摘要
目的 :研究凝结芽孢杆菌制成口服液及胶囊剂的稳定性 ,并预测其有效期。方法 :以经典恒温法进行加速试验 ,在不同时间取样 ,测定样品中活菌数 ,建立动力学方程 ,对口服液进行了光加速试验。对胶囊剂进行了加温高湿加速试验及光加速试验。结果 :口服液经温度加速试验3批样品有效期分别为421d、423d、433d ,口服液对光照稳定 ;胶囊剂经高温高湿加速其有效期为2a ,并对光照稳定。结论 :凝结芽孢杆菌制剂较为稳定 。
Objective: To study the stability of bacillus coagulans(TQ33) oral solution and capsule, and predict their shelf-life. Methods: Apply classical constant temperature method to accelerate experiment to determine the number of bacteria alive by sampling at the different times, and then establish dynamic equation. Accelerating experiments were practised by exposing oral solution to light and capsule to light, high temperature and heavy moisture. Results: The oral solution and capsule are stable to light. The shelf-life of three lot samples of oral solution is 421, 423 and 433 days respectively and that of capsule is two years. Conclusion: This pharmaceutical product is practically stable and meets the requirement of stability.
出处
《天津医科大学学报》
2000年第4期394-396,共3页
Journal of Tianjin Medical University
