论文部分内容阅读
参照《中国药典》2010年版二部无菌检查法的要求,建立适用于注射用替加环素的无菌检查法。分别选择0.1%蛋白胨水溶液与p H 7.0氯化钠-蛋白胨缓冲液,及含0.1%,0.5%,1%吐温80的0.1%蛋白胨水溶液液为稀释液和冲洗液,加1 mol/L无菌Mg SO4试剂0,0.5,0.8,1,2 m L作为中和剂,冲洗量分别为500,600,800,1 000 m L。采用薄膜过滤法,共4个影响因素的17种方法,先以替加环素的敏感菌株金黄色葡萄球菌作为代表菌考察17种方法的优劣,再选择最佳方法分别以大肠埃希菌、金黄色葡萄球菌、枯草芽孢杆菌、生孢梭菌、白色念珠菌和黑曲霉为试验菌进行方法学验证。结果发现以含有1%吐温80的0.1%蛋白胨水溶液为冲洗液,以无菌Mg SO4试剂为中和剂,适宜冲洗量的方法可消除样品抑菌性。采用方法 17(取注射用替加环素20瓶,薄膜过滤法处理,以含1%吐温80的0.1%蛋白胨水溶液为稀释液和冲洗液,10 m L/瓶稀释,滤过,冲洗,冲洗量:500 m L/管,100 m L/次,过滤完成后加入1 m L的1 mol/L无菌Mg SO4作为中和剂,以金黄色葡萄球菌为阳性对照菌)可作为注射用替加环素的无菌检查法。
According to “Chinese Pharmacopoeia” 2010 edition two sterile test requirements, the establishment of suitable for injection of tigecycline sterility test. The solutions of 0.1% peptone and p H 7.0 sodium chloride-peptone, 0.1%, 0.5% and 1% Tween 80 were used as diluent and rinsing solution, respectively, and 1 mol / L Bacteria MgSO4 reagent 0,0.5,0.8,1,2 m L as a neutralizing agent, flushing volume were 500,600,800,1 000 m L. Using membrane filtration method, a total of four influencing factors of 17 kinds of methods, first with tigecycline sensitive strains Staphylococcus aureus as a representative of the advantages and disadvantages of 17 methods, and then choose the best method were Escherichia coli , Staphylococcus aureus, Bacillus subtilis, Clostridium sporogenes, Candida albicans and Aspergillus niger as test bacteria for methodological verification. The results showed that the antibacterial activity of the sample could be eliminated by using 0.1% peptone aqueous solution containing 1% Tween 80 as the washing solution and using the sterile MgSO4 reagent as the neutralizing agent. Method 17 (take 20 bottles of tigecycline for injection, treated by membrane filtration method, diluted with 10% L of peptone solution containing 1% Tween 80 as diluent and rinsing solution, filtered, rinsed, Flushing volume: 500 m L / tube, 100 m L / time, 1 m L of 1 mg / L sterile MgSO 4 as a neutralizing agent and Staphylococcus aureus as positive control after filtration Sterilization of tigecycline.