蒙脫石是一種層狀結構、片狀結晶的硅酸鹽粘土礦,對致病菌及毒素有吸附和固定作用,應用于腹瀉等胃腸道疾病。由于其來源于礦物、成分復雜,質量控制存在難點,原料及制劑的分析方法有別于其他藥物。雜質礦物、粒度和吸附力檢查等項目分別表征了蒙脫石的安全性及有效性,參照國內外質量標準的收載情況,著重介紹蒙脫石原料及散劑質量控制中上述項目的設立目的、方法特點及研究進展。

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.