重黄温敏凝胶中重楼皂苷Ⅵ含量测定及体外释放研究  

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

作　　者：孙媛 丁江生 万近福 SUN Yuan;DING Jiangsheng;WAN Jinfu(Yunnan Institute of Materia Medica,Kunming 650111,China;Yunnan Baiyao Group Innovation and R&D Center,Kunming 650111,China;Yunnan Province Company Key Laboratory for Traditional Chinese Medicine and Ethnic Drug of New Drug Creation,Kunming 650111,China)

机构地区：[1]云南省药物研究所,昆明650111 [2]云南白药集团创新研发中心,昆明650111 [3]云南省中药和民族药新药创制企业重点实验室,昆明650111

出　　处：《天津中医药大学学报》2020年第2期226-230,共5页Journal of Tianjin University of Traditional Chinese Medicine

基　　金：云南省科技厅项目(2018DC002)。

摘　　要：[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。[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.

关 键 词：重黄温敏凝胶 重楼皂苷VI 体外释放 高效液相色谱-蒸发光散射检测 

分 类 号：R284.1[医药卫生—中药学]