鼻康喷雾剂的质量控制标准研究

摘要

目的：测定鼻康喷雾剂中辛夷花含木兰脂素的含量，控制每毫升＞30μg。方法采用高效液相色谱法，色谱柱为 Allsphere-C18柱（250㎜×4.6㎜，5μg）。乙腈∶3.3％四氢呋喃溶液（36∶64）为流动相，流速为1.2mL· min -1；检测波长：278nm，结果木兰脂素在0.0936～1.872μg · min -1范围内具有良好线性关系，平均回收率为98.6％，RSD1.26％。结论用HPLC法测定木兰脂素含量和薄层色谱鉴别麻黄碱，可控制鼻康喷雾剂内在质量。%OBJECTIVE To determine the content of magnoliae jysuh ( C23 H28 O7 ) >30μg · min-1 in Bikang Nebula.METHODS The HPLC analysis was carried out on Allsphere-C18 column (250mm ×4.6mm,5μg),the mixture of acetonitrile and 3.3%Tetrahydrofuran solutionis ( 36∶64 ) was used as the mobile phase.The flow rate was 1.0mL· min -1.The detection wavelength was at 278nm.RESULTS The linear range of magnoliae jysuh was at 0.0936 ~1.872μg · mL-1 , the average recoverg of the method was 98.6% and the RSD was 1.26%.CONCLUSION The HPLC and TLC can be control quality of Bikang Nebula.