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建立数学模型综合评价倍他米松片的质量
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| 篇名： | 建立数学模型综合评价倍他米松片的质量 |
| TITLE： | |
| 摘要： | 目的：考察不同企业生产的倍他米松片的质量差异，为最终建立药品相对质量优劣评价体系提供参考。方法：根据理想点法的原理和步骤，建立数学模型，将倍他米松片的3个检验指标（含量、含量均匀度和溶出度）参数以理论最佳点作理想值，以药品合格标准作下限值，转化成各指标的评价指数；各检验指标的评价指数经过理想点法计算，得到综合评价结果。结果： 3家企业生产的倍他米松片样品的综合评价结果经方差分析，P＝0.54＞0.05，即差异无统计学意义，说明各企业药品的整体质量良好。结论：利用数学模型评价不同企业生产的同品种药品的质量差异具有一定的可行性和可操作性。 |
| ABSTRACT： | OBJECTIVE：To investigate the quality differences of Betamethasone tablet from different enterprises， and provide reference for the eventual establishment of the drug relative quality evaluation system. METHODS： According to the principle and steps of the ideal point method， a mathematical model was established. And the perfect point of the 3 inspection parameters （content， content uniformity and dissolution） of Betamethasone tablet was regarded as the upper limit theoretically， and the permissible point as the prescribed minimum in the model. After homogenizing the initial data or ones to be quantifiable were translated into evaluation parameters；and the evaluation parameters were calculated by ideal point method to receive comprehensive evaluation results. RESULTS： According to variance analysis， there was no significant difference in the comprehensive evaluation results of Betamethasone tablet from different enterprises（P＝0.54＞0.05）， indicating that the overall quality of Betamehasone tablet was good. CONCLUSIONS： The mathematical model of quality evaluation with different drug has certain feasibility and operability. |
| 期刊： | 2016年第27卷第3期 |
| 作者： | 朱静毅，徐 力，李 奇，闻琍毓 |
| AUTHORS： | ZHU Jingyi，XU Li，LI Qi，WEN Liyu |
| 关键字： | 数学模型；理想点法；倍他米松片；药品质量；质量评价 |
| KEYWORDS： | Mathematical model； Ideal point method； Betamehasone tablet； Quality of drug； Quality evaluation |
| 阅读数： | 351 次 |
| 本月下载数： | 3 次 |
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