【摘要】 目的:建立HPLC测定白头翁总皂苷乳剂中白头翁皂苷B3及白头翁皂苷BD含量的方法,测定该乳剂体外释放度。方法:采用液液萃取法处理样品,HPLC进行检测。色谱条件为Diamonsil C18色谱柱(4.6 mm×250 mm,5μm),C18保护柱(4.0 mm×3.0 mm),柱温40℃,流动相乙腈-水-四氢呋喃(52∶45∶3),流速1.0 mL·min-1,检测波长203 nm,进样量10μL。采用改良的动态透析法进行白头翁总皂苷乳剂及白头翁总皂苷水溶液的体外释药试验。结果:白头翁皂苷B3和白头翁皂苷BD的线性范围分别为0.01～1(r=0.999 6),0.01～2(r=0.999 8)g·L-1,精密度的RSD分别为3.19%,1.17%,重复性RSD分别为1.40%,1.60%,平均回收率分别为99.63%,100.27%。3批白头翁总皂苷乳剂中白头翁皂苷B3质量浓度分别为0.186,0.190,0.191 g·L-1,白头翁皂苷BD分别为0.069,0.065,0.066 g·L-1。该乳剂中白头翁皂苷B3及白头翁皂苷BD在pH 7.4磷酸盐缓冲液中12 h的累积释放率分别91.30%,74.97%。结论:建立的方法准确、灵敏,适用于白头翁乳剂指标成分含量及释放度的测定。更多还原

【Abstract】 Objective: To establish an RP-HPLC method for determination of pulsatilla saponin B3 and pulsatilla saponin BD in pulsatilla total saponins emulsions,and determine its in vitro release. Method: Liquidliquid extraction method was adopted to dispose samples and HPLC was adopted to detect. Chromatographic conditions were as follows: Diamonsil C18column( 4. 6 mm × 250 mm,5 μm),C18guard column( 4. 0 mm × 3. 0mm),column temperature 40 ℃,mobile phase of acetonitrile-water-tetrahydrofuran( 52 ∶ 45 ∶ 3),flow rate 1. 0mL·min- 1,detection wavelength 203 nm,injection volume 10 μL. In vitro release tests of pulsatilla total saponins emulsions and pulsatilla total saponins solution were adopted modified dynamic dialysis. Result: Linear ranges of pulsatilla saponin B3 and pulsatilla saponin BD were 0. 01-1( r = 0. 999 6) and 0. 01-2( r = 0. 999 8)g·L- 1,RSD of precision were 3. 19% and 1. 17%,RSD of repetition were 1. 40% and 1. 60%,average recoveries were 99. 63% and 100. 27%. The concentration of pulsatilla saponin B3 in three batches of pulsatilla total saponins emulsions were 0. 186,0. 190,0. 191 g · L- 1,the concentration of pulsatilla saponin BD were0. 069,0. 065,0. 066 g·L- 1,respectively. Cumulative release of pulsatilla saponin B3 and pulsatilla saponin BD from emulsions in pH 7. 4 phosphate buffer reached 91. 30% and 74. 97% within 12 h, respectively.Conclusion: This established method was accurate,sensitive and suitable for determination of index components and release of Pulsatillae Radix emulsions.更多还原