纳米碳酸钙肠溶生物黏附片的质量评价方法研究  

Quality assessment of nanometer calcium carbonate enteric-coated bioadhesive tablets

作　　者：魏科达[1,2] 徐虹[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：《中南药学》2009年第10期741-744,共4页Central South Pharmacy

摘　　要：目的建立纳米碳酸钙肠溶生物黏附片的质量评价方法。方法采用紫外分光光度法来研究NCaEBT的释放度;采用酸碱滴定法来测定NCaEBT的含量;以自制生物黏附测定装置测定NCaEBT的黏附力。结果NCaE-BT在pH 1.0盐酸溶液中稳定、不释放,而在pH 6.0醋酸缓冲溶液中开始释放,4 h的累积释放度〉75%;纳米碳酸钙含量在0-500 mg线性关系良好（R2=0.999 4）,平均回收率为97.56%,RSD为1.3%;NCaEBT的黏附力为24.9 g.cm-2。结论NCaEBT含量、释放度和黏附力的测定方法简便、快速、准确,可作为其质量评价方法。Objective To establish a quality assessment for nanometer calcium carbonate enteric-coated bioadhesive tablets（NCaEBT）.Methods The release property of NCaEBT was evaluated by ultraviolet spectrophotometry.The content of NCaEBT was determined by acid-base titration,and the bioadhesive property of NCaEBT was evaluated by the bioadhesive equipment.Results NCaEBT did not dissolve in 2 h in hydrochloric acid,but strarted to dissolve in pH 6.0 HAc buffer solution.The accumulation release reached over 75% in 4 h.The detection content range of nanometer calcium carbonate was 0～500 mg,the linearity was good,the average recovery rate was 97.2%,and RSD=1.3%.The adhesive force of NCaEBT was 24.9 g·cm^-2.Conclusion The assay for release profile determination and adhesive force determination is simple,quick and accurate.It could be used for the quality assessment of NCaEBT.

关 键 词：纳米碳酸钙 驱铅 肠溶生物黏附片 质量评价 

分 类 号：R965[医药卫生—药理学]