脑瘤克胶囊质量标准的建立  

Quality Standard for Naoliuke Capsules

作　　者：张先林[1] 孙蕾[1] 吴旭彤[1] 

机构地区：[1]江苏省中医院,南京210029

出　　处：《中国药师》2014年第8期1421-1423,共3页China Pharmacist

基　　金：江苏省中医药管理局资助课题(编号:LZ11038)

摘　　要：目的：建立脑瘤克胶囊的质量标准.方法：采用TLC法鉴别成方制剂中姜半夏、莪术、石菖蒲、猪苓;采用HPLC法对吉马酮含量进行定量测定.色谱柱为Agilent HC-C18 （2）柱（150 mm×4.6 mm,5 μm）,流动相为乙腈.水（50：50）,流速为1.0 ml·min-1;检测波长为216nm,柱温为30℃,进样量为5μl.结果：TLC斑点清晰,分离度良好,阴性对照无干扰;吉马酮线性范围为7.824～78.240 μg·ml-1（r =0.999 9）,平均加样回收率为100.31％,RSD=2.09％ （n=9）.结论：该法简便、灵敏、重复性好,所建标准可用于脑瘤克胶囊的质量控制.Objective： To establish the quality standard for Naoliuke capsules. Methods： Pinelliae Rhizoma Praeparatum cum Zingibere et Alumine, Curcumae Rhizoma, Aeori Tatarirunvii Rhizoma and Polyporu were identified by TLC. An HPLC method was used to determine the content of germacrone. An Agilent HC-CIs （2） column （150 mm × 4.6 mm, 5 μm ）was used and the mobile phase was acetonitrile-water（50： 50）. The flow rate was 1.0ml · min -1 and the detection wavelength was 216nm. The column tempera- ture was 30℃ and the injection volume was 10pJ. Results： The TLC spots were clear and well-separated without negative interference. The good linear correlation existed within the range of 7. 824-78. 240 μg · ml- l for germacrone（ r = 0. 999 9 ）and the average recovery was 100.31% with RSD of 2.09% （n =9）. Conchlsion： The method is simple, accurate and reproducible, and it can be used in the quality control of Naoliuke capsules.

关 键 词：脑瘤克胶囊 吉马酮 薄层色谱法 高效液相色谱法 质量标准 

分 类 号：TQ460.72[医药卫生—药物分析学]