摘要
目的建立适宜的小规格高浓度(3mL∶0.5g)奥硝唑注射液无菌检查方法。方法参考2015年版《中国药典(四部)》通则1101无菌检查法,采用薄膜过滤-中和剂、稀释-中和联合法探索。结果阳性对照组培养管均混浊;试验Ⅰ组中6种试验菌培养管均未出现混浊;试验Ⅱ组和试验Ⅲ组中白色念珠菌和黑曲霉培养管均混浊,而其余菌均未生长;试验Ⅳ组中枯草芽孢杆菌、白色念珠菌和黑曲霉培养管均混浊,其余菌均未生长;试验Ⅴ组中枯草芽孢杆菌、白色念珠菌和黑曲霉培养管明显混浊,但金黄色葡萄球菌、大肠埃希菌和生孢梭菌由于过滤过程中产生泡沫不易观察;试验Ⅵ组中试验菌培养管均混浊(生孢梭菌培养管在第5天出现混浊),浊度较阳性对照组轻;试验Ⅶ组中试验菌培养管均混浊(生孢梭菌培养管第3天变混浊),浊度与对照组相近;试验Ⅷ组试验菌培养管均混浊(生孢梭菌培养管第2天混浊),该组方法较试验Ⅶ组更合理。结论所建立的稀释-中和剂薄膜过滤法适用于小规格(3mL∶0.5g)奥硝唑注射液的无菌检查。
Objective To establish an appropriate aseptic test method for small-scale and high-concentration ornidazole injection of 3mL∶0.5 g.Methods Referring to the General Principle 1101″aseptic test method″in Chinese Pharmacopoeia(2015 edition,VolumeⅣ),the combined method membrane filtration-neutralizer,dilution-neutralization was used to explore the aseptic test method of small-scale high-concentration ornidazole injection.Results The culture tubes of the positive control group were turbid.The culture tubes of the six test bacteria in test group I did not appear turbid.The culture tubes of Candida albicans and Aspergillus niger in test groupⅡand test groupⅢwere turbid,while the remaining bacteria did not grow.The culture tubes of Bacillus subtilis,Candida albicans and Aspergillus niger were all turbid in test groupⅣ,and the remaining bacteria were not growing.The culture tubes of Bacillus subtilis,Candida albicans and Aspergillus niger were obviously turbid in test groupⅤ,but Staphylococcus aureus,Escherichia coli and Clostridium sporogenes were difficult to observe due to the foam generated during the filtration process.The culture tubes of Clostridium sporogenes in test groupⅥwere turbid on the 5th day,and the turbidity was lighter than that in the positive control group.In test groupⅦ,the culture tubes of the test bacteria were all turbid and the Clostridium sporogenes culture tube became turbid on the 3rd day,and the turbidity was similar to that of the control group.The culture tubes of test bacteria in groupⅧwere turbid,and the culture tube of Clostridium sporogenes were turbid on the 2 nd day;the method of this group was more reasonable than that in groupⅧ.Conclusion The established aseptic test method is suitable for the aseptic check of small-scale(3mL∶0.5g)ornidazole injection.
作者
贾萌
贺聪莹
周志云
杨晓莉
JIA Meng;HE Congying;ZHOU Zhiyun;YANG Xiaoli(Shaanxi Institute for Foodand Drug Control·Key Laboratory of Pharmaceutical Microbiology Testing Technology,Xi′an,Shaanxi,China 710065)
出处
《中国药业》
CAS
2020年第15期47-51,共5页
China Pharmaceuticals
基金
陕西省重点研发计划项目[2019SF-062]。
关键词
奥硝唑注射液
薄膜过滤法
无菌检查法
聚山梨酯80
ornidazole injection
membrane filtration method
aseptic test method
polysorbate 80
