褐藻酸硫酸酯凝胶剂的质量考察及安全性研究  

Quality investigation and safety evaluation of alginic acid sulfate gel

作　　者：田丽男 孟晓依 王世欣[1,2] 王力 高江明 赵峡 管华诗[1,2] 李春霞[1] TIAN Li-nan;MENG Xiao-yi;WANG Shi-xin;WANG Li;GAO Jiang-ming;ZHAO Xia;GUAN Hua-shi;LI Chun-xia(Key Laboratory of Marine Drugs,Ministry of Education,Shandong Provincial Key Laboratory of Glycoscience and Glycotechnology,School of Medicine and Pharmacy,Ocean University of China,Qingdao 266003,China;Marine Biomedical Research Institute of Qingdao,Qingdao 266071,China)

机构地区：[1]中国海洋大学海洋药物教育部重点实验室,山东省糖科学与糖工程重点实验室,医药学院,山东青岛266003 [2]青岛海洋生物医药研究院,山东青岛266071

出　　处：《中国海洋药物》2019年第6期1-7,共7页Chinese Journal of Marine Drugs

基　　金：山东省重大科技创新专项（2018SDKJ0404）;青岛市海洋生物医药科技创新中心项目（2017-CXZX01-3-11）资助

摘　　要：目的制备褐藻酸硫酸酯凝胶剂,并对其进行质量考察及安全性评价。方法以褐藻酸硫酸酯为有效成分制备凝胶剂,从外观、装样量、酸碱度、黏度、有效成分含量及微生物限度方面对凝胶剂质量进行考察,并对其生物安全性进行评价,包括细胞毒性、刺激性及致敏性。结果制备得到了性状良好、性质稳定的褐藻酸硫酸酯凝胶剂,并且具有较高的生物安全性,为后期褐藻酸硫酸酯药物或医用功能制品的开发奠定了基础。Objective To prepare alginic acid sulfate gel and inspect its quality and safety evaluation.Methods The gel was prepared with alginic acid sulfate as effective components.The quality of the gel was investigated in terms of appearance,loading amount,pH,viscosity,effective components content and microbial limit.Its biosafety was evaluated,including cytotoxicity,irritation and allergenicity.Results The alginic acid sulfate gel with stable properties was prepared and it had good biosafety.It could provide basis for the development of alginic acid sulfate drug or medical functional products.

关 键 词：褐藻酸硫酸酯 凝胶剂 质量考察 安全性 

分 类 号：R943[医药卫生—药剂学]