摘要: |
建立了复方阿莫西林乳房注入剂无菌检查方法。按《中国兽药典》2005年版一部附录进行试验,采用直接加入法,以0.1%聚乙二醇或1%吐温-80的0.1%中性酪蛋白胨灭菌水溶液为稀释液,取样品10g加稀释液200ml,以每1mg阿莫西林中加9000单位的青霉素酶为灭活剂量,可消除样品对各菌株的抗菌活性。复方阿莫西林乳房注入剂可用该方法进行无菌检查。 |
关键词: 乳房注入剂 直接加入法 无菌检查 |
DOI: |
投稿时间:2012-03-31修订日期:2012-07-17 |
基金项目:十一五科技支撑计划(2006BAD31B08) |
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Confirmatory Experiment of Sterility Test Method forCompound Amoxicillin Intramammary Infusion |
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(China Institute of Veterinary Drug Control) |
Abstract: |
A method of sterility test for the compound amoxicillin intramammary infusion was established. The membrane filtration method and the direct inoculation method of sterility test in the appendix of Veterinary Pharmacopoeia of the People′s Republic of China (2010 edition) were used. Finally, the direct inoculation method was adopted. The antibacterial activity of various strains could be eliminated with at least 9000 units penicillinase each 1 milligram amoxicillin. The direct inoculation method was suitable for the sterility test of the compound amoxicillin intramammary infusion. |
Key words: Intramammary Infusion penicillinase sterility test |