不同药物性质及工艺对口服固体制剂成型的影响

The Influence of Drug Properties and Productive Technologies on The Molding of Solid Oral Preparations

目的:考察物质基础显著差异的药物性质及不同的生产工艺对制剂成型工艺的影响。方法:单一成份的化学药以及成分较复杂的中药成方制剂,比较浸膏干燥方式和制粒方式之间的差异。结果与结论:单体成分的阿司匹林肠溶片性质稳定;黄连上清片浸膏热风循环干燥较带式真空干燥水分低,带式真空干燥浸膏粉吸湿性较热风循环干燥大,黄连上清片带式真空干燥浸膏经二次制粒后抗张强度降低,片重差异得到改善;复方牛黄消炎胶囊制粒后颗粒性质较差,制剂难度大,有待于进一步完善。

Objective To investigate the influence of the drug properties with significant difference in components, and the drug productive technologies on the molding of solid oral preparations. Methods Single - component medicine and multi - components medi- cines were selected to compare the difference of extracts drying methods and granule methods. Results and Conclusion The preparation property of Aspirin Enteric - coated Tablets was more stable than others. The moisture of Huanglianshangqing extracts on hot - wind circle drying was low than their were on band - type vacuum drying, but it was on the contrary in hygroscopicity. The tensile strength and weight of Huanglianshangqing Tablets on band - type vacuum drying was significant improved after secondary granulation. It was hard for Fufang Niuhuang Xiaoyan Capsules to pelletize for its poor granule character, which remains to improve further.