消炎利胆颗粒质量标准研究  

Study on Quality Standard of Xiaoyan Lidan Granules

作　　者：宁火华 邬秋萍 钟瑞建 丁银平 

机构地区：[1]江西省食品药品检验所,南昌330029

出　　处：《中国药品标准》2012年第4期261-264,共4页Drug Standards of China

摘　　要：目的:修订完善消炎利胆颗粒的质量标准。方法:采用薄层色谱法鉴别消炎利胆颗粒中的穿心莲、溪黄草和苦木;采用高效液相色谱法定量检测消炎利胆颗粒中穿心莲内酯和脱水穿心莲内酯的含量。结果:穿心莲、溪黄草和苦木的薄层色谱鉴别效果好,专属性强,分离度高,且阴性样品无干扰;穿心莲内酯在0.021 6～0.64 8μg范围呈良好线性,平均加样回收率为98.64%(RSD=1.0%);脱水穿心莲内酯在0.049 84～1.075 2μg范围呈良好线性,平均加样回收率为97.75%(RSD=1.2%)。结论:本法操作简便,结果准确,重现性好,能够对消炎利胆颗粒进行定性和定量控制,符合中成药的质控要求。Objective： To revise a quality standard of Xiaoyan Lidan Granules. Method ： TLC was applied to the identification of Andrographitis Paniculatae Herba, Isodi Lophanthoidis Herba and Picrasmae Ramulus et folium in Xiaoyan lidan Granules. In addition, HPLC was used to determine the contents of andrographolide and dehydroandrographolide in Xiaoyan Lidan Granules. Result： TLC identification of Andrographitis Paniculatae Herha, Isodi Lophanthoidis Herba and Picrasmae Ramulus et folium had an excellent result , and a good specialization . The negative control showed no interference. Andrographolide had a good linearity in the range of 0. 021 6- 0. 648 p,g , the average recovery was 98.64% （ RSD = 1.0% ）. Dehydroandrographolide had a good linearity in the range of 0. 049 84- 1. 075 2 μg , the average recovery was 97.75% （RSD = 1.2% ）. Conclusion： This method was simple, accurate and with good reproducibility. It could be used for quality control of Xiaoyan Lidan Granules.

关 键 词：消炎利胆颗粒 穿心莲内酯 脱水穿心莲内酯 高效液相色谱法 

分 类 号：R921.2[医药卫生—药学]