共查询到15条相似文献，搜索用时 187 毫秒
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为建立盐酸头孢噻呋无菌原料的无菌检查方法，本试验按照方法适用性试验的有关要求，对前处理、冲洗总量等进行了考察。取供试品500mg，加10mL2.6%无菌碳酸钠溶液使溶解，再转移至490mL0.85%无菌氯化钠溶液中，作为供试液按照薄膜过滤法处理，用pH7.0无菌氯化钠-蛋白胨缓冲液为冲洗液，每张滤膜每次冲洗量为100mL，冲洗5次。结果显示，方法适用性试验中，供试品6种阳性菌试验组与阳性菌对照组相比均生长良好，供试品组、阴性对照组均无菌生长，说明供试品在该条件下已消除其抑菌作用，方法合理，结果准确、可靠，可作常规无菌检查法。 相似文献
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本试验旨在对伊维菌素微乳制剂进行无菌检查方法学验证和无菌检查试验,确认本试验所用的方法适用于该制剂的无菌检查。按《中国兽药典》2005版一部(附录118)所载"无菌检查法"项下进行试验,通过对阳性对照菌、不同量冲洗液等条件的选择,采用薄膜过滤法对10瓶供试品(每种试验菌的样品量)进行检测,建立了无菌检查方法。经方法验证,用400mL 0.1%蛋白胨水溶液冲洗后,含供试品容器中的7个阳性菌试验组与阳性菌对照组相比均生长良好,说明供试品的该检验量在该检验条件下无抑菌作用或其抑菌作用可以忽略不计,可以用该方法进行供试品的无菌检查。对3批供试品进行无菌检查,阳性对照菌均在24h内生长良好,阴性对照均澄清,无菌生长,3批供试品均澄清,无菌生长,无菌检查试验结果符合规定。 相似文献
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建立了复方磺胺喹噁啉溶液的微生物限度检验方法。采用薄膜过滤法,通过固定的冲洗量并观察试验菌回收率来确定适宜的检验方法。结果表明,样品在冲洗量为500 mL时对细菌、霉菌无抑制作用。复方磺胺喹噁啉溶液微生物限度检查应采用薄膜过滤法,冲洗量为500mL。 相似文献
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苄星氯唑西林乳房注入剂无菌检查方法研究 总被引：1，自引：1，他引：0
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-80 pH 7.0氯化钠—蛋白胨缓冲液冲洗,冲洗量400 mL/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. 相似文献
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复方阿莫西林乳房注入剂无菌检查方法的确立 总被引：2，自引：0，他引：2
建立了复方阿莫西林乳房注入剂的无菌检查方法。根据《中国兽药典》2010年版一部附录要求,通过比较薄膜过滤法和直接加入法对本品的适用性,最终选用直接加入法作为无菌检查方法,即以每1 mg阿莫西林中加入9000单位的青霉素酶来消除供试品的抑菌活性,并通过无菌方法验证,证明该方法适用于对复方阿莫西林乳房注入剂进行无菌检查。 相似文献
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XING Shou-ye ZHOU Xu-zheng LI Bing NIU Jian-rong WEI Xiao-juan ZHANG Ji-yu 《中国畜牧兽医》2016,43(1):256-260
The assay was aimed to study the sterility test and validation test of ivermectin microemulsion preparation and establish a sterility test method for ivermectin microemulsion preparation.The test method was carried out according to the method in volumeⅠ, Chinese Veterinary Pharmacopoeia Edition 2005.By choosing positive control bacteria and defining washing volumes in sterility test, the membrane-filter method was used to test the quantity of 10 bottles of test samples, and the sterility test was established.The result of method validation test showed that the test and all of positive control bacteria and microorganism growth after each filter being washed with 400 mL 0.1% peptone solution.It illustrated that the samples had no antimicrobial activity under the sample quantity and test condition.This method was available for sterility test of ivermectin microemulsion preparation.Using this method to test three lots test samples, the results showed that the positive control bacteria grew well within 24 h.The negative control bacteria and three lots test samples were sterile.It indicated that sterility test results met the requirements. 相似文献
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Hallberg JW Wachowski M Moseley WM Dame KJ Meyer J Wood SL 《Veterinary therapeutics : research in applied veterinary medicine》2006,7(1):35-42
This study evaluated the efficacy of intramammary infusion of ceftiofur hydrochloride for the treatment of intramammary infections present at the last milking of lactation and for prevention of new intramammary infections during the nonlactating period. Cows were randomly assigned to five treatments (untreated negative control, 125, 250, and 500 mg of ceftiofur, and a positive control group receiving 300 mg cephapirin benzathine). A dose of 125 mg of ceftiofur per mammary quarter was effective for treatment of existing infections present at the time of milk cessation, but only the 500-mg dose of ceftiofur per mammary quarter was effective for both treatment of existing intramammary infections at the time of milk cessation and for prevention of new intramammary infections during the nonlactating period. 相似文献