叶黄素越橘咀嚼片的制备及缓解视疲劳评价

Preparation of lutein and bilberry chewable tablet and its evaluation on asthenopia relief

目的:研制一种具有缓解视疲劳作用的叶黄素越橘咀嚼片,并筛选和优化叶黄素越橘咀嚼片最佳配方,探讨其缓解视疲劳作用。方法:采用干法制粒法制备叶黄素越橘咀嚼片,通过单因素实验,选择合适的矫味剂(蓝莓果汁粉、柠檬酸)、填充剂(木糖醇、预胶化淀粉)、干性黏合剂(微晶纤维素)、润滑剂(硬脂酸镁)、叶黄素微粒和越橘提取物配比。通过对咀嚼片口感、硬度、脆碎度、颗粒流动性、感官评价等方面的考察筛选配方,通过放大试验确定最佳配方,并选择30例视力易疲劳者进行缓解视疲劳自我评价。结果:叶黄素越橘咀嚼片最佳配方为每片中叶黄素微粒100 mg,欧洲越橘提取物20 mg,木糖醇470 mg,蓝莓果汁粉300 mg,预胶化淀粉250 mg,硬脂酸镁30 mg,微晶纤维素20 mg,柠檬酸10 mg;按此配方所得咀嚼片中叶黄素含量0.94 g/100g,花青素含量0.48 g/100g;缓解视疲劳自我评价显示视疲劳症状明显减轻。结论:叶黄素越橘咀嚼片酸甜可口,色泽均匀,硬度适中,服用方便,具有缓解视疲劳功效。

Objective ：To develop a lutein and bilberry chewable tablet which can help relief asthenopia, screening and optimizing chewable tablets＇ formula as well as exploring its effects on relieving asthenopia were studied. Methods ：Lutein and bilberry chewable tablets were prepared by dry granulation method. By single factor experiments, the appropriate amount of blueberry juice powder and citric acid, filler of xylitol and pregelatinized starch, dry adhesive of microcrystalline cellulose, lubricant of magnesium stearate, as well as the best ratio of lutein microparticles and vaccinium myrtillus extracts were selected. The formula was screened according to the taste, hardness, friability, particle flowability, and sensory evaluation of the chewable tablet. Then the optimized formula was determined by amplifying test ~ 30 adults with eye-fatigue were selected in self-evaluation test for asthenopia relief effect. Results .. The optimum formula per tablet was ： 100 mg of lutein microparticles, 20 mg of vaceinium myrtillus extract, 470 mg of xylitol, 300 mg of blueberry juice powder, 250 mg of pregelatinized starch, 30 mg of magnesium stearate, 20 mg of microcrystalline cellulose, and 10 mg of citric acid. According to this formula,the lutein content in the chewable tablet was 0.94 g/100g, and the anthocyanin content was 0.48g/100g. The self- evaluation of asthenopia relieving showed that the visual fatigue symptoms were significantly alleviated. Conclusion ~ Lutein and bilberry chewable tablets had good sweet and sour taste, uniform color, moderate hardness, easy taking with and have the effect of relieving asthenopia.