目的 以杜仲叶Eucommiae Folium水提液为模型药物，通过探索液、固体物料指标成分含量相关性，构建面向中药澄清精制膜工艺过程评估的简便方法。方法 将杜仲叶水提液依次以多种微滤和超滤膜集成工艺澄清、精制，杜仲叶水提原液记为W1，过200 nm陶瓷膜透过液记为W2，之后分别过相对分子质量为10 000、3500超滤膜，透过液记为W3、W4，测量过膜前后药效物质（粗多糖、总黄酮、总多酚、绿原酸）和大分子非药效杂质（蛋白质）含量。并开展液、固体物料指标成分含量相关性模型的理论推导。结果 发现指标性成分在干浸膏中的含量为指标性成分在液体物料中的含量与固含率的比值，以绿原酸与总蛋白为例进行验证，实测值与估算值极为接近。结论 作为实际生产中对膜澄清、精制工艺科学、合理性判断的一种简便方法，该模型虽有一定局限性，但作为解决复杂体系膜工程化问题的手段，则表现出较大的灵活性和实用性，可为基于膜过程的中药制药分离工艺智能化提供新的思路与方法。

Objective The water extract of Eucommiae Folium was chosen as the model formulae for this study. The correlations between the concentrations of indicative components in liquid extracts and solid form were used to facilitate convenient indication, for which the membrane performance can be evaluated as a clarification and refinement process in the pharmaceutical process of TCM manufacturing. Method The extract was processed through an integrated membrane system of microfiltration and nanofiltration for clarification and refinement purpose. The original extract was noted as W1 and the permeate from the microfiltration process by the 200 nm ceramic membrane was noted as W2. Then the permeate from the microfiltration process was treated with ultrafiltration process of membrane with molecular weight cut-off value of 10 000 and 3500 respectively. The permeate from the 10 000 and 3500 membrane process was noted as W3 and W4 namely. The concentrations of the bioactive components (i.e. polysaccharides, total flavonoids, total polyphenols, and chlorogenic acid) as well as the inactive composition (i.e. proteins) in the liquid extracts before and after the membrane treatment were measured. Quantitative analysis was carried out to investigate the feasibility of using the concentrations of indicative components in the liquid the extracts as an indicator of the quantity in solid form. Result It was found that the quantity of the indicative components in solid can be estimated by the concentrations of the components in the water extract divided by the solid fraction of the extract. The results were confirmed by the analytical tests and estimation of chlorogenic acids and proteins. Conclusion The estimation approach can provide feasible way for the evaluation during the clarification and refinement processes by the integrated membrane technologies for TCM manufacturing. It is important to note that though the abovementioned approach has certain limitations, it provides an insightful path that allows scientists and engineers to closely monitor the compositions in the liquid extracts for final product evaluation, offering navigation to process optimization with flexibility.

R283.6

国家科技部重点研发计划"中医药现代化研究"重点专项（2019YFC1711300）；中国博士后科学基金资助项目（2020M672575）