盐酸溴己新葡萄糖注射液无菌检查方法研究  

Study on Sterility Test of Bromhexine Hydrochloride and Glucose Injection

作　　者：章瑛 张春华 刘彭浩邦 王杰 刘绪平 ZHANG Ying;ZHANG Chunhua;LIU Penghaobang;WANG Jie;LIU Xuping(Jiangxi Institute for Drug Control,NMPA Key Laboratory of Quality Evaluation of Quality Evalution of Traditional Chinese Patent Medicine,Jiangxi Provincial Engineering Research Center for Drug and Medical Device Quality,Nanchang Jiangxi 330029,China;Jiangxi University of traditional Chinese medicine,Nanchang Jiangxi 330103,China)

机构地区：[1]江西省药品检验检测研究院,国家药品监督管理局中成药质量评价重点实验室江西省药品与医疗器械质量工程技术研究中心,江西南昌330029 [2]江西中医药大学,江西南昌330103

出　　处：《药品评价》2021年第9期540-542,共3页Drug Evaluation

摘　　要：目的:建立盐酸溴己新葡萄糖注射液的无菌检查方法。方法:按照《中国药典》2015年版四部无菌检查法(1101)规定的研究方法,对盐酸溴己新葡萄糖注射液进行实验研究。结果:盐酸溴己新葡萄糖注射液无菌方法选用薄膜过滤法,以金黄色葡萄球菌、白色念珠菌作为敏感菌株进行预试验,菌落正常生长。经方法适用性实验,所有实验菌落均可正常生长。结论:盐酸溴己新葡萄糖注射液的无菌检查采用薄膜过滤法(不冲洗),方法可行、结果可靠。Objective:Objective to establish a method for sterility test of bromhexine hydrochloride and glucose injection.Methods:Bromhexine hydrochloride glucose injection was studied according to the research methods of sterility test method(1101)in"Chinese Pharmacopoeia"(2015 Edition).Results:The membrane filtration method was used in the sterility test of bromhexine hydrochloride glucose injection.Staphylococcus aureus and Candida albicans were used as sensitive strains for pre-test,and the colony grew normally.After the method applicability test,all experimental colonies can grow normally.Conclusion:The sterility test of bromhexine hydrochloride glucose injection was carried out by membrane filtration method(without washing).The method is feasible and the results are reliable.

关 键 词：盐酸溴己新葡萄糖注射液 灭菌 无菌检查 薄膜过滤 

分 类 号：R927.1[医药卫生—药学]