摘要
基于质量源于设计理念及对研发产品剂型特点和工艺的理解,设计并优化维生素E咀嚼片处方。通过对物料特性的分析并确定影响咀嚼片的关键质量属性(CQAs)为口感、甜度和含量等,优化咀嚼片的处方和工艺参数。优选出维生素E咀嚼片的工艺参数为处方中微晶纤维素用量10%,赤藓糖醇用量60%,乳粉用量25%,交联羧甲纤维素用量2.5%,硬脂酸镁0.3%。在采用此工艺参数时,可获得咀嚼口感好并带有本品特有香味的产品,工艺稳定,适合大工业生产。
Based on the concept of quality by design and the understanding of the characteristics of dosage form and also the process of the product,the formulation of vitamin E chewable tablet was designed and optimized.The properties of the materials were analyzed and the critical quality attributes(CQAs)of chewable tablets were determined as taste,sweetness and content.The formulation and process parameters of chewable tablets were optimized.The optimum technological parameters of vitamin E chewable tablet were as follow:the dosage of microcrystalline cellulose was 10%,erythritol was 60%,milk powder was 25%,crosslinked sodium carboxymethylcellulose was 2.5%and magnesium stearate was 0.3%,and the products with good chewing taste and special flavor were obtained.The process was stable and suitable for industrial production.
作者
邢耿佳
黄仪友
张黎
陈强
张旭光
XING Gengjia;HUANG Yiyou;ZHANG Li;CHEN Qiang;ZHANG Xuguang(By-Health Co.,Ltd.,Zhuhai 519040)
出处
《食品工业》
CAS
2022年第5期120-124,共5页
The Food Industry
关键词
维生素E
咀嚼片
质量源于设计
正交试验
vitamin E
chewable tablets
quality by design
orthogonal test
