摘要
目的对2010~2020年我国保健食品软胶囊的审批情况进行分析,为保健食品软胶囊的监管、申报、研发和改良提供参考。方法通过检索原国家食品药品监督管理总局网站及国家市场监督管理总局网站公布的保健食品数据信息及药智网食品数据库汇总2010~2020年已获批准的软胶囊剂保健食品相关信息,并对其进行归纳总结。结果检索得到获批保健食品9875件,其中软胶囊剂1950件获批,占比19.70%;涉及21个保健功能,主要集中在增强免疫、辅助降血脂等方面;涉及到的原料为脂溶性成分;囊壳材料通常是由明胶、增塑剂、水及附加剂组成。结论软胶囊剂型在我国未来的保健食品行业具有较好的行业前景,适合脂溶性成分保健品的制备,新型囊壳材料的产业化仍需进一步研究改良。
Objective To provide reference for the supervision,reporting,R&D and improvement of health food soft capsules,the approval status of health food soft capsules in China from 2010 to 2020 was analyzed.Methods Through searching the website of China Food and Drug Administration,State Administration of Market Regulation and Yaozhi,the information of soft capsule health food approved from 2010 to 2020 was summarized.Results The search results showed that 9875 pieces of health food were approved,of which 1950 pieces of soft capsules were approved,accounting for 19.70%.These soft capsules involved 21 health care functions,mainly focusing on enhancing immunity,assisting in reducing blood lipid and other aspects.The related raw materials are fat-soluble components and the bladder material was typically composed of gelatin,a plasticizer,water,and additives.Conclusion The soft capsule dosage form has a good industrial prospect in the future health food industry of China,and is suitable for the preparation of health products with fat-soluble components.The industrialization of the novel capsule shell material still needs further research and improvement.
作者
张纯刚
张甜甜
付慧敏
关雪峰
程岚
ZHANG Chungang;ZHANG Tiantian;FU Huimin;GUAN Xuefeng;CHENG Lan(College of Pharmacy,Liaoning University of Traditional Chinese Medicine,Dalian 116620,China;Liaoning University of Traditional Chinese Medicine,Shenyang 110032,China;Department of Pharmacy,Changzhi Medical College,Changzhi 046000,China;Qimeng Co.,Ltd.,Chifeng 024330,China;Shenyang Pharmaceutical University,Shenyang 110016,China)
出处
《沈阳药科大学学报》
CAS
CSCD
北大核心
2023年第7期935-940,共6页
Journal of Shenyang Pharmaceutical University
基金
国家重点研发计划(2018YFC1706903)
内蒙古自治区科技重大专项(2021ZD0017)
辽宁省自然科学基金指导计划项目(2019-ZD-0968)
中医脏象理论及应用国家教育部重点实验室一般项目(zyzx1809)
沈阳市中青年科技创新人才项目(RC200204)。
关键词
软胶囊
保健食品
国产和进口
审批
soft capsule
health food
domestic and imported
approval
