摘要
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。
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 long-term test,the index of samples was stable.The samples were different among different manufacturers in terms of granularity,absorbability,content in accelerated and long-term test.CONCLUSION：The stability of Montmorillonite powder is influenced by high humidity.It is suggested to keep airproof and dry environment during storage and transplantation. The stabilities of Montmorillonite powder are different among different manufacturers.
出处
《中国药房》
CAS
CSCD
北大核心
2011年第1期41-44,共4页
China Pharmacy
关键词
蒙脱石散
厂家
稳定性
考察
Montmorillonite powder
Manufacturers
Stability
Investigation
