基于QbD理念的保健食品祛斑颗粒成型工艺研究

Study on the Molding Process of Quban Granule of Health Food Based on QbD Concept and its Acute Toxicity Evaluation

目的:基于质量源于设计(QbD)理念对袪斑颗粒成型工艺进行研究。方法:以祛斑方提取膏为模型,根据保健食品法规要求和祛斑方特点制定目标产品(祛斑颗粒)质量概况(QTPP)和产品关键质量属性(CQAs),应用失效模型与影响分析法(FMEA)辨识关键工艺参数(CPPs),以颗粒的成型率、溶化性、吸湿率、脆碎度、标志性成分含量等为评价指标,优选出最佳成型工艺。结果:优选的祛斑颗粒成型工艺:以提取膏与乳糖、可溶性淀粉比例为2∶4∶2制软材,经制湿颗粒(16目筛),70℃干燥,整粒(14目筛),混匀即得。结论:建立的袪斑颗粒成型工艺稳定可行,可为保健食品颗粒剂的成型工艺设计提供参考。

Objective:Based on the concept of quality by design(QbD),the molding process of Quban granule was studied.Methods:Using Quban Granule extracting solution as model,based on the characteristics of health food regulations and Quban Granule to establish the quality target product profile(QTPP)and product critical quality attributes(CQAs),failure model and effects analysis(FMEA)to identify the critical process parameters(CPPs),with forming rate,solubility,moisture absorption rate,friability,iconic component content as the evaluation indexs,such as optimizing the best molding process.Results:The optimal molding process of Quban granule was as follows:the ratio of Quban Granule extracting solution to lactose and soluble starch was 2∶4∶2 to make soft material,after wet granulating(16 mesh screen),drying at 70℃,crushing(14 mesh screen)and mixing.Conclusion:The established Quban granule molding process is stable and feasible,which can provide reference for the molding process of health food granule.