开窍醒脑滴鼻剂定量质量标准的方法学研究

Study on quality standard of resuscitation refreshing nasal drops

目的建立开窍醒脑滴鼻剂的含量测定方法。方法采用高效液相色谱法对栀子苷、姜黄素含量进行测定；采用气相色谱法对冰片、麝香酮含量进行测定。结果桅子苷在30～150μg／mL范围内、姜黄素在4～40μg／mL范围内线性关系良好，r≥0．9997（n=7）。麝香酮在0．005—0．25μg／mL范围内、右旋龙脑在0．05—2．56μg／mL范围内线性关系良好，r≥0．9997（n=6）。结论本研究建立的栀子苷、姜黄素、冰片和麝香酮等的含量测定方法灵敏、准确、可靠，且重现性好，可用于开窍醒脑滴鼻剂的含量测定质量控制。

Objective To establish resuscitation refreshing nasal drops method for the determination. Methods Determination of Jasminoidin and Curcumin in Resuscitation refreshing Nasal drops by HPLC,determination of Borneol and Museone in Resuscitation refreshing Nasal drops by GC. Results In the examination of Jasminoidin and Cureumin,the calibration curve was linear in the range of 30 - 150μ g/mL and 4 -40μ g/mL,r ≥ 0.9997 （n=7）. in the examination of Borneol and Muscone, the calibration curve was linear in the range of 0.005-0.25 μg/mL and 0.05- 2.56 μ g/mL, r ≥ 0.9997,n=6 ）. Conclusion Demonstrates that these methods are simple, accurate and reliable and with good reproducibility,which can be used for Resuscitation refreshing Nasal drops quality control.