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建立硫酸庆大霉素注射液的无菌检查方法。本试验取硫酸庆大霉素注射液,按《中国药典》2005年版二部附录所载的“无菌检查法”项下进行方法学验证试验。结果表明:采用本试验方法进行硫酸庆大霉素注射液的无菌检查,供试品无菌生长,而六株阳性菌生长良好,该方法可行。
To establish a sterile test of gentamicin sulfate injection. This test to take gentamicin sulfate injection, according to “Chinese Pharmacopoeia” 2005 edition of the two appendices contained in the “sterile test method” under the methodological validation test. The results showed that the test method was used to carry out the sterility test of gentamicin sulfate injection for the aseptic growth of the test sample, while the growth of six positive bacteria was good. This method is feasible.