葛根芩连滴丸的质量标准研究  

Study on quality standard of Gegen Qinlian dropping pills

作　　者：宋凤兰[1] 何洋[1] 何琳[1] 何立美 

机构地区：[1]广东药学院医药化工学院,广东中山528453 [2]广东药学院中药学院,广东广州510006

出　　处：《广东药学院学报》2014年第4期439-443,共5页Academic Journal of Guangdong College of Pharmacy

基　　金：2013年国家级大学生创新创业训练计划项目(201310573014)

摘　　要：目的：建立葛根芩连滴丸的质量标准。方法采用薄层色谱法对滴丸中的葛根、黄芩、黄连进行定性鉴别；采用高效液相色谱法同时测定滴丸中的葛根素、盐酸小檗碱、黄芩苷。以甲醇-0.2%（体积分数）H3PO4（三乙胺调pH值至3.85）为流动相,梯度洗脱,流速为1.0 mL·min-1,检测波长为265 nm,柱温为35℃。结果定性鉴别分离度好,阴性无干扰；葛根素、盐酸小檗碱和黄芩苷的质量浓度分别在0．8175-13.08μg·mL-1（ r=0.9999）、5.160~82.56μg·mL-1（ r=0.9999）和12.39~198.2μg·mL-1（ r=0.9998）范围内与相应峰面积呈良好线性关系,平均加样回收率（n=9）分别为101.6%（RSD=1．0%）、98.2%（ RSD=0.6%）和100.6%（ RSD=1.0%）。结论所建方法简单准确、重复性好,可用于葛根芩连滴丸的质量控制。Objective To establish a method for the quality control of Gegen Qinlian dropping pills. Methods Puerariae lobatae Radix, Scutellariae Radix, Coptidis Rhizoma were identified by TLC and the contents of puerarin,berberine hydrochloride and baicalin were determined by HPLC. The mobile phase was consisted of methanol and 0.2% phosphoric acid（ pH adjusted to 3.85 with triethylamine） at a flow rate of 1.0 mL·min-1 in a gradient elution. The detection wavelength was set at 265 nm and the column temperature was at 35 ℃. Results TLC identifications were performed with high resolution and without negative interference. The calibration curves were linear within the range of 0.817 5-13.08 μg·mL-1（ r=0.999 9） for puerarin,5.160-82.56 μg·mL-1（r=0.999 9） for berberine hydrochloride and 12.39-198.2 μg·mL-1（r=0.999 8） for berberine,respectively. The average recoveries（ n=9） were 101.6%（ RSD=1.0%） for puerarin,98.2%（ RSD=0.6%） for berberine hydrochloride and 100. 6%（ RSD=1. 0%） for berberine, respectively. Conclusion The method was simple and accurate with a good reproducibility,and can be used for the quality control of Gegen Qinlian dropping pills.

关 键 词：葛根芩连滴丸 葛根素 盐酸小檗碱 黄芩苷 高效液相色谱法 

分 类 号：R286.0[医药卫生—中药学]