纳米枸杞多糖合生元靶向微生态调节剂的制备及质量研究

目的制备合生元结肠靶向微生态调节剂，并建立其质量标准。方法球磨法制备枸杞多糖纳米粒，并将其与双歧杆菌、结肠粘附材料按一定比例装填入结肠靶向胶囊中，制备成合生元结肠靶向微生态调节剂；苯酚-硫酸法测定制剂中多糖含量，平板活菌计数法检测制剂中活菌数量。结果球磨法制备的枸杞多糖纳米粒成类球形，表面圆整，无粘连，80％粒径集中在464nm；合生元结肠靶向微生态调节剂符合2010版药典对胶囊剂的质量要求。结论按本法制备的合生元结肠靶向微生态调节剂安全可靠，其质量符合2010版药典对胶囊剂的质量要求。

Preparation and quality evaluation of nano LBP synbiotics colon targeting microecological modulator

Objective To prepare the synbiotics colon targeting microecology modulator,and establish the standard of quality.Method Lycium polysaccharide nanoparticles were prepared by ball milling method,mixed with bifidobacterium and carbomer in certain proportion,then filled into capsules to get the colon targeting synbiotics microecological modulator.The content of polysaccharide in the preparation was determined by phenol sulfuric acid method;The quantity of viable organism in the preparation was detected by plate count method.Result Lycium polysaccharide nanoparticles were spherical and round with no adhesions,and the size of 80% of particles was around 464 nm.The quality of the colon targeting synbiotics microecological modulator meet the requirements for capsules presented in the 2010 version of Pharmacopoeia.Conclusion The colon targeting synbiotics microecological modulator prepared with the above method is safe and reliable,and its quality meets the requirements of the 2010 version of Pharmacopoeia for capsules.