露源胶囊质量标准的提高  

Improvement of Quality Standard for Luyuan Capsules

作　　者：曹金一[1] 杜群 马善波[1,3] 胡本祥[3] 文爱东[1] 石小鹏[1] 杨志福[1] 乔逸[1] Cao Jinyi Du Qun Ma Shanbo Hu Benxiang Wen Aidong Shi Xiaopeng Yang Zhifu QiaoYi(Department of Pharmacy of Xijing Hospital, the Fourth Military Medical University, Xi＇ an 710032, China Food and Drug Inspection and Testing Center of Xianyang Department of Pharmacy, Shannxi University of Chinese Medicine)

机构地区：[1]第四军医大学西京医院药剂科,西安710032 [2]咸阳市食品药品检验检测中心 [3]陕西中医药大学药学院

出　　处：《中国药师》2017年第2期354-356,共3页China Pharmacist

基　　金：军队医疗制剂标准提高科研专项课题(编号:14ZJZ07)

摘　　要：目的:建立露源胶囊的质量标准。方法:采用TLC法对主要成分枸杞子、女贞子等进行定性鉴别;采用HPLC法测定制何首乌中有效成分2,3,5,4'-四羟基二苯乙烯-2-O-β-D-葡萄糖苷的含量,色谱柱:Agilent Eclipse XDB-C_(18)(250 mm×4.6 mm,5μm),流动相:乙腈-水(20∶80),流速:0.6 ml·min^(-1),检测波长:320 nm,柱温:35℃,进样量:5μl。结果:TLC色谱斑点清晰,在与对照药材或对照品色谱相应的位置上,显相同颜色的荧光主斑点,阴性样品无干扰;制何首乌中有效成分2,3,5,4'-四羟基二苯乙烯-2-O-β-D-葡萄糖苷线线性浓度为0.184~1.840μg(r=1.000 0),平均回收率为102.0%,RSD为1.1%(n=5)。结论:本方法操作简便,专属性高、重复性好,可作为露源胶囊的质量控制方法。Objective： To establish the quality standard for Luyuan capsules. Methods： The two main herbs in the preparation, wolPDerry and ligustrum were identified by TLC qualitatively. The content of 2,3,5,4＇- four hydroxy two styrene -2- O-β-D - glucoside in amultiflorum was determined by HPLC. The chromatographic separation was carried out by using an Agilent Eclipse XDB-C18 （251） mm × 4.6 mm,5 μl）column. The mobile phase consisted of acetonitrile-water （20：80） with gradient elution at a flow rate of 0.6 ml min-1 , and the injection volume was 5 μl. The detection wavelength and column temperature was 320 nm and 35 ℃ ,respeetively. Results： The characteristics under a microscope were ohvious. The spots in TLC were clear without any interference. The linear range of 2,3,5,4＇- four hydroxy two styrene -2- O-β-D - glueoside was 0.184-1. 840 ℃g（ r = 1. 000 0）. The average recovery was 102.0% and RSD was 1.1% （n = 5）. Conclusion： The method is simple with high specificity and good repeatability, whleh can he used as the quality control method of Luyuan capsules.

关 键 词：露源胶囊 质量标准 高效液相色谱法 薄层色谱法 

分 类 号：TQ460.72[医药卫生—药物分析学]