因卡膦酸二钠胶囊的研制及质量控制  

Preparation and the quality control of Incadronate Capsules

作　　者：何拥军[1] 谢敏浩[1] 罗世能[1] 刘娅灵[1] 邹霈[1] 

机构地区：[1]江苏省原子医学研究所,江苏无锡214063

出　　处：《中国现代应用药学》2006年第S3期913-915,共3页Chinese Journal of Modern Applied Pharmacy

摘　　要：目的探讨因卡膦酸二钠胶囊的制备工艺、质量标准,并对其稳定性进行研究。方法进行处方筛选确定处方,研究制备工艺;用紫外分光光度法测定含量、含量均匀度及溶出度;HPLC法测定有关物质;并通过对外观、含量、溶出度、有关物质等指标的考察进行了稳定性研究。结果该制剂制备工艺可行,质控方法可靠,稳定性好。结论该制剂易于制备,质量可控,质量稳定。OBJECTIVE To prepare and study the quality control of Incadronate capsule.METHODS The content,content uniformity and dissolution were determined by UV,and the related substance was determined by HPLC.Stability of appearance,content,dissolution and related substance were investigated. RESULTS The preparation technic was viable and the quality control methods were trustiness.CONCLUSION The preparation of Incadronate capsules is simple, the quality can be controlled.The Incadronate capsules are stability.

关 键 词：骨质疏松症 二膦酸盐 因卡膦酸二钠 胶囊 质量控制 

分 类 号：TQ463.6[化学工程—制药化工]