Yin Lianhong, Lu Binan, Qi Yan, Xu Lina, Han Xu, Xu Youwei, Peng Jinyong, Sun Changkai
College of Pharmacy, Dalian Medical University, Dalian, China.
J Pharm Biomed Anal. 2009 May 1;49(4):1101-8. doi: 10.1016/j.jpba.2009.01.039. Epub 2009 Feb 10.
A simple and sensitive high-performance liquid chromatography coupled with diode array detection (HPLC-DAD) method was investigated for simultaneous determination of 11 components (chlorogenic acid, coptisine, epiberberine, jatrorrhizine, berberine, palmatine, baicalin, wogonoside, baicalein, wogonin and chrysin) in Qinhuanghouzheng (QHHZ) capsule and Xiaoerqingre (XEQR) tablet, for quality control of these two well-known traditional Chinese medicines (TCMs). The method was established using an Eclipse Plus C(18) (150 mm x 4.6 mm i.d., 5 microm) column. The mobile phase comprising methanol (A) 3% phosphoric acid (B) (pH 2.0, adjusted by triethylamine) was used to elute the targets in gradient elution mode. Flow rate and detection wavelength were set at 0.8 mL/min and 270 nm, respectively. All calibration curves showed good linearity with R(2) > 0.9995. Inter- and intra-day precisions for all investigated components expressed as relative standard deviation (R.S.D.) ranged from 0.26% to 1.77%. Recoveries measured at three concentrations were in the range of 95.0-103.0% with R.S.D. < or = 3%. The validated method is simple, reliable, and successfully applied to determine the contents of the selected compounds in QHHZ capsule and XEQR tablet for quality evaluation and control. The 11 main active marker compounds measured occur only in 2 or 3 plant species out of 7-10 species comprising the two TCMs. Additional procedures need to be developed for the quality control of plant materials other than Coptis chinensis Franch, Scutellaria baicalensis Georgi and Phellodendron amurense Rupr.
研究了一种简单灵敏的高效液相色谱-二极管阵列检测法(HPLC-DAD),用于同时测定芩黄喉症胶囊和小儿清热片中的11种成分(绿原酸、黄连碱、表小檗碱、药根碱、小檗碱、巴马汀、黄芩苷、汉黄芩苷、黄芩素、汉黄芩素和白杨素),以对这两种著名的传统中药进行质量控制。该方法采用Eclipse Plus C(18)(150 mm×4.6 mm内径,5μm)色谱柱建立。流动相由甲醇(A)-3%磷酸(B)(pH 2.0,用三乙胺调节)组成,以梯度洗脱模式洗脱目标物。流速和检测波长分别设定为0.8 mL/min和270 nm。所有校准曲线均显示出良好的线性,R(2)>0.9995。所有研究成分的日间和日内精密度以相对标准偏差(R.S.D.)表示,范围为0.26%至1.77%。在三个浓度下测得的回收率在95.0-103.0%范围内,R.S.D.≤3%。该验证方法简单、可靠,已成功应用于测定芩黄喉症胶囊和小儿清热片中所选化合物的含量,以进行质量评估和控制。所测定的11种主要活性标记化合物仅存在于组成这两种中药的7-10种植物中的2或3种植物中。对于除黄连、黄芩和黄柏以外的植物材料的质量控制,还需要开发额外的程序。