重黄温敏凝胶中重楼皂苷Ⅵ含量测定及体外释放研究

目的]建立重黄温敏凝胶中重楼皂苷VI的含量测定方法,并进行体外释放研究。方法]采用HPLC-ELSD法,色谱柱为CAPCELL PAK C8柱(4.6 mm×250 mm,5μm),乙腈(A)-水(B)为流动相,梯度洗脱(0~15 min,25%~35%A;15~35 min,35%~40%A;35~40 min,40%~60%A),柱温25℃,流速1.0 mL/min,进样量10μL,漂移管温度92℃,载气流速2.9 L/min。以体外溶蚀法,对重黄温敏凝胶的累积释放情况,进行考察。结果]重楼皂苷VI在0.4300~4.3000 mg范围内线性良好,lgA=1.7969lgC+4.3989(r2=0.9999),定量限为0.0540 mg,平均回收率为101.70%(RSD=1.17%,n=9),体外释放符合Higuchi方程。结论]该方法方便、稳定、高效,可用于重黄温敏凝胶体外释放研究。

Determination and release in vitro of polyphyllin VI in ChongHuang thermosensitive in situ gel

Objective]To establish a determination method for the content of polyphyllin VI in ChongHuang thermosensitive in situ gel and to study the release in vitro.Methods]A HPLC-ELSD method was adopeted with the CAPCELL PAK C8 column(4.6 mm×250 mm,5μm),with the mobile phaseconsisting of acetonitrile(A)-water(B)at the flow rate of 1.0 mL/min(0~15 min,25%~35%A;15~35 min,35%~40%A;35~40 min,40%~60%A),with the column temperature 25℃,with the injection volume 10μL,with the drift tube temperature 92℃and the carrier gas pressure was 2.9 L/min.Results]The polyphyllin VI has good linearity in the range of 0.4300~4.3000 mg,lgA=1.7969lgC+4.3989(R2=0.9999),The average recovery rate was 101.70%(RSD=1.17%,n=9).The in vitro release study indicated that drug release of polyphyllin VI was best fitted to Higuchi equation.Conclusion]The established method is proved to be convenient,stable and efficient.