不同厂家蒙脱石散的稳定性考察

目的:考察不同厂家蒙脱石散的稳定性,为评价和控制药品质量提供依据。方法:通过影响因素试验、加速试验及长期试验,从制剂的性状、外观均匀度、酸碱度、粒度、吸附力、含量等指标方面考察4个厂家蒙脱石散在各自包装条件下的稳定性情况。结果:除在高湿条件下各指标变化较大外,在其他试验中各厂家制剂各指标变化均不大;但在加速和长期试验中不同厂家制剂在粒度、吸附力、含量等方面存在差异。结论:高湿环境对蒙脱石剂稳定性影响较大,建议在贮存及运输过程中应注意密封、干燥;不同厂家的制剂稳定性存在差异。

Study on the Stability of Montmorillonite Powder from Different Manufacturers

OBJECTIVE:To investigate the stability of Montmorillonite powder from different manufacturers,and to provide a basis for drug quality evaluation and control.METHODS:The stability of Montmorillonite powder from 4 manufacturers with different packages were investigated by the influencing factor test,accelerated test,and long-term test in respect of property,appearance,pH value,granularity,absorbability,content,etc.RESULTS:Under the condition of high humidity,the samples were instable.In accelerated test and l...