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目的将益生菌双歧杆菌与枸杞多糖提取物设计为口服结肠定位给药系统(OCDDS),制备0710合生元结肠靶向微生态调节剂,考查其体外释放行为及体内定位作用。方法以枸杞中多糖为指标,对制剂进行体外溶出实验,并利用X-射线跟踪技术验证0710合生元结肠靶向微生态调节剂在人体内的靶向性。结果该制剂在人工胃液2 h、人工小肠液4 h,几乎不释药,而在人工结肠液中6 h释药达到100%,符合中国药典2005年版对缓释制剂的规定,且体内实验在结肠中黏附性较好。结论0710合生元结肠靶向微生态调节剂在体外结肠液中释放良好,在体内结肠具有靶向性,达到制剂设计要求。
OBJECTIVE To design probiotics Bifidobacterium and LBP extracts as oral colon-specific delivery system (OCDDS), and to prepare 0710 biocontrol colon-targeted microecological regulator to investigate their in vitro release behavior and in vivo localization. Methods Lycium barbarum polysaccharide as an indicator of the preparation in vitro dissolution experiments and the use of X-ray tracing technology to verify 0710 co-colon colonization of micro-ecological regulator targeting in the human body. Results The preparation released almost no drug in the artificial gastric juice for 2 h and artificial intestinal fluid for 4 h, whereas the release in artificial colon juice reached 100% in 6 h, which accorded with the provisions of the Chinese Pharmacopoeia 2005 edition for sustained release preparations. Colon adhesion is better. Conclusions The 0710 biomimetic colon-targeted microecological modulator released well in colonic fluid in vitro and targeted in the colon to achieve the formulation design requirements.