摘要
目的:建立壳聚糖妇用抗菌栓的无菌检查方法。方法:依据《中华人民共和国药典》2015年版四部1101无菌检查法,采用直接接种法、薄膜过滤法进行壳聚糖妇用抗菌栓无菌检查并进行方法学验证。结果:样品管无菌生长,六株阳性对照菌生长良好。结论:通过方法学验证说明建立的无菌检查法适用于壳聚糖妇用抗菌栓的无菌检查,保证无菌检查方法的有效性。
Objective:A sterility test method for chitosan antibacterial suppository for women was established.Methods:The test method was carried out according to the method in 1101,Volume IV,Chinese Pharmacopoeia Edition 2015.By choosing direct inoculation method and membrane filtration,the sterility tests were established.Results:The validation tests were engaged,and the method show that all of six strains positive control tubes reveal growth of microorganism and the control gives no evidence of growth.Conclusion:The methodology validation demonstrated that the established method was suitable for sterility test of chitosan antibacterial suppository for women.The validity of sterility test is assured.
作者
孙明波
李勇
刘赞
陈文博
SUN Ming-bo;LI Yong;LIU Zan;CHEN Wen-bo(Liaoning Medical Device Test Institute,Liaoning Shenyang 110179)
出处
《中国医疗器械信息》
2018年第7期17-18,39,共3页
China Medical Device Information
关键词
壳聚糖妇用抗菌栓
无菌检查法
方法验证
chitosan antibacterial suppository for women
sterility test
method validation tests
