盐酸莫西沙星氯化钠注射液无菌检查方法优化  

Optimization of the Sterility Test Method for Moxifloxacin Injection

作　　者：蓝福胜 郑挺 王晓英 程琳 林玉双 LAN Fu-sheng;ZHENG Ting;WANG Xiao-ying;CHEN Ling;LIN Yu-shuang(Fujian Institute for Food and Drug Quality Control,Fuzhou 350001,China;Fujian Inspection and Research Institute for Product Quality,Fuzhou 350001,China)

机构地区：[1]福建省食品药品质量检验研究院,福建福州350001 [2]福建省产品质量检验研究院,福建福州350001

出　　处：《海峡药学》2023年第7期48-51,共4页Strait Pharmaceutical Journal

摘　　要：目的优化盐酸莫西沙星氯化钠注射液的无菌检查方法。方法按照《中华人民共和国药典》2020年版无菌检查方法适用性试验相关要求,采用HPLC法测定混合纤维素(MCE)膜、尼龙(N66)膜和聚偏二氟乙烯(PVDF)膜过滤后膜上样品的残留量,确定样品吸附性小的滤膜;采用HPLC法测定4种不同冲洗液(0.1%无菌蛋白胨水溶液、pH 7.0无菌氯化钠-蛋白胨缓冲液、0.9%无菌氯化钠溶液及含卵磷脂和聚山梨酯80组分的0.9%无菌氯化钠溶液)分别冲洗300 mL、500 mL后膜上样品的残留量,确定适宜的冲洗液。结果药典规定的6种试验菌均可在5 d内正常生长。结论采用薄膜过滤法选择滤膜材质为PVDF或N66的集菌培养器,在冲洗液中添加0.1%卵磷脂和0.5%聚山梨酯80能减少冲洗液用量,且降低因冲洗对污染菌造成的机械损伤并缩短检验耗时和节约检验成本。OBJECTIVE To optimize the sterility test for moxifloxacin injection.METHODS According to the Chinese Pharm acopoeia(2020 edition)membrane-filter procedure,the residue of moxifloxacin which filtered through the mixed cellulose ester,nylon membran and PVDF membran were tested by HPLC,and the residue of moxifloxacin on membran which rinsed by 0.1%peptone water,sodium chloride peptone buffer pH 7.0,physiological saline or diluent optimized(0.9%aseptic sodium chloride solution contained lecithin and polyssorbide 80)were compared.RESULTS Six test strains required for sterility test according to Chinese pharm acopoeia(2020 edition)exhibited good growth.CONCLUSION If PVDF or N66 were selected,the volume of flushing fluid added 0.1%lecithin and 0.5%polyssorbate 80 reduced clearly,which would abate the mechanical pain for contaminating bacteria,save the inspection cost and time.

关 键 词：莫西沙星 无菌检查 薄膜过滤 方法适用性试验 

分 类 号：R927[医药卫生—药学]