摘要
目的:研究地衣芽孢杆菌活菌肠溶胶囊处方工艺及稳定性。方法:采用现有地衣芽孢杆菌活菌胶囊内容物作为囊芯物,进行处方工艺研究,并通过加速试验6个月(40℃±2℃、RH75%±5%)和长期试验36个月(25℃±2℃、RH60%±10%)稳定性考察。结果:该品在加速和长期条件下,各项指标与0月相比无显著变化。结论:地衣芽孢杆菌活菌肠溶胶囊处方工艺可行,质量稳定。
Objective： To stdudy the preparation and stability of bacillus licheniformi enteric-coated capsules. Methods： The formulation was optimized by choice of the content in bacillus licheniformi capsules,the stability was observed by accelerated test（ 40℃ ± 2℃ 、RH75% ± 5%,6 months） and long term test（ 25 ℃ ± 2 ℃ 、RH60% ± 10%,36 months）. Results： Under accelerated test and long term test,compared with 0 months all the detection index were not significantly different. Conclusion： Both the formulation and preparation technique of bacillus licheniformi enteric-coated capsules are feasible and the quality is stable.
出处
《中国药物评价》
2016年第4期204-207,共4页
Chinese Journal of Drug Evaluation
关键词
地衣芽孢杆菌活菌
肠溶胶囊
处方
工艺
稳定性
Bacillus licheniformi
Enteric-coated capsules
Formulation
Technique
Stability
