【摘要】 目的建立半边旗抗癌二萜5F口服微乳剂的质量标准并考察稳定性。方法采用液相色谱-紫外检测法测定口服微乳剂中有效成分5F的含量,色谱条件为Hypersil C18(4.6 mm×250 mm,5μm)色谱柱,流动相为甲醇∶水∶醋酸(55∶45∶0.045,V/V)流速1.0 ml·min-1,柱温35℃,检测波长242 nm。采用4 000 r/min离心5 h及10 000 r/min高速离心20 min考察微乳剂的稳定性,采用长期静置法考察温度及光照对口服微乳剂稳定性的影响。结果高效液相色谱法测定5F的含量在0.12~2.4μg·ml-1范围内线性关系良好,平均回收率为92.9%。高速离心对微乳稳定性无影响,温度及光照条件下半边旗5F口服微乳稳定性良好,未出现破乳、分层或析出现象。结论实验建立的分析方法灵敏可靠,可作为半边旗口服微乳剂的质量控制方法,半边旗口服微乳剂稳定性好。更多还原

【Abstract】 Objective To establish the quality standard of Ps L oral microemulsion containing mainly 5F( ent-11α-hydroxy-15-oxo-kaur-16-en-19-oic-acid),and to evaluate its stability. Methods The content was determined by HPLC. The column was Hypersil C18( 4. 6mm × 250 mm,5 μm),the mobile phase was the mixture of methanol-water-acetic acid( 55: 45: 0.045,V / V) with a flow rate of 1. 0 m L·min-1,the detective wavelength was 242 nm,and the column temperature was maintained at 35℃. The factors such as centrifuge,temperature and light were adopted to evaluate the stability of the oral microeulsion. Results The linearity for 5F was obtained over the range of 0. 12 ~ 2. 4 μg·m L-1( r2= 0. 9988),the average recovery of5 F was 89. 8%. The microemulsion was stable with no demulsification or delamination after centrifugation at 4000 r / min for 5h or10000 r / min for 20 min, and it was also stable with a period of store under different temperature or microemulsion.Conclusion the method of HPLC-UV was sensitive and reliable that can be used as quality control method of Ps L5 F oral microemulsion. The stability of the oral microemulsion was good.更多还原