苦豆子总碱泡腾栓的稳定性试验

Stability Testing of Total Alkaloids of Sophora Alopecuroides Effervescent Suppository

目的:考察不同因素对苦豆子总碱泡腾栓稳定性的影响,为制剂临床应用和贮存提供依据。方法:按《中国药典》2005年版规定,进行影响因素试验、加速试验、长期试验,以考察其外观,色泽,融变时限,氧化苦参碱、苦参碱、槐果碱的含量变化。结果:本品在低温(-18℃)、加速试验、长期试验务件下性状、外观、氧化苦参碱、苦参碱、槐果碱的含量均符合规定。在25℃、相对湿度(RH)(60±10)%,裸露10 d,栓面出现粘稠物。结论:本品应密闭、阴凉、干燥处保存。

Objective： To investigate the different facrors on stability of total alkaloids of Sophora alopecuroides effervescent suppository to provid the experimental data for clinical application and storage of the preparation. Method： According to the relevant guidelines of the Chinese Pharmacopoeia , the factors of influence test and accelerate test and long time test was conducted to investigate the changes in appearance, mehry time limit and content. Result： Under conditions of freezing temperature（ - 18 ℃）, accelerate test and long time test, appearance and content were eligible;after the bareness （25℃ ,RH60 ± 10% ,10 d）, the appearance of effervescent suppository had dope. Conclusion： The preparation should be stored in cool and dry place and protected from strong light.