防芷鼻炎片质量标准研究

Study on Quality Standard for Fangzhi Biyan Tablet

目的制定防芷鼻炎片的质量标准。方法用TLC鉴别白芷、白芍、甘草、防风;以HPLC测定欧前胡素的含量。选用Agilent Eclipse XDB-C18柱(4.6mm×250mm,5μm),流动相为甲醇-0.1%磷酸溶液(65∶35),流速为1mL/min,检测波长为248nm。结果TLC色谱中斑点清晰,易于识别;HPLC法精密度、重现性良好。欧前胡素在0.076～0.684μg范围内有较好的线性关系,平均回收率98.63%(RSD=1.52%)。结论本法可有效控制防芷鼻炎片的质量。

Objective To establish the method for quality standard of Fangzhi Biyan Tablet. Methods Radix Angelicae Dahuricae, Radix Paeoniae Alba, Radix Saposhnikiviae and Radix Glycyrrhizae in the tablet were identified by TLC. The content of Imperatorin in this medicine was determined by HPLC. The Agilent Eclipse XDB-C18（4.6 mm×250 mm, 5μm） was used, mobile phase was methanol-0, 1%phosphoric acid solution （65 ： 35）, flow rate was 1.0 mL/min, detection wavelength was 248 nm. Remits The TLC spots developed were fairly and simply identical. HPLC was accurate and reproducible. Imperatorin show a good liner relationship at range of 0.076-0.684μg, the recovery was 98.63% （RSD=1.52%）. Conclusion These methods can be used to control the quality of Fangzhi Biyan Tablet effectively.