益生菌产品工艺验证均一性指标的论证选择
Demonstration and selection of homogeneity indicators for probiotic product process validation
张学荣 1蔡良平 1刘文得 1李珍 1苏杜威1
作者信息
- 1. 汤臣倍健股份有限公司,广东珠海 519000
- 折叠
摘要
益生菌产品功效成分主要为益生菌,其检测的重复性差异较大.益生菌产品辅料主要为益生元,其检测存在成本高,操作复杂等问题,所以益生菌产品在执行工艺验证时,均一性考察检测指标难于选择.通过对益生菌产品中辅料蛋白质的测定、不同益生菌粉配比产品中蛋白质含量测定、蛋白质测定方法定量限考察等试验,证实益生菌产品选择蛋白质作为工艺验证中均一性指标的合理性.同时根据不同人群对不同益生菌产品的需求,考察了多种益生菌蛋白含量以及多种益生菌产品的蛋白含量,证实选择蛋白质做均一性指标在不同产品中的合理性.
Abstract
The functional components of probiotics products are mainly probiotics,and their repeatability varies greatly.Its excipients are mainly prebiotics,and its detection has many problems such as high cost and complex operation,so it is difficult to select homogeneity detection indexes in the process validation of probiotics products.In this paper,it is proved that protein can be used as the homogeneity index of probiotic product process validation.
关键词
工艺验证/均一性/蛋白质/益生菌产品Key words
process validation/homogeneity/protein/probiotic products引用本文复制引用
出版年
2024
NETL
NSTL
万方数据