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机构地区:[1]北京中医药大学中药学院,北京100102 [2]北京中医药大学基建处,北京100029
出 处:《世界科学技术-中医药现代化》2015年第1期243-248,共6页Modernization of Traditional Chinese Medicine and Materia Medica-World Science and Technology
基 金:国家自然科学基金委面上项目(81173562):膜乳化耦合溶剂挥发法的方法研究及微球性质规则模型的建立;负责人:蔡程科;北京中医药大学创新团队发展计划资助项目(2011-CXTD-13):北京中医药大学复方中药制药研究创新团队;负责人:杜守颖;北京中医药大学自主选题项目(2014-JYBZZ-XS-085):水飞蓟宾过膜微粒的制备工艺及药效学研究;负责人:伊辛
摘 要:目的采用不锈钢膜乳化溶剂挥发法制备水飞蓟宾微粒。方法:以微粒粒径及径距为指标,结合单因素考察和均匀设计,确定水飞蓟宾微粒制备的优化工艺条件。在单因素膜管孔径、油相水相体积比、水相浓度、乳液与PVA溶液体积比、药物浓度与过膜压力中,筛选出对结果影响较大的3个因素,即水相浓度、油相水相浓度与过膜压力。结果:通过均匀设计得优化工艺条件为,水相浓度为5%、油相水相体积比1:4、过膜压力0.2 MPa。本实验中水飞蓟宾微粒的平均值D(0.5)为3.22μm,平均span值为1.26,在电子显微镜下观察,药物微粒整齐、均匀。结论:通过不锈钢膜乳化法制备水飞蓟宾微粒,可得到粒径均一、可控的水飞蓟宾微粒,该工艺简单、快速、稳定、可靠。Silybin particles were prepared through innovative stainless steel film method. Regarding the average size of particles and span as the index factors, and in consideration of single factor investigation and uniform design, the optimum process conditions for preparation of the silybin particles were determined. Three factors, i.e. the concentration of PVA, medicated ethyl acetate and PVA solution volume ratio, pressure, were selected as the single factors. Based on the results of uniform design test, the optimized condition was that the concentration of PVA was 5%, medicated ethyl acetate and PVA solution volume ratio was 1:4, and the extrusion pressure was 0.2 MPa. The average particle size was 3.22 bern, and the average diameter was 1.26. Observed through electronic microscope, the particle sllape looked regularand uniform. Through the method of stainless sleel membrane emulsificalion, lhe silybin particle was prepared with uniformity and qualily control. The process was simple, rapid, stable, and uniform.
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