瑞舒伐他汀钙片剂的处方工艺及稳定性  

Investigation of formulation,preparation and stability of rosuvastatin calcium tablets

作　　者：高原[1] 张丽娟[1] 连天雁 姚翀[1] 台宗光 王晓宇[1] 高申[1] 

机构地区：[1]第二军医大学长海医院药学部,上海200433 [2]上海市皮肤科医院药剂科,上海200070

出　　处：《第二军医大学学报》2015年第9期1029-1033,共5页Academic Journal of Second Military Medical University

摘　　要：目的获得重现性好、质量稳定的瑞舒伐他汀钙片处方和工艺。方法筛选合适的处方,分别采用高速搅拌制粒和沸腾床制粒制备舒伐他汀钙颗粒,考察对颗粒性质、压片特性和溶出度等质量的影响,考察所选处方和制备工艺的重现性,并进行制剂的影响因素研究。结果高速搅拌制粒比沸腾床制粒工艺更优;按筛选的处方工艺制备的3批中试样品满足质量要求;其溶出度与原研药"Crestor"溶出行为相似;光照、湿度和温度影响瑞舒伐他汀钙片剂的稳定性。结论所筛选的处方和工艺重现性良好、质量稳定。Objective To explore the formulation and preparation technique of rosuvastatin calcium tablets with satisfactory stability and reproducibility. Methods Using suitable formulations, we prepared the rosuvastatin calcium granulates by high shear mixer and fluid bed separately, and compared their influences on the granulate properties, tablet characteristics and dissolution. The reproducibility of formulation and preparation technique was investigated. Furthermore, the factors affecting the formulation were also investigated. Results Compared with the fluid bed, granulation using high sheer mixer was more suitable for preparing rosuvastatin calcium granulates. The selected formulation and preparation technique yielded 3 batches of rosuvastatin calcium tablets which met the quality requirement. The tablets had a comparable dissolution profiles to ＂Crestor ＂ of AstraZeneca. The stability of rosuvastatin calcium was largely affected by the strong light, high humidity and high temperature. Conclusion The optimized formulation and preparation technique have good reproducibility for preparing rosuvastatin calcium tablets, which have good stability.

关 键 词：瑞舒伐他汀钙 溶出度 制药工艺学 药物化学 高速搅拌制粒机 沸腾床 药物稳定性 

分 类 号：R943.4[医药卫生—药剂学]