基于波长切换技术建立加味小柴胡胶囊质量标准  

Quality Standard for Flavored Xiaochaihu Yigan Capsules by HPLC with Wavelength Switch

作　　者：王信[1] 李彩东[1] 潘新波[1] 张伟[1] 

机构地区：[1]兰州市第二人民医院,兰州730046

出　　处：《中国药师》2016年第8期1597-1599,共3页China Pharmacist

基　　金：兰州市科技计划项目(编号:2013-3-54)

摘　　要：目的:建立加味小柴胡方-益肝胶囊的质量标准。方法:采用TLC法对制剂中柴胡、黄芩进行薄层定性鉴别;运用HPLC波长切换法对制剂中党参炔苷和柴胡皂苷a的含量进行同时测定,分析条件如下:菲罗门ODS C_(18)柱(250 mm×4.6 mm,5μm),以乙腈-0.1%磷酸水溶液为流动相,梯度洗脱,流速1.0 ml·min^(-1),党参炔苷检测波长267 nm(出峰时间前后3 min),柴胡皂苷检测波长210 nm(出峰时间前后3 min),其余采集时间仍为254 nm。结果:薄层鉴别斑点清晰,阴性无干扰。党参炔苷和柴胡皂苷a分别在0.042~0.630μg和0.036~0.540μg范围内线性关系良好,相关系数分别为0.999 2、0.999 6,平均加样回收率分别为100.85%和99.73%,RSD分别为1.08%(n=9)和2.80%(n=9)。结论:本方法准确、可靠、稳定、重复性好,可用于益肝胶囊的质量控制。Objective： To establish the quality standard for flavored Xiaochaihu Yigan capsules. Methods： TLC was used for the qualitative identification of Codonopsis pilosula（ Franch.） Nannf. and Bupleurum chinense DC. The contents of lobetyolin and saikosaponin a were determined by HPLC. The HPLC separation was performed on a Phenomenex C_（18）column（ 250 mm × 4. 6 mm,5μm）with acetonitrile-0. 1% phsophonic acid as the mobile phase with gradient elution,and the flow rate was 1. 0 ml·min^（-1）,the wavelength for lobetyolin was 267 nm（ 3min before and after the peak） and 210 nm for saikosaponin a（ 3 min before and after the peak）,and 254 nm during the rest time. Results： The results of TLC showed that the relevant spots were clear without interference from the negative samples. The calibration curve was linear within the range of 0. 042-0. 630 μg for lobetyolin（ r = 0. 999 2） and 0. 036-0. 540 μg for saikosaponin a（ r = 0. 999 6）. The average recovery was 100. 85%（ RSD = 1. 08%,n = 9） and 99. 73%（ RSD =2. 80%,n = 9）,respectively. Conclusion： The established method is accurate,reliable,stable and repeatable,which can be used for the quality control of Yigan capsules.

关 键 词：益肝胶囊 质量标准 薄层色谱法 HPLC波长切换法 党参炔苷 柴胡皂苷A 

分 类 号：TQ460.72[医药卫生—药物分析学]