纳米碳酸钙肠溶生物黏附片的制备工艺研究  

Preparation technology of nanometer calcium carbonate enteric-coated bioadhesive tablets

作　　者：魏科达[1,2] 徐幸民[1,2] 方平飞[1] 赵绪元[1,2] 

机构地区：[1]中南大学药学院,长沙410013 [2]中南大学湘雅二医院药剂科,长沙410011

出　　处：《中国新药杂志》2010年第14期1275-1280,共6页Chinese Journal of New Drugs

摘　　要：目的:研究纳米碳酸钙肠溶生物黏附片(NCaEBT)的制备工艺。方法:片芯处方筛选以HPMCK4M和CP 940的用量为考察因素,以Ca2+在1,4 h的累积释放度和黏附力为指标,采用星点设计-效应面优化法,确定片芯优化处方;对优化处方下制备的NCaEBT片芯以丙烯酸树脂Eudragit L100-55为肠溶液进行肠溶包衣,考察肠溶衣增重对NCaEBT的影响。结果:片芯处方筛选时以多元线性方程拟合的效果为佳,且具有较高的可信度,优化处方为片芯中HPMC K4M和CP 940的含量分别为15和27.5 mg,肠溶衣增重为片芯的10%。结论:本课题研制的NCaEBT体外试验能够实现肠定位、生物黏附和缓慢释放的特征,可用于开发成为驱铅治疗药物。Objective：To study the preparation technology of nanometer calcium carbonate enteric-coated bioadhesive tablets（NCaEBT）.Methods：The pellet of NCaEBT was prepared with two different granules.The formulation of NCaEBT pellet was optimized by central composite design/response surface methodology with the independent variables of the amount of HPMC K4M and CP 940,and with the dependent variables of the dissolution of Ca2＋ at 1,4 h and adhesive property of pellet.The coating level of Eudragit L100-55 on the NCaEBT was investigated.Results：Regression coefficients of first order model were preferred.Optimized formulation of pellet of NCaEBT consisted of 15 mg HPMC K4M and 27.5 mg CP 940.The coating level of Eudragit L100-55 was about 10%.Conclusion：The NCaEBT showed the characteristic of enteric target,bioadhesive,delayed release in vitro,which may be developed for lead intoxicated therapy.

关 键 词：纳米碳酸钙 驱铅 肠溶 生物黏附 星点设计-效应面法 

分 类 号：R943.4[医药卫生—药剂学]