摘要
目的:提高咳特灵胶囊的质量标准,改进TLC定性方法,增加定量方法。方法:用TLC法对方中的小叶榕进行定性鉴别;并用HPLC法对方中马来酸氯苯那敏进行含量测定。结果:本品定性鉴别薄层色谱特征明显,专属性强;方法学考察表明,马来酸氯苯那敏进样量在0.0520～0.3117μg范围内具有良好的线性关系(r=0.9999),平均回收率为97.82%(n=9),RSD=0.90%。结论:所设计方法简便、准确、重现性好,可用于咳特灵胶囊的质量控制。
Objective：To improve the quality standard for Keteling Capsules. To improve the TLC quantitative method and to increase qualititative method. Methods：Folium fici Microcarpae Belladonnae was identified by TLC. Chlorphenamine Maleate was determind by HPLC. Results：The quality control studies showed that the characteristic for identification by TLC was distinct and highly specific. The methodological studies showed that a good linear corre- lation for the chlorphenamine maleate existed in the range of 0. 052 0 - 0. 311 7 μg（ r = 0. 999 9）. The average recovery of forsythin was 97.82% （ n = 9） with RSD =0. 90%. Conclusion：The method is simple,aeeurate,reproducible and earl be used for quality eontrol of Keteling Capsules.
出处
《中国药品标准》
CAS
2008年第4期270-273,共4页
Drug Standards of China
