接骨丹胶囊的质量标准研究  

Quality Control of Jiegudan Capsules

作　　者：耿燕楠[1] 崔维刚 周利章 石俊英[3] Geng Yannan Cui Weigang Zhou Lizhang Shi Junying(Affiliated Hospital of ShanDong university of traditional chinese medicine, Jinan 250011, China Linyi Food and Drug Inspecting and Testing CenterLinyi 276001, China Shandong University of Traditional Chinese Medicine,Jinan 250355,China)

机构地区：[1]山东中医药大学附属医院,山东济南250011 [2]临沂市食品药品检验检测中心,山东临沂276001 [3]山东中医药大学,山东济南250355

出　　处：《山东化工》2017年第8期90-92,97,共4页Shandong Chemical Industry

摘　　要：目的:完善接骨丹胶囊的质量标准。方法:增加薄层色谱法对接骨丹胶囊中延胡索和栀子进行定性鉴别,采用高效液相色谱法测定制剂中柚皮苷的含量。采用Agilent Cl_8柱,流动相为以甲醇-冰醋酸-水(33∶2∶65),检测波长283nm。结果:定性鉴别方法专属性强;含量测定中柚皮苷范围为0.03146μg^0.2517μg(r=0.9999),平均回收率为98.17%。结论:建立的分析方法稳定、准确,可用于该制剂的质量控制。Objective： To establish a method for the quality control of Jiegudan Capsules. Method： Radix Corydalis Rhizoma andFructus Gardeniae in Jiegudan Capsules were identified by TLC. The content of naringin was determined by HPLC. Thechromatographic conditions were ： Agilent CI8 colmnn, mobile phase being methanol - glacial acetic acid - water （ 33 ： 2 ： 65 ）,and the detection wavelength at 283 nm. Resuhs： The qualitative identification with TLC was specific. The linear ranges ofnaringin were 0.03146μg - 0.2517 μg（ r = 0. 9999）, the average recovery was 98.17%. Conclusion ： This method is sensitive,stable and accurate. It can be used for the quality control of Jiegudan Capsules.

关 键 词：接骨丹胶囊 薄层色谱法 柚皮苷 液相色谱法 质量标准 

分 类 号：R283.6[医药卫生—中药学]