蔗糖铁注射液过滤除菌前配制液的微生物限度检查方法研究

发布时间：2018-10-05 17:05

【摘要】：目的:建立蔗糖铁注射液过滤除菌前配制液的微生物限度检查方法。方法:按照2015版《中国药典》(四部)"通则1005"和"通则1006"微生物限度检查方法,分别采用平皿法和薄膜过滤法检查需氧菌(金黄色葡萄球菌、铜绿假单胞菌、枯草芽孢杆菌、白色念珠菌、黑曲霉)数、霉菌及酵母菌(白色念珠菌、黑曲霉)数,通过比较试验菌回收率来确定适宜的方法,并进行方法验证。结果:以平皿法进行试验,铜绿假单胞菌和枯草芽孢杆菌的回收率分别为2%、5%,用p H 7.0氯化钠-蛋白胨缓冲液稀释样品原液10倍后,试验菌回收率范围为88%～96%,但培养基颜色较深。以薄膜过滤法不加冲洗液进行试验,试验菌回收率范围为88%～95%;加入冲洗液后,试验菌回收率范围为91%～103%。经验证,加入冲洗液的薄膜过滤法回收率为50%～200%,符合规定。结论:本试验建立的薄膜过滤法较平皿法试验菌回收率高且加入冲洗液后,试验菌回收率更高,滤膜表面均无颜色较深的物质残留影响计数,适用于蔗糖铁注射液过滤除菌前配制液的微生物限度检查。
[Abstract]:Objective: to establish a microbiological limit test method for the preparation of iron sucrose injection before filtration and sterilization. Methods: according to the microbiological limit test methods of 2015 edition of Chinese Pharmacopoeia (four parts), "General Rule 1005" and "General Rule 1006", aerobic bacteria (Staphylococcus aureus, Pseudomonas aeruginosa, Bacillus subtilis) were examined by plate method and membrane filtration method, respectively. The number of Candida albicans and Aspergillus Niger, the number of mold and yeast (Candida albicans, Aspergillus Niger) were determined by comparing the recovery rate of the tested bacteria, and the method was verified. Results: the recoveries of Pseudomonas aeruginosa and Bacillus subtilis were 2% and 5%, respectively. After diluting the sample solution with pH 7.0 sodium chloride-peptone buffer solution for 10 times, the recovery rate of Pseudomonas aeruginosa and Bacillus subtilis was 10 times. The recovery rate of the tested bacteria was 88% and 96%, but the color of the culture medium was dark. The results showed that the recovery rate of the bacteria was 88% 95% by membrane filtration without flushing liquid, and 911% 103% after the addition of the washing liquid. It was verified that the recovery rate of the membrane filtration method was 50 ~ 200, which was in accordance with the regulations. Conclusion: the membrane filtration method established in this study has a higher recovery rate than the flat-dish method, and the recovery rate of the tested bacteria is higher than that of the flushing solution, and the surface of the filter membrane does not have the effect of dark color substance residue count. It is suitable for microbial limit examination of the preparation liquid before filtration and sterilization of iron sucrose injection.
【作者单位】：广州中医药大学中药学院;解放军第458医院;广东天普生化医药股份有限公司;
【分类号】：R927.1

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