响应面法优化黄果梨咀嚼片制备配方

Optimization of preparation formula of Pyrus xerophila chewable tablets by response surface methodology

中文关键词:  黄果梨  咀嚼片  响应面法  质量标准  配方优化

英文关键词:Pyrus xerophila  chewable tablets  response surface method  quality standard  formula optimization

中文摘要:

      目的 采用响应面法优化黄果梨咀嚼片制备配方, 并进行质量检测。方法 以青海同仁黄果梨为原料, 采用粉末直接压片工艺, 以休止角、卡尔指数和感官评分为指标, 采用单因素和响应面试验优化黄果梨咀嚼片的制备工艺, 并按照片剂质量标准进行硬度、脆碎度、崩解时限、片重差异的检测。结果 黄果梨咀嚼片最佳配方为: 黄果梨粉添加量32%、绵白糖添加量26%、微晶纤维素添加量15%、麦芽糊精添加量12%、硬脂酸镁添加量1%、黄果梨浸膏添加量12%、50%乙醇添加量2.55 mL/100 g。在此配方下制得的黄果梨咀嚼片, 其感官评分值为80.20。质量检验表明, 黄果梨咀嚼片硬度均大于30 N, 片重差异在±7.5%范围之内, 减失重量百分比小于0.5%, 制得样品均在15 min内崩解完成, 符合质量标准。结论 通过响应面法得到的黄果梨咀嚼片制备配方可为青海丰富的黄果梨资源开发提供实践思路和理论依据。

英文摘要:

      Objective To optimize the formulation of Pyrus xerophila chewable tablets by response surface methodology and conduct quality inspections. Methods The Pyrus xerophila (Tongren, Qinghai) chewable tablets were prepared by direct powder compression using angle of repose, Carr’s index and sensory score as the indicators, the single factor test and response surface methodology were used to optimize the preparation process, and the hardness, friability, disintegration time and difference in tablet weight were detected according to the quality standards of the tablets. Results The optimal formula of Pyrus xerophila chewable tablets was as follows: 32% of Pyrus xerophila powder, 26% of soft sugar, 15% of microcrystalline cellulose, 12% of maltodextrin, 1% of magnesium stearate, 12% of Pyrus xerophila extract and 2.55 mL/100 g of 50% ethanol. The sensory score of Pyrus xerophila chewable tablets prepared under the above conditions was 80.20. The quality inspection showed that the hardness of Pyrus xerophila chewable tablets was greater than 30 N, the difference in tablet weight was within 7.5%, and the percent of loss weight was less than 0.5%, all the prepared samples disintegrated within 15 min and met the quality standards. Conclusion The preparation formula of Pyrus xerophila chewable tablets by response surface methodology can provide practical ideas and theoretical basis for the development of rich Pyrus xerophila resources in Qinghai.