基于微量量热法的无菌制剂快速无菌检查方法研究.docVIP

基于微量量热法的快速检查方法研究任永申 （430074武汉中南民族大学药学院药物分析教研室， [摘要10h内检出各阳性菌（金黄色葡萄球菌、大肠埃希菌、铜绿假单胞菌、枯草芽孢杆菌、生孢梭菌、白色念珠菌、黑曲霉），检出限度100cfu），并能够快速检出模式药物未灭菌样品与灭菌不彻底样品，较常规检查方法更为灵敏快速。结论 本文建立的微量量热无菌检查法灵敏、快速、准确，可实现自动在线监测，可以作为无菌检查的新方法。 [关键词 微量量热法；无菌检查；方法学考察；无菌制剂；微生物污染；复方茵陈注射液；灵敏度；检测时间 [中图法分类号 [文献标志码[基金项目] 国家自然科学基金[通信作者] ，E-mail: zh@126com；肖小河，E-mail: @126com Early and quickly detection for microbial contamination in sterility preparation by microcalorimetry Ren Yongshen1,2, Zhang Ping2 , Lv Hongyu2, Xiao Xiaohe1,2 (1Department of pharmaceutical analysis, Pharmacy College, South-Central University for Nationalities, Wuhan, Hubei Province, 430074; 2 China Military Institute of Chinese Materia Medica, 302 China Military Hospital of China, Beijing, 100039,China) [Abstract] Objective To establish a rapid and sensitive sterility test new method, so as to overcome the limitation of the long detection cycle (generally 14-21days), low sensitivity, low degree of automation, prone to cause the misjudge of conventional sterility test. Methods Microcalorimetry was adopted to?establish a novel sterility test method, and was compared with normal sterility test method. Methodology investigation was carried out so as to ascertain the sensitivity of microcalorimetric sterility test, and Fufang Yinchen Injection was chosen as a model, to ensure the discriminate capability of this method on Norm-sterilized Samples (Norm-SS), Non-sterilized Samples (Non-SS) and Sub-sterilized Samples (Sub-SS). Results The results showed that microcalorimetric sterility test could detect out the positive indicator bacteria such as Staphylococcus aureus (S. aureus), Escheichia coli (E. coli), Pseudomonas aeruginosa (P. aeruginosa), Bacillus subtilis (B. subtilis), Clostridium sporogenes (C. sporogenes), Candida albicans (C. albicans) and Aspergillus niger (A. niger), all within 10 hours and with the detection limitation under 100CFU; and could distinguish the Non-SS and Sub-SS from Norm-SS accurat