目的 采用牛磺脱氧胆酸钠（sodium taurodeoxycholate，STD）与二氢杨梅素（dihydromyricetin，DMY）进行共无定形体系（coamorphous system，CAS）制备考察，以改善DMY溶解性能和物理稳定性。方法 通过减压旋转蒸发法进行制备，根据溶解度考察DMY与STD最佳物质的量比；利用粉末X射线衍射、差示扫描量热分析、傅里叶变换红外光谱、拉曼光谱和扫描电子显微镜技术表征其固态特征，并考察其在不同pH值缓冲液中的溶解度，选择最佳物质的量比的共无定形体系进行过饱和粉末溶出考察，并进一步探究其物理稳定性、原辅料相容性、吸湿及引湿性质。结果 固态表征结果显示，DMY与STD存在分子间相互作用，具有单一玻璃化转变温度；溶解度结果显示，在DMY与STD的物质的量比为1∶1、1∶2、1∶3的CAS中，DMY的溶解度均高于其原料药及其物理混合物；物质的量比为1∶3时，DMY-STD-CAS-3中DMY在不同介质下平衡溶解度均明显提升；在40 ℃、75%相对湿度条件下，其稳定性高达3个月。结论 DMY-STD-CAS大幅提高了DMY的溶解度和溶出度，并具有良好的物理稳定性。

Objective To prepare a coamorphous system (CAS) of sodium taurodeoxycholate (STD) and dihydromyricetin (DMY) to improve the solubility and physical stability of DMY. Methods The CAS was prepared by vacuum rotary evaporation. The optimal molar ratio of DMY to STD was determined based on solubility. The solid-state characteristics were characterized by powder X-ray diffraction, differential scanning calorimetry, Fourier transform infrared spectroscopy, Raman spectroscopy, and scanning electron microscopy. The solubility in different pH buffer solutions was investigated. The supersaturated powder dissolution of the CAS with the optimal molar ratio was examined, and its physical stability, compatibility of raw materials and excipients, and hygroscopic and moisture-attracting properties were further explored. Results The solid-state characterization showed that there was an intermolecular interaction between DMY and STD, and a single glass transition temperature was observed. Solubility results indicated that the solubility of DMY in the CAS with molar ratios of 1:1, 1:2 and 1:3 was higher than that of the raw material and its physical mixture. The equilibrium solubility of DMY in DMY-STD-CAS-3 (molar ratio 1:3) has significantly increased under different media. The stability was maintained for up to three months at 40 ℃ and 75% relative humidity.Conclusion DMY-STD-CAS significantly improved the solubility and dissolution rate of DMY and exhibited good physical stability.

R283.6

国家自然科学基金资助项目（82260827）；国家自然科学基金资助项目（U1812403-4-4）；贵州省自然科学基金会（［2020］1Z069）；贵州省科技计划项目（黔科合支撑［2020］4Y240号）；贵州省高层次创新型人才十层次人才项目（黔科合平台人才-GCC［2023］048）；贵州省科技创新基地（黔科合中引地［2023］003）