| 复方阿莫西林乳房注入剂无菌检查方法的优化 |
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| 引用本文： | 韩宁宁,彭文绣,王轩,赵晖,杨秀玉,戴青,赵富华.复方阿莫西林乳房注入剂无菌检查方法的优化[J].中国兽药杂志,2023,57(1):32-42. |
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| 作者姓名： | 韩宁宁 彭文绣 王轩 赵晖 杨秀玉 戴青 赵富华 |
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| 作者单位： | 中国兽医药品监察所,,,,,,中国兽医药品监察所 |
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| 基金项目： | 农业行业（国家）标准项目兽药国家标准制修订计划（项目编号：2017H060） |
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| 摘 要： | 将阿莫西林乳房注入剂无菌检查方法由直接接种法优化为薄膜过滤法。采用肉豆蔻酸异丙酯将样品破乳，与pH 6.0磷酸盐缓冲液混合进行萃取，取萃取后的水相薄膜过滤，采用pH 7.0无菌氯化钠-蛋白胨缓冲液进行冲洗，冲洗完毕加入硫乙醇酸盐液体培养基和胰酪大豆胨液体培养基，定量加入青霉素酶破坏残余的阿莫西林，按照规定条件培养。该方法与直接接种法相比，操作简单，可靠性增强，结果判断准确性提高。
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| 关 键 词： | 复方阿莫西林乳房注入剂 无菌 薄膜过滤法 直接接种法 |
| 收稿时间： | 2022/10/19 0:00:00 |
| 修稿时间： | 2023/1/12 0:00:00 |
Optimization of Sterility Test Method of Compound Amoxicillin Intramammary Infusion |
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| Institution: | China Institute of Veterinary Drug Control,,,,,, |
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| Abstract: | The sterility test method of amoxicillin intramammary infusion was optimized from direct inoculation method to membrane filtration method. The sample was demulsified with isopropyl myristate, mixed with pH6.0 phosphate buffer solution for extraction. The aqueous phase was filtered through membrane after extraction. The membrane was washed with pH7.0 sterile sodium chloride-peptone buffer solution, added with thioglycollate liquid medium and tryptophan soybean peptone liquid medium after washing, added penicillin enzyme quantitatively to destroy residual amoxicillin, and cultured according to the specified conditions. Compared with the direct inoculation method, the method is simple, reliable and accurate. |
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| Keywords: | Compound amoxicillin intramammary infusion Sterility test Membrane filtration method Direct inoculation method |
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