凹凸棒石散剂质量标准研究

Study on Quality Standards of Attupulgite Clay Powders

目的 研究凹凸棒石散剂的质量标准。方法 采用红外光谱法及显色法对凹凸棒石进行鉴别 ,并按卫生部部颁标准(试行 )测定其细度、酸碱度及铁、镁、铝的含量 ;采用HPLC法测定制剂吸附前后士的宁溶液浓度 ,由其变化值求出其吸附力 ;采用重量法对凹凸棒石散剂进行含量测定 ,并对其进行卫生学检查。结果 凹凸棒石红外光谱与标准品图谱基本一致 ;其pH值为 8.4 9,细度大部分都小于 7.6 μm ,凹凸棒石约吸附 4 .4 0mg·g-1士的宁 ,每袋凹凸棒石散剂中凹凸棒石含量 3.0± 0 .3g。结论 实验结果表明 ,该方法简便、准确 ,是凹凸棒石散剂质量标准可控可行的方法。

Aim To establish quality standards of attupulgite clay powders.Methods The material of attupulgite clay was analyzed.It was identified by IR and color reaction.The fineness,pH and the content of iron of attupulgite clay were determined as described in the standard of chinese ministry of health.Its absorptivity was determined by the change of strychnine in HPLC.The quality of attupulgite clay powders was controlled on drying directly,and at last it was got across hygienic examination.Results Infra-red spectrum of attupulgite clay was same as that of the standard sample.Most of its particle size was less than 7.6μm,pH was 8.49 and the content of iron was 7.44%.1g attupulgite clay adsorbed 4.40mg·g -1 strychnine.In attupulgite clay powders,attupulgite clay was 3.0±0.3g.Conclusion The results indicate that these methods are simple and accurate.They are quality control methods of attupulgite clay powders.