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综述中药制药过程中超滤膜完整性评价手段,整理超滤膜完整性评价手段的文献,并结合中药制药过程中超滤技术应用特点进行发展趋势分析。直接、间接完整性检测法均具有一定的实用性,但是应用范围有待进一步评价,其中常用的气泡点法和扩散流法可对膜完整性进行快速评价,但无法在使用过程中进行检测;替代挑战实验法多采用外源性探针,灵敏度高却存在污染。现有的膜完整性检测方法无法满足中药制药过程中无外源性添加污染、指标灵敏、在线监控的要求,经分析发现间接检查法是未来膜完整性评价方法的研究方向,寻找内源性探针对提升膜完整性的检测水平具有重要意义。
This review summarizes the methods of evaluating the integrity of UF membrane during the process of TCM and summarizes the literature on the evaluation of the UF membrane integrity. The development trend of UF membrane based on the characteristics of ultrafiltration is also analyzed. Both direct and indirect integrity tests have some practicality, but the scope of application needs further evaluation. Among them, the common bubble point method and diffusion flow method can rapidly evaluate the membrane integrity but can not be detected during use. Challenge experimental method to use more exogenous probes, high sensitivity but there is pollution. The existing membrane integrity testing method can not meet the requirement of exogenously added pollution, sensitive indicator and on-line monitoring in the process of traditional Chinese medicine manufacturing. According to the analysis, indirect inspection method is the research direction of future membrane integrity evaluation method, looking for endogenous Probe to improve the integrity of the membrane detection level is of great significance.