| 头孢地尼胶囊的处方工艺研究 |
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| 引用本文： | 康,帅.头孢地尼胶囊的处方工艺研究[J].河北工业科技,2012,29(4):208-210. |
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| 作者姓名： | 康 帅 |
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| 作者单位： | 华北制药股份有限公司研发中心,河北石家庄,050015 |
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| 摘 要： | 为优选头孢地尼胶囊的处方工艺并考察其重现性及稳定性,根据辅料相容性结果,采用正交设计试验,以4种介质溶出相似性(f2因子)为指标综合评分,筛选最优处方。以羧甲基纤维素钙为崩解剂,聚氧乙烯(40)硬脂酸酯为增溶剂,二氧化硅为助流剂,硬脂酸镁为润滑剂,采用湿法制粒工艺。结果表明,优选的头孢地尼胶囊处方工艺合理,成品质量稳定。
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| 关 键 词： | 头孢地尼 处方工艺 正交试验 |
| 收稿时间： | 2012/3/9 0:00:00 |
| 修稿时间： | 2012/4/18 0:00:00 |
Research into formulation and technology of cefdinir capsules |
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| KANG Shuai.Research into formulation and technology of cefdinir capsules[J].Hebei Journal of Industrial Science & Technology,2012,29(4):208-210. |
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| Authors: | KANG Shuai |
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| Institution: | KANG Shuai(Research and Development Centre,North China Pharmaceutical Company Limited,Shijiazhuang Hebei 050015,China) |
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| Abstract: | To optimize the formulation and technology of cefdinir capsules and investigate its reproducibility and stability,the formula is optimized by using orthogonal design according to comprehensive score of the four dissolution media dissolution similarity(f2 factor).The excipient compatibility is observed,with carboxymethylcellulose calcium as disintegrant,polyoxyl 40 stearate as solubilizer,silicon dioxide as flow aid and magnesium stearate as lubricant and wet granulation.The preparation process is simple and reasonable,and the quality of the products is stable. |
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| Keywords: | cefdinir formulation and technology orthogonal test |
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