目的 解决制药行业中膜技术应用存在的技术瓶颈, 建立快速可行的超滤膜孔径评价方法。方法 在前期研究的基础上, 筛选出三七皂苷R₁及人参皂苷Rg₁、Rb₁和Rd为指标成分, 累积各成分在截留相对分子质量(MWCO)1×10³～1×10⁵超滤膜中的分离数据, 分析系列截留率(R)与膜MWCO数据之间的相关性。结果 三七皂苷R₁及人参皂苷Rg₁、Rb₁和Rd的R与超滤膜MWCO之间可以拟合成分段方程, 回归系数均大于0.98, 通过多种超滤膜进行检测验证。结论 建立了以成分累计R进行初步评判, 进而采用方程计算的膜孔径评价方法, 该方法对实验条件要求低, 成本低, 且结果准确, 将有效提升膜分离技术在制药行业中的推广应用。

Objective To solve the technical bottleneck in the application of membrane technology in pharmaceutical industry and to establish a fast and feasible method for evaluating molecular weight cut-off (MWCO) of ultrafiltration membrane. Methods Based on works, Panax notoginseng saponins (PNS), R₁, Rg₁, Rb₁, and Rd, were selected as indexes for filtering with series ultrafiltration membranes, the retention rate of PNS was accumulated and analyzed with different MWCOs (1 × 10³—1 × 10⁵). Results The relevant equations were fitted by linear and exponential function, the regression coefficients of equations between the retention rates of PNS and MWCOs were bigger than 0.98. Then, the equations were applied for calculating the different MWCOs of being-measured ultrafiltration membranes. Conclusion Preliminary judgment is obtained by comparison analysis of cumulative retention rate, and then the optimal MWCO under tested membranes is calculated by subsection equations. This research results have provided a simple and rapid method of evaluating the membrane MWCOs for pharmaceutical industries.

国家自然科学基金资助项目(81373980);江苏省高校自然科学研究基金项目(12KJB360009);南京中医药大学青年自然科学基金资助项目(13XZR24);江苏高校优势学科建设工程资助项目