对蒙脱石国家标准中杂质检查项目的讨论  

Discussion on the Impurity Inspection of the National Standard of Montmorillonite

作　　者：王绯[1] 

机构地区：[1]国家药典委员会,北京100061

出　　处：《中国药事》2012年第12期1343-1347,共5页Chinese Pharmaceutical Affairs

摘　　要：目的将方英石和其他杂质检查纳入蒙脱石国家标准中,完善其原料标准。方法论述了蒙脱石国家标准中方英石和其他杂质检查项目制定的必要性、检查方法的建立和具体内容。结果与结论通过对蒙脱石国家标准中晶体杂质矿物,即致癌物质方英石等的有效控制,促使制剂生产企业为保证产品质量的稳定性而选择优质的原矿,最大限度地减少有害杂质含量,真正意义上保证产品的安全性和有效性,同时也为今后非晶态杂质的标准研究制定奠定了基础。Objective To perfect the national standard of montmorillonitein by integrating the specific contents of inspection for cristobalite and other impurities.Methods The necessity,the development and specific content of cristobalite and other impurities inspection in the national standard of montmorillonite for perfecting national standards were reviewed.Results and Conclusion Because cristobalite in the crystal impurity minerals can cause cancer,it must be controlled effectively in accordance with the montmorillonite national standard.This strict requirement would force preparation production enterprises to choose high quality source of ore to ensure the montmorillonitein safety and reduce the content of harmful impurities to a minimum level,so as to guarantee the safety and efficacy of product in its true sense.This standard perfection would also lay a foundation for establishing non-crystal impurities specifications in the future.

关 键 词：蒙脱石 方英石 石英 X-射线粉末衍射 国家标准 

分 类 号：R926[医药卫生—药学]