地衣芽孢杆菌活菌肠溶胶囊处方工艺及稳定性研究

地衣芽孢杆菌活菌肠溶胶囊处方工艺及稳定性研究

王彦君

东北制药集团股份有限公司

收稿日期:2016-04-08 修回日期:2016-04-08 出版日期:2016-08-25 发布日期:2016-08-25

Study on preparation and stability of bacillus licheniformi enteric coated capsules

Northeast Pharmaceutical Group Co., Ltd

Received:2016-04-08 Revised:2016-04-08 Online:2016-08-25 Published:2016-08-25

摘要/Abstract

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(整肠生)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℃EeEe2℃、RH75%EeEe5℃)和长期试验36个月(25℃EeEe2℃、RH60%EeEe10%)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。

Abstract: 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 (zhengchangsheng), the stability was observed by accelerated test (40℃EeEe2℃、RH75?Ee5℃,6 months) and Long term test (25℃EeEe2℃、RH60?Ee10%,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 its quality is stable.

王彦君. 地衣芽孢杆菌活菌肠溶胶囊处方工艺及稳定性研究[J]. .