丹知青娥片的质量标准研究  

Study on Quality Standard of Danzhi Qing'e Tablets

作　　者：耿莲[1,2] 彭四威[1,2] 熊文[1,2] 刘海涛[1,2] 王跃飞[1,2] 

机构地区：[1]天津市现代中药重点实验室-省部共建国家重点实验室培育基地,天津300457 [2]天津中医药大学中医药研究院,天津300193

出　　处：《中药新药与临床药理》2015年第3期387-391,共5页Traditional Chinese Drug Research and Clinical Pharmacology

基　　金：国家重大新药创制科技重大专项项目(2012ZX09103201-046)

摘　　要：目的采用高效液相色谱法和薄层色谱法,建立丹知青娥片的质控标准。方法 Agilent Eclipse XDB-C18色谱柱(4.6 mm×150 mm,5μm);流动相:乙腈-0.1%甲酸水溶液梯度洗脱;柱温:20℃;流速:1.0m L·min-1;检测波长:246 nm、258 nm和286 nm;采用薄层色谱法和高效液相色谱法对丹知青娥片中的补骨脂、知母、丹参进行定性鉴别和含量测定。结果芒果苷、丹酚酸B、补骨脂素、异补骨脂素在13 min内均能达到良好分离,线性关系良好(r≥0.9999);芒果苷、丹酚酸B、补骨脂素、异补骨脂素的平均加样回收率分别为99.6%、99.8%、99.1%和99.9%,RSD分别为2.37%、1.36%、1.54%和2.05%。芒果苷、丹酚酸B、补骨脂素、异补骨脂素平均含量分别为4.42,18.54,1.21和1.06 mg·g-1,高于含量下限;薄层色谱法鉴别丹知青娥片中的补骨脂、知母、丹参,分离度良好,斑点清晰,专属性强,重现性好。结论该方法灵敏、快速、准确、专属性强,适用于丹知青娥片的质量控制。Objective To establish a method for the quality control of Danzhi Qing＇e Tablets by high performance liquid chromatography（HPLC） and thin layer chromatography（TLC）. Methods The chromatographic separation was performed on a XDB-C18column（4.6 mm×150 mm,5 μm） with gradient elution of acetonitrile and 0.1 % formic acid aqueous solution at a flow rate of 1.0 m L·min-1. Column temperature was fixed at 20 ℃. Detection wavelengths were chosen as 246 nm,258 nm and 286 nm,respectively. TLC mehtod was established to identify Fructus Psoraleae,Rhizoma Anemarrhenae,Radix Salvia Miltiorrhizae in Danzhi Qing＇e Tablets,and HPLC was used to determine the contents of mangiferin, salvianolic acid B, psoralen and isopsoralen in the tablets. Results A good separation of psoralen, isopsoralen, mangiferin and salvianolic acid B was obtained within 13 minutes. The linearity of these compounds was good（r≥0.9999）. The average recoveries of mangiferin,salvianolic acid B,psoralen and isopsoralen were 99.6 %,99.8 %,99.1 % and 99.9 % with RSD being 2.37 %,1.36 %,1.54 % and 2.05 %,respectively.The average amount of mangiferin,salvianolic acid B,psoralen and isopsoralen was 4.42,18.54,1.21,1.06 mg·g-1,higher than the content of lower limit. Identification of Fructus Psoraleae, Rhizoma Anemarrhenae, Radix Salvia Miltiorrhizae in Danzhi Qing＇e Tablets by TLC exhibited good separation, and high specificity and reproducibility.Conclusion This method is rapid,simple,accurate and specific,which is suitable for the quality control of Danzhi Qing＇e Tablets.

关 键 词：丹知青娥片 含量测定 系统适用性 耐用性 鉴别 

分 类 号：R284.1[医药卫生—中药学]