过程能力指数在粉末直压工艺研究中的应用

Application of process capability index in powder direct pressing process

中文关键词:  过程能力指数  统计过程控制  粉末直接压片  微晶纤维素  片重差异

英文关键词:process capability indices  statistical process control  direct powder compression  microcrystalline  tablet weight variation tolerances

中文摘要:

      目的 研究普通型微晶纤维素及102型微晶纤维素对粉末直接压片的B族维生素片片重稳定性的影响, 选出最适合制备B族维生素片的微晶纤维素应用方案。方法 以可衡量片重稳定性的过程能力指数为主要评价指标, 关联压片压力、脆碎度及崩解时间为辅助评价指标, 分别考察普通型微晶纤维素、102型微晶纤维素及两者以不同比例组合使用时制备B族维生素片的工艺顺应性。结果 在粉末直接压片中, 普通型微晶纤维素及102型微晶纤维对B族维生素片的压片压力、脆碎度及崩解的影响差异较小; 102型微晶纤维素的片重稳定性明显优于普通型微晶纤维素, 但两者以3:1的比例组合使用, 是最适合的使用方案。结论 在粉末直接压片的工艺研究中, 借助过程能力指数, 可获得较高性价比的工艺配方。

英文摘要:

      Objective To study the effects of ordinary microcrystalline cellulose and 102 type microcrystalline cellulose on the stability of B-Complex vitamins tablets, which was directly pressed by powder, in order to find out the most suitable scheme for the preparation of B-Complex vitamin tablets. Methods With the process capability index as the main measurement, the pressure, fragility and disintegration time as the secondary indexes, the process compliance of ordinary microcrystalline cellulose, 102 type microcrystalline cellulose and their combination in different proportions were investigated. Results In powder direct compression, the influence of ordinary microcrystalline cellulose and 102 type microcrystalline cellulose on the compression pressure, fragility and disintegration of B-Complex vitamin tablets was similar. The stability of tablet weight of 102 type microcrystalline cellulose was significantly better than that of ordinary microcrystalline cellulose, but their combination in the ratio of 3:1 was the most suitable scheme. Conclusions In the process research of powder direct compression, the process formula which has a good ratio of property to price can be obtained with the help of process capability index.