中文摘要：

目的以木犀草苷、迷迭香酸和田蓟苷为指标，检测香青兰提取物（EDM）及其指标成分在不同溶剂和助溶剂中的质量浓度和不同pH值下的表观油水分配系数（P）及其体外胃肠液中的稳定性，为今后新剂型的选择和制备提供参考。方法采用沉淀法测定提取物在不同溶剂和表面活性剂溶液中的平衡溶解度，采用摇瓶法测定其在正辛醇．水及磷酸缓冲盐中的P，并考察其在体外胃肠液中的稳定性。采用HPLC测定指标成分的量，色谱柱为Shim-pack ODS（250mm×4．6mm，5μm），流动相为乙腈-0．5％甲酸水溶液，梯度洗脱：0～30min，15％乙腈；30～55min，15％～25％乙腈；55～80min，25％～35％乙腈；体积流量1．0mL／min，检测波长324nm，柱温35℃。结果在37℃时，提取物（3个指标成分）在酸性缓冲溶液中的平衡溶解度均有明显降低，在碱性缓冲液中随pH值的增高平衡溶解度逐渐增加。在32g／L的十二烷基硫酸钠（SDS）溶液中木犀草苷、迷迭香酸和田蓟苷的平衡溶解度分别提高到1679．61、1249．20、2765．27μg/mL，增溶效果最好。EDM（3种成分）的P分别为0．1731（1gP=-0．7618）、0．0684（1gP=-1．1650）和1．0829（1gP=0．0346），且随溶液pH值的升高逐渐增加。三者均在人工肠液中稳定，除木犀草苷以外，均在人工胃液中稳定。结论建立的方法可准确测定EDM及其指标成分的溶解度和尸等，同时，在体外胃肠液环境中较稳定，为EDM今后的新剂型设计提供实验参考。

英文摘要：

Objective Taking luteolin-7-O-β-D-glucuronide, rosmarinic acid, and tilianin as indexes, the concentration of extracts from Dracocephalum moldavica （EDM） and their index components in various media, surfactant solution, and apparent oil/water partition coefficient （P） was detected in different pH values, then the stability of EDM in artificial gastrointestinal fluid was investigated. This research would give the reference for the selection and preparation of further novel formulation. Methods Apparent solubility of EDM in various media and surfactant solution was determined by precipitation method and a shake flask method was used to determine the P of octanol-water/phosphate buffer salt, the stability of EDM in artificial gastrointestinal fluid was investigated. HPLC was adopted to determine the concentration of the index components with Shim-pack ODS column （250 mm × 4.6 mm, 5 μm）, mobile phase of acetonitrile （A）-0.5% formic acid aqueous solution （B） for gradient elution （0-30 min, 15% A; 30-55 min, 15%-25% A; 55-80 min, 25%-35% A） as the mobile phase at a flow rate of 1.0 mL/min. The detection wavelength was set at 324 nm and the column temperature was maintained at 35 ℃. Results At 37 ℃, the equilibrium solubility of the three index components in acid buffer solution increased obviously in water, but in alkaline the buffer solution of the equilibrium solubility decreased with pH increasing. In 32 g/L sodium dodecyl sulfate solution, the equilibrium solubility of luteolin, rosmarinic acid, and tilianin increased to 1 679.61, 1 249.2, and 2765.27 μg/mL. The P ofluteolin-7-O-13-D-glucuronide, rosmarinic acid, and tilianin were 0.173 1 （lgP = -0.761 8）, 0.068 4 （lgP = -1.165 0）, and 1.082 9 （lgP = 0.034 6）, and increased as pH rising. EDM in artificial gastrointestinal fluid was stable （except luteolin）. Conclusion The methods can be used to determine the apparent solubility, the P value of the extracts and their index components; The EDM in artificial gastrointest