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重黄温敏凝胶中重楼皂苷Ⅵ含量测定及体外释放研究
孙媛,丁江生,万近福
1.云南白药集团创新研发中心, 昆明 650111;2.云南省中药和民族药新药创制企业重点实验室, 昆明 650111
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10 μL,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0.430 0~4.300 0 mg范围内线性良好,lgA=1.796 9lgC +4.398 9(r2=0.999 9),定量限为0.054 0 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。
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
DOI:10.11656/j.issn.1673-9043.2020.02.23
分类号:R284.1
基金项目:云南省科技厅项目(2018DC002)。
Determination and release in vitro of polyphyllin VI in ChongHuang thermosensitive in situ gel
SUN Yuan1,2,3, DING Jiangsheng1,2,3, WAN Jinfu1,2,3
1.Yunnan Institute of Materia Medica, Kunming 650111, China;2.Yunnan Baiyao Group Innovation and R&D Center, Kunming 650111, China;3.Yunnan Province Company Key Laboratory for Traditional Chinese Medicine and Ethnic Drug of New Drug Creation, Kunming 650111, China
Abstract:
[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,5 μm),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 10 μL,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 0.430 0~4.300 0 mg,lgA=1.796 9lgC+4.398 9(R2=0.999 9),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.
Key words:  Chonghuang thermosensitive in situ gel  polyphyllin VI  in vitro release  HPLC-ELSD
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