药用级凹凸棒黏土质量指标的初步研究

A Pilot Study on the Quality Index of Pharmaceutical Grade Attapulgite

研究药用级凹凸棒黏土的质量标准。分析比较美国药典(USP)、英国药典(BP)和我国卫生部标准(MOH)中凹凸棒黏土的质量指标,按照美国药典规定的方法,用红外光谱(FT-IR)和X-射线衍射(XRD)对经自然沉降法纯化处理的盱眙凹土进行鉴别,并对其重金属含量、微生物限度、pH值、失重、粉末细度等指标进行检测。检测结果符合药典规定,检测方法简单易行,可用于药用级凹凸棒黏土质量的控制。

The quality index of pharmaceutical grade attapulgite was studied in this paper. To establish quality standards for pharmaceutical grade attapulgite in China, the quality index of attapulgite recorded in United States pharmacopoeia （USP） standards, British pharmacopoeia （ BP） standards and Chinag ministry of health （MOH） standards were compared and analyzed. In accordance with the methods described in USP, Xuyi Attapulgite, which was purified with natural sedimentation, was differentiated by means of fourier transform infra- red spectroscopy （ FT - IR） and X - ray diffraction （ XRD ）. The quality indexes of Xuyi Attapulgite, such as the content of heavy metal, microbial limit, pH value, weight loss and fineness of attapulgite clay, were examined. The result shows that the quality of attapulgite meets the requirement of USP. The detection methods are simple and practicable, and they can be used in the quality control of pharmaceutical grade attapulgite.