盐酸头孢噻呋无菌检查方法的建立

Establishment of the Sterility Test Method for Ceftiofur Hydrochloride

关键词:  盐酸头孢噻呋  无菌检查  薄膜过滤  方法适用性试验

Key words:  ceftiofur hydrochloride  sterility test  membrane filtration  method applicability test

摘要:

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。

Abstract:

In order to establish an sterility test method for sterile material of ceftiofur hydrochloride ,the pretreatment and washing methods were investigated in accordance with the relevant requirements of the method suitability test . Samples were dissolved by 2.6% sterile sodium carbonate solution, then transferred to 0.85% sterile sodium chloride solution. The test solution was treated by membrane filtration and the pH 7.0 sterile sodium chloride-peptone buffer solution was used as the washing solution. Each filter membrane was washed 5 times with a washing capacity of 100 mL. The results showed that the six positive bacteria test groups grew as well as the positive bacteria control group, the test group and the negative control group grew aseptically. These indicated that the test samples had eliminated its bacteriostasis under the test conditions. The sterility test method is reasonable and the results are accurate and reliable, It could be used as a routine aseptic test method for the preparation.