测定天王补心丸和归脾丸中细叶远志皂苷的含量

Determination of tenuifolin in Tianwang Buxinwan and Guipiwan by HPLC

目的:建立含远志中成药中细叶远志皂苷的含量测定方法。方法:采用高效液相色谱法,AlltimaC18色谱柱(4.6 mm×250 mm,5μm),流动相甲醇-0.05%磷酸溶液(65∶35),检测波长202 nm,流速1.0 mL.min-1。结果:细叶远志皂苷的理论塔板数为2 500。回归方程Y=5.239×106X-6.247×105(r2=0.999 4),线性范围10～500μg.mL-1,平均回收率为97.5%(RSD均小于3.0%),最低检出浓度为5.50μg.mL-1。结论:检测含远志中成药中细叶远志皂苷含量方法简便,结果准确,重现性好,可作为含远志的复方制剂质量控制标准。

Objcetive：A quantitative method was developed for the determination of tenuifolin in Tianwang Buxinwan and Guipiwan by HPLC. Method： The samples were separated by Alhima C18 column （4.6 mm × 250 mm, 5 μm ） using methanol - 0.05% phosphoric acid （65：35 ） as a mobile phase, flow rate was 1.0 mL · min^-1 and wavelength was set at 202 nm. Result： Tenuifolin was detected in both Chinese preparations. The number of theoretical plates calculated by tenuifolin peak was 2 500. The regression equation of tenuifolin was Y = 5.239 × 10^6 X-6. 247 × 10^5 （ r^2 = 0. 999 4） and the liner range was 10-500 g · mL^-1. The average recovery of tenuifolin was 97.5% （ RSD less than 3.0% ）. The LOD of tenuifolin was 5.50 g · mL^-1. Condusion： The method is sensitive, rapid and accurate.