蒙脱石及其制剂质量控制研究进展  

Research progress on quality control of montmorillonite and preparation

作　　者：安彦[1] 王卫[1] 

机构地区：[1]天津市药品检验所,天津300070

出　　处：《药物评价研究》2016年第3期493-497,共5页Drug Evaluation Research

摘　　要：蒙脱石是一种层状结构、片状结晶的硅酸盐粘土矿,对致病菌及毒素有吸附和固定作用,应用于腹泻等胃肠道疾病。由于其来源于矿物、成分复杂,质量控制存在难点,原料及制剂的分析方法有别于其他药物。杂质矿物、粒度和吸附力检查等项目分别表征了蒙脱石的安全性及有效性,参照国内外质量标准的收载情况,着重介绍蒙脱石原料及散剂质量控制中上述项目的设立目的、方法特点及研究进展。Montmorillonite is a kind of layered structure and crystalline silicate clay minerals, which has adsorption and immobilization of bacteria and toxins, and is applied to the gastrointestinal diseases such as diarrhea. Because of its complex composition, the quality control is difficult, and the analysis methods of raw materials and preparations are different from other drugs. Montmorillonite of safety and effectiveness of the impurity minerals, particle size, and adsorption force examination project were characterized, referring to domestic and international quality standards that load, focuses on the establishment of montmorillonite and powder of quality control in the project objective, method, characteristics, and research progress.

关 键 词：蒙脱石 蒙脱石散 杂质矿物 粒度 吸附力 质量控制 

分 类 号：R282.710.5[医药卫生—中药学]