星点的设计―效应面法优化亚麻木酚素缓释片处方.docVIP

星点的设计―效应面法优化亚麻木酚素缓释片处方 　　摘要：目的 采用星点设计-效应面法优化亚麻木酚素缓释片处方。方法 以羟丙基甲基纤维素（HPMC）、乙基纤维素（EC）和淀粉的用量为考察因素，分别以亚麻木酚素在2、6、12 h的累积释放度为评价指标，采用星点设计-效应面优化法进行处方优选试验，并进行优化处方的验证分析。结果 最终确定缓释片的最佳处方为HPMC用量为43%，EC用量为26%，淀粉用量为17%，优化处方的考察指标预测值与观察值非常接近。结论 通过星点设计-效应面优化法建立的模型预测性良好，可用于亚麻木酚素缓释片处方的优化。 　　关键词：亚麻木酚素；缓释片；星点设计-效应面法 　　DOI：10.3969/j.issn.1005-5304.2016.04.023 　　中图分类号：R283.5 文献标识码：A 文章编号：1005-5304（2016）04-0087-04 　　Optimization of Prescription of Flaxseed Lignans Sustained-release Tablets by Central Composite Design-response Surface Methodology LIU Xiao-shuan， LI Ji-wen， WU Xiao-qin， SHU Jin， JIAO Zheng-hua， QIAN Meng-ru， BI Ying-yan （TCM Hospital of Gansu Province， Lanzhou 730050， China） 　　Abstract： Objective To optimize the prescription of flaxseed lignans sustained release tables by central composite design-response surface methodology. Methods With HPMC， EC and starch dosage as factors， and flaxseed lignans in 2， 6 and 12 h of cumulative release as evaluation indexes， central composite design-response surface optimization method was used to conduct prescription optimization experiments， and optimized prescription analysis was carried out. Results The optimal prescription of flaxseed lignans sustained release tables was as following： HPMC dosage was 43%； EC was 26%； starch content was 17%. Optimized index forecast values were very close to the observed values. In vitro release test of three selected optimal formulations indicated that there existed high approximation between the observed and estimated values. Conclusion It shows that the established model is suitable for flaxseed lignans sustained release tables， which can be used in the optimization of the prescription of flaxseed lignans sustained release tables. 　　Key words： flaxseed lignans； sustained-release tablets； central composite design-response surface methodology 　　亚麻木酚素是与人体雌激素十分相似的植物雌激素，具有抗氧化、延缓衰老[1]、抗肿瘤[2]、预防骨质疏松[3]、降低血清胆固醇[4]等功效，尤其在减轻妇女绝经期症状、预防乳腺癌、前列腺癌等方面有良好疗效[5]，在预防糖尿病方面发挥着重要的作用[6]。本研究以丙基甲基纤维素（HPMC）、乙基纤维素（EC）为混合