【作者】 王晓辉；

【导师】 李永吉；

【作者基本信息】 黑龙江中医药大学 ， 药剂学， 2006， 硕士

【摘要】 肠道感染性疾病发病率高，并发症多，严重地危害着人民的健康和生活质量。目前其治疗药物主要是采用普通的口服片剂、栓剂、灌肠剂等剂型，但这些剂型存在使用不便、疗效不理想、复发率高和不良反应多等缺点。立克宁肠溶微丸为具有清热解毒、消炎止痢等功效的现代中药制剂，具有在胃中不释放，在小肠中定位释放的作用。从而使药物长时间浓集在小肠部位，提高了治疗效果。本研究在前期研究基础上，主要对立克宁肠溶微丸的微丸成型工艺、肠溶包衣工艺和初步质量标准进行了研究。 在微丸成型工艺研究中采用挤出—滚圆法制备含药丸芯，经处方因素和工艺因素考察，确定立克宁肠溶微丸的成型工艺，制备所得粒径为10～18目的微丸收率在80％以上，结果比较理想。旋转包衣锅包衣法对立克宁肠溶微丸的含药丸芯包肠溶衣，单因素考察确立了包衣工艺。以丙烯酸树树脂Ⅱ号、Ⅲ号为主要薄膜包衣物料，所制得包衣微丸成品率高，体外溶出度实验表明，药物能够达到在小肠定位释放的要求。同时采用TLC进行定性研究，采用HPLC进行定量研究，测定了丁香苦苷的含量，从而为立克宁肠溶微丸的质量标准的制定提供了依据。 本研究不仅可以为立克宁肠溶微丸大生产提供了科学依据，为其进一步研究开发奠定了基础，而且可以为中药肠溶微丸的研究积累了经验。更多还原

【Abstract】 Intestinal tract infectious diseases break out widely and have many complications. It not only does great harm to people’s health and life, but also affect people’s production and work.Currently the dosage forms of the treating drug are ordinary oral tablet, suppository, clyster and so on.However, these dosage forms have shortages, such as used inconvenience, the efficacy is not ideal, relapse rate is high and number of adverse reactions is more.Likening intestinal pellets is a modern Chinese medicine preparation which has antiseptic and antiviral curative effects, with no release in the stomach and positioning release in intestine.So that the drug can prolong and improve pharmacodynamic action due to high dense in intestine.In the basis of preliminary studies, this study includes shaping technology, coating technology and primary quality standards study for Likening intestinal pellet.This study prepared pellet cores with extrusion-spheronization method, after the prescription factor and the technology factor inspected, we determined Likening intestinal pellets the preparation technology, by which we obtained particle size 10-18 mesh pellets receiving rate above 75%, the result is quite ideal.The method of revolving pot coating contains pill core by intestinal materials. The single factor inspection has established the coating technology. Acrylic acid resin Ⅱ, Ⅲ was the main thin film coating material, the coating pellet rate of finished products was high, finished produce can achieve at the intestines department release request by dissolve determination in vitro. At the same time the syringpicroside was qualitative investigation by the thin layer chromatography and quantitative investigation by HPLC. Thus the quality standard of Likening intestinal pellets was set up.更多还原