龙血竭喷雾膜剂的质量控制

Quality Control of Dragon's Blood Spraying Film Agent

目的研究龙血竭喷雾膜剂的质量控制方法。方法测定喷雾膜剂的pH和黏度，纳米粒度仪联用显微镜检测龙血竭喷雾膜剂的药物分散均匀程度和粒径；采用超高效液相色谱法对龙血素B含量进行测定。WatersBEHC18色谱柱（2．1mm×100mm，1．7μm）；检测波长为280nm；柱温40℃。流动相为0．1％甲酸水溶液-乙腈，流速0．8mL·min-1。结果龙血竭喷雾膜剂的pH和黏度稳定；药物分散较均匀，药物粒径小；龙血素B浓度在15．51-77．54μg范围内线性关系良好。结论该方法准确可控，稳定性强，重复性好，可较全面控制龙血竭喷雾膜剂的质量。

Objective To study the quality control methods for dragon＇s blood spraying film agent. Methods The pH value and viscosity of dragon＇s blood spraying film agent were detected. Drug dispersed homogeneous degree and particle sizes were determined with Nano Particle Size Analyzer and microscope. Content of Loureirin B was measured by Ultra Performance Liquid-Chromtography （UPLC）. UPLC was performed on Waters BEH C18 column （2.1 mmxl00 mm, 1.7 μm）, the wavelength was 280 nm, the column temperature was 40℃, and the mobile phase was 0.1% formic acid aqueous solution and aeetonitrile, and the flow rate was 0.8 mL ·min-1. Results The pH value and viscosity of dragon＇s blood spraying film agent were stable, drug dispersion was homogeneous, and particle size of the drug was tiny. The concentration of Loureirin B had a good linear relationship in the range of 15.51-77.54 μg. Conclusion This method can be accurately controlled, has good stability and repeatability, and can fully control quality of dragon＇s blood soraying film agent.