布洛芬肠溶滴丸的制备及其体外释药考察  

Preparation and Drug Release in vitro of Ibuprofen Enteric Dropping Pills

作　　者：胡拥军[1] 宋玲[1] Hu Yongjun;Song Ling(Department of Pharmacy,Hubei Maternal and Child Health Hospital,Wuhan 430070,China)

机构地区：[1]湖北省妇幼保健院药剂科,武汉430070

出　　处：《中国药师》2018年第11期2076-2078,共3页China Pharmacist

摘　　要：目的:制备布洛芬(IPF)肠溶滴丸,并考察其体外释药特性。方法:以PEG6000为基质,用正交试验筛选IPF滴丸的最佳处方及工艺;用正交试验对肠溶包衣材料及包衣工艺进行优化。以市售IPF片为对照,转篮法对IPF肠溶滴丸的体外释药进行考察。结果:IPF肠溶滴丸最佳制备条件为:IPF与基质的质量比为1∶3,滴速为65滴/min,滴制温度为90℃,冷凝液温度为10℃,肠溶材料为10%聚丙烯酸树脂Ⅱ。市售IPF片在人工胃液中释药明显,而IPF肠溶滴丸在其中无明显释药;在人工肠液中IPF肠溶滴丸的释药速度显著高于市售IPF片(P <0. 05)。结论:IPF肠溶滴丸处方工艺简单,具有明显的肠溶效果,值得进一步研发。Objective： To prepare ibuprofen （IPF） enteric dropping pills and study the drug release in vitro. Methods： PEG6000 was used as the base, the optimal formula and preparation process of IPF dropping pills were screened by an orthogonal design, and then the enteric coating material and the coating process were optimized by an orthogonal design. Compared with the marketed IPF tablets, the drug release of IPF enteric dropping pills in vitro was studied using a suspended basket method. Results ： The optimal preparation conditions of IPF enteric dropping pills were as follows ： the ratio of IPF to the base was 1 ： 3, the dropping speed was 65 drops·min^-1, the dropping temperature was 90, the temperature of cooling solvent was 10℃, and the enteric coating material was 10% polyaerylic resin II. The marketed IPF tablets released drug significantly in artificial gastric fluid, while IPF enteric dropping pills showed no notable drug release. In artificial intestinal fluid, IPF enteric dropping pills released drug more quickly than the marketed IPF tablets （ P 〈 0.05 ）. Conclusion： The formula and preparation process of IPF enteric dropping pills are simple with promising en- teric effect, which are valuable to be studied further.

关 键 词：布洛芬 肠溶滴丸 体外释药 

分 类 号：R944.9[医药卫生—药剂学]