香诃止泻颗粒剂提取分离和成型工艺研究

Study on Extraction,Isolation and Formation of Xianghe-Made Anti-Diarrhea Granules

目的建立香诃止泻颗粒剂提取分离和成型工艺条件。方法采用L9(3)4正交设计法水提分离工艺进行考察,并通过单因素考察建立颗粒剂成型工艺。结果香诃止泻颗粒剂提取分离工艺优选为:12倍水,浸泡2.5 h,煎煮3次,每次1.0 h,合并煎液,药液浓缩至相对密度0.8,10 000 r/min高速离心30 min,得上清液。成型工艺优选为:上清液浓缩至相对密度1.0,按药辅比1:1.5加入辅料混匀后,泵速1.0m L/min,进风口温度130℃,出风口温度90℃,喷雾制备细粉,用95%乙醇为润湿剂制备软材后,挤出制粒。结论优化的提取、分离和成型工艺合理、可行、稳定可控,可为申报医疗机构制剂奠定基础。

Objective： To establish the conditions of extraction,isolation and formation of Xianghe-made anti-diarrhea granules.Methods： The L9（ 3）4 orthogonal design method was used to investigate the extraction and isolation processes. And the granule formation process was established through one factor investigation method. Results： The extraction and isolation processes of Xianghe-made anti-diarrhea granules were indicated as follows： resolve Xianghe in 12 times of water; soak it for 2. 5 hours,boil it for an hour,repeat for 3 times and combine the liquid,concentrate the decoction to relative density as 0. 8,centrifuge it at 10 000 r/min for 30 minutes to obtain the supernatant. The formation process was preferred as follows： concentrate the supernatant to a relative density of 1. 0,adjust the ratio of drug component to auxiliary component as 1 to 1. 5 with 1. 0 m L/min of pump speed,set the air inlet temperature as 130℃,and the outlet temperature as 90℃ to spray and make fine powder,wet the soft material with 95% ethanol and form granules. Conclusion： The optimized extraction,isolation and formation processes are reasonable,feasible,stable and controllable,and can lay the foundation for the application of officially medical agents.