小儿喜食片质量标准探讨  

Study on the quality control method of Xiaoerxishi tablet

作　　者：胡伶俐 章泽恒[2] 

机构地区：[1]湖南省新邵县人民医院药剂科,429000 [2]湖南省药品审评认证与不良反应监测中心,长沙市410013

出　　处：《临床合理用药杂志》2010年第23期15-16,共2页Chinese Journal of Clinical Rational Drug Use

摘　　要：目的建立小儿喜食片的质量标准。方法采用薄层色谱法(TLC)法对方中枳壳、白术、山楂进行定性鉴别,并用高效液相色谱法(HPLC)对制剂中枳壳所含柚皮苷进行含量测定。结果枳壳、白术、山楂的TLC结果好,阴性无干扰。柚皮苷在0.19～0.97μg范围内具有良好的线性关系,相关系数r=0.9999,平均加样回收率为101.33%,RSD为1.65%(n=6)。结论该方法可准确地进行定性、定量测定,可用于小儿喜食片的质量控制。Objective To develop the quality standard of Xiaoerxishi tablet.Methods Fructus aurantii,rhizoma atrctylodis macrocephalae and fructus crataegi in Xiaoerxishi tablet were identified by TLC;Naringin in fructus aurantii was determinated by HPLC.Results Fructus aurantii,rhizoma atrctylodis macrocephalae and fructus crataegi had a good results,and negative non-interference.Naringin showed a good linear relationship at a range of 0.19-0.97μg,r=0.9999,the average recovery was 101.33% and RSD was 1.65%（n=6）.Conclusion The method can be accurate qualitative and quantitative determination and can be used for the quality control of Xiaoerxishi tablet.

关 键 词：小儿喜食片 柚皮苷 高效液相色谱法 质量标准 

分 类 号：R286[医药卫生—中药学]