苄星氯唑西林乳房注入剂无菌检查方法研究

Study on the Sterility Test Method for Cloxacillin Benzathine Intramammary Infusion

本试验旨在建立苄星氯唑西林乳房注入剂无菌检查法并进行验证。采用离心—薄膜过滤—酶中和相结合的方法,按照《中国兽药典》2010年版一部附录进行试验。结果显示采用离心—薄膜过滤—酶中和相结合的方法,以0.5%聚山梨酯-80pH 7.0氯化钠—蛋白胨缓冲液冲洗,冲洗量400mL/膜,在最后的培养基中加入不少于300万单位的青霉素酶可有效消除样品对各试验菌株的抗菌活性;验证试验结果显示各验证菌生长良好,各供试品管均未见菌生长。结果表明本试验成功建立了可靠、准确、可用于苄星氯唑西林乳房注入剂的无菌检查法。

The assay was aimed to establish and verify the sterility test for cloxacillin benzathine intramammary infusion.Centrifugation-membrane filtration-enzyme neutralization method were used and verified on the basis of the appendix to Veterinary Pharmacopoeia of the People’s Republic of China（2010edition）.The results showed that the antibacterial activity of various strains could be eliminated with centrifugation-membrane filtration-enzyme neutralization method which needed at least 3million units penicillinase and 400 mL 0.5% polysorbate-80 sodium chloride（pH 7.0）-peptone buffer solution as flushing fluid.In validation test,all the test strains grew well and bacteria was not found in the tube of test sample.The results showed that centrifugation-membrane filtration-enzyme neutralization method was an accurate and reliable method,and could be used for sterility test of cloxacillin benzathine intramammary infusion.