炎可宁片薄层鉴别及含量测定研究

Research by the TLC and Determination Imperatorin of HPLC for Yankening Tablet

目的：建立炎可宁片薄层鉴别、含量测定标准,更有效地控制该产品质量。方法：采用薄层色谱法对处方小檗碱、黄连、大黄、黄芩进行定性鉴别研究;含量采用高效液相色谱（HPLC）测定制剂中的黄芩苷。高效液相色谱条件：色谱柱：Dikma C18（5μm,250×4.6mm）;流动相：甲醇-水-磷酸（47：53：0.2）;流速：1.0ml/min;柱温：35℃;检测波长：280nm。结果：TLC、HPLC准确、可靠,HPLC回收率为99%~101%,RSD为1.02%。结论：建立的薄层色谱法和高效液相色谱法专属性强、准确度高、重复性好,可用于炎可宁片的质量控制。

Objective： To set up TLC and content standard of Yankening Tablet. Methods： To determine imperatorin baica- lin of Yankening Tablet by TLC and high performance HPLC, to control content of Yankening Tablet effectively. Chromatographic column： KromasilODS-1C18, （5μm, 250×4. 6mm） mobilephase： methanol-water-orthophosphorieaeid （47： 53： 0. 2）; flow rate： 1.0ml/min; column temperature： 35℃ ; detected wavelength： 280nm. Results： TLC and HPLC was reliable and accurate, HPLC recovery rates were 99% - 101%. RSD were 1.02%. Conclusion： To set up method of TLC and HPLC has specificity accuracy good repeatability; the standard may use to control content of Yankening Tablet.