辅酶Q10保健食品原料技术要求研究

Study on the technical requirements of coenzyme Q10 as health food raw materials

目的验证保健食品原料辅酶Q10主要质量指标的参数,并对不同工艺生产的产品质量一致性进行研究。方法根据2020年版《中国药典》和食品安全国家标准对40批次辅酶Q10原料的标志性成分、有关物质、异构体、污染物残留量及微生物指标等项目进行检测。结果所有搜集原料中辅酶Q10含量均大于99.2%;最大单一杂质含量范围在0.27%~0.37%之间,总杂质在0.45%~0.85%之间;所有样品菌落总数均小于10 CFU/g,大肠菌群、金黄色葡萄球菌、沙门菌均未检出,酵母菌、霉菌总数均小于10 CFU/g;水分、炽灼残渣、污染物残留检测结果均符合相关要求。结论采集的所有辅酶Q10作为保健食品原料均符合2020年版《中国药典》和GB 16740—2014《食品安全国家标准保健食品》的要求。

Objective To verify the main quality indexes of coenzyme Q10,and study the quality consistency of coenzyme Q10 produced by different processes.Methods According to the Chinese Pharmacopoeia(2020 version)and national food safety standards,the main quality indexes such as coenzyme Q10 components,moisture,related substances,isomers,contaminant residues and microbial indexes of 40 batches of raw materials were detected.Results The content of coenzyme Q10 in all collected materials was above 99.2%;the maximum single impurity ranged from 0.27%to 0.37%;the total impurity ranged from 0.45%to 0.85%.The total number of colonies in all samples was less than 10 CFU/g,Escherichia coli,Staphylococcus aureus and Salmonella were not detected,and the total number of yeasts and molds were less than 10 CFU/g.The results of moisture and contaminant residues all met the requirements.Conclusion All coenzyme Q10 collected as health food raw materials met the requirements of Chinese Pharmacopoeia(2020 version)and GB 16740-2014 National Food Safety Standard Health Food.