熊胆丸定性定量方法的研究

Study on qualitation and quantitation method of Xiongdan pills

目的:建立熊胆丸的定性定量方法。方法:采用TLC法对方中的熊胆、黄连、龙胆、栀子进行定性鉴别;采用GC法同时测定熊胆丸中冰片、薄荷脑的含量。采用安捷伦DB-WAX毛细管柱(30 m×0.45 mm×0.85μm),载气为氮气,FID检测器,流速:3.0 mL.min-1;分流比为25∶1;进样体积为1μL。结果:TLC色谱中可检出熊胆、黄连、龙胆、栀子;龙脑浓度在56.0～672.0μg.mL-1范围内呈线性关系,3个浓度的平均回收率(n=3)分别为99.4%,101.6%,100.7%;薄荷脑浓度在56.9～683.3μg.mL-1内呈线性关系,3个浓度的平均回收率(n=3)分别为101.4%,100.0%,101.3%。结论:该方法操作简便,重复性好,结果准确可靠,适用于该药的质量控制。

Objective：To establish the methods for qualitation and quantitation of Xiongdan pills. Methods： Bear gall, Rhizoma Coptidis,Radix Gentianae and Fructus Gardeniae were identified by TLC ;The content of borneol and menthol was determined by GC. The sample was determined with Agilent DB - WAX capillary column （30 m × 0. 45 mm× 0. 85 μm） by GC. The detector was FID, N2 was as carrier gas. The flow rate was 3.0 mL · min^ - 1 ; split injection was conducted with split radio of 25： 1. Results：Bear gall, Rhizoma Coptidis, Radix Gentianae and Fructus Gardeniae could be identified by TLC;The linear range of borneol was 56. 0 -672.0 μg · mL^1 and the average r coveries of 3 concentrations（ n = 3 ） were 99.4% , 101.6%, 100. 7%, respectively ; The linear range of menthol was 56.9 - 683.3μg · mL^1 and the average recoveries of 3 concentrations （ n = 3 ） were 101.4% , 100. 0% , 101.3 % , respectively. Conclusion：This method is simple, convenient, accurate and repeatable, and can be used for quality control of Xiongdan pills.