9999),平均回收率为99.7%(RSD=2.2%,n=9)。结论:本法简便、可靠、准确,可用于该制剂的质量控制。Objective ： To establish the quality standard for Jiechangning enema. Method ： Herbra Ludiwigiae Prostratae and Pollen Typhae in the preparation were identified by TLC. The content of gallic acid in Jiechangning enema was determined by HPLC. Agilent TC-C18（250 mm ×4.6 mm,5 μm） column was used with the mobile phase consisted of methauol-0. 1% aqueous phosphoric acid （5： 95 ） at the temperature of 35℃. The flow rate was 0. 8 ml·min^-1 and detection wavelength was 273 nm. Result： The TLC spots developed were quite clear. The linear range of gallic acid was within the range of 4. 985-1 994.0 ng （ r = 0. 9999 ）, and the average recovery was 99. 7% with RSD of 2. 2% （n = 9）. Conclusion： The method is simple, reliable, accurate, and can be used as the quality control method for Jiechangning enema.

关 键 词：结肠宁 质量标准 薄层色谱法 高效液相色谱法 

分 类 号：TQ460.72[医药卫生—药物分析学]