目的 研究醇料比对双黄连制剂醇沉效果及沉淀物形态的影响，探讨醇沉沉淀物分形维数综合评价醇沉效果的可行性。方法 针对双黄连制剂醇沉工艺，采用HPLC法与重量分析法，考察醇料比对指标成分综合保留率与滤饼含液率的影响；采用直接观察、原子力显微镜观察及"面积-周长"法，考察醇料比对沉淀物表观形态、微观形态及分形维数的影响。运用Pearson相关分析方法，分析醇沉沉淀物分形维数分别与指标成分综合保留率和滤饼含液率之间的相关性。结果 随着醇料比的增大，指标成分综合保留率与沉淀物分形维数均逐渐增大，而滤饼含液率则逐渐减小；沉淀物分形维数与指标成分综合保留率呈正相关，与滤饼含液率呈负相关。结论 在双黄连制剂醇沉工艺中，醇沉沉淀物分形维数可作为反映醇沉效果的综合评价指标，以期为后续双黄连制剂醇沉工艺可视化的精细控制研究提供参考。

Objective The effect of ethanol to material ratio on ethanol precipitation and sediment morphology of Shuanghuanglian preparation (SHLP) were researched, and the feasibility of comprehensive evaluation of ethanol precipitation sediment fractal dimension was discussed. Methods For the SHLP ethanol precipitation process, HPLC and gravimetric analysis were used to investigate the effects of ethanol to material ratio on the overall retention of the index components and the liquid content of the filter cake. The direct observation, atomic force microscope observation and "area-perimeter" calculation method were used to investigate the influence of ethanol to material ratio on the apparent morphology, micro-morphology and fractal dimension of the precipitate. At the same time, Pearson correlation analysis method was used to investigate the correlation between the fractal dimension and the above evaluation index of ethanol precipitation effect. Results With the increase of the ethanol to material ratio, the comprehensive retention of the index components and the fractal dimension of the ethanol precipitation precipitates was gradually increased, while the liquid content of the filter cake was gradually decreased. Therefore, the fractal dimension of sediment was positively correlated with the comprehensive retention rate of index components, but negatively correlated with the liquid content of the filter cake. Conclusion The fractal dimension of ethanol precipitation sediment can be used as comprehensive evaluation index for reflecting the ethanol precipitation effect in the SHLP ethanol precipitation process, which can provide a reference for the visualized fine control research of the subsequent SHLP ethanol precipitation process.

R283.6

国家药典委员会研究课题（ZG2018-7-02）；江西省教育厅科技研究项目（GJJ170706）；江西省卫计委中医药科研课题（20183008）；江西中医药大学一流学科建设科研启动基金项目（JXSYLXK-ZHYAO001）