蒙脱石散质量评价及对现行质量标准的探讨  

Quality Evaluation and Discussion on the Current Quality Standards of Montmorillonite Powder

作　　者：安彦[1] 左志辉[1] 王卫[1] 唐素芳[1] 罗毅[1] 

机构地区：[1]天津市药品检验所,天津300070

出　　处：《中国药品标准》2012年第3期172-177,共6页Drug Standards of China

摘　　要：目的:评价国内蒙脱石散质量,并根据探索性试验结果对现行质量标准提出一些建议。方法:依据现行国家标准检验,并在此基础上增加重金属铅和砷含量测定、X射线衍射(XRD)检测杂质矿物、粒度分布考察等探索性试验。结果:所收集的215批蒙脱石散中不合格批数为3批,不合格率为1.4%;合格批数为212批,合格率为98.6%。结论:从按现行标准检验的结果分析,目前国内蒙脱石散产品质量状况良好;建议对现行质量标准的X射线衍射、粒度、吸附力及含量测定等项目进行修订。Objective： Evaluate the quality of domestic Montmorillonite Powder, and offer some suggestions on the current quality standards according to the exploratory results. Methods： On the basis of current quality standards, we added other determinations, such as the heavy metals lead, arsenic content determination, X-ray diffraction （XRD） detection of impurities in minerals, particle size distribution investigated exploratory experiments. Results： 3 batches failed in all 215 batches of Montmorillonite Powder collected, failure rate was 1.4% ; 212 batches qualified, with a pass rate of 98. 6%. Conclusion： According to the current standard, this results showed that currently the montmofillonite powder product quality was in good condition; but we suggested on revising the current quality standard of X-ray diffraction, particle size, adsorption force and content of Montmorillonite powder.

关 键 词：蒙脱石散 质量评价 质量标准 探讨 

分 类 号：R921.2[医药卫生—药学]