伊维菌素微乳无菌检查方法学的研究

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。

Study on Sterility Test Method of Ivermectin Microemulsion

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.