| 引用本文: | 郑小玲,梁法勇,田卓,钱凌,李珏,李樱红,王知坚.外用液体药用高密度聚乙烯瓶无菌检查法的研究[J].中国现代应用药学,2021,38(6):730-733. |
| ZHENG Xiaoling,LIANG Fayong,TIAN Zhuo,QIAN Ling,LI Jue,LI Yinghong,WANG Zhijian.Study on Sterility Test Method of External Liquid Medical High-density Polyethylene Bottle[J].Chin J Mod Appl Pharm(中国现代应用药学),2021,38(6):730-733. |
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| 外用液体药用高密度聚乙烯瓶无菌检查法的研究 |
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郑小玲1, 梁法勇1, 田卓2, 钱凌1, 李珏1, 李樱红1, 王知坚3
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1.浙江省食品药品检验研究院, 药品微生物检测与预警重点实验室, 杭州 310004;2.中华人民共和国大连海关, 大连 116000;3.浙江省药品化妆品审评中心, 杭州 310012
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| 摘要: |
| 目的 建立外用液体药用高密度聚乙烯瓶（大面积烧伤及严重损伤皮肤用）无菌检查方法，并进行方法适用性检查。方法 洗脱液为灭菌生理盐水，参照中国药典2015年版通则1101中医疗器具的取样量进行取样，加入1/2标示容量的氯化钠注射液，振摇30 s，合并提取液，薄膜过滤法检查。结果 无菌检查前处理研究中金黄色葡萄球菌、大肠埃希菌、枯草芽孢杆菌、白色念珠菌和黑曲霉5种菌的洗脱回收率符合中国药典要求；方法适用性试验中试验菌生长均良好。结论 本法取样量和样品前处理科学有效，适用于外用液体药用高密度聚乙烯瓶（大面积烧伤及严重损伤皮肤用）的无菌检查。 |
| 关键词: 无菌检查 高密度聚乙烯瓶 前处理研究 薄膜过滤法 |
| DOI：10.13748/j.cnki.issn1007-7693.2021.06.017 |
| 分类号:R927.12 |
| 基金项目: |
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| Study on Sterility Test Method of External Liquid Medical High-density Polyethylene Bottle |
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ZHENG Xiaoling1, LIANG Fayong1, TIAN Zhuo2, QIAN Ling1, LI Jue1, LI Yinghong1, WANG Zhijian3
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1.Zhejiang Institute for Food and Drug Control, NMPA Key Laboratory for Testing and Risk Warning of Pharmaceutical Microbiology, Hangzhou 310004, China;2.Dalian Customs District P. R. China, Dalian 116000, China;3.Zhejiang Province Drug Cosmetics Review Center, Hangzhou 310012, China
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| Abstract: |
| OBJECTIVE To establish a sterility test method for external liquid medical high-density polyethylene bottle(for extensive burns and severe skin damage), and check the suitability of the method. METHODS The sterilized saline was used as a eluent. According to the sampling amount of medical devices in general rule 1101 of Chinese Pharmacopoeia 2015 Edition, 1/2 labeled volume of sodium chloride injection was added, and the sample was shaken for 30 s. The extracts were combined and examined by membrane filtration. RESULTS The eluting recovery rates of Staphylococcus aureus, Escherichia coli, Bacillus subtilis, Candida albicans and Aspergillus niger in the study of pretreatment for sterility test were in line with the requirements of Chinese Pharmacopoeia. The growth of the tested bacteria was good in the method suitability test. CONCLUSION This method is scientific and effective in sample quantity and sample pretreatment. It is suitable for sterility test of external liquid medical high-density polyethylene bottle(for large area burn and severe skin injury). |
| Key words: sterility test high-density polyethylene bottle pretreatment study membrane filtration |
