期刊文献+

一次性使用无菌阴道扩张器无菌检查方法适用性研究 被引量:4

Suitability study of aseptic inspection method with sterile vaginal dilator for single use
原文传递
导出
摘要 目的建立一种一次性使用无菌阴道扩张器无菌检查方法适用性试验方法。方法按中国药典2015版通则1101项下规定的方法,以硫乙醇酸盐流体培养基作为厌氧菌和需氧菌检查培养基,以胰酪大豆胨液体培养基作为真菌和需氧菌检查培养基。以金黄色葡萄球菌、大肠埃希菌、枯草芽胞杆菌、生孢梭菌、白色念珠菌和黑曲霉为试验菌进行方法适用性研究。供试品采用薄膜过滤接种法,冲洗液为0.9%氯化钠注射液,冲洗量为100 ml/膜,以金黄色葡萄球菌为阳性对照菌进行无菌检查。结果 2种材质样品无菌检查均合格,阳性对照菌生长良好。结论该方法适用于以聚丙烯和聚苯乙烯为材质的一次性使用无菌阴道扩张器的无菌检查。该方法具有污染小、方便快捷的特点,可作为医疗器械生产企业和各级监督部门进行该类产品无菌检查方法适用性试验时的参考。 Objective To establish an aseptic inspection method for suitability study of sterile vaginal dilator for single use.Methods According to the general provision 1101 of the 2015 edition of Chinese Pharmacopoeia,The thioglycollate fluid culture medium was used as an inspection medium for anaerobic bacteria and aerobic bacteria,and trypticase soybean mash liquid medium was used as an inspection medium for Fungus and aerobic bacteria. The method applicability test was conducted by using Staphylococcus aureus,Escherichia coli,Bacillus subtilis,Clostridium sporogenes,Candida albicans and Aspergillus niger as the test bacteria. The samples were inoculated by membrane filtration method. The rinse solution was 0. 9% sodium chloride injection,with the injection content as 100 ml for each membrane. Staphylococcus aureus was used as the positive control bacteria for sterility test. Results The two kinds of material samples were qualified in sterility test,and the positive control bacteria grew well. Conclusion This method can be used for the sterile vaginal dilator for single use made of polypropylene or polystyrene. The method is of low pollution and time-saving. It can be used as a reference to the manufacturing enterprises and the supervision departments.
作者 李闻涛 毛毅 绳芬 黎隽 LI Wen - tao;MAO Yi;SHENG Fen;LI Jun(Shaanxi Medical Equipment Quality Supervision and Inspection Institute, Xi'an, Shaanxi 712046, China)
出处 《中国卫生检验杂志》 CAS 2018年第12期1523-1525,共3页 Chinese Journal of Health Laboratory Technology
关键词 一次性使用无菌阴道扩张器 无菌检查 方法适用性 Sterile vaginal dilator for single use Sterility test Method suitability test
  • 引文网络
  • 相关文献

参考文献10

二级参考文献28

共引文献39

同被引文献43

引证文献4

;
使用帮助 返回顶部