| 正交设计优化孟鲁司特钠片的处方工艺 |
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| 引用本文： | 闫虹,吴玉波,丛艳,李宝. 正交设计优化孟鲁司特钠片的处方工艺[J]. 中国药房, 2011, 0(29): 2743-2745 |
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| 作者姓名： | 闫虹 吴玉波 丛艳 李宝 |
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| 作者单位： | 哈尔滨医科大学附属第四医院药学部;黑龙江三元阳普医药有限公司;黑龙江天龙药业有限公司; |
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| 摘 要： | 目的:制备孟鲁司特钠片,筛选其最佳处方工艺。方法:采用正交设计法,以与进口孟鲁司特钠片的相似因子f2为指标,对自制孟鲁司特钠片中微晶纤维素与乳糖的比例(A),交联羧甲基纤维素钠(B)、羟丙基纤维素(C)和硬脂酸镁(D)的处方用量百分比进行优选,并进行验证试验。结果:优选所得A、B、C、D分别为41∶45、2.5%、5.5%、0.80%,3批优化处方所制样品f2值均大于50,2种制剂溶出曲线基本相似,30min时累积溶出度均能达到80%以上。结论:自制孟鲁司特钠片处方合理,制备工艺简单易行,体外溶出度良好。
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| 关 键 词： | 孟鲁司特钠片 溶出度 正交试验 处方工艺 |
Optimization of the Formula Technology of Montelukast Sodium Tablets by Orthogonal Test |
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| YAN Hong,WU Yu-bo CONG Yan LI Bao. Optimization of the Formula Technology of Montelukast Sodium Tablets by Orthogonal Test[J]. China Pharmacy, 2011, 0(29): 2743-2745 |
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| Authors: | YAN Hong WU Yu-bo CONG Yan LI Bao |
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| Affiliation: | YAN Hong,WU Yu-bo(Dept. of Pharmacy,The Forth Affiliated Hospital of Harbin Medical University,Harbin 150001,China) CONG Yan(Heilongjiang Sanyuan Yangpu Pharmaceutical Co.,Ltd.,Harbin 150090,China) LI Bao(Heilongjiang Tianlong Pharmaceutical Co.,China) |
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| Abstract: | OBJECTIVE： To prepare Montelukast sodium tablets, and to optimize the formula technology. METHODS： The proportion of lactose and MCC （A）, dosage of croscarmellose sodium （B）, hyprolose （C） and magnesium stearate （D） were opti- mized by orthogonal test using similar factorf2 of imported Montelukast sodium tablets as index. Validation test was conducted. RESULTS： The optimal formulation of Montelukast sodium tablet was as followed： A, B, C, D were 41 ： 45, 2.5%, 5.5% and 0.80%. The values ofj~ of 3 batches of samples were more than 50. Dissolution curves of 2 kinds of preparations were similar, and the dissolution rate at 30 min was more than 80%. CONCLUSION： The formula and preparation process of Montelukast sodium tablet is simple and feasible with good dissolution rate. |
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| Keywords: | Montelukast sodium tablets Dissolution rate Orthogonal test Formula technology |
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