氯霉素无菌检查方法学研究  

Study on Aseptic Methodology of Chloramphenicol

作　　者：杨光梅 管茂东 黄燕 任云伟 陈纯洁 梅艳 郭利群[1,3] YANG Guang-mei;GUAN Mao-dong;HUANG Yan;REN Yun-wei;CHEN Chun-jie;MEI Yan;GUO Li-qun(Yunnan Institute of Science and Yunnan Modern Ethnic Medicine Engineering Technology Research Center,Kunming 650217,China;Yunnan Ethnic Medicine Sub-center of National Traditional Chinese Medicine Modernization Engineering and Technology Research Center,Kunming 650217,China;Yun Botanical Pharmaceutical Co.,Ltd.,Kunming 605109,China)

机构地区：[1]云南省科学技术院云南现代民族药工程技术研究中心,云南昆明650217 [2]国家中药现代化工程技术研究中心民族药分中心,云南昆明650217 [3]云南植物药业有限公司,云南昆明605109

出　　处：《药物生物技术》2023年第2期136-139,共4页Pharmaceutical Biotechnology

基　　金：云南省院士专家工作站(No.202005AF150001,No.202005AF150011);云南省科技厅科技计划项目(No.202003AC100013)。

摘　　要：建立氯霉素原料的无菌检查方法。参照《中国药典》无菌检查法规定薄膜过滤法进行氯霉素无菌检查法适用性试验:精密称取本品150 mg,用500 mL无菌的含0.5%吐温-80的0.9%氯化钠溶液溶解。使用KSF330集菌培养器进行过滤(集菌仪转速为160 r/min),再用0.1%蛋白胨无菌溶液为稀释液分次冲洗滤膜(每筒冲洗量100 mL/次分次冲洗,共10次),按规定加入培养基进行培养、观察。实验结果显示,氯霉素用本法进行无菌检测方法适用性符合要求。本品该检验量在此检验条件下无抑菌作用或已经可以消除了抑菌性,能科学、准确、可靠、有效地检出样品受污染的程度以保证产品质量,为原料控制、产品生产提供无菌保障。经方法学验证,所建立方法能为氯霉素原料无菌检查质量评价提供可靠依据。In order to establish the sterility test method of chloramphenicol raw materials,according to the sterility test of China Pharmacopoeia,the applicability test of sterility test of chloramphenicol was carried out by membrane filtration:150 mg of chloramphenicol was accurately weighed and dissolved in 500 mL of sterile 0.9%sodium chloride solution containing 0.5%Tween-80.Use KSF330 bacteria collector to filter(the rotating speed of the bacteria collector is 160 r/min),then use 0.1%peptone sterile solution as diluent to wash the filter membrane in several times(100 mL/drum,10 times in total),and add the culture medium to culture and observe according to the regulations.The results show that the applicability of this method for sterility test of chloramphenicol meets the requirements.Under this test condition,the test quantity of this product has no bacteriostatic effect or has been eliminated.It can scientifically,accurately,reliably and effectively detect the contaminated degree of the sample to ensure the product quality and provide aseptic guarantee for raw material control and product production.The established method can provide reliable basis for quality evaluation of sterility test of chloramphenicol raw materials.

关 键 词：氯霉素 无菌检查 抑菌作用 培养器 冲洗液 溶解液 薄膜过滤法 

分 类 号：R91[医药卫生—药学]