星点设计-效应面法优选软胶囊囊壳抗老化处方  

Optimal soft-gelatin capsule shell anti-aging prescription based on central composite design/response surface methodology

作　　者：孙倩楠 赵娜[1] 刘明菲 朱澄云[1] 王中彦[1] SUN Qiannan;ZHAO Na;LIU Mingfei;ZHU Chengyun;WANG Zhongyan(School of Pharmacy,Shenyang Pharmaceutical University,Shenyang 110016,China)

机构地区：[1]沈阳药科大学药学院,辽宁沈阳110016

出　　处：《沈阳药科大学学报》2018年第9期712-718,共7页Journal of Shenyang Pharmaceutical University

摘　　要：目的通过对软胶囊囊壳处方成分及剂量筛选优化,改善囊壳交联老化反应所引起的崩解迟释的状况。方法通过星点设计-效应面法,模拟三维立体的数据模型,对增塑剂的比例,崩解剂和抗氧剂的种类和剂量进行筛选优化,结合酸度调节剂和水解大豆蛋白单因素筛选,完成软胶囊壳的抗老化处方筛选。结果当增塑剂甘油与山梨醇质量比为1.95∶1;崩解剂采用聚乙二醇-400,聚乙二醇-400与明胶质量比为0.06∶1;抗氧剂采用赖氨酸,赖氨酸与明胶质量比为0.05∶1,水解大豆蛋白与明胶质量比为0.08∶1时,软胶囊囊壳具有相对稳定且较大的平衡溶胀量和较短的崩解时间。结论上述三种因素对明胶的交联老化反应具有显著的改善作用。柠檬酸和水解大豆蛋白可以显著缩短老化囊壳的崩解时间,且水解大豆蛋白的作用优于柠檬酸。由星点设计-效应面法设计得出的最佳处方合理、稳定且可行。Objective To improve the delayed disintegrating situation of soft-gelatin capsule shell caused by crosslinking reaction through optimizing and screening prescription. Methods Through the central composite design/response surface method and three-dimensional simulation data model, the ratio of plasticizer, the kinds and dosage of disintegrating agent and antioxidant were screened and optimized. Then a single factor investigation for acidity regulators and hydrolyzed soy protein was performed. Results When the ratio of glycerol and sorbitol was 1.95 ;the ratio of PEG 400 and gelatin was 0. 06：1 ,the ratio of lysine and gelatin was 0. 05 ： 1, hydrolyzed protein and gelatin was 0. 08 ： 1, the soft-gelatin capsules shell had the optimal indicator response value. Conclusion The above three factors have a significant influence on the response value of soft-gelatin capsules shell. Citric acid and hydrolyzed protein can shorten significantly the disintegration time, and the effect of hydrolyzed protein is better. The optimum prescription optimized by the central composite design/response surface method is reasonable, stable and feasible.

关 键 词：软胶囊 星点设计 效应面法 

分 类 号：R94[医药卫生—药剂学]