褐藻酸硫酸酯凝胶剂无菌检查方法的建立及应用  

Establishment and application of sterile examination method for alginate sulfate gel

作　　者：王力[1,2] 郝丽桦 王世欣 田丽男[1] 高江明 李春霞 WANG Li;HAO Li-hua;WANG Shi-xin;TIAN Li-nan;GAO Jiang-ming;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;Laboratory for Marine Drugs and Bioproducts of Qingdao Pilot National Laboratory for Marine Science and Technology,Qingdao 266237,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 [3]青岛海洋科学与技术试点国家实验室海洋药物与生物制品功能实验室,山东青岛266237

出　　处：《中国海洋药物》2021年第5期42-45,共4页Chinese Journal of Marine Drugs

基　　金：山东省重大科技创新专项(2018SDKJ0404)资助。

摘　　要：目的建立褐藻酸硫酸酯凝胶剂无菌检查方法,并对褐藻酸硫酸酯凝胶剂进行无菌检查。方法按照《中国药典》2015版四部1101直接接种法的要求,对褐藻酸硫酸酯凝胶剂进行无菌检查方法学建立。结果各试验菌株与阳性菌株同步生长,阴性对照无菌株生长。结果表明,建立的无菌检查方法用于褐藻胶硫酸酯凝胶是可行有效的;各批次褐藻酸硫酸酯凝胶剂在14 d内无菌株生长,均符合无菌产品的要求。Objective To establish a method for sterile examination of alginate sulfate gel and verify the applicability of the method.Methods According to the requirements of the direct inoculation method in the general rule 1101 of Chinese Pharmacopoeia(2015 edition,volumeⅣ),the methodology of sterile examination of alginate sulfate gel was established.Results The test groups grew synchronously with the positive strains while the negative control had no strain growth.Each batch of alginate sulfate gel had no strain growth in 14 days,which met the requirements of sterile products.The results showed that the established sterile examination method was feasible and effective for alginate sulfate gel.

关 键 词：褐藻酸硫酸酯凝胶剂 无菌检查 方法建立 

分 类 号：R927.1[医药卫生—药学]