【摘要】 目的建立HPLC法同时检测复方骆驼蓬子凝胶剂和软膏剂中6种主要成分(鸭嘴花碱、氢溴酸东莨菪碱、硫酸阿托品、骆驼蓬碱、去氢骆驼蓬碱、秋水仙碱)的含量测定方法。方法采用Agilent Eclipse Plus C18色谱柱(4.6mm×250mm,5μm),流动相0.1%乙酸铵缓冲溶液-乙腈梯度洗脱,检测波长250nm及264nm,流速1.0mL/min,柱温27℃,进样量10μL。结果鸭嘴花碱在0.94~229.00μg/mL浓度范围内线性关系良好(r=0.999 7),平均加样回收率为90.63%(RSD=1.7%);氢溴酸东莨菪碱在1.87~457.00μg/mL浓度范围内线性关系良好(r=0.999 1),平均加样回收率为93.90%(RSD=1.3%);硫酸阿托品在1.39~340.00μg/mL浓度范围内线性关系良好(r=0.999 2),平均加样回收率为97.05%(RSD=2.6%);骆驼蓬碱在1.84~450.00μg/mL浓度范围内线性关系良好(r=0.999 6),平均加样回收率为104.13%(RSD=1.6%);去氢骆驼蓬碱在1.05~256.00μg/mL浓度范围内线性关系良好(r=0.999 4),平均加样回收率为101.70%(RSD=1.9%);秋水仙碱在0.19~46.00μg/mL浓度范围内线性关系良好(r=0.999 9),平均加样回收率为101.26%(RSD=7.1%)。凝胶样品中鸭嘴花碱的平均含量为0.28mg/g,氢溴酸东莨菪碱的平均含量为0.94mg/g,硫酸阿托品的平均含量为0.99mg/g,骆驼蓬碱的平均含量为1.14mg/g,去氢骆驼蓬碱的平均含量为1.48mg/g,秋水仙碱的平均含量为0.01mg/g。软膏样品中鸭嘴花碱的平均含量为0.51mg/g,氢溴酸东莨菪碱的含量为0.86mg/g,硫酸阿托品的含量为0.54mg/g,骆驼蓬碱的含量为2.34mg/g,去氢骆驼蓬碱的含量为1.60mg/g,秋水仙碱的含量为0.28mg/g。结论本法可同时测定复方骆驼蓬子水凝胶贴剂中鸭嘴花碱、氢溴酸东莨菪碱、硫酸阿托品、骆驼蓬碱、去氢骆驼蓬碱、秋水仙碱的含量,且同时适用于复方骆驼蓬子软膏剂的含量测定,方法准确、结果稳定,可为复方骆驼蓬子凝胶剂及软膏剂的质量评价提供科学依据。更多还原

【Abstract】 Objective To establish the HPLC method content determination on six main components(vasicine,scopolamine hydrobromide,atropine sulfate,harmaline,harmine and colchicine)of Compound Luotuopengzi hydrogel patches and ointments.Methods The separation was performed on a Agilent Eclipse Plus C18(4.6 mm×250 mm,5μm)column with 0.1%ammonium acetate buffer-acetonitrile as mobile phase(gradient elution),at250 nm and 264 nm UV detection wavelength,with 1.0 mL/min flow rate,27℃column temperature and 10μL sample size.Results The calibration curve for vasicine was linear within the range of 0.94~229.00μg/mL(r =0.999 7).The average recovery of vasicine was(90.63±1.8)%(RSD=1.7%).The calibration curve for scopolamine hydrobromide was linear within the range of 1.87~457.00μg/mL(r =0.999 1).The average recovery of scopolamine hydrobromide was(93.90±1.4)%(RSD=1.3%).The calibration curve for atropine sulfate was linear within the range of 1.39~340.00μg/mL(r=0.999 2).The average recovery of atropine sulfate was(97.05±2.7)%(RSD=2.6%).The calibration curve for harmaline was linear within the range of 1.84~450.00μg/mL(r=0.999 6).The average recovery of harmaline was(104.13±1.6)%(RSD=1.6%).The calibration curve for harmine was linear within the range of 1.05~256.00μg/mL(r=0.999 4).The average recovery of harmine was(101.70±1.9)%(RSD=1.9%).The calibration curve for colchicine was linear within the range of 0.19~46.00μg/mL(r=0.999 9).The average recovery of colchicine was(101.26±7.2)%(RSD=7.1%).The average content of vasicine,scopolamine hydrobromide,atropine sulfate,harmaline,harmine and colchicine in the hydrogel patches sample is 0.28,0.94,0.99,1.14,1.48 and 0.01 mg/g,respectively.The average content of vasicine,scopolamine hydrobromide,atropine sulfate,harmaline,harmine and colchicine in the ointments sample is0.51,0.86,0.54,2.34,1.60,0.28 mg/g,respectively.Conclusion The method is suitable to determine the six kinds of materials of Compound Luotuopengzi hydrogel patches and ointments,which is accurate and reliable in the quality control of Compound Luotuopengzi hydrogel patches and ointments.更多还原