| 李敏,龚亚,曹健,等.磺胺嘧啶鱼肝油滴鼻剂微生物限度检查方法的建立[J].安徽医药,2021,25(8):1497-1500. |
| 磺胺嘧啶鱼肝油滴鼻剂微生物限度检查方法的建立 |
| Establishment of microbial limit test method for sulfadiazine fish oil nasal drops |
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| DOI：10.3969/j.issn.1009-6469.2021.08.004 |
| 中文关键词: 磺胺嘧啶鱼肝油滴鼻剂 微生物限度检查 培养基稀释法 中和法 |
| 英文关键词: Sulfadiazine fish oil nasal drops Microbial limit test Dilution method Neutralization method |
| 基金项目:军队医疗机构制剂标准提高科研专项课题( 14ZJZ06-2) |
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| 中文摘要: |
| 目的建立磺胺嘧啶鱼肝油滴鼻剂的微生物限度检查方法。方法按《中国药典》(2015年版)四部规定，采用平皿法、培养基稀释法进行磺胺嘧啶鱼肝油滴鼻剂的微生物计数方法适用性试验，并采用直接接种法、培养基稀释法和中和法进行控制菌检查方法适用性试验。结果所建立的检查方法对金黄色葡萄球菌、铜绿假单胞菌、枯草芽孢杆菌、白色念珠菌、黑曲霉 5种验证菌株的回收率均在 0.50~2.00，控制菌(大肠埃希菌、铜绿假单胞菌、金黄色葡萄球菌)可检出，结果符合中国药典规定。结论磺胺嘧啶鱼肝油滴鼻剂的微生物限度检查中需氧菌采用培养基稀释法(0.2毫升 /皿)，霉菌及酵母菌采用平皿法( 1毫升 /皿)，控制菌检查采用中和法( 0.5%对氨基苯甲酸)进行检查。方法简便可行，结果准确可靠。 |
| 英文摘要: |
| Objective To establish microbial limit test method for sulfadiazine fish oil nasal drops.Methods According to the requirements in Chinese Pharmacopoeia (vol. Ⅳ, 2015 edition), the plate method and the dilution method were used for the applicabilitytest of the microbial count for sulfadiazine fish oil nasal drops, and the direct inoculation method, the medium dilution method and theneutralization method were used for the applicability test of control bacteria.Results The method established had a recovery rate of 0.50-2.00 for five test bacteria, including Staphylococcus aureus, Pseudomonas aeruginosa, Bacillus subtilis, Candida albicans and As? pergillus niger, control bacteria (Escherichia coli, Staphylococcus aureus, Pseudomonas aeruginosa) could be detected, which were consistent with the Chinese pharmacopoeia.Conclusion In the microbial limit test of sulfadiazine fish oil nasal drops, aerobic bacteria areexamined by medium dilution method (0.2 mL/dish), mold and yeast by plate method (1 mL/dish), and the control bacteria are examinedby neutralization method (0.5% p-aminobenzoic acid). The method is simple and feasible, and the result is accurate and reliable. |
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