瑶药天钻的质量标准研究

目的:建立瑶药天钻药材的质量标准。方法:分别对天钻药材进行显微鉴别和薄层色谱(TLC)鉴别;按照《中国药典》方法进行水分、总灰分、酸不溶性灰分、浸出物检查;采用高效液相色谱法测定药材中马兜铃酸的含量:色谱柱为Phenomenex Gemini C18(250 mm×4.6 mm,5μm),流动相为乙腈-水(含0.34%三乙胺、0.94%乙酸,梯度洗脱),检测波长为260 nm。结果:天钻药材的显微特征明显;TLC图中能清晰显现与马兜铃酸A对应的点;马兜铃酸A的质量浓度在1.703¹09.000μg/ml范围内与其峰面积积分值呈良好的线性关系(r=0.999 9),平均加样回收率分别为97.54%、101.16%、101.15%,RSD分别为0.22%、0.63%、0.39%(n=3)。结论:所建标准可用于天钻药材的质量控制。产自广西、云南的11批天钻药材在显微、外观等方面质量相对稳定,但马兜铃酸A的含量差异较大。

Quality Study of Yao Medicine Aristolochia kwangsiensis

OBJECTIVE： To establish quality control of Yao medicine Aristolochia kwangsiensis. METHODS： The samples were identified by microscopic identification and TLC; according to the method of Chinese Pharmacopoeia, moisture, total ash, acid-insoluble ash and extract were detected; the content of aristolochic acid was determined by HPLC. The separation was per- formed on Phenomenex Gemini C18（250 mm×4.6 mm, 5 μm） column with mobile phase consisted of acetonitrile-water （containing 0.34% triethylamine, 0.94% acetic acid, gradient elution） at detection wavelength of 260 nm. RESULTS： Microscopic characteris- tics of A. kwangsiensis were distinctive; TLC spots were clear; the linear range of aristolochic acid A were 1.703-109.000 μg/ml （r=0.999 9） with average recoveries of 97.54% （RSD=0.22% , n=3） , 101.16% （RSD=0.63% , n=3） and 101.15% （RSD=0.39 %, n= 3）. CONCLUSIONS： Established standard can be used for quality control of A. kwangsiensis. The microscopy and ap- pearance of 11 batches of A. kwangsiensis from Guangxi and Yunnan province have kept stable, but there is great difference in the content of aristolochic acid A.