参味合剂质量控制研究  

Quality control for Shenwei Mixture

作　　者：管敏[1] 王淼[1] 达庆国[1] 

机构地区：[1]南京中医药大学附属医院,江苏南京210029

出　　处：《安徽医药》2014年第8期1440-1443,共4页Anhui Medical and Pharmaceutical Journal

基　　金：南京中医药大学附属医院院级立项课题(No Y09038-1d)

摘　　要：目的建立参味合剂的质量控制方法。方法采用TLC法对制剂中五味子、麦冬、甘草进行定性鉴别;采用HPLC法测定制剂中五味子醇甲含量,色谱柱为Diamonsil C18柱（5μm,250 mm×4.6 mm）;流动相为甲醇—水（58∶42）;检测波长为250nm。结果在TLC色谱中检出五味子、麦冬和甘草,阴性对照无干扰;五味子醇甲进样量在0.3012-3.012μg范围内与峰面积呈良好的线性关系,r=0.999 99,平均加样回收率为98.55%,RSD=1.05%（n=6）。结论所建立TLC鉴别方法和HPLC含量测定方法专属性强,结果准确,重现性好,可作为参味合剂的质量控制。Objective To formulate a method for quality control of Shenwei Mixture. Methods Radix codonopsis,fructus schisandrae and licorice were identified by thin layer chromatography. Schisandrol was determined by high performance liquid chromatography,with diamonsil C18column（ 5 μm,4. 6 mm × 250 mm） as chromatographic column. The mobile phase consisted of methanol∶ water（58∶42）.The detection wavelength was 250nm. Results Radix codonopsis,fructus schisandrae and licorice were detected by TLC. And negative control was without interference. Schisandrol showed a good linear relationship within a range of 0. 301 2 - 3. 012 μg（r = 0. 999 99）.The average recovery was 98. 55%. RSD was 1. 05%（n = 6）. Conclusions The established methods are specific,accurate,reproducible,which can be used for quality control of Shenwei Mixture.

关 键 词：质量控制 五味子醇甲 五味子 麦冬 甘草 

分 类 号：R286.0[医药卫生—中药学]