返魂草干粉吸入剂的含量测定及体外肺沉积率考察

Content Determination and in Vitro Lung Deposition Properties of Senecio Cannabifolius Less.DPIs

目的建立高效液相色谱法测定返魂草干粉吸入剂中返魂草素Ⅱ含量的方法,并对其体外沉积性质进行初步考察。方法采用Eclipse XDB-C18柱（4.6 mm×150 mm,5μm）,流动相为CH3OH-5 mmol/L NaH2PO4配制的6 mmol/L的四丁基溴化铵（2 mol/L的NaOH调pH7.0）（30∶70）,检测波长230 nm,流速1.0 ml/min。采用双层液体碰撞器测定返魂草干粉吸入剂的有效部位沉积量。结果返魂草素Ⅱ在5~150μg/ml（r=0.9994）范围内与峰面积呈良好的线性关系,平均回收率为97.2%,RSD为1.4%（n=5）,体外肺沉积率大于10%。结论本含量测定方法准确可靠、重复性好,该制剂的体外肺沉积率符合要求。

Objective To establish an high performance liquid chromatography method for determination of FanhuncaoinⅡin Senecio cannabifolius Less.DPIs,and investigate its deposition property in vitro.Methods An Eclipse XDB-C18 column（4.6 mm×150 mm,5 μm） was used with a mixture of methanol-buffer solution（5 mmol/L sodium dihydrogen phosphate and 6 mmol/L tetrabutylammonium bromide,adjusted to pH 7.0 with 2 mol/L sodium hydroxide）（30∶70） as the mobile phase.The flow rate was 1.0 ml/min and the detection wavelength was set at 230 nm.The in vitro deposition properties of the powder were assessed with a twin stage impinge.Results The linear range of FanhuncaoinⅡwas 5-150 μg/ml（r=0.9994）.The average recovery was 97.2%,and RSD was 1.4%（n=5）.The in vitro deposition test showed that the lung deposition rate was more than 10%.Conclusion This method is credible,reproducible and suitable for determination of Senecio cannabifolius Less.DPIs.The in vitro lung deposition rate meets the standard.