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| 瑞舒伐他汀钙片剂的处方工艺及稳定性 |
| 高原1,张丽娟1,连天雁2,姚翀1,台宗光1,王晓宇1,高申1* |
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(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
*通信作者) |
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| 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。 |
| 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 |
| DOI：10.3724/SP.J.1008.2015.01029 |
| 投稿时间：2014-12-28修订日期：2015-05-02 |
| 基金项目: |
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| Investigation of formulation, preparation and stability of rosuvastatin calcium tablets |
| GAO Yuan1,ZHANG Li-juan1,LIAN Tian-yan2,YAO Chong1,TAI Zong-guang1,WANG Xiao-yu1,GAO Shen1* |
(1. Department of Pharmacy, Changhai Hospital, Second Military Medical University, Shanghai 200433, China;
2. Department of Pharmacy, Shanghai Dermatology Hospital, Shanghai 200070, China
*Corresponding author) |
| Abstract: |
| 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. |
| Key words: rosuvastatin calcium dissolution pharmaceutical technology pharmaceutical chemistry high sheer mixer fluid bed drug stability |
