【摘要】 目的建立氢溴酸高乌甲素分散片溶出度的高效液相色谱(HPLC)测定方法,考察其溶出效果。方法采用小杯法测定溶出度,以水为溶剂,转速50 r.min-1,检测波长为252 nm,测定3批氢溴酸高乌甲素分散片的溶出曲线,并与市售氢溴酸高乌甲素片比较。结果氢溴酸高乌甲素在9.76～73.20μg.mL-1浓度范围内线性关系良好(r=0.999 7);平均回收率为100.3%。3批氢溴酸高乌甲素分散片溶出度均一性好,10 min内累积溶出度>80.0%。结论该方法简便快捷,准确实用,适用于氢溴酸高乌甲素分散片的质量控制,自行研制的氢溴酸高乌甲素分散片较普通片溶出快。更多还原

【Abstract】 Objective To establish a HPLC method for investigating the dissolution of lappaconitine hydrobromide dispersible tablets. Methods Dissolution of 3 batches of lappaconitine hydrobromide dispersible tablets was detected by using small cup method with distilled water as solvant,rotation rate at 50 r·min-1 and UV-Vis at 252 nm,which was compared with the commercial lappaconitine hydrobromide tablets. Results The linear range of lappaconitine hydrobromide was 9.76-73.20 μg·mL-1(r=0.999 7).The average recovery was 100.3%.The same batch showed good uniformity,and the dissolution of different batches were all above 80.0% within 10 min. Conclusion This method is simple,sensitive and accurate,which can be used in the quality control of lappaconitine hydrobromide dispersible tablets.The dissolution rate of dispersible tablets is faster than the commercial lappaconitine hydrobromide ones.更多还原